[Federal Register: November 3, 1999 (Volume 64, Number 212)]
[Proposed Rules]
[Page 59917-59966]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03no99-67]
[[Page 59917]]
_______________________________________________________________________
Part IV
Department of Health and Human Services
_______________________________________________________________________
Office of the Secretary
_______________________________________________________________________
45 CFR Parts 160 Through 164
Standards for Privacy of Individually Identifiable Health Information;
Proposed Rule
[[Page 59918]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
45 CFR Parts 160 through 164
RIN 0991-AB08
Standards for Privacy of Individually Identifiable Health
Information
AGENCY: Office of the Assistant Secretary for Planning and Evaluation,
DHHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This rule proposes standards to protect the privacy of
individually identifiable health information maintained or transmitted
in connection with certain administrative and financial transactions.
The rules proposed below, which would apply to health plans, health
care clearinghouses, and certain health care providers, propose
standards with respect to the rights individuals who are the subject of
this information should have, procedures for the exercise of those
rights, and the authorized and required uses and disclosures of this
information.
The use of these standards would improve the efficiency and
effectiveness of public and private health programs and health care
services by providing enhanced protections for individually
identifiable health information. These protections would begin to
address growing public concerns that advances in electronic technology
in the health care industry are resulting, or may result, in a
substantial erosion of the privacy surrounding individually
identifiable health information maintained by health care providers,
health plans and their administrative contractors. This rule would
implement the privacy requirements of the Administrative Simplification
subtitle of the Health Insurance Portability and Accountability Act of
1996.
DATES: Comments will be considered if received as provided below, no
later than 5 p.m. on January 3, 2000.
ADDRESSES: Submit electronic comments at the following web site: https:/
/aspe.hhs.gov/admnsimp/.
Mail comments (1 original, 3 copies, and, if possible, a floppy
disk ) to the following address: U.S. Department of Health and Human
Services, Assistant Secretary for Planning and Evaluation, Attention:
Privacy-P, Room G-322A, Hubert H. Humphrey Building, 200 Independence
Avenue SW, Washington, DC 20201.
If you prefer, you may deliver your written comments (1 original, 3
copies, and, if possible, a floppy disk) to the following address: Room
442E, 200 Independence Avenue, SW, Washington, DC 20201.
See the SUPPLEMENTARY INFORMATION section for further information
on comment procedures, availability of copies of this document and
electronic access to this document.
FOR FURTHER INFORMATION CONTACT: Roxanne Gibson (202) 260-5083.
SUPPLEMENTARY INFORMATION: Comment procedures, availability of copies,
and electronic access.
Comment procedures: All comments should include the full name,
address and telephone number of the sender or a knowledgeable point of
contact. Written comments should include 1 original and 3 copies. If
possible, please send an electronic version of the comments on a 3\1/2\
inch DOS format floppy disk in Adobe Acrobat Portable Document Format
(PDF) (preferred) HTML (preferred), ASCII text, or popular word
processor format (Microsoft word, Corel WordPerfect).
Because of staffing and resource limitations, we cannot accept
comments by electronic mail or facsimile (FAX) transmission, and all
comments and content are to be limited to the 8.5 wide by 11.0 high
vertical (also referred to as "portrait") page orientation.
Additionally, it is requested that if identical/duplicate comment
submissions are submitted both electronically and in paper form that
each submission clearly indicate that it is a duplicate submission. In
each comment, please specify the section of this proposed rule to which
the comment applies.
Comments received in a timely fashion will be available for public
inspection (by appointment), as they are received, generally beginning
approximately three weeks after publication of a document in Room 442E
of the Department's offices at 200 Independence Avenue, SW.,
Washington, DC 20201 on Monday through Friday of each week from 8:30
a.m. to 5 p.m. (phone: 202-260-5083).
After the close of the comment period, comments submitted
electronically and written comments that we are technically able to
convert will be posted on the Administrative Simplification web site
(https://aspe.hhs.gov/admnsimp/).
Copies: To order copies of the Federal Register containing this
document, send your request to: New Orders, Superintendent of
Documents, PO Box 371954, Pittsburgh, PA 15250-7954. Specify the date
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The cost for each copy is $8.00. As an alternative, you can view and
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libraries throughout the country that receive the Federal Register.
Electronic Access: This document is available electronically at
https://aspe.hhs.gov/admnsimp/ as well as at the web site of the
Government Printing Office at https://www.access.gpo.gov/su__docs/aces/
aces140.html.
I. Background
A. Need for privacy standards.
B. Statutory background.
C. Administrative costs.
D. Consultations.
E. Summary and purpose of the proposed rule.
1. Applicability.
2. General rules.
3. Scalability.
4. Uses and disclosures with individual authorization.
5. Uses and disclosures for treatment, payment and health care
operations.
6. Permissible uses and disclosures for purposes other than
treatment, payment and health care operations.
7. Individual rights.
8. Administrative requirements and policy development and
documentation.
9. Preemption.
10. Enforcement.
11. Conclusion.
II. Provisions of the proposed rule.
A. Applicability.
1. Covered entities.
2. Covered information.
3. Interaction with other standards.
4. References to other laws.
B. Definitions.
1. Act.
2. Covered entity.
3. Health care.
4. Health care clearinghouse.
5. Health care provider.
6. Health information.
7. Health plan.
8. Secretary.
9. Small health plan.
10. Standard.
11. State.
12. Transaction.
13. Business partner.
14. Designated record set.
15. Disclosure.
16. Health care operations.
17. Health oversight agency.
18. Individual. 419. Individually identifiable health
information.
20. Law enforcement official.
21. Payment.
22. Protected health information.
23. Psychotherapy notes.
24. Public health authority.
25. Research.
[[Page 59919]]
26. Research information unrelated to treatment.
27. Treatment.
28. Use.
29. Workforce.
C. General rules.
1. Use and disclosure for treatment, payment, and health care
operations.
2. Minimum necessary use and disclosure.
3. Right to restrict uses and disclosures.
4. Creation of de-identified information.
5. Application to business partners.
6. Application to information about deceased persons.
7. Adherence to the notice of information practices.
8. Application to covered entities that are components of
organizations that are not covered entities.
D. Uses and disclosures with individual authorization.
1. Requirements when the individual has initiated the
authorization.
2. Requirements when the covered entity initiates the
authorization.
3. Model forms.
4. Plain language requirement.
5. Prohibition on conditioning treatment or payment.
6. Inclusion in the accounting for uses and disclosures.
7. Revocation of an authorization by the individual.
8. Expired, deficient, or false authorization.
E. Uses and disclosures permitted without individual
authorization.
1. Uses and disclosures for public health activities.
2. Use and disclosure for health oversight activities.
3. Use and disclosure for judicial and administrative
proceedings.
4. Disclosure to coroners and medical examiners.
5. Disclosure for law enforcement.
6. Uses and disclosure for governmental health data systems.
7. Disclosure of directory information.
8. Disclosure for banking and payment processes.
9. Uses and disclosures for research.
10. Uses and disclosures in emergency circumstances.
11. Disclosure to next-of-kin.
12. Additional uses and disclosures required by other law.
13. Application to specialized classes.
F. Rights of individuals.
1. Rights and procedures for a written notice of information
practices.
2. Rights and procedures for access for inspection and copying.
3. Rights and procedures with respect to an accounting of
disclosures.
4. Rights and procedures for amendment and correction.
G. Administrative requirements.
1. Designation of a privacy official.
2. Training.
3. Safeguards.
4. Internal complaint process.
5. Sanctions.
6. Duty to mitigate.
H. Development and documentation of policies and procedures.
1. Uses and disclosures of protected health information.
2. Individual requests for restricting uses and disclosures.
3. Notice of information practices.
4. Inspection and copying.
5. Amendment or correction.
6. Accounting for disclosures.
7. Administrative requirements.
8. Record keeping requirements.
I. Relationship to other laws
1. Relationship to State laws.
2. Relationship to other federal laws.
J. Compliance and Enforcement.
1. Compliance
2. Enforcement.
III. Small Business Assistance
1. Notice to individuals of information practices.
2. Access of individuals to protected health information.
3. Accounting for uses and disclosures.
4. Amendment and correction.
5. Designated Privacy official.
6. Training.
7. Safeguards.
8. Complaints.
9. Sanctions.
10. Documentation of policies and procedures.
11. Minimum Necessary.
12. Business partners.
13. Special disclosures that do not require authorization--
public health, research, etc.
14. Verification.
IV. Preliminary Regulatory Impact Analysis
A. Relationship of this Analysis to Analyses in Other HIPAA
Regulations.
B. Summary of Costs and Benefits.
C. Need for the Proposed Action.
D. Baseline Privacy Protections.
1. Professional Codes of Conduct and the Protection of Health
Information.
2. State Laws.
3. Federal Laws.
E. Costs.
F. Benefits.
G. Examination of Alternative Approaches.
1. Creation of de-identified information.
2. General rules.
3. Use and disclosure for treatment, payment, and health care
operations.
4. Minimum necessary use and disclosure.
5. Right to restrict uses and disclosures.
6. Application to business partners.
7. Application to information about deceased persons.
8. Uses and disclosures with individual authorization.
9. Uses and disclosures permitted without individual
authorization.
10. Clearinghouses and the rights of individuals.
11. Rights and procedures for a written notice of information
practices.
12. Rights and procedures for access for inspection and copying.
13. Rights and procedures with respect to an accounting of
disclosures.
14. Rights and procedures for amendment and correction.
15. Administrative requirements.
16. Development and documentation of policies and procedures.
17. Compliance and Enforcement.
V. Initial Regulatory Flexibility Analysis
A. Introduction.
B. Economic Effects on Small Entities
1. Number and Types of Small Entities Affected.
2. Activities and Costs Associated with Compliance.
3. The burden on a typical small business.
VI. Unfunded Mandates
A. Future Costs.
B. Particular regions, communities, or industrial sectors.
C. National productivity and economic growth.
D. Full employment and job creation.
E. Exports.
VII. Environmental Impact
VIII. Collection of Information Requirements
IX. Executive Order 12612: Federalism
X. Executive Order 13086: Consultation and Coordination with Indian
Tribal Governments
List of Subjects in 45 CFR Parts 160 and 164
Appendix: Sample Provider Notice of Information Practices
I. Background
A. Need for Privacy Standards.
[Please label comments about this section with the subject: "Need
for privacy standards"]
The maintenance and exchange of individually identifiable health
information is an integral component of the delivery of quality health
care. In order to receive accurate and reliable diagnosis and
treatment, patients must provide health care professionals with
accurate, detailed information about their personal health, behavior,
and other aspects of their lives. Health care providers, health plans
and health care clearinghouses also rely on the provision of such
information to accurately and promptly process claims for payment and
for other administrative functions that directly affect a patient's
ability to receive needed care, the quality of that care, and the
efficiency with which it is delivered.
Individuals who provide information to health care providers and
health plans increasingly are concerned about how their information is
used within the health care system. Patients want to know that their
sensitive information will be protected not only during the course of
their treatment but also in the future as that information is
maintained and/or transmitted within and outside of the health care
system. Indeed, a Wall Street Journal/ABC poll on September 16, 1999
asked Americans what concerned them most in the coming century. "Loss
of personal privacy" was the first or second concern of 29 percent of
respondents. All other issues, such a terrorism, world war, and global
warming had scores of 23 percent or less.
Efforts to provide legal protection against the inappropriate use
of individually identifiable health
[[Page 59920]]
information have been, to date, undertaken primarily by the States.
States have adopted a number of laws designed to protect patients
against the inappropriate use of health information. A recent survey of
these laws indicates, however, that these protections are quite uneven
and leave large gaps in their protection. See Health Privacy Project,
"The State of Health Privacy: An Uneven Terrain," Institute for
Health Care Research and Policy, Georgetown University (July 1999)
(https://www.healthprivacy.org).
A clear and consistent set of privacy standards would improve the
effectiveness and the efficiency of the health care system. The number
of entities who are maintaining and transmitting individually
identifiable health information has increased significantly over the
last 10 years. In addition, the rapid growth of integrated health care
delivery systems requires greater use of integrated health information
systems. The expanded use of electronic information has had clear
benefits for patients and the health care system as a whole. Use of
electronic information has helped to speed the delivery of effective
care and the processing of billions of dollars worth of health care
claims. Greater use of electronic data has also increased our ability
to identify and treat those who are at risk for disease, conduct vital
research, detect fraud and abuse, and measure and improve the quality
of care delivered in the U.S.
The absence of national standards for the confidentiality of health
information has, however, made the health care industry and the
population in general uncomfortable about this primarily financially
driven expansion in the use of electronic data. Many plans, providers,
and clearinghouses have taken steps to safeguard the privacy of
individually-identifiable health information. Yet they must currently
rely on a patchwork of State laws and regulations that are incomplete
and, at times, inconsistent. The establishment of a consistent
foundation of privacy standards would, therefore, encourage the
increased and proper use of electronic information while also
protecting the very real needs of patients to safeguard their privacy.
The use of these standards will most clearly benefit patients who
are, in increasing numbers, indicating that they are apprehensive about
the use and potential use of their health information for inappropriate
purposes. A national survey released in January 1999 indicated that
one-fifth of Americans already believe that their personal health
information has been used inappropriately. See California HealthCare
Foundation, "National Survey: Confidentiality of Medical Records,"
January 1999 (conducted by Princeton Survey Research Associates)
(https://www.chcf.org). Of even greater concern, one-sixth of
respondents indicated that they had taken some form of action to avoid
the misuse of their information, including providing inaccurate
information, frequently changing physicians, or avoiding care. The use
of these standards will help to restore patient confidence in the
health care system, providing benefits to both patients and those who
serve them.
In order to administer their plans and provide services, private
and public health plans, health care providers, and health care
clearinghouses must assure their customers (such as patients, insurers,
providers, and health plans) that the health care information they
collect, maintain, use, or transmit will remain confidential. The
protection of this information is particularly important where it is
individually identifiable. Individuals have an important and legitimate
interest in the privacy of their health information, and that interest
is threatened where there is improper use or disclosure of the
information. The risk of improper uses and disclosures has increased as
the health care industry has begun to move from primarily paper-based
information systems to systems that operate in various electronic
forms. The ease of information collection, organization, retention, and
exchange made possible by the advances in computer and other electronic
technology afford many benefits to the health care industry and
patients. At the same time, these advances have reduced or eliminated
many of the logistical obstacles that previously served to protect the
confidentiality of health information and the privacy interests of
individuals.
Congress recognized the need for minimum national health care
privacy standards to protect against inappropriate use of individually
identifiable health information by passing the Health Insurance
Portability and Accountability Act of 1996 (HIPAA), Public Law 104-191,
which called for the enactment of a privacy statute within three years
of the date of enactment. The legislation also called for the Secretary
of Health and Human Services to develop and send to the Congress
recommendations for protecting the confidentiality of health care
information, which she did on September 11, 1997. The Congress further
recognized the importance of such standards by providing the Secretary
of Health and Human Services with authority to promulgate health
privacy regulations in lieu of timely action by the Congress. The need
for patient privacy protection also was recognized by the President's
Advisory Commission on Consumer Protection and Quality in the Health
Care Industry in its recommendations for a Consumer Bill of Rights and
Responsibilities (November, 1997).
B. Statutory Background.
[Please label comments about this section with the subject:
"Statutory background"]
The Congress addressed the opportunities and challenges presented
by the health care industry's increasing use of and reliance on
electronic technology in the Health Insurance Portability and
Accountability Act of 1996 (HIPAA), Public Law 104-191, which was
enacted on August 21, 1996. Sections 261 through 264 of HIPAA are known
as the Administrative Simplification provisions. The major part of
these Administrative Simplification provisions are found at section 262
of HIPAA, which enacted a new part C of title XI of the Social Security
Act (hereinafter we refer to the Social Security Act as the "Act" and
we refer to all other laws cited in this document by their names).
In section 262, Congress recognized and sought to facilitate the
efficiencies and cost savings for the health care industry that the
increasing use of electronic technology affords. Thus, section 262
directs HHS to issue standards to facilitate the electronic exchange of
information with respect to financial and administrative transactions
carried out by health plans, health care clearinghouses, and health
care providers who transmit electronically in connection with such
transactions. HHS proposed such standards in a series of Notices of
Proposed Rulemaking (NPRM) published on May 7, 1998 (63 FR 25272 and
25320), and June 16, 1998 (63 FR 32784). At the same time, Congress
recognized the challenges to the confidentiality of health information
presented by the advances in electronic technology and communication.
Section 262 thus also directs HHS to develop standards to protect the
security, including the confidentiality and integrity, of such
information. HHS issued an NPRM proposing security standards on August
12, 1998 (63 FR 43242).
Congress has recognized that privacy standards must accompany the
electronic data interchange standards and that the increased ease of
transmitting and sharing individually
[[Page 59921]]
identifiable health information must be accompanied by an increase in
the privacy and confidentiality. In fact, a significant portion of the
first Administrative Simplification section that was debated on the
floor of the Senate in 1994 (as part of the Health Security Act) was
made up of privacy provision. Although the requirement for the issuance
of concomitant privacy standards remained as part of the bill passed by
the House of Representatives, in conference the requirement for privacy
standards was removed from the standard-setting authority of title XI
(section 1173 of the Act) and placed in a separate section of HIPAA,
section 264. Subsection (b) of section 264 required the Secretary of
HHS to develop and submit to the Congress recommendations for:
(1) The rights that an individual who is a subject of
individually identifiable health information should have.
(2) The procedures that should be established for the exercise
of such rights.
(3) The uses and disclosures of such information that should be
authorized or required.
The Secretary's Recommendations were submitted to the Congress on
September 11, 1997, and are summarized below. Section 264(c)(1)
provides that:
If legislation governing standards with respect to the privacy
of individually identifiable health information transmitted in
connection with the transactions described in section 1173(a) of the
Social Security Act (as added by section 262) is not enacted by
(August 21, 1999), the Secretary of Health and Human Services shall
promulgate final regulations containing such standards not later
than (February 21, 2000). Such regulations shall address at least
the subjects described in subsection (b).
As the Congress did not enact legislation governing standards with
respect to the privacy of individually identifiable health information
prior to August 21, 1999, HHS has now, in accordance with this
statutory mandate, developed proposed rules setting forth standards to
protect the privacy of such information.
These privacy standards have been, and continue to be, an integral
part of the suite of Administrative Simplification standards intended
to simplify and improve the efficiency of the administration of our
health care system.
Part C of title XI consists of sections 1171 through 1179 of the
Act. These sections define various terms and impose several
requirements on HHS, health plans, health care clearinghouses, and
health care providers who conduct the identified transactions
electronically.
The first section, section 1171 of the Act, establishes definitions
for purposes of part C of title XI for the following terms: code set,
health care clearinghouse, health care provider, health information,
health plan, individually identifiable health information, standard,
and standard setting organization.
Section 1172 of the Act makes the standard adopted under part C
applicable to: (1) Health plans, (2) health care clearinghouses, and
(3) health care providers who transmit health information in electronic
form in connection with transactions referred to in section 1173(a)(1)
of the Act (hereinafter referred to as the "covered entities").
Section 1172 also contains requirements concerning the adoption of
standards, including the role of standard setting organizations and
required consultations, summarized below.
Section 1173 of the Act requires the Secretary to adopt standards
for transactions, and data elements for such transactions, to enable
health information to be exchanged electronically. Section 1173(a)(1)
describes the transactions that are covered, which include the nine
transactions listed in section 1173(a)(2) and other transactions
determined appropriate by the Secretary. The remainder of section 1173
sets out requirements for the specific standards the Secretary is to
adopt: unique health identifiers, code sets, security standards,
electronic signatures, and transfer of information among health plans.
Of particular relevance to this proposed rule is section 1173(d), the
security standard provision. The security standard authority applies to
both the transmission and the maintenance of health information and
requires the entities described in section 1172(a) to maintain
reasonable and appropriate safeguards to ensure the integrity and
confidentiality of the information, protect against reasonably
anticipated threats or hazards to the security or integrity of the
information or unauthorized uses or disclosures of the information, and
to ensure compliance with part C by the entity's officers and
employees.
In section 1174 of the Act, the Secretary is required to establish
standards for all of the above transactions, except claims attachments,
by February 21, 1998. A proposed rule for most of the transactions was
published in 1998 with the final rule expected by the end of 1999. The
delay was caused by the deliberate consensus building process working
with industry and the large number of comments received (about 17,000).
Generally, after a standard is established, it may not be changed
during the first year after adoption except for changes that are
necessary to permit compliance with the standard. Modifications to any
of these standards may be made after the first year, but not more
frequently than once every 12 months. The Secretary also must ensure
that procedures exist for the routine maintenance, testing, enhancement
and expansion of code sets and that there are crosswalks from prior
versions.
Section 1175 of the Act prohibits health plans from refusing to
process, or from delaying processing of, a transaction that is
presented in standard format. It also establishes a timetable for
compliance: each person to whom a standard or implementation
specification applies is required to comply with the standard within 24
months (or 36 months for small health plans) of its adoption. A health
plan or other entity may, of course, comply voluntarily before the
effective date. The section also provides that compliance with
modifications to standards or implementation specifications must be
accomplished by a date designated by the Secretary, which date may not
be earlier than 180 days from the notice of change.
Section 1176 of the Act establishes civil monetary penalties for
violation of the provisions in part C of title XI of the Act, subject
to several limitations. Penalties may not be more than $100 per person
per violation and not more than $25,000 per person for violations of a
single standard for a calendar year. The procedural provisions of
section 1128A of the Act apply to actions taken to obtain civil
monetary penalties under this section.
Section 1177 establishes penalties for any person that knowingly
uses a unique health identifier, or obtains or discloses individually
identifiable health information in violation of the part. The penalties
include: (1) A fine of not more than $50,000 and/or imprisonment of not
more than 1 year; (2) if the offense is "under false pretenses," a
fine of not more than $100,000 and/or imprisonment of not more than 5
years; and (3) if the offense is with intent to sell, transfer, or use
individually identifiable health information for commercial advantage,
personal gain, or malicious harm, a fine of not more than $250,000 and/
or imprisonment of not more than 10 years. We note that these penalties
do not affect any other penalties that may be imposed by other federal
programs.
[[Page 59922]]
Under section 1178 of the Act, the requirements of part C, as well
as any standards or implementation specifications adopted thereunder,
preempt contrary State law. There are three exceptions to this general
rule of preemption: State laws that the Secretary determines are
necessary for certain purposes set forth in the statute; State laws
that the Secretary determines address controlled substances; and State
laws relating to the privacy of individually identifiable health
information that are contrary to and more stringent than the federal
requirements. There also are certain areas of State law (generally
relating to public health and oversight of health plans) that are
explicitly carved out of the general rule of preemption and addressed
separately.
Section 1179 of the Act makes the above provisions inapplicable to
financial institutions or anyone acting on behalf of a financial
institution when "authorizing, processing, clearing, settling,
billing, transferring, reconciling, or collecting payments for a
financial institution." Finally, as explained above, section 264
requires the Secretary to issue standards with respect to the privacy
of individually identifiable health information transmitted in
connection with the transactions described in section 1173(a)(1).
Section 264 also contains a preemption provision that provides that
contrary provisions of State laws that are more stringent than the
federal standards, requirements, or implementation specifications will
not be preempted.
C. Administrative Costs
Section 1172(b) of the Act provides that "(a)ny standard adopted
under this part (part C of title XI of the Act) shall be consistent
with the objective of reducing the administrative costs of providing
and paying for health care." As is more fully discussed in the
Regulatory Impact and Regulatory Flexibility analyses below, we
recognize that the proposed privacy standards would entail substantial
initial and ongoing administrative costs for entities subject to the
rules. However, as the analyses also indicate, even if the rules
proposed below are considered in isolation, they should produce
administrative and other cost savings that should more than offset such
costs on a national basis. It is also the case that the privacy
standards, like the security standards authorized by section 1173(d) of
the Act, are necessitated by the technological advances in information
exchange that the remaining Administrative Simplification standards
facilitate for the health care industry. The same technological
advances that make possible enormous administrative cost savings for
the industry as a whole have also made it possible to breach the
security and privacy of health information on a scale that was
previously inconceivable. The Congress recognized that adequate
protection of the security and privacy of health information is a sine
qua non of the increased efficiency of information exchange brought
about by the electronic revolution, by enacting the security and
privacy provisions of the law. Thus, even if the rules proposed below
were to impose net costs, which we do not believe they do, they would
still be "consistent with" the objective of reducing administrative
costs for the health care system as a whole.
D. Consultations
[Please label comments about this section with the subject:
"Consultations"]
The Congress explicitly required the Secretary to consult with
specified groups in developing the standards under sections 262 and
264. Section 264(d) of HIPAA specifically requires the Secretary to
consult with the National Committee on Vital and Health Statistics
(NCVHS) and the Attorney General in carrying out her responsibilities
under the section. Section 1172(b)(3) of the Act, which was enacted by
section 262, requires that, in developing a standard under section 1172
for which no standard setting organization has already developed a
standard, the Secretary must, before adopting the standard, consult
with the National Uniform Billing Committee (NUBC), the National
Uniform Claim Committee (NUCC), the Workgroup for Electronic Data
Interchange (WEDI), and the American Dental Association (ADA). Section
1172(f) also requires the Secretary to rely on the recommendations of
the NCVHS and consult with other appropriate federal and State agencies
and private organizations.
We engaged in the required consultations including the Attorney
General, NUBC, NUCC, WEDI and the ADA. We consulted with the NCVHS in
developing the Recommendations, upon which this proposed rule is based.
In addition we are continuing to consult with this committee by
requesting the committee to review this proposed rule and provide
comments, and recommendations will be taken into account in developing
the final regulation. We consulted with representatives of the National
Congress of American Indians, the National Indian Health Board, and the
self governance tribes. We also met with representatives of the
National Governors' Association, the National Conference of State
Legislatures, the National Association of Public Health Statistics and
Information Systems, and a number of other State organizations to
discuss the framework for the proposed rule, issues of special
interests to the States, and the process for providing comments on the
proposed rule.
In addition to the required consultations, we met with numerous
individuals, entities, and agencies regarding the regulation, with the
goal of making these standards as compatible as possible with current
business practices, while still enhancing privacy protection. Relevant
federal agencies participated in an interagency working group, with
additional representatives from all operating divisions and many staff
offices of HHS. The following federal agencies and offices were
represented on the interagency working group: the Department of
Justice, the Department of Commerce, the Social Security
Administration, the Department of Defense, the Department of Veterans
Affairs, the Department of Labor, the Office of Personnel Management,
and the Office of Management and Budget. The interagency working group
developed the policies of the proposed rules set forth below.
E. Summary and Purpose of the Proposed Rule
[Please label comments about this section with the subject:
"Summary and purpose"]
The following outlines the provisions and operations of this
proposed rule and is intended to provide a framework for the following
preamble. A more detailed discussion of the authority, rationale, and
implementation can be found in Section II of the preamble, Provisions
of the Proposed Rule.
As described in more detail in preamble section I.B, above, the
HIPAA requires the Secretary of HHS to promulgate a series of standards
relating to the electronic exchange of health information. Collectively
these are known as the Administrative Simplification provisions. In
addition to those standards, the Secretary was required to develop and
submit to the Congress recommendations for the privacy rights that an
individual who is a subject of individually identifiable health
information should have, the procedures that should be established for
the exercise of such rights, and the
[[Page 59923]]
uses and disclosures of such information that should be authorized.
On September 11, 1997, the Secretary presented to the Congress her
Recommendations for protecting the "Confidentiality of Individually-
Identifiable Health Information" (the "Recommendations"), as
required by section 264 (a) of HIPAA. In those Recommendations, the
Secretary called for new federal legislation to create a national floor
of standards that provide fundamental privacy rights for patients, and
that define responsibilities for those who use and disclose
identifiable health information.
The Recommendations elaborated on the components that should be
included in privacy legislation. These components included new
restrictions on the use and disclosure of health information, the
establishment of new consumer rights, penalties for misuse of
information, and redress for those harmed by misuse of their
information. The Recommendations served, to the extent possible under
the HIPAA legislative authority, as a template for the rules proposed
below. They are available on the HHS website at https://aspe.hhs.gov/
admnsimp/pvcrec.htm.
The Secretary's Recommendations set forth the a framework for
federal privacy legislation. Such legislation should:
Allow for the smooth flow of identifiable health
information for treatment, payment, and related operations, and for
specified additional purposes related to health care that are in the
public interest.
Prohibit the flow of identifiable information for any
additional purposes, unless specifically and voluntarily authorized by
the subject of the information.
Put in place a set of fair information practices that
allow individuals to know who is using their health information, and
how it is being used.
Establish fair information practices that allow
individuals to obtain access to their records and request amendment of
inaccurate information.
Require persons who hold identifiable health information
to safeguard that information from inappropriate use or disclosure.
Hold those who use individually identifiable health
information accountable for their handling of this information, and to
provide legal recourse to persons harmed by misuse.
We believed then, and still believe, that there is an urgent need
for legislation to establish comprehensive privacy standards for all
those who pay and provide for health care, and those who receive
information from them.
This proposed rule implements many of the policies set forth in the
Recommendations. However, the HIPAA legislative authority is more
limited in scope than the federal statute we recommend, and does not
always permit us to propose the policies that we believe are optimal.
Our major concerns with the scope of the HIPAA authority include the
limited number of entities to whom the proposed rule would be
applicable, and the absence of strong enforcement provisions and a
private right of action for individuals whose privacy rights are
violated.
The Recommendations call for legislation that applies to health
care providers and payers who obtain identifiable health information
from individuals and, significantly, to those who receive such
information from providers and payers. The Recommendations follow
health information from initial creation by a health plan or health
care provider, through various uses and disclosures, and would
establish protections at each step: "We recommend that everyone in
this chain of information handling be covered by the same rules."
However, the HIPAA limits the application of our proposed rule to
health plans, health care clearinghouses, and to any health care
provider who transmits health information in electronic form in
connection with transactions referred to in section 1173(a)(1) of the
Act (the "covered entities"). Unfortunately, this leaves many
entities that receive, use and disclose protected health information
outside of the system of protection that we propose to create.
In particular, the proposed regulation does not directly cover many
of the persons who obtain identifiable health information from the
covered entities. In this proposed rule we are, therefore, faced with
creating new regulatory permissions for covered entities to disclose
health information, but cannot directly put in place appropriate
restrictions on how many likely recipients of such information may use
and re-disclose such information. For example, the Secretary's
Recommendations proposed that protected health information obtained by
researchers not be further disclosed except for emergency
circumstances, for a research project that meets certain conditions,
and for oversight of research. In this proposed rule, however, we
cannot impose such restrictions. Additional examples of persons who
receive this information include workers compensation carriers,
researchers, life insurance issuers, employers and marketing firms. We
also do not have the authority to directly regulate many of the persons
that covered entities hire to perform administrative, legal,
accounting, and similar services on their behalf, and who would obtain
health information in order to perform their duties. This inability to
directly address the information practices of these groups leaves an
important gap in the protections provided by the proposed rule.
In addition, only those providers who engage in the electronic
administrative simplification transactions can be covered by this rule.
Any provider who maintains a solely paper information system would not
be subject to these privacy standards, thus leaving another gap in the
system of protection we propose to create.
The need to match a regulation limited to a narrow range of covered
entities with the reality of information sharing among a wide range of
entities leads us to consider limiting the type or scope of the
disclosures permitted under this regulation. The disclosures we propose
to allow in this rule are, however, necessary for smooth operation of
the health care system and for promoting key public goals such as
research, public health, and law enforcement. Any limitation on such
disclosures could do more harm than good.
Requirements to protect individually identifiable health
information must be supported by real and significant penalties for
violations. We recommend federal legislation that would include
punishment for those who misuse personal health information and redress
for people who are harmed by its misuse. We believe there should be
criminal penalties (including fines and imprisonment) for obtaining
health information under false pretenses, and for knowingly disclosing
or using protected health information in violation of the federal
privacy law. We also believe that there should be civil monetary
penalties for other violations of the law and that any individual whose
rights under the law have been violated, whether negligently or
knowingly, should be permitted to bring an action for actual damages
and equitable relief. Only if we put the force of law behind our
rhetoric can we expect people to have confidence that their health
information is protected, and ensure that those holding health
information will take their responsibilities seriously.
In HIPAA, Congress did not provide such enforcement authority.
There is no private right of action for individuals to enforce their
rights, and we are concerned that the penalty structure
[[Page 59924]]
does not reflect the importance of these privacy protections and the
need to maintain individuals' trust in the system. For these and other
reasons, we continue to call for federal legislation to ensure that
privacy protection for health information will be strong and
comprehensive.
1. Applicability
a. Entities covered. Under section 1172(a) of the Act, the
provisions of this proposed rule apply to health plans, health care
clearinghouses, and to any health care provider who transmits health
information in electronic form in connection with transactions referred
to in section 1173(a)(1) of the Act (the "covered entities"). The
terms health plan, health care provider, and health care clearinghouse
are defined in proposed Sec. 160.103.
As noted above, because we do not have the authority to apply these
standards directly to any entity that is not a covered entity, the
proposed rule does not directly cover many of the persons who obtain
identifiable health information from the covered entities. Examples of
persons who receive this information include contractors, third-party
administrators, researchers, public health officials, life insurance
issuers, employers and marketing firms. We would attempt to fill this
gap in our legislative authority in part by requiring covered entities
to apply many of the provisions of rule to the entities with whom they
contract for administrative and other services. The proposed provision
is outlined in more detail below in the discussion of business
partners.
b. Protected health information. We propose to apply the
requirements of this rule to the subset of individual identifiable
health information which is maintained or transmitted by covered
entities and which is or has been in electronic form. The provisions of
the rule would apply to the information itself, referred to as
protected health information in this rule, and not to the particular
records in which the information is contained. Once information has
been maintained or transmitted electronically by a covered entity, the
protections would follow the information in whatever form, including
paper records, in which it exists (while it is held by a covered
entity).
We understand that our proposal would create a situation in which
some health information would be protected while other similar
information (e.g., health information contained in paper records that
has not been maintained or transmitted electronically) would not be
protected. We are concerned about the potential confusion that such a
system might entail, but we believe that applying the provisions of the
rule to information only in electronic form would result in no real
protection for health care consumers. We have requested comment on
whether we should extend the scope of the rule to all individually
identifiable health information, including purely paper records,
maintained by covered entities. Although we are concerned that
extending our regulatory coverage to all records might be inconsistent
with the intent of the provisions in the HIPAA, we believe that we do
have the authority to do so and that there are sound rationale for
providing a consistent level of protection to all individually
identifiable health information held by covered entities.
2. General Rules
The purpose of our proposal is to define and limit the
circumstances in which an individual's protected heath information may
be used or disclosed by others. We are proposing to make the use and
exchange of protected health information relatively easy for health
care purposes, and more difficult for purposes other than health care.
Covered entities would be prohibited from using or disclosing
protected health information except as provided in the proposed rule.
Under the rule, covered entities could use or disclose protected health
information with individual authorization, as provided in proposed
Sec. 164.508. Covered entities could use or disclose protected health
information without authorization for treatment, payment and health
care operations, as provided in Sec. 164.506(a). (The terms
"treatment," "payment" and "health care operations" are defined
in proposed Sec. 164.504). Covered entities also would be permitted to
use or disclose a patient's protected health information without
authorization for specified public and public policy-related purposes,
including public health, research, health oversight, law enforcement,
and use by coroners, as provided in proposed Sec. 164.510. Covered
entities would be permitted to use and disclose protected health
information when required to do so by other law, such as mandatory
reporting under state law or pursuant to a search warrant.
Covered entities would be required by this rule to disclose
protected health information for only two purposes: to permit
individuals to inspect and copy protected health information about
them, pursuant to proposed Sec. 164.514, and for enforcement of this
rule pursuant to proposed Sec. 164.522.
Under our proposal, most uses and disclosures of an individual's
protected health information would not require explicit authorization
by the individual, but would be restricted by the provisions of the
rule. As discussed in section II.C. of this preamble, we propose to
substitute regulatory protections for the pro forma authorizations that
are used today. The rules would create a sphere of privacy protection
that includes covered entities who engage in treatment or payment, and
the business partners they hire to assist them. While written consent
for these activities would not be required, new restrictions on both
internal uses and external disclosures would be put in place to protect
the information.
Our proposal is based on the principle that a combination of strict
limits on how plans and providers can use and disclose identifiable
health information, adequate notice to patients about how such
information will be used, and patients' rights to inspect, copy and
amend protected health information about them, will provide patients
with better privacy protection and more effective control over the
dissemination of their information than alternative approaches to
patient protection and control.
A central aspect of this proposal is the principle of "minimum
necessary" disclosure. (See proposed Sec. 164.506(a)). With certain
exceptions, permitted uses and disclosures of protected health
information would be restricted to the minimum amount of information
necessary to accomplish the purpose for which the information is used
or disclosed, taking into consideration practical and technological
limitations (including the size and nature of the covered entity's
business) and costs. While we recognize that there are legitimate uses
of protected health information for which patient authorization should
not be required, the privilege of this access carries with it an
obligation to safeguard the information. Covered entities would be
required to take steps to limit the amount of protected health
information used or disclosed to the information necessary to meet the
purpose of the use or disclosure. These policies could include limiting
access to the information to a subset of employees who need to use the
information in the course of their work, and limiting the amount of
information disclosed from a record to the information needed by the
recipient to fulfill the purpose of the disclosure.
We propose that individuals be able to request that a covered
entity restrict the protected health information that
[[Page 59925]]
results from that encounter (with the exception of encounters for
emergency treatment) from further use or disclosure for treatment,
payment, and health care operations. (See proposed Sec. 164.506(c)).
Covered entities would not be required to agree to restrictions
requested by individuals; the rule would only enforce a restriction
that has been agreed to by the covered entity and the individual.
Today's health care system is a complex business involving multiple
individuals and organizations engaging in a variety of commercial
relationships. An individual's privacy should not be compromised when a
covered entity engages in such normal business relationships. To
accomplish this result, the rule would, with narrow exceptions, require
covered entities to ensure that the business partners with which they
share protected health information understand--through contract
requirements " that they are subject to standards regarding use and
disclosure of protected health information and agree to abide by such
rules. (See proposed Sec. 164.506(e)). Other than for purposes of
treatment consultation or referral, we would require a contract to
exist between the covered entity and the business partner that would,
among other specified provisions, limit the business partner's uses and
disclosures of protected health information to those permitted by the
contract and would impose certain security, inspection and reporting
requirements on the business partner.
We do not intend to interfere with business relationships in the
health care industry, but rather to ensure that the privacy of the
information shared in these relationships is protected. Business
partners would not be permitted to use or disclose protected health
information in ways that would not be permitted by the covered entity
itself.
3. Scalability
The privacy standards would need to be implemented by all covered
entities, from the smallest provider to the largest, multi-state health
plan. For this reason, we propose the privacy principles and standards
that covered entities must meet, but leave the detailed policies and
procedures for meeting these standards to the discretion of each
covered entity. We intend that implementation of these standards be
flexible and scalable, to account for nature of each covered entity's
business, as well as the covered entity's size and resources. A single
approach to implementation of these requirements would be neither
economically feasible nor effective in safeguarding health information
privacy. Instead, we would require that each covered entity assess its
own needs and devise and implement privacy policies appropriate to its
size, its information practices, and its business requirements.
Examples of how implementation of these standards are scalable are
provided in the relevant sections of this preamble. (See, also, the
discussion in preamble sections II.C. and III.)
4. Uses and Disclosures With Individual Authorization
The rule would require that covered entities have authorization
from individuals before using or disclosing their protected health
information for any purpose not otherwise recognized by this rule. In
Sec. 164.508, we propose rules for obtaining authorizations.
Authorizations are needed in a wide array of circumstances. Entities
not covered by this rule often want access to individually identifiable
health information . For example, a potential employer may require
health information as part of a background check for security purposes,
or the patient may request a plan or provider to disclose information
to obtain eligibility for disability benefits or to an attorney for use
in a law suit. Covered entities may also seek such an authorization in
order to use protected health information for a purpose not otherwise
permitted under this rule. For example, a health plan may wish to use a
person's records for developing a marketing strategy.
The proposed authorization requirements are intended to ensure that
an individual's authorization is truly voluntary. We would prohibit
covered entities from conditioning treatment or payment on the
individual agreeing to disclose information for other purposes. We also
would require authorizations to clearly and specifically describe the
information to be disclosed. If an authorization is sought so that a
covered entity may sell, barter, or otherwise exchange the information
for purposes other than treatment, payment, or health care operations,
the covered entity would have to disclose this fact on the
authorization form. We would also require authorizations to be
revocable. We do not seek to limit the purposes for which authorization
of records disclosure may be sought, but rather to ensure that these
authorizations are voluntary, fair, and enforceable.
While the provisions of this proposed rule are intended to make
authorizations for treatment and payment purposes unnecessary, some
States may continue to require them. This rule would not supersede such
State requirements generally, but would impose a new requirement that
such State-mandated authorizations must be physically separate from an
authorization for other purposes described in this rule.
5. Uses and Disclosures for Treatment, Payment and Health Care
Operations
Under this rule, covered entities with limited exceptions would be
permitted to use and disclose protected health information without
individual authorization for treatment and payment purposes, and for
related purposes that we have defined as health care operations. (See
Sec. 164.506.) We would construe the terms "treatment" and
"payment" broadly. In section II.B. of this preamble, we describe the
types of activities that would be considered health care operations.
6. Permissible Uses and Disclosures for Purposes Other Than Treatment,
Payment and Health Care Operations
Individually identifiable health information is needed to support
certain national priority activities, such as reducing health care
fraud, improving the quality of treatment through research, protecting
the public health, and responding to emergency situations. In many
cases, the need to obtain authorization for use of health information
would create significant obstacles in efforts to fight crime,
understand disease, and protect public health. We examined the many
uses that the health professions, related industries, and the
government make of health information and we are aware of the concerns
of privacy and consumer advocates about these uses.
After balancing privacy and other social values, we are proposing
rules that would permit use or disclosure of health information without
individual authorization for the following national priority activities
and activities that allow the health care system to operate smoothly:
Oversight of the health care system
Public health functions
Research
Judicial and administrative proceedings
Law enforcement
Emergency circumstances
To provide information to next-of-kin
For identification of the body of a deceased person, or
the cause of death
For government health data systems
For facility patient directories
To banks, to process health care payments and premiums
For management of active duty military and other special
classes of individuals
[[Page 59926]]
Where other law requires such disclosure and no other
category of permissible disclosures would allow the disclosure
The rule would specify conditions that would need to be met in
order for the use or disclosure of protected health information to be
permitted for each of these purposes. (See Sec. 164.514) We have
proposed conditions tailored to the need for each type of use or
disclosure, and to the types of organizations involved in each such
activity. These uses and disclosures, and the conditions under which
they may occur, are discussed in section II. F of this preamble.
The uses and disclosures that would be permitted under proposed
rule would be just that--permissible. Thus, for disclosures that are
not compelled by other law, providers and payers would be free to
disclose or not, according to their own policies and ethical
principles. We propose these rules as a basic set of legal controls,
but ethics and professional practice may dictate more guarded
disclosure policies. At the same time, nothing in this rule would
provide authority for a covered entity to restrict or refuse to make a
disclosure mandated by other law.
7. Individual Rights
We are proposing to establish several basic rights for individuals
with respect to their protected health information. We propose that
individuals be able to obtain access to protected health information
about them, which would include a right to inspect and obtain a copy of
such information. See proposed Sec. 164.514. The right of access would
extend to an accounting of disclosures of the protected health
information for purposes other than treatment, payment, and health care
operations. See proposed Sec. 164.515.
In Sec. 164.512, we also propose that individuals have a right to
receive a written notice of information practices from covered
entities. While the primary purpose of this notice would be to inform
individuals about the uses and disclosures that a covered entity would
intend to make with the information, the notice also would serve to
limit the activities of the covered entity--an otherwise lawful use or
disclosure that does not appear in the entity's notice would not be
permitted. The covered entity's uses and disclosures could be stated in
broad terms, but an entity would not be able to make a use or
disclosure that is not included in its notice. The covered entity could
modify its notice at any time and apply revised practices to existing
and new information held by the covered entity.
In addition, we propose that individuals have the right to request
amendment or correction of protected health information that is
inaccurate or incomplete. See proposed Sec. 164.516. We are proposing
procedural requirements and deadlines to implement each of these
individual rights.
8. Administrative Requirements and Policy Development and Documentation
In our Recommendations, we call for a federal law that requires
holders of identifiable health information to implement safeguards to
protect it from inappropriate access, use or disclosure. No legislation
or rule can effectively specify how to do this for every holder of
health information. But federal rules can and should require those who
hold identifiable health information to develop and implement basic
administrative procedures to protect that information and protect the
rights of the individual with respect to that information.
To accomplish this goal, we propose that covered entities be
required to designate a privacy official, develop a privacy training
program for employees, implement safeguards to protect health
information from intentional or accidental misuse, provide some means
for individuals to lodge complaints about the covered entity's
information practices, and develop a system of sanctions for employees
and business partners who violate the entity's policies or procedures.
(See proposed Sec. 164.518.). We also propose, in Sec. 164.520, to
require covered entities to maintain documentation of their policies
and procedures for complying with the requirements of this proposed
rule. The purpose of these requirements is to ensure that covered
entities make explicit decisions about who would have access to
protected health information, how that information would be used within
the entity, and when that information would or would not be disclosed
to other entities.
9. Preemption
The HIPAA provides that the rule promulgated by the Secretary may
not preempt state laws that are in conflict with the regulatory
requirements and that provide greater privacy protections. The HIPAA
also provides that standards issued by the Secretary will not supercede
certain other State laws, including: State laws relating to reporting
of disease or injury, child abuse, birth or death, public health
surveillance, or public health investigation or intervention; State
regulatory reporting; State laws which the Secretary finds are
necessary to prevent fraud and abuse, to ensure appropriate State
regulation of insurance, for State reporting on health care delivery or
costs, or for other purposes; or, State laws which the Secretary finds
address controlled substances. These provisions are discussed in more
detail in preamble section II.I.1.
This proposed rule also must be read in conjunction with other
federal laws and regulations that address the use and disclosure of
health information. These issues are discussed in preamble section
II.I.2.
In general, the rule that we are proposing would create a federal
floor of privacy protection, but would not supercede other applicable
law that provide greater protection to the confidentiality of health
information. In general, our rule would not make entities subject to a
state laws to which they are not subject today.
10. Enforcement
The HIPAA grants the Secretary the authority to impose civil
monetary penalties against covered entities which fail to comply with
the requirements of this rule, and also establishes criminal penalties
for certain wrongful disclosures of protected health information. The
civil fines are capped at $25,000 for each calendar year for each
provision that is violated. The criminal penalties are graduated,
increasing if the offense is committed under false pretenses, or with
intent to sell the information or reap other personal gain. The statute
does not provide for a private right of action for individuals.
We propose to create a complaint system to permit individuals to
make complaints to the Secretary about potential violations of this
rule. We also propose that covered entities develop a process for
receiving complaints from individuals about the entities' privacy
practices. (See Sec. 164.522.) Our intent would be to work with covered
entities to achieve voluntary compliance with the proposed standards.
11. Conclusion
Although the promise of these proposed standards cannot become
reality for many patients because of the gaps in our authority, we
believe they would provide important new protections. By placing strict
boundaries around the ways covered entities could use and disclose
information, these rules would protect health information at its
primary sources: health plans and health care providers. By requiring
covered entities to inform patients about how their information is
being used and
[[Page 59927]]
shared, by requiring covered entities to provide access to that
information, and by ensuring that authorizations would be truly
voluntary, these rules would provide patients with important new tools
for understanding and controlling information about them. By requiring
covered entities to document their privacy practices, this rule would
focus attention on the importance of privacy, and reduce the ways in
which privacy is compromised through inattention or misuse.
With the Secretary's recommenda-tions and these proposed rules, we
are attempting to further two important goals: to allow the free flow
of health information needed to provide and promote high quality health
care, while assuring that individuals' health information is properly
protected. We seek a balance that permits important uses of information
privacy of people who seek care and healing. We believe our
Recommendations find that balance, and have attempted to craft this
proposed rule to strike that balance as well.
We continue to believe, however, that federal legislation is the
best way to guarantee these protections. The HIPAA legislative
authority does not allow full implementation of our recommended
policies in this proposed rule. The legislation limits the entities
that can be held responsible for their use of protected health
information, and the ways in which the covered entities can be held
accountable. For these and other reasons, we continue to call upon
Congress to pass comprehensive federal privacy legislation. Publication
of this proposed rule does not diminish our firm conviction that such
legislation should be enacted as soon as possible.
II. Provisions of the Proposed Rule
We propose to establish a new subchapter C to title 45 of the Code
of Federal Regulations. Although the rules proposed below would only
establish two new parts (parts 160 and 164), we anticipate the new
subchapter C will eventually contain three parts, part 160, 162, and
164, with parts 161 and 163 being reserved for future expansion, if
needed. Part 160 will contain general requirements and provisions
applicable to all of the regulations issued under sections 262 and 264
of Public Law 104-191 (the Administrative Simplification provisions of
HIPAA). We anticipate that Part 162 will contain the Administrative
Simplification regulations relating to transactions, code sets and
identifiers. The new part 164 will encompass the rules relating to the
security standards authorized by section 1173(d), the electronic
signature standard authorized by section 1173(e), and the privacy rules
proposed below.
The new part 164 will be composed of two subparts: subparts A and
E, with B, C, and D being reserved. Subpart A will consist of general
provisions and subpart E will consist of the final privacy rules.
Because the new part 160 will apply to the privacy rules, as well as
the other Administrative Simplification rules, it is set out below.
A. Applicability
[Please label comments about this section with the subject:
"Applicability"]
The discussion below describes the entities and the information
that would be subject to the proposed regulation.
1. Covered Entities
The standards in this proposed regulation would apply to all health
plans, all health care clearinghouses, and all health care providers
that transmit health information in an electronic form in connection
with a standard transaction. In this proposed rule, these entities are
referred to as "covered entities." See definition at proposed
Sec. 160.103.
A health plan is defined by section 1171 to be an individual or
group plan that provides for, or pays the cost of, medical care. The
statute expressly includes a significant group of employee welfare
benefit plans, state-regulated insurance plans, managed care plans, and
essentially all government health plans, including Medicare, Medicaid,
the veterans health care program, and plans participating in the
Federal Employees Health Benefits Program. See discussion of the
definition in section II.B.
A health care provider would be a provider of services as defined
in section 1861(u) of the Act, 42 U.S.C. 1395x, a provider of medical
or other health services as defined in section 1861(s) of the Act, and
any other person who furnishes, bills or is paid for health care
services or supplies in the normal course of business. See discussion
of the definition in section II.B. Health care providers would be
subject to the provisions of the rule if they transmit health
information in electronic form in connection with a standard
transaction. Standard transactions include claims and equivalent
encounter information, eligibility and enrollment transactions, premium
payments, claims attachments, and others. See proposed Sec. 160.103.
Health care providers who themselves do not directly conduct electronic
transactions would become subject to the provisions of the proposed
rule if another entity, such as a billing agent or hospital, transmits
health information in electronic form in connection with a standard
transaction on their behalf.
A health care clearinghouse would be a public or private entity
that processes or facilitates the processing of nonstandard data
elements of health information into standard data elements. See section
1171(2) of the Act. For purposes of this rule, we would consider
billing services, repricing companies, community health management
information systems or community health information systems, "value-
added" networks, switches and similar organizations to be health care
clearinghouses for purposes of this part only if they actually perform
the same functions as a health care clearinghouse. See discussion of
the definition in section II.B.
2. Covered Information
We propose to apply the standards in this proposed regulation to
individually identifiable health information that is or has been
electronically transmitted or maintained by a covered entity, including
such information when it is in non-electronic form (e.g., printed on
paper) or discussed orally. In this proposed regulation, such
information is referred to as "protected health information." See
discussion of the definition in section II.B. Under HIPAA, our
authority to promulgate privacy standards extends to all individually
identifiable health information, in any form, maintained or transmitted
by a covered entity. For reasons discussed below, we are proposing to
limit the application of the proposed standards to protected health
information. Below we invite comment on whether we should apply the
standards to a broader set of individually identifiable health
information in the future.
Under the proposal, the standards apply to information, not to
specific records. Thus, once protected health information is
transmitted or maintained electronically, the protections afforded by
this regulation would apply to the information in any form and continue
to apply as the information is printed, discussed orally or otherwise
changed in form. It would also apply to the original paper version of
information that is at some point transmitted electronically. The
authority for, and implications of, this scope are discussed in detail
in this section, below.
This proposed regulation would not apply to information that has
never been electronically maintained or transmitted by a covered
entity.
a. Legislative authority. Under HIPAA, we have authority to
promulgate a
[[Page 59928]]
privacy standard that applies to all individually identifiable health
information transmitted or maintained by a covered entity, including
information in a non-electronic form. We recognize that there may be an
expectation that we would apply privacy standards only to information
that is electronically maintained and transmitted. Our prior proposals
under HIPAA have addressed only electronically maintained and
transmitted information. See Notices of Proposed Rulemaking (NPRM)
published on May 7, 1998 (63 FR 25272 and 25320), June 16, 1998 (63 FR
32784), and the proposed security standards published on August 12,
1998 (63 FR 43242).
In considering the appropriate reach of the proposed privacy
standards, however, we determined that limiting the standards to
electronic information would not be consistent with the requirement in
HIPAA for the Secretary to address privacy, confidentiality and
security concerns relating to individually identifiable health
information.
The HIPAA statute, taken as a whole, contemplates an information
protection system that assures the privacy, confidentiality and
integrity of health information. Two provisions in subtitle F of HIPAA
address privacy and confidentiality concerns: section 264, titled
"Recommendations with Respect to Privacy of Certain Health
Information" and section 1173(d), titled "Security Standards for
Health Information." See 42 U.S.C. 1320d-1320d-8, enacted as sections
262 and 264 of HIPAA.
In enacting HIPAA, Congress recognized that the increased
accessibility of health information made possible by the widespread and
growing use of electronic media and the new federal mandate for
increased standardization of data, requires enhanced privacy and
confidentiality protections. The House Report links privacy and
security concerns stating: "The standards adopted would protect the
privacy and confidentiality of health information. Health information
is considered relatively "safe" today, not because it is secure, but
because it is difficult to access. These standards improve access and
establish strict privacy protections." House Report No. 496, 104th
Cong., 2d. Sess., at 99.
Section 264(c) authorizes the Secretary to protect the privacy of
individually identifiable health information transmitted in connection
with the standard transactions. Section 1173(d) authorizes the
Secretary to prescribe requirements that address the security,
integrity, and confidentiality of health information maintained or
transmitted, in any form or medium, by the covered entities.
Neither the privacy authority in section 264(c) nor the security
authority in 1173(d) exclusively limit the scope of protection to
electronic information. Section 264(c) of HIPAA requires the Secretary
to issue a regulation setting privacy standards for individually
identifiable health information "transmitted in connection with the
transactions described in section 1173(a)." This statutory language is
not on its face limited to electronic transmissions of individually
identifiable health information, although electronic transmissions of
such information are clearly within its scope. Moreover, the section
requires the regulations to address "at least" the subjects of the
Secretary's Recommendations, which focus on individually identifiable
health information, without reference to whether the information is
electronic or not.
The security provision also is not limited by its terms to
electronically maintained information. Rather, section 1173(d) applies
throughout to "health information," a statutorily defined term that
clearly covers information in both its electronic and non-electronic
forms.
In HIPAA, when Congress intended to limit health information to its
electronic form, it did so explicitly. Section 1172(a)(3) of the
statute says that the standards apply to health plans and to health
care providers who transmit health information in electronic form in
connection with the standard transactions (emphasis added); by
contrast, the section 1173(d) requirements for information maintained
or transmitted are not similarly qualified.
Further support for the premise that the standards may reach
information that is maintained or transmitted non-electronically is
found within section 1173(d) itself. That section explicitly
distinguishes within one subsection (Sec. 1173(d)(1)(A)) between
"record systems used to maintain health information" and
"computerized record systems." Thus, the conclusion may be drawn that
the record systems covered by the Sec. 1173(d) security standards are
intended to include record systems other than those that are
exclusively electronic or "computerized."
Finally, the section that generally defines the HIPAA standard
transactions, section 1173(a), is not limited by its terms to
transactions that are electronic. Rather, although all of the
transactions described can be performed electronically, all take paper
and some take oral forms as well. Indeed, the purpose of the standards,
including the security and privacy standards, is stated as "to enable
electronic exchange." This purpose would not preclude (and in fact
would support) requirements that relate to non-electronic media where
they support the overall goal of enabling electronic information
exchange. Thus, we believe that the statute authorizes a privacy
regulation covering health information in any form or medium maintained
or transmitted by the covered entities.
Although we believe that HIPAA authorizes the Secretary to issue
regulations covering individually identifiable health information in
any form, the proposed privacy standards in this NPRM are directed to
protecting only individually identifiable health information that is or
at some point has been electronically maintained or transmitted by a
covered entity. Those standards do not cover health information that
has never been in electronic form.
We are proposing this approach because we believe that it focuses
most directly on the primary concern raised by HIPAA: the fact that
growing use of computerization in health care, including the rapid
growth of electronic transfers of health information, gives rise to a
substantial concern about the confidentiality of the health care
information that is part of this growing electronic commerce. At the
same time, could not adequately address the confidentiality concerns
associated with electronic transfers of health information unless we
address the resulting uses and disclosures of such information, in
whatever form. Indeed, the protection offered by this standard would be
devoid of meaning if all non-electronic records and transmissions were
excluded. In that event, access to "protected" health information
would become merely a matter of obtaining the information in a paper or
oral form. Such a narrow reading of the statute would lead to a system
in which individually identifiable health information transmitted as
part of a claim would be protected only until the information was
printed or read aloud, at which point protection would disappear.
Previously protected information could be freely printed and
redistributed, regardless of limits on further electronic
redistribution. The statutory language does not compel such an
anomalous result.
In developing our proposal, we considered other approaches for
determining the information that would be subject to the privacy
standards. We
[[Page 59929]]
considered but rejected limiting the scope of the proposal to
information in electronic form. For the reasons discussed above, such a
narrow interpretation would render the standards nearly meaningless. We
also considered applying the privacy standards to all individually
identifiable health information in any form maintained or transmitted
by a covered entity. There are clear advantages to this approach,
including permitting covered entities to treat all individually
identifiable health information under the same standards. We rejected
that approach in favor of our proposed approach which we believe is
more focused at the public concerns over health information
confidentiality in an electronic communications age. We also were
concerned about imposing additional burden with respect to health
information that was less likely to present privacy concerns: paper
records that are never reduced to electronic form are less likely to
become disseminated broadly throughout the health care system. We
invite comment on the approach that we are proposing and on whether
alternate approaches to determining the health information that would
be subject to this regulation would be more appropriate.
We also considered making use of other statutory authorities under
which we impose general operating or management conditions for programs
(e.g., Medicare, grant programs) to enhance these proposed privacy
protections. Doing so could enable us to apply these privacy standards
to a wider range of entities than are currently affected, such as
health care providers who do not transmit standard transactions
electronically. We use many other authorities now to impose
confidentiality and privacy requirements, although the current rules
lack consistency. It is not clear whether using these other authorities
would create more uniform protections or expanded enforcement options.
Therefore we request comment on the concept of drawing on other
authorities to amplify the protections of these privacy standards.
b. Application to records containing protected and unprotected
health information. Once transmitted or maintained electronically,
protected health information is often mixed with unprotected health
information in the same record. For example, under the proposed rules,
information from a medical record that is electronically transmitted by
a provider to a health plan and then returned to the original record
would become protected health information, even though the rest of the
information contained in the paper record may not be subject to these
privacy rules.
We reiterate that under the proposed rule, the protections would
apply to the information itself, not to the particular record in which
it is contained or transmitted. Therefore, an entity could not maintain
duplicate records and only apply the protections to the information
contained in the record that is electronically maintained or
transmitted. For example, once an individual's name and diagnostic code
is transmitted electronically between covered entities (or business
partners), that information must be protected by both the transmitting
and receiving entities in every record, written, electronic or other,
in which it appears.
We recognize that this approach may require some additional
administrative attention to mixed records (records containing protected
and unprotected health information) to ensure that the handling of
protected health information conforms with these regulations. We
considered ways to limit application of these protections to avoid such
potential administrative concerns. However, these regulations would
have little effect if not applicable to otherwise protected health
information simply because it was combined with unprotected health
information--any information could be lawfully disclosed simply by
including some additional information. Likewise, these regulations
would have no meaning if entities could then avoid applying the
protections merely by maintaining separate duplicate records. A way to
limit these rules to avoid application to mixed information without
sacrificing basic protections is not apparent.
Unlike the potential issues inherent in the protection of oral
information, there may be relatively simple ways to reduce possible
confusion in protecting mixed records. The risk of inappropriate use or
disclosure of protected health information in a mixed record can be
eliminated simply by handling all information in mixed records as if it
were protected. It also may be possible to develop a "watermark"
analogous to a copyright label, designating which written information
is protected. We welcome comments on how best to protect information in
mixed records, without creating unnecessary administrative burdens.
Finally, we recognize that these rules may create awkward
boundaries and enforcement ambiguities, and seek comment on how best to
reduce these ambiguities while maintaining the basic protections
mandated by the statute.
3. Interaction With Other Standards
The privacy standards in this proposed regulation would be closely
integrated with other standards that have been proposed under the HIPAA
Administrative Simplification title. This is particularly true with
respect to the proposed security standards published on August 12, 1998
(63 FR 43242).
We understand that we are proposing a broader scope of
applicability with respect to covered information under these privacy
standards than we have previously proposed under the security standard.
We intend to solicit additional comments regarding the scope of
information that should be addressed under the security standard in the
near future.
We also recognize that in this NPRM we are publishing slightly
different definitions for some of the concepts that were defined in
previously published NPRMs for the other standards. The differences
resulted from the comments received on the previous NPRMs as well as
the conceptual work done in the development of this NPRM. As we publish
the final rules, we will bring all the definitions into conformance.
4. References to Other Laws
The provisions we propose in this rule would interact with numerous
other laws. For example, proposed Sec. 164.510 provides standards for
certain uses or disclosures that are permitted in this rule, and in
some cases references activities that are authorized by other
applicable law, such as federal, State, tribal or territorial laws. In
cases where this rule references "law" or "applicable law" we
intend to encompass all applicable laws, decisions, rules, regulations,
administrative procedures or other actions having the effect of law. We
do not intend to exclude any applicable legal requirements imposed by a
governmental body authorized to regulate in a given area. Where
particular types of law are at issue, such as in the proposed
provisions for preemption of State laws in subpart B of part 160, or
permitted disclosures related to the Armed Forces in Sec. 164.510(m),
we so indicate by referring to the particular type of law in question
(e.g., "State law" or "federal law").
When we describe an action as "authorized by law," we mean that a
legal basis exists for the activity. The phrase "authorized by law"
is a term of art that includes both actions that are permitted and
actions that are required by law. When we specifically discuss an
action that is "required" or "mandated," we mean that a law compels
(or conversely, prohibits) the performance
[[Page 59930]]
of the activity in question. For example, in the health oversight
context, disclosure of health information pursuant to a valid Inspector
General subpoena, grand jury subpoena, civil investigative demand, or a
statute or regulation requiring production of information justifying a
claim would constitute a disclosure required by law.
B. Definitions. (Secs. 160.103 and 164.504)
[Please label comments about this section with the subject:
"Definitions"]
Section 1171 of the Act defines several terms and our proposed
rules would, for the most part, simply restate the law or adopt
definitions previously defined in the other HIPAA proposed rules. In
some instances, we propose definitions from the Secretary's
Recommendations. We also propose some new definitions for convenience
and efficiency of exposition, and others to clarify the application and
operation of this rule. We describe the proposed definitions and
discuss the rationale behind them, below.
Most of the definitions would be defined in proposed Secs. 160.103
and 164.504. The definitions at proposed Sec. 160.103 apply to all
Administrative Simplification standards, including this privacy rule
and the security standard. The definitions proposed in Sec. 164.504
would apply only to this privacy rule. Certain other definitions are
specific to particular sections of the proposed rule and are provided
in those sections. The terms that are defined at proposed Sec. 160.103
follow:
1. Act. We would define "Act" to mean the Social Security Act, as
amended. This definition would be added for convenience.
2. Covered entity. This definition would be provided for
convenience of reference and would mean the entities to which part C of
title XI of the Act applies. These are the entities described in
section 1172(a)(1): Health plans, health care clearinghouses, and
health care providers who transmit any health information in electronic
form in connection with a transaction referred to in section 1173(a)(1)
of the Act (a "standard transaction"). In the preamble we
occasionally refer to health plans and the health care providers
described above as "covered plans," "covered providers," or
"covered plans and providers."
We note that health care providers who do not submit HIPAA
transactions in standard form become covered by this rule when other
entities, such as a billing service or a hospital, transmit standard
electronic transactions on their behalf. The provider could not
circumvent these requirements by assigning the task to its agent, since
the agent would be deemed to be acting as the provider.
3. Health care. We would define the term "health care" as it is
defined in the Secretary's Recommendations. Health care means the
provision of care, services, or supplies to a patient and includes any:
(1) Preventive, diagnostic, therapeutic, rehabilitative, maintenance,
or palliative care, counseling, service, or procedure with respect to
the physical or mental condition, or functional status, of a patient or
affecting the structure or function of the body; (2) sale or dispensing
of a drug, device, equipment, or other item pursuant to a prescription;
or (3) procurement or banking of blood, sperm, organs, or any other
tissue for administration to patients.
4. Health care clearinghouse. We would define "health care
clearinghouse" as defined by section 1171(2) of the Act. The Act
defines a "health care clearinghouse" as a "public or private entity
that processes or facilitates the processing of nonstandard data
elements of health information into standard data elements." In
practice, clearinghouses receive transactions from health care
providers, health plans, other health care clearinghouses, or business
partners of such entities, and other entities, translate the data from
a given format into one acceptable to the entity receiving the
transaction, and forward the processed transaction to that entity.
There are currently a number of private clearinghouses that contract or
perform this function for health care providers. For purposes of this
rule, we would consider billing services, repricing companies,
community health management information systems or community health
information systems, "value-added" networks, switches and similar
organizations to be health care clearinghouses for purposes of this
part only if they actually perform the same functions as a health care
clearinghouse.
We would note that we are proposing to exempt clearinghouses from a
number of the provisions of this rule that would apply to other covered
entities (see Secs. 164.512, 164.514 and 164.516 below), because in
most cases we do not believe that clearinghouses would be dealing
directly with individuals. In many instances, clearinghouses would be
considered business partners under this rule and would be bound by
their contracts with covered plans and providers. See proposed
Sec. 164.506(e). We would adopt this position with the caveat that the
exemptions would be void for any clearinghouse that had direct contact
with individuals in a capacity other than that of a business partner.
5. Health care provider. Section 1171(3) of the Act defines
"health care provider" as a "provider of medical services as defined
in section 1861(u) of the Act, a provider of medical or other health
services as defined in section 1861(s) of the Act, and any other person
who furnishes health care services or supplies." We are proposing to
define "health care provider" as the Act does, and clarify that a
health care provider is limited to any person or organization that
furnishes, bills, or is paid for, health care services or supplies in
the normal course of business. This definition would include a
researcher who provides health care to the subjects of research, free
clinics, and a health clinic or licensed health care professional
located at a school or business.
Section 1861(u) of the Act contains the Medicare definition of a
provider, which encompasses institutional providers, such as hospitals,
skilled nursing facilities, home health agencies, and comprehensive
outpatient rehabilitation facilities. Section 1861(s) of the Act
defines other Medicare facilities and practitioners, including assorted
clinics and centers, physicians, clinical laboratories, various
licensed/certified health care practitioners, and suppliers of durable
medical equipment. The last portion of the proposed definition
encompasses appropriately licensed or certified health care
practitioners or organizations, including pharmacies and nursing homes
and many types of therapists, technicians, and aides. It also would
include any other individual or organization that furnishes health care
services or supplies in the normal course of business. An individual or
organization that bills and/or is paid for health care services or
supplies in the normal course of business, such as a group practice or
an "on-line" pharmacy accessible on the Internet, is also a health
care provider for purposes of this statute.
For a more detailed discussion of the definition of health care
provider, we refer the reader to our proposed rule (Standard Health
Care Provider Identifier) published on May 7, 1998, in the Federal
Register (63 FR 25320).
6. Health information. We would define "health information" as it
is defined in section 1171(4) of the Act. "Health information" would
mean any information, whether oral or recorded in any form or medium,
that is created or received by a health care provider, health plan,
public health authority, employer, life insurer, school or
[[Page 59931]]
university, or health care clearinghouse; and that relates to the past,
present, or future physical or mental health or condition of an
individual, the provision of health care to an individual, or the past,
present, or future payment for the provision of health care to an
individual.
In this paragraph we attempt to clarify the relationship between
the defined terms "health information," "individually identifiable
health information" and "protected health information." The term
"health information" encompasses the universe of information governed
by the administrative simplification requirements of the Act. For
example, under section 1173 of the Act, the Secretary is to adopt
standards to enable the electronic exchange of all health information.
However, protection of personal privacy is primarily a concern for the
subset of health information that is "individually identifiable health
information," as defined by the Act (see below). For example, a
tabulation of the number of students with asthma by school district
would be health information, but since it normally could not be used to
identify any individuals, it would not usually create privacy concerns.
The definition of individually identifiable health information omits
some of the persons or organizations that are described as creating or
receiving "health information." Some sections of the Act refer
specifically to individually identifiable health information, such as
section 1177 in setting criminal penalties for wrongful use or
disclosure, and section 264 in requesting recommendations for privacy
standards. Finally, we propose the phrase "protected health
information" (Sec. 164.504) to refer to the subset of individually
identifiable health information that is used or disclosed by the
entities that are subject to this rule.
7. Health plan. We would define "health plan" essentially as
section 1171(5) of the Act defines it. Section 1171 of the Act refers
to several definitions in section 2791 of the Public Health Service
Act, 42 U.S.C. 300gg-91, as added by Public Law 104-191. For clarity,
we would incorporate the referenced definitions as currently stated
into our proposed definitions.
As defined in section 1171(5), a "health plan" is an individual
plan or group health plan that provides, or pays the cost of, medical
care (see section 2791(a) of the Public Health Service Act (PHS Act)).
This definition would include, but is not limited to, the 15 types of
plans listed in the statute, as well as any combination of them. The
term would include, when applied to public benefit programs, the
component of the government agency that administers the program. Church
plans and government plans are included to the extent that they fall
into one or more of the listed categories.
Health plan" includes the following singly or in combination:
a. "Group health plan" (as currently defined by section 2791(a)
of the PHS Act). A group health plan is a plan that has 50 or more
participants (as the term "participant" is currently defined by
section 3(7) of ERISA) or is administered by an entity other than the
employer that established and maintains the plan. This definition
includes both insured and self-insured plans.
Section 2791(a)(1) of the PHS Act defines "group health plan" as
an employee welfare benefit plan (as defined in current section 3(1) of
ERISA) to the extent that the plan provides medical care, including
items and services paid for as medical care, to employees or their
dependents directly or through insurance, or otherwise.
b. "Health insurance issuer" (as currently defined by section
2791(b) of the PHS Act).
Section 2971(b) of the PHS Act defines a "health insurance
issuer" as an insurance company, insurance service, or insurance
organization that is licensed to engage in the business of insurance in
a State and is subject to State law that regulates insurance.
c. "Health maintenance organization" (as currently defined by
section 2791(b) of the PHS Act). Section 2791(b) of the PHS Act
currently defines a "health maintenance organization" as a federally
qualified health maintenance organization, an organization recognized
as such under State law, or a similar organization regulated for
solvency under State law in the same manner and to the same extent as
such a health maintenance organization. These organizations may include
preferred provider organizations, provider sponsored organizations,
independent practice associations, competitive medical plans, exclusive
provider organizations, and foundations for medical care.
d. Part A or Part B of the Medicare program (title XVIII of the
Act).
e. The Medicaid program (title XIX of the Act).
f. A "Medicare supplemental policy" as defined under section
1882(g)(1) of the Act. Section 1882(g)(1) of the Act defines a
"Medicare supplemental policy" as a health insurance policy that a
private entity offers a Medicare beneficiary to provide payment for
expenses incurred for services and items that are not reimbursed by
edicare because of deductible, coinsurance, or other limitations under
edicare. The statutory definition of a Medicare supplemental policy
excludes a number of plans that are similar to Medicare supplemental
plans, such as health plans for employees and former employers and for
members and former members of trade associations and unions. A number
of these health plans may be included under the definitions of "group
health plan" or "health insurance issuer," as defined in paragraphs
"a" and "b" above.
g. A "long-term care policy," including a nursing-home fixed
indemnity policy. A "long-term care policy" is considered to be a
health plan regardless of how comprehensive it is.
h. An employee welfare benefit plan or any other arrangement that
is established or maintained for the purpose of offering or providing
health benefits to the employees of two or more employers. This
includes plans that are referred to as multiple employer welfare
arrangements ("MEWAs").
i. The health care program for active military personnel under
title 10 of the United States Code. See paragraph "k", below, for
further discussion.
j. The veterans health care program under chapter 17 of title 38 of
the United States Code. This health plan primarily furnishes medical
care through hospitals and clinics administered by the Department of
Veterans Affairs (VA) for veterans enrolled in the VA health care
system.
k. The Civilian Health and Medical Program of the Uniformed
Services (CHAMPUS) as defined in 10 U.S.C. 1072(4). We note that the
Act's definition of "health plan" omits several types of health care
provided by the Department of Defense (DOD). Sections 1171(5)(I) and
1171(5)(K) cover only the health care program for active duty personnel
(see 10 U.S.C. 1074(a)) and the CHAMPUS program (see 10 U.S.C. 1079,
1086). What is omitted is health care provided in military treatment
facilities to military retirees (see 10 U.S.C. 1074(b)), to dependents
of active duty personnel and to dependents of retirees (see 10 U.S.C.
1076), to Secretarial designees such as members of Congress, Justices
of the Supreme Court, and to foreign military personnel under NATO
status of forces agreements. Health care provided by the DOD in
military facilities to the aforementioned persons is not included as a
"health plan" under HIPAA. However, these facilities would still be
considered to be health care providers.
l. The Indian Health Service program under the Indian Health Care
Improvement Act (25 U.S.C. 1601, et.
[[Page 59932]]
seq.). This program furnishes services, generally through its own
health care providers, primarily to persons who are eligible to receive
services because they are of American Indian or Alaskan Native descent.
m. The Federal Employees Health Benefits Program under 5 U.S.C.
chapter 89. This program consists of health insurance plans offered to
active and retired federal employees and their dependents. Although
section 1171(5)(M) of the Act refers to the "Federal Employees Health
Benefit Plan," this and any other rules adopting administrative
simplification standards will use the correct name, the Federal
Employees Health Benefits Program. One health plan does not cover all
federal employees; over 350 health plans provide health benefits
coverage to federal employees, retirees, and their eligible family
members. Therefore, we will use the correct name, The Federal Employees
Health Benefits Program, to make clear that the administrative
simplification standards apply to all health plans that participate in
the Program.
n. An approved State child health plan for child health assistance
that meets the requirements of section 2103 of the Act, which
established the Children's Health Insurance Program (CHIP).
o. A Medicare Plus Choice organization as defined in 42 CFR 422.2,
with a contract under 42 CFR part 422, subpart K.
p. Any other individual plan or group health plan, or combination
thereof, that provides or pays for the cost of medical care. This
category implements the language at the beginning of the statutory
definition of the term "health plan": "The term 'health plan' means
an individual or group plan that provides, or pays the cost of, medical
care * * * Such term includes the following, and any combination
thereof * * *" This statutory language is general, not specific.
oreover, the statement that the term "health plan" "includes" the
specified plans implies that the term also covers other plans that meet
the stated criteria. One approach to interpreting this introductory
language in the statute would be to make coverage decisions about plans
that may meet these criteria on a case-by-case basis. Instead we
propose to clarify its coverage by adding this category to the proposed
definition of "health plan"; we seek public comment on its
application. The Secretary would determine which plans that meet the
criteria in the preceding paragraph are health plans for purposes of
title II of HIPAA.
Consistent with the other parts of HIPAA, the provisions of this
rule generally would not apply to certain types of insurance entities,
such as workers' compensation and automobile insurance carriers, other
property and casualty insurers, and certain forms of limited benefits
coverage, even when such arrangements provide coverage for health care
services. 29 U.S.C. 1186(c). We note that health care providers would
be subject to the provisions of this rule with respect to the health
care they provide to individuals, even if such providers seek or
receive reimbursement from an insurance entity that is not a covered
entity under these rules. However, nothing in this rule would be
intended to prevent a health care provider from disclosing protected
health information to a non-covered insurance entity for the purpose of
obtaining payment for services. Further, under proposed
Sec. 164.510(n), this rule would permit disclosures by health care
providers of protected health information to such insurance entities
and to other persons when mandated by applicable law for the purposes
of determining eligibility for coverage or benefits under such
insurance arrangements. For example, a State workers' compensation law
that requires disclosure of protected health information to an insurer
or employer for the purposes of determining an individual's eligibility
for medical or other benefits, or for the purpose of determining
fitness for duty, would not be disturbed by this rule.
8. Secretary. This term means the Secretary of Health and Human
Services and any other officer or employee of the Department of Health
and Human Services to whom the authority involved has been delegated.
It is provided for ease of reference.
9. Small health plan. The HIPAA does not define a "small health
plan," but instead explicitly leaves the definition to be determined
by the Secretary. We propose to adopt the size classification used by
the Small Business Administration. We would therefore define a "small
health plan" as a health plan with annual receipts of $5 million or
less. 31 CFR 121.201. This differs from the definition of "small
health plan" in prior proposed Administrative Simplification rules. We
will conform the definitions in the final Administrative Simplification
rules.
10. Standard. The term "standard" would mean a prescribed set of
rules, conditions, or requirements concerning classification of
components, specification of materials, performance or operations, or
delineation of procedures in describing products, systems, services, or
practices. This definition is a general one, to accommodate the varying
functions of the specific standards proposed in the other HIPAA
regulations, as well as the rules proposed below.
11. State. This term would include the 50 States, the District of
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, and
Guam. This definition follows the statutory definition of "State" in
section 1101(a) of the Act.
12. Transaction. We would define "transaction," as we have done
in other Administrative Simplification regulations, to mean the
exchange of information between two parties to carry out financial or
administrative activities related to health care. A transaction would
be (1) any of the transactions listed in section 1173(a)(2) of the Act,
and (2) any transaction determined appropriate by the Secretary in
accordance with Section 1173(a)(1) of the Act.
A "transaction" would mean any of the following:
a. Health claims or equivalent encounter information. This
transaction could be used to submit health care claim billing
information, encounter information, or both, from health care providers
to payers, either directly or via intermediary billers and claims
clearinghouses.
b. Health care payment and remittance advice. This transaction
could be used by a health plan to make a payment to a financial
institution for a health care provider (sending payment only), to send
an explanation of benefits remittance advice directly to a health care
provider (sending data only), or to make payment and send an
explanation of benefits remittance advice to a health car provider via
a financial institution (sending both payment and data).
c. Coordination of benefits. This transaction could be used to
transmit health care claims and billing payment information between
payers with different payment responsibilities where coordination of
benefits is required or between payers and regulatory agencies to
monitor the furnishing, billing, and/or payment of health care services
within a specific health care/insurance industry segment.
d. Health claims status. This transaction could be used by health
care providers and recipients of health care products or services (or
their authorized agents) to request the status of a health care claim
or encounter from a health plan.
e. Enrollment and disenrollment in a health plan. This transaction
could be used to establish communication
[[Page 59933]]
between the sponsor of a health benefit and the payer. It provides
enrollment data, such as subscriber and dependents, employer
information, and primary care health care provider information. A
sponsor would be the backer of the coverage, benefit, or product. A
sponsor could be an employer, union, government agency, association, or
insurance company. The health plan would refer to an entity that pays
claims, administers the insurance product or benefit, or both.
f. Eligibility for a health plan. This transaction could be used to
inquire about the eligibility, coverage, or benefits associated with a
benefit plan, employer, plan sponsor, subscriber, or a dependent under
the subscriber's policy. It also could be used to communicate
information about or changes to eligibility, coverage, or benefits from
information sources (such as insurers, sponsors, and payers) to
information receivers (such as physicians, hospitals, third party
administrators, and government agencies).
g. Health plan premium payments. This transaction could be used by,
for example, employers, employees, unions, and associations to make and
keep track of payments of health plan premiums to their health
insurers. This transaction could also be used by a health care
provider, acting as liaison for the beneficiary, to make payment to a
health insurer for coinsurance, copayments, and deductibles.
h. Referral certification and authorization. This transaction could
be used to transmit health care service referral information between
health care providers, health care providers furnishing services, and
payers. It could also be used to obtain authorization for certain
health care services from a health plan.
i. First report of injury. This transaction could be used to report
information pertaining to an injury, illness, or incident to entities
interested in the information for statistical, legal, claims, and risk
management processing requirements.
j. Health claims attachments. This transaction could be used to
transmit health care service information, such as subscriber, patient,
demographic, diagnosis, or treatment data for the purpose of a request
for review, certification, notification, or reporting the outcome of a
health care services review.
k. Other transactions as the Secretary may prescribe by regulation.
Under section 1173(a)(1)(B) of the Act, the Secretary may adopt
standards, and data elements for those standards, for other financial
and administrative transactions deemed appropriate by the Secretary.
These transactions would be consistent with the goals of improving the
operation of the health care system and reducing administrative costs.
In addition to the above terms, a number of terms are defined in
proposed Sec. 164.504, and are specific to the proposed privacy rules.
They are as follows:
13. Business partner. This term would mean a person to whom a
covered entity discloses protected health information so that the
person can carry out, assist with the performance of, or perform on
behalf of, a function or activity for the covered entity. Such term
includes any agent, contractor or other person who receives protected
health information from the covered entity (or from another business
partner of the covered entity) for the purposes described in the
previous sentence. It would not include a person who is an employee, a
volunteer or other person associated with the covered entity on a paid
or unpaid basis.
14. Designated record set. This term would be defined as a group of
records under the control of a covered entity from which information is
retrieved by the name of the individual or by some identifying number,
symbol, or other identifying particular assigned to the individual, and
which is used by the covered entity to make decisions about the
individual. The concept of a "designated record set" is derived from
the Privacy Act's concept of a "system of records." Under the Privacy
Act, federal agencies must provide an individual with access to
"information pertaining to him which is contained in [a system of
records]." 5 U.S.C. 552a(d)(1). A "system of records" is defined as
"a group of any records under the control of any agency from which
information is retrieved by the name of the individual or by some
identifying number, symbol, or other identifying particular assigned to
the individual." 5 U.S.C. 552a(a)(5). Under this rule, we would
substitute the term "covered entity" for "agency" and limit the
information to that used by the covered entity to make decisions about
the individual.
We would define a "record" as "any item, collection, or grouping
of protected health information maintained, collected, used, or
disseminated by a covered entity." Under the Privacy Act, "the term
'record' means any item, collection, or grouping of information about
an individual that is maintained by an agency, including, but not
limited to, his education, financial transactions, medical history, and
criminal or employment history and that contains his name, or the
identifying number, symbol, or other identifying particular assigned to
the individual, such as a finger or voice print or a photograph." 5
U.S.C. 552a(a)(4). For purposes of this rule we propose to limit the
information to protected health information, as defined in this rule.
"Protected health information" already incorporates the concept of
identifiability, and therefore our definition of "record" is much
simpler.
For health plans, designated record sets would include, at a
minimum, the claims adjudication, enrollment, and patient accounting
systems. For health care providers, designated record sets would
include, at a minimum, the medical records and billing records.
Designated record set would also include a correspondence system, a
complaint system, or an event tracking system if decisions about
individuals are made based, in whole or in part, on information in
those systems. Files used to backup a primary data system or the
sequential files created to transmit a batch of claims to a
clearinghouse are clear examples of data files which would not fall
under this definition.
We note that a designated record set would only exist for types of
records that a covered entity actually "retrieves" by an identifier,
and not records that are only "retrievable" by an identifier. In many
cases, technology will permit sorting and retrieving by a variety of
fields and therefore the "retrievable" standard would be relatively
meaningless.
15. Disclosure. This term would be defined as the release,
transfer, provision of access to, or divulging in any other manner of
information outside the entity holding the information.
16. Health care operations. We propose the term "health care
operations" to clarify the activities we consider to be "compatible
with and directly related to" treatment and payment and therefore
would not require authorization from the individual for use or
disclosure of protected health information.
Under our proposal, "health care operations" means the following
services or activities if provided by or on behalf of a covered health
plan or health care provider for the purposes of carrying out the
management functions of such plan or provider necessary for the support
of treatment or payment:
Conducting quality assessment and improvement activities,
including evaluating outcomes, and developing clinical guidelines;
[[Page 59934]]
Reviewing the competence or qualifications of health care
professionals, evaluating practitioner and provider performance, health
plan performance, conducting training programs in which undergraduate
and graduate students and trainees in all areas of health care learn
under supervision to practice as health care providers (e.g., residency
programs, grand rounds, nursing practicums), accreditation,
certification, licensing or credentialing activities;
Insurance rating and other insurance activities relating
to the renewal of a contract for insurance, including underwriting,
experience rating, and reinsurance, but only when the individuals are
already enrolled in the health plan conducting such activities and only
when the use or disclosure of such protected health information relates
to an existing contract of insurance (including the renewal of such a
contract);
Conducting or arranging for auditing services, including
fraud and abuse detection and compliance programs; and
Compiling and analyzing information in anticipation of, or
for use in, civil or criminal legal proceedings.
Our definition proposes to limit health care operations to
functions and activities performed by a health plan or provider or by a
business partner on behalf of a health plan or a provider. Our
definition anticipates that in order for treatment and payment to
occur, protected health information would be used within entities,
would be shared with business partners, and in some cases would be
shared between covered entities (or their business partners). However,
a health care operation should not result in protected health
information being disclosed to an entity that is not the covered entity
(or a business partner of such entity) on whose behalf the operation is
being performed. For example, a health plan may request a health care
provider to provide protected health information to the health plan, or
to a business partner of the health plan, as part of an outcomes
evaluation effort relating to providers affiliated with that plan. This
would be a health care operation.
We are aware that the health care industry is changing and that
these categories, though broad, may need to be modified to reflect
different conditions in the future.
17. Health oversight agency. We would define the term "health
oversight agency" as it is defined in the Secretary's Recommendations.
See section II.E. below for further discussion.
18. Individual. We would define "individual" to mean the person
who is the subject of protected health information. We would define the
term to include, with respect to the signing of authorizations and
other rights (such as access, copying, and correction), various types
of legal representatives. The term would include court-appointed
guardians or persons with a power of attorney, including persons making
health care decisions for incapacitated persons, persons acting on
behalf of a decedent's estate, where State or other applicable law
authorizes such legal representatives to exercise the person's rights
in such contexts, and parents subject to certain restrictions explained
below. We would define this term to exclude foreign military and
foreign diplomatic personnel and their dependents who receive health
care provided or paid for by the DOD or other federal agency or entity
acting on its behalf, and overseas foreign national beneficiaries of
health care provided by the DOD or other federal agency, or non-
governmental organization acting on its behalf.
a. Disclosures pursuant to a power of attorney. The definition of
an individual would include legal representatives, to the extent
permitted under State or other applicable law. We considered several
issues in making this determination.
A "power of attorney" is a legal agreement through which a person
formally grants authority to another person to make decisions on the
person's behalf about financial, health care, legal, and/or other
matters. In granting power of attorney, a person does not give up his
or her own right to make decisions regarding the health care,
financial, legal, or other issues involved in the legal agreement.
Rather, he or she authorizes the other person to make these decisions
as well.
In some cases, an individual gives another person power of attorney
over issues not directly related to health care (e.g., financial
matters) while informally relying on a third person (either implicitly
or through verbal agreement) to make health care decisions on his or
her behalf. In such situations, the person with power of attorney could
seek health information from a health plan or provider in order to
complete a task related to his or her power of attorney. For example, a
person with financial power of attorney may request health information
from a health plan or provider in order to apply for disability
benefits on the individual's behalf.
In developing proposed rules to address these situations, we
considered two options: (1) Allowing health plans and health care
providers to disclose health information without authorization directly
to the person with power of attorney over issues not directly related
to health care; and (2) prohibiting health plans or health care
providers from disclosing health information without authorization
directly to such persons and stating that disclosure without
authorization is permitted only to persons designated formally (through
power of attorney for health care) or informally as the patient's
health care decision-maker. We believe that both options have merit.
The first option recognizes that the responsibilities of persons
with power of attorney often are broad, and that even when the power of
attorney agreement does not relate directly to health care, the person
with power of attorney at times has a legitimate need for health
information in order to carry out his or her legal responsibility. The
second option recognizes that when an individual is competent to make
health care decisions, it is appropriate for him or her (or, if the
individual wishes, for the informally designated health care decision
maker) to decide whether the covered entity should disclose health
information to someone with power of attorney over issues not directly
related to health care.
In light of the fact that laws vary by State regarding power of
attorney and that implementation of either option could be in the
individual's interest, we would allow health plans and health care
providers to disclose protected health information without
authorization directly to persons with power of attorney to handle any
issue on the individual's behalf, in accordance with State or other
applicable laws regarding this issue.
This definition also accounts for situations in which a competent
individual has granted one person power of attorney over health care
issues yet, in practice, relies on another person to make health care
decisions. We recognize that, by giving power of attorney for health
care issues to one person and involving another person informally in
making treatment decisions, the individual is, in the first instance,
formally granting consent to release his or her health information and,
in practice, granting consent to release medical information to the
second person. Therefore, we would allow a health plan or provider,
pursuant to State or other applicable law, to disclose protected health
information without authorization to a person with power of attorney
for the patient's health care and to a person
[[Page 59935]]
informally designated as the patient's health care decision maker.
b. Disclosures pertaining to incapacitated individuals. Covered
entities would be permitted to disclose protected health information to
any person making health care decisions for an incapacitated person
under State or other applicable law. This definition defers to current
laws regarding health care decision-making when a patient is not a
minor and is incapable of making his or her own decisions. We propose
to permit information to follow such decision-making authority. It is
our intent not to disturb existing practices regarding incapacitated
patients.
Applicable laws vary significantly regarding the categories of
persons who can make health care decisions when a patient is incapable
of making them. For example, some State laws establish a hierarchy of
persons who may make medical decisions for the incapacitated person
(e.g., first a person with power of attorney, if not then next-of-kin,
if none then close friend, etc.). In other States, health care
providers may exercise professional judgment about which person would
make health care decisions in the patient's best interest. We also
recognize that federal agencies have, in some cases, established rules
regarding such patients. For example, the DOD has established
requirements regarding military personnel who are based overseas and
who have become incapable of making their own decisions.
Because laws vary regarding patients unable to make their own
decisions and because these patients' interests could be served through
a variety of arrangements, we would allow health plans and health care
providers to disclose information in accordance with applicable laws
regarding incapacitated patients.
c. Disclosures pertaining to minors. In general, because the
definition of individual would include parents, a parent, guardian, or
person acting in loco parentis could exercise the rights established
under this regulation on behalf of their minor (as established by
applicable law) children. However, in cases where a minor lawfully
obtains a health care service without the consent of or notification to
a parent, the minor would be treated as the individual for purposes of
exercising any rights established under this regulation with respect to
protected health information relating to such health services. Laws
regarding access to health care for minors and confidentiality of their
medical records vary widely; this proposed regulation recognizes and
respects the current diversity of the law in this area. It would not
affect applicable regulation of the delivery of health care services to
minors, and would not preempt any law authorizing or prohibiting
disclosure of individually identifiable health information of minor
individuals to their parents. The disclosure of individually
identifiable health information from substance abuse records is also
addressed by additional requirements established under 42 CFR part 2.
d. Foreign recipients of defense related health care. We would
define the term "individual" to exclude foreign military and foreign
diplomatic personnel and their dependents who receive health care
provided by or paid for by the DOD or other federal agency, or by an
entity acting on its behalf, pursuant to a country-to-country agreement
or federal statute. We would also exclude from this term overseas
foreign national beneficiaries of health care provided by the DOD or
other federal agency or by a non-governmental organization acting on
behalf of DOD or such agency. This exclusion is discussed in section
II.E.l3.
e. Disclosures pertaining to deceased persons. This provision is
discussed in Section II.C.6.
19. Individually identifiable health information. We would define
"individually identifiable health information" as it is defined in
section 1171(6) of the Act. While the definition of individually
identifiable health information does not expand on the statutory
definition, we recognize that the issue of how the identifying
characteristics can be removed from such information (referred to in
this rule as de-identification) presents difficult operational issues.
Accordingly, we propose in Sec. 164.506(d) an approach for de-
identifying identifiable information, along with restrictions designed
to ensure that de-identified information is not used inappropriately.
The privacy standards would apply to "individually identifiable
health information," and not to information that does not identify the
individual. We are aware that, even after removing obvious identifiers,
there is always some probability or risk, however remote, that any
information about an individual can be attributed. A 1997 MIT study
showed that, because of the public availability of the Cambridge,
assachusetts voting list, 97 percent of the individuals in Cambridge
whose data appeared in a data base which contained only their nine
digit zip code and birth date could be identified with certainty.
1 Their information had been "de-identified" (some obvious
identifiers had been removed) but it was not anonymous (it was still
possible to identify the individual).
---------------------------------------------------------------------------
\1\ Sweeney, L. Guaranteeing Anonymity when Sharing Medical
Data, the Datafly System. Masys, D., Ed. Proceedings, American
edical Informatics Association, Nashville, TN: Hanley & Belfus,
Inc., 1997:51-55.
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It is not always obvious when information identifies the subject.
If the name and identifying numbers (e.g., SSN, insurance number, etc.)
are removed, a person could still be identified by the address. With
the address removed, the subject of a medical record could be
identified based on health and demographic characteristics (e.g., age,
race, diagnosis). "Identifiability" varies with the location of the
subject; there could be hundreds of people in Manhattan who have the
same age, race, gender, and diagnosis, but only one such person in a
small town or rural county. Gauging the risk of identification of
information requires statistical experience and expertise that most
covered entities will not possess.
Obvious identifiers on health information could be replaced with
random numbers or encrypted codes, which can prevent the person using
the record from identifying the subject, but which allow the person
holding the code to re-identify the information. Information with coded
or encrypted identifiers would be considered "de-identified" but not
"anonymous," because it is still possible for someone to identify the
subject.
We considered defining "individually identifiable health
information" as any information that is not anonymous, that is, for
which there is any possibility of identifying the subject. We rejected
this option, for several reasons. First, the statute suggests a
different approach. The term "individually identifiable health
information" is defined in HIPAA as health information that "* * *
identifies the individual, or with respect to which there is a
reasonable basis to believe that the information can be used to
identify the individual." By including the modifier "reasonable
basis," Congress appears to reject the absolute approach to defining
"identifiable."
Second, covered entities may not have the statistical
sophistication to know with certainty when sufficient identifying
information has been removed so that the record is no longer
identifiable. We believe that covered entities need more concrete
guidance as to when information will and will not be "identifiable"
for purposes of this regulation.
[[Page 59936]]
Finally, defining non-identifiable to mean anonymous would require
covered entities to comply with the terms of this regulation with
respect to information for which the probability of identification of
the subject is very low. We want to encourage covered entities and
others to remove obvious identifiers or encrypt them whenever possible;
use of the absolute definition of "identifiable" would not promote
this salutary result.
For these reasons, we propose at Sec. 164.506(d)(2)(ii) that there
be a presumption that, if specified identifying information is removed
and if the holder has no reason to believe that the remaining
information can be used by the reasonably anticipated recipients alone
or in combination with other information to identify an individual,
then the covered entity is presumed to have created de-identified
information.
At the same time, in proposed Sec. 164.506(d)(2)(iii), we would
leave leeway for more sophisticated data users to take a different
approach. We would include a "reasonableness" standard so that
entities with sufficient statistical experience and expertise could
remove or code a different combination of information, so long as the
result is still a low probability of identification. With this
approach, our intent is to provide certainty for most covered entities,
while not limiting the options of more sophisticated data users.
In Sec. 164.504, we propose to define "individually identifiable
health information" to mean health information created or received by
a health care provider, health plan, employer or health care
clearinghouse, that could be used directly or indirectly to identify
the individual who is the subject of the information. Under proposed
Sec. 164.506(d)(2)(ii), information would be presumed not to be
"identifiable" if:
All of the following data elements have been removed or
otherwise concealed: Name; address, including street address, city,
county, zip code, or equivalent geocodes; names of relatives and
employers; birth date; telephone and fax numbers; e-mail addresses;
social security number; medical record number; health plan beneficiary
number; account number; certificate/license number; any vehicle or
other device serial number; web URL; Internet Protocol (IP) address;
finger or voice prints; photographic images; and any other unique
identifying number, characteristic, or code (whether generally
available in the public realm or not) that the covered entity has
reason to believe may be available to an anticipated recipient of the
information, and
The covered entity has no reason to believe that any
reasonably anticipated recipient of such information could use the
information alone, or in combination with other information, to
identify an individual. Thus, to create de-identified information,
entities that had removed the listed identifiers would still have to
remove additional data elements if they had reason to believe that a
recipient could use the remaining information, alone or in combination
with other information, to identify an individual. For example, if the
"occupation" field is left intact and the entity knows that a
person's occupation is sufficiently unique to allow identification,
that field would have to be removed from the relevant record. The
presumption does not allow use or disclosure if the covered entity has
reason to believe the subject of the information can be re-identified.
Our concern with the potential for re-identification is heightened by
our limited jurisdiction under HIPAA. Because we can only regulate
health care providers, health plans and health care clearinghouses, we
cannot prohibit other recipients of de-identified information from
attempting to re-identify it.
To assist covered entities in ascertaining whether their attempts
to create de-identified information would be successful, the Secretary
would from time to time issue guidance establishing methods that
covered entities could use to determine the identifiability of
information. This guidance would include information on statistical and
other tests that could be performed by covered entities in assessing
whether they have created de-identified information. The manner in
which such guidance would be published and distributed will be
addressed in the final regulation. We solicit comment on the best ways
in which to inform covered entities of appropriate and useful
information on methods that they can use to determine whether
information is de-identified.
In enforcing this regulation, the Secretary would consider the
sophistication of covered entities when determining whether a covered
entity had reason to believe that information that it had attempted to
de-identify continued to identify the subject. Covered entities that
routinely create and distribute de-identified data would be expected to
be aware of and to use advanced statistical techniques, including the
guidance issued by the Secretary, to ensure that they are not
improperly disclosing individually identifiable health information.
Covered entities that rarely create de-identified information would not
be expected to have the same level of knowledge of these statistical
methods, and generally could rely on the presumption that information
from which they have removed the listed identifiers (and provided that
they do not know that the information remains identifiable) is de-
identified. We solicit comment on whether the enforcement approach that
we are suggesting here and our overall approach relating to the
creation of de-identified information would provide sufficient guidance
to covered entities to permit them to create, use and disclose de-
identified information.
In addition, we propose to permit entities with appropriate
statistical experience and expertise (obtained through a statistical
consultant or staff with statistical expertise) to decide that some of
the above named data elements could be retained in the de-identified
data set if: (1) The entity determines that the probability of
identifying an individual with the remaining information is very low,
or (2) the entity has converted the "identifiable" data elements into
data elements that, in combination with the remaining information, have
a very low probability of being used to identify an individual. An
example of such a conversion would be the translation of birth date
into age expressed in years or, if still determined to convey
"identifiability," age expressed in categories of years (e.g., age 18
to 24). In making these determinations, the entity must consider the
data elements taken together as well as any additional information that
might reasonably be available to a recipient. Examples of the types of
entities that would have the statistical experience and expertise to
make this type of judgment include large health research institutions
such as medical schools with epidemiologists and statisticians on the
faculty; federal agencies such as the National Center for Health
Statistics, the Agency for Health Care Policy and Research, FDA, the
Bureau of the Census, and NIH; and large corporations that do health
research such as pharmaceutical manufacturers with epidemiologists and
statisticians on staff.
An important component of this approach to defining
"identifiable" would be the prohibition on re-identification of
health information. We propose that a covered entity that is a
recipient of de-identified information who attempts to re-identify such
de-identified information for a purpose for which protected health
information could not be used or disclosed under
[[Page 59937]]
this rule be deemed to be in violation of the law. See proposed
Sec. 164.506(d) and section II.C. below. There may be circumstances,
however, when recipients of de-identified information will have a
legitimate reason to request that the de-identified information be re-
identified by the originating covered entity. For example, if a
researcher received de-identified information from a covered entity and
the research revealed that a particular patient was misdiagnosed, the
covered entity should be permitted to re-identify the patient's health
information so that the patient could be informed of the error and seek
appropriate care. One of the principal reasons entities retain
information in coded form, rather than rendering it anonymous, is to
enable re-identification of the information for appropriate reasons.
Although we would anticipate that the need for re-identification would
be rare, entities that expect to have to perform this function should
establish a process for determining when re-identification is
appropriate. Once covered entities re-identify information, it becomes
protected information and may, therefore, be used and disclosed only as
permitted by this regulation.
The phrase "individually identifiable" information is already in
use by many HHS agencies and others. In particular, the Common Rule
regulation includes "identifiable private information" in its
definition of "human subject." Because of this, medical records
research on "identifiable private information" is subject to Common
Rule consent and IRB review requirements. It would not be our intent to
suggest changes to this practice. Researchers and others can and are
encouraged to continue to use more stringent approaches to protecting
information.
We invite comment on the approach that we are proposing and on
alternative approaches to standards for covered entities to determine
when health information can reasonably be considered no longer
individually identifiable.
20. Law enforcement official. We propose a new definition of "law
enforcement official," to mean an officer of the United States or a
political subdivision thereof, who is empowered by law to conduct an
investigation or official proceeding inquiring into a violation of, or
failure to comply with, any law; or a criminal, civil, or
administrative proceeding arising from a violation of, or failure to
comply with, any law.
21. Payment. We offer a new definition of payment. The term
"payment" would mean activities undertaken by a health plan (or by a
business partner on behalf of a health plan) to determine its
responsibilities for coverage under the health plan policy or contract
including the actual payment under the policy or contract, or by a
health care provider (or by a business partner on behalf of a provider)
to obtain reimbursement for the provision of health care, including:
Determinations of coverage, improving payment
methodologies or coverage policies, or adjudication or subrogation of
claims;
Risk adjusting payments based on enrollee health status
and demographic characteristics;
Billing, claims management, medical review, medical data
processing;
Review of health care services with respect to medical
necessity, coverage under a health plan policy or contract,
appropriateness of care, or justification of charges; and,
Utilization review activities, including pre-certification
and preauthorization of services.
Our proposed definition is intended to capture the necessary
sharing of protected health information among health care providers who
provide care, health plans and other insurers who pay for care, their
business partners, as well as sponsors of group health plans, such as
employers, who pay for care and sometimes provide administrative
services in conjunction with health plan payment activities. For
example, employers sometimes maintain the eligibility file with respect
to a group health plan.
Our proposed definition anticipates that protected health
information would be used for payment purposes within entities, would
be shared with business partners, and in most cases would be shared
between health care providers and health plans (and their business
partners). In some cases, a payment activity could result in the
disclosure of protected health information by a plan to an employer or
to another payer of health care, or to an insurer that is not a covered
entity, such as for coordination of benefits or to a workers
compensation carrier. For example, a health plan could disclose
protected health information to an employer in connection with
determining the experience rate for group coverage.
We are concerned that disclosures for payments may routinely result
in disclosures of protected health information to non-covered entities,
such as employers, which are not subject to the use and disclosure
requirements of this rule. We considered prohibiting disclosures to
employers without individual authorization, or alternatively, requiring
a contractual relationship, similar to the contracts required for
business partners, before such disclosures could occur. We note that
the National Committee on Quality Assurance has adopted a standard for
the year 2000 that would require health plans to "have policies that
prohibit sending identifiable personal health information to fully
insured or self-insured employers and provide safeguards against the
use of information in any action relating to an individual" (Standard
R.R.6, National Committee for Quality Assurance 2000 Standards).
We did not adopt either of these approaches, however, because we
were concerned that we might disrupt some beneficial activities if we
were to prohibit or place significant conditions on disclosures by
health plans to employers. We also recognize that employers are paying
for health care in many cases, and it has been suggested to us that
they may need access to claims and other information for the purposes
of negotiating rates, quality improvement and auditing their plans and
claims administrators. We invite comment on the extent to which
employers currently receive protected health information about their
employees, for what types of activities protected health information is
received, and whether any or all of these activities could be
accomplished with de-identified health information. We also invite
other comments on how disclosures to employers should be treated under
this rule.
22. Protected health information. We would create a new definition
of "protected health information" to mean individually identifiable
health information that is or has been electronically maintained or
electronically transmitted by a covered entity, as well as such
information when it takes any other form. For example, protected health
information would remain protected after it is read from a computer
screen and discussed orally, printed onto paper or other media,
photographed, or otherwise duplicated. We note that individually
identifiable health information created or received by an employer as
such would not be considered protected health information, although
such information created or received by an employer in its role as a
health plan or provider would be protected health information.
Under this definition, information that is "electronically
transmitted" would include information exchanged with a computer using
electronic media, even when the information is physically
[[Page 59938]]
moved from one location to another using magnetic or optical media
(e.g., copying information from one computer to another using a floppy
disc). Transmissions over the Internet (i.e., open network), Extranet
(i.e., using Internet technology to link a business with information
only accessible to collaborating parties), leased lines, dial-up lines,
and private networks would all be included. Telephone voice response
and "faxback" (i.e., a request for information from a computer made
via voice or telephone keypad input with the requested information
returned as a fax) systems would be included because these are computer
output devices similar in function to a printer or video screen. This
definition would not include "paper-to-paper" faxes, or person-to-
person telephone calls, video teleconferencing, or messages left on
voice-mail. The key concept that determines if a transmission meets the
definition is whether the source or target of the transmission is a
computer. The medium or the machine through which the information is
transmitted or rendered is irrelevant.
Also, information that is "electronically maintained" would be
information stored by a computer or on any electronic medium from which
the information may be retrieved by a computer. These media include,
but are not limited to, electronic memory chips, magnetic tape,
magnetic disk, or compact disc (CD) optical media.
Individually identifiable health information that is part of an
"education record" governed by the Family Educational Rights and
Privacy Act (FERPA), 20 U.S.C. 1232g, would not be considered protected
health information. Congress specifically addressed such information
when it enacted FERPA to protect the privacy rights of students and
parents in educational settings. FERPA applies to educational records
that are maintained by educational agencies and institutions that are
recipients of federal funds from the Department of Education. FERPA
requires written consent of the parent or student prior to disclosure
of education records except in statutorily specified circumstances. We
do not believe that Congress intended to amend or preempt FERPA in
enacting HIPAA.
Individually identifiable health information of inmates of
correctional facilities and detainees in detention facilities would be
excluded from this definition because unimpeded sharing of inmate
identifiable health information is crucial for correctional and
detention facility operations. In a correctional or detention setting,
prison officials are required by law to safely house and provide health
care to inmates. These activities require the use and disclosure of
identifiable health information. Therefore, correctional and detention
facilities must routinely share inmate health information among their
health care and other components, as well as with community health care
facilities. In order to maintain good order and protect the well-being
of prisoners, the relationship between such facilities and inmates or
detainees involves a highly regulated, specialized area of the law
which has evolved as a carefully balanced compromise with due deference
to institutional needs and obligations.
Federal and other prison facilities routinely share health
information with community health care facilities in order to provide
medical treatment to persons in their custody. It is not uncommon for
inmates and detainees to be transported from one facility to another,
for example, for the purpose of making a court appearance in another
jurisdiction, or to obtain specialized medical care. In these and other
circumstances, law enforcement agencies such as the Federal Bureau of
Prisons (the Bureau), the United States Marshals Service (USMS), the
Immigration and Naturalization Service, State prisons, county jails,
and U.S. Probation Offices, share identifiable health information about
inmates and detainees to ensure that appropriate health care and
supervision of the inmate or detainee is maintained. Likewise, these
agencies must, in turn, share health information with the facility that
resumes custody of the inmate or detainee.
Requiring an inmate's or detainee's authorization for disclosure of
identifiable health information for day-to-day operations would
represent a significant shift in correctional and detention management
philosophy. If correctional and detention facilities were covered by
this rule, the proposed provisions for individual authorizations could
potentially be used by an inmate or detainee to override the safety and
security concerns of the correctional/custodial authority; for example,
an inmate being sent out on a federal writ could refuse to permit the
Bureau to disclose a suicide history to the USMS. Additionally, by
seeking an authorization to disclose the information, staff may give
the inmate or detainee advance notice of an impending transfer, which
in turn may create security risks.
Therefore we propose to exclude the individually identifiable
health information of inmates of correctional facilities and detainees
in detention facilities from the definition of protected health
information. We note that existing federal laws limiting the disclosure
and release of information (e.g., FOIA/Privacy Act) protect the privacy
of identifiable federal inmate health information. Subject to certain
limitations, these laws permit inmates and detainees to obtain and
review a copy of their medical records and to correct inaccurate
information.
Under this approach, the identifiable health information held by
correctional and detention facilities of persons who have been released
would not be protected. The facilities require continued access to such
information for security, protection and health care purposes because
inmates and detainees are frequently readmitted to correctional and
detention facilities. However, concern has been expressed about the
possibility that absent coverage by this proposed rule, correctional
and detention facilities may disclose information about former inmates
and detainees without restriction. We therefore request comments on
whether identifiable health information held by correctional and
detention facilities about former inmates and detainees should be
subject to this rule, and the potential security concerns and burden
such a requirement might place on these facilities.
23. Psychotherapy notes. We would define "psychotherapy notes" to
mean detailed notes recorded (in any medium) by a health care provider
who is a mental health professional documenting or analyzing the
contents of conversation during a private counseling session or a
group, joint, or family counseling session. Such notes are used only by
the therapist who wrote them, maintained separately from the medical
record, and not involved in the documentation necessary for health care
treatment, payment, or operations. Such term would not include
medication prescription and monitoring, counseling session start and
stop times or the modalities and frequencies of treatment furnished,
results of clinical tests, or a brief summary of the following items:
diagnosis, functional status, the treatment plan, symptoms, prognosis
and progress to date.
24. Public health authority. We would define "public health
authority" as an agency or authority of the United States, a State, a
territory, a political subdivision of a State or territory, or an
Indian tribe that is responsible for public health matters as part of
its official mandate.
25. Research. We would define "research" as a systematic
investigation,
[[Page 59939]]
including research development, testing and evaluation, designed to
develop or contribute to generalizable knowledge. We further explain
that "generalizable knowledge" is knowledge related to health that
can be applied to populations outside of the population served by the
covered entity.
This is the definition of "research" in the federal regulation
that protects human subjects, entitled The Federal Policy for the
Protection of Human Subjects (often referred to as the "Common Rule,"
at 45 CFR part 46). This definition is well understood in the research
community and elsewhere, and we propose to use it here to maintain
consistency with other federal regulations that affect research.
26. Research information unrelated to treatment. We would define
"research information unrelated to treatment" as information that is
received or created by a covered entity in the course of conducting
research for which there is insufficient scientific and medical
evidence regarding the validity or utility of the information such that
it should not be used for the purpose of providing health care,\2\ and
with respect to which the covered entity has not requested payment from
a health plan.
---------------------------------------------------------------------------
\2\ For example, validity is an indicator of how well a test
measures the property or characteristic it is intended to measure
and the reliability of a test, i.e., whether the same result is
obtained each time the test is used. Validity is also a measurement
of the accuracy with which a test predicts a clinical condition.
Utility refers to the degree to which the results of test can be
used to make decisions about the subsequent delivery of health care.
---------------------------------------------------------------------------
27. Treatment. We would define "treatment" to mean the provision
of health care by, or the coordination of health care (including health
care management of the individual through risk assessment, case
management, and disease management) among, health care providers, or
the referral of an individual from one provider to another, or
coordination of health care or other services among health care
providers and third parties authorized by the health plan or the
individual. Our definition is intended to relate only to services
provided to an individual and not to an entire enrolled population.
28. Use. We would propose a new definition of the term "use" to
mean the employment, application, utilization, examination or analysis
of health information within an entity that holds the information.
29. Workforce. We would define "workforce" to mean employees,
volunteers, trainees and other persons under the direct control of a
covered entity, including persons providing labor on an unpaid basis.
C. General Rules. (Sec. 164.506)
[Please label comments about this section with the subject:
"Introduction to general rules"]
The purpose of our proposal is to define and limit the
circumstances in which an individual's protected health information
could be used or disclosed by covered entities. As discussed above, we
are proposing to make the use and exchange of protected health
information relatively easy for health care purposes and more difficult
for purposes other than health care.
As a general rule, we are proposing that protected health
information not be used or disclosed by covered entities except as
authorized by the individual who is the subject of such information or
as explicitly provided by this rule. Under this proposal, most uses and
disclosures of an individual's protected health information would not
require explicit authorization by the individual, but would be
restricted by the provisions of the rule. Covered entities would be
able to use or disclose an individual's protected health information
without authorization for treatment, payment and health care
operations. See proposed Sec. 164.506(a)(1)(i). Covered entities also
would be permitted to use or disclose an individual's protected health
information for specified public and public policy-related purposes,
including public health, research, health oversight, law enforcement,
and use by coroners. Covered entities would be permitted by this rule
to use and disclose protected health information when required to do so
by other law, such as a mandatory reporting requirement under State law
or pursuant to a search warrant. See proposed Sec. 164.510. Covered
entities would be required by this rule to disclose protected health
information for only two purposes: To permit individuals to inspect and
copy protected health information about them (see proposed
Sec. 164.514) and for enforcement of this rule (see proposed
Sec. 164.522(e)).
The proposed rule generally would not require covered entities to
vary the level of protection of protected health information based on
the sensitivity of such information. We believe that all protected
health information should have effective protection from inappropriate
use and disclosure by covered entities, and except for limited classes
of information that are not needed for treatment and payment purposes,
we have not provided additional protection to protected health
information that might be considered particularly sensitive. We would
note that the proposed rule would not preempt provisions of other
applicable laws that provide additional privacy protection to certain
classes of protected health information. We understand, however, that
there are medical conditions and treatments that individuals may
believe are particularly sensitive, or which could be the basis of
stigma or discrimination. We invite comment on whether this rule should
provide for additional protection for such information. We would
appreciate comment that discusses how such information should be
identified and the types of steps that covered entities could take to
provide such additional protection. We also invite comment on how such
provisions could be enforced.
Covered entities of all types and sizes would be required to comply
with the proposed privacy standards outlined below. The proposed
standards would not impose particular mechanisms or procedures that
covered entities must adopt to implement the standards. Instead, we
would require that each affected entity assess its own needs and
devise, implement, and maintain appropriate privacy policies,
procedures, and documentation to address its business requirements. How
each privacy standard would be satisfied would be business decisions
that each entity would have to make. This allows the privacy standards
to establish a stable baseline, yet remain flexible enough to take
advantage of developments and methods for protecting privacy that will
evolve over time.
Because the privacy standards would need to be implemented by all
covered entities, from the smallest provider to the largest, multi-
state health plan, a single approach to implementing these standards
would be neither economically feasible nor effective in safeguarding
health information privacy. For example, in a small physician practice,
the office manager might be designated to serve as the privacy official
as one of many duties (see proposed Sec. 164.518(a)) whereas at a large
health plan, the privacy official may constitute a full time position
and have the regular support and advice of a privacy staff or board.
Similarly, a large enterprise may make frequent electronic
disclosures of similar data. In such a case, the enterprise would be
expected to remove identifiers or to limit the data fields that are
disclosed to fit the purpose of the disclosure. The process would be
documented and perhaps even automated. A solo physician's office,
however, would not be expected to have
[[Page 59940]]
the same capabilities to limit the amount of information disclosed,
although, in the cases of disclosures involving a small number of
records, such an office could be expected to hide identifiers or to
limit disclosures to certain pages of the medical record that are
relevant to the purpose of the disclosure.
In taking this approach, we intend to strike a balance between the
need to maintain the confidentiality of protected health information
and the economic cost of doing so. Health care entities must consider
both aspects in devising their solutions. This approach is similar to
the approach we proposed in the Notice of Proposed Rulemaking for the
administrative simplification security and electronic signature
standards.
1. Use and Disclosure for Treatment, Payment, and Health Care
Operations. (Sec. 164.506(a))
[Please label comments about this section with the subject:
"Treatment, payment, and health care operations"]
We are proposing that, subject to limited exceptions for
psychotherapy notes and research information unrelated to treatment
discussed below, a covered entity be permitted to use or disclose
protected health information without individual authorization for
treatment, payment or health care operations.
The Secretary's Recommendations proposed that covered entities be
able to use individually identifiable health information without
authorization of the identified individual for treatment and payment
and for purposes that are "compatible with and directly related to"
treatment and payment. The Recommendations further explained that the
terms "treatment" and "payment" were to be construed broadly,
encompassing treatment and payment for all patients. They also noted
that the test of "compatible with and directly related to" is meant
to be more restrictive than the test currently used in the Privacy Act,
5. U.S.C. 552a, for determining whether a proposed "routine use" is
sufficiently related to the primary purpose for which the information
would be collected to permit its release under the proposed "routine
use." The Privacy Act permits release of such information if the
proposed routine use is "compatible with" the purpose for which the
information is collected. Our proposal is intended to be consistent
with this discussion from the Secretary's Recommendations.
a. General rule for treatment, payment, and health care operations.
We are not proposing to require individual authorizations of uses and
disclosures for health care and related purposes, although such
authorizations are routinely gathered today as a condition of obtaining
health care or enrolling in a health plan. Although many current
disclosures of health information are made pursuant to individual
authorizations, these authorizations provide individuals with little
actual control over their health information. When an individual is
required to sign a blanket authorization at the point of receiving care
or enrolling for coverage, that consent is often not voluntary because
the individual must sign the form as a condition of treatment or
payment for treatment. Individuals are also often asked to sign broad
authorizations but are provided little or no information about how
their health information may be or will in fact be used. Individuals
cannot make a truly informed decision without knowing all the possible
uses, disclosures and re-disclosures to which their information will be
subject. In addition, since the authorization usually precedes creation
of the record, the individual cannot predict all the information the
record may contain and therefore cannot make an informed decision as to
what would be released.
Our proposal is intended to make the exchange of protected health
information relatively easy for health care purposes and more difficult
for purposes other than health care. For individuals, health care
treatment and payment are the core functions of the health care system.
This is what they expect their health information will be used for when
they seek medical care and present their proof of insurance to the
provider. Consistent with this expectation, we considered requiring a
separate individual authorization for every use or disclosure of
information but rejected such an approach because it would not be
realistic in an increasingly integrated health care system. For
example, a requirement for separate patient authorization for each
routine referral could impair care, by delaying consultation and
referral, as well as payment.
We therefore propose that covered entities be permitted to use and
disclose protected health information without individual authorization
for treatment and payment purposes, and for related purposes that we
have defined as health care operations. For example, health care
providers could maintain and refer to a medical record, disclose
information to other providers or persons as necessary for consultation
about diagnosis or treatment, and disclose information as part of
referrals to other providers. Health care providers also could use a
patient's protected health information for payment purposes such as
submitting a claim to a payer. In addition, they could use a patient's
protected health information for health care operations, such as use
for an internal quality oversight review. We would note that, in the
case of an individual where the provider has agreed to restrictions on
use or disclosure of the patient's protected health information, the
provider is bound by such restrictions as provided in Sec. 164.506(c).
Similarly, health plans could use an enrollee's protected health
information for payment purposes, such as reviewing and paying health
claims that have been submitted to it, pre-admission screening of a
request for hospitalization, or post-claim audits of health care
providers. Health plans also could use an enrollee's protected health
information for health care operations, such as reviewing the
utilization patterns or outcome performance of providers participating
in their network.
Further, as described in more detail below, health care providers
and health plans would not need individual authorization to provide
protected health information to a business partner for treatment,
payment or health care operations functions if the other requirements
for disclosing to business partners are met. See proposed
Sec. 164.506(e).
We intend that the right to use and disclose protected health
information be interpreted to apply for treatment and payment of all
individuals. For example, in the course of providing care to a patient,
a physician could wish to examine the records of other patients with
similar conditions. Likewise, a physician could consult the records of
several people in the same family or living in the same household to
assist in diagnosis of conditions that could be contagious or that
could arise from a common environmental factor. A health plan or a
provider could use the protected health information of a number of
enrollees to develop treatment protocols, practice guidelines, or to
assess quality of care. All of these uses would be permitted under this
proposed rule.
Our proposal would not restrict to whom disclosures could be made
for treatment, payment or operations. For example, covered entities
could make disclosures to non-covered entities for payment purposes,
such as a disclosure to a workers compensation carrier for coordination
of benefits purposes. We note, however, that when disclosures are made
to non-covered entities, the
[[Page 59941]]
ability of this proposed rule to protect the confidentiality of the
information ends. This points to the need for passage of more
comprehensive privacy legislation that would permit the restrictions on
use and disclosure to follow the information beyond covered entities.
We also propose to prohibit covered entities from seeking
individual authorization for uses and disclosures for treatment,
payment and health care operations unless required by State or other
applicable law. As discussed above in this section, such authorizations
could not provide meaningful privacy protections or individual control
and could in fact cultivate in individuals erroneous understandings of
their rights and protections.
The general approach that we are proposing is not new. Some
existing State health confidentiality laws permit disclosures without
individual authorization to other health care providers treating the
individual, and the Uniform Health-Care Information Act permits
disclosure "to a person who is providing health-care to the patient"
(9 part I, U.L.A. 475, 2-104 (1988 and Supp. 1998)). We believe that
this approach would be the most realistic way to protect individual
confidentiality in an increasingly data-driven, electronic and
integrated health care system. We recognize, however, that particularly
given the limited scope of the authority that we have under this
proposed rule to reach some significant actors in the health care
system, that other approaches could be of interest. We invite comments
on whether other approaches to protecting individuals' health
information would be more effective.
b. Health care operations. We considered the extent to which the
covered entities might benefit from further guidance on the types of
activities that appropriately would be considered health care
operations. The term is defined in proposed Sec. 164.504. In the
debates that have surrounded privacy legislation before the Congress,
there has been substantial discussion of the definition of health care
operations, with some parties advocating for a very broad definition
and others advocating a more restrictive approach.
Given the lack of consensus over the extent of the activities that
could be encompassed within the term health care operations, we
determined that it would be helpful to identify activities that, in our
opinion, are sufficiently unrelated to the treatment and payment
functions to require a individual to authorize use of his or her
information. We want to make clear that these activities would not be
prohibited, and do not dispute that many of these activities are indeed
beneficial to both individuals and the institutions involved.
Nonetheless, they are not necessary for the key functions of treatment
and payment and therefore would require the authorization of the
individual before his/her information could be used. These activities
would include but would not be limited to:
The use of protected health information for marketing of
health and non-health items and services;
The disclosure of protected health information for sale,
rent or barter;
The use of protected health information by a non-health
related division of the same corporation, e.g., for use in marketing or
underwriting life or casualty insurance, or in banking services;
The disclosure, by sale or otherwise, of protected health
information to a plan or provider for making eligibility or enrollment
determinations, or for underwriting or risk rating determinations,
prior to the individual's enrollment in the plan;
The disclosure of information to an employer for use in
employment determinations; and
The use or disclosure of information for fund raising
purposes.
We invite comments on the activities within the proposed
definitions of "treatment," "payment," and "health care
operations," as well as the activities proposed to be excluded from
these definitions.
c. Exception for psychotherapy notes. We propose that a covered
health care provider not be permitted to disclose psychotherapy notes,
as defined by this proposed rule, for treatment, payment, or health
care operations unless a specific authorization is obtained from the
individual. In addition, a covered entity would not be permitted to
condition treatment of an individual, enrollment of an individual in a
health plan, or payment of a claim for benefits made by or on behalf of
an individual on a requirement that the individual provide a specific
authorization for the disclosure of psychotherapy notes.
We would define "psychotherapy notes" to mean detailed notes
recorded (in any medium) by a health care provider who is a mental
health professional documenting or analyzing the contents of
conversation during a private counseling session or a group, joint, or
family counseling session. Such notes could be used only by the
therapist who wrote them, would have to be maintained separately from
the medical record, and could not be involved in the documentation
necessary for health care treatment, payment, or operations (as defined
in Sec. 164.504). Such term would not include medication prescription
and monitoring, counseling session start and stop times or the
modalities and frequencies of treatment furnished, results of clinical
tests, or summaries of the following items: diagnoses, functional
status, the treatment plan, symptoms, prognosis and progress to date.
Psychotherapy notes are of primary value to the specific provider
and the promise of strict confidentiality helps to ensure that the
patient will feel comfortable freely and completely disclosing very
personal information essential to successful treatment. Unlike
information shared with other health care providers for the purposes of
treatment, psychotherapy notes are more detailed and subjective and are
subject to unique rules of disclosure. In Jaffee v. Redmond, 518 U. S.
1 (1996), the Supreme Court ruled that conversations and notes between
a patient and psychotherapist are confidential and protected from
compulsory disclosure. The language in the Supreme Court opinion makes
the rationale clear:
Like the spousal and attorney-client privileges, the
psychotherapist-patient privilege is "rooted in the imperative need
for confidence and trust." * * * Treatment by a physician for
physical ailments can often proceed successfully on the basis of a
physical examination, objective information supplied by the patient,
and the results of diagnostic tests. Effective psychotherapy, by
contrast, depends upon an atmosphere of confidence and trust in
which the patient is willing to make a frank and complete disclosure
of facts, emotions, memories, and fears. Because of the sensitive
nature of the problems for which individuals consult
psychotherapists, disclosure of confidential communications made
during counseling sessions may cause embarrassment or disgrace. For
this reason, the mere possibility of disclosure may impede
development of the confidential relationship necessary for
successful treatment. As the Judicial Conference Advisory Committee
observed in 1972 when it recommended that Congress recognize a
psychotherapist privilege as part of the Proposed Federal Rules of
Evidence, a psychiatrist's ability to help her patients "is
completely dependent upon (the patients') willingness and ability to
talk freely. This makes it difficult if not impossible for (a
psychiatrist) to function without being able to assure * * *
patients of confidentiality and, indeed, privileged communication.
Where there may be exceptions to this general rule * * *, there is
wide agreement that confidentiality is a sine qua non for successful
psychiatric treatment. * * *"
By protecting confidential communications between a
psychotherapist and her patient
[[Page 59942]]
from involuntary disclosure, the proposed privilege thus serves
important private interests. * * * The psychotherapist privilege
serves the public interest by facilitating the provision of
appropriate treatment for individuals suffering the effects of a
mental or emotional problem. The mental health of our citizenry, no
less than its physical health, is a public good of transcendent
importance.
That it is appropriate for the federal courts to recognize a
psychotherapist privilege under Rule 501 is confirmed by the fact
that all 50 States and the District of Columbia have enacted into
law some form of psychotherapist privilege. * * * Because state
legislatures are fully aware of the need to protect the integrity of
the fact finding functions of their courts, the existence of a
consensus among the States indicates that "reason and experience"
support recognition of the privilege. In addition, given the
importance of the patient's understanding that her communications
with her therapist will not be publicly disclosed, any State's
promise of confidentiality would have little value if the patient
were aware that the privilege would not be honored in a federal
court. * * * Jaffee, 518 U.S. 7-9.
The special status of the psychotherapist privilege in our society
as well as the physical and conceptual segregation of the psychotherapy
notes makes this prohibition on disclosures for treatment, payment and
health care operations without a specific authorization from the
individual reasonable and practical.
We note that the policy being applied to psychotherapy notes
differs from the policy being applied to most other types of protected
health information. For most protected health information, a covered
entity would be prohibited from soliciting an authorization from an
individual for treatment, payment and health operations unless such an
authorization is required by other applicable law. In this case,
because of the special status of psychotherapy notes as described
above, we propose that a specific authorization be required before such
notes can be disclosed within the treatment and payment systems. We
propose this special treatment because there are few reasons why other
health care entities should need the psychotherapy notes about an
individual, and in those cases, the individual is in the best position
to determine if the notes should be disclosed. For example, an
individual could authorize disclosure if they are changing health care
providers. Since we have defined psychotherapy notes in such a way that
they do not include information that health plans would need to process
a claim for services, special authorizations for payment purposes
should be rare. We would note that the provisions governing
authorizations under Sec. 164.508 would apply to the special
authorizations under this provision.
We also propose that covered entities not be permitted to condition
treatment or payment decisions on a requirement that an individual
provide a specific authorization for the use or disclosure of
psychotherapy notes. The special protections that are being proposed
would not be meaningful if covered entities could coerce individuals by
conditioning treatment or payment decisions on a requirement that the
individual authorize use or disclosures of such notes. This requirement
would not prohibit the provider that creates the psychotherapy notes
information from using the notes for treatment of the individual. The
provider could not, however, condition the provision of treatment on a
requirement that the individual authorize the use of the psychotherapy
notes by the covered entity for other purposes or the disclosure of the
notes by the provider to others.
We considered including other disclosures permitted under proposed
Sec. 164.510 within the prohibition described in this provision, but
were unsure if psychotherapy notes were ever relevant to the public
policy purposes underlying those disclosures. For example, we would
assume that such notes are rarely disclosed for public health purposes
or to next of kin. We solicit comment on whether there are additional
categories of disclosures permitted under proposed Sec. 164.510 for
which the disclosure of psychotherapy notes by covered entities without
specific individual authorization would be appropriate.
d. Exception for research information unrelated to treatment. Given
the voluntary, often altruistic, nature of research participation, and
the experimental character of data generated from many research
studies, research participants should have assurances that the
confidentiality of their individually identifiable information will be
maintained in a manner that respects these unique characteristics. In
the process of conducting health research, some information that is
collected could be related to the delivery of health care to the
individual and some could be unrelated to the care of the individual.
Some information that is generated in the course of a research study
could have unknown analytic validity, clinical validity, or clinical
utility. In general, unknown analytic or clinical validity means that
the sensitivity, specificity, and predictive value of the research
information is not known. Specifically, analytic validity refers to how
well a test performs in measuring the property or characteristic it is
intended to measure. Another element of the test's analytical validity
is its reliability--that is, it must give the same result each time.
Clinical validity is the accuracy with which a test predicts a clinical
condition. Unknown clinical utility means that there is an absence of
scientific and medical agreement regarding the applicability of the
information for the diagnosis, prevention, or treatment of any malady,
or the assessment of the health of the individual.
We would define "research information unrelated to treatment" as
information that is received or created by a covered entity in the
course of conducting research for which there is insufficient
scientific and medical evidence regarding the validity or utility of
the information such that it should not be used for the purpose of
providing health care, and with respect to which the covered entity has
not requested payment from a health plan.
Such information should never be used in a clinical treatment
protocol but could result as a byproduct of such a protocol. For
example, consider a study which involves the evaluation of a new drug,
as well as an assessment of a genetic marker. The drug trial includes
physical and radiographic examinations, as well as blood tests to
monitor potential toxicity of the new drug on the liver; all of these
procedures are part of the provision of health care, and therefore,
would constitute "protected health information," but not "research
information unrelated to treatment." In the same study, the
investigators are searching for a genetic marker for this particular
disease. To date, no marker has been identified and it is uncertain
whether or not the preliminary results from this research study would
prove to be a marker for this disease. The genetic information
generated from this study would constitute "research information
unrelated to treatment".
We solicit comment on this definition of "research information
unrelated to treatment" and how it would work in practice.
Because the meaning of this information is currently unknown, we
would prohibit its use and disclosure for treatment, payment and health
care operations unless a specific authorization is obtained from the
subject of the information. Failing to limit the uses and disclosures
of this information within the health payment system would place
research participants at increased risk of discrimination, which could
result in
[[Page 59943]]
individuals refusing to volunteer to participate in this type of
research. Without the special protections that we are proposing, we are
concerned that much potentially life-saving research could be halted.
oreover, because this information that lacks analytical or clinical
validity and clinical utility, and because we have defined it in terms
that preclude researchers from seeking third-party reimbursement for
its creation, there would not be a reason for this information to be
further used or disclosed within the treatment and payment system
without individual authorization.
We also propose that covered entities not be permitted to condition
treatment or payment decisions on a requirement that an individual
provide a specific authorization for the use or disclosure of research
information unrelated to treatment. The special protections that are
being proposed would not be meaningful if covered entities could coerce
individuals into authorizing disclosure by conditioning treatment or
payment decisions on a requirement that the individual authorize
disclosures of such information. This requirement would not prohibit
the covered entity that creates the information from using the
information for the research purposes for which it was collected. The
entity could not, however, condition the provision of treatment on a
requirement that the individual authorize use of research information
unrelated to treatment by the covered entity for other purposes or the
disclosure of the information by the covered entity to others.
We considered including other of the uses and disclosures that
would be permitted under Sec. 164.510 within the prohibition described
in this provision, but were unsure if research information unrelated to
treatment would ever be relevant to the public policy purposes
underlying those disclosures. We solicit comment on whether there are
additional categories of uses or disclosures that would be permitted
under proposed Sec. 164.510 for which the use or disclosure of such
information by covered entities without specific individual
authorization would be appropriate.
2. Minimum Necessary Use and Disclosure. (Sec. 164.506(b))
[Please label comments about this section with the subject:
"Minimum necessary"]
We propose that, except as discussed below, a covered entity must
make all reasonable efforts not to use or disclose more than the
minimum amount of protected health information necessary to accomplish
the intended purpose of the use or disclosure, taking into
consideration practical and technological limitations.
In certain circumstances, the assessment of what is minimally
necessary is appropriately made by a person other than the covered
entity; in those cases, discussed in this paragraph, and reflected in
proposed Sec. 164.506(b)(1)(i), the requirements of this section would
not apply. First, the covered entity would not be required to make a
"minimum necessary" analysis for the standardized content of the
various HIPAA transactions, since that content has been determined
through regulation. Second, with one exception, when an individual
authorizes a use or disclosure the covered entity would not be required
to make a "minimum necessary" determination. In such cases, the
covered entity would be unlikely to know enough about the information
needs of the third party to make a "minimum necessary" determination.
The exception, when the "minimum necessary" principle would apply to
an authorization, is for authorizations for use of protected health
information by the covered entity itself. See proposed
Sec. 164.508(a)(2). Third, with respect to disclosures that are
mandatory under this or other law, and which would be permitted under
the rules proposed below, public officials, rather than the covered
entity, would determine what information is required (e.g., coroners
and medical examiners, State reporting requirements, judicial
warrants). See proposed Secs. 164.510 and 164.506(b)(1)(ii). Fourth,
disclosure made pursuant to a request by the individual for access to
his or her protected health information presents no possible privacy
threat and therefore lies outside this requirement. See proposed
Sec. 164.506(b)(1)(i).
Under this proposal, covered entities generally would be required
to establish policies and procedures to limit the amount of protected
health care information used or disclosed to the minimum amount
necessary to meet the purpose of the use or disclosure, and to limit
access to protected health information only to those people who need
access to the information to accomplish the use or disclosure. With
respect to use, if an entity consists of several different components,
the entity would be required to create barriers between components so
that information is not used inappropriately. For example, a health
plan that offers other insurance products would have policies and
procedures to prevent protected health information from crossing over
from one product line to another. The same principle applies to
disclosures. For example, if a covered entity opts to disclose
protected health information to a researcher pursuant to proposed
Sec. 164.510(j), it would need to ensure that only the information
necessary for the particular research protocol is disclosed.
It should be noted that, under section 1173(d) of the Act, covered
entities would also be required to satisfy the requirements of the
Security standards, by establishing policies and procedures to provide
access to health information systems only to persons who require
access, and implement procedures to eliminate all other access. Thus,
the privacy and security requirements would work together to minimize
the amount of information shared, thereby lessening the possibility of
misuse or inadvertent release.
A "minimum necessary" determination would need to be consistent
with and directly related to the purpose of the use or disclosure and
take into consideration the ability of a covered entity to delimit the
amount of information used or disclosed and the relative burden imposed
on the entity. The proposed minimum necessary requirement is based on a
reasonableness standard: covered entities would be required to make
reasonable efforts and to incur reasonable expense to limit the use and
disclosure of protected health information as provided in this section.
In determining what a reasonable effort is under this section,
covered entities should take into consideration the amount of
information that would be used or disclosed, the extent to which the
use or disclosure would extend the number of individuals or entities
with access to the protected health information, the importance of the
use or disclosure, the likelihood that further uses or disclosures of
the protected health information could occur, the potential to achieve
substantially the same purpose with de-identified information, the
technology available to limit the amount of protected health
information that is used or disclosed, the cost of limiting the use or
disclosure, and any other factors that the covered entity believes are
relevant to the determination. We would expect that in most cases where
covered entities have more information than is necessary to accomplish
the purpose of a use or disclosure, some method of limiting the
information that is used or disclosed could be found.
We note that all of the uses and disclosures subject to the
requirements of this provision are permissive; the minimum necessary
provision does not
[[Page 59944]]
apply to uses or disclosures mandated by law. Covered entities should
not make uses or disclosures of protected health information where they
are unable to make any efforts to reasonably limit the amount of
protected health information used or disclosed for a permissive
purpose. Where there is ambiguity regarding the particular information
to be used or disclosed, this provision should be interpreted to
require the covered entity or make some effort to limit the amount of
information used or disclosed.
We note that procedures for implementing the minimum necessary
requirement for uses would often focus on limiting the physical access
that employees, business partners and others would have to the
protected health information. Procedures which limit the specific
employees or business partners, or the types of employees or business
partners, who would be qualified to gain access to particular records
would often be appropriate. Covered entities with advanced
technological capabilities should also consider limiting access to
appropriate portions of protected health information when it would be
practical to do so.
The "minimum necessary" determination would include a
determination that the purpose of the use or disclosure could not be
reasonably accomplished with information that is not identifiable. Each
covered entity would be required to have policies for determining when
information must be stripped of identifiers before disclosure. If
identifiers are not removed simply because of inconvenience to the
covered entity, the "minimum necessary" rule would be violated.
Similarly, disclosure of an entire medical record, in response to a
request for something other than the entire medical record, would
presumptively violate the "minimum necessary" rule. Except where the
individual has specifically authorized use or disclosure of the full
medical record, when a covered entity receives a request for an entire
medical record, the covered entity could not, under these proposed
rules, disclose the entire record unless the request included an
explanation of why the purpose of the disclosure could not reasonably
be accomplished without the entire medical record.
The decisions called for in determining what would be the minimum
necessary information to accomplish an allowable purpose should include
both a respect for the privacy rights of the subjects of the medical
record and the reasonable ability of covered entities to delimit the
amount of individually identifiable health information in otherwise
permitted uses and disclosures. For example, a large enterprise that
makes frequent electronic disclosures of similar data would be expected
to remove identifiers or to limit the data fields that are disclosed to
fit the purpose of the disclosure. An individual physician's office
would not be expected to have the same capabilities to limit the amount
of information disclosed, although, in the cases of disclosures
involving a small number of records, such an office could be expected
to hide identifiers or to limit disclosures to certain pages of the
medical record that are relevant to the purpose of the disclosure.
Even where it might not be reasonable for a covered entity to limit
the amount of information disclosed, there could be opportunities, when
the use or disclosure does not require authorization by the individual,
to reduce the scope of the disclosure in ways that substantially
protect the privacy interests of the subject. For example, if a health
researcher wants access to relatively discrete parts of medical records
that are presently maintained in paper form for a large number of
patients with a certain condition, it could be financially prohibitive
for the covered entity to isolate the desired information. However, it
could be reasonable for the covered entity to allow the researcher to
review the records on-site and to abstract only the information
relevant to the research. Much records research is done today through
such abstracting, and this could be a good way to meet the "minimum
necessary" principle. By limiting the physical distribution of the
record, the covered entity would have effectively limited the scope of
the disclosure to the information necessary for the purpose.
Proposed Sec. 164.506(b) generally would place the responsibility
for determining what disclosure is the "minimum necessary" on the
covered entity making the disclosure. The exception would be for health
plan requests for information from health care providers for auditing
and related purposes. In this instance, since the provider is not in a
position to negotiate with the payer, the duty would be shifted to the
payer to request the "minimum necessary" information for the purpose.
See proposed Sec. 164.506(b)(1)(iv). Whenever a health plan requests a
disclosure, it would be required to limit its requests to the
information to achieve the purpose of the request. For example, a
health plan seeking protected health information from a provider or
other health plan to process a payment should not request the entire
health record unless it is actually necessary.
In addition, the proposal would permit covered entities to
reasonably rely on requests by certain public agencies in determining
the minimum necessary information for certain disclosures. For example,
a covered entity that reasonably relies on the requests of public
health agencies, oversight agencies, law enforcement agencies, coroners
or medical examiners would be in compliance with this requirement. See
proposed Sec. 164.506(b)(3).
As discussed in prior HIPAA proposed rulemakings, it is likely to
be easier to limit disclosure when disclosing computerized records than
when providing access to paper records. Technological mechanisms to
limit the amount of information available for a particular purpose, and
make information available without identifiers, are an important
contribution of technology to personal privacy. For example, the fields
of information that are disclosed can be limited, identifiers
(including names, addresses and other data) can be removed, and
encryption can restrict to authorized personnel the ability to link
identifiers back to the record.
For electronic information covered by the proposed rules, the
"minimum necessary" requirement would mean reviewing, forwarding, or
printing out only those fields and records relevant to the user's need
for information. Where reasonable (based on the size, sophistication
and volume of the covered entity's electronic information systems),
covered entities would configure their record systems to allow
selective access to different portions of the record, so that, for
example, administrative personnel get access to only certain fields,
and medical personnel get access to other fields. This selective access
to information would be implemented using the access control technology
discussed in the electronic security regulation.
For non-electronic information covered by the proposed rules,
"minimum necessary" would mean the selective copying of relevant
parts of protected health information or the use of "order forms" to
convey the relevant information. These techniques are already in use in
the health care environment today, not because of privacy
considerations, but because of the risk of losing access to the full
medical record when needed for clinic or emergency visits.
[[Page 59945]]
This rule would require, in proposed Sec. 164.520, that each
covered entity document the administrative policies and procedures that
it will use to meet the requirements of this section. With respect to
the "minimum necessary" compliance standard, such procedures would
have to describe the process or processes by which the covered entity
will make minimum necessary determinations, the person or persons who
will be responsible for making such determinations, and the process in
place to periodically review routine uses and disclosures in light of
new technologies or other relevant changes. Proposed uses or
disclosures would have to be reviewed by persons who have an
understanding of the entity's privacy policies and practices, and who
have sufficient expertise to understand and weigh the factors described
above. See proposed Sec. 164.506(b)(2). The policies that would be
reasonable would vary depending on the nature and size of the covered
entity. For large enterprises, the documentation of policies and
procedures might identify the general job descriptions of the people
that would make such decisions throughout the organization.
In addition, the procedures would provide that the covered entity
will review each request for disclosure individually on its own merits
(and, for research, the documentation of required IRB or other
approval). Covered entities should not have general policies of
approving all requests (or all requests of a particular type) for
disclosures or uses without carefully considering the factors
identified above as well as other information specific to the request
that the entity finds important to the decision.
We understand that the requirements outlined in this section do not
create a bright line test for determining the minimum necessary amount
of protected health information appropriate for most uses or
disclosures. Because of this lack of precision, we considered
eliminating the requirement altogether. We also considered merely
requiring covered entities to address the concept within their internal
privacy procedures, with no further guidance as to how each covered
entity would address the issue. These approaches were rejected because
minimizing both the amount of protected health information used and
disclosed within the health care system and the number of persons who
have access to such information is vital if we are to successfully
enhance the confidentiality of people's personal health information. We
invite comments on the approach that we have adopted and on alternative
methods of implementing the minimum necessary principle.
3. Right to Restrict Uses and Disclosures. (Sec. 164.506(c))
[Please label comments about this section with the subject: "Right
to restrict"]
We propose to permit in Sec. 164.506(c) that individuals be able to
request that a covered entity restrict further uses and disclosures of
protected health information for treatment, payment, or health care
operations, and if the covered entity agrees to the requested
restrictions, the covered entity could not make uses or disclosures for
treatment, payment or health care operations that are inconsistent with
such restrictions, unless such uses or disclosures are mandated by law.
This provision would not apply to health care provided to an individual
on an emergency basis.
This proposal would not restrict the right of a provider to make an
otherwise permissible disclosure under Sec. 164.510, such as a
disclosure for public health or emergency purposes. While there is
nothing in this proposed rule that would prohibit a provider and an
individual from agreeing in advance not to make such disclosures, such
an agreement would not be enforceable through this proposed rule.
We should note that there is nothing in this proposed rule that
requires a covered entity to agree to a request to restrict, or to
treat or provide coverage to an individual requesting a restriction
under this provision. Covered entities who do not wish to, or due to
contractual obligations cannot, restrict further use or disclosure
would not be obligated to treat an individual making a request under
this provision. For example, some health care providers could feel that
it is medically inappropriate to honor patient requests under this
provision. The medical history and records of a patient, particularly
information about current medications and other therapies, are often
very much relevant when new treatment is sought, and the patient cannot
seek to withhold this information from subsequent providers without
risk.
Under this proposal, individuals could request broad restrictions
on further uses and disclosures for treatment, payment or health care
operations, or could request more limited restrictions relating to
further uses or disclosures of particular portions of the protected
health information or to further disclosures to particular persons.
Covered entities could choose to honor the individual's request, could
decline to treat or provide coverage to the individual, or could
propose an alternative restriction of further use or disclosure. The
covered entity would not be bound by an individual's request for
restriction until its scope has been agreed to by the individual and
the provider. Once an agreement has been reached, however, a covered
entity that uses or discloses the protected health information
resulting from the encounter in any manner that violates such agreement
would be in violation of this provision.
We are not proposing to extend this right to individuals receiving
emergency medical care, because emergency situations may not afford
sufficient opportunity for the provider and patient to discuss the
potential implications of restricting further use and disclosure of the
resulting medical information. Additionally, a health care provider may
not be free to refuse treatment to an emergency patient if the provider
does not wish to honor a request to restrict further use or disclosure
of health information, leaving the provider in an unfair position where
she or he must choose between permitting medical harm to come to the
patient or honoring a request that she or he feels may be inappropriate
or which may violate the provider's business practices or contractual
obligations. Some health care providers are legally required to treat
emergency patients (e.g., hospital emergency rooms), and would have no
opportunity to refuse treatment as a result of a request to restrict
further use and disclosure under this provision. Under the pressure of
an emergency, a provider should not be expected to adhere to the
restrictions associated with a particular individual's information.
Under this proposal, covered entities would not be responsible for
ensuring that agreed-upon restrictions are honored when the protected
health information leaves the control of the covered entity or its
business partners. For example, a provider would not be out of
compliance if information she or he disclosed to another provider
(consistent with the agreed upon restrictions and with notice of the
applicable restrictions on uses and disclosures) is subsequently used
or disclosed in violation of the restrictions.
The agreement to restrict use and disclosure under this provision
would have to be documented to be binding on the covered entity. In
proposed Sec. 164.520, we would require covered entities to develop and
document policies and procedures reasonably designed to ensure that the
requests are followed, i.e., that unauthorized uses and disclosures are
not made.
[[Page 59946]]
We note that this proposed rule would not permit covered entities
to require individuals to invoke their right to restrict uses and
disclosures; only the patient could make a request and invoke this
right to restrict.
We considered providing individuals substantially more control over
their protected health information by requiring all covered entities to
attempt to accommodate any restrictions on use and disclosure requested
by patients. We rejected this option as unworkable. While industry
groups have developed principles for requiring patient authorizations,
we have not found widely accepted standards for implementing patient
restrictions on uses or disclosures. Restrictions on information use or
disclosure contained in patient consent forms are sometimes ignored
because they may not be read or are lost in files. Thus, it seems
unlikely that a requested restriction could successfully follow a
patient's information through the health care system--from treatment to
payment, through numerous operations, and potentially through certain
permissible disclosures. Instead we would limit the provision to
restrictions that have been agreed to by the covered entity.
We recognize that the approach that we are proposing could be
difficult because of the systems limitations described above. However,
we believe that the limited right for patients included in this
proposed rule can be implemented because it only applies in instances
in which the covered entity agrees to the restrictions. We assume that
covered entities would not agree to restrictions that they are unable
to implement.
We considered limiting the rights under this provision to patients
who pay for their own health care (or for whom no payment was made by a
health plan). Individuals and health care providers that engage in
self-pay transactions have minimal effect on the rights or
responsibilities of payers or other providers, and so there would be
few instances when a restriction agreed to in such a situation would
have negative implications for the interests of other health care
actors. Limiting the right to restrict to self-pay patients also would
reduce the number of requests that would be made under this provision.
We rejected this approach however, because the desire to restrict
further uses and disclosures arises in many instances other than self-
pay situations. For example, a patient could request that his or her
records not be shared with a particular physician because that
physician is a family friend. Or an individual could be seeking a
second opinion and might not want his or her treating physician
consulted. Individuals have a legitimate interest in restricting
disclosures in these situations. We solicit comment on the
appropriateness of limiting this provision to instances in which no
health plan payment is made on behalf of the individual.
In making this proposal, we recognize that it could be difficult in
some instances for patients to have a real opportunity to make
agreements with covered entities, because it would not be clear in all
cases which representatives of a covered entity could make an agreement
on behalf of the covered entity. There also are concerns about the
extent to which covered entities could ensure that agreed-upon
restrictions would be followed. As mentioned above, current
restrictions contained in patient consent forms are sometimes ignored
because the person handling the information is unaware of the
restrictions. We solicit comments on the administrative burdens this
provision creates for covered entities, such as the burdens of
administering a system in which some information is protected by
federal law and other information is not.
We would note that we expect that systems for handling patient
requests to restrict use and disclosure of information will become more
responsive as technology develops. Therefore, we will revisit this
provision as what is practicable changes over time. Proposed
requirements for documenting internal procedures to implement this
proposed provision are included in proposed Sec. 164.520. We request
comments on whether the final rule should provide examples of
appropriate, scalable systems that would be in compliance with this
standard.
4. Creation of De-identified Information (164.506(d))
[Please label comments about this section with the subject:
"Creation of de-identified information"]
In this rule we are proposing that covered entities and their
business partners be permitted to use protected health information to
create de-identified health information. Covered entities would be
permitted to further use and disclose such de-identified information in
any way, provided that they do not disclose the key or other mechanism
that would enable the information to be re-identified, and provided
that they reasonably believe that such use or disclosure of de-
identified information will not result in the use or disclosure of
protected health information. See proposed Sec. 164.506(d)(1). This
means that a covered entity could not disclose de-identified
information to a person if the covered entity reasonably believes that
the person would be able to re-identify some or all of that
information, unless disclosure of protected health information to such
person would be permitted under this proposed rule. In addition, a
covered entity could not use or disclose the key to coded identifiers
if this rule would not permit the use or disclosure of the identified
information to which the key pertains. If a covered entity re-
identifies the de-identified information, it may only use or disclose
the re-identified information consistent with these proposed rules, as
if it were the original protected health information.
In some instances, covered entities creating de-identified health
information could want to use codes or identifiers to permit data
attributable to the same person to be accumulated over time or across
different sources of data. For example, a covered entity could
automatically code all billing information as it enters the system,
substituting personal identifiers with anonymous codes that permit
tracking and matching of data but do not permit people handling the
data to create protected health information. Such a mechanism would be
permissible as long as the key to unlocking the codes is not available
to the people working with the de-identified information, and the
entity otherwise makes no attempt to create protected health
information from the de-identified information.
There are many instances in which such individually identifiable
health information is stripped of the information that could identify
individual subjects and is used for analytical, statistical and other
related purposes. Large data sets of de-identified information can be
used for innumerable purposes that are vital to improving the
efficiency and effectiveness of health care delivery, such as
epidemiological studies, comparisons of cost, quality or specific
outcomes across providers or payers, studies of incidence or prevalence
of disease across populations, areas or time, and studies of access to
care or differing use patterns across populations, areas or time.
Researchers and others often obtain large data sets with de-identified
information from providers and payers (including from public payers) to
engage in these types of studies. This information is valuable for
public health activities (e.g., to identify cost-effective
interventions for a particular disease) as well as for
[[Page 59947]]
commercial purposes (e.g., to identify areas for marketing new health
care services).
We intend that this proposed provision will permit the important
health care research that is being conducted today to continue under
this rule. Indeed, it would be our hope that covered entities, their
business partners, and others would make greater use of de-identified
health information than they do today, when it is sufficient for the
research purpose. Such practice would reduce the confidentiality
concerns that result from the use of individually identifiable health
information for some of these purposes. The selective transfer of
health information without identifiers into an analytic database would
significantly reduce the potential for privacy violations while
allowing broader access to information for analytic purposes, without
the overhead of audit trails and IRB review. For example, providing de-
identified information to a pharmaceutical manufacturer to use in
determining patterns of use of a particular pharmaceutical by general
geographic location would be appropriate, even if the information were
sold to the manufacturer. Such analysis using protected health
information would be research and therefore would require individual
authorization or approval by an IRB or similar board. We note that data
that includes an individual's address is "identifiable" by definition
and could not be used in such databases.
We invite comment on the approach that we are proposing and on
whether alternative approaches to standards for entities determining
when health information can reasonably be considered no longer
individually identifiable.
5. Application to business partners. (Sec. 164.506(e))
[Please label comments about this section with the subject:
"Business partners"]
In Sec. 164.506(e), we propose to require covered entities to take
specific steps to ensure that protected health information disclosed to
a business partner remains protected. We intend these provisions to
allow customary business relationships in the health care industry to
continue while providing privacy protections to the information shared
in these relationships. Business partners would not be permitted to use
or disclose protected health information in ways that would not be
permitted of the covered entity itself under these rules.
Other than for purposes of consultation or referral for treatment,
we would allow covered entities to disclose protected health
information to business partners only pursuant to a written contract
that would, among other specified provisions, limit the business
partner's uses and disclosures of protected health information to those
permitted by the contract, and would impose certain security,
inspection and reporting requirements on the business partner. We would
hold the covered entity responsible for certain violations of this
proposed rule made by their business partners, and require assignment
of responsibilities when a covered entity acts as a business partner of
another covered entity.
a. Who is a business partner? Under this proposed rule, a business
partner would be a person to whom the covered entity discloses
protected health information so that the person can carry out, assist
with the performance of, or perform on behalf of, a function or
activity for the covered entity. This would include contractors or
other persons who receive protected health information from the covered
entity (or from another business partner of the covered entity) for the
purposes described in the previous sentence, including lawyers,
auditors, consultants, third-party administrators, health care
clearinghouses, data processing firms, billing firms, and other covered
entities. This would not include persons who would be members of the
covered entity's workforce. The key features of the relationship would
be that the business partner is performing an activity or function for
or on behalf of the covered entity and that the business partner
receives protected health information from the covered entity as part
of providing such activity or function.
Many critical functions are performed every day by individuals and
organizations that we would define as business partners. Under the
proposal, billing agents, auditors, third-party administrators,
attorneys, private accreditation organizations, clearinghouses,
accountants, data warehouses, consultants and many other actors would
be considered business partners of a covered entity. Most covered
entities will use one or more business partners, to assist with
functions such as claims filing, claims administration, utilization
review, data storage, or analysis. For example, if a covered entity
seeks accreditation from a private accreditation organization and
provides such organization with protected health information as part of
the accreditation process, the private accreditation organization would
be a business partner of the covered entity. This would be true even if
a third party, such as an employer or a public agency, required
accreditation as a condition of doing business with it. The
accreditation is being performed for the covered entity, not the third
party, in such cases.
The covered entity may have business relationships with
organizations that would not be considered to be business partners
because protected health information is not shared or because services
are not provided to the covered entity. For example, a covered entity
could contract with another organization for facility management or
food services; if these organizations do not receive protected health
information for these functions or activities, they would not be
considered business partners. In the case where a covered entity
provides management services to another organization, the other
organization would not be a business partner because it would be
receiving, not providing, a service or function.
Under the proposal, a covered entity could become a business
partner of another covered entity, such as when a health plan acts as a
third-party administrator to an insurance arrangement or a self-funded
employee benefit plan. In such cases, we propose that the authority of
the covered entity acting as a business partner to use and disclose
protected health information be constrained to the authority that any
business partner in the same situation would have. Thus, the authority
of a covered entity acting as a business partner to use and disclose
protected health information obtained as a business partner would be
limited by the contract or arrangement that created the business
partner relationship.
In most cases, health care clearinghouses would fall under our
definition of "business partner" because they receive protected
health information in order to provide payment processing and other
services to health plans, health care providers and their business
partners, a case that would fall under our definition of "business
partner." Therefore, although health care clearinghouses would be
covered entities, in many instances under this proposed rule they would
also be treated as business partners of the health care providers or
health plans for whom they are performing a service. We would note that
because health care clearinghouses would generally be operating as
business partners, we are proposing not to apply several requirements
to health care clearinghouses that we otherwise would apply to covered
plans and providers, such as requiring a notice of information
[[Page 59948]]
practices, access for inspection and copying, and accommodation of
requests for amendment or correction. See proposed Secs. 164.512,
164.514 and 164.516.
b. Limitations on use or disclosure.
i. Scope of the covered entity's authority.
Under this proposed rule, a business partner would be acting on
behalf of a covered entity, and we propose that its use or disclosure
of protected health information be limited to the same extent that the
covered entity for whom they are acting would be limited. Thus, a
business partner could have no more authority to use or disclose
protected health information than that possessed by the covered entity
from which the business partner received the information. For example,
a business partner could not sell protected health information to a
financial services firm without individual authorization because the
covered entity would not be permitted to do so under these proposed
rules. We would note that a business partner's authority to use and
disclose protected health information could be further restricted by
its contract with a covered entity, as described below.
We are not proposing to require the business partners of covered
entities to develop and distribute a notice of information practices,
as provided in proposed Sec. 164.512. A business partner would,
however, be bound by the terms of the notice of the covered entity from
which it obtains protected health information. For example, if a
covered entity provided notice to its subscribers that it would not
engage in certain permissible disclosures of protected health
information, we are proposing that such a limitation would apply to all
of the business partners of the covered entity that made the
commitment. See proposed Sec. 164.506(e). We are proposing this
approach so that individuals could rely on the notices that they
receive from the covered entities to which they disclose protected
health information. If the business partners of a covered entity were
able to make wider use or make more disclosures than the covered
entity, the patients or enrollees of the covered entity would have
difficulty knowing how their information was being used and to whom it
was being disclosed.
ii. Scope of the contractual agreement.
We are also proposing that a business partner's use and disclosure
of protected health information be limited by the terms of the business
partner's contractual agreement with the covered entity. We propose
that a contract between a covered entity and a business partner could
not grant the business partner authority to make uses or disclosures of
protected health information that the covered entity itself would not
have the authority to make. The contract between a covered entity and a
business partner could further limit the business partner's authority
to use or disclose protected health information as agreed to by the
parties. Further, the business partner would have to apply the same
limitations to its subcontractors (or persons with similar
arrangements) who assist with or carry out the business partner's
activities.
To help ensure that the uses and disclosures of business partners
would be limited to those recognized as appropriate by the covered
entities from whom they receive protected health information, subject
to the exception discussed below, we are proposing that covered
entities be prohibited from disclosing protected health information to
a business partner unless the covered entity has entered into a written
contract with the business partner that meets the requirements of this
subsection. See proposed Sec. 164.506(e)(2)(i). The written contract
between a covered entity and a business partner would be required to:
Prohibit the business partner from further using or
disclosing the protected health information for any purpose other than
the purpose stated in the contract.
Prohibit the business partner from further using or
disclosing the protected health information in a manner that would
violate the requirements of this proposed rule if it were done by the
covered entity. As discussed above, the covered entity could not permit
the business partner to make uses or disclosures that the covered
entity could not make.
Require the business partner to maintain safeguards as
necessary to ensure that the protected health information is not used
or disclosed except as provided by the contract. We are only proposing
a general requirement; the details can be negotiated to meet the
particular needs of each arrangement. For example, if the business
partner is a two-person firm the contractual provisions regarding
safeguards may focus on controlling physical access to a computer or
file drawers, while a contract with a business partner with 500
employees would address use of electronic technologies to provide
security of electronic and paper records.
Require the business partner to report to the covered
entity any use or disclosure of the protected health information of
which the business partner becomes aware that is not provided for in
the contract.
Require the business partner to ensure that any
subcontractors or agents to whom it provides protected health
information received from the covered entity will agree to the same
restrictions and conditions that apply to the business partner with
respect to such information.
Establish how the covered entity would provide access to
protected health information to the subject of that information, as
would be required under Sec. 164.514, when the business partner has
made any material alteration in the information. The covered entity and
the business partner would determine in advance how the covered entity
would know or could readily ascertain, when a particular individual's
protected health information has been materially altered by the
business partner, and how the covered entity could provide access to
such information.
Require the business partner to make available its
internal practices, books and records relating to the use and
disclosure of protected health information received from the covered
entity to HHS or its agents for the purposes of enforcing the
provisions of this rule.
Establish how the covered entity would provide access to
protected health information to the subject of that information, as
would be required under Sec. 164.514, in circumstances where the
business partner will hold the protected health information and the
covered entity will not.
Require the business partner to incorporate any amendments
or corrections to protected health information when notified by the
covered entity that the information is inaccurate or incomplete.
At termination of the contract, require the business
partner to return or destroy all protected health information received
from the covered entity that the business partner still maintains in
any form to the covered entity and prohibit the business partner from
retaining such protected health information in any form.
State that individuals who are the subject of the
protected health information disclosed are intended to be third party
beneficiaries of the contract.
Authorize the covered entity to terminate the contract, if
the covered entity determines that the business partner has repeatedly
violated a term of the contract required by this paragraph.
Each specified contract term above would be considered a separate
implementation specification under this proposal for situations in
which a
[[Page 59949]]
contract is required, and, as discussed below, a covered entity would
be responsible for assuring that each such implementation standard is
met by the business partner. See proposed Sec. 164.506(e)(2). The
contract could include any additional arrangements that do not violate
the provisions of this regulation.
The contract requirement that we are proposing would permit covered
entities to exercise control over their business partners' activities
and provide documentation of the relationship between the parties,
particularly the scope of the uses and disclosures of protected health
information that business partners could make. The presence of a
contract also would formalize the relationship, better ensuring that
key questions such as security, scope of use and disclosure, and access
by individuals are adequately addressed and that the roles of the
respective parties are clarified. Finally, a contract can bind the
business partner to return any protected health information from the
covered entity when the relationship is terminated.
In lieu of a contracting requirement, we considered imposing only
affirmative duties on covered entities to ensure that their
relationships with business partners conformed to the standards
discussed in the previous paragraph. Such an approach could be
considered less burdensome and restrictive, because we would be leaving
it to the parties to determine how to make the standards effective. We
rejected this approach primarily because we believe that in the vast
majority of cases, the only way that the parties could establish a
relationship with these terms would be through contract. We also
determined that the value of making the terms explicit through a
written contract would better enable the parties to know their roles
and responsibilities, as well as better enable the Secretary to
exercise her oversight role. In addition, we understand that most
covered entities already enter into contracts in these situations and
therefore this proposal would not disturb general business practice. We
invite comment on whether there are other contractual or non-
contractual approaches that would afford an adequate level of
protection to individuals' protected health information. We also invite
comment on the specific provisions and terms of the proposed approach.
We are proposing one exception to the contracting requirement: when
a covered entity consults with or makes a referral to another covered
entity for the treatment of an individual, we would propose that the
sharing of protected health information pursuant to that consultation
or referral not be subject to the contracting requirement described
above. See proposed Sec. 164.506(e)(1)(i). Unlike most business partner
relationships, which involve the systematic sharing of protected health
information under a business relationship, consultation and referrals
for treatment occur on a more informal basis among peers, and are
specific to a particular individual. Such exchanges of information for
treatment also appear to be less likely to raise concerns about further
impermissible use or disclosure, because health care providers
receiving such information are unlikely to have a commercial or other
interest in using or disclosing the information. We invite comment on
the appropriateness of this exception, and whether there are additional
exceptions that should be included in the final regulation.
We note that covered health care providers receiving protected
health information for consultation or referral purposes would still be
subject to this rule, and could not use or disclose such protected
health information for a purpose other than the purpose for which it
was received (i.e., the consultation or referral). Further, we note
that providers making disclosures for consultations or referrals should
be careful to inform the receiving provider of any special limitations
or conditions to which the disclosing provider has agreed to impose
(e.g., the disclosing provider has provided notice to its patients that
it will not make disclosures for research).
Under the system that we are proposing, business partners
(including business partners that are covered entities) that have
contracts with more than one covered entity would have no authority to
combine, aggregate or otherwise use for a single purpose protected
health information obtained from more than one covered entity unless
doing so would have been a lawful use or disclosure for each of the
covered entities that supplied the protected health information that is
being combined, aggregated or used. In addition, the business partner
must be authorized through the contract or arrangement with each
covered entity that supplied the protected health information to
combine or aggregate the information. For example, a business partner
of a health plan would be permitted to disclose information to another
health plan for coordination of benefits purposes, if such a disclosure
were authorized by the business partner's contract with the covered
entity that provided the protected health information. However, a
business partner that is performing an audit of a group medical
practice on behalf of several health plans could not combine protected
health information that it had received from each of the plans, even if
the business partner's contracts with the plans attempted to allow such
activity, because the plans themselves would not be permitted to
exchange protected health information for such a purpose. A covered
entity would not be permitted to obtain protected health information
through a business partner that it could not otherwise obtain itself.
We further note that, as discussed above in section II.C.4, under
our proposal a business partner generally could create a database of
de-identified health information drawn from the protected health
information of more than one covered entity with which it does
business, and could use and disclose information and analyses from the
database as they see fit, as long as there was no attempt to re-
identify the data to create protected health information. In the
example from the preceding paragraph, the business partner could review
the utilization patterns of a group medical practice on behalf of
several groups of plans by establishing a data base of de-identified
health information drawn from all of its contracts with covered
entities and review the use patterns of all of the individuals in the
data base who had been treated by the medical group. The results of the
analyses could be used by or distributed to any person, subject to the
limitation that the data could not be identified. We would caution that
business partners releasing such information and analyses would need to
ensure that they do not inadvertently disclose protected health
information by releasing examples or discussing specific cases in such
a way that the information could be identified by people receiving the
analysis or report.
c. Accountability. We are proposing that covered entities be
accountable for the uses and disclosures of protected health
information by their business partners. A covered entity would be in
violation of this rule if the covered entity knew or reasonably should
have known of a material breach of the contract by a business partner
and it failed to take reasonable steps to cure the breach or terminate
the contract. See proposed Sec. 164.506(e)(2)(iii). A covered entity
that is aware of impermissible uses and disclosures by a business
partner would be responsible for taking such steps as are necessary to
prevent further improper use or disclosures and, to the extent
practicable, for mitigating any harm caused by such violations.
[[Page 59950]]
This could include, for example, requiring the business partner to
retrieve inappropriately disclosed information (even if the business
partner must pay for it) as a condition of continuing to do business
with the covered entity. A covered entity that knows or should know of
impermissible use of protected health information by its business
partner and fails to take reasonable steps to end the breach would be
in violation of this rule.
Where a covered entity acts as a business partner to another
covered entity, the covered entity that is acting as business partner
would also be responsible for any violations of the regulation.
We considered requiring covered entities to terminate relationships
with business partners if the business partner committed a serious
breach of contact terms required by this subsection or if the business
partner exhibited a pattern or practice of behavior that resulted in
repeated breaches of such terms. We rejected that approach because of
the substantial disruptions in business relationships and customer
service when terminations occur. We instead require the covered entity
to take reasonable steps to end the breach and mitigate its effects. We
would expect covered entities to terminate the arrangement if it
becomes clear that a business partner cannot be relied upon to maintain
the privacy of protected health information provided to it. We invite
comments on our approach here and whether requiring automatic
termination of business partner contracts would be warranted in any
circumstances.
We also considered imposing more strict liability on covered
entities for the actions of their business partners, just as principals
are strictly liable for the actions of their agents under common law.
We decided, however, that this could impose too great a burden on
covered entities, particularly small providers. We are aware that, in
some cases, the business partner will be larger and more sophisticated
with respect to information handling than the covered entity. Therefore
we instead opted to propose that covered entities monitor use of
protected health information by business partners, and be held
responsible only when they knew or reasonably should have known of
improper use of protected health information.
Our intention in this subsection is to recognize the myriad
business relationships that currently exist and to ensure that when
they involve the exchange of protected health information, the roles
and responsibilities of the different parties with respect to the
protected health information are clear. We do not propose to
fundamentally alter the types of business relationships that exist in
the health care industry or the manner in which they function. We
request comments on the extent to which our proposal would disturb
existing contractual or other arrangements among covered entities and
business partners.
6. Application to Information About Deceased Persons (Sec. 164.506(f))
[Please label comments about this section with the subject:
"Deceased persons"]
We are proposing that information otherwise protected by these
regulations retain that protection for two years after the death of the
subject of the information. The only exception that we are proposing is
for uses and disclosures for research purposes.
HIPAA includes no temporal limitations on the application of the
privacy protections. Although we have the authority to protect
individually identifiable health information maintained by a covered
entity indefinitely, we are proposing that the requirements of this
rule generally apply for only a limited period, as discussed below. In
traditional privacy law, privacy interests, in the sense of the right
to control use or disclosure of information about oneself, cease at
death. However, good arguments exist in favor both of protecting and
not protecting information about the deceased. Considering that one of
the underlying purposes of health information confidentiality is to
encourage a person seeking treatment to be frank in the interest of
obtaining care, there is good reason for protecting information even
after death. Federal agencies and others sometimes withhold sensitive
information, such as health information, to protect the privacy of
surviving family members. At the same time, perpetual confidentiality
has serious drawbacks. If information is needed for legitimate
purposes, the consent of a living person legally authorized to grant
such consent must be obtained, and the further from the date of death,
the more difficult it may be to identify the person. The administrative
burden of perpetual protection may eventually outweigh the privacy
interests served.
The proposed two-year period of confidentiality, with an exception
for uses and disclosures for research purposes, would preserve dignity
and respect by preventing uncontrolled disclosure of information
immediately after death while allowing access to the information for
proper purposes during this period and for any purpose thereafter. We
would not subject the use or disclosure of protected health information
of deceased individuals to the requirements in proposed Sec. 164.510(j)
governing most uses and disclosures for research because we believe
that it is important to remain as consistent as possible with the
Common Rule. The Common Rule does not consider deceased persons to be
"human subjects" and therefore they have never been covered in the
standard research protocol assessments conducted under the Common Rule.
The Department of Health and Human Services will examine this issue in
the context of an overall assessment of the Common Rule. Pending the
outcome of this examination, we concluded that this exception was
warranted so as not to interfere with standard research practice. We
invite comments on whether the exception that we are proposing is
necessary, or whether existing research using the protected health
information of deceased individuals could proceed under the
requirements of proposed Sec. 164.510(j).
Under our proposal, and subject to the exceptions discussed above,
the right to control the individual's health information within that
two-year time period would be held by an executor or administrator, or
in the absence of such an officer, by next-of-kin, as determined under
applicable law, or in absence of both, by the holder of the health
information. This is reflected in the proposed definition of
"individual" discussed above. The legally authorized representative
would make decisions for the individual with regard to uses or
disclosures of the information for purposes not related to treatment,
payment or health care operations. Likewise, an authorized
representative could exercise the individual rights of inspection,
copying, amendment or correction under proposed Secs. 164.514 and
164.516.
Under our proposal, information holders could choose to keep
information confidential for a longer period. These proposed rules also
would not override any legally required prohibitions on disclosure for
longer periods.
One area of concern regarding the proposed two-year period of
protection relates to information on individual genetic make-up or
individual diseases and conditions that may be hereditary. Under the
proposed rules, covered entities would be legally allowed to use such
information or to disclose records to others, such as commercial
collectors
[[Page 59951]]
of information, two years after the death of the individual. Since
genetic information about one family member may reveal health
information about other members of that family, the health data
confidentiality of living relatives could be compromised by such uses
or disclosures. Likewise, information regarding the hereditary diseases
or conditions of the deceased person may reveal health information
about living relatives. In the past, information that may not have been
legally protected was de facto protected for most people because of the
difficulty of its collection and aggregation. With the dramatic
proliferation of large electronic databases of information about
individuals, growing software-based intelligence, and the declining
cost of linking information from disparate sources, such information
could now be more readily and cost-effectively accessed.
While various State laws have been passed specifically addressing
privacy of genetic information, there is currently no federal
legislation that deals with these issues. We considered extending the
two-year period for genetic and hereditary information, but were unable
to construct criteria for protecting the possible privacy interests of
living children without creating extensive burden for information
holders and hampering health research. We invite comments on whether
further action is needed in this area and what types of practical
provisions may be appropriate to protect genetic and hereditary health
information.
7. Adherence to the Notice of Information Practices (Sec. 164.506(g))
[Please label comments about this section with the subject:
"Adherence to notice"]
In Sec. 164.506(g), we are proposing that covered plans and
providers be required to adhere to the statements reflected in the
notice of information practices that would be required under proposed
Sec. 164.512. In binding covered plans and providers to their notices,
we intend to create a system where open and accurate communication
between entities and individuals would become necessary and routine.
The corollary to this general rule is that the covered plan or provider
would be permitted to modify its notice at any time.
The information practices reflected in the most recent notice would
apply to all protected health information regardless of when the
information was collected. For example, if information was collected
during a period when the notice stated that no disclosures would be
made to researchers, and the covered plan or provider later decided
that it wanted to disclose information to researchers, the entity would
then need to revise its notice. The entity would be permitted to
disclose all of the information in its custody to researchers as long
as the notice is revised and re-distributed as provided below in
Sec. 164.512. We considered permitting a covered entity to change its
information practices only with respect to protected health information
obtained after it revised its notice. Such a requirement would ensure
individuals that the notice they received when they disclosed
information to the covered entity would continue to apply to that
information. We rejected that approach because compliance with such a
standard would require covered entities to segregate or otherwise mark
information to be based on the information practices that were in
effect at different times. Such an approach would make covered entities
extremely reluctant to revise the information practices, and otherwise
would be extremely burdensome to administer.
We are concerned that by requiring covered plans and providers to
adhere to the practices reflected in their notice, we would encourage
entities to create broad, general notices so that all possible uses,
disclosures and other practices would be included. Such broad notices
would not achieve the goals of open and accurate communication between
entities and individuals. We welcome comments on this requirement and
alternative proposals to achieve the same goals.
8. Application to Covered Entities That Are Components of Organizations
That Are Not Covered Entities
[Please label comments about this section with the subject:
"Component entities"]
In this section we describe how the provisions of this proposed
rule apply to persons or organizations that provide health care or have
created health plans but are primarily engaged in other unrelated
activities. Examples of such organizations include schools that operate
on-site clinics, employers who operate self-funded health plans, and
information processing companies that include a health care services
component. The health care component (whether or not separately
incorporated) of the organization would be the covered entity.
Therefore, any movement of protected health information into another
component of the organization would be a "disclosure," and would be
lawful only if such disclosure would be authorized by this regulation.
In addition, we propose to require such entities to create barriers to
prevent protected health information from being used or disclosed for
other activities not authorized or permitted under these proposed
rules.
For example, schools frequently employ school nurses or operate on-
site clinics. In doing so, the nurse or clinic component of the school
would be acting as a provider, and must conform to this proposed rule.
School clinics would be able to use protected health information
obtained in an on-site clinic for treatment and payment purposes, but
could not disclose it to the school for disciplinary purposes except as
permitted by this rule. Similarly, an employee assistance program of an
employer could meet the definition of "provider," particularly if
health care services are offered directly by the program. Protected
health information obtained by the employee assistance program could be
used for treatment and payment purposes, but not for other purposes
such as hiring and firing, placement and promotions, except as may be
permitted by this rule.
D. Uses and Disclosures With Individual Authorization (Sec. 164.508)
[Please label comments about this section With the subject:
"Individual authorization"]
This section addresses the requirements that we are proposing when
protected health information is disclosed pursuant to the individual's
explicit authorization. The regulation would require that covered
entities have authorization from individuals before using or disclosing
their protected health information for any purpose not otherwise
recognized by this regulation. Circumstances where an individual's
protected health information may be used or disclosed without
authorization are discussed in connection with proposed Secs. 164.510
and 164.522 below.
This section proposes different conditions governing such
authorizations in two situations in which individuals commonly
authorize covered entities to disclose information:
Where the individual initiates the authorization because
he or she wants a covered entity to disclose his or her record, and
Where a covered entity asks an individual to authorize it
to disclose or use information for purposes other than treatment,
payment or health care operations.
In addition, this section proposes conditions where a covered
entity or the individual initiates an authorization for use or
disclosure of psychotherapy notes or research information unrelated
[[Page 59952]]
to treatment. See discussion above in section II.C.1.c.
Individually identifiable health information is used for a vast
array of purposes not directly related to providing or paying for an
individual's health care. Examples of such uses include targeted
marketing of new products and assessing the eligibility of an
individual for certain public benefits or for commercial products based
on their health status. Under these rules, these types of uses and
disclosures could only be made by a covered entity with the specific
authorization of the subject of the information. The requirements
proposed in this section are not intended to interfere with normal uses
and disclosures of information in the health care delivery or payment
process, but only to permit control of uses extraneous to health care.
The restrictions on disclosure that the regulation would apply to
covered entities may mean that some existing uses and disclosures of
information could take place only if the individual explicitly
authorized them under this section.
Authorization would be required for these uses and disclosures
because individuals probably do not envision that the information they
provide when getting health care would be disclosed for such unrelated
purposes. Further, once a patient's protected health information is
disclosed outside of the treatment and payment arena, it could be very
difficult for the individual to determine what additional entities have
seen, used and further disclosed the information. Requiring an
authorization from the patient for such uses and disclosures would
enhance individuals' control over their protected health information.
We considered requiring a uniform set of requirements for all
authorizations, but concluded that it would be appropriate to treat
authorizations initiated by the individual differently from
authorizations sought by covered entities. There are fundamental
differences in the uses of information and in the relationships and
understandings among the parties in these two situations. When
individuals initiate authorizations, they are more likely to understand
the purpose of the release and to benefit themselves from the use or
disclosure. When a covered entity asks the individual to authorize
disclosure, we believe the entity should make clear what the
information will be used for, what the individual's rights are, and how
the covered entity would benefit from the requested disclosure.
Individuals seek disclosure of their health information to others
in many circumstances, such as when applying for life or disability
insurance, when government agencies conduct suitability investigations,
and in seeking certain job assignments where health is relevant.
Another common instance is tort litigation, where an individual's
attorney needs individually identifiable health information to evaluate
an injury claim and asks the individual to authorize disclosure of
records relating to the injury to the attorney.
There could also be circumstances where the covered entity asks an
individual to authorize use or disclosure of information, for example
to disclose it to a subsidiary to market life insurance to the
individual. Similarly, the covered entity might ask that the individual
authorize it to send information to a person outside that covered
entity--possibly another covered entity or class of covered entity--for
purposes outside of treatment, payment, or health care operations. See
proposed Sec. 164.508(a)(2)(ii).
1. Requirements When the Individual Has Initiated the Authorization
We are proposing several requirements that would have to be met in
the authorization process when the individual has initiated the
authorization.
The authorization would have to include a description of the
information to be used or disclosed with sufficient specificity to
allow the covered entity to know to which information the authorization
references. For example, the authorization could include a description
of "laboratory results from July 1998" or "all laboratory results"
or "results of MRI performed in July 1998." The covered entity would
then use or disclose that information and only that information. If the
covered entity does not understand what information is covered by the
authorization, the use or disclosure would not be permitted unless the
covered entity were able to clarify the request.
We are proposing no limitations on the information to be disclosed.
If an individual wishes to authorize a covered entity to disclose his
or her entire medical record, the authorization could so specify. But
in order for the covered entity to disclose the entire medical record,
the authorization would have be specific enough to ensure that
individuals have a clear understanding of what information is to be
disclosed under the circumstances. For example, if the Social Security
Administration seeks authorization for release of all health
information to facilitate the processing of benefit applications, then
the description would need to specify "all health information."
We would note that our proposal does not require a covered entity
to disclose information pursuant to an individual's authorization.
Therefore individuals may face reluctance on the part of covered
entities that receive authorizations requiring them to classify and
selectively disclose information when they do not benefit from the
activity. Individuals would need to consider this when specifying the
information in the authorization. Covered entities may respond to
requests to analyze and separate information for selective disclosure
by providing the entire record to the individual, who may then redact
and release the information to others.
We do not propose to require an authorization initiated by an
individual to state a purpose. When the individual has initiated the
authorization, the entity would not need to know why he or she wants
the information disclosed. Ideally, anyone asking an individual to
authorize release of individually identifiable health information would
indicate the purpose and the intended uses. We are unable to impose
requirements on the many entities that make such requests, and it would
not be feasible to ask covered entities to make judgments about
intended uses of records that are disclosed. In the absence of legal
controls in this situation, the prudent individual would obtain a clear
understanding of why the requester needs the information and how it
would be used.
We are proposing that the authorization would be required to
identify sufficiently the covered entity or covered entities that would
be authorized to use or disclose the protected health information by
the authorization. Additionally, the authorization would be required to
identify the person or persons that would be authorized to use or
receive the protected health information with sufficient specificity to
reasonably permit a covered entity responding to the authorization to
identify the authorized user or recipient. When an authorization
permits a class of covered entities to disclose information to an
authorized person, each covered entity would need to know with
reasonable certainty that the individual intended for it to release
protected health information under the authorization.
Often, individuals provide authorizations to third parties, who
present them to one or more covered entities. For example, an
authorization could be completed by an individual
[[Page 59953]]
and provided to a government agency, authorizing the agency to receive
medical information from any health care provider that has treated the
individual within a defined period. Such an authorization would be
permissible (subject to the other requirements of this part) if it
sufficiently identifies the government entity as the recipient of the
disclosures and it sufficiently identifies the health care providers
who would be authorized to release the individual's protected health
information under the authorization.
We are proposing that the authorization must state a specific
expiration date. We considered providing an alternative way of
describing the termination of the authorization, such as "the
conclusion of the clinical trial," or "upon acceptance or denial of
this application for life insurance" (an "event"), but we are
concerned that covered entities could have difficulty implementing such
an approach. We also considered proposing that if an expiration date
were indicated on the authorization, it be no more than two or three
years after the date of the signature. We are soliciting comment on
whether an event can be a termination specification, and whether this
proposed rule should permit covered entities to honor authorizations
with "unlimited" or extremely lengthy expiration dates or limit it to
a set term of years, such as two or three years.
We are proposing that the authorization include a signature or
other authentication (e.g., electronic signature) and the date of the
signature. If the authorization is signed by an individual other than
the subject of the information to be disclosed, that individual would
have to indicate his or her authority or relationship with the subject.
The authorization would also be required to include a statement
that the individual understands that he or she may revoke an
authorization except to the extent that action has been taken in
reliance on the authorization.
When an individual authorizes disclosure of health information to
other than a covered entity, the information would no longer be
protected under this regulation once it leaves the covered entity.
Therefore, we propose that the authorization must clearly state that
the individual understands that when the information is disclosed to
anyone except a covered entity, it would no longer be protected under
this regulation.
We understand that the requirements that we are imposing here would
make it quite unlikely that an individual could actually initiate a
completed authorization, because few individuals would know to include
all of these elements in a request for information. We understand that
in most instances, individuals accomplish authorizations for release of
health records by completing a form provided by another party, either
the ultimate recipient of the records (who may have a form authorizing
them to request the records from the record holders) or a health care
provider or health plan holding the records (who may have a form that
documents a request for the release of records to a third party). For
this reason, we do not believe that our proposal would create
substantial new burdens on individuals or covered entities in cases
when an individual is initiating an authorized release of information.
We invite comment on whether we are placing new burdens on individuals
or covered entities. We also invite comment on whether the approach
that we have proposed provides sufficient protection to individuals who
seek to have their protected health information used or disclosed.
2. Requirements When the Covered Entity Initiates the Authorization
We are proposing that when covered entities initiate the
authorization by asking individuals to authorize disclosure, the
authorization be required to include all of the items required above as
well as several additional items. We are proposing additional
requirements when covered entities initiate the request for
authorization because in many cases it could be the covered entity, and
not the individual, that achieves the primary benefit of the
disclosure. We considered permitting covered entities to request
authorizations with only the basic features proposed for authorizations
initiated by the individual, for the sake of simplicity and
consistency. However, we believe that additional protections would be
merited when the entity that provides or pays for health care requests
an authorizations to avert possible coercion.
When a covered entity asks an individual to sign an authorization,
we propose to require that it provide on the authorization a statement
that identifies the purposes for which the information is sought as
well as the proposed uses and disclosures of that information. The
required statements of purpose would provide individuals with the facts
they need to make an informed decision as to whether to allow release
of the information. Covered entities and their business partners would
be bound by the statements provided on the authorization, and use or
disclosure by the covered entity inconsistent with the statement would
constitute a violation of this regulation. We recognize that the
covered entities cannot know or control uses and disclosures that will
be made by persons who are not business partners to whom the
information is properly disclosed. As discussed above, authorizations
would need to notify individuals that when the information is disclosed
to anyone except a covered entity, it would no longer be protected
under this regulation.
We propose to require that authorizations requested by covered
entities be narrowly tailored to authorize use or disclosure of only
the protected health information necessary to accomplish the purpose
specified in the authorization. The request would be subject to the
minimum necessary requirement as discussed in section II.C.2. We would
prohibit the use of broad or blanket authorizations requesting the use
or disclosure of protected health information for a wide range of
purposes. Both the information that would be used or disclosed and the
specific purposes for such uses or disclosures would need to be
specified in the notice.
We are proposing that when covered entities ask individuals to
authorize use or disclosure for purposes other than for treatment,
payment, or health care operations, they be required to advise
individuals that they may inspect or copy the information to be used or
disclosed as provided in proposed Sec. 164.514, that they may refuse to
sign the authorization, and that treatment and payment could not be
conditioned on the patient's authorization. For example, a request for
authorization to use or disclose protected health information for
marketing purposes would need to clearly state that the individual's
decision would have no influence on his or her health care treatment or
payment. In addition, we are proposing that when a covered entity
requests an authorization, it must provide the individual with a copy
of the signed authorization form.
Finally, we are proposing that when the covered entity initiates
the authorization and the covered entity would be receiving financial
or in-kind compensation in exchange for using or disclosing the health
information, the authorization would include a statement that the
disclosure would result in commercial gain to the covered entity. For
example, a health plan may wish to sell or rent its enrollee mailing
list. A pharmaceutical company may offer a provider a discount on its
products if
[[Page 59954]]
the provider can obtain authorization to disclose the demographic
information of patients with certain diagnoses so that the company can
market new drugs to them directly. A pharmaceutical company could pay a
pharmacy to send marketing information to individuals on its behalf.
Each such case would require a statement that the requesting entity
will gain financially from the disclosure.
We considered requiring a contract between the provider and the
pharmaceutical company in this type of arrangement, because such a
contract could enhance protections and enforcement options against
entities who violate these rules. A contract also would provide covered
entities a basis to enforce any limits on further use or disclosures by
authorized recipients. Although we are not proposing this approach now,
we are soliciting comment on how best to protect the interests of the
patient when the authorization for use or disclosure would result in
commercial gain to the covered entity.
3. Model Forms
Covered entities and third parties that wish to have information
disclosed to them would need to prepare forms for individuals to use to
authorize use or disclosure. A model authorization form is displayed in
Appendix to this proposed rule. We considered presenting separate model
forms for the two different types of authorizations (initiated by the
individual and not initiated by the individual). However, this approach
could be subject to misuse and be confusing to covered entities and
individuals, who may be unclear as to which form is appropriate in
specific situations. The model in the appendix accordingly is a unitary
model, which includes all of the requirements for both types of
authorization.
4. Plain Language Requirement
We are proposing that all authorizations must be written in plain
language. If individuals cannot understand the authorization they may
not understand the results of signing the authorization or their right
to refuse to sign. See section II.F.1 for more discussion of the plain
language requirement.
5. Prohibition on Conditioning Treatment or Payment
We propose that covered entities be prohibited, except in the case
of clinical trial as described below, from conditioning treatment or
payment for health care on obtaining an authorization for purposes
other than treatment, payment or health care operations. This is
intended to prevent covered plans and providers from coercing
individuals into signing an authorization for a disclosure that is not
necessary for treatment, payment or health care operations. For
example, a provider could not refuse to treat an individual because the
individual refused to authorize a disclosure to a pharmaceutical
manufacturer for the purpose of marketing a new product.
We propose one exception to this provision: health care providers
would be permitted to condition treatment provided as part of a
clinical trial on obtaining an authorization from the individual that
his or her protected health information could be used or disclosed for
research associated with such clinical trial. Permitting use of
protected health information is part of the decision to receive care
through a clinical trial, and health care providers conducting such
trials should be able to condition participation in the trial on the
individual's willingness to authorize that his or her protected health
information be used or disclosed for research associated with the
trial. We note that the uses and disclosures would be subject to the
requirements of Sec. 164.510(j) below.
Under the proposal, a covered entity would not be permitted to
obtain an authorization for use or disclosure of information for
treatment, payment or health care operations unless required by
applicable law. Where such an authorization is required by law,
however, it could not be combined in the same document with an
individual authorization to use or disclosure of protected health
information for any purpose other than treatment, payment or health
care operations (e.g., research). We would require that a separate
document be used to obtain any other individual authorizations to make
it clear to the individual that providing an authorization for such
other purpose is not a condition of receiving treatment or payment.
6. Inclusion in the Accounting and Disclosures
As discussed in section II.H.6, we propose that covered entities be
required to keep a record of all disclosures for purposes other than
treatment, payment or health care operations, including those made
pursuant to authorization. In addition, we propose that when an
individual requests such an accounting or requests a copy of a signed
authorization form, the covered entity must give a copy to the
individual. See proposed Sec. 164.515.
7. Revocation of an Authorization by the Individual
We are proposing that an individual be permitted to revoke an
authorization at any time except to the extent that action has been
taken in reliance on the authorization. See proposed Sec. 164.508(e).
That is, an individual could change her or his mind about an
authorization and cancel it, except that she or he could not thereby
prevent the use or disclosure of information if the recipient has
already acted in reliance on the authorization. For example, an
individual might cancel her or his authorization to receive future
advertisements, but the entity may be unable to prevent mailing of the
advertisements that the covered entity or third party has already
prepared but not yet mailed.
An individual would revoke the old authorization and sign a new
authorization when she or he wishes to change any of the information in
the original authorization. Upon receipt of the revocation, the covered
entity would need to stop processing the information for use or
disclosure to the greatest extent practicable.
8. Expired, Deficient, or False Authorization
The model authorization form or a document that includes the
elements set out at proposed Sec. 164.508 would meet the requirements
of this proposed rule and would have to be accepted by the covered
entity. Under Sec. 164.508(b), there would be no "authorization"
within the meaning of the rules proposed below if the submitted
document has any of the following defects:
The date has expired;
On its face it substantially fails to conform to any of
the requirements set out in proposed Sec. 164.508, because it lacks an
element;
It has not been filled out completely. Covered entities
may not rely on a blank or incomplete authorization;
The authorization is known to have been revoked; or
The information on the form is known by the person holding
the records to be materially false.
We understand that it would be difficult for a covered entity to
confirm the identity of the person who signed the authorization. We
invite comment on reasonable steps that a covered entity could take to
be assured that the individual who requests the disclosure is whom she
or he purports to be.
[[Page 59955]]
E. Uses and Disclosures Permitted Without Individual Authorization
(Sec. 164.510)
[Please label comments about this section with the subject:
"Introduction to uses and disclosures without individual
authorization"]
This section describes uses and disclosures of protected health
information that covered entities could make for purposes other than
treatment, payment, and health care operations without individual
authorization, and the conditions under which such uses and disclosures
could be made. We propose to allow covered entities to use or disclose
protected health information without individual authorization for such
purposes if the use or disclosure would comply with the applicable
requirements of this section.
These categories of allowable uses and disclosures are designed to
permit and promote key national health care priorities, and to ensure
that the health care system operates smoothly. For each of these
categories, this rule would permit--but not require--the covered entity
to use or disclose protected health information without the
individual's authorization. Some covered entities could conclude that
the records they hold, or portions of them, should not be used or
disclosed for one or more of these permitted purposes without
individuals' authorization (absent a law mandating such disclosure),
even under the conditions imposed here. The proposed regulation is
intended to reflect the importance of safeguarding individuals'
confidentiality, while also enabling important national priority
activities that require protected health information.
We considered permitting uses and disclosures only where law
affirmatively requires the covered entity to use or disclose protected
health information. However, because the activities described below are
so important to the population as a whole, we decided to permit a
covered entity to use or disclose information to promote those
activities even when such activities are not legally mandated. In some
cases, however, we would permit a use or disclosure only when such use
or disclosure is authorized by other law. The requirements for
verification of legal authority are discussed in each relevant section.
Where another law forbids the use or disclosure of protected health
information without the individual's authorization, nothing in this
section would permit such use or disclosure.
Other law may require use or disclosure of protected health
information. If such a use or disclosure is not otherwise addressed in
proposed Sec. 164.510(b) through (m), we would in proposed
Sec. 164.510(n) permit covered entities to use or disclose protected
health information without individual authorization pursuant to any law
that mandates such use or disclosure. To be in compliance with this
rule, the covered entity must meet the requirements of such other law
requiring the use or disclosure. Similarly, nothing in this rule would
provide authority for a covered entity to restrict or refuse to make a
use or disclosure mandated by other law.
The HIPAA legislative authority generally does not bring the
entities that receive disclosures pursuant to this section, including
public health authorities, oversight and law enforcement agencies,
researchers, and attorneys, under the jurisdiction of this proposed
rule. We therefore generally cannot propose restrictions on the further
use and disclosure of protected health information obtained by the
recipients of these disclosures (unless the recipient is also a covered
entity). We believe, however, that in most instances it is sound policy
to restrict further uses and disclosures of such protected health
information. For example, the Secretary's Recommendations proposed that
protected health information obtained by researchers not be further
disclosed except for emergency circumstances, for a research project
that meets certain conditions, and for oversight of research. We
believe that federal legislation should include appropriate
restrictions on further use and disclosure of protected health
information received by entities for purposes such as those described
in this section. We note that, under S.578 (introduced by Senator
Jeffords), protected health information disclosed for oversight could
not be used against the subject of the protected health information
unless the action arises out of and is directly related to a health
care fraud or a fraudulent claim for benefits, unless such use is
judicially authorized. We believe such safeguards strike the right
balance between encouraging national priority oversight activities and
protecting individuals' privacy.
The provisions of this section contain requirements related to use
and requirements related to disclosure, as appropriate to each of the
purposes discussed. For many of these purposes, only requirements
relating to disclosure are proposed because there are no appropriate
internal uses for such a purpose. Examples include disclosures for
next-of-kin and disclosures for banking and financial purposes.
For many of these permitted disclosures, we would require the
covered entity to verify the identity of the requestor and his or her
legal authority to make the request. Requirements for verifying the
identity and authority of requests for information are further
discussed in II.G, "Administrative Requirements." As discussed in
more detail in section II.G.3. of this preamble, the verification
requirement would apply where the identity of the person making the
request is not already known to the covered entity (e.g., where the
disclosure is not part of a routine business transaction). We would ask
health plans and health care providers to take reasonable steps to
verify the identity of persons requesting protected health information,
such as asking to see a badge or other proof of the identity of
government officials, and would allow covered entities to rely on the
statement of government officials and others regarding the legal
authority for the activity. We would not require covered entities to
make an independent inquiry into the legal authority behind requests
for protected health information.
The provisions below would permit covered entities to use or
disclose protected health information without individual authorization,
pursuant to certain requirements. Although health care clearinghouses
would be defined as covered entities under this rule, in most instances
clearinghouses will be receiving and maintaining protected health
information as the business partner of a covered health plan or
provider. In such cases, proposed Sec. 164.510(a)(2) provides that the
clearinghouses that hold protected health information as business
partners would not be permitted to make uses or disclosures otherwise
permitted by this section unless such uses or disclosures also were
permitted under the terms of the contract between the clearinghouse and
the business partner.
1. Uses and Disclosures for Public Health Activities (Sec. 164.510(b))
[Please label comments about this section with the subject: "Public
health"]
We propose to permit covered entities to disclose protected health
information without individual authorization to public health
authorities carrying out public health activities authorized by law, to
non-governmental entities authorized by law to carry out public health
activities, and to persons who may be at risk of contracting or
spreading a disease (when other law
[[Page 59956]]
authorizes notification). Where the covered entity also is a public
health agency, such as a public hospital or local health department, it
would be permitted to use protected health information in all cases in
which it would be permitted to disclose such information for public
health activities under this section.
a. Importance of public health and need for protected health
information. Public health authorities are responsible for promoting
health and quality of life by preventing and controlling disease,
injury, and disability. Inherent in the collection of information for
public health activities is a balancing of individual versus communal
interests. While the individual has an interest in maintaining the
privacy of his or her health information, public health authorities
have an interest in the overall health and well-being of the entire
population of their jurisdictions. To accomplish this, public health
authorities engage in a number of activities, including: traditional
public health surveillance; investigations and interventions with
respect to communicable diseases; registries (such as immunization or
cancer registries); programs to combat diseases that involve contacting
infected persons and providing treatment; and actions to prevent
transmission of serious communicable diseases.
Public health activities also include regulatory investigations and
interventions such as pre-market review of medical products, and
evaluations of the risk-benefit profile of a drug or medical product
before and after approval (relying on critical epidemiological
techniques and resources such as HMO claims databases and medical
records). Public health agencies use the results of analyses to make
important labeling changes and take other actions, such as the removal
of non-compliant products from the market.
We considered requiring individual authorization for certain public
health disclosures, but rejected this approach because many important
public health activities would not be possible if individual
authorization were required. In the case of contagious diseases, for
example, if individual authorization were required before individually
identifiable information could be provided to public health workers,
many other people who may be harboring contagious diseases may be
missed by efforts to halt the spread of disease because they failed to
provide the appropriate individual authorization. Their failure to
authorize could place the general population at risk for contracting an
infectious disease. Furthermore, always requiring individual
authorization to disclose protected health information to public health
authorities would be impractical due to the number of reports and the
variety of sources from which they are made. If individuals were
permitted to opt out from having their information included in these
public health systems, the number of persons with a particular
condition would be undercounted. Furthermore, the persons who did
authorize the inclusion of their information in the system might not be
representative of all persons with the disease or condition.
We also considered limiting certain public health disclosures to
de-identified health information. However, identifiable information
could be required in order to track trends in a disease over time, and
to assess the safety of medical treatments. While de-identified
information could be appropriate for many public health activities,
there are also many public health activities that require individual
identifiers. We decided not to attempt to define specific public health
activities for which only de-identified information could be disclosed,
in part because public health data collection requirements would be
better addressed in public health laws, and in part to reflect the
variation in information technologies available to public health
authorities. Instead, we rely on the judgment of public health
authorities as to what information would be necessary for a public
health activity. See discussion in section II.C.2.
b. Public health activities. We intend a broad reading of the term
"public health activities" to include the prevention or control of
disease, injury, or disability. We considered whether to propose a
narrow or broad scope of public health activities for which disclosure
without individual authorization would be permitted. For the reasons
described above, we believe that both the general public and individual
interests are best served by a broad approach to public health
disclosures.
We therefore propose that covered entities be permitted to disclose
protected health information to public health authorities for the full
range of public health activities described above, including reporting
of diseases, injuries, and conditions, reporting of vital events such
as birth and death to vital statistics agencies, and a variety of
activities broadly covered by the terms public health surveillance,
public health investigation, and public health intervention. These
would include public health activities undertaken by the FDA to
evaluate and monitor the safety of food, drugs, medical devices, and
other products. These terms would be intended to cover the spectrum of
public health activities carried out by federal, State, and local
public health authorities. The actual authorities and terminology used
for public health activities will vary under different jurisdictions.
We do not intend to disturb or limit current public health activities.
c. Permitted recipients of disclosures for public health
activities. Disclosures without individual authorization for public
health activities would be permitted to be made to only three types of
persons: public health authorities, non-governmental entities
authorized by law to carry out public health activities, and persons
who may be at risk of contracting or spreading a disease, if other law
authorizes notification.
i. Public health authorities.
We propose to define "public health authority" broadly, based on
the function being carried out, not the title of the public entity.
Therefore, disclosures under this proposed rule would not be limited to
traditional public health entities such as State health departments.
Other government agencies and entities carry out public health
activities in the course of their missions. For example, the
Occupational Safety and Health Administration, the Mine Safety and
Health Administration, and the National Institute for Occupational
Safety and Health conduct public health investigations related to
occupational health and safety. The National Transportation Safety
Board investigates airplane and train crashes in an effort to reduce
mortality and injury by making recommendations for safety improvements.
Similar inquiries are conducted by the military services. The Food and
Drug Administration reviews product performance prior to marketing, and
investigates adverse events reported after marketing by industries,
health professionals, consumers, and others. The Environmental
Protection Agency investigates the effects of environmental factors on
health. The definition of public health authority reflects the need for
access to data and information including protected health information
by these other agencies and authorities consistent with their official
mandates under applicable law.
ii. Non-governmental entities carrying out public health
activities.
The proposed rule would further provide that disclosures may be
made not only to government agencies, but also to other public and
private entities
[[Page 59957]]
as otherwise required or authorized by law. For example, this would
include tracking medical devices, where the initial disclosure is not
to a government agency, but to a device manufacturer that collects
information under explicit legal authority, or at the direction of the
Food and Drug Administration. Also, the cancer registries mentioned
above could be operated by non-profit organizations such as
universities funded by public health authorities which receive reports
from physicians and laboratories pursuant to State statutory
requirements to report.
We considered limiting public health disclosures to only government
entities, but the reality of current public health practice is that a
variety of activities are conducted by public health authorities in
collaboration with non-governmental entities. Federal agencies also use
a variety of mechanisms including contracts, grants, cooperative
agreements, and other agreements such as memoranda of understanding to
carry out and support public health activities. These relationships
could be based on specific or general legal authorities. It is not our
intent to disturb these relationships. Limiting the ability to
collaborate with other entities and designate them to receive protected
health information, could potentially have an adverse impact on public
health practice.
iii. Persons who may be at risk of contracting or spreading a
disease.
The proposed rule would allow disclosure to a person who could have
been exposed to a communicable disease or may otherwise be at risk of
contracting or spreading a disease or condition and is authorized by
law to be notified as necessary in the conduct of a public health
intervention or investigation. Physicians, in carrying out public
health interventions authorized by law, can notify persons who have
been exposed to a communicable disease, or who otherwise may be at risk
of contracting or spreading a disease or condition. That notification
may implicitly or explicitly reveal the identity of the individual with
the disease to which the person could have been exposed, but should be
permitted as a disclosure in the course of a legally authorized public
health intervention or investigation. The proposed rule would not (and,
under the HIPAA legislative authority, cannot) impose a confidentiality
obligation on the person notified.
d. Additional requirements. Under proposed Sec. 164.518(c), covered
entities would have to verify the identity of the person requesting
protected health information and the legal authority supporting that
request, before the disclosure would be permitted under this
subsection. Preamble section II.G.3 describes these requirements in
more detail.
We note that to the extent that the public health authority is
providing treatment as defined in proposed Sec. 164.504, the public
health authority would be a covered health care provider for purposes
of that treatment, and would be required to comply with this
regulation.
We also note that the preemption provision of the HIPAA statute
creates a special rule for a subset of public health disclosures: this
regulation cannot preempt State law regarding "public health
surveillance, or public health investigation or intervention * * *".
2. Use and Disclosure for Health Oversight Activities.
(Sec. 164.510(c))
[Please label comments about this section with the subject: "Health
oversight"]
In section Sec. 164.510(c), we propose to allow covered entities to
disclose protected health information to public oversight agencies (and
to private entities acting on behalf of such agencies) without
individual authorization, for health oversight activities authorized by
law. In cases in which a covered entity is also an oversight agency, it
would be permitted to use protected health information in all cases in
which it would be permitted to disclose such information for health
oversight activities under this section.
a. Importance of oversight and need for protected health
information. Oversight activities are critical to support national
priorities, including combating fraud in the health care industry,
ensuring nondiscrimination, and improving the quality of care. The
goals of public agencies' oversight activities are: to monitor the
fiscal and programmatic integrity of health programs and of government
benefit programs; to ensure that payments or other benefits of these
programs are being provided properly; to safeguard health care quality;
to monitor the safety and efficacy of medical products; and to ensure
compliance with statutes, regulations, and other administrative
requirements applicable to public programs and to health care delivery.
Oversight activities are a national priority in part because of the
losses in the healthcare system due to error and abuse. For example,
the HHS Office of Inspector General recently estimated losses due to
improper Medicare benefit payments to be about seven percent. See
"Improper Fiscal Year 1998 Medicare Fee-For Service-Payments,"
transmittal from Inspector General June Gibbs Brown to HCFA
Administrator Nancy-Ann Min DeParle (February 9, 1999). Similarly, the
final report of the President's Advisory Commission on Consumer
Protection and Quality in the Health Care Industry concluded that
"employing the extensive knowledge and expertise of organizations that
oversee health care quality * * * is essential to quality
improvement." (https://www.hcqualitycommission.gov/final/chap09.html)
There are certain oversight activities done as statistical
inquiries that can be conducted without direct access to individually
identifiable health information. However, many instances exist in which
government oversight agencies, and private entities under contracting
to act on their behalf, need to examine individually identifiable
health information to conduct their investigations effectively. For
example, to determine whether a hospital has engaged in fraudulent
billing practices, it could be necessary to examine billing records for
a set of individual cases. Billing abuses are detected by cross-
checking the records of specific patients to see the medical
documentation in support of a service. To determine whether a health
plan is complying with federal or State health care quality standards,
it may be necessary to examine individually identifiable health
information. Other inquiries require review of individually
identifiable health information to identify specific instances of the
anomalies in treatment or billing patterns detected in statistical
analysis. Even in most statistical inquiries of the type just
described, in a paper environment particular patient charts must be
examined, and the patient's name would be disclosed because it would be
on each page of the chart.
b. Proposed requirements. Specifically, we would permit covered
entities to disclose protected health information without individual
authorization to a health oversight agency to conduct oversight
activities authorized by law. Disclosures also could be made to private
entities working under a contract with or grant of authority from one
or more of the government oversight agencies described above. As
discussed below, oversight activities by private entities operating
pursuant to contracts with covered entities, such as accreditation
organizations, would not be permitted to receive information under this
provision, even if accreditation by such an organization is recognized
by law as fulfilling a government requirement or
[[Page 59958]]
condition of participation in a government program (often referred to
as "deemed status").
Under our rule, oversight activities would include conducting or
supervising the following activities: Audits; investigations;
inspections; civil, criminal or administrative proceedings or actions;
and other activities necessary for appropriate oversight of the health
care system, of government benefit programs for which health
information is relevant to beneficiary eligibility, and of government
regulatory programs for which health information is necessary for
determining compliance with program standards. This regulation does not
create any new right of access to health records by oversight agencies,
and could not be used as authority to obtain records not otherwise
legally available to the oversight agency.
Under our rule, a health oversight agency would be defined as a
public agency authorized by law to conduct oversight activities
relating to the health care system, a government program for which
health information is relevant to determining beneficiary eligibility
or a government regulatory program for which health information is
necessary for determining compliance with program standards. Examples
of agencies in the first category would include State insurance
commissions, State health professional licensure agencies, Offices of
Inspectors General of federal agencies, the Department of Justice,
State Medicaid fraud control units, Defense Criminal Investigative
Services, the Pension and Welfare Benefit Administration, the HHS
Office for Civil Rights, and the FDA. Examples of agencies in the
second category include the Social Security Administration and the
Department of Education. Examples of agencies in the third category
include the workplace safety programs such as the Occupational Health
and Safety Administration and the Environmental Protection Agency.
Agencies that conduct both oversight and law enforcement activities
would be subject to this provision when conducting oversight
activities.
In cases where health oversight agencies are working in tandem with
other agencies overseeing public benefit programs to address
compliance, fraud, or other integrity issues that could span across
programs, the oversight activities of the team would be considered
health oversight and disclosure to and among team members would be
permitted under the proposed rule to the extent permitted under other
law. For example, a fraud investigation could attempt to find a pattern
of abuse across related programs, such as Medicaid and the supplemental
security income program. Protected health information could be
disclosed to the team of oversight agencies and could be shared among
such agencies for oversight activities.
Public oversight agencies sometimes contract with private entities
to conduct program integrity activities on a public agency's behalf.
Such audits or investigations may include, for example, program
integrity reviews of fraud and abuse in billing Federal and State
health care programs; investigations conducted in response to consumer
complaints regarding the quality or accessibility of a particular
provider, health plan, or facility; and investigations related to
disciplinary action against a health care provider, health plan, or
health care facility. Covered entities may disclose protected health
information to these agents to the extent such disclosure would be
permitted to the public oversight body.
In many cases today, public agencies' contracts with private
entities conducting investigations on their behalf require the private
oversight organization to implement safeguards to protect individual
privacy. HIPAA does not provide statutory authority to regulate the
contracts between public oversight entities and their agents. However,
we encourage public oversight entities to include privacy safeguards in
all such contracts, and believe it would be appropriate for federal
legislation to impose such safeguards.
In developing our proposal, we considered but rejected the option
of providing an exemption from the general rules for situations in
which a covered entity has a contract with a private accreditation
organization to conduct an accreditation inspection. In such instances,
the accreditation organization is performing a service for the covered
entity much like any other contractor. The situation is not materially
different in instances where accreditation from a private organization
would have the effect of "deeming" the covered entity to be in
compliance with a government standard or condition of participation in
a government program. In both cases, the accreditation organization is
performing a service for the covered entity, not for the government. In
our considerations, we were unable to identify a reason that covered
entities should hold these contractors to lesser standards than their
other contractors. Individuals' privacy interests would not be
diminished in this situation, nor is there any reason why such
accreditation organizations should not be held to the requirements
described above for business partners. Proposed rules for disclosure to
these entities are discussed in section II.C.5., "Application to
business partners." We invite comment on our proposed approach.
c. Additional considerations. We do not propose any new
administrative or judicial process prior to disclosure. This regulation
would permit disclosure of protected health information without
compulsory process where such disclosure is otherwise allowed. However,
this regulation also would not abrogate or modify other statutory
requirements for administrative or judicial determinations or for other
procedural safeguards, nor would it permit disclosures forbidden by
other law.
Under this Sec. 164.518(c), covered entities would have an
obligation to verify the identity of the person requesting protected
health information and the legal authority behind the request before
the disclosure would be permitted under this subsection. Preamble
section II.G.3. describes these requirements in more detail.
3. Use and Disclosure for Judicial and Administrative Proceedings
(Sec. 164.510(d))
[Please label comments about this section with the subject:
"Judicial and administrative proceedings"]
In Sec. 164.510(d), we propose to permit covered entities to
disclose protected health information in a judicial or administrative
proceeding if the request for such protected health information is made
through or pursuant to an order by a court or administrative tribunal.
A court order would not be required if the protected health information
being requested relates to a party to the proceeding whose health
condition is at issue, or if the disclosure would otherwise be
permitted under this rule. A covered entity that also is a government
entity would be permitted to use protected health information in a
judicial or administrative proceeding under the same conditions that it
could make a disclosure of protected health information under this
paragraph.
a. Importance of judicial and administrative process and the need
for protected health information. Protected health information is often
needed as part of an administrative or judicial proceeding. Examples of
such proceedings would include personal injury or medical malpractice
cases or other lawsuits in which the medical condition of a person is
at issue, and judicial or administrative proceedings to determine
whether an illness or injury was caused by workplace conditions or
[[Page 59959]]
exposure to environmental toxins. The information may be sought well
before a trial or hearing, to permit the party to discover the
existence or nature of testimony or physical evidence, or in
conjunction with the trial or hearing, in order to obtain the
presentation of testimony or other evidence. These uses of health
information are clearly necessary to allow the smooth functioning of
the legal system. Requiring the authorization of the subject prior to
disclosure could mean that crucial information would not be available,
and could be unfair to persons who have been wronged.
b. Proposed requirements. We propose to permit covered entities to
disclose protected health information in a judicial or administrative
proceeding if the request for such protected health information is made
through or pursuant to a court order or an order by an administrative
law judge specifically authorizing the disclosure of protected health
information. The exception to this requirement is where the protected
health information being requested relates to a party to the proceeding
whose health condition is at issue, and where the disclosure is made
pursuant to lawful process (e.g., a discover order) or is otherwise
authorized by law. We note that this would not apply where the
disclosure would otherwise be permitted under this rule.
The proposed provisions of this section are intended to apply to
the broad spectrum of judicial and administrative procedures by which
litigants, government agencies, and others request information for
judicial or administrative proceedings, including judicial subpoenas,
subpoenas duces tecum, notices of deposition, interrogatories,
administrative subpoenas, and any disclosure pursuant to the Federal
Rules of Civil Procedures, the Federal Rules of Criminal Procedures,
comparable rules of other courts (including State, tribunal, or
territorial courts) and comparable rules of administrative agencies.
Under the rule, a covered entity could not respond to such requests
unless they determined that the request is pursuant to a court order
authorizing disclosure of protected health information or if the
individual who is the subject of the protected health information is a
party to the proceeding and his or her medical condition or history is
at issue.
Covered entities generally would not be required to conduct any
independent investigation of the legality of the process under which
the protected health information is being sought, but would need to
review the request protected health information to ensure that the
disclosure would meet the terms of this provision. Where the request is
accompanied by an order from a court, the covered entity could rely on
a statement in the order authorizing disclosure of protected health
information. The statement could be a general one, indicating that
protected health information is relevant to the matter, or it could
identify specifically what protected health information may be
disclosed. The covered entity could rely on either type of statement,
but it could not disclose more information than was authorized by the
court where the scope of the authorized disclosure is clear.
Where the request is not accompanied by a court order or order from
an administrative law judge, the covered entity would be required to
determine whether the request relates to the protected health
information of a litigant whose health is at issue, a written statement
from the requester certifying that the protected health information
being requested is about a litigant to the proceeding and that the
health condition of such litigant is at issue at such proceeding. Such
a certification could be from the agency requesting the information
(e.g., in an administrative proceeding) or from legal counsel
representing a party to litigation. We invite comments on whether this
requirement is overly burdensome and on whether it is sufficient to
protect protected health information from unwarranted disclosures.
We are not proposing to preclude a covered entity from contesting
the nature or scope of the process when the procedural rules governing
the proceeding so allow and covered entities could well choose to
assert privileges against disclosure on behalf of individuals.
In developing our proposal, we considered permitting covered
entities to disclose protected health information pursuant to any
request made in conjunction with a judicial or administrative
proceeding. We rejected this option because we believe that current
procedures for document production could result in unwarranted
disclosure of protected health information. Under current practice,
requests for documents are developed by the parties to a proceeding,
with little review or oversight unless the request is challenged by the
opposing party. In many instances, the parties make very broad
discovery requests that result in the production of large numbers of
documents for review. Recipients of broad motions for document
production often provide the requester with a substantial quantity of
material, expecting the requester to page through the documents to
identify the ones that are relevant to the proceeding. While such a
process may be appropriate for many types of records, we are concerned
that it could lead to substantial breaches of privacy where the
material being requested is protected health information. We are unsure
if it is appropriate for private attorneys, government officials and
others who develop such requests to be able to circumvent the
protections provided by this rule with simple motions for document
production that have not been subject to third-party review.
Under our proposal, therefore, a party to a proceeding that wishes
production of information that includes protected health information
would generally need to seek judicial review of the request. If a court
determines that a request for protected health information is
appropriate to the proceeding, a covered entity can produce the
protected health information pursuant to an otherwise lawful request.
We propose an exception to the general requirement for judicial
review for protected health information for instances in which the
protected health information of a party to the proceeding is relevant
to the proceeding. In such instances, the party will have counsel who
can object to an overly broad or unwarranted discovery of the party's
protected health information or will receive the discovery request
directly and, again, will have an opportunity to object prior to
disclosure.
We note that there are other existing legal requirements governing
the disclosure of protected health information, and which govern the
procedures in federal, State and other judicial and administrative
proceedings. For example, 42 U.S.C. 290dd-2 and the implementing
regulations, 42 CFR part 2, will continue to govern the disclosure of
substance abuse patient records. There may also be provisions of a
particular State's law governing State judicial or administrative
proceedings, including State medical record privacy statutes, as well
as precedential court opinions, which apply to the circumstances
described in the section, that will not be preempted by this part.
Also, the discovery of psychiatric counseling records in federal
proceedings governed by section 501 of the Federal Rules of Evidence,
has been restricted in certain circumstances, by Jaffee v. Redmond, 116
S. Ct. 1923 (1996). These more stringent rules would remain in place.
[[Page 59960]]
4. Disclosure to Coroners and Medical Examiners (Sec. 164.510(e))
[Please label comments about this section with the subject:
"Coroners and medical examiners"]
In Sec. 164.510(e), we propose to allow covered entities to
disclose protected health information without individual authorization
to coroners and medical examiners, as authorized by law, for
identification of a deceased person or to determine cause of death.
a. Importance of disclosure to coroners and medical examiners and
the need for protected health information. Coroners and medical
examiners, who under State or other law typically are public officials,
have a legitimate need to obtain protected health information in an
expeditious manner in order to carry out their legal responsibility to
identify deceased persons and determine cause of death. Such disclosure
would be clearly in the public interest, and should be included among
the types of disclosures for which the public interest in efficient
sharing of medical information outweighs any individual privacy
interests that may be compromised.
b. Proposed requirements. Proposed Sec. 164.510(e) would allow
covered entities to disclose protected health information about a
deceased person without individual authorization to coroners and
medical examiners, consistent with other law, for the purpose of a
post-mortem investigation.
We recognize that a deceased person's medical record could include
information that potentially could reveal health information about
others, for example, relatives who have the same genetically linked
disease as the deceased individual. In developing this section of the
proposed rule, we considered requiring covered entities to redact any
protected health information about persons other than the deceased
before giving the record to coroners or medical examiners.
We rejected this option for two reasons. First, coroners and
medical examiners typically need significant portions of a deceased
person's medical record, and, in some cases, all medical records that
are available, to conduct a post-mortem investigation, which may also
include an autopsy. Second, they need to obtain the record quickly,
because there is a limited time period after death within which an
autopsy can be conducted. Requiring covered entities to take the time
to review and redact portions of the health information before
providing it to a coroner or medical examiner would create delays that
could make it impossible to conduct an autopsy appropriately. Nothing
in this rule would prohibit a covered entity from undertaking such
redaction on its own initiative so long as the information provided
would meet the needs of the coroner or medical examiner.
In addition to these two reasons, it is our understanding that
health care providers, as a standard record keeping practice, rarely
identify specific persons other than the patient in the record. We are
soliciting comment on whether health care providers routinely identify
other persons specifically in a individual's record and if so, whether
we should require the provider to redact the information about the
other person before providing it to a coroner or medical examiner.
Under Sec. 164.518(c), covered entities would have an obligation to
verify the identity of the coroner or medical examiner making the
request for protected health information and the legal authority
supporting the request, before the disclosure would be permitted under
this subsection. Preamble section II.G.3. describes these requirements
in more detail.
We intend to allow only those disclosures that are authorized by
other applicable law. Laws vary widely regarding release of health
information to coroners and medical examiners for the purposes of
identifying deceased persons or determining cause of death, and we do
not intend to disturb those practices.
5. Disclosure for Law Enforcement (Sec. 164.510(f))
[Please label comments about this section with the subject: "Law
enforcement"]
In Sec. 164.510(f), we propose to permit covered entities to
disclose protected health information without individual authorization
to a law enforcement official conducting a law enforcement inquiry
authorized by law if the request for protected health information is
made pursuant to a judicial or administrative process, as described
below. Similarly, we propose to permit covered entities to disclose
protected health information to a law enforcement official without
individual authorization for the conduct of lawful intelligence
activities. We also propose to permit covered entities to disclose
protected health information to a law enforcement official about the
victim of a crime, abuse or other harm, if the information is needed to
determine both whether a violation of law by a person other than the
victim has occurred and whether an immediate law enforcement activity
might be necessary. We would further permit such disclosure for the
purpose of identifying a suspect, fugitive, material witness, or
missing person, if the covered entity discloses only limited
identifying information. Finally, we would permit disclosure of
protected health information by a health plan or a health care provider
without individual authorization to law enforcement officials if the
plan or provider believed in good faith that the disclosed protected
health information would constitute evidence of criminal conduct that
constitutes health care fraud, occurred on the premises of the covered
entity, or was witnessed by an employee of the covered entity.
i. Law enforcement need for protected health information. Law
enforcement officials need protected health information for their
investigations in a variety of circumstances. Health information about
a victim of a crime may be needed to investigate the crime, or to allow
prosecutors to determine the proper charge. For some crimes, the
severity of the victim's injuries will determine what charge should be
brought against a suspect. The medical condition of a defendant could
also be relevant to whether a crime was committed, or to the
seriousness of a crime. The medical condition of a witness could be
relevant to the reliability of that witness. Medical, billing,
accounting or other documentary records in the possession of a covered
entity can be important evidence relevant to criminal fraud or
conspiracy investigations. Nor is this list of important uses by law
enforcement exhaustive.
In many cases, the law enforcement official will obtain such
evidence through legal process, such as judicially executed warrant, an
administrative subpoena, or a grand jury subpoena. In other
circumstances, time constraints preclude use of such process. For
example, health information may be needed when a law enforcement
official is attempting to apprehend an armed suspect who is rapidly
fleeing. Health information may be needed from emergency rooms to
locate a fleeing prison escapee or criminal suspect who was injured and
is believed to have stopped to seek medical care.
Protected health information could be sought as part of a law
enforcement investigation, to determine whether and who committed a
crime, or it could be sought in conjunction with the trial to be
presented as evidence. These uses of medical information are clearly in
the public interest. Requiring the authorization of the subject prior
to disclosure could impede important law enforcement activities by
making
[[Page 59961]]
apprehension and conviction of some criminals difficult or impossible.
As described above, this proposed rule seeks to respond
appropriately to new risks to privacy that could emerge as the form of
medical records changes in coming years. The administrative
simplification mandated by HIPAA will lead to far greater exchanges of
individually identifiable health information among covered entities in
the future, increasingly in electronic form. If a misperception were to
develop that law enforcement had instant and pervasive access to
medical records, the goals of this proposed regulation could be
undermined. For instance, individuals might become reluctant to seek
needed care or might report inaccurately to providers to avoid
revealing potentially embarrassing or incriminating information. In
addition, popular concerns about government access to sensitive medical
records might impede otherwise achievable progress toward
administrative simplification. We believe that the proposed
prophylactic and administrative rules governing disclosure to law
enforcement officials, as described below, are justified in order to
avoid these harms in the future.
ii. Proposed requirements. In Sec. 164.510(f), we propose to permit
covered entities to disclose protected health information to law
enforcement officials conducting or supervising a law enforcement
inquiry or proceeding authorized by law if the request for protected
health information is made:
Pursuant to a warrant, subpoena, or order issued by a
judicial officer;
Pursuant to a grand jury subpoena;
Pursuant to an administrative subpoena or summons, civil
investigative demand, or similar certification or written order issued
pursuant to federal or state law where (i) the records sought are
relevant and material to a legitimate law enforcement inquiry; (ii) the
request is as specific and narrowly drawn as is reasonably practicable
to meet the purposes of the inquiry; and (iii) de-identified
information could not reasonably be used to meet the purposes of the
inquiry;
For limited identifying information where necessary to
identify a suspect, fugitive, witness, or missing person;
By a law enforcement official requesting protected health
information about an individual who is, or who is suspected to be, the
victim of a crime, abuse or other harm, if such law enforcement
official represents that (i) such information is needed to determine
whether a violation of law by a person other than the victim has
occurred and (ii) immediate law enforcement activity which depends on
the official obtaining such information may be necessary;
For the conduct of lawful intelligence activities
conducted pursuant to the National Security Act of 1947 (50 U.S.C. 401
et seq.) or in connection with providing protective services to the
President or other individuals pursuant to section 3056 of title 18,
United States Code, and the disclosure is otherwise authorized under
Federal or state law; or
To law enforcement officials when a covered entity
believes in good faith that the disclosed protected health information
constitutes evidence of criminal conduct that: (i) Arises out of and is
directly related to the receipt of health care or payment for health
care (including a fraudulent claim for health care) or qualification
for or receipt of benefits, payments or services based on a fraudulent
statement or material misrepresentation of the health of a patient;
(ii) occurred on the premises of the covered entity; or (iii) was
witnessed by an employee or other workforce member of the covered
entity.
In drafting the proposed rule, we have attempted to match the level
of procedural protection for privacy with the nature of the law
enforcement need for access. Therefore, access for law enforcement
under this rule would be easier where other rules would impose
procedural protections, such as where access is granted after review by
an independent judicial officer. Access would also be easier in an
emergency situation or where only limited identifying information would
be provided. By contrast, this rule proposes stricter standards for
administrative requests, where other rules could not impose appropriate
procedural protections.
Under the first part of this proposal, we would authorize
disclosure of protected health information pursuant to a request that
has been reviewed by a judicial officer. Examples of such requests
include State or federal warrants, subpoenas, or other orders signed by
a judicial officer. Review by a judicial officer is significant
procedural protection for the proper handling of individually
identifiable health information. Where such review exists, we believe
that it would be appropriate for covered entities to disclose
individually identifiable health information pursuant to the order.
Under the second part of this proposal, we would authorize
disclosure of protected health information pursuant to a State or
federal grand jury subpoena. Information disclosed to a grand jury is
covered by significant secrecy protections, such as under Federal Rule
of Criminal Procedure 6(e) and similar State laws. Our understanding is
that State grand juries have secrecy protections substantially as
protective as the federal rule. We solicit comment on whether there are
any State grand jury secrecy provisions that are not substantially as
protective.
Under the third part of this proposal, we would set somewhat
stricter standards than exist today for disclosure pursuant to
administrative requests, such as an administrative subpoena or summons,
civil investigative demand, or similar process authorized under law.
These administrative actions do not have the same procedural
protections as review by an independent judicial officer. They also do
not have the grand jury secrecy protections that exist under federal
and State law. For administrative requests, an individual law
enforcement official can define the scope of the request, sometimes
without any review by a superior, and present it to the covered entity.
We propose, therefore, that a greater showing should be made for an
administrative request before the covered entity would be permitted to
release protected health information. We also believe that the somewhat
stricter test for administrative requests would provide some reason for
officials to choose to obtain protected health information through
process that includes the protections offered by judicial review or
grand jury secrecy.
We therefore propose that a covered entity could disclose protected
health information pursuant to an administrative request, issued
pursuant to a determination that: (i) The records sought are relevant
and material to a legitimate law enforcement inquiry; (ii) the request
is as specific and narrowly drawn as is reasonably practicable; and
(iii) de-identified information could not reasonably be used to meet
the purpose of the request.
Because our regulatory authority does not extend to law enforcement
officials, we are seeking comment on how to create an administrable
system for implementing this three-part test. We do not intend that
this provision require a covered entity to second guess representations
by an appropriate law enforcement official that the three part test has
been met.
To verify that the three-part test has been met, we propose that a
covered entity be permitted to disclose protected health information to
an appropriate law enforcement official pursuant to a subpoena or other
covered administrative request that on its face indicates that the
three-part test has
[[Page 59962]]
been met. In the alternative, where the face of the request does not
indicate that the test has been met, a covered entity could disclose
the information upon production of a separate document, signed by a law
enforcement official, indicating that the three-part test has been met.
Under either of these alternatives, disclosure of the information can
also be made if the document applies any other standard that is as
strict or stricter than the three-part test.
This approach would parallel the research provisions of proposed
Sec. 164.510(j). Under that section, disclosure would be authorized by
a covered entity where the party seeking the records produces a
document that states it has met the standards for the institutional
review board process. We solicit comments on additional, administrable
ways that a law enforcement official could demonstrate that the
appropriate issuing authority has determined that the three-part test
has been met.
We solicit comment on the burdens and benefits of the proposed
three-part test for administrative requests. For covered entities, we
are interested in comments on how burdensome it would be to determine
whether the three-part test has been met, and we would explore
suggestions for approaches that would be more easily administered. For
law enforcement, we are interested in the potential impact that this
approach might have on current law enforcement practices, and the
extent to which law enforcement officials believe that their access to
information critical to law enforcement investigations could be
impaired. We solicit comment on the burden on law enforcement
officials, compared to current practice, of writing the administrative
requests. We would also like comments on whether there are any federal,
State, or local laws that would create an impediment to application of
this section, including the proposed three-part test. If there are such
impediments, we would solicit comment on whether extending the
effective date of this section could help to prevent difficulties. On
the benefit side, we are interested in comments on the specific gains
for privacy that would result from requiring law enforcement to comply
with greater procedures than currently exist for gaining access to
protected health information.
As the fourth part of this proposal, we address limited
circumstances where the disclosure of health information by covered
entities would not be made pursuant to lawful process such as judicial
order, grand jury subpoena, or administrative request. In some cases
law enforcement officials could seek limited but focused information
needed to obtain a warrant. For example, a witness to a shooting may
know the time of the incident and the fact that the perpetrator was
shot in the left arm, but not the identity of the perpetrator. Law
enforcement would then have a legitimate need to ask local emergency
rooms whether anyone had presented with a bullet wound to the left arm
near the time of the incident. Law enforcement may not have sufficient
information to obtain a warrant, but instead would be seeking such
information. In such cases, when only limited identifying information
is disclosed and the purpose is solely to ascertain the identity of a
person, the invasion of privacy would be outweighed by the public
interest.
In such instances, we propose to permit covered entities to
disclose "limited identifying information" for purposes of
identifying a suspect, fugitive, material witness, or missing person.
We would define "limited identifying information" as the name,
address, social security number, date of birth, place of birth, type of
injury, date and time of treatment, and date of death. Disclosure of
any additional information would cause the covered entity to be out of
compliance with this provision, and subject to sanction. The request
for such information could be made orally or in writing. Requiring the
request to be in writing could defeat the purposes of this provision.
We solicit comment on whether the list of "limited identifying
information" is appropriate, or whether additional identifiers, such
as blood type, also should be permitted disclosures under this section.
Alternatively, we solicit comment on whether any of the proposed items
on the list are sufficiently sensitive to warrant a legal process
requirement before they should be disclosed.
Under the fifth part of the proposal, we would clarify that the
protected health information of the victim of a crime, abuse or other
harm could be disclosed to a law enforcement official if the
information is needed to determine both whether a violation of law by a
person other than the victim has occurred and whether an immediate law
enforcement activity might be necessary. There could be important
public safety reasons for obtaining medical records or other protected
health information quickly, perhaps before there would be time to get a
judicial order, grand jury subpoena, or administrative order. In
particular, where the crime was violent, information about the victim's
condition could be needed to present to a judge in a bond hearing in
order to keep the suspect in custody while further evidence is sought.
Information about the victim also could be important in making an
appropriate charging decision. Rapid access to victims' medical records
could reduce the risk of additional violent crimes, such as in cases of
spousal or child abuse or in situations where the protected health
information could reveal evidence of the identity of someone who is
engaged in ongoing criminal activities.
In some of these instances, release of protected health information
would be authorized under other sections of this proposed regulation,
pursuant to provisions for patient consent, health oversight,
circumstances, or disclosure pursuant to mandatory reporting laws for
gunshot wounds or abuse cases. (As discussed later in section II.I, our
rule would not be construed to invalidate or limit the authority,
powers or procedures established under any law that provides for
reporting of injury, child abuse or death.) In addition,
Sec. 164.510(k) addressing emergency circumstances would permit covered
entities to disclose protected health information in instances where
the disclosure could prevent imminent harm to the individuals or to the
public. However, we propose to include this fifth provision for law
enforcement access to ensure that immediate need for law enforcement
access to information about a victim would be permitted under this
rule.
Under the sixth part of this proposal, we seek to assure that this
rule would not interfere with the conduct of lawful security functions
in protection of the public interest, as defined by the Congress.
Therefore, we would allow disclosure of protected health information
for the conduct of lawful intelligence activities conducted pursuant to
the National Security Act of 1947. Similarly, we would allow disclosure
of protected health information for providing protective services to
the President or other individuals pursuant to section 3056 of title
18, United States Code. Where such disclosures are authorized by
Federal or state law, we would not interfere with these important
national security activities.
Under the final part of this proposal, we would permit covered
entities that uncover evidence of health care fraud to disclose the
protected health information that evidences such fraud to law
enforcement officials without receiving a request from such officials.
This provision would permit covered entities to make certain
disclosures to law enforcement officials on their own
[[Page 59963]]
initiative if the information disclosed constitutes evidence of
criminal conduct that arises out of and is directly related to (i) the
receipt of health care or payment for health care (including a
fraudulent claim for health care) or (ii) qualification for or receipt
of benefits, payments or services based on a fraudulent statement or
material misrepresentation of the health of a patient. Similarly, we
would permit covered entities on their own initiative to disclose to
law enforcement officials protected health information that the covered
entity believes in good faith constitutes evidence of criminal conduct
that either occurred on the covered entity's premises or was witnessed
by an employee (or other workforce member) of the covered entity. In
such situations, covered entities should be permitted to take
appropriate steps to protect the integrity and safety of their
operations or to assure that the such criminal conduct is properly
prosecuted.
To be protected by this provision, the covered entity would have to
have good faith belief that the disclosed protected health information
was evidence of such conduct. If the covered entity disclosed protected
health information in good faith but was wrong in its belief that the
information evidenced a legal violation, the covered entity would not
be subject to sanction under this regulation. We would not require the
covered entity to accurately predict the outcome of a criminal
investigation.
There also are situations where law enforcement officials would
need access to information for emergency circumstances. In those cases,
the disclosure could be made under Sec. 164.510(k), "Disclosure in
emergency circumstances."
Pursuant to Sec. 164.518(c), covered entities would have an
obligation to verify the identity of the person seeking disclosure of
protected health information and the legal authority behind the
request. As described in section II.H.3. of this preamble, we would
permit covered entities to rely on a badge or similar identification to
confirm that the request for protected health information is being made
by a law enforcement official. If the request is not made in person, we
would permit the covered entity to rely on official letter head or
similar proof.
Where the covered entity must verify that lawful process has been
obtained, Sec. 164.518(c) would require the covered entity to review
the document evidencing the order. The covered entity could not
disclose more information than was authorized in the document.
Because the regulation applies to covered entities, and not to the
law enforcement officials seeking the protected health information, the
covered entity would not be in a position to determine with any
certainty whether the underlying requirements for the process have been
met. For instance, it may be difficult for the covered entity to
determine whether the three-part test has been met for an
administrative request. In light of this difficulty facing covered
entities, the proposed rule would include a good faith provision. Under
that provision, covered entities would not be liable under the rule for
disclosure of protected health information to a law enforcement
official where the covered entity or its business partners acted in a
good faith belief that the disclosure was permitted under this title.
We solicit comment on the extent to which this good faith provision
would make the proposed rule less burdensome on covered entities and
law enforcement officials. We also solicit comment on the extent to
which the provision could undermine the effectiveness of the provision.
For requests for the conduct of intelligence activities or for
protective services, covered entities would be required to verify the
identity of the person or entity requesting the information, through a
badge or other identification, or official letter head, as just
described. If such verification of identity is obtained, covered
entities would be permitted to reasonably rely on the representations
of such persons that the request is for lawful national security or
protective service activities and is authorized by law. Similarly, to
disclose limited identifying information, covered entities would be
required to obtain verification that the request comes from a law
enforcement official, and would be permitted to reasonably rely on such
official's representation that the information is needed for the
purpose of identifying a suspect, fugitive, material witness, or
missing person and is authorized by law.
iii. Additional considerations. This section is not intended to
limit or preclude a covered entity from asserting any lawful defense or
otherwise contesting the nature or scope of the process when the
procedural rules governing the proceeding so allow, although it is not
intended to create a basis for appealing to federal court concerning a
request by state law enforcement officials. Each covered entity would
continue to have available legal procedures applicable in the
appropriate jurisdiction to contest such requests where warranted. This
proposed rule would not create any new affirmative requirement for
disclosure of protected health information. Similarly, this section is
not intended to limit a covered entity from disclosing protected health
information for law enforcement purposes where other sections of the
rule permit such disclosure, e.g., as permitted by Sec. 164.510 under
emergency circumstances, for oversight or public health activities, to
coroners or medical examiners, and in other circumstances permitted by
the rule.
In obtaining protected health information, law enforcement
officials would have to comply with whatever other law was applicable.
In certain circumstances, while this subsection could authorize a
covered entity to disclose protected health information to law
enforcement officials, there could be additional applicable statutes
that further govern the specific disclosure. If the preemption
provisions of this regulation do not apply, the covered entity must
comply with the requirements or limitations established by such other
law, regulation or judicial precedent. See proposed Secs. 160.201
through 160.204. For example, if State law would permit disclosure only
after compulsory process with court review, a provider or payer would
not be allowed to disclose information to state law enforcement
officials unless the officials had complied with that requirement.
Similarly, disclosure of substance abuse patient records subject to, 42
U.S.C. 290dd-2, and the implementing regulations, 42 CFR part 2, would
continue to be governed by those provisions.
In some instances, disclosure of protected health information to
law enforcement officials would be compelled by other law, for example,
by compulsory judicial process or compulsory reporting laws (such as
laws requiring reporting of wounds from violent crimes, suspected child
abuse, or suspected theft of prescription controlled substances).
Disclosure of protected health information under such other mandatory
law would be permitted under proposed Sec. 164.510(n).
In developing our proposal, we considered permitting covered
entities to disclose protected health information pursuant to any
request made by a law enforcement official, rather than requiring some
form of legal process or narrowly defined other circumstances. We
rejected this option because we believe that in most instances some
form of review should be required. Individuals' expectation of privacy
with respect to their health information is sufficiently strong to
require some form of process prior to disclosure to the
[[Page 59964]]
government. At the same time, we recognize that the public interest
would not be served by requiring such formal process in every instance.
Under our proposal, therefore, law enforcement could obtain certain
identifying information in order to identify suspects and witnesses,
and could obtain information for national security or protective
services activities or in emergency circumstances. Similarly, we would
not require process before a law enforcement official could obtain
information about the victim of a crime, where the information is
necessary as the basis for immediate action. In addition, in seeking an
appropriate balance between public safety and individuals' expectation
of privacy, we are proposing that covered entities not be subject to
enforcement under this regulation if they disclose protected health
information to law enforcement officials in a good faith belief that
the disclosure was permitted under this title.
We solicit comment on what additional steps, if any, are
appropriate for allowing law enforcement access to protected health
information. We are interested in comments concerning situations where
needed access to protected health information would not be available
under these or other provisions of this proposed rule. We also seek
comment on specific privacy or other concerns that would apply if the
final regulation included provision for law enforcement access to
protected health information without requiring a judicial order, grand
jury subpoena, or administrative request, under such additional defined
circumstances.
In some of these instances, release of protected health information
would be authorized under the proposed regulation pursuant to
provisions for patient consent, health oversight, emergency
circumstances, or under mandatory reporting laws for gunshot wounds or
abuse cases. We are interested in comments concerning situations where
needed access to protected health information would not be available
under these or other provisions of this proposed rule. We also seek
comment on specific privacy or other concerns that would apply if the
final regulation included provision for law enforcement access to
protected health information without requiring a judicial order, grand
jury subpoena, or administrative request, under such additional defined
circumstances.
Our proposal with respect to law enforcement has been shaped by the
limited scope of our regulatory authority under HIPAA, which applies
only to the covered entities and not to law enforcement officials. We
believe the proposed rule sets the correct standards for when an
exception to the rule of non-disclosure is appropriate for law
enforcement purposes. There may be advantages, however, to legislation
that applies the appropriate standards directly to judicial officers,
prosecutors in grand juries, and to those making administrative or
other requests for protected health information, rather than to covered
entities as in the proposed regulation. These advantages could include
measures to hold officials accountable if they seek or receive
protected health information contrary to the legal standard. In
Congressional consideration of law enforcement access, there have also
been useful discussions of other topics, such as limits on re-use of
protected health information gathered in the court of oversight
activities. These limitations on our regulatory authority provide
additional reason to support comprehensive medical privacy legislation.
6. Uses and Disclosures for Governmental Health Data Systems
(Sec. 164.510(g))
[Please label comments about this section with the subject:
"Governmental health data systems"]
In Sec. 164.510(g), we propose to permit covered entities to
disclose protected health information for inclusion in State or other
governmental health data systems without individual authorization when
such disclosures are authorized by State or other law in support of
policy, planning, regulatory or management functions.
a. Importance of Governmental health data systems and the need for
protected health information. Governmental agencies collect and analyze
individually identifiable health information as part of their efforts
to improve public policies and program management, improve health care
and reduce costs, and improve information available for consumer
choices. Governments use the information to analyze health care
outcomes, quality, costs and patterns of utilization, effects of public
policies, changes in the health care delivery system, and related
trends. These important purposes are related to public health, research
and oversight (although the information in State or other governmental
data systems usually is not collected specifically to audit or evaluate
health care providers or for public health surveillance). The data are
an important resource that can be used for multiple public policy
evaluations.
The collection of health information by governmental health data
systems often occurs without specification of the particular analyses
that could be conducted with the information. These governmental data
collection programs frequently call for reporting of information for
all individuals treated or released by specified classes of providers.
For example, many States request and receive from hospitals records
containing individual diagnosis and treatment data for all discharges
from their facilities. State hospital discharge data have been used to
compare treatment practices and costs between hospitals, to evaluate
implications for funding of health care, as well as to provide hospital
"report cards" to consumers. As part of its general evaluation
activities, the DOD maintains a very large database, called the
Comprehensive Clinical Evaluation Program, involving military personnel
who have reported illnesses possibly arising from service during the
Gulf War.
b. Proposed requirements. We propose to permit covered entities to
disclose protected health information for inclusion in State or other
governmental health data systems when such disclosure is authorized by
law for analysis in support of policy, planning, regulatory, and
management functions. The recipient of the information must be a
government agency (or privacy entity acting on behalf of a government
agency). Where the covered entity is itself a government agency that
collects health data for analysis in support of policy, planning,
regulatory, or management functions, it would be permitted to use
protected health information in all cases in which it is permitted to
disclose such information for government health data systems under this
section.
We believe that Congress intended to permit States, Tribes,
territories, and other governmental agencies to operate health data
collection systems for analyzing and improving the health care system.
In section 1178(c), "State regulatory reporting," HIPAA provides that
it is not limiting the ability of a State to require a health plan to
report, or to provide access to, information for a variety of oversight
activities, as well as for "program monitoring and evaluation." We
also believe that the considerations Congress applied to State
capacities to collect data would apply to similar data collection
efforts by other levels of government, such as those undertaken by
Tribes, territories and federal agencies. Therefore, we considered two
questions regarding governmental health data systems; first,
[[Page 59965]]
which entities could make such disclosures; and second, what type of
legal authority would be necessary for the disclosure to be permitted.
We considered whether to allow disclosure by all covered entities
to governmental data collection systems or to limit permitted
disclosures to those made by health plans, as specified in the
regulatory reporting provision of HIPAA. While this provision only
mentions data collected from health plans, the conference agreement
notes that laws regarding "State reporting on health care delivery or
costs, or for other purposes" should not be preempted by this rule.
States would be likely to require sources of information other than
health plans, such as health care providers or clearinghouses, in order
to examine health care delivery or costs. Therefore, we do not believe
it is appropriate to restrict States' or other governmental agencies'
ability to obtain such data. This viewpoint is consistent with the
Recommendations, which would permit this disclosure of protected health
information by all covered entities.
We also asked what type of law would be required to permit
disclosure without individual authorization to governmental health data
systems. We considered requiring a specific statute or regulation that
requires the collection of protected health information for a specified
purpose. A law that explicitly addresses the conditions under which
protected health information is collected would provide individuals and
covered entities with a better understanding of how and why the
information is to be collected and used.
We understand, however, that explicit authority to collect
information is not always included in relevant law. Governmental
agencies may collect health data using a broad public health or
regulatory authority in statute or regulation. For example, a law may
call on a State agency to report on health care costs, without
providing specific authority for the agency to collect the health care
cost data they need do so. Consequently, the agency may use its general
operating authority to request health care providers to release the
information. We recognize that many governmental agencies rely on broad
legal authority for their activities and do not intend this proposed
rule to hamper those efforts.
Under Sec. 164.518(c), covered entities would have an obligation to
verify the identity of the person requesting protected health
information, and the legal authority behind the request before the
disclosure would be permitted under this subsection. Preamble section
II.G.3. describes these requirements in more detail.
7. Disclosure of Directory Information (Sec. 164.510(h))
[Please label comments about this section with the subject:
"Directory information"]
In Sec. 164.510(h), we propose to permit covered entities to
disclose information that could reveal protected health information
about an individual for purposes of a facility patient directory, if
the individual has indicated consent to such disclosures, or if the
individual who is incapacitated had not previously expressed a
preference in this regard and a covered entity determines that
including such information in the directory would be consistent with
good medical practice. Directory information could include only the
person's name, location in the institution, and general condition.
a. Importance of directory information and need for protected
health information. When individuals enter inpatient facilities, they
are not always able to contact people who may need to know their
whereabouts, want to visit them, or want to send them flowers or some
other expression of concern. Today, facilities typically operate
patient directories, allowing confirmation of a person's presence in a
facility, providing the room number for visits and deliveries, and
sometime providing general information on the patient's condition.
These services cannot be performed without disclosing protected health
information. Since most patients find this a welcome convenience, we
believe it would be important to allow these practices to continue.
However, not everyone may appreciate this service. We are proposing to
accommodate the wishes of such people, where possible.
b. Proposed requirements. In Sec. 164.510(h), we would require
covered entities to ask individuals whether they wish to be included in
the entity's directory. For individuals who are incapacitated or
otherwise unable to communicate their wishes and who have not
previously expressed a preference, the decision would be left to the
discretion of the covered entity, consistent with good medical
practice. We note that legal representatives could make such decisions
on behalf of persons who are incapacitated or otherwise unable to
communicate their wishes, consistent with State or other law, since
they would stand as the "individual." In the absence of a legal
representative or prior expression of a preference by the individual,
the decision would be left to the discretion of the covered entity,
consistent with good medical practice.
i. Individuals capable of making decisions.
For individuals who are not incapacitated, this rule would require
the covered entity to ask whether information about the individual's
presence in the facility, room number and general condition can be
included in the general patient directory. When individuals are capable
of making such a determination, their wishes should be respected.
We considered whether also to require covered entities to allow an
individual to specify that information can be provided to specific
persons but not others. For example, someone may feel that it is
acceptable to release information to family members but not to friends.
While we would like to respect individuals' wishes to the greatest
extent possible, we are concerned about placing on covered entities the
burden of verifying the identify of a person requesting directory
information. We are therefore not including this additional
requirement, but are requesting comments on current practices and how
such requests might be accommodated.
We would not require a formal individual authorization pursuant to
Sec. 164.508. A verbal or other informal inquiry and agreement would be
sufficient. We require only that individuals be given the choice.
ii. Incapacitated individuals.
If an individual is not able to make determinations as to whether
location or status information should be released to family and
friends, and had not in the past expressed a preference in this regard,
we would leave the decision as to whether to include the individual in
a directory to the discretion of the covered entity. Often individuals
are unconscious or otherwise unable due to a medical condition to
communicate their wishes to the entity and no representative is
available to act for them. In these cases, we encourage the covered
entity to take into consideration a number of factors when deciding
whether or not to include such an individual in the directory:
Could disclosing that an individual is in the facility
reasonably cause danger of harm to the individual? For example, if a
person is unconscious and receiving treatment for injuries resulting
from physical abuse from an unknown source, an entity may determine
that revealing that the individual is in the facility could give the
attacker enough information to seek out the individual and repeat the
abuse.
[[Page 59966]]
Could disclosing the location within the facility of the
patient give information about the condition of the patient? If a
patient's room number would reveal the nature of the medical condition,
the entity may decide that it is inappropriate to give that
information. For example, if one floor of a hospital has been
specifically designated as the psychiatric floor, simply saying that a
patient is located on that floor discloses some information about the
condition of the individual.
Is it necessary or appropriate to give the status of a
patient to family or friends? Covered entities often need information
from family or friends for the treatment of an incapacitated
individual. For example, if a patient is unconscious, family or friends
may be able to give valuable information that will assist the care
giver in making urgent decisions. Family members or friends may be able
to give information on drugs or medications that the individual has
been taking. On the other hand, it may be that revealing the status of
an individual gives more information than the individual would have
disclosed if they could make the determination themselves.
If an individual had, prior to becoming incapacitated,
expressed a desire not to be included in such a directory and the
covered entity learns of that statement of preference, the covered
entity would be required to act in accordance with the stated
preference.
Individuals who enter a facility incapacitated and then improve to
the point of being able to make their own determinations should be
asked within a reasonable time period for permission to include
information in the facility's directory.
When the condition of an individual who has opted not to allow
protected health information to be included in the facility's directory
deteriorates, and the individual is no longer capable of making
disclosure decisions, the covered entity would be required to abide by
the individual's initial decision. However, such a decision should not
prevent a provider from contacting the family if such contact is
required for good medical practice. A provider could need information
from the family to treat a newly incapacitated person. If good medical
practice would include contacting family or friends, the individual's
initial request should not prohibit such contact. But the covered
entity would still be prohibited from including information about the
individual in its directory.
8. Disclosure for Banking and Payment Processes (Sec. 164.510(i))
[Please label comments about this section with the subject:
"Banking and payment processes"]
In Sec. 164.510(i), we propose to allow covered entities to
disclose protected health information to financial institutions, or
entities acting for financial institutions, if necessary for processing
payments for health care and health care premiums.
a. Importance of financial transactions and the need for protected
health information. Checks that individuals use to pay for health care
typically include the names of providers or provider groups that could
implicitly identify the medical condition for which treatment was
rendered. Similarly, a credit card transaction will also reveal the
identify of the provider and thus potentially the nature of the medical
condition involved. While such information would constitute protected
health information under this rule, there is no practical way of
concealing this information when the provider deposits the check or
claims credit card payment. Failure to allow this kind of disclosure of
protected health information would impede the efficient operations of
the health care system.
b. Proposed requirements. We propose that covered entities be
permitted to disclose protected health information to financial
institutions for the specific purposes listed in the section. The
permissible purposes are those identified in the statute, and the
regulatory text would copy the statutory list of allowable uses.
Under section 1179 of the Act, activities of financial institutions
are exempt from HIPAA's Administrative Simplification requirements to
the extent that those activities constitute "authorizing, processing,
clearing, settling, billing, transferring, reconciling, or collecting
payments" for health care or health plan premiums. This section of the
statute states that financial institutions can use or disclose
protected health information for these purposes. We read this part of
the statute as indicating that Congress intended that this regulation
not impede the efficient processing of these transactions, and
accordingly are allowing covered entities to disclose protected health
information to financial institutions for the purposes listed in
section 1179 of the statute.
Proposed Sec. 164.510(i) would not allow covered entities to
include any diagnostic or treatment information in the data transmitted
to financial institutions. Such information is never necessary to
process a payment transaction. We believe that, in most cases, the
permitted disclosure would include only: (1) The name and address of
the account holder; (2) the name and address of the payer or provider;
(3) the amount of the charge for health services; (4) the date on which
health services were rendered; (5) the expiration date for the payment
mechanism, if applicable (i.e., credit card expiration date); and (6)
the individual's signature. At this time, we are not proposing to
include in the regulation an exclusive list of information that could
be lawfully disclosed for this purpose. We are, however, soliciting
comment on whether more elements would be necessary for these banking
and payment transactions and on whether including a specific list of
the protected health information that could be disclosed is an
appropriate approach.
We understand that financial institutions may also provide covered
entities that accept payment via credit card with software that, in
addition to fields for information required to process the transaction,
includes blank fields in which health plans or health care providers
may enter any type of information regarding their patients, such as
diagnostic and treatment information, or other information that the
covered entity wished to track and analyze. Other financial
institutions could provide services to covered entities that constitute
"health care operations" as defined in proposed Sec. 164.504.
We do not know whether and to what extent health plans and health
care providers are using such software to record and track diagnostic
and treatment and similar information. However, we recognize that the
capability exists and that if a plan or provider engages in this
practice, information not necessary for processing the payment
transaction could be forwarded to financial institutions along with
other information used to process payments. Disclosing such information
to a financial institution (absent a business partner relationship)
would violate the provisions of this rule.
We also understand that banks, in addition to offering traditional
banking services, may be interested in offering additional services to
covered entities such as claims management and billing support. Nothing
in this regulation would prohibit banks from becoming the business
partners of covered entities in accordance with and subject to the
conditions of Sec. 164.506(e). If a bank offers an integrated package
of traditional banking services and health claims and billing services,
it could do
[[Continued on page 59967]]
[Federal Register: November 3, 1999 (Volume 64, Number 212)]
[Proposed Rules]
[Page 59967-60016]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03no99-68]
[[pp. 59967-60016]] Standards for Privacy of Individually Identifiable Health
Information
[[Continued from page 59966]]
[[Page 59967]]
so through a business partner arrangement that meets the requirements
of proposed Sec. 164.506(e). Any services offered by the bank that are
not on the list of exempt services in 1179 would be subject to the
terms of this rule.
We recognize that financial institutions' role in providing
information management systems to customers is evolving and that in the
future, banks and credit card companies could develop and market to
health plans and health care providers software designed specifically
to record and track diagnostic and treatment information along with
payment information. In light of the rapid evolution of information
management technology available to plans and providers, we seek comment
on the types of services that financial institutions are performing or
may soon perform for covered entities, and how these services could be
best addressed by this proposed rule.
Finally, we note that we would impose no verification requirements
for most routine banking and payment activities. However, if a bank or
financial institution seeks information outside payment processing
transactions (e.g., during a special audit), we would require the
covered entity to take reasonable steps to verify the identity of the
person requesting the disclosure.
9. Uses and Disclosures for Research (Sec. 164.510(j))
[Please label comments about this section with the subject:
"Research"]
In Sec. 164.510(j), we propose to permit covered entities to use
and disclose protected health information for research without
individual authorization, provided that the covered entity receives
documentation that the research protocol has been reviewed by an
Institutional Review Board or equivalent body--a privacy board--and
that the board found that the research protocol meets specified
criteria (regarding protected health information) designed to protect
the subject. Absent such documentation, the subject's protected health
information could be disclosed for research only with the individual's
authorization, pursuant to the authorization requirements in proposed
Sec. 164.508.
Our proposed requirements for this disclosure build on the
requirements for such disclosure under the Federal regulation that
protects human subjects in research conducted or funded by the Federal
government, the Federal Policy for the Protection of Human Subjects
(often referred to as the "Common Rule"), first published for several
agencies at 56 FR 28,002-028, 032 (1991), and codified for the
Department of Health and Human Services at 45 CFR part 46.
a. Importance of research and the need for protected health
information. Much important and sometimes lifesaving knowledge has come
from studies that used individually identifiable health information,
including biomedical and behavioral research, epidemiological studies,
health services research, and statistical activities. This type of
research has lead to dramatic improvements in the nation's health. For
example, the results of such research include the association of a
reduction in the risk of heart disease with dietary and exercise
habits, the association between the use of diethylstilbestrol (DES) by
pregnant women and vaginal cancer in their daughters, and the value of
beta-blocker therapy in reducing re-hospitalizations and in improving
survival among elderly survivors of acute myocardial infarction.
Likewise, research on behavioral, social, and economic factors that
affect health, and the effect of health on other aspects of life may
require individually identifiable health information. Studies of this
kind can yield important information about treatment outcomes and
patterns of care, disease surveillance and trends, health care costs,
risk factors for disease, functional ability, and service utilization--
which may ultimately lead to improvements in the quality of patient
care, the identification and eradication of public health threats, and
the development of new devices and pharmaceutical products. For
example, such research uncovered the fact that disease screening and
treatment patterns vary with the race of the person, which in turn has
lead to focused outreach programs to improve health. Such research
showed that the results of certain highly invasive surgical treatments
are better when the care is provided in hospitals that performed a high
volume of these procedures.
It is not always possible for researchers to obtain the consent of
every subject that a researcher may wish to include within a study.
Thousands of records may be involved. Tracking down the subjects may
entail costs that make the research impracticable. The requirement to
obtain consent also may lead to biased study results, because those who
refuse consent may be more or less likely than average to have a
particular health problem or condition. This may be a particular
concern where the research topic involves sensitive or potentially
embarrassing information. At the same time, the privilege of using
individually identifiable health information for research purposes
without individual authorization requires that the information be used
and disclosed under strict conditions that safeguard individuals'
confidentiality.
b. Definition of research. In proposed Sec. 164.504, we would
define "research" as a systematic investigation, including research
development, testing and evaluation, designed to develop or contribute
to generalizable knowledge. This is the definition of "research" in
the Common Rule. This definition is well understood in the research
community and elsewhere, and we propose to use it here to maintain
consistency with other federal regulations that affect research.
For purposes of determining whether an activity is research under
this proposed rule, it would not be relevant whether the information is
given gratis, sold, bartered, rented, or otherwise provided for
commercial gain. The purpose of this proposed rule regarding disclosure
of protected health information for research is to protect the subjects
of the information. Where the activity meets the definition of research
and involves use or disclosure of protected health information, the
rules in this section would apply. We request comments on any aspect of
our proposed definition of research.
We understand that research and health care operations often look
alike, and may overlap. We have provided definitions for these terms in
Sec. 164.504. We solicit comments on ways to further distinguish
between research and operations, or otherwise clarify the application
of this rule to such activities.
c. Privacy board review requirement. In Sec. 154.510(j), we would
require covered entities that wish to use or disclose protected health
information for research without individual authorization to obtain
documentation that a privacy board has reviewed the research protocol
and has determined that specified criteria (described below) for waiver
of authorization for use or disclosure of the information have been
met. The board could be an IRB constituted under the Common Rule, or an
equivalent privacy board that meets the requirements in this proposed
rule. We propose to apply these requirements to uses and disclosures of
protected health information by all covered entities, regardless of the
source of funding of the research.
We propose no requirements for the location or sponsorship of the
IRB or privacy board. The covered entity could
[[Page 59968]]
create such a board, and could rely on it to review proposals for uses
and disclosure of records. An outside researcher could come to the
covered entity with the necessary documentation from his or her own
university IRB. A covered entity could engage the services of an
outside IRB or privacy board to obtain the necessary documentation. The
documentation would have to be reviewed by the covered entity prior to
a use or disclosure subject to this provision.
Under our proposal, we would require that the documentation
provided by the IRB or privacy board state: (1) That the waiver of
authorization has been approved by the IRB or privacy board; (2) that
the board either is an IRB established in accordance with the HHS
regulations (45 CFR 46.107) or equivalent regulations of another
federal agency, or is a privacy board whose members (i) have
appropriate expertise for review of records research protocols, (ii) do
not have a conflict of interest with respect to the research protocol,
and (iii) include at least one person not affiliated with the
institution conducting the research; (3) that the eight criteria for
waiver of authorization (described below) are met by the protocol; and
(4) the date of board approval of the waiver of authorization. We would
also require that the documentation be signed by the chair of the IRB
or privacy board.
i. Application to disclosures and uses regardless of funding
source.
The Common Rule describes conditions under which research may be
conducted when obtaining authorization is not possible. Those
conditions are intended to ensure that research on human subjects,
including research using their health records, is conducted in a manner
that minimizes or eliminates the risk of harm to individuals. The
Common Rule has been adopted by seventeen Federal agencies,3
representing most of the federal agencies sponsoring human subjects
research.
---------------------------------------------------------------------------
\3\ The following 17 Departments and Agencies have adopted the
Common Rule: (1) Department of Agriculture; (2) Department of
Commerce; (3) Department of Defense; (4) Department of Education;
(5) Department of Energy; (6) Department of Health and Human
Services; (7) Department of Housing and Urban Development; (8)
Department of Justice; (9) Department of Transportation; (10)
Department of Veterans Affairs; (11) International Development
Cooperative Agency: Agency for International Development; (12)
Consumer Product Safety Commission; (13) Environmental Protection
Agency; (14) National Aeronautics and Space Administration; (15)
National Science Foundation; (16) Social Security Administration;
(17) Central Intelligence Agency. In addition, the White House
Office of Science and Technology Policy is a signatory to the Common
Rule, but its policy is not codified in the Code of Federal
Regulations.
---------------------------------------------------------------------------
However, a significant amount of research involving protected
health information is currently conducted in the absence of these
federal protections. Pharmaceutical companies, health plans, and
colleges and universities conduct research supported by private funds.
Identifiable information currently is being disclosed and used by these
entities without individual authorization without any assessment of
risk or of whether individual privacy interests are being adequately
protected.
The Secretary's Recommendations call for the extension of the
Common Rule principles for waiver of authorization for research uses
and disclosures of identifiable health information to all research. The
Recommendations also propose additional principles that directly
address waiver of authorization for research use of such information.
The Recommendations would require an external board to review proposals
for research on health information under criteria designed to ensure
that the need for waiver of authorization is real, that the public
interest in the research outweighs the individual's privacy interest,
and that privacy will be protected as much as possible. In addition,
the Secretary's Recommendations proposed important restrictions on use
and re-disclosure of information by researchers, and requirements for
safeguarding protected information, that are not currently applied
under the Common Rule.
Under the Secretary's Recommendations, these requirements would
apply to researchers who want to use or obtain identifiable information
without first obtaining the authorization of the individual who is the
subject of the information. However, under HIPAA, we do not have the
authority to regulate researchers unless the researcher is also acting
as a provider, as in a clinical trial. We can only directly regulate
health care providers, health plans, and health care clearinghouses.
This means that for most research-related disclosures of health
information, we can directly regulate the entities that disclose the
information, but not the recipients of the information. Therefore, in
order to implement the principles in the Secretary's Recommendations,
we must impose any protections on the health plans and health care
providers that use and disclose the information, rather than on the
researcher seeking the information.
We understand that this approach involves imposing burdens on
covered entities rather than on researchers. However, our jurisdiction
under this statute leaves us the choice of taking this approach, or
failing to provide any protection for individuals whose information is
made the subject of research, or requiring individual authorization
whenever a covered entity wants to disclose protected health
information for research. The second approach would provide no
protection for individuals, and the third approach would make much
important research impossible. Therefore, we are proposing a mechanism
that we believe imposes as little burden as possible on the covered
entity while providing enhanced protection for individuals. This is not
the approach we advocate for new federal privacy legislation, where we
would propose that standards be applied directly to researchers, but it
would be a useful and appropriate approach under the HIPAA legislative
authority.
We considered a number of other approaches for protecting
information from research subjects, particularly when covered entities
use protected health information internally for research. We considered
approaches that would apply fewer requirements for internal research
uses of protected health information; for example, we considered
permitting covered entities to use protected health information for
research without any additional review. We also considered options for
a more limited review, including requiring that internal uses for
research using protected health information be reviewed by a designated
privacy official or by an internal privacy committee. Another option
that we considered would require covered entities to have an IRB or
privacy board review their administrative procedures, either for
research or more generally, but not to require such review for each
research project. See the preamble section II.E.9.
We are not recommending these approaches because we are concerned
about applying fewer protections to subjects of private sector research
than are applied to subjects of federally-funded research subject to
Common Rule protections, where IRB review is required for internal
research uses of protected health information. At the same time, we
recognize that the proposed rule would place new requirements on
research uses and disclosures for research projects not federally-
funded. We solicit comment on the approach that we are proposing,
including on whether the benefits of the IRB or privacy board reviews
would outweigh the burdens associated with
[[Page 59969]]
the proposed requirements. We also solicit comment on whether
alternative approaches could adequately protect the privacy interests
of research subjects. We are interested in the extent to which the
proposed rule could affect the amount and quality of research
undertaken by covered entities or by researchers receiving information
from covered entities. People commenting on the proposed rule also may
wish to address the appropriateness of applying different procedures or
different levels of protection to federally and nonfederally-funded
research. We would note that, as discussed below, privacy boards or
IRBs could adopt procedures for "expedited review" similar to those
provided in the Common Rule (Common Rule Sec. ____.110) for review of
records research that involves no more than minimal risk. The
availability of expedited review may affect the burden associated with
the proposed approach.
ii. Documentation of privacy board approval. We considered several
options for applying Common Rule principles to research not reviewed by
Common Rule IRBs through imposing requirements on covered entities. We
chose the use of the privacy board because it gives covered entities
the maximum flexibility consistent with protecting research subjects.
Under this approach, each covered entity that wants to use or disclose
protected health information for research without individual
authorization could obtain the required documentation directly from an
existing privacy board, an internal privacy board created by the
covered entity, or from a privacy board used by the researcher.
We considered prohibiting disclosure of protected health
information for research unless covered entities enter into contracts,
enforceable under law, which would require the researcher to meet the
review criteria. Under this approach, the covered entity would be
required to enter into a contract with the researcher in order to be
permitted to disclose protected health information without individual
authorization. In the contract, the researcher would agree to meet the
criteria described below, as well as the additional restrictions on
reuse and disclosure and the physical safeguards (also described
below), in exchange for obtaining the information from the covered
entity.
We did not adopt this approach because of the potentially
burdensome administrative costs that could stem from the need to
negotiate the contracts and ensure that they are legally enforceable
under law. In addition, the covered entity may have little incentive to
enforce these contracts. However, we seek comments on whether the
benefits of this approach outweigh the burdens, whether we could expect
the burdens to be eased by the development of model contracts by local
universities or professional societies, and whether covered entities
could be expected to enforce these contracts. We also seek comments on
whether covered entities could be given a choice between the
documentation approach proposed in this NPRM and a contract approach.
We are particularly interested in comments on this approach, because it
appears to be the only mechanism for including restrictions on reuse
and disclosure by researchers in this proposed rule.
iii. Use of boards that are not IRBs. The Secretary's
Recommendations state that privacy protections for private sector
records research should be modeled on the existing Common Rule
principles. The cornerstone of the Common Rule approach to waiver of
authorization is IRB approval. At the same time, we understand that
Common Rule IRBs are not the only bodies capable of performing an
appropriate review of records research protocols. In working with the
Congress to develop comprehensive privacy legislation, we have explored
the use of limited purpose privacy boards to review research involving
use or disclosure of health information. If the review criteria and
operating rules of the privacy board are sufficiently consistent with
the principles stated in the Secretary's Recommendations to afford the
same level of protection, there would be no need to insist that the
review board be a formal Common Rule IRB.
Among the Common Rule requirements for IRB membership, as stated in
45 CFR 46.107, are the following:
Each IRB must have members with varying backgrounds and
appropriate professional competence as necessary to review research
protocols.
Each IRB must include at least one member who is not
affiliated with the institution or related to a person who is
affiliated with the institution.
No IRB member may participate in review of any project in
which the member has a conflict of interest.
We propose to require that a covered entity could not use or
disclose protected health information for research without individual
authorization if the board that approved the waiver of authorization
does not meet these three criteria.
We considered applying the additional criteria for IRB membership
stated in the Common Rule. However, many of the additional criteria are
relevant to research generally, but less relevant for a board whose
sole function is to review uses or disclosures of health information.
In addition, the Common Rule IRB membership criteria are more detailed
than the criteria for privacy board membership we propose here. Since
our legislative authority reaches to covered entities, but not to the
privacy board directly, we decided that imposing additional or more
detailed requirements on privacy boards would impose added burdens on
covered entities that did not clearly bring concomitant increases in
patient protections. We continue to support more complete application
of Common Rule criteria directly to these privacy boards through
federal legislation. We believe the approach we propose here strikes
the appropriate balancing between protecting individuals' privacy
interests and keeping burdens on covered entities to a minimum.
d. Criteria. In Sec. 164.510(j)(2)(iii), we propose to prohibit the
use or disclosure of protected health information for research without
individual authorization unless the covered entity has documentation
indicating that the following criteria are met:
The use or disclosure of protected health information
involves no more than minimal risk to the subjects;
The waiver or alteration will not adversely affect the
rights and welfare of the subjects;
The research could not practicably be carried out without
the waiver or alteration;
Whenever appropriate, the subjects will be provided with
additional pertinent information after participation;
The research would be impracticable to conduct without the
protected health information;
The research project is of sufficient importance to
outweigh the intrusion into the privacy of the individual whose
information would be disclosed;
There is an adequate plan to protect the identifiers from
improper use and disclosure; and
There is an adequate plan to destroy the identifiers at
the earliest opportunity consistent with conduct of the research,
unless there is a health or research justification for retaining the
identifiers.
The first four criteria are in the Common Rule. (The Common Rule
Sec. ____.116(d)).4 These criteria were
[[Page 59970]]
designed for research generally, and not specifically to protect
individuals' privacy interests regarding medical records research. For
this reason, the Secretary's Recommendations include the last four
criteria, which were developed specifically for research on medical
records.
---------------------------------------------------------------------------
\4\ It should be noted that for the Department of Defense, 10
U.S.C. 980 prohibits the waiver of informed consent. Only those
studies that qualify for exemption per 45 CFR 46.101(b), or studies
that do not meet the 45 CFR part 46 definition of human subjects
research can be performed in the absence of a process to provide
informed consent to prospective subjects. This proposed rule would
not affect DOD's implementation of 10 U.S.C. 980.
---------------------------------------------------------------------------
As part of the IRB or privacy board's review of the use of
protected health information under the research protocol, we assume
that in case of a clinical trial, it would also review whether any
waiver of authorization could also include waiver of the subject's
right of access to such information during the course of the trial. See
Sec. 164.514(b)(iv).
We recognize that the fourth criterion may create awkward
situations for some researchers. Where authorization has been waived,
it may be difficult to later approach individuals to give them
information about the research project. However, in some cases the
research could uncover information that would be important to provide
to the individual (e.g., the possibility that they are ill and should
seek further examination or treatment). For this reason, we are
including this criterion in the proposed rule.
We also recognize that the fifth criterion, which would ask the
board to weigh the importance of the research against the intrusion of
privacy, would require the board to make a more subjective judgment
than that required by the other criteria. This balancing, we feel, goes
to the heart of the privacy interest of the individual. We understand,
however, that some may view this criterion as a potential impediment to
certain types of research. We solicit comment on the appropriateness of
the criterion, the burden it would place on privacy boards and IRBs,
and its potential effects on the ability of researchers to obtain
information for research.
The Secretary's Recommendations propose that a researcher who
obtains protected health information this way should be prohibited from
further using or disclosing it except when necessary to lessen a
serious and imminent threat to the health or safety of an individual or
to the public health, or for oversight of the research project, or for
a new research project approved by an IRB or similar board. In addition
the Recommendations propose an obligation on researchers to destroy the
identifiers unless an IRB or similar board determines that there is a
research or health justification for retaining them and an adequate
plan to protect them from improper disclosure.
We do not have the authority under HIPAA to place such requirements
directly on researchers. While criteria to be met in advance can be
certified in documentation through board review of a research protocol,
a board would have no way to assess or certify a researcher's behavior
after completion of the protocol (e.g., whether the researcher was
engaging in improper reuse or disclosure of the information, or whether
the researcher had actually destroyed identifiers). We instead propose
to require the researcher to show a plan for safeguarding the
information and destroying the identifiers, which the privacy board or
IRB can review and evaluate in determining whether the requested
disclosure is proper. We solicit comment on how to include ongoing
protections for information so disclosed under this legislative
authority without placing excessive burdens on covered entities.
We note that privacy boards or IRBs could adopt procedures for
"expedited review" similar to those provided in the Common Rule
(Common Rule Sec. ______.110) Under the Common Rule's expedited review
procedure, review of research that involves no more than minimal risk,
and involves only individuals' medical records may be carried out by
the IRB chairperson or by one or more reviewers designated by the
chairperson from among the members of the IRB. The principle of
expedited review could be extended to other privacy boards for
disclosures for records-based research. Like expedited review under the
Common Rule, a privacy board could choose to have one or more members
review the proposed research.
e. Additional provisions of this proposed rule affecting research.
i. Research including health care.
To the extent that the researcher studying protected health
information is also providing treatment as defined in proposed
Sec. 164.504, such as in a clinical trial, the researcher would be a
covered health care provider for purposes of that treatment, and would
be required to comply with all the provisions of this rule applicable
to health care providers.
ii. Individual access to research information.
The provisions of Sec. 164.514 of this proposed rule, regarding
individual access to records, would also apply where the research
includes the delivery of health care. We are proposing an exception for
clinical trials where the information was obtained by a covered
provider in the course of a clinical trial, the individual has agreed
to the denial of access when consenting to participate in the trial (if
the individual's consent to participate was obtained), and the trial is
in still in progress.
iii. Research on records of deceased persons.
In Sec. 164.506(f), we propose that, unlike the protections
provided by the remainder of this rule, the protections of this
proposed rule will end at the death of the subject for the purpose of
disclosure of the subject's information for research purposes. In
general, this proposed rule would apply to the protected health
information of an individual for two years after the individual's
death. However, requiring IRB or privacy board review of research
studies that use only health information from deceased persons would be
a significant change from the requirements of the Common Rule, which
apply to individually identifiable information about living individuals
only. In addition, some of the Common Rule criteria for waiver of
authorization are not readily applicable to deceased persons. To avoid
a conflict between Common Rule requirements and the requirements of
this proposed rule, we are proposing that the protections of this
proposed rule end at the death of the subject for the purpose of
disclosure of the subject's information for research purposes.
iv. Verification.
In Sec. 164.518(c), we propose to require covered entities to
verify the identity of most persons making requests for protected
health information and, in some cases, the legal authority behind that
request. For disclosures of protected health information for research
purposes under this subsection, the required documentation of IRB or
privacy board approval would constitute sufficient verification. No
additional verification would be necessary under Sec. 164.518(c).
f. Application to research covered by the Common Rule. Some
research projects would be covered by both the Common Rule and the
HIPAA regulation. This proposed rule would not override the Common
Rule. Thus, where both the HIPAA regulation and the Common Rule would
apply to research conducted by a covered entity, both sets of
regulations would need to be followed. Because only half of the
substantive criteria for board approval proposed in this rule are
applied by IRBs today, this would entail new responsibilities for IRBs
in these situations. However, we believe that the additional burden
would be minimal, since the IRBs will already be reviewing the research
protocol, and will be asked
[[Page 59971]]
only to assess the protocol against some additional criteria. This
burden is justified by the enhancement of privacy protections gained by
applying rules specifically designed to protect the subjects of medical
records research.
We considered excluding research covered by the Common Rule from
the provisions of this proposed rule. We rejected this approach for two
reasons. First, the additional proposed requirements applied through
HIPAA are specifically designed to protect the privacy interests of the
research subjects, and the small additional burden on IRBs would be
outweighed by the improved protections for individuals. Second, such an
approach would allow federally-funded research to proceed under fewer
restrictions than privately funded research. We believe that the source
of funding of the research should not determine the level of protection
afforded to the individual.
We note that the definition of "identifiable" information
proposed in Sec. 164.504 of this rule differs from the interpretation
of the term under the Common Rule. In particular, if a covered entity
encodes identifiers as required under Sec. 164.506(d) before
undertaking a disclosure of health information for research purposes,
the requirements of this section would not apply. However, the encoded
information would still be considered "identifiable" under the Common
Rule and therefore may fall under the human subjects regulations.
g. Obtaining the individual's authorization for research use or
disclosure of protected health information. If a covered entity chooses
to obtain individual authorization for use or disclosure of information
for research, the requirements applicable to individual authorizations
for release of protected health information would apply. These
protections are described in Sec. 164.508.
For research projects to which both the Common Rule and this
proposed rule would apply, both sets of requirements for obtaining the
authorization of the subject for research would apply. As with criteria
for waiver of authorization, this proposed rule would impose
requirements for obtaining authorization that are different from Common
Rule requirements for obtaining consent. In particular, the regulation
would require more information to be given to individuals regarding who
could see their information and how it would be used. For the reasons
explained above, we are proposing that both sets of requirements apply,
rather than allow federally-funded research to operate with fewer
privacy protections than privately-funded research.
h. Need to assess the Common Rule. In general, the Common Rule was
designed to protect human subjects participating in research projects
from physical harm. It was not specifically designed to protect an
individual's medical records when used for research. For research in
which only the medical information of the human subject is used, i.e.,
records research, there are several ways in which the Common Rule
protections could be enhanced.
In developing these proposed regulations, and in reviewing the
comprehensive medical privacy legislation pending before Congress, it
has become clear that the Department's human subject regulations (45
CFR part 46, 21 CFR part 50, and 21 CFR part 56) may not contain all of
the safeguards necessary to protect the privacy of research
participants. Because the source of research funding should not dictate
the level of privacy protection afforded to a research subject, the
Secretary of HHS will immediately initiate plans to review the
confidentiality provisions of the Common Rule.
To further that process, we solicit comments here on how Common
Rule protections for the subjects of records review should be enhanced.
For example, we will consider the adequacy of the Common Rule's
provisions regarding conflict of interest, expedited review, exemptions
(such as the exemption for certain research on federal benefits
programs), deceased subjects, and whether IRB's should place greater
emphasis on confidentiality issues when reviewing research protocols.
We also seek comment on whether the Common Rule requirements for
obtaining consent for records research should be modified to reflect
the specific risks entailed in such research.
In addition, because seventeen other Departments and Agencies are
signatories to the Common Rule and each has its own human subject
regulations, the Secretary of HHS will consult with these Departments
and Agencies regarding potential changes to the Common Rule.
10. Uses and Disclosures in Emergency Circumstances (Sec. 164.510(k))
[Please label comments about this section with the subject:
"Emergency circumstances"]
In Sec. 164.510 (k), we propose to permit covered entities to use
or disclose protected health information in emergencies, consistent
with applicable law and standards of ethical conduct, based on a
reasonable belief that the use or disclosure is necessary to prevent or
lessen a serious and imminent threat to the health or safety of any
person or the public.
a. Importance of emergency response and the need for protected
health information. Circumstances could arise that are not otherwise
covered in the rules proposed in Secs. 164.510(b) and 164.510(f) for
law enforcement and public health, where covered entities may need to
disclose protected health information to prevent or lessen a serious
and imminent threat of harm to persons or the public. Persons at risk
include the individual who is the subject of the protected health
information as well as others. Through their professional activities,
covered entities, particularly health care providers, may obtain
information that leads them to believe that an individual is at risk of
harm to him or herself, or poses a threat to others. This information
could be needed by emergency and first responders (including law
enforcement officials) to deal with or prevent an emergency situation
posing a serious and imminent threat of harm to such persons or the
public.
b. Proposed requirements. We would permit covered entities,
consistent with applicable law and standards of ethical conduct, to
disclose protected health information based on a reasonable belief that
the disclosure is necessary to prevent or lessen a serious and imminent
threat to the health or safety of a person or the public. Covered
entities would only be permitted to make such disclosures to persons
who are reasonably able to prevent or lessen the threat, including to
the target of the threat.
Anticipating all circumstances under which emergency disclosure
could be necessary is not possible. This section must be stated in
somewhat general terms. We intend to permit covered entities to respond
to emergency requests for protected health information, where it is
reasonable for the covered entity to believe that such disclosure would
prevent or reduce a serious emergency situation. Such emergencies may
threaten a single person or the general public. We do not intend to
permit disclosure of protected health information in response to
hypothetical scenarios or potential emergencies that are not imminent
and serious. This permitted disclosure would be narrow; it should not
become a loophole for disclosures not permitted by the other provisions
of the proposed rule.
[[Page 59972]]
This provision would permit disclosure of relevant information in
response to credible requests from law enforcement, public health, or
other government officials. The covered entity would be permitted to
reasonably rely on credible representations that an emergency exists
and that protected health information could lessen the threat. If the
disclosure was made in a good faith belief that these circumstances
exist, it would be lawful under this section. A covered entity could
also disclose protected health information on its own initiative if it
determined that the disclosure were necessary, consistent with other
applicable legal or ethical standards. Our proposed rule is intended to
permit such disclosures where they are otherwise permitted by law or
ethical standards. We do not intend to permit disclosures by health
care providers or others that are currently prohibited by other law or
ethical standards.
Disclosure for emergency circumstances could be authorized by
statute or common law and could also be addressed in medical
professional ethics and standards. For example, the American Medical
Association Principles of Medical Ethics on Confidentiality provides
that:
[T]he obligation to safeguard patient confidences is subject to
certain exceptions that are ethically and legally justified because
of overriding social consideration. Where a patient threatens to
inflict serious bodily harm to another person or to him or herself
and there is a reasonable probability that the patient may carry out
the threat, the physician should take reasonable precautions for the
protection of the intended victim, including notification of law
enforcement authorities.
The duty to warn third persons at risk has been addressed in court
cases, and the provision proposed permits disclosures in accord with
such legal duties. The leading case on this issue is Tarasoff v.
Regents of the University of California, 17 Cal. 3d 425 (1976). In that
case, a therapist's patient made credible threats against the physical
safety of a specific person. The Supreme Court of California found that
the therapist involved in the case had an obligation to use reasonable
care to protect the intended victim of his patient against danger,
including warning the victim of the peril. Many States have adopted
(judicially or legislatively) versions of the Tarasoff duty to warn,
but not all States have done so. This proposed rule is not intended to
create a duty to warn or disclose but would simply permit the
disclosure under the emergency circumstances consistent with other
applicable legal or ethical standards.
An emergency disclosure provision does present some risks of
improper disclosure. There will be pressures and uncertainties when
disclosures are requested under emergency circumstances, and decisions
must often be made instantaneously and without the ability to seek
individual authorization or to perform complete verification of the
request. We believe that this risk would be warranted when balancing
the individual's interest in confidentiality against the societal
interests to preserve life and protect public safety in those rare
emergency circumstances where disclosure is necessary. A covered entity
that makes a reasonable judgement under such pressure and discloses
protected health information in good faith would not be held liable for
wrongful disclosure if circumstances later prove not to have warranted
the disclosure.
We would also exempt emergency disclosures from provisions that
allow individuals to request restrictions on uses and disclosures of
their protected health information for treatment, payment and health
care operations. In emergency situations, health care professionals
need to have any information that will allow them to respond to the
emergency circumstance, and cannot be expected to take the time to
remind themselves of restrictions on particular information. See
proposed Sec. 164.506(c).
11. Disclosure to Next-of-Kin (Sec. 164.510(l))
[Please label comments about this section with the subject: "Next-of-
kin"]
In Sec. 164.510(l), we propose to require health care providers to
obtain a verbal agreement from the individual before disclosing
protected health information to next-of-kin, to other family members,
or to others with whom the individual has a close personal
relationship. Where it is not practical or feasible to request and
obtain such verbal agreement, providers could disclose to next-of-kin,
to other family members, or to others with whom an individual has a
close personal relationship, protected health information that is
directly relevant to the person's involvement in the individual's care,
consistent with good professional health practice and ethics.
a. Importance of disclosures to next-of-kin and the need for
protected health information. In some cases, disclosure of protected
health information to next-of-kin, to other relatives, or to persons
with whom the individual has a close personal relationship and who are
involved in caring for or helping the individual, can facilitate
effective health care delivery. We do not intend to impede the
disclosure of protected health information to relatives or friends when
expeditious disclosure of such information clearly would be in the
individual's best interest.
b. Proposed requirements. We propose that when an individual has
the capacity to make his or her own health decisions, providers could
disclose protected health information to the individual's next-of-kin,
to other relatives, or to persons with whom the individual has a close
personal relationship, if the individual has verbally agreed to such
disclosure. Verbal agreement could be indicated informally, for
example, from the fact that the individual brought a family member or
friend to the physician appointment and is actively including the
family member or friend in the discussion with the physician. If,
however, the situation is less clear and the provider is not certain
that the individual intends for the family member or friend to be privy
to protected health information about the individual, the provider
would be required to ask the individual. In these cases, when verbal
agreement can be obtained, that agreement would be sufficient
verification of the identity of the person to meet the requirements of
Sec. 164.518(c).
We would also permit health care providers to disclose protected
health information without verbal agreement to next-of-kin, to other
relatives, or to persons with whom the individual has a close personal
relationship, if such agreement cannot practicably or reasonably be
obtained and the disclosure is consistent with good health professional
practice and ethics. When verbal agreement cannot be obtained, the
provider would be required to take reasonable steps to verify the
identity of the family member or friend in order to meet the
verification requirement under Sec. 164.518(c). Verbal inquiry would
suffice; we would not require any specific type of identity check.
We considered requiring a written authorization for each disclosure
in these situations, but rejected that option because it is not
practicable and does not provide sufficient additional privacy
protection to justify the burden it would place on health care
providers and individuals. Many of these conversations are unscheduled
and of short duration, and requiring a written authorization may impede
treatment and detain the individual. Therefore we would allow a one-
time verbal agreement and (where required) verification to suffice for
disclosure of protected health information relevant to
[[Page 59973]]
the individual's care. For example, a health care provider could
disclose protected health information about an individual's treatment
plan to the individual's adult child who is taking the individual home
from the hospital, if the provider has verbally requested and
individual has agreed to providing the adult child with relevant
information about aspects of the individual's health care. Disclosure
also could be appropriate in cases where a verbal agreement cannot
practicably be obtained. For example, a pharmacist could be guided by
his or her professional judgment in dispensing a filled prescription to
someone who claims to be picking it up on behalf of the individual for
whom the prescription was filled.
In such cases, disclosures would have to follow the "minimum
necessary" provisions of proposed Sec. 164.506(b). For example, health
care providers could not disclose without individual authorization
extensive information about the individual's surgery or past medical
history to the neighbor who is simply driving the individual home and
has no need for this information. We request comment on this approach.
The proposed definition of "individual" addresses related
disclosures regarding minors and incapacitated individuals.
12. Additional Uses and Disclosures Required by Other Law
(Sec. 164.510(n))
[Please label comments about this section with the subject:
"Additional uses and disclosures required by other law"]
In Sec. 164.510(n) we propose to allow covered entities to use or
disclose protected health information if such use or disclosure is not
addressed elsewhere in Sec. 164.510, is required by other law, and the
disclosure meets all the relevant requirements of such law.
Other laws may require uses or disclosures of protected health
information for purposes not captured by the other provisions of
proposed Sec. 164.510. An example is State workers' compensation laws,
which could require health care providers to disclose protected health
information to a workers' compensation insurer or to an employer.
Covered entities generally could make uses and disclosures required by
such other laws.
Where such a use or disclosure would also be addressed by other
provisions of this regulation, the covered entity would also have to
follow the requirements of this regulation. Where the provisions of the
other law requirements are contrary to the provisions in this proposed
rule and more protective of the individual's privacy, the provisions of
the other law would generally control. See discussion in section II.I
below.
We have included this section because it is not our intention to
obstruct access to information deemed important enough by other
authorities to require it by law. We considered omitting this provision
because we are concerned that we do not know enough about the required
disclosures it would encompass, but decided to retain it in order to
raise the issue of permitting disclosures for other, undetermined
purposes. We solicit comment on the possible effects of omitting or
narrowing this provision.
Under this section, health care providers could make reports of
abuse of any person that are required by State law. All States require
reports of abuse. All States require reporting to child protective
agencies of instances of child abuse or neglect that they identify, and
most States require similar reports of abuse or neglect of elderly
persons. These are valuable requirements which we support and
encourage. The Act (in section 1178(b)) specifically requires that this
regulation not interfere with State requirements for reporting of
abuse. Additionally, all States require health care providers to report
gunshot wounds and certain other health conditions related to violence;
this provision would permit such reports.
Section 164.518(c), requiring verification of the identity and
legal authority of persons requesting disclosure of protected health
information would apply to disclosures under Sec. 164.510(n). As noted
above, we are not familiar with all of the disclosures of protected
health information that are mandated by State law, so we cannot be
certain that the verification requirements in Sec. 164.518(c) would
always be appropriate. We solicit comments on whether those
requirements would be appropriate for all disclosures that would be
permitted here.
13. Application to Specialized Classes (Sec. 164.510(m))
In the following categories we propose use and disclosure
provisions that respond to the unique circumstances of certain federal
programs. We request comment on whether additional provisions are
necessary to comply with the suitability and national security
determination requirements of Executive Order 10450, as amended, and
other national security laws.
a. Application to military services.
[Please label comments about this section with the subject:
"Military services"]
To address the special circumstances of the Armed Forces and their
health care systems, we propose to permit military and other federal
providers and health plans to use and disclose protected health
information about active duty members of the Armed Forces for certain
purposes, and to exclude from coverage under this rule health
information about certain persons who receive care from military
providers.
i. Members of the Armed Forces.
The primary purpose of the health care system of the military
services differs in its basic character from that of the health care
system of society in general. The special nature of military service is
acknowledged by the Constitutional provision for separate lawmaking for
them (U.S. Constitution, article I, section 8, clause 14) and in their
separate criminal justice system under the Uniform Code of Military
Justice (10 U.S.C. 801, et seq.).
The military health care system, like other federal and civilian
health care systems, provides medical care and treatment to its
beneficiary population. However, it also serves a critical national
defense purpose, ensuring that the Armed Forces are in a state of
medical readiness to permit the discharge of those responsibilities as
directed by the National Command Authority.
The health and well-being of military members is key and essential.
This is true whether such personnel are serving in the continental
United States or overseas or whether such service is combat-related or
not. In all environments, operational or otherwise, the Armed Forces
must be assured that its personnel are medically qualified to perform
their responsibilities. This is critical as each and every person
performs a vital service upon which others must rely in executing a
specified defense requirement. Unqualified personnel not only
jeopardize the possible success of an assignment or operation, but they
pose an undue risk and danger to others.
To assure that such persons are medically fit, health information
is provided to proper command authorities regarding military members
performing certain critical functions for medical screening and other
purposes so that determinations can be made regarding the ability of
such personnel to perform assigned duties. For example, health
information is provided regarding:
[[Page 59974]]
A pilot receiving medication that may affect alertness;
An Armed Forces member with an intolerance for a vaccine
necessary for deployment to certain geographical areas;
Any significant medical or psychological changes in a
military member who is a member of the Nuclear Weapons Personnel
Reliability Program;
A military recruit or member with an illness or injury
which disqualifies him or her from military service;
Compliance with controlled substances policies.
The military and the Coast Guard obtain such information from their
own health care systems, as well as from other agencies that provide
health care to service members, such as the Department of
Transportation (DOT), which is responsible for the United States Coast
Guard and other federal agencies which provide medical care to members
of the Armed Forces (e.g., the Department of State (DOS) provides such
care to military attaches and Marine security personnel assigned to
embassies and consulates overseas, the Department of Veterans Affairs
provides care in certain areas of the country or in cases involving
specialized services). Other health care providers could also provide
information, for example, when a private sector physician treats a
member injured in an accident.
The special needs of the DOD and DOT for accessing information for
purposes other than treatment, payment or health care operations were
recognized in the Secretary's Recommendations. We considered several
options for accommodating the unique circumstances of a military health
care environment. We considered providing special rule-making authority
to the DOD and other federal agencies which provide care to members of
the military, but HIPAA does not allow for such delegation by the
Secretary of HHS. Therefore, we propose that health care providers and
health plans of the DOD, the DOT, the DOS, the Department of Veterans
Affairs as well as any other person or entity providing health care to
Armed Forces personnel, could use or disclose protected health
information without individual authorization for activities deemed
necessary by appropriate military command authorities to assure the
proper execution of the military mission.
The appropriate military command authorities, the circumstances in
which use or disclosure without individual authorization would be
required, and the activities for which such use or disclosure would
occur in order to assure proper execution of the military mission,
would be identified through Federal Register notices promulgated by the
DOD or the DOT (for the Coast Guard). The verification requirements in
Sec. 164.518(c) would apply to disclosures permitted without
authorization.
This proposal would not confer authority on the DOD or the DOT to
enact rules which would permit use or disclosure of health information
that is restricted or controlled by other statutory authority.
ii. Foreign diplomatic and military personnel.
The Department of Defense, as well as other federal agencies,
provide medical care to foreign military and diplomatic personnel, as
well as their dependents. Such care is provided pursuant to either
statutory authority (e.g., 10 U.S.C. 2549) or international agreement.
The care may be delivered either in the United States or overseas.
Also, where health care is provided in the United States, it may be
furnished by non-government providers when government delivered care is
not available or the beneficiary elects to obtain private as opposed to
government health care. Examples include:
Foreign military personnel being trained, or assigned to
U.S. military organizations, in the United States who receive care from
either government or private health care providers;
The DOD operated medical clinic which provides care to all
allied military and diplomatic personnel assigned to NATO SHAPE
Headquarters in Brussels, Belgium;
The DOS, which also is engaged in arranging health care
for foreign diplomatic and military personnel and their families, could
also have legitimate needs for information concerning the health
services involved.
We believe that the statute was not intended to cover this unique
class of beneficiaries. These persons are receiving U.S., either
private or governmental, furnished health care, either in the United
States or overseas, because of the beneficiary's military or diplomatic
status. For such personnel, we believe that the country-to-country
agreements or federal statutes which call for, or authorize, such care
in furtherance of a national defense or foreign policy purpose should
apply. We propose to exclude foreign military and diplomatic personnel
and their dependents who receive health care provided by or paid for by
the DOD or other federal agency, or by an entity acting on its behalf
pursuant to a country-to-country agreement or federal statute, from the
definition of an "individual" in Sec. 164.504. Therefore, the health
information created about such persons by a DOD or other federal agency
health care provider would not be protected under this rule. However,
information created about such persons by covered health care providers
whose services are not paid for by or provided on behalf of a federal
agency would be protected health information.
iii. Overseas foreign national beneficiaries.
The Department of Defense, as well as other federal agencies and
U.S.-based non-governmental organizations, provide health care to
foreign nationals overseas incident to U.S. sponsored missions or
operations. Such care is provided pursuant to federal statute,
international agreement, international organization sponsorship, or
incident to military operations (including humanitarian and
peacekeeping operations). Examples include:
The DOD provides general health care to an indigenous
population incident to military deployment;
The DOD provides health care to captured and detained
personnel as a consequence of overseas combat operations. Such care is
mandated by international agreement, i.e., the Geneva Conventions. The
most recent example involves the surrender or capture of Iraqi soldiers
during the conduct of Operation Desert Storm;
A number of federal agencies and non-governmental
organizations provide health care services as part of organized
disaster relief or other humanitarian programs and activities around
the world.
We believe that the statute did not contemplate these unique
beneficiary populations. Under circumstances where healthcare is being
furnished to foreign nationals incident to sanctioned U.S. activities
overseas, application of these proposed rules could have the unintended
effect of impeding or frustrating the conduct of such activities, and
producing incongruous results. Examples include:
Requiring preparation of a notice advising the local
population of the information practices of the DOD incident to
receiving free medical care as part of disaster relief.
Medical information involving a prisoner of war could not
be disclosed, without the prisoner's consent, to U.S. military
authorities who have responsibility for operating the POW camps.
Therefore, we propose to exclude overseas foreign national
beneficiaries of health care provided by the DOD or other federal
agency, or by non-governmental organizations acting on behalf of a
federal agency, from the
[[Page 59975]]
definition of an individual. This exclusion would mean that any health
information created when providing health care to this population would
not be protected health information and therefore not covered by these
rules.
iv. Disclosure to the Department of Veterans Affairs.
Upon completion of an individual's military service, the DOD
routinely transfers that person's entire military service record,
including protected health information, to the Department of Veterans
Affairs so the file can be retrieved quickly if the individual or his/
her dependents apply for veterans benefits. This practice was initiated
in an effort to expedite veterans benefits eligibility determinations
by ensuring timely access to complete, accurate information on the
veteran's military service. Under the proposed rule, the transfer of
these files would require individual authorization if protected health
information is included. While this change could increase the time
necessary for benefits processing in some cases, we believe the privacy
interests outweigh the related administrative challenges. We invite
comment on whether our assessment of costs and benefits is accurate. We
also invite comment on alternative methods for ensuring privacy while
expediting benefits processing.
b. Application to the Department of Veterans Affairs.
[Please label comments about this section with the subject:
"Department of Veterans Affairs"]
We propose to permit protected health information to be used
without individual authorization by and among components of the
Department of Veterans Affairs that determine eligibility for or
entitlement to, or that provide, benefits under laws administered by
the Secretary of Veterans Affairs.
This exemption recognizes that the Veterans Administration is two
separate components: The Veterans Health Administration (which operates
health care facilities) and the Veterans Benefits Administration (which
operates the Veterans disability program). The close integration of the
operations of the two components may make requiring individual
authorizations before transferring protected health information
particularly disruptive. Further, the Veterans Health Administration
transfers medical information on a much larger scale than most other
covered entities, and requiring individual authorization for transfers
among components could compromise the Department of Veterans Affairs'
ability to fulfill its statutory mandates.
Nonetheless, we invite comments on this approach. In particular, we
are interested in whether the requirement for individual authorization
for disclosure of medical records for use in benefits calculations
would increase privacy protections for veterans, or whether it would be
of questionable value since most veterans would authorize disclosure if
it were tied to their benefits. We also are interested in comments on
whether the proposed approach would unreasonably hamper the Department
of Veterans Affairs in its ability to make accurate benefits
determinations in cases in which individuals chose not to authorize
disclosure.
c. Application to the Department of State.
[Please label comments about this section with the subject:
"Department of State"]
We propose to permit the Department of State to use and disclose
protected health information for certain purposes unrelated to its role
as a health care provider but necessary for the achievement of its
mission.
i. Importance of Foreign Service determinations and the need for
protected health information.
The Secretary of State administers and directs the Foreign Service.
As contemplated in the Foreign Service Act, the Foreign Service is "to
serve effectively the interests of the United States" and "provide
the highest caliber of representation in the conduct of foreign
affairs;" members of the Foreign Service are to be available to serve
in assignments throughout the world. As called for under the Foreign
Service Act, the DOS has established a health care program to promote
and maintain the physical and mental health of members of the Service
and that of other Government employees serving abroad under chief of
mission authority, as well as accompanying family members. The DOS
provides health care services to thousands of Foreign Service officers,
other government employees and their families serving abroad, many of
whom are frequently changing posts or assignments.
Worldwide availability for service is a criterion for entrance into
the Foreign Service, so that applicants with conditional offers of
employment must undergo medical clearance examinations to establish
their physical fitness to serve in the Foreign Service on a worldwide
basis prior to entrance into the Foreign Service. Employees and
accompanying family members also must be medically cleared before
assignments overseas, to preclude assignment to posts where existing
medical conditions would be exacerbated or where resources to support
an existing medical condition are inadequate.
The DOS uses protected health information gained through its role
as a health care provider to fulfill its other responsibilities. The
information is used to make medical clearance and fitness decisions as
well as other types of determinations requiring medical information
(such as fitness for duty or eligibility for disability retirement of
Foreign Service members). Such information is also used to determine
whether to immediately evacuate an individual for evaluation or
treatment, or to determine whether to allow an employee or family
member to remain in a position or at post abroad. An individual's
record can include medical information provided to the DOS with the
individual's authorization by outside health care providers, protected
health information about treatment provided or paid for by the DOS, and
medical information collected from non-treatment processes such as the
clearance process.
ii. Proposed requirements.
We are proposing to exempt the DOS from the requirement to obtain
individual authorization (Sec. 164.508) in order to use or disclose
protected health information maintained by its health care program in
certain cases. Specifically, the exemption would apply to the
disclosure or use of protected health information of the following
individuals for the following purposes: (1) Of applicants to the
Foreign Service for medical clearance determinations of physical
fitness to serve in the Foreign Service on a worldwide basis,
including: medical and mental conditions limiting assignability abroad;
conformance to occupational physical standards, where applicable; and
suitability;
(2) of members of the Foreign Service and other United States
Government employees assigned to serve abroad under Chief of Mission
authority, for (a) medical clearance determinations for assignment to
posts abroad, including: medical and mental conditions limiting such
assignment; conformance to occupational physical standards, where
applicable; continued fitness for duty, suitability, and continuation
of service at post (including decisions on curtailment); (b) separation
medical examinations; and (c) determinations of eligibility of members
of the Foreign Service for disability retirement (whether on
application of the employee or the Secretary);
[[Page 59976]]
(3) of eligible family members of Foreign Service or other United
States Government employees, for medical clearance determinations like
those described in (2) above to permit such family members to accompany
employees to posts abroad on Government orders, as well as
determinations regarding family members remaining at post and
separation medical examinations.
The proposed exemption is intended to maintain the DOS's procedures
regarding internal of medical information in conformance with the
Privacy Act of 1974, as amended, and 42 CFR Part 2, which would
continue to apply to the DOS. The verification requirements of
Sec. 164.518(c) would apply to these disclosures.
The DOS is considering the need to add national security
determinations under Executive Order 10450, as amended, and other
suitability determinations to the exempted purposes listed above. We
therefore request comment as to the purposes for which use or
disclosure of protected health information without individual
authorization by the DOS would be appropriate.
d. Application to employees of the intelligence community.
[Please label comments about this section with the subject:
"Intelligence community"]
We propose to permit covered entities to disclose protected health
information about individuals who are employees of the intelligence
community (as defined in Section 4 of the National Security Act, 50
U.S.C. 401a), and their dependents, to intelligence community agencies
without individual authorization when authorized by law.
This provision addresses the special circumstances of the national
intelligence community. The preservation of national security depends
to a large degree on the health and well-being of intelligence
personnel. To determine fitness for duty, including eligibility for a
security clearance, these agencies must have continued access to the
complete health records of their employees. To ensure continued fitness
for duty, it is critical that these agencies have access to the entire
medical record on a continuing basis. An incomplete medical file that
excluded mental health information, for instance, could result in an
improper job placement and a potential breach in security.
The term "intelligence community" is defined in section 4 of the
National Security Act, 50 U.S.C. 401a, to include: the Office of the
Director of Central Intelligence, which shall include the Office of the
Deputy Director of Central Intelligence, the National Intelligence
Council (as provided for in 50 U.S.C. 403-5(b)(3) [1]), and such other
offices as the Director may designate; the Central Intelligence Agency;
the National Security Agency; the Defense Intelligence Agency; the
National Imagery and Mapping Agency; the National Reconnaissance
Office; other offices within the DOD for the collection of specialized
national intelligence through reconnaissance programs; the intelligence
elements of the Army, the Navy, the Air Force, the Marine Corps, the
Federal Bureau of Investigation, the Department of the Treasury, and
the Department of Energy; the Bureau of Intelligence and Research of
the Department of State; and such other elements of any other
department or agency as may be designated by the President, or
designated jointly by the Director of Central Intelligence and the head
of the department or agency concerned, as an element of the
intelligence community.
We would permit covered entities to disclose protected health
information concerning employees of the intelligence community and
their dependents where authorized by law. The verification requirements
of Sec. 164.518(c) would apply to these disclosures.
F. Rights of individuals.
[Please label comments about this section with the subject:
"Introduction to rights of individuals"]
The following proposed sections are intended to facilitate
individual understanding of and involvement in the handling of their
protected health information. Four basic individual rights would be
created under this section: the right to a notice of information
practices; the right to obtain access to protected health information
about them; the right to obtain access to an accounting of how their
protected health information has been disclosed; and the right to
request amendment and correction of protected health information.
The rights described below would apply with respect to protected
health information held by health care providers and health plans. We
are proposing that clearinghouses not be subject to all of these
requirements. We believe that as business partners of covered plans and
providers, clearinghouses would not usually initiate or maintain direct
relationships with individuals. The contractual relationship between a
clearinghouse (as a business partner) and a covered plan or provider
would bind the clearinghouse to the notice of information practices
developed by the plan or provider and it will include specific
provisions regarding inspection, copying, amendment and correction.
Therefore, we do not believe the clearinghouses should be required to
provide a notice or provide access for inspection, copying, amendment
or correction. We would require clearinghouses to provide an accounting
of any disclosures for purposes other than treatment, payment and
health care operations to individuals upon request. See proposed
Sec. 164.515. It is our understanding that the vast majority of the
clearinghouse function falls within the scope of treatment, payment,
and health care operations and therefore we do not believe providing
this important right to individuals will impose a significant burden on
the industry. We invite comment on whether or not we should require
clearinghouses to comply with all of the provisions of the individual
rights section.
1. Rights and Procedures for a Written Notice of Information Practices.
(Sec. 164.512)
[Please label comments about this section with the subject:
"Notice of information practices"]
a. Right to a written notice of information procedures. We are
proposing that individuals have a right to an adequate notice of the
information practices of covered plans and providers. The notice would
be intended to inform individuals about what is done with their
protected health information and about any rights they may have with
respect to that information. Federal agencies must adhere to a similar
notice requirement pursuant to the Privacy Act of 1974 (5 U.S.C.
552a(e)(3)).
We are not proposing that business partners (including health care
clearinghouses) be required to develop a notice of information
practices because, under this proposed rule, they would be bound by the
information practices of the health plan or health care provider with
whom they are contracting.
We considered requiring covered plans or providers to obtain a
signed copy of the notice form (or some other signed indication of
receipt) when they give the form to individuals. There are advantages
to including such a requirement. A signed acknowledgment would provide
evidence that the notice form has been provided to the individual.
Further, the request to the individual to formally acknowledgment
receipt would highlight the importance of the notice, providing
additional encouragement for the individual to
[[Page 59977]]
read it and ask questions about its content.
We are concerned, however, that requiring a signed acknowledgment
would significantly increase the administrative and paperwork burden of
this provision. We also are unsure of the best way for health plans to
obtain a signed acknowledgment because plans often do not have face-to-
face contact with enrollees. It may be possible to collect an
acknowledgment at initial enrollment, for example by adding an
additional acknowledgment to the enrollment form, but it is less clear
how to obtain it when the form is revised. We solicit comment on
whether we should require a signed acknowledgment. Comments that
address the relative advantages and burdens of such a provision would
be most useful. We also solicit comment on the best way to obtain
signed acknowledgments from health plans if such a provision is
included in the final rule. We also solicit comments on other
strategies, not involving signed acknowledgments, to ensure that
individuals are effectively informed about the information practices of
covered plans or providers.
b. Revising the notice. We are proposing that covered plans and
providers be permitted to change their policies and procedures at any
time. Before implementing a change in policies and procedures, the
covered plan or provider must revise its notice accordingly. However,
where the covered plan or provider determines that a compelling reason
exists to take an action that violates its notice, it may do so only if
it documents the reason supporting the action and revises its notice
within 30 days of taking such action. The distribution requirements
that would apply when the notice has been materially revised are
discussed in detail below.
c. Content of the notice. In Sec. 164.512, we propose the
categories of information that would be required in each notice of
information practices, the specific types of information that would
have to be included in each category, and general guidance as to the
presentation of written materials. A sample notice is provided in the
Appendix to this preamble. This sample notice is provided as an example
of how the policies of a specific covered health care provider could be
presented in a notice. Each covered health plan and health care
provider would be required to create a notice that complies with the
requirements of this proposed rule and reflects its own unique
information practices. It does not indicate all possible information
practices or all issues that could be addressed in the notice. Covered
plans and providers may want to include significantly more detail, such
as the business hours during which an individual could review their
records or its standard time frame for responding to requests to review
records; entities could choose to list all types of mandatory
disclosures.
In a separate section of this proposed rule, we would require
covered plans or providers to develop and document policies and
procedures relating to use, disclosure, and access to protected health
information. See proposed Sec. 164.520. We intend for the documentation
of policies and procedures to be a tool for educating the entity's
personnel about its policies and procedures. In addition, the
documentation would be the primary source of information for the notice
of information practices. We intend for the notice be a tool for
educating individuals served by the covered plan or provider about the
information practices of that entity. The information contained in the
notice would not be as comprehensive as the documentation, but rather
provide a clear and concise summary of relevant policies and
procedures.
We considered prescribing specific language that each covered plan
or provider would include in its notice. The advantages of this
approach would be that the recipient would get exactly the same
information from each covered plan or provider in the same format, and
that it would be convenient for covered plans or providers to use a
uniform model notice.
There are, however, several disadvantages to this approach. First,
and most important, no model notice could fully capture the information
practices of every covered plan or provider. Large entities will have
different information practices than small entities. Some health care
providers, for example academic teaching hospitals, may routinely
disclose identifiable health information for research purposes. Other
health care providers may rarely or never make such disclosures. To be
useful to individuals, each entity's notice of information practices
should reflect its unique privacy practices.
Another disadvantage of prescribing specific language is that it
would limit each covered plan or provider's ability to distinguish
itself in the area of privacy protections. We believe that if
information on privacy protections were readily available, individuals
might compare and select plans or providers based on their information
practices. In addition, a uniform model notice could easily become
outdated. As new communication methods or technologies are introduced,
the content of the notices might need to reflect those changes.
A covered plan or provider that adopts and follows the notice
content and distribution requirements described below, we would
presume, for the purposes of compliance, that the plan or provider has
provided adequate notice. However, the proposed requirements for the
content of the notice are not intended to be exclusive. Covered plans
or providers could include additional information and additional
detail, beyond that required. In particular, all federal agencies must
still comply with the Privacy Act of 1974. For federal agencies that
are covered plans or providers, this would mean that the notice must
comply with the notice requirements provided in the Privacy Act as well
as those included in this proposed rule.
i. Uses and disclosures of protected health information.
In proposed Sec. 164.512, we would require each covered plan and
provider to include in the notice an explanation of how it uses and
discloses protected health information. The explanation must be
provided in sufficient detail as to put the individual on notice of the
uses and disclosures expected to be made of his or her protected health
information. As explained above in section II.C.5, covered plans and
providers may only use and disclose protected health information for
purposes stated in this notice.
This section of the notice might be as simple as a statement that
information will be used and disclosed for treatment, payment,
administrative purposes, and quality assurance. If the entity will be
using or disclosing the information for other purposes, the notice must
include a brief explanation. For example, some entities might include a
statement that protected health information will be used for clinician
education and disclosed for research purposes. We are soliciting
comment on the level of detail that should be required in describing
the uses and disclosures, specifically with respect to uses and
disclosures for health care operations.
In addition we would require that notices distinguish between those
uses and disclosures the entity makes that are required by law and
those that are permitted but not required by law. By distinguishing
between uses and disclosures that an entity is required to make those
that the entity is choosing to make, the notice would provide the
[[Page 59978]]
individual with a clearer understanding of the entity's privacy
practices.
For uses and disclosures required by law, the notice need only list
the categories of disclosures that are authorized by law, and note that
it complies with such requirements. This language could be the same for
every covered entity within a State, territory or other locale. We
encourage states, state professional associations, and other
organizations to develop model language to assist covered plans or
providers in preparing this section of the notice.
For each type of permissible use or disclosure that the entity
makes (e.g., research, public health, and next-of-kin), the notice
would include a brief statement explaining the entity's policy with
respect to that type of disclosure. For example, if all relevant laws
permit health care providers to disclose protected health information
to public health without individual authorization, the entity would
need to develop policies and procedures regarding when and how it will
make such disclosures. The entity would then document those policies
and procedures as required by Sec. 164.520 and the notice would include
a statement of these policies. For example, the notice might state "we
will disclose your protected health information to public health
authorities upon request."
We considered requiring the notice to include not only a discussion
the actual disclosure practices of the covered entity, but also a
listing or discussion of all additional disclosures that are authorized
by law. We considered this approach because, under this proposed rule,
covered plans or providers would be permitted to change their
information practices at any time, and therefore individuals would not
be able to rely on the entity's current policies alone to understand
how their protected health information may be used in the future. We
recognize that in order to be fully informed, individuals need to
understand when their information could be disclosed.
We rejected this approach because we were concerned that a notice
with such a large amount of information could be burdensome to both the
individuals receiving the notices and the entities required to prepare
and distribute them. There are a substantial number of required and
permitted disclosures under State or other applicable law, and this
rule generally would permit them to be made.
Alternatively, we considered requiring that the notice include all
of the types of permissible disclosures under this rule (e.g., public
health, research, next-of-kin). We rejected that approach for two
reasons. First, we felt that providing people with notice of the
intended or likely disclosures of their protected health information
was more useful than describing all of the potential types of
disclosures. Second, in many States and localities, different laws may
affect the permissible disclosures that an entity may make, in which
case a notice only discussing permissible disclosures under the federal
rule would be misleading. While it would be possible to require covered
plans or providers to develop notices that discuss or list disclosures
that would be permissible under this rule and other law, we were
concerned that such a notice may be very complicated because of the
need to discuss the interplay of federal, State or other law for each
type of permissible disclosure. We invite comments on the best approach
to provide most useful information to the individuals without
overburdening either covered plans or providers or the recipients of
the notices.
In Sec. 164.520, we are proposing to require all covered entities
to develop and document policies and procedures for the use of
protected health information. The notice would simply summarize those
documented policies and procedures and therefore would entail little
additional burden.
ii. Required statements.
We are proposing that the notice include several basic statements
to inform the individual of their rights and interests with respect to
protected health information. First, we propose to require the notice
to inform individuals that the covered plan or provider will not use or
disclose their protected health information for purposes not listed in
the notice without the individual's authorization. Individuals need to
understand that they can authorize a disclosure of their protected
health information and that the covered entity may request the
individual to authorize a disclosure, and that such disclosures are
subject to their control. The notice should also inform individuals
that such authorizations can be revoked.
Second, we propose that the notice inform individuals that they
have the right to request that the covered plan or provider restrict
certain uses and disclosures of protected health information about
them. The notice would also inform individuals that the covered plan or
provider is not required to agree to such a request.
Third, we propose that the notice also inform individuals about
their right of access to protected health information for inspection
and copying and to an accounting of disclosures as provided in proposed
Secs. 164.514 and 164.515. In addition, the notice would inform
individuals about their right to request an amendment or correction of
protected health information as proposed in Sec. 164.516. The notice
would include brief descriptions of the procedures for submitting
requests to the covered plan or provider.
Fourth, the notice would be required to include a statement that
there are legal requirements that require the covered plan or provider
to protect the privacy of its information, provide a notice of
information practices, and abide by the terms of that notice.
Individuals should be aware that there are government requirements in
place to protect their privacy. Without this statement, individuals may
not realize that covered plans or providers are required to take
measures to protect their privacy, and may therefore be less interested
in pursuing their rights or finding out more information.
Fifth, the notice would be required to include a statement that the
entity may revise its policies and procedures with respect to uses or
disclosures of protected health information at any time and that such a
revision could result in additional uses or disclosures without the
individual's authorization. The notice also should inform the
individual how a revised notice would be made available when material
revisions in policies and procedures are made. For example, when a
provider makes a material change to its notice, proposed
Sec. 164.512(e) would require the provider to post a new notice.
Finally, we propose that the notice inform individuals that they
have the right to complain to the covered entity and to the Secretary
if they believe that their privacy rights have been violated.
iii. Identification of a contact person for complaints and
additional information.
We propose that the notice be required to identify a contact person
or office within the covered plan or provider to receive complaints, as
provided in proposed Sec. 164.518(a)(2), and to help the individual
obtain further information on any of the issues identified in the
notice. A specific person would not need to be named in the notice. It
could be an office or general number where someone who can answer
privacy questions or concerns can be reached.
In Sec. 164.518(d), we are proposing that covered plans and
providers permit individuals to submit complaints to the covered
entity. We are proposing that the contact person identified in the
[[Page 59979]]
notice be responsible for initially receiving such complaints. The
contact person might or might not be responsible for processing and
resolving complaints, but, if not, he or she would forward the
complaints to the appropriate personnel or office. See discussion of
the complaint process in section II.G.4, below.
In addition to receiving complaints, the contact person would be
able to help the individual obtain further information on any of the
issues identified in the notice. The contact person would be able to
refer to the documented policies and procedures required by proposed
Sec. 164.520. We would not prescribe a formal method for responding to
questions.
The administrative requirements section below, proposed
Sec. 164.518(a), would also require the entity to designate an official
to develop policies for the use and disclosure of protected health
information and to supervise personnel with respect to use and
disclosure of protected health information. We would not require this
official to also be the contact person. Depending on the size and
structure of the entity, it might be appropriate to require one person
to fill both roles.
iv. Date the notice was produced.
We are proposing that covered plans and providers include the date
that the notice was produced on the face of the notice. We would also
encourage the provider to highlight or otherwise emphasize any changes
to help the individual recognize such changes.
d. Requirements for distribution of the notice. It is critical to
the effectiveness of this proposed rule that individuals be given the
notice often enough to remind them of their rights, but without
overburdening covered plans or providers. We propose that all covered
plans and providers would be required to make their notice available to
any individual upon request, regardless of whether the requestor is
already a patient or enrollee. We believe that broad availability would
encourage individuals or organizations to compare the privacy practices
of plans or providers to assist in making enrollment or treatment
choices. We also propose additional distribution requirements for
updating notices, which would be different for health plans and health
care providers. The requirements for health plans and health care
providers are different because we recognize that they have contact
with individuals at different points in time in the health care system.
i. Health plans.
We considered a variety of combinations of distribution practices
for health plans and are proposing what we believe is the most
reasonable approach. We would require health plans to distribute the
notice by the effective date of the final rule, at enrollment, within
60 days of a material change to the plan's information practices, and
at least once every three years.
We considered requiring health plans to post the notice either in
addition to or instead of distribution. Because most individuals rarely
visit the office of their health plan, we do not believe that this
would be an effective means of communication. We also considered either
requiring distribution of the notice more or less frequently than every
three years. As compared to most health care providers, we believe that
health plans often are larger and have existing administrative systems
to cost effectively provide notification to individuals. Three years
was chosen as a compromise between the importance of reminding
individuals of their plans' information practices and the need to keep
the burden health plans to the minimum necessary to achieve this
objective. We are soliciting comment on whether requiring a notice
every three years is reasonable for health plans.
ii. Health care providers.
We are proposing to require that covered health care providers
provide a copy of the notice to every individual served at the time of
first service delivery, that they post the notice in a clear and
prominent location where it is reasonable to expect individuals seeking
service from the provider to be able to read the notice, and that
copies be available on-site for individuals to take with them. In
addition, we are proposing to require that covered health care
providers provide a copy of the notice to individuals they are
currently serving at their first instances of service delivery within a
year of the effective date of the final rule.
We would not require health care providers to mail or otherwise
disseminate their notices after giving the notice to individuals at the
time of the first service delivery. Health care providers' patient
lists may include individuals they have not served in decades. It would
be difficult for providers to distinguish between "active" patients,
those who are seen rarely, and those who have moved to different
providers. While some individuals will continue to be concerned with
the information practices of providers who treated them in the distant
past, overall the burden of an active distribution requirement would
not be outweighed by improved individual control and privacy
protection.
We recognize that some health care providers, such as clinical
laboratories, pathologists and mail order pharmacies, do not have face-
to-face contact with individuals during service delivery. Such
providers would be required to provide the required notice in a
reasonable period of time following first service delivery, through
mail, electronic notice (i.e. e-mail), or other appropriate medium. For
example, a web-based pharmacy could meet this distribution requirement
by providing a prominent and conspicuous link to its notice on its home
page and by requiring review of that notice before processing an order.
If a provider wishes to make a material change in the information
practices addressed in the notice, it would be required to revise its
notice in advance. After making the revision, the provider would be
required to post the new notice promptly. We believe that this approach
creates the minimum burden for health care providers consistent with
giving individuals a clear source of accurate information.
e. Plain language requirement. We are proposing to apply a plain
language requirement to notices developed by covered plans or providers
under these proposed rules. A covered plan or provider could satisfy
the plain language requirement if it made a reasonable effort to:
organize material to serve the needs of the reader; write sentences in
the active voice, use "you" and other pronouns; use common, everyday
words in sentences; write in short sentences; and divide material into
short sections.
We also considered proposing formatting specifications such as
requiring the covered plan or provider to use easy-to-read design
features (e.g., lists, tables, graphics, contrasting colors, and white
space), type face, and font size in the notice. We are soliciting
comment on whether these additional format specifications should be
required.
The purpose of the notice proposed in the rules below is to tell
the recipient how protected health information collected about them
will be used. Recipients who cannot understand the entity's notice
would miss important information about their privacy rights and how the
entity is protecting health information about them. One of the goals of
this proposed rule is to create an environment of open communication
and transparency with respect to the use and disclosure of protected
health information. A lack of clarity in the notice could undermine
this goal and
[[Page 59980]]
create misunderstandings. Covered plans or providers have an incentive
to make their notice statements clear and concise. We believe that the
more understandable notices are, the more confidence the public will
have in the entity's commitment to protecting the privacy of health
information.
It is important that the content of the notice be communicated to
all recipients and therefore we would encourage the covered plan or
provider to consider alternative means of communicating with certain
populations. We note that any covered entity that is a recipient of
federal financial assistance is generally obligated under title VI of
the Civil Rights Act of 1964 to provide material ordinarily distributed
to the public in the primary languages of persons with limited English
proficiency in the recipients' service areas. Specifically, this title
VI obligation provides that, where a significant number or proportion
of the population eligible to be served or likely to be directly
affected by a federally assisted program need service or information in
a language other than English in order to be effectively informed of or
participate in the program, the recipient shall take reasonable steps,
considering the scope of the program and the size and concentration of
such population, to provide information in language appropriate to such
persons. For entities not subject to title VI, the title VI standards
provide helpful guidance for effectively communicating the content of
their notices to non-English speaking populations.
We also would encourage covered plans or providers to be attentive
to the needs of individuals who cannot read. For example, an employee
of the entity could read the notice to individuals upon request or the
notice could be incorporated into a video presentation that is played
in the waiting area.
The requirement of a printed notice should not be interpreted as a
limitation. For example, if an individual who is requesting a notice
from a covered plan or providers were to ask to receive the notice via
e-mail, the requirements of this proposed rule could be met by
providing the notice via e-mail. The proposed rule would not preclude
the use of alternative forms of providing the notice and we would
encourage covered plans or providers to use other forms of
distribution, such as posting their privacy notices on their web sites.
While this will not substitute for paper distribution when that is
requested by an individual, it may reduce the number of requests for
paper copies.
2. Rights and Procedures for Access for Inspection and Copying
(Sec. 164.514)
a. Right of access for inspection or copying. (Sec. 164.514(a))
[Please label comments about this section with the subject:
"Access for inspection or copying"]
In Sec. 164.514, we are proposing that, with very limited
exceptions, individuals have a right to inspect and copy protected
health information about them maintained by a covered health plan or
health care provider in a designated record set. Individuals would also
have a right of access to protected health information in a designated
record set that is maintained by a business partner of a covered plan
or provider when such information is not a duplicate of the information
held by the plan or provider, including when the business partner is
the only holder of the information or when the business partner has
materially altered the protected health information that has been
provided to it.
This right of access means that an individual would be able to
either inspect or obtain copies of his or her health information
maintained in a designated record set by covered plans and providers
and, in limited circumstances, by their business partners. Inspection
and copying is a fundamental aspect of protecting privacy; this right
empowers individuals by helping them to understand the nature of the
health information about them that is held by their providers and plans
and to correct errors. In order to facilitate an open and cooperative
relationship with providers and allow the individual a fair opportunity
to know what information is held by an entity, inspection and copying
should be permitted in almost every case.
While the right to have access to one's information may appear
somewhat different from the right to keep information private, these
two policy goals have always been closely tied. For example,
individuals are given an almost absolute right of access to information
in federal health record systems under the Privacy Act of 1974 (5
U.S.C. 552a(d)). The Privacy Protection Study Commission recommended
that this right be available. (Personal Privacy in an Information
Society 299 (1977)). The right of access was a key component of the
President's Advisory Commission on Consumer Protection and Quality in
the Health Care Industry recommendations in the Consumer Bill of Rights
and Responsibilities. The Commission's report stated that consumers
should "have the right to review and copy their own medical records
and request amendments to their records." (Consumer Bill of Rights and
Responsibilities, Chapter Six: Confidentiality of Health Information,
November 1997). Most recently, the Health Privacy Project issued a
statement of "Best Principles for Health Privacy" that included the
same recommendation. Health Privacy Project, Institute for Health
Policy Solutions, Georgetown University (June 1999) (https://
www.healthprivacy.org).
Open access to health information can benefit both the individuals
and the covered entities. It allows individuals to better understand
their own diagnosis and treatment, and to become more active
participants in their health care. It can increase communication,
thereby enhancing individuals' trust in their health care providers and
increasing compliance with the providers' instructions. If individuals
have access to and understand their health information, changing
providers may not disrupt health care or create risks based on lack of
information (e.g., drug allergies or unnecessary duplication of tests).
i. Information available for inspection and copying.
In Sec. 164.514(a), we are proposing to give the individual a right
of access to information that is maintained in a designated record set.
We intend to provide a means for individuals to have access to any
protected health information that is used to affect their rights and
interests. This would include, for example, information that would be
used to make health care decisions or information that would be used in
determining whether an insurance claim would be paid. Covered plans or
providers often incorporate the same protected health information that
is used to make these types of decisions into a variety of different
data systems. Not all of those data systems will be utilized to make
determinations about specific individuals. For example, information
systems that are used for quality control analyses are not usually used
to make determinations about a specific patient. We would not require
access to these other systems.
In order to ensure that individuals have access to the protected
health information that is used, we are introducing the concept of a
"designated record set." In using the term "designated record set,"
we are drawing on the concept of a "system of records" that is used
in the Privacy Act. Under the Privacy Act, federal agencies must
provide an individual with access to "information pertaining to him
which
[[Page 59981]]
is contained in (a system of records)." 5 U.S.C. 552a(d)(1). A
"system of records" is defined as "a group of any records under the
control of any agency from which information is retrieved by the name
of the individual or by some identifying number, symbol, or other
identifying particular assigned to the individual." 5 U.S.C.
552a(a)(5). Under this rule, a "designated record set" would be "a
group of any records under the control of any covered entity from which
information is retrieved by the name of the individual or by some
identifying number, symbol, or other identifying particular assigned to
the individual." See discussion in section II.B.
Files used to backup a primary data system or the sequential files
created to transmit a batch of claims to a clearinghouse are clear
examples of data files which do not fall under this definition. We
rejected requiring individual access to all records in which she or he
was identifiable because of the extreme burden it would place on
covered plans or providers without providing additional information or
protection for the individual. We also rejected using the subset of
such records which were accessed directly by individual identifiers
because of the redundancy of information involved and the increasing
use of database management systems to replace legacy systems that do
sequential processing. These would be accessed by individual identifier
but would contain redundant data and be used for routine processing
that did not directly affect the individual. We concluded that access
to only such record sets that were actually accessed by individual
identifier and that were used to make substantive decisions that affect
individuals would provide the desired information with a minimum of
burden for the covered plans or providers.
We note that the standard would apply to records that are
"retrieved" by an identifier and not records that are only
"retrievable" by an identifier. In many cases, technology will permit
sorting and retrieving by a variety of fields and therefore the
"retrievable" standard would be relatively meaningless. We intend to
limit access to those sets of records actually used to affect the
interests of the individual.
We believe that by providing access to protected health information
maintained in a designated record set, we would be ensuring that
individuals will be able to inspect or copy relevant and appropriate
information without placing too significant of a burden on covered
plans or providers. We are soliciting comment on whether limiting
access to information maintained in a designated record set is an
appropriate standard when applied to covered plans and providers and
their business partners.
ii. Right of access to information maintained by business partners.
In Sec. 164.506(e), we are proposing that covered plans and
providers include specific terms in their contract with each business
partner. One of the required terms would be that the business partner
must provide for inspection and copying of protected health information
as provided in this section. Because our authority is limited by HIPAA
to the covered entities, we must rely upon covered plans and providers
to ensure that all of the necessary protected health information
provided by the individual to the plan or provider is available for
inspection and copying. We would require covered plans and providers to
provide access to information held in the custody of a business partner
when it is different from information maintained by the covered plan or
provider. We identified two instances where this seemed appropriate:
when the protected health information is only in the custody of a
business partner and not in the custody of the covered plan or
provider; and when protected health information has been materially
altered by a business partner. We are soliciting comment on whether
there are other instances where access should be provided to protected
health information in the custody of a business partner.
Other than in their capacity as business partners, we are not
proposing to require clearinghouses to provide access for inspection
and copying. As explained above in section II.C.5, clearinghouses would
usually be business partners under this proposed rule and therefore
they would be bound by the contract with the covered plan or provider.
See proposed Sec. 164.506(e). We carefully considered whether to
require clearinghouses to provide access for inspection and copying
above and beyond their obligations as a business partner, but
determined that the typical clearinghouse activities of translating
record formats and batching transmissions do not involve setting up
designated record sets on individuals. Although the data maintained by
the clearinghouse is protected health information, it is normally not
accessed by individual identifier and an individual's records could not
be found except at great expense. In addition, although clearinghouses
process protected health information and discover errors, they do not
create the data and make no changes in the original data. They,
instead, refer the errors back to the source for correction. Thus,
individual access to clearinghouse records provides no new information
to the individual but could impose a significant burden on the
industry.
As technology improves it is likely that clearinghouses will find
ways to take advantage of databases of protected health information
that aggregate records on the basis of the individual subject of the
information. This technology would allow more cost-effective access to
clearinghouse records on individuals and therefore access for
inspection and copying could be appropriate and reasonable.
iii. Duration of the right of access.
We are proposing that covered plans and providers be required to
provide access for as long as the entity maintains the protected health
information. We considered requiring covered plans and providers to
provide access for a specific period or defining a specific retention
period. We rejected that approach because many laws and professional
standards already designate specific retention periods and we did not
want to create unnecessary confusion. In addition, we concluded that
individuals should be permitted to have access for as long as the
information is maintained by the covered plan or provider. We are
soliciting comments on whether we should include a specific duration
requirement in this proposed rule.
b. Grounds for denial of access for inspection and copying.
Proposed Sec. 164.514 would permit denial of inspection and copying
under very limited circumstances. The categories of denials would not
be mandatory; the entity could always elect to provide all of the
requested health information to the individual. For each request by an
individual, the entity could provide all of the information requested
or it could evaluate the requested information, consider the
circumstances surrounding the individual's request, and make a
determination as to whether that request should be granted or denied.
We intend to create narrow exceptions to the stated rule of open access
and we would expect covered plans and providers to employ these
exceptions rarely, if at all.
In proposing these categories of permissible denials, we are not
intending to create a legal duty for the entity to review all of the
health information before releasing it. Rather, we are proposing them
as a means of preserving the flexibility and judgment of covered plans
or providers under appropriate circumstances.
[[Page 59982]]
Entities subject to the Privacy Act would not be able to deny a
request for inspection and copying under all of the circumstances
permitted by this proposed rule. They would continue to be governed by
the denials permitted by the Privacy Act and applicable regulations.
See section II.I.4.a for further discussion.
i. Disclosures reasonably likely to endanger life or physical
safety.
In Sec. 164.514(b)(1)(i), we propose that covered plans and
providers be permitted to deny a request for inspection or copying if a
licensed health care professional has determined that, in the exercise
of reasonable professional judgment, the inspection and copying
requested is reasonably likely to endanger the life or physical safety
of the individual or another person. Denial based on this provision, as
with all of the provisions in this section, would be discretionary.
While it is important to protect the individual and others from
physical harm, we are also concerned about the subjectivity of the
standard and are soliciting comments on how to incorporate a more
objective standard into this provision.
We are proposing that covered plans and providers should only
consider denying a request for inspection and copying under this
provision in situations where a licensed health care professional (such
as a physician, physician's assistant or nurse) makes the determination
that access for inspection and copying would be reasonably likely to
endanger life or physical safety. We are proposing to require a
licensed health care professional to make the determination because it
would rely entirely on the existing standards and ethics in the medical
profession. In some instances, the covered plan or provider would be a
licensed health care professional and therefore, he or she could make
the determination independently. However, when the request is made to a
health plan, the entity would need to consult with a health care
professional in order to deny access under this provision.
We are soliciting comments as to whether the determination under
this provision should be limited to health care professionals who have
an existing relationship with the individual. While such a limitation
would significantly restrict the scope of this provision and could
reduce the number of denials of requests for inspection and copying, it
could also ensure that the determination of potential harm is as
accurate as possible.
By proposing to allow covered plans and providers to deny a request
for inspection and copying based on potential endangerment, we are not
suggesting that entities should deny a request on that basis. This
provision is not intended to be used liberally as a means of denial of
individual inspection and copying rights for all mental health records
or other "sensitive" health information. Each request for access
would have to be assessed on its own merits. We would expect the
medical community to rely on its current professional standards for
determining what constitutes a threat to life or physical safety.
As explained above, we are not proposing to create a new "duty"
whereby entities can be held liable for failure to deny inspection and
copying. We simply are acknowledging that some providers, based on
reasonable professional judgment, may already assume a duty to protect
an individual from some aspect of their health information because of
the potential for physical harm. The most commonly cited example is
when an individual exhibits suicidal or homicidal tendencies. If a
health care professional determines that an individual exhibits such
tendencies and that permitting inspection or copying of some of their
health information could reasonably result in the individual committing
suicide, murder or other physical violence, then the individual could
be denied access to that information.
We considered whether covered plans and providers should be
permitted to deny access on the basis of sensitivity of the health
information or the potential for causing emotional or psychological
harm. Many States allow denial of access on similar grounds. In
balancing the desire to provide individual access against the need to
protect the individual, we concluded that the individual access should
prevail because in the current age of health care , it is critical that
the individual is aware of his or her health information.
Therefore, if a health care professional determines that inspection
and copying of the requested information may cause emotional or
psychological harm, but is not reasonably likely to endanger the life
or physical safety of the individual or another person, then the
covered plan or provider would not be permitted to deny the
individual's request. If the entity is concerned about the potential
for emotional or psychological harm, we would encourage it to offer
special procedures for explaining the information or counseling the
individual. For example, an entity could offer to have a nurse or other
employee review the information or the format with the individual or
provide supplemental written materials explaining a diagnosis. If the
entity elects to offer such special procedures, the entity would not be
permitted to condition inspection and copying upon compliance with the
procedures. We are not proposing to require covered plans or providers
to establish any informational or counseling procedures and we are not
proposing that individuals be required to comply with any procedures in
order to obtain access to their protected health information. We invite
comment on whether a standard such as emotional distress or
psychological harm should be included as a reason for which a covered
plan or provider could deny a request for inspection or copying.
ii. Disclosures likely to cause harm to another individual.
We propose that covered plans and providers be permitted to deny a
request for inspection or copying if the information requested is about
another person (other than a health care provider) and a licensed
health care professional has determined that inspection or copying is
reasonably likely to cause substantial harm to that other person. We
believe that it is rare that information about one person would be
maintained within the health records of another without one or both of
their knowledge. On some occasions when health information about one
person is relevant to the care of another, a physician may incorporate
it into the latter's record, such as information from group therapy
sessions and illnesses with a genetic component. In some instances the
information could be shared without harm, or may already be known to
the individual. There may, however, be situations where disclosure
could harm the other person, such as by implicitly revealing facts
about past sexual behavior, nonpaternity, or similarly sensitive
information. This provision would permit withholding of information in
such cases.
We believe that this determination should be based on the existing
standards and ethics in the medical profession. We are soliciting
comments on whether the determination under this provision should be
limited to health care professionals who have an existing relationship
with the person who is expected to be harmed as a result of the
inspection or copying.
Information about a third party may appear in an individual's
records unbeknownst to the individual. In such cases if the individual
chooses to exercise her right to inspect her protected health
information, the covered plan or provider providing her access would be
making an
[[Page 59983]]
unauthorized disclosure unless the third party has provided a written
authorization. We considered requiring that access to such information
be denied because the third party had not provided an authorization. We
considered proposing that the covered plan or provider would be
required to deny an individual's request for access to any information
about another person, unless there was a potential for harm to the
individual who would be denied. This would have been the only instance
where we would require that access be denied as a general rule. We
recognized that such requirements would ultimately require covered
plans and providers to review every piece of protected health
information before permitting inspection and copying to determine if
information about another person was included and whether the requester
would be harmed without such information. We concluded that this would
impose a significant burden on covered plans and providers. We seek
comment on whether and how often individual health records contain
identifiable information about other persons, and current practice
relating to the handling of such information in response to individual
requests for access.
iii. Disclosures of confidential information likely to reveal the
source.
We propose that covered plans or providers be permitted to deny a
request for inspection and copying if the entity determines that the
requested information was obtained under a promise of confidentiality
from someone other than a health care provider and such access would be
likely to reveal the source of the information. This provision is
intended to preserve an entity's ability to maintain an implicit or
explicit promise of confidentiality.
Covered plans and providers would not be permitted to deny access
when the information has been obtained from another health care
provider. An individual is entitled to have access to all information
about him or her generated by the health care system (apart from the
other exceptions we propose here), and confidentiality promises by
health care providers to other providers should not interfere with that
access.
iv. Disclosures of clinical trial information.
While a clinical trial is research, it is also health care as
defined in Sec. 160.103, and the information generated in the course of
the trial would be protected health information. In
Sec. 164.514(b)(iv), we are proposing that a researcher/provider could
deny a request for inspection and copying of the clinical trial record
if the trial is still in progress, and the subject-patient had agreed
to the denial of access in conjunction with the subject's consent to
participate in the trial. The IRB or privacy board would determine
whether such waiver of access to information is appropriate, as part of
its review of the research protocol. In the rare instances in which
individuals are enrolled in trials without consent (such as those
permitted under FDA regulations, at 21 CFR 50.23), the covered entity
could deny access to information during the course of the trial even
without advance subject consent.
Clinical trials are often masked--the subjects do not know the
identity of the medication they are taking, or of other elements of
their record while the trial is in progress. The research design
precludes their seeing their own records and continuing in the trial.
Thus it is appropriate for the patient to waive the right to see the
record while the trial is in progress. This understanding would be an
element of the patient's consent to participate in the trial; if the
consent signed by the patient did not include this fact, the patient
would have the normal right to see the record. In all cases, the
subject would have the right to see the record after the trial is
completed.
As with all grounds for denial of access, denial would not be
required under these circumstances. We would expect all researchers to
maintain a high level of ethical consideration for the welfare of trial
participants and provide access where appropriate. For example, if a
participant has a severe adverse reaction, disclosure of information
during the course of the trial may be necessary to give the participant
adequate information for proper treatment decisions.
v. Disclosure of information compiled for a legal proceeding.
In Sec. 164.514(b)(1)(v), we are proposing that covered plans and
providers be permitted to deny a request for inspection and copying if
the information is compiled in reasonable anticipation of, or for use
in, a legal proceeding. This provision would permit the entity to deny
access to any information that relates specifically to legal
preparations but not to the individual's underlying health information.
For example, when a procedure results in an adverse outcome, a
hospital's attorney may obtain statements or other evidence from staff
about the procedure, or ask consultants to review the facts of the
situation for potential liability. Any documents containing protected
health information that are produced as a result of the attorney's
inquiries could be kept from the individual requesting access. This
provision is intended to incorporate the attorney work-product
privilege. Similar language is contained in the Privacy Act and has
been interpreted to extend beyond attorneys to information prepared by
"lay investigators."
We considered limiting this provision to "civil" legal
proceedings but determined that such a distinction could create
difficulties in implementation. In many situations, information is
gathered as a means of determining whether a civil or criminal
violation has occurred. For example, if several patients were
potentially mistreated by a member of a provider's staff, the provider
may choose to get copies of the patients' records and interview other
staff members. The provider may not know at the time they are compiling
all of this information whether any investigation, civil or criminal,
will take place. We are concerned that if we were to require the entity
to provide the individual with access to this information, we might
unreasonably interfere with this type of internal monitoring.
c. Provision of other protected health information where access for
inspection and copying is denied. In proposed Sec. 164.514(b)(2), we
would require a covered plan or provider that elects to deny a request
for inspection or copying as provided above to make any other protected
health information requested available to the individual to the extent
possible consistent with the denial. The plan or provider could redact
or otherwise exclude only the information that falls within one or more
of the denial criteria described above and would be required to permit
inspection and copying of all remaining information. This provision is
key to the right to inspect and copy one's health information. We
intend to create narrow exceptions to the stated rule of open access
for inspection and copying and we would expect covered plans or
providers to employ these exceptions rarely, if at all. In the event
that a covered plan or provider would find it necessary to deny access,
then the denial would need to be as limited in scope as possible.
d. Procedures to effect right of access for inspection and copying.
In Sec. 164.514(c) and (d), we are proposing that covered plans and
providers be required to have procedures that enable individuals to
exercise their rights to inspect and obtain a copy of protected health
information as explained above.
[[Page 59984]]
We considered whether this proposed rule should include detailed
procedures governing a individual's request for inspection and copying.
Because this proposed rule will affect such a wide range of entities,
we concluded that it should only provide general guidelines and that
each entity should have the discretion to develop procedures consistent
with its own size, systems, and operations.
i. Time limits.
In Sec. 164.514(d)(2), we are proposing that the covered plans and
providers would take action upon the request as soon as possible but
not later than 30 days following receipt of the request. We considered
the possibility of not including a time limitation but rather imposing
a "reasonableness" requirement on the covered plans or providers. We
concluded that the individual is entitled to know when to expect a
response. This is particularly important in the context of health
information, where an individual may need access to his or her
information in order to make decisions about care. Therefore, in order
to determine what would be "reasonable," we examined the time
limitations provided in the Privacy Act, the Freedom of Information Act
(FOIA), and several State laws.
If the entity had fulfilled all of its duties under this proposed
rule within the required time period, then the entity should not be
penalized for any delay by the individual. For example, if, within the
30 days, a provider approves a request for inspection and copying,
makes copies of the requested information, and notifies the individual
that this information is available to be picked up and paid for at the
provider's office, then the provider's duty would be discharged under
the rule. The individual might not be able to pick up the information
for another two weeks, but this extra time should not be counted
against the provider.
The Privacy Act requires that upon receipt of a request for
amendment (not access), the agency would send an acknowledgment to the
individual within 10 working days. (5 U.S.C. 552a (d)(2)). We
considered several options that included such an acknowledgment
requirement. An acknowledgment would be valuable because it would
assure the individual that their request was received. Despite the
potential value of requiring an acknowledgment, we concluded that it
could impose a significant administrative burden on some of the covered
plans and providers. This proposed rule will cover a wide range of
entities with varying capacities and therefore, we are reluctant to
create requirements that would overwhelm smaller entities or interfere
too much with procedures already in place. We would encourage plans and
providers to have an acknowledgment procedure in place, but would not
require it at this point. We are soliciting comment on whether this
proposed rule should require such an acknowledgment.
We also considered whether to include specific procedures governing
"urgent" or "emergency" requests. Such procedures would require
covered plans and providers to respond in a shorter time frame. We
recognize that circumstances may arise where an individual will request
inspection and copying on an expedited basis and we encourage covered
plans or providers to have procedures in place for handling such
requests. We are not proposing additional regulatory time limitations
to govern in those circumstances. The 30-day time limitation is
intended to be an outside deadline, rather than an expectation. Rather,
we would expect a plan or provider to always be attentive to the
circumstances surrounding each request and respond in an appropriate
time frame, not to exceed 30 days.
Finally, we considered including a section governing when and how
an entity could have an extension for responding to a request for
inspection and copying. For example, the FOIA provides that an agency
may request additional time to respond to a request if the agency needs
to search for and collect the requested records from facilities that
are separate from the office processing the request; to search for,
collect, and appropriately examine a voluminous amount of separate and
distinct records; and to consult with another entity or component
having a substantial interest in the determination of the request. We
determined that the criteria established in the FOIA are tailored to
government information systems and therefore may not be appropriate for
plans and providers covered by this proposed rule. Furthermore, we
determined that the 30-day time period would be sufficient for
responding to requests for inspection and copying and that extensions
should not be necessary. We are soliciting comments on whether a
structured extension procedure should be included in this proposed
rule.
ii. Notification of accepted requests.
In Sec. 164.514(d)(3), we are proposing that covered plans or
providers be required to notify the individual of the decision to
provide access and of any steps necessary to fulfill the request. In
addition we propose that the entity provide the information requested
in the form or format requested if it is readily producible in such
form or format. Finally, if the covered plan or provider accepts an
individual's request, it would be required to facilitate the process of
inspection and copying.
For example, if the plan or provider will be making copies and
sending them directly to the individual with an invoice for copying
costs, then it would need to ensure that the individual is aware of
this procedure in advance and then send the information within the 30-
day time period. If the plan or provider has procedures that require
the individual to inspect the health information on site, then in
addition to notifying the individual of the procedure, the entity would
need to ensure that there are representatives available during
reasonable business hours at the usual business address who can assist
with inspection and copying. If the plan or provider maintains health
information electronically and the individual requests an electronic
copy, the plan or provider would need to accommodate such request if
possible.
iii. Copying fees.
In proposed Sec. 164.514(d)(3)(iv), we would permit a covered plan
or provider to charge a reasonable, cost-based fee for copying health
information provided pursuant to this section. We considered whether we
should follow the practice in the FOIA and include a structured fee
schedule. We concluded that the FOIA was developed to reflect the
relatively uniform government costs and that this proposed rule would
apply to a broader range of entities. Depending on the size of the
entity, copying costs could vary significantly. Therefore, we propose
that the entity simply charge a reasonable, cost-based fee.
The inclusion of a fee for copying is not intended to impede the
ability of individuals to copy their records. Rather, it is intended to
reduce the burden on covered plans and providers. When establishing a
fee for copying, we encourage covered plans and providers to consider
the impact on individuals of such a cost. If the cost is excessively
high, some individuals would not be able to obtain a copy. We would
encourage covered plans or providers to make efforts to keep the fee
for copying within reach of all individuals.
iv. Statement of denial of access for inspection and copying.
In Sec. 164.514(d)(4), we propose that a covered plan or provider
that denies an individual's request for inspection and copying in whole
or in part be required to provide the individual with a written
statement in plain language explaining the reason for the denial. The
statement could include a direct reference to the section of the
regulation relied upon for
[[Page 59985]]
the denial, but the regulatory citation alone would not sufficiently
explain the reason for the denial. The statement would need to include
the name and number of the contact person or office within the entity
who is responsible for receiving complaints. In addition, the statement
would need to include information regarding the submission of a
complaint with the Department pursuant to Sec. 164.522(b).
We considered proposing that covered plans and providers provide a
mechanism for appealing a denial of inspection and copying. We believe,
however, that the requirement proposed in Sec. 164.518(d) that covered
plans and providers have complaint procedures to address patient and
enrollee privacy issues generally would allow the individual to raise
the issue of a denial with the covered plan or provider. We would
expect the complaint procedures to be scalable; for example, a large
plan might develop a standard complaint process in each location where
it operates whereas, a small practice might simply refer the original
request and denial to the clinician in charge for review. We would
encourage covered plans and providers to institute a system of appeals,
but would not require it by regulation. In addition, the individual
would be permitted to file a complaint with the Department pursuant to
Sec. 164.522(b).
3. Rights and Procedures With Respect to an Accounting of Disclosures.
(Sec. 164.515)
[Please label comments about this section with the subject:
"Accounting of disclosures"]
a. Right to accounting of disclosures. In this rule, we propose
that individuals have a right to receive an accounting of all instances
where protected health information about them is disclosed by a covered
entity for purposes other than treatment, payment, and health care
operations, subject to certain time-limited exceptions for disclosures
to law enforcement and oversight agencies as discussed below. Providing
such an accounting would allow individuals to understand how their
health information is shared beyond the basic purposes of treatment,
payment and health care operations.
We considered whether to require covered entities to account for
all disclosures, including those for treatment, payment and health care
operations. We rejected this approach because it would be burdensome
and because it would not focus on the disclosures of most interest to
individuals. Upon entering the health care system, individuals are
generally aware that their information will be used and shared for the
purpose of treatment, payment and health care operations. They have the
greatest interest in an accounting of circumstances where the
information was disclosed for other purposes that are less easy to
anticipate. For example, an individual might not anticipate that his or
her information would be shared with a university for a research
project, or would be requested by a law enforcement agency.
We are not proposing that covered entities include uses and
disclosures for treatment, payment and health care operations in the
accounting. We believe that it is appropriate for covered entities to
monitor all uses and disclosures for treatment, payment and health care
operations, and they would be required to do so for electronically
maintained information by the Security Standard. However, we do not
believe that covered entities should be required to provide an
accounting of the uses and disclosures for treatment payment and health
care operations.
The proposed Security Standard would require that "[e]ach
organization * * * put in place audit control mechanisms to record and
examine system activity. They would be important so that the
organization can identify suspect data access activities, assess its
security program, and respond to potential weaknesses." The purpose of
the audit control mechanism, or audit trail, in the Security Standard
would be to provide a means for the covered entity to police access to
the protected health information maintained in its systems. By
contrast, the purpose of the accounting would be to provide a means for
individuals to know how the covered entity is disclosing protected
health information about them. An audit trail is critical to
maintaining security within the entity and it could be constructed in
such a way to enable the covered plan or provider to satisfy the
requirements of both regulations. For example, every time protected
health information was used or disclosed, the audit mechanism could
prompt the user for a "purpose." If the disclosure was for a purpose
other than treatment, payment or health care operations, then the
information could be flagged or copied into a separate database. This
would allow the entity to both monitor security and have the ability to
provide an accurate accounting upon request.
Covered entities should know how all protected health information
is used and disclosed, but should not be required to provide an
exhaustive accounting of all uses and disclosures to individuals upon
request. Such an accounting could be extremely long and detailed. It
would place a tremendous burden on the covered entities and it could be
far too detailed to adequately inform the individual. We determined
that when individuals seek health care, they understand that
information about them will be used and disclosed in order to provide
treatment or obtain payment and therefore, they would have the most
significant interest in knowing how protected health information was
used and disclosed beyond the expected realm of treatment, payment and
health care operations. We are soliciting comment on whether the scope
of accounting strikes an appropriate balance between providing
information to the individual and imposing requirements on covered
entities.
We are proposing that covered entities be required to provide an
accounting of disclosures for as long as the entity maintains the
protected health information. We considered only requiring the
accounting for a specified period of time, but concluded that
individuals should be permitted to learn how their information was
disclosed for as long as the information is maintained by the covered
plan or provider. We are soliciting comments on whether we should
include a specific time period in this proposed rule.
b. Procedures for providing an accounting of disclosures.
i. Form or format.
This proposed rule does not specify a particular form or format for
the accounting. In order to satisfy the accounting requirement, a
covered entity could elect to maintain a systematic log of disclosures
or it could elect to rely upon detailed record keeping that would
permit the entity to readily reconstruct the history when it receives a
request from an individual. We would require that covered entities be
able to respond to a request for accounting within a reasonable time
period. In developing the form or format of the accounting, covered
entities should adopt policies and procedures that will permit them to
respond to requests within the 30-day time period in this proposed
rule.
ii. Content of the accounting of disclosures.
We are proposing that the accounting include all disclosures for
purposes other than treatment, payment, and health care operations,
subject to certain exceptions for disclosures to law enforcement and
oversight agencies, discussed below. This would also include
disclosures that are authorized by the individual. The accounting would
include the date of each disclosure; the name and address of the
[[Page 59986]]
organization or person who received the protected health information;
and a brief description of the information disclosed. For all
disclosures that are authorized by the individual, we are proposing
that the covered entity maintain a copy of the authorization form and
make it available to the individual with the accounting.
We considered whether the accounting of disclosures should include
the name of the person who authorized the disclosure of information.
The proposed Security Standard would require covered entities to have
an audit mechanism in place to monitor access by employees. We
concluded that it was unnecessary and inappropriate to require the
covered entity to include this additional information in the
accounting. If the individual identifies an improper disclosure by an
entity, he or she should hold the entit--not the employee of the
entity--accountable. It is the responsibility of the entity to train
its workforce about its policies and procedures for the disclosure of
protected health information and to impose sanctions if such policies
and procedures are violated.
We are proposing that protected health information that is
disclosed to a health oversight or law enforcement agency would be
excluded from the accounting if the oversight or law enforcement agency
provides a written request stating that the exclusion is necessary for
a specified time period because access by the individual during that
time period would be reasonably likely to impede the agency's
activities. The written request must specifically state how long the
information should be excluded. At the expiration of that period, the
covered entity would be required to include the information in an
accounting for the individual.
We are proposing this time-limited exclusion for law enforcement
and oversight activities because we do not intend to unreasonably
interfere with investigations and other activities that are in the
public interest. The Recommendations simply provide that disclosures to
law enforcement and oversight agencies should be excluded from the
accounting where access by the individual could be reasonably likely to
impede the agency's activities. We were concerned that it would be
difficult for covered entities to determine whether access by the
individual was "reasonably likely to impede the agency's activities."
In order to address this concern, we considered excluding all
disclosures to law enforcement and oversight from the accounting, but
concluded that such an exclusion would be overly broad. As a means of
creating a clearly defined rule for the covered entity to follow, we
are proposing that covered entities require a time-limited, written
statement from the oversight or law enforcement agency. We are
soliciting comment on whether this time-limited exclusion strikes the
appropriate balance between ensuring individual access to an accounting
of disclosures and preserving the integrity of law enforcement and
oversight investigations.
iii. Time limits.
We are proposing that the accounting of disclosures, including
copies of signed authorization forms, be made available to the
individual as quickly as the circumstances require, but not later than
30 days following receipt of the request.
4. Rights and Procedures for Amendment and Correction (Sec. 164.516)
[Please label comments about this section with the subject: "Amendment
or correction"]
a. Right to request amendment or correction of protected health
information. This proposed rule would provide an individual with the
right to request a covered plan or provider to amend or correct
protected health information relating to the individual. A covered plan
or provider would be required to accommodate requests with respect to
any information that the covered plan or provider determines to be
erroneous or incomplete, that was created by the plan or provider, and
that would be available for inspection and copying under proposed
Sec. 164.514.
i. Accuracy and completeness.
The first criteria that a covered entity would need to consider is
whether the protected health information at issue is either erroneous
or incomplete. The basic concept comes from the Privacy Act of 1974,
governing records held by Federal agencies, which permits an individual
to request correction or amendment of a record "which the individual
believes is not accurate, relevant, timely, or complete." (5 U.S.C.
552a(d)(2)). We would adopt the standards of "accuracy" and
"completeness" and draw on the clarification and analysis of these
terms that has emerged in administrative and judicial interpretations
of the Privacy Act over the last 25 years.
We are not proposing to permit correction on the basis of an
individual's belief that information is irrelevant or untimely. The
Privacy Act of 1974 imposes affirmative obligations on Federal agencies
to maintain records with accuracy, relevance, timeliness, and
completeness, and permits individuals to seek correction of records
that do not meet that standard. The amendment and correction right
complements and helps to enforce the agency obligation.
Our view is that the relevance and timeliness standards, while very
appropriate for Federal agencies generally, would be difficult to
impose by regulation upon health record keeping, which depends to a
large extent on clinical judgment. The increasingly-recognized impact
of lifestyle and environmental factors on health may, for example,
motivate physicians to record information which appears irrelevant, but
which may in fact serve as a diagnostic clue, or which may alert later
users of the record to clinically relevant aspects of the patient's
life. We invite comment on how any such standard might be structured to
avoid interfering inappropriately with clinical judgment.
We also are concerned about the burden that requests for amendment
or correction may place on covered plans and providers and have tried
to limit the process to those situations where amendment or correction
would appear to be most important. We invite comment on whether our
approach reasonably balances burden with adequately protecting
individual interests.
We note that for Federal agencies that are also covered plans or
providers, the rule we are proposing would not diminish their present
obligations under the Privacy Act of 1974, under which all four factors
are bases for amendment and correction.
ii. Original creator of the information.
We propose to require a covered plan or provider to accommodate a
request for amendment or correction if the plan or provider created the
information in dispute.
We considered requiring covered plans and providers to amend or
correct any erroneous or incomplete information it maintains,
regardless of whether it created the information. Under this approach,
if the plan or provider did not create the information, then it would
have been required to trace the information back to the original source
to determine accuracy and completeness. We rejected this option because
we concluded that it would not be appropriate to require the plan or
provider that receives a request to be responsible for verifying the
accuracy or completeness of information that it did not create. We also
were concerned about the burden that would be imposed on covered plans
and providers if they were required to trace the source of any
erroneous or
[[Page 59987]]
incomplete information transmitted to them.
We would rely on a combination of three other requirements to
ensure that protected health information remains as accurate as
possible as it travels through the health care system. First, we are
proposing that a covered plan or provider that makes an amendment or
correction be required to notify any relevant persons, organizations,
or other entities of the change or addition. Second, we are proposing
that other covered plans or providers that receive such a notification
be required to incorporate the necessary amendment or correction.
Finally, we are proposing that covered plans or providers require their
business partners who receive such notifications to incorporate any
necessary amendments or corrections. See discussion in section
II.F.4.c.iii. We are soliciting comments whether this approach would
effectively ensure that amendments and corrections are communicated
appropriately.
iii. Information available for amendment or correction.
We are proposing that the right to request amendment or correction
extend to all protected health information that would be available for
inspection and copying under Sec. 164.514. We would only require
covered plans and providers to amend or correct that information
maintained in a designated record set but would encourage the
development of systems that would accommodate these types of changes
for all data collections. For protected health information that is
maintained solely by a business partner or that has been materially
altered by a business partner, the covered plan or provider would need
to make arrangements with the business partner to accommodate any
requests.
This right would not be intended to interfere with medical
practice, or modify standard business record keeping practices. Perfect
records are not required, but instead a standard of reasonable accuracy
and completeness should be used. In addition, this right would not be
intended to provide a procedure for substantive review of decisions
such as coverage determinations by payers. It would only affect the
content of records, not the underlying truth or correctness of
materials recounted therein. Attempts under the Privacy Act of 1974 to
use this correction mechanism as a basis for collateral attack on
agency determinations have generally been rejected by the courts. The
same results would be intended here.
iv. Duration of the right to request amendment or correction.
We are proposing that covered plans and providers be required to
accommodate requests for amendment or correction for as long as the
entity maintains the protected health information. We considered
requiring covered plans and providers to accommodate requests for a
specific period or defining a specific retention period. We rejected
that approach because many laws and professional standards already
designate specific retention periods and we did not want to create
confusion. In addition, we concluded that individuals should be
permitted to request amendments or corrections for as long as the
information is maintained by the covered plan or provider. We are
soliciting comments on whether we should include a specific duration
requirement in this proposed rule.
b. Grounds for denial of request for amendment or correction. We
are proposing that a covered plan or provider would be permitted to
deny a request for amendment or correction if, after a reasonable
review, the plan or provider determines that it did not create the
information at issue, the information would not be available for
inspection and copying under proposed Sec. 164.514, the information is
accurate and complete, or if it is erroneous or incomplete, it would
not adversely affect the individual.
c. Procedures for requesting amendment or correction.
i. Individual requests for amendment or correction.
In Sec. 164.516, we are proposing that covered plans and providers
be required to have procedures that enable individuals to exercise
their rights to request amendment or correction, including a means by
which individuals can request amendment or correction of protected
health information about them. We considered whether this proposed rule
should include detailed procedures governing an individual's request.
But as with the procedures for requesting inspection and copying, we
are only providing a general requirement and permitting each plan or
provider to develop procedures in accordance with its needs. Once the
procedures are developed, the plan or provider would document them in
accordance with section Sec. 164.520 and include a brief explanation in
the notice that is provided to individuals pursuant to section
Sec. 164.512.
ii. Time limits.
We are proposing that the covered plan or provider would take
action on a request for amendment or correction as quickly as the
circumstances require, but not later than 60 days following the
request. The justification for establishing a time limitation for
amendment and correction is virtually identical to that provided for
the time limitation for inspection and copying. We concluded that the
entity should be provided with some additional flexibility in this
context. Depending on the nature of the request, an amendment or
correction could require significantly more time than a request for
inspection and copying. If a covered plan or provider needed more than
30 days to make a decision, we would encourage, but not require, it to
send an acknowledgment of receipt to the individual including an
explanation of the reasons for the delay and a date when the individual
can expect a final decision.
iii. Acceptance of a request for amendment or correction.
If a covered plan or provider accepts an individual's request for
amendment or correction, it would be required to make the appropriate
amendments or corrections. In making the change, the entity would have
to either add the amended or corrected information as a permanent part
of the record or mark the challenged entries as amended or corrected
entries and, if appropriate, indicate the place in the record where the
amended or corrected information is located. Covered plans or providers
would not be required to expunge any protected health information, but
rather mark it as erroneous or incomplete.
We also propose in Sec. 164.506(e) that entities include a contract
requirement that when the covered plan or provider notifies the
business partner of an amendment or correction, the business partner
must make the necessary amendments or corrections to protected health
information in its custody.
In Sec. 164.516(c)(3), we are proposing that, upon accepting an
amendment or correction, the covered plan or provider would be required
to make reasonable efforts to notify relevant persons, organizations,
or other entities of the change or addition. An entity would be
required to notify such persons that the individual identifies, or that
the covered plan or provider identifies as (1) a recipient of the
erroneous or incomplete information, and (2) a person who:
Has relied upon that information to the detriment of the
individual; or
Is a person who may foreseeably rely on such erroneous or
incomplete information to the detriment of the individual.
We are concerned about the potential burden that this notification
requirement would impose on covered plans and providers. We do not,
however, anticipate that a significant
[[Page 59988]]
number of requests would be submitted to any entity and therefore the
need for such notifications would be rare. In addition, we determined
that because health information can travel so quickly and efficiently
in the modern health care system, the need for notification outweighed
the potential burden. It is important to note that a reasonableness
standard should be applied to the notification process--if the
recipient has not relied upon the erroneous or incomplete information
to the detriment of the individual or if it is not foreseeable that the
recipient will do so, then it would not be reasonable for the covered
plan or provider to incur the time and expense of notification. If,
however, the incorrect information is reasonably likely to be used to
the detriment of the individual, the entity should make every effort to
notify the recipients of the information of the changes as quickly as
possible.
iv. Denial of a request for amendment or correction.
In proposed Sec. 164.516(c)(4), we would require a covered plan or
provider to provide the individual with a written statement in plain
language of the reason for the denial and permit the individual to file
a written statement of disagreement with the decision to deny the
request.
The statement prepared by covered plan or provider would be
required to explain the basis for the denial. The statement would
include a description of how the individual may complain to the covered
plan or provider as provided in Sec. 164.518(d). The statement would
include the name and number of the contact person within the plan or
provider who is responsible for receiving complaints. The statement
also would include information regarding filing a complaint with the
Secretary pursuant to Sec. 164.522(b)(1), including the mailing address
and any forms that may be available. Finally, the statement would
explain that the individual has the right to file a written statement
of disagreement that would be maintained with the disputed information
and the procedure for filing such a statement of disagreement.
If the individual chooses to file a statement of disagreement, then
the covered plan or provider must retain a copy of the statement with
the protected health information in dispute. The covered plan or
provider could require that the statement be a reasonable length,
provided that the individual has reasonable opportunity to state the
nature of the disagreement and offer his or her version of accurate and
complete information. In all subsequent disclosures of the information
requested to be amended or corrected, the covered plan or provider
would be required to include a copy of its statement of the basis for
denial and, if provided by the individual, a copy of his or her
statement of disagreement. If the statement submitted by the individual
is unreasonably long, the covered plan or provider could include a
summary in subsequent disclosures which reasonably explains the basis
of the individual's position. The covered plan or provider would also
be permitted to provide a rebuttal to the individual's statement of
disagreement and include the rebuttal statement in any subsequent
disclosures.
We considered requiring the covered plan or provider to provide a
mechanism for appealing denials of amendment or correction but
concluded that it would be too burdensome. We are soliciting comment on
whether the approach we have adopted reasonably balances the burdens on
covered plans or providers with the rights of individuals.
v. Receipt of a notification of amendment or correction.
If a covered plan or provider receives a notification of erroneous
or incomplete protected health information as provided in proposed
Sec. 164.516(d), we are proposing that the covered plan or provider or
be required to make the necessary amendment or correction to protected
health information in its custody that would be available for
inspection and copying. This affirmative duty to incorporate amendments
and corrections would be necessary to ensure that individuals'
protected health information is as accurate and complete as possible as
it travels through the health care system.
G. Administrative Requirements (Sec. 164.518)
[Please label comments about this section with the subject:
"Introduction to administrative requirements"]
In Sec. 164.518, we are proposing general administrative
requirements for covered entities. We would require all covered
entities to designate a privacy official, train members of their
workforce regarding privacy requirements, safeguard protected health
information, and establish sanctions for members of the workforce who
do not abide by the entity's privacy policies and procedures. In
addition, we are proposing that covered plans and providers be required
to establish a means for individuals to complain to the covered plan or
provider if they believe that their privacy rights have been violated.
In the discussions of each proposed provision, we provide examples of
how different kinds of covered entities could satisfy these
requirements.
1. Designation of a Privacy Official (Sec. 164.518(a))
[Please label comments about this section with the subject: "Privacy
official"]
In proposed Sec. 164.518(a)(1), we would require covered entities
to designate an employee or other person to serve as the official
responsible for the development of policies and procedures for the use
and disclosure of protected health information. The designation of an
official would focus the responsibility for development of privacy
policy.
We considered whether covered entities should be required to
designate a single official or an entire board. We concluded that a
single official would better serve the purposes of focusing the
responsibility and providing accountability within the entity. The
implementation of this requirement would depend on the size of the
entity. For example, a small physician's practice might designate the
office manager as the privacy official, and he or she would assume this
as one of his or her broader administrative responsibilities. A large
entity might appoint a person whose sole responsibility is privacy
policy, and he or she might choose to convene a committee representing
several different components of the entity to develop and implement
privacy policy.
In proposed Sec. 164.518(a)(2), we would require a covered entity
to designate a contact person or office to receive complaints and
provide information about the matters covered by the entity's notice.
The covered entity could, but would not be required to, designate the
designated privacy official as the entity's contact person.
In proposed Sec. 164.512, we would require the covered plan or
provider's privacy notice to include the name of a contact person for
privacy matters. We would not require that the contact person and the
designated privacy official be the same person. This would be left to
the discretion of each covered entity.
2. Training (Sec. 164.518(b))
[Please label comments about this section with the subject:
"Training"]
In proposed Sec. 164.518(b), we would require covered entities to
provide training on the entities policies and procedures with respect
to protected health information. Each entity would be required to
provide initial training by the date on which this proposed rule
becomes applicable. After that date, each covered entity would have to
[[Page 59989]]
provide training to new members of the workforce within a reasonable
time period after joining the entity. In addition, we are proposing
that when a covered entity makes material changes in its privacy
policies or procedures, it would be required to retrain those members
of the workforce whose duties are directly affected by the change
within a reasonable time of making the change.
The entities would be required to train all members of the
workforce (e.g., all employees, volunteers, trainees, and other persons
under the direct control of a persons working on behalf of the covered
entity on an unpaid basis who are not business partners) who are likely
to have contact with protected health information.
Upon completion of the training, the person would be required to
sign a statement certifying that he or she received the privacy
training and will honor all of the entity's privacy policies and
procedures. Entities would determine the most effective means of
communicating with their workforce. For example, in a small physician
practice, the training requirement could be satisfied by providing each
new member of the workforce with a copy of the practice's information
policies and requiring members of the workforce to acknowledge that
they have reviewed the policies. A large health plan could provide for
a training program with live instruction, video presentations or
interactive software programs. The small physician practice's solution
would not protect the large plan's data, and the plan's solution would
be neither economically feasible nor necessary for the small physician
practice.
At least once every three years after the initial training, covered
entities would be required to have each member of the workforce sign a
new statement certifying that he or she will honor all of the entity's
privacy policies and procedures. The initial certification would be
intended to make members of the workforce aware of their duty to adhere
to the entity's policies and procedures. By requiring a recertification
every three years, they would be reminded of this duty.
We considered several different options for recertification. We
considered proposing that members of the workforce be required to
recertify every six months, but concluded that such a requirement would
be too burdensome. We considered proposing that recertification be
required annually consistent with the recommendations of The American
Health Information Management Association (Brandt, Mary D., Release and
Disclosure: Guidelines Regarding Maintenance and Disclosure of Health
Information, 1997). We concluded that annual recertification could also
impose a significant burden on covered entities.
We also considered requiring that the covered entity provide
"refresher" training every three years in addition to the
recertification. We concluded that our goals could be achieved by only
requiring recertification once every three years, and retraining in the
event of material changes in policy. We are soliciting comment on this
approach.
3. Safeguards (Sec. 164.518(c))
[Please label comments about this section with the subject:
"Safeguards"]
In proposed Sec. 164.518(c), we would require covered entities to
put in place administrative, technical, and physical safeguards to
protect against any reasonably anticipated threats or hazards to the
privacy of the information, and unauthorized uses or disclosures of the
information. We proposed similar requirements for certain electronic
information in the Notice of Proposed Rulemaking entitled the Security
and Electronic Signature Standards (HCFA-0049-P), which can be found at
63 FR 43241. We are proposing parallel and consistent requirements for
safeguarding the privacy of protected health information.
a. Verification procedures. As noted in section II.E. above, for
many permitted disclosures the covered entity would be responding to a
request for disclosure of protected health information. For most
categories of permitted disclosures, when the request for disclosure of
protected health information is from a person with whom the covered
entity does not routinely do business, we would require the covered
entity to verify the identity of the requestor. In addition, for
certain categories of disclosures, covered entities would also be
required to verify the requestor's legal authority to make the request.
Under Sec. 164.514, a covered entity would be required to give
individuals access to protected health information about them (under
most circumstances). The covered entity would also be required to take
reasonable steps to verify the identity of the individual making the
request for access. We do not propose to mandate particular
identification requirements (e.g., drivers licence, photo ID, etc), but
rather would leave this to the discretion of the covered entity.
Covered entities would be required to verify both the identity of
persons requesting protected health information and their authority for
requesting such information when the request is from a person with whom
the covered entity does not routinely do business and the disclosure
would be permitted by the following subsections of Sec. 164.510: under
Sec. 164.510(b) for public health, under Sec. 164.510(c) for oversight,
under Sec. 164.510(e) to coroners and medical examiners, under
Sec. 164.510(f) for law enforcement, under Sec. 164.510(g) for
governmental health data systems, under Sec. 164.510(m) for special
classes, and for disclosures required by other laws under
Sec. 164.510(n). Covered entities would be required to verify the
identity of the requester by examination of reasonable evidence, such
as a written statement of identity on agency letterhead, an
identification badge, or similar proof of official status. Similarly,
covered entities would be required to verify the legal authority
supporting the request by examination of reasonable evidence, such as a
written request provided on agency letterhead that describes the legal
authority for requesting the release. Unless Sec. 164.510 explicitly
requires written evidence of legal process or other authority before a
disclosure may be made, a public official's proof of identity and the
official's oral statement that the request is authorized by law would
be presumed to constitute the required reasonable evidence of legal
authority. Where Sec. 164.510 does require written evidence of legal
process or authority, only the required written evidence will suffice.
We considered specifying the type of documentation or proof that
would be acceptable, but decided that the burden of such specific
regulatory requirements on covered entities would be unnecessary.
Therefore, we propose only a general requirement for reasonable
verification of identity and legal authority.
In Sec. 164.522, we would require disclosure to the Secretary for
purposes of enforcing this regulation. When a covered entity is asked
by the Secretary to disclose protected health information for
compliance purposes, the covered entity should verify the same
information that it would verify for any other law enforcement or
oversight request for disclosure.
In some circumstances a person or entity acting on behalf of a
government agency may make a request for disclosure of protected health
information under these subsections. For example, public health
agencies may contract with a nonprofit agency to collect and analyze
certain data. In such cases the covered entity would be required to
verify the requestor's identity and authority through
[[Page 59990]]
examination of reasonable documentation that the requestor is acting on
behalf of the government agency. Reasonable evidence would include a
written request provided on agency letterhead that describes the legal
authority for requesting the release and states that the person or
entity is acting under the agency's authority, or other documentation,
including a contract, a memorandum of understanding, or purchase order
that confirms that the requestor is acting on behalf of the government
agency.
For disclosures permitted under Sec. 164.510(k) for emergency
circumstances and under Sec. 164.510(l) to next-of-kin, legal authority
for the request would not be an issue. Therefore covered entities would
only be required to verify the identity of the person requesting the
disclosure. Where protected health information is requested by next-of-
kin, covered entities would be required to make reasonable verbal
attempts to establish the identity of the person making the request.
Written proof would not be required. Covered entities could rely on
prior acquaintance with the next-of-kin; verbal verification of
identity would not be required at each encounter. Where protected
health information is requested in an emergency, the covered entity
would similarly not be required to demand written proof that the person
requesting the protected health information is legally authorized.
Reasonable reliance on verbal representations would be appropriate in
such situations.
When another person is acting as the individual through power of
attorney or other legal authority, covered entities would also be
required to make reasonable attempts to ascertain that the person
making the request has the necessary legal authority or relationship in
order to make the disclosure. For example, a health care provider could
require a copy of a power of attorney, or could ask questions to
determine that an adult acting for a young child has the requisite
relationship to the child.
Most disclosures under Sec. 164.510(i) are routine transactions
with banking and other financial institutions. As noted above, for
routine transactions there would be no verification requirements.
However, should such financial institution make a special request for
information in addition to the information routinely provided for
payment purposes (e.g., pursuant to a fraud or similar investigation),
the covered entity would be required to obtain reasonable evidence of
the identity of the person requesting the information.
The conditions for disclosures for judicial and administrative
proceedings and research are discussed in Sec. 164.510 (d) and
Sec. 164.510(j), respectively. Conditions for permitted disclosures
under Sec. 164.510(h) for facility directories include no verification
requirements.
b. Whistleblowers. In Section Sec. 164.518(c)(4), we would address
the issue of disclosures by employees or others of protected health
information in whistleblower cases. We would clarify that under the
proposed rule, a covered entity would not be held in violation because
a member of their workforce or a person associated with a business
partner of the covered entity discloses protected health information
that such person believes is evidence of a civil or criminal violation,
and the disclosure is: (1) Made to relevant oversight agencies and law
enforcement or (2) made to an attorney to allow the attorney to
determine whether a violation of criminal or civil law has occurred or
to assess the remedies or actions at law that may be available to the
person disclosing the information.
Allegations of civil and criminal wrongdoing come from a variety of
sources. Sometimes an individual not otherwise involved in law
enforcement uncovers evidence of wrongdoing, and wishes to bring that
evidence to the attention of appropriate authorities. Persons with
access to protected health information sometimes discover evidence of
billing fraud or similar violations; important evidence of unlawful
activities may be available to employees of covered entities, such as
billing clerks or nurses.
Some whistleblower activities can be accomplished without
individually identifiable health information. There are, however,
instances in which only identifiable information will suffice to
demonstrate that an allegation of wrongdoing merits the investment of
legal or investigatory resources. A billing clerk who suspects that a
hospital has engaged in fraudulent billing practices may need to use
billing records for a set of specific cases to demonstrate the basis of
his suspicion to an oversight agency.
The persons who find such evidence are likely to be employees of
the suspect entity. Congress and the states have recognized the
importance of whistleblowing activities by acting to protect
whistleblowers from retaliation. Federal statutes that include
protections for whistleblowers who contact appropriate authorities
include the Clear Air Act, the Federal Water Pollution Control Act, the
Toxic Substances Control Act, and the Safe Drinking Water Act. Congress
also passed the Whistleblower Protection Act, to protect federal
employees who complain about improper personnel practices at federal
agencies. At least eleven states have passed whistleblower protection
laws that protect both private and public employees who provide
evidence of wrongdoing to the appropriate authorities, and many more
states have laws that provide such protections only for public
employees.
The qui tam provisions of the Federal False Claims Act go further,
and provide a mechanism for the individual to prosecute a case against
a person who has allegedly defrauded the government. Like traditional
whistleblower actions, qui tam actions were created by the Congress to
further the public interest in effective government. Qui tam suits are
an important way that individuals can protect the public interest, by
investing their own time and resources to help reduce fraud. And, also
like whistleblower actions, the individual may need protected health
information to convince an attorney that a viable qui tam case exists.
We would note that this section would not apply to information
requested by oversight agencies, law enforcement officials, or
attorneys, even prior to initiation of an investigation or law suit. It
would apply only to a disclosure initiated by a member of an entity's
workforce or a person associated with one of its business partners.
We are concerned that a person, in the guise of "whistleblowing,"
might, maliciously or otherwise, disclose protected health information
without any actual basis to believe that there has been a violation of
the law. We are concerned, however, with adding qualifying language
that may restrict such disclosures and, therefore, impede the pursuit
of law violators. We seek comments regarding whether this provision
should include any limitations (e.g., a requirement that only the
minimum amount of information necessary for these purposes can be
disclosed).
4. Internal Complaint Process (Sec. 164.518(d))
In proposed Sec. 164.518(d), we would require covered plans and
providers to have some mechanism for receiving complaints from
individuals regarding the covered plan's or provider's compliance with
the requirements of this proposed rule. The covered plan or provider
would be required to accept complaints about any aspect of their
practices regarding protected health information. For example,
individuals would be able to file a complaint when
[[Page 59991]]
they believe that protected health information relating to them has
been used or disclosed improperly, that an employee of the plan or
provider has improperly handled the information, that they have
wrongfully been denied access to or opportunity to amend the
information, or that the entity's notice does not accurately reflect
its information practices. We would not require that the entity develop
a formal appeals mechanism, nor that "due process" or any similar
standard be applied. We would not require that covered entities respond
in any particular manner or time frame. We are proposing two basic
requirements for the complaint process. First, the covered plan or
provider would be required to identify a contact person or office in
the notice of information practices for receiving complaints. This
person or office could either be responsible for handling the
complaints or could put the individual in touch with the appropriate
person within the entity to handle the particular complaint. See
proposed Sec. 164.512. This person could, but would not have to be, the
entity's privacy official. See Sec. 164.518(a)(2). Second, the covered
plan or provider would be required to maintain a record of the
complaints that are filed and a brief explanation of the resolution, if
any.
Covered plans and providers could implement this requirement
through a variety of mechanisms based on their size and capabilities.
For example, a small practice could assign a clerk to log in written
and/or verbal complaints as they are received, and assign one physician
to review all complaints monthly, address the individual situations and
make changes to policies or procedures as appropriate. Results of the
physician's review of individual complaints then could be logged by the
clerk. A larger provider or health plan could choose to implement a
formal appeals process with standardized time frames for response.
We considered requiring covered plans and providers to provide a
formal internal appeal mechanism, but rejected that option as too
costly and burdensome for some entities. We also considered eliminating
this requirement entirely, but rejected that option because a complaint
process would give covered plans or providers a way to learn about
potential problems with privacy policies or practices, or training
issues. We also hope that providing an avenue for covered plans or
providers to address complaints would lead to increased consumer
satisfaction. We believe this approach strikes a reasonable balance
between allowing covered plans or providers flexibility and
accomplishing the goal of promoting attention to improvement in privacy
practices. If an individual and a covered plan or provider are able to
resolve the individual's complaint, there may be no need for the
individual to file a complaint with the Secretary under proposed
Sec. 164.522(b). However, an individual has the right to file a
complaint with the Secretary at any time. An individual may file a
complaint with the Secretary before, during, after, or concurrent with
filing a compliant with the covered plan or provider or without filing
a complaint with the covered plan or provider.
We are considering whether modifications of these complaint
procedures for intelligence community agencies may be necessary to
address the handling of classified information and solicit comment on
the issue.
5. Sanctions (Sec. 164.518(e))
[Please label comments about this section with the subject:
"Sanctions"]
In proposed Sec. 164.518(e), we would require all covered entities
to develop and apply when appropriate sanctions for failure to comply
with policies or procedures of the covered entity or with the
requirements of this proposed rule. All members of the workforce who
have regular contact with protected health information should be
subject to sanctions, as would the entity's business partners. Covered
entities would be required to develop and impose sanctions appropriate
to the nature of the issue. The type of sanction applied would vary
depending on factors such as the severity of the violation, whether the
violation was intentional or unintentional, and whether the violation
indicates a pattern or practice of improper use or disclosure of
protected health information. Sanctions could range from a warning to
termination.
We considered specifying particular sanctions for particular kinds
of violations of privacy policy, but rejected this approach for several
reasons. First, the appropriate sanction will vary with the entity's
particular policies. Because we cannot anticipate every kind of privacy
policy in advance, we cannot predict the response that would be
appropriate when that policy is violated. In addition, it is important
to allow covered entities to develop the sanctions policies appropriate
to their business and operations.
6. Duty To Mitigate (Sec. 164.518(f))
[Please label comments about this section with the subject: "Duty to
mitigate"]
We propose that covered entities be required to have procedures for
mitigating, to the extent practicable, any deleterious effect of a use
or disclosure of protected health information by their members of their
workforce or business partners.
With respect to business partners, we also propose that covered
entities have an affirmative duty to take reasonable steps in response
to breaches of contract terms. For example, a covered entity that
becomes aware that a business partner has improperly disclosed
protected health information could require that business partner to
take steps to retrieve the disclosed information. The covered entity
also could require that business partner to adopt new practices to
better assure that protected health information is appropriately
handled. Covered entities generally would not be required to monitor
the activities of their business partners, but would be required to
take steps to address problems of which they become aware, and, where
the breach is serious or repeated, would also be required to monitor
the business partner's performance to ensure that the wrongful behavior
has been remedied. For example, the covered entity could require the
business partner to submit reports or subject itself to audits to
demonstrate compliance with the contract terms required by this rule.
Termination of the arrangement would be required only if it becomes
clear that a business partner cannot be relied upon to maintain the
privacy of protected health information provided to it.
We expect that sanctions would be more formally described and
consistently carried out in larger, more sophisticated entities.
Smaller, less sophisticated entities would be given more latitude and
flexibility. For such smaller entities and less sophisticated entities,
we would not expect a prescribed sanctions policy, but would expect
that actions be taken if repeated instances of violations occur.
H. Development and Documentation of Policies and Procedures
(Sec. 164.520)
[Please label comments about this section with the subject: "Policies
and procedures"]
In proposed Sec. 164.520, we would require covered entities to
develop and document their policies and procedures for implementing the
requirements of this rule. This requirement is intended as a tool to
facilitate covered entities' efforts to develop appropriate policies to
implement this rule, to ensure that the members of its workforce and
business partners understand and carry out expected privacy practices,
and to assist
[[Page 59992]]
covered entities in developing a notice of information practices.
The scale of the policies developed should be consistent with the
size of the covered entity. For example, a smaller employer could
develop policies restricting access to health plan information to one
designated employee, empowering that employee to deny release of the
information to corporate executives and managers unless required for
health plan administration. Larger employers could have policies that
include using contractors for any function that requires access to
protected health information or requiring all reports they receive for
plan administration to be de-identified unless individual authorization
is obtained.
Clearly, implementation of these requirements would differ
significantly based on the size, capabilities and activities of each
covered entity. A solo practitioner's documentation of her policies and
procedures could provide relatively straightforward statements, such
as:
This practice does not use or disclose any protected health
information that is not authorized or permitted under the federal
privacy regulation and therefore does not request any authorized
disclosures from patients. Staff R.N. reviews all individually
authorized requests for disclosures to ensure they contain all
required elements and reviews the copied information to ensure only
authorized information is released in response. Information requests
that would require extensive redaction will be denied.
Larger entities with many functions and business relationships and
who are subject to multi-state reporting and record-keeping
requirements would need to develop and document more extensive
policies. A health plan would need to describe all activities that
would be considered health care operations and identify the use and
disclosure requirements of each activity. A health plan may determine
that underwriting department employees must provide a written request,
approved by a team leader, to access any identifiable claims
information; that such requests must be retained and reviewed every
quarter for appropriateness; and the underwriting department must
destroy such information after use for an approved activity. We urge
professional associations to develop model policies, procedures and
documentation for their members of all sizes.
We are proposing general guidelines for covered entities to develop
and document their own policies and procedures. We considered a more
uniform, prescriptive approach but concluded that a single approach
would be neither effective in safeguarding protected health information
nor appropriate given the vast differences among covered entities in
size, business practices and level of sophistication. It is important
that each covered entity's internal policies and procedures for
implementing the requirements of this regulation are tailored to the
nature and number of its business arrangements, the size of its patient
population, its physical plant and computer system, the size and
characteristics of its workforce, whether it has one or many locations,
and similar factors. The internal policies and procedures appropriate
for a clearinghouse would not be appropriate for a physician practice;
the internal policies and procedures appropriate for a large, multi-
state health plan would not be appropriate for a smaller, local health
plan.
After evaluating the requirements of federal, State, or other
applicable laws, covered entities should develop policies and
procedures that are appropriate for their size, type, structure, and
business arrangements. Once a covered plan or provider has developed
and documented all of the policies and procedures as required in this
section, it would have compiled all of the information needed to
develop the notice of information practices required in Sec. 164.512.
The notice is intended to include a clear and concise summary of many
of the policies and procedures discussed in this section. Further, if
an individual has any questions about the entity's privacy policies
that are not addressed by the notice, a representative of the entity
can easily refer to the documented policies and procedures for
additional information.
Before making a material change in a policy or procedure, the
covered entity would, in most instances, be required to make the
appropriate changes to the documentation required by this section
before implementing the change. In addition, covered plans and
providers would be required to revise the notice of information
practices in advance. Where the covered entity determines that a
compelling reason exists to take an action that is inconsistent with
its documentation or notice before making the necessary changes, it may
take such action if it documents the reasons supporting the action and
makes the necessary changes within 30 days of taking such action.
In an attempt to ensure that large entities develop coordinated and
comprehensive policies and procedures as required by this section, we
considered proposing that entities with annual receipts greater than $5
million 5 be required to have a privacy board review and
approve the documentation of policies and procedures. As originally
conceived, the privacy board would only serve to review research
protocols as described in Sec. 164.510(j). We believe that such a board
could also serve as "privacy experts" for the covered entity and
could review the entity's documented policies and procedures. In this
capacity, the overriding objective of the board would be to foster
development of up-to-date, individualized policies that enable the
organization to protect health information without unnecessarily
interfering with the treatment and payment functions or business needs.
This type of review is particularly important for large entities who
would have to coordinate policies and procedures among a large staff,
but smaller organizations would be encouraged, but not required, to
take a similar approach (i.e., have a widely representative group
participate in the development and/or review of the organization's
internal privacy policies and the documentation thereof). We solicit
comment on this proposal.
---------------------------------------------------------------------------
\5\ The Small Business Administration defines small businesses
in the health care field as those generating less than $5 million
annually. Small businesses represent approximately 85% of health
care entities.
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We also considered requiring the covered entity to make its
documentation available to persons outside the entity upon request. We
rejected this approach because covered entities should not be required
to share their operating procedures with the public, or with their
competitors.
We recognize that the documentation requirement in this proposed
rule would impose some paperwork burden on covered plans and providers.
However, we believe that it is necessary to ensure that covered plans
and providers establish privacy policies procedures in advance of any
requests for disclosure, authorization, or subject access. It is also
necessary to ensure that covered entities and members of their
workforce have a clear understanding of the permissible uses and
disclosures of protected health information and their duty to protect
the privacy of such information under specific circumstances.
1. Uses and Disclosures of Protected Health Information
We propose that covered entities be required to develop and
document policies and procedures for how protected health information
would be used and disclosed by the entity and its
[[Page 59993]]
business partners. The documentation would include policies to ensure
the entity is in compliance with the requirements for use and
disclosure pursuant to an individual's authorization. This would also
include documentation of how the covered entity would comply with
individual's revocation of an authorization, as provided in proposed
Sec. 164.508(e). For example, upon receipt of a revocation, the entity
may need to take steps to notify each business partner that is
responsible for using or disclosing protected health information on
behalf of the covered entity based on the individual's authorization.
Because the entity is ultimately responsible for the protected health
information, it may want written confirmation from the business partner
that it received notice of the revocation.
The covered entity would be required to include policies and
procedures necessary to address disclosures required by applicable law.
For example, the covered entity may want to include a list of the
relevant reporting requirements such as those for abuse, neglect and
communicable disease and its policies and procedures for complying with
each requirement.
It would also include policies and procedures for uses and
disclosures without the individual's authorization, including uses and
disclosures for treatment, payment and health care operations under
Sec. 164.506(a)(1)(i). The documentation should address all of the
legally permissible uses and disclosures that the covered entity is
reasonably likely to make and should clearly specify the policy of the
entity with respect to each. For example, all covered plans and
providers face a reasonable likelihood of a request for disclosure from
a health oversight agency, so every covered plan and provider should
develop and document policies and procedures for responding to such
requests. However, a provider that only treats adults would not need to
specify a policy with respect to state laws that authorize disclosure
relating to measles in young children. In this latter case, the
provider knows that he or she is not reasonably likely to make such a
disclosure and therefore, could wait until he or she is presented with
such a request before developing the necessary policies and procedures.
The documentation would include the entity's policies and procedure
for complying with the requirements of proposed Sec. 164.506(e) for
disclosing protected health information to business partners, including
policies and procedures for monitoring the business partners,
mitigating harm, and imposing sanctions where appropriate.
It would address the policies and procedures for implementation of
the minimum necessary requirement as provided in proposed
Sec. 164.506(b). It would also include policies and procedures
addressing the creation of de-identified information pursuant to
Sec. 164.506(d). For example, a plan could have a policy that requires
employees to remove identifiers from protected health information for
all internal cost, quality, or performance evaluations. The plan would
document this policy and the procedures for removing the identifiers.
2. Individual Requests for Restricting Uses and Disclosures
We propose to require covered health care providers to document how
they would implement an individual's request to restrict uses and
disclosures. Under proposed Sec. 164.506(c)(1)(iii), a covered entity
need not agree to such restrictions. This section of the documentation
would describe who (if anyone) in the covered entity is permitted to
agree to such restrictions, and if such restrictions were accepted, how
they would be implemented. For example, a provider may require that
once an individual has requested a limitation on a use or disclosure,
the affected information is stamped, marked or kept in a separate file.
The provider could also have a policy of never agreeing to requests for
such restrictions.
3. Notice of Information Practices
We propose to require covered plans and providers to document their
policies and procedures for complying with the requirement in
Sec. 164.512 to develop, make available or disseminate, and amend their
notices of information practices. This documentation would address, at
a minimum, who is responsible for developing and updating the notice,
who would serve as the "contact" person on the notice, how the notice
would be disseminated to individuals, and how to respond to inquiries
regarding information practices.
4. Inspection and Copying
We propose to require covered plans and providers to document
policies and procedures to address how they would receive and comply
with individual requests for inspection, and copying, in compliance
with Sec. 164.514 of this proposed rule. Policies and procedures should
address, at a minimum, a listing of the designated record sets to which
access will be provided, any fees to be charged, and the reasons (if
any) that the entity would deny a request for inspection and copying.
5. Amendment or Correction
We propose to require covered plans and providers to develop and
document policies and procedures to address how they would receive and
comply with individual requests for amendment or correction of their
records, in compliance with Sec. 164.516 of this proposed rule.
Policies and procedures should include the process for determining
whether a request for amendment or correction should be granted, the
process to follow if a request is denied, and how the entity would
notify other entities, including business partners, if the request is
accepted. For example, if a covered entity accepts an individual's
request for an amendment or correction, the entity could document
specific procedures regarding how to make the appropriate additions or
notations to the original information. Without such documentation,
members of the workforce could accidentally expunge or remove the
incorrect information.
6. Accounting for Disclosures
We propose to require covered entities to develop and document
their policies and procedures for complying with the requirement in
Sec. 164.515 to provide on request an accounting for disclosures for
purposes other than treatment, payment or health care operations. In
order to respond to requests for accounting within a reasonable period
of time, the entity would need to have a system for accounting in place
well in advance of any potential requests. The entity would need to
evaluate its record keeping system and determine how best to build in
the capacity to respond to such a request. For example, if the entity
chooses to keep a regular log of disclosures, it would have to begin
keeping such logs routinely. If instead the entity chooses to rely on a
record keeping system to reconstruct an accounting, it should develop
appropriate procedures for members of the workforce to follow when
faced with an individual's request.
7. Administrative Requirements
We propose to require covered entities to document their policies
and procedures for complying with the applicable administrative
requirements in proposed Sec. 164.518. This would include designation
of the privacy official required by Sec. 164.518(a) including a
description of his or her responsibilities; a description of how the
entity would comply with the
[[Page 59994]]
training and certification requirements for members of its workforce
under Sec. 164.518(b); a description of the covered entity's safeguards
required by Sec. 164.518(c); a description of how the covered plan or
provider would meet the requirements of Sec. 164.518(d) to receive
individual's complaints; a description of how the covered entity would
meet the requirements for sanctioning members of its workforce under
Sec. 164.518(e); and a description of how the covered entity would take
steps to mitigate any deleterious effect of a use or disclosure of
protected health information as required by Sec. 164.518(f).
The documentation would also address how access to protected health
information is regulated by the entity, including safeguards, including
the procedures that would be required by proposed Sec. 164.518. For
covered entities that are part of a larger organization that is not a
covered entity (e.g., an on-site clinic at a university or the group
health plan component of an employer), we would require such entities
to develop and document policies and procedures that ensure that
protected health information does not flow outside the health care
component of the organization in violation of this proposed rule. For
example, a school-based health clinic should have policies and
procedures to prevent treatment information from crossing over into the
school's record system.
Many disclosures would require verification of the identity of the
person making the request, and sometimes also verification of the legal
authority behind the request. The documentation required by this
section would include a description of the entity's verification
policies (e.g., what proof would be acceptable), and who would be
responsible for ensuring that the necessary verification has occurred
before the information is disclosed.
8. Record Keeping Requirements
We propose record keeping requirements related to several
provisions. In addition to the documentation of policies and procedures
described above, we would require covered entities, as applicable, to:
document restrictions on uses and disclosures agreed to pursuant to
Sec. 164.506(c); maintain copies of authorization forms and signed
authorizations (Sec. 164.508) and contracts used with business partners
(Sec. 164.506(e)); maintain notices of information practices developed
under Sec. 164.512; maintain written statements of denials of requests
for inspection and copying pursuant to Sec. 164.514; maintain any
response made to a request from an individual for amendment or
correction of information, either in the form of the correction or
amendment or the statement of the reason for denial and, if supplied,
the individual's statement of disagreement, for as long as the
protected health information is maintained (Sec. 164.516); maintain
signed certifications by members of the workforce required by
Sec. 164.518(b); and, maintain a record of any complaints received
(Sec. 164.518(d)). Unless otherwise addressed in this proposal, covered
entities would be required to retain these documents for six years,
which is the statute of limitations period for the civil penalties. We
note that additional records or compliance reports may be required by
the Secretary for enforcement of this rule. (Sec. 164.522(d)(1)).
I. Relationship to Other Laws
1. Relationship to State Laws
[Please label comments about this section with the subject:
"Relationship to State laws"]
Congress addressed the issue of preemption of State law explicitly
in the statute, in section 1178 of the Act. Consonant with the
underlying statutory purpose to simplify the financial and
administrative transactions associated with the provision of health
care, the new section 1178(a)(1) sets out a "general rule" that State
law provisions that are contrary to the provisions or requirements of
part C of title XI or the standards or implementation specifications
adopted or established thereunder are preempted by the federal
requirements. The statute provides three exceptions to this general
rule: (1) For State laws which the Secretary determines are necessary
to prevent fraud and abuse, ensure appropriate State regulation of
insurance and health plans, for State reporting on health care
delivery, and other purposes; (2) for State laws which address
controlled substances; and (3) for State laws relating to the privacy
of individually identifiable health information which, as provided for
by the related provision of section 264(c)(2), are contrary to and more
stringent than the federal requirements. Section 1178 also carves out,
in sections 1178(b) and 1178(c), certain areas of State authority which
are not limited or invalidated by the provisions of part C of title XI;
these areas relate to public health and State regulation of health
plans.
Section 264 of HIPAA contains a related preemption provision.
Section 264(c)(2) is, as discussed above, an exception to the "general
rule" that the federal standards and requirements preempt contrary
State law. Section 264(c)(2) provides, instead, that contrary State
laws that relate to the privacy of individually identifiable health
information will not be preempted by the federal requirements, if they
are "more stringent" than those requirements. This policy, under
which the federal privacy protections act as a floor, but not a ceiling
on, privacy protections, is consistent with the Secretary's
Recommendations.
Aside from the cross-reference to section 264(c)(2) in section
1178(a)(2)(B), several provisions of section 1178 relate to the
proposed privacy standards. These include the general preemption rule
of section 1178(a)(1), the carve-out for public health and related
reporting under section 1178(b), and the carve-out for reporting and
access to records for the regulation of health plans by States under
section 1178(c). Other terms that occur in section 264(c)(2) also
appear in section 1178: The underlying test for preemption--whether a
State law is "contrary" to the federal standards, requirements or
implementation specifications--appears throughout section 1178(a),
while the issue of what is a "State law" for preemption purposes
applies throughout section 1178. In light of these factors, it seems
logical to develop a regulatory framework that addresses the various
issues raised by section 1178, not just those parts of it implicated by
section 264(c)(2). Accordingly, the rules proposed below propose
regulatory provisions covering these issues as part of the general
provisions in proposed part 160, with sections made specifically
applicable to the proposed privacy standard where appropriate.
a. The "general rule" of preemption of State law. Section
1178(a)(1) provides the following "general rule" for the preemption
of State law:
Except as provided in paragraph (2), a provision or requirement
under this part (part C of title XI), or a standard or
implementation specification adopted or established under sections
1172 through 1174, shall supersede any contrary provision of State
law, including a provision of State law that requires medical or
health plan records (including billing information) to be maintained
or transmitted in written rather than electronic form.
As we read this provision, the provisions and requirements of part C of
title XI, along with the standards and implementation specifications
adopted thereunder, do not supplant State law, except to the extent
such State law is "contrary" to the federal statutory or regulatory
scheme. Moreover, the provisions and requirements of part C of
[[Page 59995]]
title XI, along with the standards and implementation specifications
adopted thereunder, do not preempt contrary State law where one of the
exceptions provided for by section 1178(a)(2) applies or the law in
question lies within the scope of the carve-outs made by sections
1178(b) and (c). Thus, States may continue to regulate in the area
covered by part C of title XI and the regulations and implementation
specifications adopted or established thereunder, except to the extent
States adopt laws that are contrary to the federal statutory and
regulatory scheme, and even those contrary State laws may continue to
be enforceable, if they come within the statutory exceptions or carve-
outs.
We note, however, that many of the Administrative Simplifications
regulations will have preemptive effect. The structure of many of the
regulations, particularly those addressing the various administrative
transactions, is to prescribe the use of a particular form or format
for the transaction in question. Where the prescribed form or format is
used, covered entities are required to accept the transaction. A State
may well not be able to require additional requirements for such
transactions consistent with the federally prescribed form or format.
b. Exceptions for State laws the Secretary determines necessary for
certain purposes. Section 1178(a)(2) lists several exceptions to the
general preemption rule of section 1178(a)(1). The first set of
exceptions are those listed at sections 1178(a)(2)(A)(i) and
1178(a)(2)(A)(ii). These exceptions are for provisions of State law
which the Secretary determines are necessary: (1) To prevent fraud and
abuse; (2) to ensure appropriate State regulation of insurance and
health plans; (3) for State reporting on health care delivery or costs;
(4) for other purposes; or (5) which address controlled substances.
Proposed Sec. 160.203(a) below provides for determinations under
these statutory provisions. The criteria at proposed Sec. 160.203(a)
follow the statute. As is more fully discussed below, however, two of
the terms used in this section of the proposed rules are defined terms:
"contrary" and "State law." The process for making such
determinations is discussed below.
c. Exceptions for State laws relating to the privacy of
individually identifiable health information. The third exception to
the "general rule" that the federal requirements, standards, and
implementation specifications preempt contrary State law concerns State
laws relating to the privacy of individually identifiable health
information. Section 1178(a)(2)(B) provides that a State law is
excepted from this general rule, which, "subject to section 264(c)(2)
of the Health Insurance Portability and Accountability Act of 1996,
relates to the privacy of individually identifiable health
information." Section 264(c)(2) of HIPAA provides that the HIPAA
privacy regulation, which is proposed in the accompanying proposed
subpart B of proposed part 160, will not supersede "a contrary
provision of State law, if the provision of State law imposes
requirements, standards, or implementation specifications that are more
stringent than the requirements, standards, or implementation
specifications imposed" under the regulation at proposed subpart E of
proposed part 164.
It is recognized that States generally have laws that relate to the
privacy of individually identifiable health information. These laws
continue to be enforceable, unless they are contrary to part C of title
XI or the standards, requirements, or implementation specifications
adopted or established pursuant to the proposed subpart x. Under
section 264(c)(2), not all contrary provisions of State privacy laws
are preempted; rather, the law provides that contrary provisions that
are also "more stringent" than the federal regulatory requirements or
implementation specifications will continue to be enforceable.
d. Definitions. There are a number of ambiguities in sections
1178(a)(2)(B) and 264(c)(2) of HIPAA. Clarifying the statute through
the regulations will generally provide substantially more guidance to
the regulated entities and the public as to which requirements,
standards, and implementation specifications apply. For these reasons,
the rules propose below to interpret several ambiguous statutory terms
by regulation.
There are five definitional questions that arise in considering
whether or not a State law is preempted under section 264(c)(2): (1)
What is a "provision" of State law? (2) What is a "State law"? (3)
What kind of State law, under section 1178(a)(2)(B), "relates to the
privacy of individually identifiable health information?" (4) When is
a provision of State law at issue "contrary" to the analogous
provision of the federal regulations? (5) When is a provision of State
law "more stringent than" the analogous provision of the federal
regulations? We discuss these questions and our proposed regulatory
answers below.
i. What is a "provision" of State law?
The initial question that arises in the preemption analysis is,
what does one compare? The statute directs this analysis by requiring
the comparison of a "provision of State law [that] imposes
requirements, standards, or implementations specifications" with "the
requirements, standards, or implementation specifications imposed
under" the federal regulation. The statute thus appears to contemplate
that what will be compared are the State and federal requirements that
are analogous, i.e., that address the same subject matter. Accordingly,
a dictionary-type definition of the term "provision" does not seem
appropriate, as the contours of a given "provision" will be largely
defined by the contours of the specific "requirement[], standard[], or
implementation specification" at issue.
What does one do when there is a State provision and no comparable
or analogous federal provision, or the converse is the case? The short
answer would seem to be that, since there is nothing to compare, there
cannot be an issue of a "contrary" requirement, and so the preemption
issue is not presented. Rather, the stand-alone requirement--be it
State or federal--is effective. There may, however, be situations in
which there is a federal requirement with no directly analogous State
requirement, but where several State requirements in combination would
seem to be contrary in effect to the federal requirement. This
situation usually will be addressed through the tests for "contrary,"
discussed below.
At this juncture, it is difficult to frame options for dealing with
this issue, because it is not clear that more of a structure is needed
than the statute already provides. Rather, we solicit comment on how
the term "provision" might be best defined for the purpose of the
preemption analysis under the statute, along with examples of possible
problems in making the comparison between a provision of State law and
the federal regulations.
ii. What is a "State law"?
It is unclear what the term "provision of State law" in sections
1178 and 264(c) means. The question is whether the provision in
question must, in order to be considered to have preemptive effect, be
legislatively enacted or whether administratively adopted or judicially
decided State requirements must also be considered. Congress explicitly
addressed the same issue in a different part of HIPAA, section 102.
Section 102 enacted section 2723 of the Public Health Service Act,
which is a preemption provision that applies to issuers of health
insurance to ERISA plans. Section 2723 contains in subsection (d)(1)
the following definition of "State law": "The term
[[Page 59996]]
"State law" includes all laws, decisions, rules, regulations, or
other State action having the effect of law, of any State. A law of the
United States applicable only to the District of Columbia shall be
treated as a State law rather than a law of the United States.
By contrast, Congress provided no definition of the term "State
law" in section 264. This omission suggests two policy options. One is
to adopt the above definition, as a reasonable definition of the term
and as an indication of what Congress probably intended in the
preemption context (the policy embodied in section 2723 is analogous to
that embodied in section 264(c)(2), in the sense that the State laws
that are not preempted are ones that provide protections to individuals
that go above and beyond the federal requirements). The other option is
to argue by negative implication that, since Congress could have but
did not enact the above definition in connection with sections 264 and
1178, it intended that a different definition be used, and that the
most reasonable alternative is to limit the State laws to be considered
to those that have been legislatively enacted.
The Department does not consider the latter option to be a
realistic one. It is legally questionable and is also likely to be
extremely confusing and unworkable as a practical matter, as it will be
difficult to divorce State "laws" from implementing administrative
regulations or decisions or from judicial decisions. Also, much State
"privacy law"--e.g., the law concerning the physician/patient
privilege--is not found in statutes, but is rather in State common law.
Finally, since health care providers and others are bound by State
regulations and decisions, they would most likely find a policy that
drew a line based on where a legal requirement originated very
confusing and unhelpful. As a result, we conclude that the language in
section 102 represents a legally supportable approach that is, for
practical reasons, a realistic option, and it is accordingly proposed
in proposed Sec. 160.202 below.
iii. What is a law that "relates to the privacy of individually
identifiable health information"?
The meaning of the term "relate to" has been extensively
adjudicated in a somewhat similar context, the issue of the preemption
of State laws by ERISA. Section 514(a) of ERISA (29 U.S.C. 1144(a))
provides that ERISA "shall supersede any and all State laws insofar as
they may now or hereafter relate to any employee benefit plan."
(Emphasis added.) The U.S. Supreme Court alone has decided 17 ERISA
preemption cases, and there are numerous lower court cases. The term
also has been interpreted in other contexts. Thus, there would seem to
be several options for defining the term "relates to": (1) By using
the criteria developed by the Supreme Court as they evolve, (2) by
using the criteria developed by the Supreme Court, but on a static
basis, and (3) based on the legislative history, by setting federal
criteria.
The first option would be based on the definition adopted in an
early ERISA case, Shaw v. Delta Airlines, Inc., 463 U.S. 85 (1983), as
it continues to evolve. In Shaw, a unanimous Supreme Court adopted a
very broad reading of the term, holding that a law "relates to" an
employee benefit plan "if it has a connection with or reference to"
such a plan. Later cases have developed a more particularized and
complex definition of this general definition. The Supreme Court has
also applied the Shaw definition outside of the ERISA context. In
orales v. Trans World Airlines, 504 U.S. 374 (1992), the Court defined
the term "relating to" in the Airline Deregulation Act by using the
definition of the term "relates to" developed under the ERISA cases
above. While this option would appear to be a supportable reading of
the statutory term, tying the agency interpretation to an evolving
court interpretation will make it more difficult to make judgments, and
particular judgments may change as the underlying court interpretations
change.
The second option we considered would "freeze" the definition of
"relates to" as the Court has currently defined it. This option also
is a supportable reading of the statutory term, but is less of a moving
target than the prior option. The complexity of the underlying court
definition presents problems.
The option selected and reflected in the rules proposed below grows
out of the movement in recent years of the Supreme Court away from the
literal, textual approach of Shaw and related cases to an analysis that
looks more at the purposes and effects of the preemption statute in
question. In New York State Conference of Blue Cross v. Travelers
Insurance Co., 514 U.S. 645 (1995), the Court held that the proper
inquiry in determining whether the State law in question related to an
employee benefit plan was to look to the objectives of the (ERISA)
statute as a guide to the scope of the State law that Congress
understood would survive. The Court drew a similar line in Morales,
concluding that State actions that affected airline rates, routes, or
services in "too tenuous, remote, or peripheral a manner" would not
be preempted. 504 U.S. at 384. The Court drew a conceptually consistent
line with respect to the question of the effect of a State law in
English v. General Electric Co., 496 U.S. 72, 84 (1990); see also, Gade
v. National Solid Wastes Management Ass'n., 505 U.S. 88 (1992). The
Court held that deciding which State laws were preempted by the OSH Act
required also looking at the effect of the State law in question, and
that those which regulated occupational safety and health in a "clear,
direct, and substantial way" would be preempted. These cases suggest
an approach that looks to the legislative history of HIPAA and seeks to
determine what kinds of State laws Congress meant, in this area, to
leave intact and also seeks to apply more of a "rule of reason" in
deciding which State laws "relate to" privacy and which do not.
The legislative history of HIPAA offers some insight into the
meaning of the term "relates to." The House Report (House Rep. No.
496, 104th Cong., 2d Sess., at 103) states that--
The intent of this section is to ensure that State privacy laws
that are more stringent than the requirements and standards
contained in the bill are not superseded.
Based on this legislative history, one could argue that the "State
laws" covered by the "relates to" clause are simply those that are
specifically or explicitly designed to regulate the privacy of personal
health information, and not ones that might have the incidental effect
of doing so. Thus, the option selected below appears to be consistent
with the Court's approach in Travelers, and, together with the
"effect" test, seems to be closer to how the Court is analyzing
preemption issues. It makes sense on a common sense basis as well, and
appears, from the little legislative history available, to be what
Congress intended in this context.
iv. When is a provision of State law "contrary" to the analogous
federal requirement?
The statute uses the same language in both section 1178(a)(1) and
section 264(c)(2) to delineate the general precondition for preemption:
the provision of State law must be "contrary" to the relevant federal
requirement, standard, or implementation specification; the term
"contrary," however, is not defined. It should be noted that this
issue (the meaning of the term "contrary") does not arise solely in
the context of the proposed privacy standard. The term "contrary"
appears throughout section 1178(a) and is a precondition for any
preemption analysis done under that section.
[[Page 59997]]
The definition set out at proposed Sec. 160.202 embodies the tests
that the courts have developed to analyze what is known as "conflict
preemption." In this analysis, the courts will consider a provision of
State law to be in conflict with a provision of federal law where it
would be impossible for a private party to comply with both State and
federal requirements or where the provision of State law "stands as an
obstacle to the accomplishment and execution of the full purposes and
objectives of Congress." This latter test has been further defined as,
where the State law in question "interferes with the methods by which
the federal statute was designed to reach (its) goal." International
Paper Co. v. Ouellette, 479 U.S. 481, 494 (1987). In Gade, the Supreme
Court applied this latter test to preempt an Illinois law and
regulations that imposed additional, non-conflicting conditions on
employers, holding that the additional conditions conflicted with the
underlying congressional purpose to have one set of requirements apply.
This test, then, is particularly relevant with respect to the other
HIPAA regulations, where Congress clearly intended uniform standards to
apply nationwide.
The Department is of the view that this definition should be
workable and is probably what Congress intended in using the term--as a
shorthand reference to the case law. We considered a broader definition
("inconsistent with"), but rejected it on the grounds that it would
have less legal support and would be no easier to apply than the
statutory term "contrary" itself.
v. What is the meaning of "more stringent'?
The issue of when a provision of State law is "more stringent"
than the comparable "requirements, standards, or implementation
specifications" of the HIPAA privacy regulation is not an easy one. In
general, it seems reasonable to assume that "more stringent" means
"providing greater privacy protection" but, such an interpretation
leads to somewhat different applications, depending on the context. For
example, a State law that provided for fewer and more limited
disclosures than the HIPAA privacy regulation would be "more
stringent." At the same time, a State law that provides for more and/
or greater penalties for wrongful disclosures than does the HIPAA
privacy regulation would also be "more stringent." Thus, in the
former case, "more stringent" means less or fewer, while in the
latter case, "more stringent" means more or greater. In addition,
some situations are more difficult to characterize. For example, if the
HIPAA privacy regulation requires disclosure to the individual on
request and a State law prohibits disclosure in the circumstance in
question, which law is "more stringent" or "provides more privacy
protection'?
A continuum of regulatory options is available. At one end of the
continuum is the minimalist approach of not interpreting the term
"more stringent" further or spelling out only a general
interpretation, such as the "provides more privacy protection"
standard, and leaving the specific applications to later case-by-case
determinations. At the other end of the continuum is the approach of
spelling out in the regulation a number of different applications, to
create a very specific analytic framework for future determinations. We
propose below the latter approach for several reasons: specific
criteria will simplify the determination process for agency officials,
as some determinations will be already covered by the regulation, while
others will be obvious; specific criteria will also provide guidance
for determinations where issue of "stringency" is not obvious; courts
will be more likely to give deference to agency determinations, leading
to greater uniformity and consistency of expectation; and the public,
regulated entities, and States will have more notice as to what the
determinations are likely to be.
The specific criteria proposed at proposed Sec. 160.202 are
extrapolated from the principles of the fair information practices that
underlie and inform these proposed rules and the Secretary's
Recommendations. For example, limiting disclosure of personal health
information obviously protects privacy; thus, under the criteria
proposed below, the law providing for less disclosure is considered to
be "more stringent." Similarly, as the access of an individual to his
or her protected health information is considered to be central to
enabling the individual to protect such information, the criteria
proposed below treat a law granting greater rights of access as "more
stringent." We recognize that many State laws require patients to
authorize or consent to disclosures of their health information for
treatment and/or payment purposes. We consider individual authorization
generally to be more protective of privacy interests than the lack of
such authorization, so such State requirements would generally stand,
under the definition proposed below.
However, we would interpret a State law relating to individual
authorization to be preempted if the law requires, or would permit a
provider or health plan to require, as a condition of treatment or
payment for health care, an individual to authorize uses or disclosures
for purposes other than treatment, payment and health care operations,
and if such authorization would override restrictions or limitations in
this regulation relating to the uses and disclosures for purposes other
than treatment, payment and health care operations. For example, if a
State law permitted or required a provider to obtain an individual
authorization for disclosure as a condition of treatment, and further
permitted the provider to include in the authorization disclosures for
research or for commercial purposes, the State law would be preempted
with respect to the compelled authorization for research or commercial
purposes. At the same time, if a State law required a provider to
obtain an individual authorization for disclosure as a condition of
treatment, and further required the provider to include an
authorization for the provider to disclosure data to a State data
reporting agency, such a law would not be preempted, because State laws
that require such data reporting are saved from preemption under
section Sec. 1178(c) of the statute.
In addition, to the extent that a State consent law does not
contain other consent or authorization requirements that parallel or
are stricter than the applicable federal requirements, those detailed
federal requirements would also continue to apply. We solicit comment
in particular on how these proposed criteria would be likely to operate
with respect to particular State privacy laws.
e. The process for making administrative determinations regarding
the preemption of State health information privacy laws. Because States
generally have laws that relate to the privacy of individually
identifiable health information, there may be conflicts between
provisions of various State laws and the federal requirements. Where
such conflicts appear to exist, questions may arise from the regulated
entities or from the public concerning which requirements apply. It is
possible that such questions may also arise in the context of the
Secretary's enforcement of the civil monetary penalty provisions of
section 1176. The Secretary accordingly proposes to adopt the following
process for responding to such comments and making the determinations
necessary to carry out her responsibilities under section 1176.
The rules proposed below would establish two related processes: one
for making the determinations called for by
[[Page 59998]]
section 1178(a)(2)(A) of the Act and the other for issuing advisory
opinions regarding whether a provision of State law would come within
the exception provided for by section 1178(a)(2)(B).
i. Determinations under section 1178(a)(2)(A).
The rules proposed below should not usually implicate section
1178(a)(2)(A), which provides that a State law will not be preempted
where the Secretary determines it is necessary for one or more of five
specific purposes: (1) To prevent fraud and abuse; (2) to ensure
appropriate State regulation of insurance and health plans; (3) for
State reporting on health care delivery or costs; (4) for other
purposes; or (5) which address controlled substances. The process for
implementing this statutory provision is proposed here, because the
issue of how such preemption issues will be handled has been raised in
prior HIPAA rulemakings and needs to be addressed, and, as explained
above, the statutory provision itself is fairly intertwined (in terms
of the specific terms used), with the preemption provisions of the
statute that relate to privacy.
The process proposed below for determinations by the Secretary
would permit States to request an exception to the general rule of
preemption. The decision to limit, at least as an initial matter, the
right to request such determinations to States was made for several
reasons. First, States are obviously most directly concerned by
preemption, in that it is State legislative, judicial, or executive
action that the federal requirements supersede. Principles of comity
dictate that States be given the opportunity to make the case that
their laws should not be superseded. Second, States are in the best
position to address the issue of how their laws operate and what their
intent is, both of which are relevant to the determination to be made.
Third, we need to control the process as an initial matter, so that the
Secretary is not overwhelmed by requests. Fourth, where particular
federal requirements will have a major impact on providers, plans, or
clearinghouses within a particular State, we assume that they will be
able to work with their State governments to raise the issue with the
Secretary; the discussion process that such negotiations should entail
should help crystallize the legal and other issues for the Secretary
and, hence, result in better determinations. We emphasize that HHS may
well revisit this issue, once it has gained some experience with the
proposed process.
Proposed Sec. 160.204(a)(1) sets out a number of requirements for
requests for determinations. In general, the purpose of these
requirements is to provide as complete a statement as possible of the
relevant information as an initial matter, to minimize the time needed
for the Secretarial determination.
The remaining requirements of proposed Sec. 160.204(a) generally
are designed to set out an orderly process and effect of the
determinations. Of particular note is proposed Sec. 160.204(a)(5),
which provides that such determinations apply only to transactions that
are wholly intrastate. We recognize that in today's economy, many,
perhaps most, transactions will be interstate, so that the effect of a
positive determination could be minimal under this provision.
Nonetheless, we think that there is no practical alternative to the
proposed policy. We do not see how it would be practical to split up
transactions that involved more than one State, when one State's law
was preempted and the other's was not. We do not see why the non-
preempted law should govern the transaction, to the extent it involved
an entity in a State whose law was preempted. Quite aside from the
sovereignty issues such a result would raise, such a result would be
very confusing for the health care industry and others working with it
and thus inconsistent with the underlying goal of administrative
simplification. Rather, such a situation would seem to be a classic
case for application of federal standards, and proposed
Sec. 160.204(a)(5) would accordingly provide for this.
ii. Advisory opinions under section 1178(a)(2)(B).
The rules proposed below lay out a similar process for advisory
opinions under section 1178(a)(2)(B). That section of the statute
provides that, subject to the requirements of section 264(c)(2) (the
provision of HIPAA that establishes the "more stringent" preemption
test), State laws that "relate to the privacy of individually
identifiable health information" are excepted from the general rule
that the HIPAA standards, requirements, and implementation
specifications preempt contrary State law.
Unlike section 1178(a)(2)(A), section 1178(a)(2)(B) does not
provide for the making of a determination by the Secretary.
Nonetheless, it is clear that the Secretary may make judgments about
the legal effect of particular State privacy laws in making compliance
and enforcement decisions. It is also foreseeable that the Secretary
will be asked to take a position on whether particular State privacy
laws are preempted or not. We have concluded that the best way of
addressing these concerns is to provide a mechanism by which the
Secretary can issue advisory opinions, so that the public may be
informed about preemption judgments the Secretary has made. See
proposed Sec. 160.204(b).
The process proposed below for requesting advisory opinions is
limited to States, for the reasons described in the preceding section.
The requirements for requests for advisory opinions are similar to the
requirements for determinations in proposed Sec. 160.204(a), but are
tailored to the different statutory requirements of sections
1178(a)(2)(A) and 264(c)(2). As with proposed Sec. 164.204(a), the
process proposed below would provide for publication of advisory
opinions issued by the Secretary on an annual basis, to ensure that the
public is informed of the decisions made in this area.
f. Carve-out for State public health laws. Section 1178(b) provides
that "Nothing in this part shall be construed to invalidate or limit
the authority, power, or procedures established under any law providing
for the reporting of disease or injury, child abuse, birth, or death,
public health surveillance, or public health investigation or
intervention." This section appears to carve out an area over which
the States have traditionally exercised oversight and authority--the
collection of vital statistics, the enforcement of laws regarding child
abuse and neglect, and the conduct of public health surveillance,
investigation, and intervention. State laws in these areas may involve
reporting of individually identifiable health information to State or
local authorities. Section 1178(b) indicates that existing or future
State laws in these areas are enforceable, notwithstanding any privacy
requirements adopted pursuant to section 264(c). In addition, covered
entities should not be inhibited from complying with requests
authorized by State law for release of information by public health
authorities for the stated purposes.
It should be noted that the limitation of section 1178(b) applies
to the "authority, power, or procedures established under any law."
Public health laws often convey broad general authorities for the
designated agency to protect public health, including enforcement
powers, and these State authorities and powers would remain
enforceable. Further, section 1178(b) also covers "procedures"
authorized by law; we read this language as including State
administrative regulations and guidelines.
The proposed rules propose to address these concerns by treating
the
[[Page 59999]]
disclosures covered by section 1178(b) as allowable disclosures for
public health activities under proposed Sec. 164.510(b). Thus, those
disclosures permitted under proposed Sec. 164.510(b) are intended to
be, with respect to disclosures authorized by State law, at least as
broad as section 1178(b). This means that disclosures that are
authorized by State law but which do not come within the scope of
proposed Sec. 164.510(b) are considered to fall outside of the
limitation of section 1178(b). In addition, since similar activities
and information gathering are conducted by the federal government,
disclosures to public health authorities authorized by federal law
would be permitted disclosures under this proposed rule and applicable
federal law will govern the use and re-disclosure of the information.
g. Carve-out for State laws relating to oversight of health plans.
Section 1178(c) provides that nothing in part C of title XI limits the
ability of States to require health plans "to report, or to provide
access to, information for management audits, financial audits, program
monitoring and evaluation, facility licensure or certification, or
individual licensure or certification." This section thus also carves
out an area in which the States have traditionally regulated health
care as an area which the statute intends to leave in place. State laws
requiring the reporting of or access to information of the type covered
by section 1178(c) will in certain cases involve the reporting of, or
access to, individually identifiable health information. Accordingly,
provision has been made for such reporting and access by making such
reporting and access permitted disclosures and uses under this proposed
rule. See proposed Sec. 164.510(c).
2. Relationship to Other Federal Laws
[Please label comments about this section with the subject:
"Relationship to other federal laws"]
The rules proposed below also would affect various federal
programs, some of which may have requirements that are, or appear to
be, inconsistent with the requirements proposed below. Such federal
programs include those programs that are operated directly by the
federal government, such as the health benefit programs for federal
employees or the health programs for military personnel. They also
include a wide variety of health services or benefit programs in which
health services or benefits are provided by the private sector or by
State or local government, but which are governed by various federal
laws. Examples of the latter types of programs would be the Medicare
and Medicaid programs, the health plans governed by the Employee
Retirement Income Security Act of 1974, 29 U.S.C. 1001, et seq.
(ERISA), the various clinical services programs funded by federal
grants, and substance abuse treatment programs.
Some of the above programs are explicitly covered by HIPAA. Section
1171 of the Act defines the term "health plan" to include the
following federally conducted, regulated, or funded programs: group
plans under ERISA which either have 50 or more participants or are
administered by an entity other than the employer who established and
maintains the plan; federally qualified health maintenance
organizations; Medicare; Medicaid; Medicare supplemental policies; the
health care program for active military personnel; the health care
program for veterans; the Civilian Health and Medical Program of the
Uniformed Services (CHAMPUS); the Indian health service program under
the Indian Health Care Improvement Act, 25 U.S.C. 1601, et seq.; and
the Federal Employees Health Benefits Program. There also are many
other federally conducted, regulated, or funded programs in which
individually identifiable health information is created or maintained,
but which do not come within the statutory definition of "health
plan." While these latter types of federally conducted, regulated, or
assisted programs are not explicitly covered by part C of title XI in
the same way that the programs listed in the statutory definition of
"health plan" are covered, the statute may nonetheless apply to
transactions and other activities conducted under such programs. This
is likely to be the case where the federal entity or federally
regulated or funded entity provides health services; the requirements
of part c are likely to apply to such an entity as a "health care
provider." Thus, the issue of how different federal requirements apply
is likely to arise in numerous contexts.
When two federal statutes appear to conflict, the courts generally
engage in what is called an "implied repeal" analysis. The first step
in such an analysis is to look for some way in which to reconcile the
apparently conflicting requirements. Only if the conflicting provisions
cannot be reconciled do courts reach the second step of the analysis,
in which they look to see whether the later statute repealed the prior
statute (to the extent of the conflict) by implication. In making such
a determination, the courts look to the later statute and its
legislative history, to see if there is evidence as to whether Congress
intended to leave the prior statute in place or whether it intended the
later statute to supersede the prior statute, to the extent of the
conflict between the two. It is not a foregone conclusion that a later
statute will repeal inconsistent provisions of a prior statute. Rather,
there are cases in which the courts have held prior, more specific
statutes not to be impliedly repealed by later, more general statutes.
As noted above, the section 1171 of the Act explicitly makes
certain federal programs subject to the standards and implementation
specifications promulgated by the Secretary, while entities carrying
out others are implicitly covered by the scope of the term "health
care provider." The legislative history of the statute is silent with
respect to how these requirements were to operate in the federal sector
vis-a-vis these and other federal programs with potentially conflicting
requirements. Congress is presumed to have been aware that various
federal programs that the privacy and other standards would reach would
be governed by other federal requirements, so the silence of the
legislative history and the limited reach of the statute would seem to
be significant. On the other hand, Congress' express inclusion of
certain federal programs in the statute also has significance, as it
constitutes an express Congressional statement that the HIPAA standards
and implementation specifications apply to these programs. In light of
the absence of relevant legislative history, we do not consider this
Congressional statement strong enough to support a conclusion of
implied repeal, where the conflict is one between the HIPAA regulatory
standards and implementation specifications and another federal
statute. However, it seems strong enough to support an inference that,
with respect to these programs, the HIPAA standards and implementation
specifications establish the federal policy in the case of a conflict
at the regulatory level.
Thus, the first principle that applies where both the HIPAA
standards and implementation specifications and the requirements of
another federal program apply is that we must seek to reconcile and
accommodate any apparently conflicting federal requirements. Two
conclusions flow from this principle. First, where one federal statute
or regulation permits an activity that another federal statute or
regulation requires, and both statutes apply to the entity in question,
there is no conflict, because it is possible to comply with both sets
of federal requirements.
[[Page 60000]]
Second, where one federal statute or regulation permits, but does not
require, an activity that another federal statute or regulation
prohibits, there is again no conflict, because it is possible to comply
with both sets of federal requirements. In each case, the entity has
lost some discretion that it would otherwise have had under the more
permissive set of requirements, but in neither case has it been
required to do something that is illegal under either federal program.
There will, however, also be cases where the privacy or other
Administrative Simplification standards and implementation
specifications cannot be reconciled with the requirements of another
federal program. In such a case the issue of implied repeal is
presented. As suggested above, we think that where the conflict is
between the privacy or other Administrative simplification regulations
and another federal statute, the regulatory requirements would give
way, because there is insufficient evidence to support a finding that
part C of title XI is intended to repeal other federal laws. For
example, if other law prohibits the dissemination of classified or
other sensitive information, this rule's requirements for granting
individuals' right to copy their own records would give way. Where the
conflict is between the Administrative Simplification regulatory
requirements and other federal regulatory requirements that are
discretionary (not mandated by the other federal law), we think that
there is also insufficient evidence to support a finding of implied
repeal of the latter regulatory requirements, where the other federal
program at issue is not one specifically addressed in section 1171.
However, where the other federal program at issue is one of the ones
which Congress explicitly intended to have the Administrative
Simplification standards and implementation specifications apply to, by
including them in the definition of "health plan" in section 1171, we
think that there is evidence that the Administrative Simplification
standards and implementation specifications should prevail over
contrary exercises of discretion under those programs.
We considered whether the preemption provision of section 264(c)(2)
of Public Law 104-191, discussed in the preceding section, would give
effect to State laws that would otherwise be preempted by federal law.
For example, we considered whether section 264(c)(2) could be read to
make the Medicare program subject to State laws relating to information
disclosures that are more stringent than the requirements proposed in
this rule, where such laws are presently preempted by the Medicare
statute. We also considered whether section 264(c)(2) could be read to
apply such State laws to procedures and activities of federal agencies,
such as administrative subpoenas and summons, that are prescribed under
the authority of federal law. In general, we do not think that section
264(c)(2) would work to apply State law provisions to federal programs
or activities with respect to which the State law provisions do not
presently apply. Rather, the effect of section 264(c)(2) is to give
preemptive effect to State laws that would otherwise be in effect, to
the extent they conflict with and are more stringent than the
requirements promulgated under the Administrative Simplification
authority of HIPAA. Thus, we do not believe that it is the intent of
section 264(c)(2) to give an effect to State law that it would not
otherwise have in the absence of section 264(c)(2).
We explore some ramifications of these conclusions with respect to
specific federal programs below. We note that the summaries below do
not identify all possible conflicts or overlaps of the proposed rules
with other federal requirements; rather, we have attempted to explain
the general nature of the relationship of the different federal
programs. We would anticipate issuing more detailed guidance in the
future, when the final privacy policies are adopted, and the extent of
conflict or overlap can be ascertained. We also invite comment with
respect to issues raised by other federal programs.
a. The Privacy Act. The Privacy Act of 1974, 5 U.S.C. 552a, is not
preempted or amended by part C of title XI. The Privacy Act applies to
all federal agencies, and to certain federal contractors who operate
Privacy Act protected systems of records on behalf of federal agencies.
It does not, however, apply to non-federal entities that are reached by
part C. While the proposed rules are applicable to federal and non-
federal entities, they are not intended to create any conflict with
Privacy Act requirements. In any situation where compliance with the
proposed rules would lead a federal entity to a result contrary to the
Privacy Act, the Privacy Act controls. In sections of the proposed
rules which might otherwise create the appearance of a conflict with
Privacy Act requirements, entities subject to the Privacy Act are
directed to continue to comply with Privacy Act requirements.
Because the Privacy Act gives federal agencies the authority to
promulgate agency-specific implementing regulations, and because the
Privacy Act also allows agencies to publish routine uses that have the
status of exceptions to the Privacy Act's general rule prohibiting
disclosure of Privacy Act protected information to third parties, the
issue of possible conflicts between the proposed Administrative
Simplification rules and existing Privacy Act rules and routine uses
must be addressed. Where the federal program at issue is one of the
ones that Congress explicitly intended to have the Administrative
Simplification standards and implementation specifications apply to, by
including them in the definition of "health plan" in section 1171, we
think that there is evidence that the Administrative Simplification
standards and implementation specifications should prevail over
contrary exercises of discretion under those programs. That is, to the
extent that a routine use is truly discretionary to an agency which is
also a covered entity under section 1172(a), the agency would not have
discretion to ignore the Administrative Simplification regulations. It
is possible, however, that in some cases there might be underlying
federal statutes that call for disclosure of certain types of
information, and routine uses could be promulgated as the only way to
implement those statutes and still comply with the Privacy Act. If this
were to happen or be the case, the routine use should prevail.
b. The Substance Abuse Confidentiality regulations. Regulations
that are codified at 42 CFR part 2 establish confidentiality
requirements for the patient records of substance abuse "programs"
that are "federally assisted." Substance abuse programs are
specialized programs or personnel that provide alcohol and drug abuse
treatment, diagnosis, or referral for treatment. 42 CFR 2.11. The term
"federally assisted" is broadly defined, and includes federal tax
exempt status and Medicare certification, among other criteria. 42 CFR
2.12(b). Such programs may not disclose patient identifying information
without the written consent of the patient, unless the information is
needed to respond to a medical emergency, or such information is
disclosed for purposes of research, audit, or evaluation. Disclosures
may not be made in response to a subpoena; rather, a court order is
required in order for a disclosure of covered records to be lawfully
made. Limited disclosures may also be made by such programs to State or
local officials under a State law requiring reporting of incidents of
suspected child abuse and neglect and
[[Page 60001]]
to law enforcement officials regarding a patient's crime on program
premises or against program personnel or a threat to commit such a
crime. 42 CFR 2.12. Unlike the rules proposed below, the
confidentiality protections continue indefinitely after death, although
part 2 would permit disclosure of identifying information relating to
the cause of death under laws relating to the collection of vital
statistics or permitting inquiry into cause of death.
It seems likely that most, if not all, programs covered by the part
2 regulations will also be covered, as health care providers, by the
rules proposed below. As can be seen from the above summary, the part 2
regulations would not permit many disclosures that would be permitted
under proposed Sec. 164.510 below, such as many disclosures for law
enforcement, directory information, governmental health data systems,
and judicial and other purposes. In addition, the general permissive
disclosure for treatment or payment purposes at proposed Sec. 164.506
below would be inconsistent with the more restrictive requirements at
part 2. In such situations, providers (or others) subject to both sets
of requirements could not make disclosures prohibited by part 2, even
if the same disclosures would be permitted under the rules proposed
below.
There are also a number of requirements of the part 2 regulations
that parallel the requirements proposed below. For example, the minimum
necessary rule, where applicable, would parallel a similar requirement
at 42 CFR 2.13(a). Similarly, the notice requirements of part 2, at 42
CFR 2.22 parallel the notice requirements proposed below, although the
notice required below would be more detailed and cover more issues. The
preemptive effect on State law should be the same under both part 2 and
section 264(c)(2). The requirements for disclosures for research
proposed below are likewise similar to those in part 2. In such cases,
health care providers would have to comply with the more extensive or
detailed requirements, but there should be no direct conflict.
Many other provisions of the proposed rules, however, simply have
no counterpart in part 2. For example, the part 2 regulations do not
require programs to maintain an accounting of uses and disclosures, nor
do they provide for a right to request amendment or correction of
patient information. Similarly, the part 2 regulations contain no
prohibition on conditioning treatment or payment on provision of an
individual authorization for disclosure. In such situations, health
care providers would be bound by both sets of requirements.
c. ERISA. ERISA was enacted in 1974 to regulate pension and welfare
employee benefit plans that are established by private sector
employers, unions, or both, to provide benefits to their workers and
dependents. An employee welfare benefit plan includes plans that
provide "through the purchase of insurance or otherwise * * * medical,
surgical, or hospital care or benefits, or benefits in the event of
sickness, accident, disability, (or) death." 29 U.S.C. 1002(1). In
1996, Public Law 104-191 amended ERISA to require portability,
nondiscrimination, and renewability of health benefits provided by
group health plans and group health insurance issuers. Numerous,
although not all, ERISA plans are covered under the rules proposed
below as "health plans."
As noted above, section 514(a) of ERISA, 29 U.S.C. 1144(a),
preempts all State laws that "relate to" any employee benefit plan.
However, section 514(b) of ERISA, 29 U.S.C. 1144(b)(2)(A), expressly
saves from preemption State laws which regulate insurance. Section of
ERISA, 29 U.S.C. 1144(b)(2)(B), provides that an ERISA plan is deemed
not to be an insurer for the purpose of regulating the plan under the
State insurance laws. Thus, under the deemer clause, States may not
treat ERISA plans as insurers subject to direct regulation by State
law. Finally, section 514(d) of ERISA, 29 U.S.C. 1144(d), provides that
ERISA does not "alter, amend, modify, invalidate, impair, or supersede
any law of the United States."
We considered whether the preemption provision of section 264(c)(2)
of Public Law 104-191, discussed in the preceding section, would give
effect to State laws that would otherwise be preempted by section
514(a) of ERISA. Our reading of the statutes together is that the
effect of section 264(c)(2) is simply to leave in place State privacy
protections that would otherwise apply and which are more stringent
than the federal privacy protections. In the case of ERISA plans,
however, if those laws are preempted by section 514(a), they would not
otherwise apply. We do not think that it is the intent of section
264(c)(2) to give an effect to State law that it would not otherwise
have in the absence of section 264(c)(2). Thus, we would not view the
preemption provisions below as applying to State laws otherwise
preempted by section 514(a) of ERISA.
Many plans covered by the rules proposed below are also subject to
ERISA requirements. To date our discussions and consultations have not
uncovered any particular ERISA requirements that would conflict with
the rules proposed below. However, we invite comment, particularly in
the form of specific identification of statutory or regulatory
provisions, of requirements under ERISA that would appear to conflict
with provisions of the rules proposed below.
d. Other federally funded health programs. There are a number of
authorities under the Public Health Service Act and other legislation
that contain explicit confidentiality requirements either in the
enabling legislation or in the implementing regulations. Many of these
are so general that there would appear to be no problem of
inconsistency, in that nothing in the legislation or regulations would
appear to restrict the assisted provider's discretion to comply with
the requirements proposed below. There are, however, several
authorities under which either the requirements of the enabling
legislation or of the program regulations would impose requirements
that would differ from the rules proposed below. We have identified
several as presenting potential issues in this regard. First,
regulations applicable to the substance abuse block grant program
funded under section 1943(b) of the Public Health Service Act require
compliance with 42 CFR part 2, and thus raise the issues identified in
section 2 above. Second, there are a number of federal programs which,
either by statute or by regulation, restrict the disclosure of patient
information to, with minor exceptions, disclosures "required by law."
See, for example, the program of projects for prevention and control of
sexually transmitted diseases funded under section 318(e)(5) of the
Public Health Service Act (42 CFR 51b.404); the regulations
implementing the community health center program funded under section
330 of the Public Health Service Act (42 CFR 51c.110); the regulations
implementing the program of grants for family planning services under
title X of the Public Health Service Act (42 CFR 59.15); the
regulations implementing the program of grants for black lung clinics
funded under 30 U.S.C. 437(a) (42 CFR 55a.104); the regulations
implementing the program of maternal and child health projects funded
under section 501 of the Act (42 CFR 51a.6); the regulations
implementing the program of medical examinations of coal miners (42 CFR
37.80(a)). These legal requirements would restrict the grantees or
other entities under the programs
[[Page 60002]]
involved from making many of the disclosures that proposed Sec. 164.510
would permit. In some cases, permissive disclosures for treatment,
payment or health care operations would also be limited. Since proposed
Sec. 164.510 is merely permissive, there would not be a conflict
between the program requirements, as it would be possible to comply
with both. However, it should be recognized that entities subject to
both sets of requirements would not have the total range of discretion
that the rules proposed below would suggest.
J. Compliance and Enforcement (Sec. 164.522)
1. Compliance
[Please label written comments about this section with the subject:
"Compliance."]
The rules proposed below at Sec. 164.522 would establish several
requirements designed to enable the Secretary to monitor and seek to
ensure compliance with the provisions of this subpart. The general
philosophy of this section is to provide a cooperative approach to
obtaining compliance, including use of technical assistance and
informal means to resolve disputes. However, in recognition of the fact
that it would not always be possible to achieve compliance through
cooperation, the section also would provide the Secretary with tools
for carrying out her statutory mandate to achieve compliance.
a. Principles for achieving compliance. Proposed Sec. 164.522(a)
would establish the principle that the Secretary will seek the
cooperation of covered entities in obtaining compliance. Section
164.522(a)(2) provides that the Secretary could provide technical
assistance to covered entities to help them come into compliance with
this subpart. It is clearly in the interests of both the covered
entities and the individuals they serve to minimize the costs of
compliance with the privacy standards. To the extent that the
Department could facilitate this by providing technical assistance, it
would endeavor to do so.
b. Individual complaints and compliance reviews. We are proposing
in Sec. 164.522(b) that individuals have the right to file a complaint
with the Secretary if they believe that a covered plan or provider has
failed to comply with the requirements of this subpart. Because
individuals would have received notice, pursuant to proposed
Sec. 164.512, of the uses and disclosures that the entity could make
and of the entity's privacy practices, they would have a basis for
making a realistic judgment as to when a particular action or omission
would be improper. The notice would also inform individuals how they
could find out how to file such complaints. We thus consider the
proposed complaint right to be one that could realistically be
exercised by individuals, given the regulatory structure proposed.
We are concerned about the burden that handling the potential
volume of such complaints would create for this Department, but we
recognize that such a complaint mechanism would provide helpful
information about the privacy practices of covered plans or providers
and could serve to identify particularly troublesome compliance
problems on an early basis.
The procedures proposed in this section are modeled on those used
by the Department's Office for Civil Rights, although they would be
adapted to reflect the requirements of this subpart. We would require
complainants to identify the entities and describe the acts or
omissions alleged to be out of compliance and would require individuals
to file such complaints within 180 days of those acts or omissions. We
have tried to keep the requirements for filing complaints as minimal as
possible, to facilitate use of this right. The Secretary would also
attempt to keep the identity of complainants confidential, if possible.
However, we recognize that it could be necessary to disclose the
identity of complainants in order to investigate the substance of their
complaints, and the rules proposed below would permit such disclosures.
The Secretary could promulgate alternative procedures for
complaints based on agency-specific concerns. For example, to protect
classified information, we may promulgate rules that would allow an
intelligence community agency to create a separate body within that
agency to receive complaints.
The Secretary would try to resolve complaints on an informal basis
wherever possible. Where a resolution could not be reached, the
Secretary could make a formal finding of noncompliance. However,
resolution could occur, and an agreement reached with the covered
entity, even after a finding that a violation occurred. The Secretary
could use the finding as a basis to initiate an action under section
1176 of the Act or to refer the matter to the Department of Justice for
prosecution under section 1177 of the Act. It should be recognized that
the decision to initiate an action under either section of the law
would be a discretionary one, and proposed Sec. 164.522 would not
require such prosecutorial action to be taken. Proposed
Sec. 164.522(e)(1)(ii) would, however, permit the use of findings made
in connection with a complaint, group of complaints, or compliance
review to be acted on in this fashion.
The rules proposed below also would provide that the Secretary
would inform both the covered plan or provider and the complainant,
whenever a decision was made on a complaint.
We are proposing in Sec. 164.522(c) that the Secretary could
conduct compliance reviews to determine whether covered entities are in
compliance. A compliance review could be based on information
indicating a possible violation of this subpart even though a formal
complaint has not been filed. As is the case with a complaint
investigation, a compliance review may examine the policies, practices
or procedures of a covered entity and may result in voluntary
compliance or in a violation or no violation finding.
c. Responsibilities of covered entities. Proposed Sec. 164.522(d)
establishes certain obligations for covered entities that would be
necessary to enable the Secretary to carry out her statutory role to
determine their compliance with these requirements. Proposed
Sec. 164.522(d)(1) would require covered entities to maintain records
as directed. Proposed Sec. 164.522(d)(2) would require them to
participate as required in compliance reviews. Proposed
Sec. 164.522(d)(3) would affirmatively establish their obligation to
provide information to the Secretary upon demand. Finally, paragraph
(d)(4) would prohibit intimidating, discriminatory or other retaliatory
actions by a covered entity against a person who files a complaint with
the Secretary; testifies, assists or participates in any manner in an
investigation, compliance review, proceeding, or hearing under this
Act; or opposes any act or practice made unlawful by this subpart. This
language is modeled after the Americans with Disabilities Act and title
VII of the Civil Rights Act of 1964. Prohibitions against retaliation
are also common throughout Department programs. The experience of the
federal government in enforcing civil rights and other laws has been
that voluntary compliance with and effective enforcement of such laws
depend in large part on the initiative of persons opposed to illegal
practices. If retaliation for opposing practices that a person
reasonably believes are unlawful were permitted to go unremedied, it
would have a chilling effect upon the willingness of persons to speak
out and
[[Page 60003]]
to participate in administrative processes under this subpart.
Opposition to practices of covered entities refers to a person's
communication of his or her good faith belief that a covered entity's
activities violate this subpart. Opposition includes, but is not
limited to, filing a complaint with the covered entity under
Sec. 164.518(d) and making a disclosure as a whistleblower under
Sec. 164.518(c)(4). This provision would not protect a person whose
manner of opposition is so unreasonable that it interferes with the
covered entities' legitimate activities. This provision would cover
such situations such as where an employee of a physician is fired in
retaliation for confronting the doctor regarding her practice of
illegally disclosing individuals' records or where a health plan drops
coverage after an enrollee argues to the plan that he has a right to
access to his records.
We recognize that under these requirements the covered entity would
be disclosing protected health information to representatives of the
Department when such information is relevant to a compliance
investigation or assessment. We recognize that this would create a
mandatory disclosure of protected health information and that such a
requirement carries significant privacy concerns. Those concerns must,
however, be weighed against the need to obtain compliance by entities
with the privacy standards, and to protect against future improper uses
and disclosures of protected health information. The proposed rule
accordingly attempts to strike a balance between these interests,
providing that the Department would not disclose such information,
except as may be necessary to enable the Secretary to ascertain
compliance with this subpart or in enforcement proceedings or as
otherwise required by law.
2. Enforcement
[Please label written comments about this section with the subject:
"Enforcement."]
Congress established a two-pronged approach to enforcement of all
of the requirements established under part C of title XI of the Act.
First, section 1176 grants the Secretary the authority to impose civil
monetary penalties against those covered entities which fail to comply
with the requirements established under part C. These penalties are to
be imposed according to the procedures established for imposition of
civil monetary penalties in section 1128A of the Act. Second, section
1177 establishes criminal penalties for certain wrongful disclosures of
individually identifiable health information.
The selection of the civil monetary penalty process at section
1128A of the Act as the enforcement mechanism for the Administrative
Simplification standards and requirements indicates the type of process
Congress believes is appropriate for civil enforcement of those
standards and requirements. The Secretary's Recommendations call for a
privacy right of action to permit individuals to enforce their privacy
rights. However, the HIPAA does not provide a private right of action,
so the Secretary lacks the authority to provide for such a remedy.
Accordingly, we would provide that individuals could file complaints
with the Secretary and the Secretary could then, when appropriate,
investigate. The Secretary may also conduct compliance reviews. See
proposed Sec. 164.522(b) and (c).
Under section 1177(a), the offense of "wrongful disclosure" is a
disclosure that violates the standards or requirements established
under part C. These would include any disclosures not otherwise
permitted under the privacy standards or the parallel security
standards.
As we noted in the Notices of Proposed Rulemaking for the other
Administrative Simplification regulations, we will propose regulations
in the future to establish these procedures. Because such procedures
will not constitute "standards" within the meaning of part C, they
would not be subject to the delay in effective date provisions that
apply to the various Administrative Simplification regulations.
III. Small Business Assistance
This rule is significant because it establishes for the first time
a federally required regime of information practices in the medical
industry. The length, and at times complexity, of the preamble
discussion may impress small businesses as creating overly burdensome
and costly requirements. We believe, however, that several features of
the rule, combined with initiatives by the Department and professional
associations, will make the rule easily administrable for the vast
majority of small businesses.
First, a significant portion of the rule addresses the topic of
signed individual authorization for disclosure of health information--
the information that the authorization would include and when such an
authorization would be required. Importantly, no patient written
authorization would be required when information is disclosed for
purposes of treatment and payment and health care operations, or when
disclosure is mandated by law. In other words, doctors who disclose
patient health information only to other doctors for treatment
purposes, or to insurance companies to process payment, or for
operational purposes can continue to do so without any change in
current practices under this proposal. Only those covered entities who
disclose health information to marketers, reporters, private
investigators, researchers, and others for purposes unrelated to
treatment, payment, and health care operations are required to get the
written consent of the patient in accordance with this rule.
Second, the Department plans to engage in outreach and education
programs to ease the implementation of this rule for small businesses.
Already, this rule provides model forms for getting patient
authorization and provides an example of a notice of information
practices (another requirement in the rule, described further below).
We also expect that professional associations will develop forms
tailored to specific groups' needs. The Department pledges to work with
professional associations to provide the greatest possible guidance to
small businesses covered by this rule.
Third, in implementing this rule, we will apply the principle of
"scalability," so that a particular entity's characteristics--
including its size, type of business, and information practices--would
be relevant to how that entity adopts procedures to comply with this
rule. Take one example--this rule requires the designation of a
"privacy official." Large health plans dealing with a vast range of
information flows may well consider hiring a full time person to
oversee compliance with the rule, to assist in planning systems
development, and to draft contracts with business partners, among other
tasks. A small doctor's office, on the other hand, may instead
determine that an existing office manager could oversee the office's
privacy policies. There would be no expectation that this small
doctor's office hire a full-time privacy official. In each of these
examples, the covered entity would be complying with the rule's
requirement that a privacy official be designated--but the ways that
each complies would reflect the different circumstances of each
entity's practice.
It is important for small businesses to understand what their
obligations would be and to implement the necessary procedures to
comply, with the help of Department's model forms and other resources
from professional associations. While most covered
[[Page 60004]]
entities would need to be in compliance within two years of the final
publication of the rule, small businesses would have an extra year to
come into compliance.
Here, we set out the principal (although not exclusive)
requirements for small businesses:
1. Notice to Individuals of Information Practices (Sec. 164.512)
Each covered entity would have to develop a notice of information
practices, which, as described above, could be modeled on the form
attached to this proposal or on model forms that we expect professional
associations to develop. The notice must accurately reflect the
entity's practices and include the elements listed in Sec. 164.512.
Covered health care providers would have to provide the notice to
individuals at first service after the effective date of the rule.
Providers are also required to post a current copy of the notice in a
clear and prominent location for individuals to see. Covered health
plans would have to provide the notice to any individual covered by the
plan when this rule becomes effective, at enrollment, and after any
material change to the notice or at least once every three years.
2. Access of Individuals to Protected Health Information
(Sec. 164.514)
Covered plans and providers would be required to allow individuals
to inspect and copy their protected health information. These plans or
providers could charge individuals a reasonable cost-based fee for
copying.
3. Accounting for Uses and Disclosures (Sec. 164.515)
Covered plans and providers would have to be able to provide an
accounting for uses and disclosures of protected health information for
purposes other than treatment, payment, or health care operations. We
expect that this burden will be very low for most small businesses,
given the nature of most disclosures by such businesses.
4. Amendment and Correction (Sec. 164.516)
Covered plans and providers would be required to allow individuals
to request amendments or corrections to their protected health
information.
5. Designated Privacy Official (Sec. 164.518(a))
Each covered entity would designate a privacy official. As
described above, in a small providers office, the office manager may be
the official in charge of making sure that the office is implementing
its privacy policies and procedures and taking complaints.
6. Training (Sec. 164.518(b))
All members of covered entities' workforces who have contact with
protected health information would be required to have some sort of
privacy training about the entity's policies and procedures and to sign
a certificate indicating that they had such training. For a small
entity, this could simply mean the privacy official briefly discussing
how they handle privacy concerns and going over the entity's notice of
information practices.
7. Safeguards (Sec. 164.518(c))
A covered entity would have to establish administrative, technical,
and physical safeguards to protect the privacy of protected health
information from unauthorized access or use. For a small provider, this
may mean having the ability to securely lock up any record that are not
being used and ensuring that records are not kept in an area where
anyone who is not authorized could view them.
8. Complaints (Sec. 164.518(d))
Every covered entity would be required to have policies and
procedures in place that allow individuals to file complaints about
possible privacy violations. For a small entity, this could mean simply
that they keep a specific file for complaints.
9. Sanctions (Sec. 164.518(e))
Covered entities would be required to develop and apply sanctions
when a member of a covered entity's work force or business partner
fails to comply with the entity's policies and procedures related to
this rule. For a small businesses, these could range from requiring a
re-training on privacy, to placing a notation of the violation in an
employee's record, to dismissal or ending a contract with a business
partner.
10. Documentation of Policies and Procedures (Secs. 164.520)
Covered entities would be required to document policies and
procedures for use and disclosure of protected health information
relating to this regulation, including elements listed in Sec. 164.520,
and would need to maintain one copy of each version of its notice of
information practices, and authorization forms. See Sec. 164.520(f) for
a full list of recordkeeping requirements.
11. Minimum Necessary (Sec. 164.506(b))
When using or disclosing protected health information for
treatment, payment, healthcare operations, and other purposes, an
entity would be required to disclose only the amount of protected
health information necessary to accomplish the intended purpose of the
use or disclosure.
12. Business Partners (Sec. 164.506(e))
For those small businesses that hire "business partners" to
assist them in carrying out their operations, this rule would require
that they take steps, including having certain terms in a contract, to
ensure that their business partners are also protecting the privacy of
individually identifiable health information. We expect that model
contracts will be developed by potential business partners and others
that can be used to fulfill the requirements of this section.
13. Special Disclosures That Do Not Require Authorization--Public
Health, Research, etc. (Sec. 164.510)
This proposed rule would also permit disclosure of patients' health
information in special cases and under certain conditions. These
disclosures would be optional under this proposed rule but may be
mandatory under other laws. The primary examples of such permissible
disclosures are for: public health purposes, for health oversight
purposes, for judicial and administrative proceedings, to coroners and
medical examiners, to law enforcement agencies, to next-of-kin, to
governmental health data systems, for research purposes, other
disclosures required by law, among others. Each of these disclosures
and uses would be subject to specific conditions, described in the
proposed rule.
14. Verification (Sec. 164.518(c)(2))
Entities would be required to have reasonable procedures to verify
the identity or authority, as applicable, of persons requesting the
disclosure of protected health information if the person making the
request is not already known to the entity. In most cases, the covered
entity could simply ask for a form of identification like a drivers
license.
IV. Preliminary Regulatory Impact Analysis
Section 804(2) of title 5, United States Code (as added by section
251 of Public Law 104-121), specifies that a "major rule" is any rule
that the Office of Management and Budget finds is likely to result in--
An annual effect on the economy of $100 million or more;
A major increase in costs or prices for consumers,
individual industries,
[[Page 60005]]
Federal, State, or local government agencies, or geographic regions; or
Significant adverse effects in competition, employment,
investment productivity, innovation, or on the ability of Unites States
based enterprises to compete with foreign-based enterprises in domestic
and export markets.
We estimate that the impact of this final rule will be over $1
billion in the first year of implementation. Therefore, this rule is a
major rule as defined in Title 5, United States Code, section 804(2).
DHHS has examined the impacts of this proposed rule under Executive
Order 12866. Executive Order 12866 directs agencies to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety effects; distributive impacts; and equity). According to
Executive Order 12866, a regulatory action is "significant" if it
meets any one of a number of specified conditions, including having an
annual effect on the economy of $100 million or adversely affecting in
a material way a sector of the economy, competition, or jobs or if it
raises novel legal or policy issues. DHHS finds that this proposed rule
is a significant regulatory action as defined by Executive Order 12866.
Also in accordance with the provisions of Executive Order 12866, this
proposed rule was reviewed by the Office of Management and Budget.
When this proposed rule becomes a final rule, in accordance with
the Small Business Regulatory Enforcement and Fairness Act (Pub. L.
104-121), the Administrator of the Office of Information and Regulatory
Affairs of the Office of Management and Budget (the Administrator) has
determined that this proposed rule would be a major rule for the
purpose of congressional review. A major rule for this purpose is
defined in 5 U.S.C. 804(2) as one that the Administrator has determined
has resulted or is likely to result in an annual effect on the economy
of $100 million or more; a major increase in costs or prices for
consumers, individual industries, federal State, or local government
agencies, or geographic regions; or significant adverse effects on
competition, employment, investment, productivity, innovation, or on
the ability of U.S.-based enterprises to compete with foreign-based
enterprises in domestic or export markets.
The Health Insurance Portability and Accountability Act of 1996
(HIPAA) projects a significant increase in the number of medical
transactions that will be conducted or transmitted electronically.
HIPAA notes the privacy needs that result when individually
identifiable health information can be transmitted quickly through
electronic information systems. While there is a compelling need to
protect the privacy of health information in today's health care
system, the expected growth of electronic systems to aide medical
diagnostics, claims processing and research makes it even more critical
to improve privacy protections.
A fundamental assumption of this regulation is that the greatest
benefits of improved privacy protection will be realized in the future
as patients gain increasing trust in health care practitioners' ability
to maintain the confidentiality of their health information.
Furthermore, our analysis rests on the principle that health
information privacy is a right, and as such, cannot be valued solely by
market costs. Because it is difficult to measure future benefits based
on present data, our estimates of the costs and benefits of this
regulation are based on the current business environment and do not
include projections beyond five years. As a result, we cannot
accurately account for all of the regulation's future costs and
benefits, but the Department is confident that future benefits will be
higher than those stated in this analysis.
In order to achieve a reasonable level of privacy protection, we
have three objectives for the proposed rule: (1) To establish baseline
standards for health care privacy protection, (2) to establish
protection for all health information maintained or transmitted by
covered entities, and (3) to protect the privacy of health information
that is maintained in electronic form, as well as health information
generated by electronic systems.
Establishing minimum standards for health care privacy protection
is an attempt to create a baseline level of privacy protection for
patients across States. The Health Privacy Project's report, The State
of Health Privacy: An Uneven Terrain 6 makes it clear that
under the current system of state laws, privacy protection is extremely
variable. Our statutory authority under HIPAA allows us to preempt
state laws when state law provides less stringent privacy protection
than the regulation. Only in cases where state law does not protect the
patient's health information as stringently as in this proposed rule,
or when state law is more restrictive of a patient's right to access
their own health care information, will our rule preempt state law. We
discuss preemption in greater detail in other parts of the preamble
(see the effects of the rule on state laws, section 2 below).
---------------------------------------------------------------------------
\6\ Janlori Goldman, Institute for Health Care Research and
Policy, Georgetown University: www.healthprivacy.org/resources.
---------------------------------------------------------------------------
Our second objective is to establish a uniform base of protection
for all health information maintained or transmitted by covered
entities. As discussed in the preamble, HIPAA restricts the type of
entities covered by the proposed rule to three broad categories: health
care providers, health care clearinghouses, and health plans. However,
there are similar public and private entities that we do not have the
authority to regulate under HIPAA. For example, life insurance
companies are not covered by this proposed rule but have access to a
large amount of protected health information. State government agencies
not directly linked to public health functions or health oversight may
also have access to protected health information. Examples of this type
of agency include the motor vehicle administration, which frequently
maintains individual health information, and welfare agencies that
routinely hold health information about their clients.
Our third objective is to protect the privacy of health information
that is maintained in electronic form, as well as health information
generated by electronic systems. Health information is currently stored
and transmitted in multiple forms, including in electronic, paper, and
oral formats. In order to provide consistent protection to information
that has been electronically transmitted or maintained, we propose that
this rule cover all personal, protected health information that has
ever been maintained or transmitted electronically. This type of
information includes output such as computer printouts, X-rays,
magnetic tape, and other information that was originally maintained or
transmitted electronically. For example, laboratory tests are often
computer generated, printed out on paper, and then stored in a
patient's record. Because such lab results were originally maintained
electronically, the post-electronic (i.e. printed) output of those lab
results would also be covered under the proposed rule.
It is important to note that the use of electronic systems to
maintain and transmit health information is growing among health care
providers, and health plans. Faulkner and Gray report that provider use
of electronically processed
[[Page 60006]]
health transactions grew from 47 percent to 62 percent between 1994 and
1998. Payer use of electronic transactions grew 17 percent between 1996
and 1997. Once all of the HIPAA administrative simplification standards
are implemented, we expect the number of electronic transactions
processed by payers and providers to grow.
The variation in business practice regarding use of paper records
versus electronic media for storing and transmitting health information
is captured by comparing the percentage of providers that submit paper
claims with those that submit electronic claims. Faulkner & Gray's
Health Data Directory 1 shows that only 40 percent of non-
edicare physician claims and 16 percent of dental claims were
submitted electronically in 1998. In contrast, 88 percent of all
pharmacy claims were submitted electronically.
---------------------------------------------------------------------------
\1\ Health Data Directory, Faulkner & Gray; 1999 Edition, pp
22-23.
---------------------------------------------------------------------------
We believe that most physicians either have, or will have in the
near future, the capacity to submit claims electronically. Faulkner and
Gray reported that 81 percent of physicians with Medicare patients
submitted their Medicare claims electronically. The difference in the
percent of electronic clams submitted to Medicare suggests that the
physicians' decisions to submit claims electronically may be heavily
influenced by the administrative requirements of the health plan
receiving the claim. Since HIPAA requires all health plans to accept
electronic transactions and, in order to compete in the technologically
driven health care market, more health plans may require electronic
claims submissions, physicians will conduct many more electronic
transactions in the near future. Therefore, it is extremely important
that adequate privacy protections are implemented now.
A. Relationship of This Analysis to Analyses in Other HIPAA Regulations
Historically, Congress has recognized that privacy standards must
accompany the electronic data interchange standards and that the
increased ease of transmitting and sharing individually identifiable
health information must be accompanied by an increase in the privacy
and confidentiality. In fact, the majority of the bulk of the first
Administrative Simplification section that was debated on the floor of
the Senate in 1994 (as part of the Health Security Act) was made up of
privacy provisions. Although the requirement for the issuance of
concomitant privacy standards remained a part of the bill passed by the
House of Representatives, the requirement for privacy standards was
removed in conference. This section was moved from the standard-setting
authority of Title XI (section 1173 of the Act) and placed in a
separate section of HIPAA, section 264. Subsection (b) of section 264
required the Secretary of HHS to develop and submit to the Congress
recommendations for:
(1) The rights that an individual who is a subject of individually
identifiable health information should have.
(2) The procedures that should be established for the exercise of
such rights.
(3) The uses and disclosures of such information that should be
authorized or required.
The Secretary's Recommendations were submitted to the Congress on
September 11, 1997, and are summarized below. Section 264(c)(1)
provides that:
If legislation governing standards with respect to the privacy
of individually identifiable health information transmitted in
connection with the transactions described in section 1173(a) of the
Social Security Act (as added by section 262) is not enacted by
(August 21, 1999), the Secretary of Health and Human Services shall
promulgate final regulations containing such standards not later
than (February 21, 2000). Such regulations shall address at least
the subjects described in subsection (b).
As the Congress did not enact legislation governing standards with
respect to the privacy of individually identifiable health information
prior to August 21, 1999, HHS has now, in accordance with this
statutory mandate, developed proposed rules setting forth standards to
protect the privacy of such information.
These privacy standards have been, and continue to be, an integral
part of the suite of Administrative Simplification standards intended
to simplify and improve the efficiency of the administration of our
health care system.
The proposed rule should be considered along with all of the
administrative simplification standards required by HIPAA. We assessed
several strategies for determining the impact of this proposed rule. We
considered whether it would be accurate to view the impact as a subset
of the overall HIPAA standards or whether this privacy component should
be viewed as an addition to the earlier impact analyses related to
HIPAA. We decided that while this proposed rule is considered one of
the HIPAA standards, any related costs or benefits should be viewed as
an addition to earlier analyses. The original HIPAA analyses did not
incorporate the expected costs and benefits of privacy regulation
because, at the time of the original analyses, we did not know whether
Congress would enact legislation or whether privacy would need to be
addressed by regulation. Therefore, much of our cost analysis is based
on the expected incremental costs above those related to other HIPAA
regulations.
B. Summary of Costs and Benefits.
The Department has estimated the costs and benefits of the proposed
rule based on several caveats. In general, it is difficult to estimate
the costs and benefits of improved privacy protection. The ability to
measure costs of the proposed regulation is limited because there is
very little data currently available on the cost of privacy protection.
The Department has not been able to estimate costs for a number of
requirements of the proposed regulation that we know will impose some
cost to covered entities. For those elements for which there are
estimated costs, data and information limitations limit the precision
of the Department's estimates; for those reasons we have provided an
overall range of costs in addition to point estimates, and welcome
further information from the public as part of the comment process.
Furthermore, the number of new privacy requirements that the regulation
will introduce to the health care industry exacerbates difficulties
estimating the benefits of privacy. Benefits are difficult to measure
because we conceive of privacy primarily as a right and secondarily as
a commodity. As discussed below, the significant benefits of the
proposed regulation to individuals and society can be demonstrated by
illustrating the serious privacy concerns raised by mental health,
substance abuse, cancer screening, and HIV/AIDS patients and the
benefits that may be derived from greater privacy.
The estimated cost of compliance with the proposed rule would be at
least $3.8 billion over five years. The cost includes estimates for the
majority of the requirements of the proposed regulation, but not all.
These estimates include costs to federal, State, and local governments.
Federal, and State and local costs are therefore a subset of total
costs. Based on a plausible range of costs for the key components of
the analysis, the cost of the regulation would likely be in the range
$1.8 to $6.3 billion over five years (not including those elements of
the regulation for
[[Page 60007]]
which we could not make any cost estimates).
The compliance costs are in addition to Administrative
Simplification estimates. The cost of complying with the privacy
regulation represents about 0.09 percent of projected national health
expenditures during the first year following the regulation's
enactment. The five-year cost of the proposed regulation also
represents 1.0 percent of the increase in health care costs that will
occur during the same five-year period.8
---------------------------------------------------------------------------
\8\ Health Care Finance Administration, Office of the Actuary,
1997.
---------------------------------------------------------------------------
The largest cost item is the amending and correcting of records,
which would represent over one-half of total costs. Provider and plan
notices, which we estimate would cost $439 million, is the second
largest cost, and inspection and copying of records is estimated to be
$405 million. The one-time costs for providers to develop policies and
procedures represent somewhat less than 10 percent of the total cost,
or $333 million. Plans would bear a substantially smaller cost--
approximately $62 million. Other systems changes would cost about $90
million over the period. The cost of administering written
authorizations would total approximately $271 million over five years.
The cost estimates include private-and public-sector costs. Many of
the public-sector cost elements will be the same as those in the
private market. However, privacy notices are likely to represent a
smaller fraction of total public-sector costs, while systems compliance
costs in the public sector may be higher than in the private sector due
to oversight and administrative requirements.
The costs presented in this document are the Department's best
estimates of the cost of implementing the proposed regulation based on
available information and data. Because of inadequate data, we have not
made cost estimates for the following components of the regulation: The
principle of minimum necessary disclosure; the requirement that
entities monitor business partners with whom they share PHI; creation
of de-identified information; internal complaint processes; sanctions;
compliance and enforcement; the designation of a privacy official and
creation of a privacy board; and additional requirements on research/
optional disclosures that will be imposed by the regulation. The cost
of these provisions may be significant in some cases, but it would be
inaccurate to project costs for these requirements given the fact that
several of these concepts are new to the industry, and there is little
direct evidence on costs. We solicit comment regarding costs of the
regulation that we have not quantified.
The privacy protections established by this regulation will provide
major social benefits. Establishing privacy protection as a fundamental
right is an important goal and will have significant, non-quantifiable
social benefits. A well-designed privacy standard can be expected to
build confidence among the public about the confidentiality of their
health information. Increased confidence in the privacy of an
individual's health information can be expected to increase the
likelihood that many people will seek treatment for particular classes
of disease, particularly mental health conditions, sexually transmitted
diseases such as HIV/AIDS, and earlier screening for certain cancers.
The increased utilization of medical services that would result from
increased confidence in privacy would lead to improved health for the
individuals involved, reduced costs to society associated with delayed
treatments, and improved public health attributable to reduced
transmission of communicable diseases.
Table 1.--The Cost of Complying with the Proposed Privacy Regulation
[In dollars]
----------------------------------------------------------------------------------------------------------------
Initial or first Annual cost after Five year (2000-
Provision year cost (2000) the first year 2004) cost
----------------------------------------------------------------------------------------------------------------
Development of Policies and Procedures--Providers $333,000,000 ..................
$333,000,000
(totaling 871,294).................................
Development of Policies and Procedures--Plans 62,000,000 ..................
62,000,000
(totaling 18,225)..................................
System Changes--All Entities........................ 90,000,000 .................. 90,000,000
Notice Development Cost--All Entities............... 20,000,000 .................. 30,000,000
Notice Issuance--Providers.......................... 59,730,000 37,152,000 208,340,000
Notice Issuance--Plans.............................. 46,200,000 46,200,000 231,000,000
Inspection/Copying.................................. 81,000,000 81,000,000 405,000,000
Amendment/Correction................................ 407,000,000 407,000,000
2,035,000,000
Written Authorization............................... 54,300,000 54,300,000 271,500,000
Paperwork/Training.................................. 22,000,000 22,000,000 110,000,000
Other Costs*........................................ **N/E N/E N/E
-----------------------------------------------------------
Total........................................... $1,165,230,000 $647,652,000 $3,775,840,000
----------------------------------------------------------------------------------------------------------------
* Other Costs include: minimum necessary disclosure; monitoring business partners with whom
entities share PHI;
creation of de-identified information; internal complaint processes; sanctions; compliance and
enforcement;
the designation of a privacy official and creation of a privacy board; additional requirements on
research/
optional disclosures that will be imposed by the regulation.
**N/E = "Not estimated".
We promote the view that privacy protection is an important
personal right, and suggest that the greatest of the benefits of the
proposed regulation are impossible to estimate based on the market
value of health information alone. However, it is possible to evaluate
some of the benefits that may accrue to individuals as a result of
proposed regulation, and these benefits, alone, demonstrate that the
regulation is warranted.
These benefits are considered both qualitatively and
quantitatively. As a framework for the discussion, the cost of the
provisions in the regulation that have been quantified is $0.46 per
health care encounter. Although the value of privacy cannot be fully
calculated, it is worth noting that if individuals would be willing to
pay more than $0.46 per health care encounter to improve health
information privacy, the benefits of the
[[Page 60008]]
proposed regulation would outweigh the cost.
Several qualitative examples illustrate the benefits of the
proposed regulation. In one case, medical privacy concerns may prevent
patients from obtaining early testing and screening for certain types
of cancer. Of types of cancer for which screening is available,
survival rates might increase to 95 percent diagnosed in the early
stages 9. For HIV/AIDS patients, new treatments for patients
who are diagnosed with HIV in the early stages may save $23,700 per
quality-adjusted year of life saved 10. Later in this
document, the potential to reduce illness and disability associated
with sexually transmitted diseases is discussed.
---------------------------------------------------------------------------
\9\ American Cancer Society. https://www.cancer.org/statistics/
97cff/97facts.html
\10\ John Hornberger et al, "Early treatment with highly
active anti-retroviral therapy (HAART) is cost-effective compared to
delayed treatment," 12th World AIDS conference, 1998.
---------------------------------------------------------------------------
We recognize that many of the costs and benefits of health
information privacy are difficult to quantify, but we believe that our
estimates represent a reasonable range of the economic costs and
benefits associated with the regulation.
C. Need for the Proposed Action.
Privacy is a fundamental right. As such, it has to be viewed
differently than any ordinary economic good. Although the costs and
benefits of a regulation need to be considered as a means of
identifying and weighing options, it is important not to lose sight of
the inherent meaning of privacy: it speaks to our individual and
collective freedom.
A right to privacy in personal information has historically found
expression in American law. All fifty states today recognize in tort
law a common law or statutory right to privacy. Many states
specifically provide a remedy for public revelation of private facts.
Some states, such as California and Tennessee, have a right to privacy
as a matter of state constitutional law. The multiple historical
sources for legal rights to privacy are traced in many places,
including Chapter 13 of Alan Westin's Privacy and Freedom and in Ellen
Alderman & Caroline Kennedy, The Right to Privacy (1995).
To take but one example, the Fourth Amendment to the United States
Constitution guarantees that "the right of the people to be secure in
their persons, houses, papers and effects, against unreasonable
searches and seizures, shall not be violated." By referring to the
need for security of "persons" as well as "papers and effects" the
Fourth Amendment suggests enduring values in American law that relate
to privacy. The need for security of "persons" is consistent with
getting patient consent before performing invasive medical procedures.
The need for security in "papers and effects" underscores the
importance of protecting information about the person, contained in
sources such as personal diaries, medical records, or elsewhere. As is
generally true for the right of privacy in information, the right is
not absolute. The test instead is what constitutes an "unreasonable"
search of the papers and effects.
The United States Supreme Court has specifically upheld the
constitutional protection of personal health information. In Whalen v.
Roe, 429 U.S. 589 (1977), the Court analyzed a New York statute that
created a database of persons who obtained drugs for which there was
both a lawful and unlawful market. The Court, in upholding the statute,
recognized at least two different kinds of interests within the
constitutionally protected "zone of privacy." "One is the individual
interest in avoiding disclosure of personal matters," such as this
proposed regulation principally addresses. This interest in avoiding
disclosure, discussed in Whalen in the context of medical information,
was found to be distinct from a different line of cases concerning
"the interest in independence in making certain kinds of important
decisions." In the recent case of Jaffee v. Redmond, 116 S.Ct. 1923
(1996), the Supreme Court held that statements made to a therapist
during a counseling session were protected against civil discovery
under the Federal Rules of Evidence. The Court noted that all fifty
states have adopted some form of the psychotherapist-patient privilege.
In upholding the federal privilege, the Supreme Court stated that it
"serves the public interest by facilitating the appropriate treatment
for individuals suffering the effects of a mental or emotional problem.
The mental health of our citizenry, no less than its physical health,
is a public good of transcendent importance."
Many writers have urged a philosophical or common-sense right to
privacy in one's personal information. Examples include Alan Westin,
Privacy and Freedom (1967) and Janna Malamud Smith, Private Matters: In
Defense of the Personal Life (1997). These writings emphasize the link
between privacy and freedom and privacy and the "personal life," or
the ability to develop one's own personality and self-expression.
Smith, for instance, states:
The bottom line is clear. If we continually, gratuitously,
reveal other people's privacies, we harm them and ourselves, we
undermine the richness of the personal life, and we fuel a social
atmosphere of mutual exploitation. Let me put it another way: Little
in life is as precious as the freedom to say and do things with
people you love that you would not say or do if someone else were
present. And few experiences are as fundamental to liberty and
autonomy as maintaining control over when, how, to whom, and where
you disclose personal material. Id. at 240-241.
Individuals' right to privacy in information about themselves is
not absolute. It does not, for instance, prevent reporting of public
health information on communicable diseases or stop law enforcement
from getting information when due process has been observed. But many
people believe that individuals should have some right to control
personal and sensitive information about themselves.
Among different sorts of personal information, health information
is among the most sensitive. Many people believe that details about
their physical self should not generally be put on display for
neighbors, employers, and government officials to see. Informed consent
laws place limits on the ability of other persons to intrude physically
on a person's body. Similar concerns apply to intrusions on information
about the person. Moving beyond these facts of physical treatment,
there is likely a greater intrusion when the medical records reveal
details about a person's mental state, such as during treatment for
mental health. If, in Justice Brandeis' words, the "right to be let
alone" means anything, then it likely applies to having outsiders have
access to one's intimate thoughts, words, and emotions.
In addition to these arguments based on the right to privacy in
personal information, market failures will arise to the extent that
privacy is less well protected than the parties would have agreed to,
if they were fully informed and had the ability to monitor and enforce
contracts. The chief market failures with respect to privacy concern
information, negotiating, and enforcement costs. The information costs
arise because of the information asymmetry between the company and the
patient--the company typically knows far more than the patient about
how the information will be used by that company. A health care
provider or plan, for instance, knows many details about how protected
health information will be generated, combined with other databases, or
sold to third parties.
[[Page 60009]]
Patients face at least two layers of cost in learning about how
their information is used. First, as with many aspects of health care,
patients face the challenge of trying to understand technical medical
terminology and practices. It will often be difficult for a patient to
understand the medical records and the implications of transferring
various parts of such records to a third party. Second, especially in
the absence of consistent national rules, patients may face significant
costs in trying to learn and understand the nature of a company's
privacy policies.
The costs of learning about companies' policies are magnified by
the difficulty patients face in detecting whether companies in fact are
complying with those policies. Patients might try to adopt strategies
for monitoring whether companies have complied with their announced
policies. For instance, if a person received health care from several
providers that promised not to sell her name to third parties, she
could report a different middle initial to each provider. She could
then identify the provider that broke the agreement by noticing the
middle initials that later appeared on an unsolicited marketing letter.
These sorts of strategies, however, are both costly (in time and
effort) and likely to be ineffective. A company using the patient's
name, for instance, could cross-check her address with her real name,
and thereby insert the correct middle initial. In addition, modern
health care often requires protected health information to flow
legitimately among multiple entities for purposes of treatment,
payment, health care operations, and other necessary uses. Even if the
patient could identify the provider whose data ultimately leaked, the
patient could not easily tell which of those multiple entities had
impermissibly transferred her information.
The cost and ineffectiveness of monitoring logically leads to less
than optimal protection of health information. Consider the incentives
facing a company that acquires protected health information. That
company gains the full benefit of using the information, including in
its own marketing efforts or in the fee it can receive when it sells
the information to third parties. The company, however, does not suffer
the full losses from disclosure of protected health information.
Because of imperfect monitoring, customers often will not learn of, and
thus not be able to enforce against, that unauthorized use. They will
not be able to discipline the company efficiently in the marketplace
for its less-than-optimal privacy practices. Because the company
internalizes the gains from using the information, but does not bear a
significant share of the cost to patients (in terms of lost privacy),
it will have a systematic incentive to over-use protected health
information. In market failure terms, companies will have an incentive
to use protected health information where the patient would not have
freely agreed to such use.
These difficulties in contract enforcement are made worse by the
third-party nature of many health insurance and payment systems. Even
where individuals would wish to bargain for privacy, they may lack the
legal standing to do so. For instance, employers often negotiate the
terms of health plans with insurers. The employee may have no voice in
the privacy or other terms of the plan, facing a take-it-or-leave-it
choice of whether to be covered by insurance. The incentive of
employers may be contrary to the wishes of employees--employers may in
some cases inappropriately insist on having access to sensitive medical
information in order to monitor employees' behavior and health status.
In light of these complexities, there are likely significant market
failures in the bargaining on privacy protection. Many privacy-
protective agreements that patients would wish to make, absent barriers
to bargaining, will not be reached. The economic, legal and
philosophical arguments become more compelling as the medical system
shifts from predominantly paper to predominantly electronic records.
From an economic perspective, market failures will arise to the extent
that privacy is less well protected than the parties would have agreed
to, if they were fully informed and had some equality of bargaining
power. The chief market failures with respect to privacy concern
information and bargaining costs. The information costs arise because
of the information asymmetry between the company and the patient--the
company typically knows far more than the patient about how the
information will be used by that company. A health care provider or
plan, for instance, knows many details about how protected health
information will be generated, combined with other databases, or sold
to third parties.
Rapid changes in information technology mean that the size of the
market failures will likely increase greatly in the markets for
personal health information. Improvements in computers and networking
mean that the costs of gathering, analyzing, and disseminating
electronic data are plunging. Market forces are leading many medical
providers and plans to shift from paper to electronic records, due both
to lower cost and the increased functionality provided by having
information in electronic form. These market changes will be
accelerated by the administrative simplification implemented by the
other regulations promulgated under HIPAA. A chief goal of
administrative simplification, in fact, is to create a more efficient
flow of medical information where appropriate. This proposed privacy
regulation is an integral part of the overall effort of administrative
simplification; it creates a framework for more efficient flows for
certain purposes, including treatment and payment, while restricting
flows in other circumstances except where appropriate institutional
safeguards exist.
If the medical system shifts to predominantly electronic records in
the near future, without use of accompanying privacy rules, then one
can imagine a near future where clerical and medical workers all over
the country may be able to pull up protected health information about
individuals--without meaningful patient consent and without effective
institutional controls against further dissemination. In terms of the
market failure, it will become more difficult for patients to know how
their health provider or plan is using their personal health
information. It will become more difficult to monitor the subsequent
flows of protected health information, as the number of electronic
flows and possible points of leakage both increase. Similarly, the
costs and difficulties of bargaining to get the patients' desired level
of use will likely rise due the greater number and types of entities
that receive protected health information.
As the benefits section, below, discusses in more detail, the
protection of privacy and correcting the market failure have practical
implications. Where patients are concerned about lack of privacy
protections, they might fail to get medical treatment that they would
otherwise seek. This failure to get treatment may be especially likely
for certain conditions, including mental health, substance abuse, and
conditions such as HIV. Similarly, patients who are concerned about
lack of privacy protections may report inaccurately to their providers
when they do seek treatment. For instance, they might decide not to
mention that they are taking prescription drugs that indicate that they
have an embarrassing condition. These inaccurate reports may lead to
mis-diagnosis and less-than-optimal treatment, including
[[Page 60010]]
inappropriate additional medications. In short, the lack of privacy
safeguards can lead to efficiency losses in the form of foregone or
inappropriate treatment.
The shift from paper to electronic records, with the accompanying
greater flows of sensitive health information, also strengthens the
arguments for giving legal protection to the right to privacy in
protected health information. In an earlier period where it was far
more expensive to access and use medical records, the risk of harm to
individuals was relatively low. In the potential near future, where
technology makes it almost free to send lifetime medical records over
the Internet, the risks may grow rapidly. It may become cost-effective,
for instance, for companies to offer services that allow purchasers to
obtain details of a person's physical and mental treatments. In
addition to legitimate possible uses for such services, malicious or
inquisitive persons may download medical records for purposes ranging
from identity theft to embarrassment to prurient interest in the life
of a celebrity or neighbor. Of additional concern, such services might
extend to providing detailed genetic information about individuals,
without their consent. Many persons likely believe that they have a
right to live in society without having these details of their lives
laid open to unknown and possibly hostile eyes. These technological
changes, in short, may provide a reason for institutionalizing privacy
protections in situations where the risk of harm did not previously
justify writing such protections into law.
States have, to varying degrees, attempted to enhance
confidentiality and correct the market problems by establishing laws
governing at least some aspects of medical record privacy. This
approach, though a step in the right direction, is inadequate. The
states themselves have a patch quilt of laws that fail to provide a
consistent or comprehensive policy, and there is considerable variation
among the states in the scope of the protections provided. Moreover,
health data is becoming increasingly "national"; as more information
becomes available in electronic form, it can have value far beyond the
immediate community where the patient resides. Neither private action
nor state laws provide a sufficiently rigorous legal structure to
correct the market failure now or in the future. Hence, a national
policy with consistent rules is a vital step toward correcting the
market failure that exists.
In summarizing the need for the proposed regulation, the discussion
here has emphasized how the proposed regulation would address
violations of a right to privacy in the information about oneself,
market failures, and the need for a national policy. These arguments
become considerably stronger with the shift from predominantly paper to
predominantly electronic records. Other arguments could supplement
these justifications. As discussed in the benefits section below, the
proposed privacy protections may prevent or reduce the risk of unfair
treatment or discrimination against vulnerable categories of persons,
such as those who are HIV positive, and thereby, foster better health.
The proposed regulation may also help educate providers, plans, and the
general public about how protected health information is used. This
education, in turn, may lead to better information practices in the
future.
Clearly, the growing problem of protecting privacy is widely
understood and a major public concern. Over 80 percent of persons
surveyed in 1999 agreed with the statement that they had "lost all
control over their personal information." A Wall Street Journal/NBC
poll on September 16, 1999 asked Americans what concerned them most in
the coming century. "Loss of personal privacy" topped the list, as
the first or second concern of 29 percent of respondents. Other issues
such as terrorism, world war, and global warming had scores of 23
percent or less. The regulation is a major step toward addressing this
public concern.
D. Baseline Privacy Protections
Determining the impact of the rule on covered entities requires us
to establish a baseline for current privacy policies. We must first
determine current practices and requirements related to protected
information--specifically, practices related to disclosure and use,
notification of individuals of information practices, inspection and
copying, amendment and correction, administrative policies, procedures,
and related documentation.
Privacy practices are most often shaped by professional
organizations that publish ethical codes of conduct and by State law.
On occasion, State laws defer to professional conduct codes. At
present, where neither professional organizations nor States have
developed guidelines for privacy practices, an entity may implement
privacy practices independently.
Professional codes of conduct or ethical behavior generally can be
found as opinions and guidelines developed by organizations such as the
American Medical Association, the American Hospital Association, and
the American Dental Association. These are generally issued though an
organization's governing body. The codes do not have the force of law,
but providers often recognize them as binding rules.
State laws are another important means of protecting health
information. While professional codes of conduct usually only have
slight variations, State laws vary dramatically. Some States defer to
the professional codes of conduct, others provide general guidelines
for privacy protection, and others provide detailed requirements
relating to the protection of information relating to specific diseases
or to entire classes of information. In cases where neither State law
nor professional ethical standards exist, the only privacy protection
individuals have is limited to the policies and standards that the
health care entity adopts.
Before we can attempt to determine the impact of the proposed rule
on covered entities, we must make an effort to establish the present
level of privacy protection. Current privacy protection practices are
determined by the standards and practices that the professional
associations have adopted for their members and by State laws.
1. Professional Codes of Conduct and the Protection of Health
Information
We examined statements issued by five major professional groups,
one national electronic network association and a leading managed care
association. There are a number of common themes that all the
organizations appear to subscribe to:
The need to maintain and protect an individual's health
information;
Development of policies to ensure the confidentiality of
protected health information;
Only the minimum necessary information should be released
to accomplish the purpose for which the information is sought.
Beyond these principles, the major associations differ with respect
to the methods used to protect health information. One critical area of
difference is the extent to which professional organizations should
release protected health information. A major mental health association
advocates the release of identifiable patient information "* * * only
when de-identified data are inadequate for the purpose at hand." A
major association of physicians counsels members who use electronically
maintained and transmitted data to require that they and their patients
know in advance who has access to protected patient data, and the
purposes for which the data will be
[[Page 60011]]
used. In another document, the association advises physicians not to
"sell" patient information to data collection companies without fully
informing their patients of this practice and receiving authorization
in advance to release of the information.
Only two of the five professional groups state that patients have
the right to review their medical records. One group declares this as a
fundamental patient right, while the second association qualifies their
position by stating that the physician has the final word on a
patient's access to their health information. This association also
recommends that its members respond to requests for access to patient
information within 10 days, and recommends that entities allow for an
appeal process when patients are denied access. The association further
recommends that when a patient contests the accuracy of the information
in their record and the entity refuses to accept the patient's change,
the patient's statement should be included as a permanent part of the
patient's record.
In addition, three of the five professional groups endorse the
maintenance of audit trails that can track the history of disclosures
of protected health information.
The one set of standards that we reviewed from a health network
association advocated the protection of private health information from
disclosure without patient authorization and emphasized that encrypting
information should be a principal means of protecting patient
information. The statements of a leading managed care association,
while endorsing the general principles of privacy protection, were
vague on the release of information for purposes other than treatment.
They suggest allowing the use of protected health information without
the patient's authorization for what they term "health promotion." It
is possible that the use of protected health information for "health
promotion" may be construed under the proposed rule as part of
marketing activities.
Based on the review of the leading association standards, we
believe that the proposed rule embodies all the major principles
expressed in the standards. However, there are some major areas of
difference between the proposed rule and the professional standards
reviewed. These include the subject individual's right of access to
health information in the covered entity's possession, relationships
between contractors and covered entities, and the requirement that
covered entities make their privacy policies and practices available to
patients through a notice and the ability to respond to questions
related to the notice. Because the proposed regulation would require
that (with a few exceptions) patients have access to their health
information that a covered entity possesses, large numbers of providers
may have to modify their current practices in order to allow patient
access, and to establish a review process if they deny a patient
access. Also, none of the privacy protection standards reviewed require
that providers or plans prepare a formal statement of privacy practices
for patients (although the major physician association urges members to
inform patients about who would have access to their protected health
information and how their health information would be used). Only one
HMO association explicitly made reference to information released for
legitimate research purposes, and none of the other statements we
reviewed discuss release of information for research purposes. The
proposed rule allows for the release of protected health information
for research purposes without an individual's authorization, but only
for research that is supervised by an institutional research board or
an equivalent privacy board. This research requirement may cause some
groups to revise their disclosure authorization standards.
2. State Laws
The second body of privacy protections is found in a myriad of
State laws and requirements. To determine whether or not the proposed
rule would preempt a State law, we first identified the relevant laws,
and second, determined whether state or federal law provides
individuals with greater privacy protection.
Identifying the relevant state statutes: Health privacy statutes
can be found in laws applicable to many issues including insurance,
worker's compensation, public health, birth and death records,
adoptions, education, and welfare. For example, Florida has over 60
laws that apply to protected health information. According to the
Georgetown Privacy Project \11\, Florida is not unique. Every State has
laws and regulations covering some aspect of medical information
privacy. In many cases, State laws were enacted to address a specific
situation, such as the reporting of HIV/AIDS, or medical conditions
that would impair a person's ability to drive a car. Identifying every
State statute, regulation, and court case that interprets statutes and
regulations dealing with patient medical privacy rights is an important
task but cannot be completed in this discussion. For the purpose of
this analysis, we simply acknowledge the complexity of State
requirements surrounding privacy issues.
---------------------------------------------------------------------------
\11\ Ibid, Goldman, p. 6.
---------------------------------------------------------------------------
Lastly, we recognize that the private sector will need to complete
a State-by-State analysis to comply with the notice and administrative
procedures portion of this proposed rule. This comparison should be
completed in the context of individual markets; therefore it is more
efficient for professional associations or individual businesses to
complete this task.
Recognizing limits of our ability to effectively summarize State
privacy laws and our difficulty in determining preemption at the
outset, we discuss conclusions generated by the Georgetown University
Privacy Project in Janlori Goldman's report, The State of Health
Privacy: An Uneven Terrain. We consider Georgetown's report the best
and most comprehensive examination of State privacy laws currently
published. The report, which was completed in July 1999, is based on a
50-state survey. However, the author is quick to point out that this
study is not exhaustive.
The following analysis of State privacy statutes and our attempt to
compare State laws to the proposed rule is limited as a result of the
large amount of State-specific data available. To facilitate
discussion, we have organized the analysis into two sections: access to
medical information and disclosure of medical information. Our analysis
is intended to suggest areas where the proposed rule appears to preempt
various State laws; it is not designed to be a definitive or wholly
comprehensive State-by-State comparison.
Access to Subject's Information: In general, State statutes provide
individuals with access to their own medical records. However, only a
few States allow individuals access to virtually all entities that hold
health information. In 33 States, individuals may access their hospital
and health facility records. Only 13 States guarantee individuals
access to their HMO records, and 16 States provide individuals access
to their medical information when it is held by insurers. Seven states
have no statutory right of patient access; three States and the
District of Columbia have laws that only assure individuals' right to
access their mental health records. Only one State permits individuals
access to records held by providers, but it excludes pharmacists from
the definition of provider. Thirteen States grant individuals statutory
right of access to pharmacy records.
[[Page 60012]]
The amount that entities are allowed to charge for copying of
individuals' records varies widely from State to State. A study
conducted by the American Health Information Management Association
\12\ found considerable variation in the amounts, structure, and
combination of fees for search and retrieval, and the copying of the
record.
---------------------------------------------------------------------------
\12\ "Practice Briefs," Journal of AHIMA; Harry Rhodes, Joan
C. Larson, Association of Health Information Outsourcing Service;
January 1999.
---------------------------------------------------------------------------
In 35 States, there are laws or regulations that set a basis for
charging individuals inspecting and copying fees. Charges vary not only
by State, but also by whether the request is related to a worker's
compensation case or a patient-initiated request. Charges also vary
according to the setting. For example, States differentiate most often
between clinics and hospitals. Also, charges vary by the number of
pages and whether the request is for X-rays or for standard medical
information.
Of the 35 States with laws regulating inspection and copying
charges, seven States either do not allow charges for retrieval of
records or require that the entity provide the first copy free of
charge. Some States may prohibit hospitals from charging patients a
retrieval and copying fee, but allow clinics to do so. It is noteworthy
that some States that do not permit charges for retrieval sometimes
allow entities to charge per-page rates ranging between $0.50 and
$0.75. In States that do allow a retrieval charge, the per-page charge
is usually $0.25. Eleven states specify only that the record holder may
charge "reasonable/actual costs."
Of the States that allow entities to charge for record retrieval
and copying, charges range from a flat amount of $1.00 to $20.00. Other
States allow entities to charge varying rates depending on the amount
of material copied. For example, an entity may charge $5.00 for the
first five pages and then a fixed amount per page. In those cases, it
appears that retrieval and copying costs were actually combined. The
remaining States have a variety of cost structures: One State allows
$0.25 per page plus postage plus a $15.00 retrieval charge. Another
State allows a $1.00 charge per page for the first 25 pages and $0.25
for each page above 25 pages plus a $1.00 annual retrieval charge. A
third state allows a $1.00 per page charge for the first 100 pages and
$0.25 for each page thereafter.
According to the report by the Georgetown Privacy Project, among
States that do grant access to patient records, the most common basis
for denying individuals access is concern for the life and safety of
the individual or others. This proposed rule considers the question of
whether to deny patient access on the basis of concern for the
individual's life or safety, concluding that the benefits of patient
access most often outweigh harm to the individual. This issue, which is
discussed in greater detail in other sections, has been resolved in
favor of promoting patient access.
The amount of time an entity is given to supply the individual with
his or her record varies widely. Many States allow individuals to amend
or correct inaccurate health information, especially information held
by insurers. However, few States provide the right to insert a
statement in the record challenging the covered entity's information
when the individual and entity disagree.13
---------------------------------------------------------------------------
\13\ Ibid, Goldman, p.20.
---------------------------------------------------------------------------
Disclosure of Health Information: State laws vary widely with
respect to disclosure of identifiable health information. Generally,
States have applied restrictions on the disclosure of health
information either to specific entities or to specific health
conditions. Just two states place broad limits on disclosure of
protected health information without regard for policies and procedures
developed by covered entities. Most States require patient
authorization before an entity may disclose health information, but as
the Georgetown report points out, "In effect, the authorization may
function more as a waiver of consent--the patient may not have an
opportunity to object to any disclosures." 14
---------------------------------------------------------------------------
\14\ Ibid, Goldman, p. 21.
---------------------------------------------------------------------------
It is also important to point out that none of the States appear to
offer individuals the right to restrict disclosure of their protected
health information for treatment. Thus, the provision of the proposed
rule that allows patients to restrict disclosure of the their protected
information is not currently included in any State law. Because the
ability to restrict disclosure currently is not a standard practice,
the proposed rule would require entities to add these capabilities to
their information systems.
State statutes often have exceptions to requiring authorization
before disclosure. The most common exceptions are for purposes of
treatment, payment, or auditing and quality assurance functions--which
are similar to the definition we have established for health care
operations, are therefore not subject to prior authorization
requirements under the proposed rule. Restrictions on re-disclosure of
protected health information also vary widely from State to State. Some
States restrict the re-disclosure of health information, and others do
not. The Georgetown report cites State laws that require providers to
adhere to professional codes of conduct and ethics with respect to
disclosure and re-disclosure of protected health information. What is
not clear is the degree to which individual information is improperly
released or used in the absence of specific legal sanctions.
Most States have adopted specific measures to provide additional
protections with regard to certain conditions or illnesses that have
clear social or economic consequences. Although the Georgetown study
does not indicate the number of States that have adopted disease-
specific measures to protect information related to sensitive
conditions and illnesses, the analysis seems to suggest that nearly all
States have adopted some form of additional protection. The conditions
and illnesses most commonly afforded added privacy protection are:
Substance abuse;
Information derived from genetic testing;
Communicable and sexually-transmitted diseases;
Mental health; and
Abuse, neglect, domestic violence, and sexual assault.
We have included a specific discussion of disclosures for research
purposes because if an entity decides to disclose information for
research purposes, it will incur costs that otherwise would be
associated with other disclosures under this rule. Some States place
restrictions on releasing condition-specific health information for
research purposes, while others allow release of information for
research without the patient's authorization. States frequently require
that researchers studying genetic diseases, HIV/AIDS, and other
sexually transmitted diseases have different authorization and privacy
controls than those used for other types of research. Some States
require approval from an IRB or agreements that the data will be
destroyed or identifiers removed at the earliest possible time. Another
approach has been for States to require researchers to obtain
sensitive, identifiable information from a State public health
department. One State does not allow automatic release of protected
health information for research purposes without notifying the subjects
that their health information may be used in research and allowing
[[Page 60013]]
them opportunity to object to the use of their
information.15
---------------------------------------------------------------------------
\15\ "Medical records and privacy: empirical effects of
legislation; A memorial to Alice Hersh'; McCarthy, Douglas B;
Shatin, Deborah; et al. Health Service Research: April 1, 1999; No.
1, Vol. 34; p. 417. The article details the effects of the Minnesota
law conditioning disclosure of protected health information on
patient authorization.
---------------------------------------------------------------------------
Comparing State statutes to the proposed rule: A comparison of
State privacy laws with the proposed rule highlights several of the
proposed rule's key implications:
No State law requires covered entities to make their
privacy and access policies available to patients. Thus, all covered
entities that have direct contact with patients will be required to
prepare a statement of their privacy protection and access policies.
This necessarily assumes that entities have to develop procedures if
they do not already have them in place.
The proposed rule will affect more entities than are
affected under many State laws. In the application of the proposed rule
to providers, plans, and clearinghouses, the proposed rule will reach
nearly all entities involved in delivering and paying for health care.
Yet because HIPAA applies only to information that has been stored and
transmitted electronically, the extent to which the proposed rule will
reach information held by covered entities is unclear.
State laws have not addressed the form in which health
information is stored. We do not know whether covered entities will
choose to treat information that never has been maintained or
transmitted electronically in the same way that they treat post-
electronic information. We also do not know what portion of information
held in non-electronic formats has ever been electronically maintained
or transmitted. Nevertheless, the proposed rule would establish a more
level floor from which States could expand the privacy protections to
include both electronic information and non-electronic information.
Among the three categories of covered entities, it appears
that plans will be the most significantly affected by the access
provisions of the proposed rule. Based on the Health Insurance
Association of America (HIAA) data,16 there are
approximately 94.7 million non-elderly persons who purchase health
insurance in the 35 States that do not provide patients a legal right
to inspect and copy their records. We do not have information on how
many of those people are in plans that grant patients inspection and
copying rights although State law does not require them to do so. We
discuss these points more fully in the cost analysis section.
---------------------------------------------------------------------------
\16\ Source Book of Health Insurance Data: 1997-1998, Health
Insurance Association of America, 1998. p. 33.
---------------------------------------------------------------------------
Although the proposed rule would establish a uniform
disclosure and re-disclosure requirement for all covered entities, the
groups most likely to be affected are health insurers, benefits
management administrators, and managed care organizations. These groups
have the greatest ability and economic incentives to use protected
health information for marketing services to both patients and
physicians without individual authorization. Under the proposed rule,
covered entities would have to obtain the individual's authorization
before they could use or disclose their information for purposes other
than treatment, payment, and health care operations--except in the
situations explicitly defined as allowable disclosures without
authorization.
While our proposed rule appears to encompass many of the
requirements found in current State laws, it also is clear that within
State laws, there are many provisions that cover specific cases and
health conditions. Certainly, in States that have no research
disclosure requirements, the proposed rule will establish a baseline
standard. But in States that do place conditions on the disclosure of
protected health information, the proposed rule may place additional
requirements on covered entities.
State privacy laws do not always apply to entities covered
by the proposed rule. For example, State laws may provide strong
privacy protection for hospitals and doctors but not for dentists or
HMOs. State laws protecting particular types of genetic testing or
conditions may be similarly problematic because they protect some types
of sensitive information and not others. In some instances, a patient's
right to inspect his or her medical record may be covered under State
laws and regulations when a physician has the medical information, but
not under State requirements when the information being sought is held
by a plan. Thus, the proposed rule would extend privacy requirements
already applicable to some entities within a State to other entities
that currently are not subject to State privacy requirements.
3. Federal Laws
The Privacy Act of 1974. Federal agencies will be required to
comply with both the Privacy Act of 1974 (5 U.S.C. 552a) and the HIPAA
regulation. The Privacy Act provides Federal agencies with a framework
and scheme for protecting privacy, and the HIPAA regulation will not
alter that scheme. Basic organizational and management features, such
as the provision of safeguards to protect the privacy of health
information and training for employees--which are required by this
proposed rule--already are required by the Privacy Act.
The proposed rule has been designed so that individuals will not
have fewer rights than they have now under the Privacy Act. It may
require that agencies obtain individual authorization for some
disclosures that they now make without authorization under routine
uses.
Private-sector organizations with contracts to conduct personal
data handling activities for the Federal government are subject to the
Privacy Act by virtue of performing a function on behalf of a Federal
agency. They too will be required to comply with both rules in the same
manner as Federal agencies.
Substance Abuse Confidentiality Statute. Organizations that operate
specialized substance abuse treatment facilities and that either
receive Federal assistance or are regulated by a Federal agency are
subject to confidentiality rules established by section 543 of the
Public Health Service Act (42 U.S.C. 290dd-2) and implementing
regulations at 42 CFR part 2.
These organizations will be subject both to that statute and to the
HIPAA regulation. The proposed rule should have little practical effect
on the disclosure policies of these organizations, because the patient
confidentiality statute governing information about substance abuse is
generally more restrictive than this proposed rule. These organizations
will continue to be subject to current restrictions on their
disclosures. The substance abuse confidentiality statute does not
address patient access to records; the proposed privacy rule makes
clear that patient access is allowed.
Federal agencies are subject to these requirements, and currently
they administer their records under both these requirements and the
Privacy Act. The Department of Veterans Affairs is subject to its own
substance abuse confidentiality statute, which is identical in
substance to the one of more general applicability. It also covers
information about HIV infection and sickle cell anemia (38 U.S.C.
7332).
Rules Regarding Protection of Human Subjects. Health care delivered
by covered entities conducting clinical trials typically are subject to
both the
[[Page 60014]]
proposed rule and to Federal regulations for protection of human re
search subjects (The Federal Policy for the Protection of Human
Subjects, codified for the Department of Health and Human Services in
Title 45 CFR part 46, and/or the Food and Drug Administration's human
subject regulations for research in support of medical product
applications to the Food and Drug Administration, or regulated by that
agency, at 21 CFR parts 50 and 56).
Current human subjects rules impose no substantive restrictions on
disclosure of patient information. Institutional review boards must
consider the adequacy of confiden tiality protections for subjects, and
researchers must tell subjects to what extent their con fidentiality
will be protected. There should be no conflict between these
requirements and the proposed rules. The proposed HIPAA regulation will
expand on the current human subjects requirements by requiring a more
detailed description of intended use of patient information. The
proposed HIPAA rule also requires additional criteria for waiver of
patient authorization.
Medicaid. States may use information they obtain in the process of
administering Medicaid only for the purposes of administering the
program, pursuant to a State plan condition in section 1902(a)(7) of
the Social Security Act, 42 U.S.C. 1396a(a)(7). The proposed HIPAA rule
applies to State Medicaid programs, which under the rule are considered
health plans. There will be no conflict in the substantive requirements
of current rules and this proposed rule. Medicaid rules regarding
disclosure of patient information are stricter than provisions of the
proposed rule; therefore, Medicaid agencies simply will continue to
follow the Medicaid rules.
ERISA. ERISA (29 U.S.C. 1002) was enacted in 1974 to regulate
pension and welfare employee benefit plans that are established by
private-sector employers, unions, or both, to provide benefits to their
workers and dependents. An employee welfare benefit plan provides
benefits--through insurance or otherwise--such as medical, surgical
benefits, as well as benefits to cover accidents, disability, death, or
unemployment. In 1996, HIPAA amended ERISA to require portability,
nondiscrimination, and renewability of health benefits provided by
group health plans and group health insurance issuers. Many, although
not all, ERISA plans are covered under the proposed rule as health
plans. We believe that the proposed rule does not conflict with ERISA.
Further discussion of ERISA can be found in the preamble for this
proposed rule.
E. Costs
Affected entities will be implementing the privacy proposed rules
at the same time many of the administrative simplification standards
are being implemented. As described in the overall impact analysis for
the administrative simplification standards in the Federal Register,
Vol. 63, No. 88, May 7, 1998, page 25344, the data handling changes
occurring due to the other HIPAA standards will have both costs and
benefits. To the extent the changes required for the privacy standards
implementations can be made concurrently with the changes required for
the other standards, costs for the combined implementation should be
only marginally higher than for the administrative simplification
standards alone. The extent of this additional cost is uncertain, in
the same way that the costs associated with each of the individual
administrative simplification standards was uncertain.
The costs associated with implementing the privacy standards will
be directly related to the number of affected entities and the number
of affected transactions in each entity.17 We chose to use
the SBA data in the RFA because we wanted our analysis to be as
consistent to SBA definitions as possible to give the greatest accuracy
for the RFA purposes. As described in the overall administrative
simplification impact estimates (Tables 1 and 2, page 25344), about
20,000 health plans (excluding non-self administered employer
plans)18 and hundreds of thousands of providers face
implementation costs. In the administrative simplification analysis,
the costs of provider system upgrades were expected to be $3.6 billion
over the period 1998-2002, and plan system cost upgrades were expected
to be $2.2 billion. (In the aggregate, this $5.8 billion cost is
expected to be more than completely offset by $7.3 billion in savings
during the 5 year period analyzed).
---------------------------------------------------------------------------
\17\ We have used two different data sources for our estimates
of the number of entities. In the regulatory impact analysis (RIA),
we chose to use the same number of entities cited in the other
Administrative Simplification rules. In the regulatory flexibility
analysis (RFA), we used the most recent data available from the
Small Business Administration (SBA).
We chose to use the Administrative Simplification estimates in
the RIA because we wanted our analysis to be as consistent as
possible with those regulations. We also believe that because the
Administrative Simplification numbers are higher than those in the
SBA data, it was the more conservative data source.
\18\ We have not included the 3.9 million "other" employer
health plans listed in HCFA's administrative simplification
regulations because these plans that are administered by a third
party. The proposed regulation will not regulate the employer-plans
but will regulate the third party administrators of the plans.
Because plan administrators have already been included in our
analysis, these other employer-sponsored plans will not incur
additional costs.
---------------------------------------------------------------------------
The relationship between the HIPAA security and privacy standards
is particularly relevant. On August 12, 1998, the Secretary published a
proposed rule to implement the HIPAA standards on security and
electronic standards. That rule specified the security requirements for
covered entities that transmit and store information specified in Part
C, Title XI of the Act. In general, that rule would establish the
administrative and technical standards for protecting "* * * any
health information pertaining to an individual that is electronically
maintained or transmitted." (63 FR 43243). The security rule is
intended to spell out the system and administrative requirements that a
covered entity must meet in order to assure itself and the Secretary
that the protected health information is safe from destruction and
tampering from people without authorization for its access.
By contrast, the privacy rule describes the policies and procedures
that would govern the circumstances under which protected health
information may be used and released with and without patient
authorization and when a patient may have access to his or her
protected medical information. This rule assumes that a covered entity
will have in place the appropriate security apparatus to successfully
carry out and enforce the provisions contained in the security rule.
Although the vast majority of health care entities are privately
owned and operated, Federal, State, and local government providers are
reflected in the total costs.19 Federal, state, and locally
funded hospitals represent approximately 26 percent of hospitals in the
United States. This is a significant portion of hospitals, but
represents a relatively small proportion of all
[[Page 60015]]
provider entities. The number of government providers who are employed
at locations other than government hospitals is significantly smaller
(approximately 2 percent of all providers). Weighting the relative
number of government hospital and non-hospital providers by the revenue
these types of providers generate, we estimate that health care
services provided directly by government entities represent 3.4 percent
of total health care services. IHS and Tribal facilities costs are
included in the total, since the adjustments made to the original
private provider data to reflect federal providers included them. In
drafting the proposed rule the Department consulted with States,
representatives of the National Congress of American Indians,
representatives of the National Indian Health Board, and a
representative of the self-governance tribes. During the consultation
we discussed issues regarding the application of Title II of HIPAA to
the States and Tribes.
---------------------------------------------------------------------------
\19\ These costs only represent those of public entities serving
in the role of provider plan. The federal costs only reflect those
incurred by a provider and plan offering Medicaid or Medicare, and
hospitals run by the federal government including those run by the
Veteran's Administration and the militry. Federal enforcement and
other costs are not included. These estimates do not reflect any
larger systems changes necessary to running federal programs.
Likewise State costs are incorporated to the extent that States
serve as providers or plans (including Medicaid).
---------------------------------------------------------------------------
Estimating the costs associated with the privacy proposed rule
involves, for each provision, consideration of both the degree to which
covered entities must modify their records management systems and
privacy policies under the proposed rule, and the extent to which there
is a change in behavior of both patients and the covered entities as a
result of the proposed rule. In the following sections we will examine
these provisions as they would apply to the various covered entities as
they undertake to comply with the proposed rule. The major costs that
covered entities will incur are one time costs associated with
implementation of the proposed rules, and ongoing costs that result
from changes in behavior that both the covered entities and patients
would make in response to the new proposed rules.
We have quantified the costs imposed by the proposed regulation to
the extent that we had adequate data. In some areas, however, there was
too little data to support quantitative estimates. As a result, the RIA
does not include cost estimates for all of the requirements of the
regulation. The areas for which explicit cost estimates have not be
made are: The principle of minimum necessary disclosure; the
requirement that entities monitor business partners with whom they
share PHI; creation of de-identified information; internal complaint
processes; sanctions; compliance and enforcement; the designation of a
privacy official and creation of a privacy board; and additional
requirements on research/optional disclosures that will be imposed by
the regulation. The cost of some of these provisions may be
significant, but it would be inaccurate to project costs for these
requirements given the fact that several of these concepts are new to
the industry.
The one time costs are primarily in the area of development and
codification of procedures. Specific activities include: (1) Analysis
of the significance of the federal regulations on covered entity
operation; (2) development and documentation of policies and procedures
(including new ones or modification of existing ones); (3)
dissemination of such policies and procedures both inside and outside
the organization; (4) changing existing records management systems or
developing new systems; and (5) training personnel on the new policies
and system changes.
Covered entities will also incur ongoing costs. These are likely to
be the result of: (1) Increased numbers of patient requests for access
and copying of their own records; (2) the need for covered entities to
obtain patient authorization for uses of protected information that had
not previously required an authorization; (3) increased patient
interest in limiting payer and provider access to their records; (4)
dissemination and implementation both internally and externally of
changes in privacy policies, procedures, and system changes; and (5)
training on the changes.
Compliance with the proposed rule will cost $3.8 billion over five
years. These costs are in addition to the administrative simplification
estimates. The cost of complying with the regulation represents 0.09
percent of projected national health expenditures the first year the
regulation is enacted. The five year costs of the proposed regulation
also represents 1.0 percent of the increase in health care costs
experienced over the same five-year period.20 Because of the
uncertainty of the data currently available, the Department has made
estimates on "low" and "high" range assumptions of the key
variables. These estimates show a range of $1.8 to $6.3 billion over
five years. It is important to note that these estimates do not include
the areas for which we have made no cost estimates (discussed above).
---------------------------------------------------------------------------
\20\ Health Care Finance Administration, Office of the Actuary,
1997.
---------------------------------------------------------------------------
Initial Costs
Privacy Policies and Procedures
With respect to the initial costs for covered entities, the
expectation that most of the required HIPAA procedures will be
implemented as a package suggests that additional costs for the privacy
standards should be small. Since the requirements for developing formal
processes and documentation of procedures mirror what will already have
been required under the security regulations, the additional costs
should be small. The expectation is that national and state
associations will develop guidelines or general sets of processes and
procedures and that these will generally be adopted by individual
member entities. Relatively few providers or entities are expected to
develop their own procedures independently or to modify significantly
those developed by their associations. Our estimates are based on
assumed costs for providers ranging from $300 to $3000, with the
weighted average being about $375. The range correlates to the size and
complexity of the provider, and is a reasonable estimate of the cost of
coordinating the policies and procedures outlined in the proposed
regulation. With fewer than 1 million provider entities, the aggregate
cost would be on the order of $300 million.
For plans, our estimate assumes that the legal review and
development of written policies will be more costly because of the
scope of their operations. They are often dealing with a large number
of different providers and may be dealing with requirements from
multiple states. Again, we expect associations to do much of the basic
legal analysis but plans are more likely to make individual
adaptations. We believe this cost will range from $300 for smaller
plans and $15,000 for the largest plans. Because there are very few
large plans in relation to the number of small plans, the weighted
average implementation costs will be about $3050.
The total cost of development of policies and procedures for
providers and plans is estimated to be $395 million over five years.
System Compliance Costs
With respect to revisions to electronic data systems, the specific
refinements needed to fulfill the privacy obligations ought to be
closely tied to the refinements needed for security obligations. The
overall administrative simplification system upgrades (procedures,
systems, and training) of $5.8 billion would certainly be
disproportionately associated with the security standard, relative to
the other 11 elements. If in privacy it constitutes 15 percent, then
the security standard would represent about $900 million system cost.
If the marginal cost of the privacy elements is another 10 percent,
[[Page 60016]]
then the addition cost would be $90 million.
Ongoing Costs
The recurrent costs may be more closely related to total numbers of
persons with claims than to the number of covered entities. The number
of individuals served by an entity will vary greatly. The number of
persons with claims will give a closer approximation of how many people
entities will have to interact with for various provisions.
Notice of Privacy Practices
No State laws or professional associations currently require
entities to provide patients "notice" of their privacy policies.
Thus, we expect that all entities will incur costs developing and
disseminating privacy policy notices. Each entity will have a notice
cost associated with each person to whom they provide services. Data
from the 1996 Medical Expenditure Panel Survey shows that there are
approximately 200 million ambulatory care encounters per year, nearly
20 million persons with a hospital episode, 7 million with home-health
episodes, and over 170 million with prescription drug use (350 million
total). For the remaining four years of the five year period, we have
estimated that, on average, a quarter of the remaining population will
enter the system, and thus receive a notice. If we account for growth
in the number of people who may enter the health care system over the
five year period of our analysis, we estimate that approximately 543
million patients will be seen at least once by one or more types of
providers.
The development cost for notices is estimated to cost $30 million
over five years, though most of this is likely to occur the first year.
The first year cost of providing notices to patients, customers and
plan enrollees would be $106 million. The total five year cost of
providing new and subsequent copies to all provider patients and
customers would be approximately $209 million.
The notice obligations of insurers apply on initial enrollment,
with updated notices at least every 3 years. However, given enrollment
changes and the sophistication of automation, we believe many plans
would find it cheaper and more efficient to provide annual notices.
The 1998 National Health Interview Survey (NHIS) from the Census
Bureau shows about 174.1 million persons are covered by private health
insurance, on an unduplicated basis. NHIS calculates that persons who
are privately insured hold approximately 1.3 policies per person. Based
on information provided by several plans, we believe most plans would
provide an independent mailing the first year, but in subsequent years
would provide notices as an inclusion in other mailings. The cost for
this would be $0.75 over five years. If we account for these duplicate
policies and assume that the cost of sending the notices to a
policyholder is $0.75, the total cost to plans would be $231 million
over five years. This includes both public and private plans.
We request comments regarding our cost estimates for development
and distribution of notices.
The costs for more careful internal operation of covered entities
to execute their formal privacy procedures are highly dependent on the
extent to which current practice tracks the future procedures. Entities
that already have strict data sharing and confidentiality procedures
will incur minimal costs, since their activities need not change much.
Entities that have not developed explicit health information privacy
policies may be compelled to obtain patient authorization in situations
where they did not previously. These changes will generate ongoing
costs as well as initial costs. We solicit comment with respect to the
way current costs differ from those projected by the requirements of
the proposed privacy rule. An example of such an area is "the minimum
necessary disclosure principle"--because of differing current
practices, we do not have data that reliably indicate how much this
provision will cost.
Inspection and Copying
The Georgetown report on State privacy laws indicates that 33
states currently give patients some right to access medical
information. The most common right of access granted by State law is
the right to inspect personal information held by physicians and
hospitals. In the process of developing estimates for the cost of
providing access and copying, we assumed that most providers currently
have procedures for allowing patients to inspect and copying their own
record. Thus, we expect that the economic impact of requiring entities
to allow individuals to access and copy their records should be
relatively small. Copying costs, including labor, should be a fraction
of a dollar per page. We expect the cost to be passed on to the
consumer.
There are few studies that address the cost of providing medical
records to patients. The most recent was a study in 1998 by the
Tennessee Comtroller of the Treasury. It found an average cost of $9.96
per request, with an average of 31 pages per request. The total cost
per page of providing copies was $0.32 per page. This study was
performed on hospitals only. The cost per request may be lower for
other types of providers, since those seeking hospital records are more
likely to be sick and have more complicated records than those in a
primary care or other type of office. An earlier report showed much
higher costs than the Tennessee study. In 1992, Rose Dunn published a
report based on her experience as a manager of medical records. She
estimated a 10 page request would cost $5.32 in labor costs only,
equaling labor cost per page of $0.53. However, this estimate appears
to reflect costs before computerization. The expected time spent per
search was 30.6 minutes; 85 percent of this time could be significantly
reduced with computerization (this includes time taken for file
retrieval, photocopying, and re-filing; file retrieval is the only time
cost that would remain under computerization.) For subsequent
estimates, we will use the Tennessee experience.
The proposed regulation states that entities may charge patients a
reasonable fee to inspect and copy their health information. For this
reason, we expect the cost of inspecting and copying an individual
medical record to be passed on to consumers who request the service.
Nonetheless, it is important to provide an estimate of the potential
costs associated with inspection and copying. We assume that 1.5
percent of patients will request access to inspect and copy their
medical record, and that the cost of accessing and copying a record is
approximately $10 (as cited in the Tennessee study). The cost of
inspection and copying is $81 million a year, or $405 million over five
years. This cost is likely to be borne entirely by the consumer.
Amendment and Correction
We have assumed that many providers make provisions to help
patients expedite amendment and correction of their medical record
where appropriate. However, as with inspection and copying, the right
to request amendment and correction of an individual's medical record
is not guaranteed by all States. Based on these assumptions and our
cost analysis, we conclude that the principal economic effect of the
proposed rule would be to expand the right to request amendment and
correction to plans and providers that are not covered by state laws or
codes of conduct. In addition, we expect that the proposed rule may
draw additional attention to the issue of record inaccuracies and
stimulate
[[Continued on page 60017]]
[Federal Register: November 3, 1999 (Volume 64, Number 212)]
[Proposed Rules]
[Page 60017-60065]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03no99-69]
[[pp. 60017-60065]] Standards for Privacy of Individually Identifiable Health
Information
[[Continued from page 60016]]
[[Page 60017]]
patient demand for access, amendment, and correction of medical
records.
Our cost calculations assume that persons who request an
opportunity to amend or correct their record have already obtained a
copy of their medical record. Therefore, the administrative cost of
amending and correcting the patient's record is completely separate
from inspection and copying costs. In this section we have only
addressed the cost of disputing a factual statement within the patient
record, and do not calculate the cost of appeals or third party review.
Administrative review of factual statements contained within a
patient's record may be expensive. Most errors may be of a nature that
a clerk or nurse can correct (e.g., the date of a procedure is
incorrect) but some may require physician review. Thus, we have
estimated that the average cost of amending and correcting a patient
record may be $75 per instance.
If amendment and correction requests are associated with two-thirds
of requests for inspection and copying, and the cost of correcting (or
noting the patient's request for correction) is $75, the total cost of
amending and correcting patient records will be $407 million annually,
or $2 billion over five years. Comments on our estimate of amendment
and correction costs would be helpful, particularly if they speak to
current amendment and correction costs or frequency in the health care
industry.
Reconstructing a History of Disclosures (Other Than for Treatment and
Payment)
To our knowledge, no current State law or professional code
requires providers and plans to maintain the capability to reconstruct
a patient's health information history. Therefore, the requirement in
this rule to be able to reconstruct the disclosure history of protected
health information is completely new. Although it is likely that some
providers and plans have already developed this capability, we assume
that all providers and plans would be required to invest in developing
the capacity to generate disclosure histories.
With respect to reconstruction of disclosure history, two sets of
costs would exist. On electronic records, fields for disclosure reason,
information recipient, and date would have to be built into the data
system. The fixed cost of the designing the system to include this
would be a component of the $90 million additional costs discussed
earlier. The ongoing cost would be the data entry time, which should be
at de minimis levels. Comments would again be especially useful with
respect to the extent to which recording the additional information
goes beyond current practice.
Authorizations
Although many States have laws that require entities to obtain
patient authorization before releasing individually identified health
information to payers and other third parties, many of the
authorization requirements either allow for blanket authorizations that
deprive the patient of meaningful control over the release of their
health information, or the authorization statutes are less stringent
than the provisions of the proposed rule. Therefore, for purposes of
estimating the economic impact of the NPRM, we are assuming that all
providers and plans will have to develop new procedures to conform to
the proposed rule.
Written patient authorization requirements will generate costs, to
the extent covered entities are currently releasing information in the
targeted circumstances without specific authority. Collecting such
authorization should have costs on the order of those associated with
providing access to records (not on a per page basis). The frequency of
such collections is unknown. Since the requirement does not apply to
treatment and payment, assuming 1 percent of the 543 million encounters
over five years might be reasonable. At a cost of about $10 each, the
aggregate cost would be about $54 million annually, or $271 million
over five years. Comments would be especially useful from entities
currently following such procedures.
Training
The ongoing costs associated with paperwork and training are likely
to be minimal. Because training happens as a regular business practice,
and employee certification connected to this training is also the norm,
we estimate that the marginal cost of paperwork and training is likely
to be small. We assume a cost of approximately $20 per provider office,
and approximately $60-100 for health plans and hospitals. Thus, we
estimate that the total cost of paperwork and training will be $22
million a year.
Conclusion
Overall, the five-year costs beyond those already shown in the
administrative simplification estimates would be about $3.8 billion
over five years, with an estimated range of $1.8 to $6.3 billion. Table
2 shows the components described above. The largest cost item is for
amendment and correction, which is over half of the estimated total
cost of the regulation. Inspection and copying, at $405 million over
five years, and issuance of notices by providers and plans, at $439
million over five years, are the second biggest components. The one-
time costs of development of policies and procedures by providers would
represent approximately 10 percent of the total cost, or $333 million.
Plans and clearinghouses would have a substantially smaller cost, about
$62 million. Other systems changes are expected to cost about $90
million over the period. Finally, the estimates do not consider all of
the costs imposed by the regulation.
Table 2.--The Cost of Complying With the Proposed Privacy Regulation
[In Dollars]
----------------------------------------------------------------------------------------------------------------
Initial or Annual cost Five year
Provision first year after the (2000-2004)
cost (2000) first year cost
----------------------------------------------------------------------------------------------------------------
Development of Policies and Procedures--Providers (totaling $333,000,000 ..............
$333,000,000
871,294).......................................................
Development of Policies and Procedures--Plans (totaling 18,225). 62,000,000 ..............
62,000,000
System Changes--All Entities.................................... 90,000,000 .............. 90,000,000
Notice Development Cost--all entities........................... 20,000,000 .............. 30,000,000
Notice Issuance--Providers...................................... 59,730,000 37,152,000 208,340,000
Notice Issuance--Plans.......................................... 46,200,000 46,200,000 231,000,000
Inspection/Copying.............................................. 81,000,000 81,000,000 405,000,000
Amendment/Correction............................................ 407,000,000 407,000,000
2,035,000,000
Written Authorization........................................... 54,300,000 54,300,000 271,500,000
[[Page 60018]]
Paperwork/Training.............................................. 22,000,000 22,000,000 110,000,000
Other Costs *................................................... **N/E N/E N/E
-----------------------------------------------
Total....................................................... 1,165,230,000 647,652,000 3,775,840,000
----------------------------------------------------------------------------------------------------------------
* Other Costs include: minimum necessary disclosure; monitoring business partners with whom
entities share PHI;
creation of de-identified information; internal complaint processes; sanctions; compliance and
enforcement;
the designation of a privacy official and creation of a privacy board; additional requirements on
research/
optional disclosures that will be imposed by the regulation.
** N/E = "Not estimated".
Costs to the Federal Government
The proposed rule will have a cost impact on various federal
agencies that administer programs that require the use of individual
health information. Federal agencies or programs clearly affected by
the rule are those that meet the definition of a covered entity. The
costs when government entities are serving as providers are included in
the total cost estimates. However, non-covered agencies or programs
that handle medical information, either under permissible exceptions to
the disclosure rules or through an individual's expressed
authorization, will likely incur some costs complying with provisions
of this rule. A sample of federal agencies encompassed by the broad
scope of this rule include the: Department of Health and Human
Services, Department of Defense, Department of Veterans Affairs,
Department of State, and the Social Security Administration.
The federal costs of complying with the regulation are included in
the estimates of total costs. The greatest cost and administrative
burden on the federal government will fall to agencies and programs
that act as covered entities, by virtue of being either a health plan
or provider. Examples include the Medicare, Medicaid, Children's Health
Insurance and Indian Health Service programs at the Department of
Health and Human Services; the CHAMPVA health program at the Department
of Veterans Affairs; and the TRICARE health program at the Department
of Defense. These and other health insurance or provider programs
operated by the federal government are subject to requirements placed
on covered entities under this proposed rule, including, but not
limited to, those outlined in Section D of the impact analysis. While
many of these federal programs already afford privacy protections for
individual health information through the Privacy Act, this rule is
expected to create additional requirements beyond those covered by
existing Privacy Act rule. Further, we anticipate that most federal
health programs will, to some extent, need to modify their existing
Privacy Act practices to fully comply with this rule.
The cost to federal programs that function as health plans will be
generally the same as those for the private sector. The primary
difference is the expectation that systems compliance costs may be
higher due to the additional burden of compliance and oversight costs.
A unique cost to the federal government will be in the area of
enforcement. The Office of Civil Rights (OCR), located at the
Department of Health and Human Services, has the primary responsibility
to monitor and audit covered entities. OCR will monitor and audit
covered entities in both the private and government sectors, will
ensure compliance with requirements of this rule, and will investigate
complaints from individuals alleging violations of their privacy
rights. In addition, OCR will be required to recommend penalties and
other remedies as part of their enforcement activities. These
responsibilities represent an expanded role for OCR. Beyond OCR, the
enforcement provisions of this rule will have additional costs to the
federal government through increased litigation, appeals, and inspector
general oversight.
Examples of other unique costs to the federal government include
such activities as public health surveillance at the Centers for
Disease Control and Prevention, health research projects at the Agency
for Health Care Policy and Research, clinical trials at the National
Institutes of Health, and law enforcement investigations and
prosecutions by the Federal Bureau of Investigations. For these and
other activities, federal agencies will incur some costs to ensure that
protected health information is handled and tracked in ways that comply
with the requirements of this title. A preliminary analysis of these
activities suggests that the federal cost will be on the order of $31
million. We are currently in the process of refining these estimates
and will include better information on them in the final rule.
Costs to State Governments
The proposed rule will also have a cost effect on various state
agencies that administer programs that require the use of individual
health information. State agencies or programs clearly affected by the
rule are those that meet the definition of a covered entity. The costs
when government entities are serving as providers are included in the
total cost estimates. However, non-covered agencies or programs that
handle medical information, either under permissible exceptions to the
disclosure rules or through an individual's expressed authorization,
will likely incur some costs complying with provisions of this rule.
Samples of state agencies encompassed by the broad scope of this rule
include the: Medicaid, Children's Health Insurance program at the
Department of Health and Human Services.
We have included state costs in the estimation of total costs. The
greatest cost and administrative burden on the state government will
fall to agencies and programs that act as covered entities, by virtue
of being either a health plan or provider. Examples include the
edicaid, Children's Health Insurance program at the Department of
Health and Human Services. These and other health insurance or provider
programs operated by state government are subject to requirements
placed on covered entities under this proposed rule, including, but not
limited to, those outlined in Section D of the impact analysis. While
many of these state programs already afford privacy protections for
individual health information through the Privacy Act, this rule is
expected to create additional requirements beyond those covered by
[[Page 60019]]
existing Privacy Act rule. Further, we anticipate that most state
health programs will, to some extent, need to modify their existing
Privacy Act practices to fully comply with this rule.
The cost to state programs that function as health plans will be
different than the private sector, much as the federal costs vary from
private plans. A preliminary analysis suggests that state costs will be
on the order of $90 million over five years. We will refine the
estimates for the state government costs for enforcement, research and
other distinct state government functions in the final rule. We welcome
comment by state and local governments which will help the Department
improve its analysis on these state costs.
F. Benefits
As we have discussed in the preamble, there are important societal
benefits associated with improving health information privacy.
Confidentiality is a key component of trust between patients and
providers, and some studies indicate that a lack of privacy may deter
patients from obtaining preventive care and treatment. 21
For these reasons, traditional approaches to estimating the value of a
commodity cannot fully capture the value of personal privacy. It may be
difficult for individuals to assign value to privacy protection because
most individuals view personal privacy as a right. Because we promote
the view that privacy protection is an important personal right, the
benefits of the proposed regulation are impossible to estimate based on
the market value of health information alone. However, it is possible
to evaluate some of the benefits that may accrue to individuals as a
result of proposed regulation, and these benefits, alone, suggest that
the regulation is warranted. Added to these benefits is the intangible
value of privacy, the personal security that we may feel when our
records are confidential, which is very real and very significant but
for which there is no economic value or proxy.
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\21\ Equifax-Harris Consumer Privacy Survey, 1994.
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There are a number of ways to discuss the expected benefits of this
proposed regulation. The first option is to discuss the benefits
qualitatively. We believe that this is necessary to give the reader a
basic understanding of how this proposed regulation will benefit
society. The second option that we have used is to quantify the
benefits of the proposed rule as they would apply to a few illness
categories that may be particularly responsive to privacy concerns.
This quantitative discussion is meant to be illustrative of the
benefits rather than a comprehensive accounting of all of the benefits
of the proposed rule. The combination of the two approaches clearly
illustrates that the benefits of the regulation are significant in
relation to the economic costs.
Before beginning our discussion of the benefits, it is important to
create a framework for how the costs and benefits may be viewed in
terms of individuals rather than societal aggregates. We have estimated
the value an insured individual would need to place on increased
privacy to make the proposed Privacy regulation a net benefit to those
who receive health insurance. Our estimates are derived from data
produced by the 1998 Current Population Survey from the Census Bureau,
and report that 220 million persons are covered by either private or
public health insurance. Joining the Census Bureau data with cost
assumptions calculated in Section E, we have estimated the cost of the
proposed regulation is $3.41 per insured individual. If we assume that
individuals who use the health care system will be willing to pay more
than $3.41 per year (or approximately $0.28 per month) to improve
health information privacy, the benefits of the proposed regulation
will outweigh the cost.
This is a conservative estimate of the number of people who will
benefit from the regulation because it assumes that only those
individuals who have health insurance will use medical services or
benefit from the provisions of the proposed regulation. Currently,
there are 44 million Americans who do not have any form of health care
insurance. In addition, the estimates do not include those who pay for
medical care directly, without any insurance or government support. By
lowering the number of users in the system, we have inflated our
estimate of the per-person cost of the regulation, therefore, we assume
that our estimate represents the highest cost to an individual.
An alternative approach to determining how people would have to
value increased privacy for this regulation to be beneficial is to look
at the costs divided by the number of encounters with health care
professionals annually. Data from the Medical Expenditure Panel Survey
(MEPS) produced by the Agency for Health Care Policy Research (AHCPR)
report approximately 1.62 billion health care visits, or encounters
annually (e.g., office visits, hospital and nursing home stays, etc.).
As with our calculation of average annual cost per insured patient, we
have divided the total cost of complying with the regulation ($751
million per year) by the total annual number of health care encounters.
The cost of instituting requirements of the proposed regulation is
$0.46 per health care encounter. If we assume that individuals would be
willing to pay more than $0.46 per health care encounter to improve
health information privacy, the benefits of the proposed regulation
will outweigh the cost.
Qualitative Discussion
A well designed privacy standard can be expected to build
confidence among the public about the confidentiality of their medical
records. The seriousness of public concerns about privacy in general
are shown in the 1994 Equifax-Harris Consumer Privacy Survey, where
"84 percent of Americans are either very or somewhat concerned about
threats to their personal privacy." 22 A 1999 report,
"Promoting Health and Protecting Privacy" notes "* * * many people
fear their personal health information will be used against them: to
deny insurance, employment, and housing, or to expose them to unwanted
judgements and scrutiny." 23 These concerns would be partly
allayed by the privacy standard. Further, increased confidence will
increase the likelihood of some people seeking treatment for particular
classes of disease. It will also change the dynamic of current
payments. Insured patients currently paying out-of-pocket for
confidentiality reasons will be more likely to file with their insurer.
The increased utilization that would result from increased confidence
in privacy could be beneficial under many circumstances. For many
medical conditions, early treatment can lead to lower costs.
---------------------------------------------------------------------------
\22\ Consumer Privacy Survey, Harris-Equifax, 1994, p. vi.
\23\ Promoting Health: Protecting Privacy, California Health
Care Foundation and Consumers Union, January 1999, p. 12.
---------------------------------------------------------------------------
Fear of disclosure of treatment is an impediment to health care for
many Americans. In the 1993 Harris-Equifax Health Information Privacy
Survey, 7 percent of respondents said they or a member of their
immediate family had chosen not to seek medical services due to fear of
harm to job prospects or other life opportunities. About 2 percent
reported having chosen not to file an insurance claim because of
concerns with privacy or confidentiality. 24 Increased
confidence on the part of patients that their privacy would be
protected would lead to increased
[[Page 60020]]
treatment among people who delay or never begin care, as well as among
people who receive treatment but pay directly (to the extent that the
ability to use their insurance benefits will reduce cost barriers to
more complete treatment).
---------------------------------------------------------------------------
\24\ Health Information Privacy Survey, Harris-Equifax, 1993,
pp. 49-50.
---------------------------------------------------------------------------
The following are four examples of areas where increased confidence
in privacy would have significant benefits. They were chosen both
because they are representative of widespread and serious health
problems, and because they are areas where reliable and relatively
complete data are available for this kind of analysis. The logic of the
analysis, however, applies to any health condition. Even for relatively
minor conditions, an individual still might be concerned with
maintaining privacy, and even a person with no significant health
problems is going to value privacy because of the possibility at some
time they will have a condition that they want to keep private.
Cancer. The societal burden of disease imposed by cancer is
indisputable. Cancer is the second leading cause of death in the
US,25 exceeded only by heart disease. In 1999, 1.38 million
new cancer cases will be diagnosed, as well as 900,000 new basal and
squamous skin cell cancers. 26 The National Cancer Institute
estimates that the overall cost of cancer is $104 billion; $35 billion
in direct medical cost, $12 billion for morbidity costs (cost of lost
productivity) and $57 billion for mortality costs.27
---------------------------------------------------------------------------
\25\ American Cancer Society. https://4a2z.com/cgi/
rfr.cgi?4CANCER-2-https://www.cancer.org/frames.html
\26\ American Cancer Society. https://www.cancer.org/statistics/
97cff/97facts.html
\27\ American Cancer Society. https://www.cancer.org/statistics/
97cff/97facts.html
---------------------------------------------------------------------------
Among the most important elements in the fight against cancer are
screening, early detection and treatment of the disease. However,
however, many patients are concerned that some screening procedures
will make them vulnerable to discrimination by insurers or employers.
These privacy concerns have been cited as a reason patients do not seek
early treatment for diseases such as cancer. As a result of forgoing
early screening, cancer patients may ultimately face a more severe
illness. For example, half of new diagnoses occur among types of cancer
for which screening is available. Based on this research, studies show
that if Americans participated in regular cancer screening, the rate of
survival among patients who have screening-accessible cancers could
increase to 95 percent.28
---------------------------------------------------------------------------
\28\ American Cancer Society. https://www.cancer.org/statistics/
97cff/97facts.html
---------------------------------------------------------------------------
Approximately 184,300 women will be diagnosed with breast cancer
this year,29 and 25,000 women will be diagnosed with ovarian
cancer.30 In the same year, almost 44,000 women will die of
breast cancer,31 and 14,500 will die from ovarian
cancer.32 Early detection of these cancers could have a
significant impact on reducing loss due to disability and death. For
example, only 24 percent of ovarian cancers are diagnosed in the early
stages. Of these, approximately 90 percent of patients survive
treatment. The survival rate of women who detect breast cancer early is
similarly high; more than 90 percent of women who detect and treat
breast cancer in its early stages will survive.33
---------------------------------------------------------------------------
\29\ Avon's Breast Cancer Crusade. https://www.pmedia.com/Avon/
library/faq.html
\30\ Ovarian Cancer National Alliance. https://
www.ovariancancer.org/index.shtml
\31\ Cancer Statistics, 1999, Landis, Murray, Bolden and Wingo.
CA: A Cancer Journal for Clinicians, Jan/Feb, 1999, Vol. 49, No. 1
\32\ Ovarian Cancer National Alliance. https://
www.ovariancancer.org/index.shtml
\33\ Breast Cancer Information Service. https://trfn.clpgh.org/
bcis/FAQ/facts2.html
---------------------------------------------------------------------------
Researchers have developed screening techniques to identify breast,
ovarian, and colon cancers, and tests have been developed to identify
the presence or absence of cellular abnormalities that may lead to
cancer. Despite these technological advances, the principle of patient
autonomy requires that patients must decide for themselves if they will
submit to screening procedures. Many individuals fear that employers
and insurers will use cancer screening to discriminate against them.
Several studies illustrate that persons with and without cancer fear
discrimination. Thus, despite the potential benefits that early
identification of cancer may yield, many researchers find that patient
concerns regarding the confidentiality of cancer screening may prevent
them from requesting the test, and result in disability or loss of
life.
HIV/AIDS. Early detection is essential for the health and survival
of an HIV (Human Immunodeficiency Virus) positive person. Concerns
about the confidentiality of HIV status may prevent some people from
getting tested. For this reason, each state has passed some sort of
legislation regarding the confidentiality of HIV status. However, HIV
status can be revealed indirectly through disclosure of HAART (Highly
Active Anti-Retroviral Therapy) or similar HIV treatment drug use. In
addition, since HIV/AIDS (Acquired Immune Deficiency Syndrome) is often
the only specially protected condition, "blacked out" information on
medical charts could indicate HIV positive status.34
Strengthening privacy protections beyond this disease could increase
confidence in privacy regarding HIV as well. Drug therapy for HIV
positive persons has proven to be a life-extending, cost-effective
tool. 35 A 1998 study showed that beginning treatment with
HAART in the early asymptomatic stage is more cost-effective than
beginning it late. After five years, only 15 percent of patients with
early treatment are estimated to develop an ADE (AIDS-defining event),
whereas 29 percent would if treatment began later. Early treatment with
HAART prolongs survival (adjusted for quality of life) by 6.2 percent.
The overall cost-effectiveness of early HAART treatment is estimated at
$23,700 per quality-adjusted year of life saved.36
---------------------------------------------------------------------------
\34\ Promoting Health: Protecting Privacy, California Health
Care Foundation and Consumers Union, January 1999, p. 13.
\35\ For example, Roger Detels, M.D., et al., in "Effectiveness
of Potent Anti-Retroviral Therapy * * * "JAMA, 1998; 280: 1497-1503
note the impact of therapy on HIV persons with respect to
lengthening the time to development of AIDS, not just delaying death
in persons who already have AIDS.
\36\ John Hornberger et al, "Early treatment with Highly Active
Anti-Retroviral Therapy (HAART) is cost-effective compared to
delayed treatment," 12th World AIDS conference, 1998.
---------------------------------------------------------------------------
Other Sexually Transmitted Diseases. It is difficult to know how
many people are avoiding testing for STDs despite having a sexually
transmitted disease. A 1998 study by the Kaiser Family Foundation found
that the incidence of disease was 15.3 million in 1996, though there is
great uncertainty due to under-reporting.37 For a
potentially embarrassing disease such as an STD, seeking treatment
requires trust in both the provider and the health care system for
confidentiality. Greater trust should lead to more testing and greater
levels of treatment. Earlier treatment for curable STDs can mean a
decrease in morbidity and the costs associated with complications.
These include expensive fertility problems, fetal blindness, ectopic
pregnancies, and other reproductive complications.38 In
addition, there could be greater overall savings if earlier treatment
translates into reduced spread of infections.
---------------------------------------------------------------------------
\37\ Sexually Transmitted Diseases in America, Kaiser Family
Foundation, 1998. p. 12.
\38\ Standard Medical information; see https://www.mayohealth.org
for examples.
---------------------------------------------------------------------------
Substance Abuse and Mental Health Treatment. When individuals have
a better understanding of the privacy practices that we are requiring
in this proposed rule, some will be less reluctant to seek substance
abuse and mental health treatment. One way that individuals will
receive this information is through the notice requirement.
[[Page 60021]]
Increased use of mental health services would be expected to be
beneficial to the persons receiving the care, to their families, and to
society at large. The individual direct benefit from treatment would
include an improved quality of life, reduced disability associated with
the mental conditions, and a reduced mortality rate. The benefit to
families would include quality of life improvements and reduced medical
costs for other family members associated with abusive behavior by the
treated individual. The benefit to society would include reduced costs
of crime and reduced future public program treatment costs.
The 1998 Substance Abuse and Mental Health Statistics Source Book
from SAMHSA reports cost-of-disease estimates from a range of studies,
suggesting several hundred billion dollars of non-treatment costs
associated with alcohol, drug, and mental (ADM) disorders. As an
example of the magnitude of costs associated with mental health
treatment, a 1997 National Institutes of Health report suggests that
the total economic cost of mental health disorders such as anxiety,
depressive (mood) disorders, eating disorders, and schizophrenia is
approximately $115.5 billion annually.39 Evidence suggests
that appropriate treatment of mental health disorders can result in 50-
80 percent of individuals experiencing improvements in these types of
conditions. Improvements in patient functioning and reduced hospital
stays could result in hundreds of million of dollars in cost savings
annually.
---------------------------------------------------------------------------
\39\ Disease-Specific Estimates of Direct and Indirect Costs of
Illness and NIH Support; 1997 Update, 1997.
---------------------------------------------------------------------------
The potential additional economic benefits associated with
improving patient confidentiality and thus encouraging some unknown
portion of individuals to either seek initial mental health treatment
or increase service use are difficult to quantify well. Nevertheless,
one can lay out a range of possible benefit levels to illustrate the
possibility of cost savings associated with an expansion of mental
health treatment to individuals who, due to protections offered by the
privacy regulation, might seek mental health treatment that they
otherwise would not have absent this regulation. This can be
illustrated by drawing upon existing data on both the economic costs of
mental illness and the treatment effectiveness of mental health
interventions.
Although figures on the number of individuals who avoid mental
health treatment due to privacy concerns do not exist, some indirect
evidence is available. A 1993 Harris-Equifax Health Information Privacy
Survey (noted earlier) found that 7 percent of respondents reported
that they or a member of their immediate family had chosen not to seek
services for a physical or mental health condition due to fear of harm
to job prospects or other life opportunities. It should be noted that
this survey is somewhat dated and represents only one estimate.
oreover, given the wording of the question, there are other reasons
aside from privacy concerns that led these individuals to respond
positively.
For the purpose of an illustration, however, assumptions can be
made about what proportion of the 7 percent responding affirmatively to
this question may have avoided seeking mental health services due to
privacy concerns. Given the proportion of mental health services that
compromise total health care services in this country, a reasonable
upper limit of the number of individuals avoiding mental health
treatment due to privacy concerns might be 1.8 percent (i.e., 25% of
7%), while a reasonable lower limit might be 0.36 percent (i.e., 5% of
7%). Taking these figures as upper and lower limits, it is possible to
estimate potential benefits by multiplying these figures by the annual
economic cost reductions associated with treatment effectiveness rates.
For example, using the upper limit of 1.8 percent, multiplying this by
the annual economic costs of mental illness ($115.5 billion) and a
treatment effectiveness rate of 80 percent, yields an estimate of
potential annual benefits of $1,663,200,000. Similarly, using the upper
limit of 1.8 percent coupled with a treatment effectiveness rate of 50
percent yields an estimate of potential annual benefits of
$1,039,500,000. Assuming a lower limit of 0.36 percent more individuals
seeking mental health treatment due to enhance privacy protections,
coupled with a treatment effectiveness rate of 80% yields an estimate
of potential annual benefits of $332,640,000. Similarly, using the
lower limit of 0.36 percent coupled with a treatment effectiveness rate
of 50 percent yields an estimate of potential annual benefits of
$207,900,000. Therefore, given the existing data on the annual economic
costs of mental illness and the rates of treatment effectiveness for
these disorders, coupled with assumptions regarding the percentage of
individuals who might seek mental health treatment under conditions of
greater privacy protections, the potential additional economic benefit
in this one treatment area could range from approximately $208 million
to $1.67 billion annually.
Table 3.--Potential Benefits of the Proposed Privacy Regulation From
Cost Savings Due to Early Treatment of Mental Health Disorders
------------------------------------------------------------------------
Total annual Percent net cost
economic cost of reduction if
Illness illness (in additional care
billions) is received
------------------------------------------------------------------------
ental Health--Anxiety Disorders.... $46.6 70-90
ental Health--Depressive (Mood) 30.4 60-80
Disorders..........................
ental Health--Eating Disorders..... 6.0 40-60
ental Health--Schizophrenia........ 32.5 60-85
-----------------------------------
Total........................... 115.5 N/A
------------------------------------------------------------------------
[[Page 60022]]
G. Examination of Alternative Approaches
1. Creation of De-identified Information (164.506(d))
We considered defining "individually identifiable health
information" as any information that is not anonymous, that is, for
which there is any possibility of identifying the subject. We rejected
this option, for several reasons. First, the statute suggests a
different approach. The term "individually identifiable health
information" is defined in HIPAA as health information that:
* * * identifies the individual, or with respect to which there is a
reasonable basis to believe that the information can be used to
identify the individual.
By including the modifier "reasonable basis," Congress appears to
reject the absolute approach to defining "identifiable." Covered
entities would not always have the statistical sophistication to know
with certainty when sufficient identifying information has been removed
so that the record is no longer identifiable. We believe that covered
entities need more concrete guidance as to when information will and
will not be "identifiable" for purposes of this regulation.
Defining non-identifiable to mean anonymous would require covered
entities to comply with the terms of this regulation with respect to
information for which the probability of identification of the subject
is very low. We want to encourage covered entities and others to remove
obvious identifiers or encrypt them whenever possible; use of the
absolute definition of "identifiable" would not promote this salutary
result.
For these reasons, we propose at Sec. 164.506(d)(2)(ii) that there
be a presumption that, if specified identifying information is removed
and if the holder has no reason to believe that the remaining
information can be used by the reasonably anticipated recipients alone
or in combination with other information to identify an individual,
then the covered entity would be presumed to have created de-identified
information.
At the same time, in proposed Sec. 164.506(d)(2)(iii), we are
leaving leeway for more sophisticated data users to take a different
approach. We are including a "reasonableness" standard so that
entities with sufficient statistical experience and expertise could
remove or code a different combination of information, so long as the
result is still a low probability of identification. With this
approach, our intent is to provide certainty for most covered entities,
while not limiting the options of more sophisticated data users.
In this rule we are proposing that covered entities and their
business partners be permitted to use protected health information to
create de-identified health information. Covered entities would be
permitted to further use and disclose such de-identified information in
any way, provided that they do not disclose the key or other mechanism
that would enable the information to be re-identified, and provided
that they reasonably believe that such use or disclosure of de-
identified information will not result in the use or disclosure of
protected health information. See proposed Sec. 164.506(d)(1). This
means that a covered entity could not disclose de-identified
information to a person if the covered entity reasonably believes that
the person would be able to re-identify some or all of that
information, unless disclosure of protected health information to such
person would be permitted under this proposed rule. In addition, a
covered entity could not use or disclose the key to coded identifiers
if this rule would not permit the use or disclosure of the identified
information to which the key pertains. If a covered entity re-
identifies the de-identified information, it may only use or disclose
the re-identified information consistent with these proposed rules, as
if it were the original protected health information.
We invite comment on the approach that we are proposing and on
whether alternative approaches to standards for entities determining
when health information can reasonably be considered no longer
individually identifiable should be considered.
2. General Rules (Sec. 164.506)
As a general rule, we are proposing that protected health
information not be used or disclosed by covered entities except as
authorized by the individual who is the subject of such information or
as explicitly provided this rule. Under this proposal, most uses and
disclosures of an individual's protected health information would not
require explicit authorization by the individual, but would be
restricted by the provisions of the rule. Covered entities would be
able to use or disclose an individual's protected health information
without authorization for treatment, payment and health care
operations. See proposed Sec. 164.506(a)(1)(i). Covered entities also
would be permitted to use or disclose an individual's protected health
information for specified public and public policy-related purposes,
including public health, research, health oversight, law enforcement,
and use by coroners. Covered entities would be permitted by this rule
to use and disclose protected health information when required to do so
by other law, such as a mandatory reporting requirement under State law
or pursuant to a search warrant. See proposed Sec. 164.510. Covered
entities would be required by this rule to disclose protected health
information for only two purposes: to permit individuals to inspect and
copy protected health information about them (see proposed
Sec. 164.514) and for enforcement of this rule (see proposed
Sec. 164.522(d)).
Covered entities of all types and sizes would be required to comply
with the proposed privacy standards outlined below. The proposed
standards would not impose particular mechanisms or procedures that
covered entities must adopt to implement the standards. Instead, we
would require that each affected entity assess its own needs and
devise, implement, and maintain appropriate privacy policies,
procedures, and documentation to address its business requirements. How
each privacy standard would be satisfied would be a business decision
that each entity would have to make. This permits the privacy standards
to establish a stable baseline, yet remain flexible enough to take
advantage of developments and methods for protecting privacy that will
evolve over time.
Because the privacy standards would need to be implemented by all
covered entities, from the smallest provider to the largest, multi-
state health plan, a single approach to implementing these standards
would be neither economically feasible nor effective in safeguarding
health information privacy. For example, in a small physician practice
the office manager might be designated to serve as the privacy official
as one of many duties (see proposed Sec. 164.518(a)) whereas at a large
health plan, the privacy official may constitute a full time position
and have the regular support and advice of a privacy staff or board.
In taking this approach, we intend to strike a balance between the
need to maintain the confidentiality of protected health information
and the economic cost of doing so. Health care entities must consider
both aspects in devising their solutions. This approach is similar to
the approach we proposed in the Notice of Proposed Rulemaking for the
administrative simplification security and electronic signature
standards.
[[Page 60023]]
3. Use and Disclosure for Treatment, Payment, and Health Care
Operations (Sec. 164.506(a))
We are proposing that, subject to limited exceptions for
psychotherapy notes and research information unrelated to treatment
discussed below, a covered entity be permitted to use or disclose
protected health information without individual authorization for
treatment, payment or health care operations.
We are not proposing to require individual authorizations of uses
and disclosures for health care and related purposes, although such
authorizations are routinely gathered today as a condition of obtaining
health care or enrolling in a health plan. Although many current
disclosures of health information are made pursuant to individual
authorizations, these authorizations provide individuals with little
actual control over their health information. When an individual is
required to sign a blanket authorization at the point of receiving care
or enrolling for coverage, that consent is often not voluntary because
the individual must sign the form as a condition of treatment or
payment for treatment. Individuals are also often asked to sign broad
authorizations but are provided little or no information about how
their health information would be or will in fact be used. Individuals
cannot make a truly informed decision without knowing all the possible
uses, disclosures and re-disclosures to which their information will be
subject. In addition, since the authorization usually precedes creation
of the record, the individual cannot predict all the information the
record could contain and therefore cannot make an informed decision as
to what would be released.
Our proposal is intended to make the exchange of protected health
information relatively easy for health care purposes and more difficult
for purposes other than health care. For individuals, health care
treatment and payment are the core functions of the health care system.
This is what they expect their health information will be used for when
they seek medical care and present their proof of insurance to the
provider. Consistent with this expectation, we considered requiring a
separate individual authorization for every use or disclosure of
information but rejected such an approach because it would not be
realistic in an increasingly integrated health care system. For
example, a requirement for separate patient authorization for each
routine referral could impair care, by delaying consultation and
referral as well as payment.
We therefore propose that covered entities be permitted to use and
disclose protected health information without individual authorization
for treatment and payment purposes, and for related purposes that we
have defined as health care operations. For example, providers could
maintain and refer to a medical record, disclose information to other
providers or persons as necessary for consultation about diagnosis or
treatment, and disclose information as part of referrals to other
providers. Providers also could use a patient's protected health
information for payment purposes such as submitting a claim to a payer.
In addition, providers could use a patient's protected health
information for health care operations, such as use for an internal
quality oversight review. We would note that, in the case of an
individual where the provider has agreed to restrictions on use or
disclosure of the patient's protected health information, the provider
would be bound by such restrictions as provided in Sec. 164.506(c).
We also propose to prohibit covered entities from seeking
individual authorization for uses and disclosures for treatment,
payment and health care operations unless required by State or other
applicable law. As discussed above in section II.C, such authorizations
could not provide meaningful privacy protections or individual control
and could in fact cultivate in individuals erroneous understandings of
their rights and protections.
The general approach that we are proposing is not new. Some
existing State health confidentiality laws permit disclosures without
individual authorization to other health care providers treating the
individual, and the Uniform Health-Care Information Act permits
disclosure "to a person who is providing health-care to the patient"
(9 Part I, U.L.A. 475, 2-104 (1988 and Supp. 1998)). We believe that
this approach would be the most realistic way to protect individual
confidentiality in an increasingly data-driven, electronic and
integrated health care system. We recognize, however, that particularly
given the limited scope of the authority that we have under this
proposed rule to reach some significant actors in the health care
system, that other approaches could be of interest. We invite comments
on whether other approaches to protecting individuals' health
information would be more effective.
4. Minimum Necessary Use and Disclosure (Sec. 164.506(b))
We propose that, except as discussed below, a covered entity must
make all reasonable efforts not to use or disclose more than the
minimum amount of protected health information necessary to accomplish
the intended purpose of the use or disclosure, taking into
consideration technological limitations.
Under this proposal, covered entities generally would be required
to establish policies and procedures to limit the amount of protected
health care information used or disclosed to the minimum amount
necessary to meet the purpose of the use or disclosure, and to limit
access to protected health information only to those people who need
access to the information to accomplish the use or disclosure. With
respect to use, if an entity consists of several different components,
the entity would be required to create barriers between components so
that information is not used inappropriately. The same principle
applies to disclosures.
A "minimum necessary" determination would need to be consistent
with and directly related to the purpose of the use or disclosure and
take into consideration the ability of a covered entity to delimit the
amount of information used or disclosed and the relative burden imposed
on the entity. The proposed minimum necessary requirement is based on a
reasonableness standard: covered entities would be required to make
reasonable efforts and to incur reasonable expense to limit the use and
disclosure of protected health information as provided in this section.
In our discussions of the minimum necessary requirement, we
considered whether or not this should apply to all entities and whether
or not it should be applied to all protected health information. We
decided that the principle of minimum necessary disclosure is critical
to the protection of privacy and that because small entities represent
83 percent of the health care industry, we would not exempt them from
this provision without undermining its effectiveness.
We understand that the requirements outlined in this section do not
create a bright line test for determining the minimum necessary amount
of protected health information appropriate for most uses or
disclosures. Because of this lack of precision, we considered
eliminating the requirement altogether. We also considered merely
requiring covered entities to address the concept within their internal
privacy
[[Page 60024]]
procedures, with no further guidance as to how each covered entity
would address the issue. These approaches were rejected because
minimizing both the amount of protected health information used and
disclosed within the health care system and the number of persons who
have access to such information is vital if we are to successfully
enhance the confidentiality of people's personal health information. We
invite comments on the approach that we have adopted and on alternative
methods of implementing the minimum necessary principle.
5. Right To Restrict Uses and Disclosures (Sec. 164.506(c))
We propose to permit in Sec. 164.506(c) that individuals be able to
request that a covered entity restrict further uses and disclosures of
protected health information for treatment, payment, or health care
operations, and if the covered entity agrees to the requested
restrictions, the covered entity could not make uses or disclosures for
treatment, payment or health care operations that are inconsistent with
such restrictions, unless such uses or disclosures are mandated by law.
This provision would not apply to health care provided to an individual
on an emergency basis.
We should note that there is nothing in this proposed rule that
would require a covered entity to agree to a request to restrict, or to
treat or provide coverage to an individual requesting a restriction
under this provision. Covered entities who do not wish to, or due to
contractual obligations cannot, restrict further use or disclosure are
not obligated to agree to a request under this provision.
We considered providing individuals substantially more control over
their protected health information by requiring all covered entities to
attempt to accommodate any restrictions on use and disclosure requested
by patients. We rejected this option as unworkable. While industry
groups have developed principles for requiring patient authorizations,
we have not found widely accepted standards for implementing patient
restrictions on uses or disclosures. Restrictions on information use or
disclosure contained in patient consent forms are sometimes ignored
because they may not be read or are lost in files. Thus, it seems
unlikely that a requested restriction could successfully follow a
patient's information through the health care system--from treatment to
payment, through numerous operations, and potentially through certain
permissible disclosures. Instead we would limit the provision to
restrictions that have been agreed to by the covered entity.
We recognize that the approach that we are proposing could be
difficult because of the systems limitations described above. However,
we believe that the limited right for patients proposed in this
proposed rule can be implemented because it only applies in instances
in which the covered entity agrees to the restrictions. We assume that
covered entities would not agree to restrictions that they are unable
to implement.
We considered limiting the rights under this provision to patients
who pay for their own health care (or for whom no payment was made by a
health plan). Individuals and providers that engage in self-pay
transactions have minimal effect on the rights or responsibilities or
payers or other providers, and so there would be few instances when a
restriction agreed to in such a situation would have negative
implications for the interests of other health care actors. Limiting
the right to restrict to self-pay patients also would reduce the number
of requests that would be made under this provision. We rejected this
approach, however, because the desire to restrict further uses and
disclosures arises in many instances other than self-pay situations.
For example, a patient could not want his or her records shared with a
particular physician because that physician is a family friend. Or an
individual could be seeking a second opinion and may not want his or
her treating physician consulted. Individuals have a legitimate
interest in restricting disclosures in these situations. We solicit
comment on the appropriateness of limiting this provision to instances
in which no health plan payment is made on behalf of the individual.
6. Application to Business Partners (Sec. 164.506(e))
In Sec. 164.506(e), we propose to require covered entities to take
specific steps to ensure that protected health information disclosed to
a business partner remains protected. We intend these provisions to
allow customary business relationships in the health care industry to
continue while providing privacy protections to the information shared
in these relationships. Business partners would not be permitted to use
or disclose protected health information in ways that would not be
permitted of the covered entity itself under these rules.
Other than for purposes of consultation or referral for treatment,
we would allow covered entities to disclose protected health
information to business partners only pursuant to a written contract
that would, among other specified provisions, limit the business
partner's uses and disclosures of protected health information to those
permitted by the contract, and would impose certain security,
inspection and reporting requirements on the business partner. We would
hold the covered entity responsible for certain violations of this
proposed rule made by their business partners, and require assignment
of responsibilities when a covered entity acts as a business partner of
another covered entity.
Under this proposed rule, a business partner would be acting on
behalf of a covered entity, and we propose that its use or disclosure
of protected health information be limited to the same extent that the
covered entity for whom they are acting would be limited. Thus, a
business partner could have no more authority to use or disclose
protected health information than that possessed by the covered entity
from which the business partner received the information. We would note
that a business partner's authority to use and disclose protected
health information could be further restricted by its contract with a
covered entity, as described below.
We are not proposing to require the business partners of covered
entities to develop and distribute a notice of information practices,
as provided in proposed Sec. 164.512. A business partner would,
however, be bound by the terms of the notice of the covered entity from
which it obtains protected health information. See proposed
Sec. 164.506(e). We are proposing this approach so that individuals
could rely on the notices that they receive from the covered entities
to which they disclose protected health information. If the business
partners of a covered entity were able to make wider use or make more
disclosures than the covered entity, the patients or enrollees of the
covered entity would have difficulty knowing how their information was
being used and to whom it was being disclosed.
We are also proposing that a business partner's use and disclosure
of protected health information be limited by the terms of the business
partner's contractual agreement with the covered entity. We propose
that a contract between a covered entity and a business partner could
not grant the business partner authority to make uses or disclosures of
protected health information that the covered entity itself would not
have the authority to make. The contract between a covered entity and a
business partner could further limit the business partner's authority
to
[[Page 60025]]
use or disclose protected health information as agreed to by the
parties. Further, the business partner would have to apply the same
limitations to its subcontractors (or persons with similar
arrangements) who assist with or carry out the business partner's
activities.
To help ensure that the uses and disclosures of business partners
are limited to those recognized as appropriate by the covered entities
from whom they receive protected health information, subject to the
exception discussed below, we are proposing that covered entities be
prohibited from disclosing protected health information to a business
partner unless the covered entity has entered into a written contract
with the business partner that meets the requirements of this
subsection. See proposed Sec. 164.506(e)(2)(i).
The contract requirement that we are proposing would permit covered
entities to exercise control over their business partners' activities
and provides documentation of the relationship between the parties,
particularly the scope of the uses and disclosures of protected health
information that business partners could make. The presence of a
contract also would formalize the relationship, better assuring that
key questions such as security, scope of use and disclosure, and access
by subject individuals are adequately addressed and that the roles of
the respective parties are clarified. Finally, a contract can bind the
business partner to return any protected health information from the
covered entity when the relationship is terminated.
In lieu of a contracting requirement, we considered imposing only
affirmative duties on covered entities to ensure that their
relationships with business partners conformed to the standards
discussed in the previous paragraph. Such an approach could be
considered less burdensome and restrictive, because we would be leaving
it to the parties to determine how to make the standards effective. We
rejected this approach primarily because we believe that in the vast
majority of cases, the only way that the parties could establish a
relationship with these terms would be through contract. We also
determined that the value of making the terms explicit through a
written contract would better enable the parties to know their roles
and responsibilities, as well as better enable the Secretary to
exercise her oversight role. In addition, we understand that most
covered entities already enter into contracts in these situations and
therefore this proposal would not disturb general business practice. We
invite comment on whether there are other contractual or non-
contractual approaches that would afford an adequate level of
protection to individuals' protected health information. We also invite
comment on the specific provisions and terms of the proposed approach.
We are proposing one exception to the contracting requirement: when
a covered entity consults with or makes a referral to another covered
entity for the treatment of an individual, we would propose that the
sharing of protected health information pursuant to that consultation
or referral not be subject to the contracting requirement described
above. See proposed Sec. 164.506(e)(1)(i). Unlike most business partner
relationships, which involve the systematic sharing of protected health
information under a business relationship, consultation and referrals
for treatment occur on a more informal basis among peers, and are
specific to a particular individual. Such exchanges of information for
treatment also appear to be less likely to raise concerns about further
impermissible use or disclosure, because providers receiving such
information are unlikely to have a commercial or other interest in
using or disclosing the information. We invite comment on the
appropriateness of this exception, and whether there are additional
exceptions that should be included in the final regulation.
We note that covered health care providers receiving protected
health information for consultation or referral purposes would still be
subject to this rule, and could not use or disclose such protected
health information for a purpose other than the purpose for which it
was received (i.e., the consultation or referral). Further, we note
that providers making disclosures for consultations or referrals should
be careful to inform the receiving provider of any special limitations
or conditions to which the disclosing provider has agreed to impose
(e.g., the disclosing provider has provided notice to its patients that
it will not make disclosures for research).
We are proposing that covered entities be accountable for the uses
and disclosures of protected health information by their business
partners. A covered entity would be in violation of this rule if the
covered entity knew or reasonably should have known of a material
breach of the contract by a business partner and it failed to take
reasonable steps to cure the breach or terminate the contract. See
proposed Sec. 164.506(e)(2)(iii). A covered entity that is aware of
impermissible uses and disclosures by a business partner would be
responsible for taking such steps as are necessary to prevent further
improper use or disclosures and, to the extent practicable, for
mitigating any harm caused by such violations. This would include, for
example, requiring the business partner to retrieve inappropriately
disclosed information (even if the business partner must pay for it) as
a condition of continuing to do business with the covered entity. A
covered entity that knows or should know of impermissible use of
protected health information by its business partner and fails to take
reasonable steps to end the breach would be in violation of this rule.
We considered requiring covered entities to terminate relationships
with business partners if the business partner committed a serious
breach of contact terms required by this subpart or if the business
partner exhibited a pattern or practice of behavior that resulted in
repeated breaches of such terms. We rejected that approach because of
the substantial disruptions in business relationships and customer
service when terminations occur. We instead require the covered entity
to take reasonable steps to end the breach and mitigate its effects. We
would expect covered entities to terminate the arrangement if it
becomes clear that a business partner cannot be relied upon to maintain
the privacy of protected health information provided to it. We invite
comments on our approach here and whether requiring automatic
termination of business partner contracts would be warranted in any
circumstances.
We also considered imposing more strict liability on covered
entities for the actions of their business partners, just as principals
are strictly liable for the actions of their agents under common law.
We decided, however, that this could impose too great a burden on
covered entities, particularly small providers. We are aware that, in
some cases, the business partner will be larger and more sophisticated
with respect to information handling than the covered entity. Therefore
we instead opted to propose that covered entities monitor use of
protected health information by business partners, and be held
responsible only when they knew or should have known of improper use of
protected health information.
Our intention in this section is to recognize the myriad of
business relationships that currently exist and to ensure that when
they involve the exchange of protected health information, the roles
and responsibilities of the different parties with respect to the
protected health
[[Page 60026]]
information are clear. We do not propose to fundamentally alter the
types of business relationships that exist in the health care industry
or the manner in which they function. We request comments on the extent
to which our proposal would disturb existing contractual or other
arrangements among covered entities and business partners.
7. Application to Information About Deceased Persons (Sec. 164.506(f))
We are proposing that information otherwise protected by these
regulations retain that protection for two years after the death of the
subject of the information. The only exception that we are proposing is
for uses and disclosures for research purposes.
HIPAA includes no temporal limitations on the application of the
privacy protections. Although we have the authority to protect
individually identifiable health information maintained by a covered
entity indefinitely, we are proposing that the requirements of this
rule generally apply for only a limited period, as discussed below. In
traditional privacy law, privacy interests, in the sense of the right
to control use or disclosure of information about oneself, cease at
death. However, good arguments exist in favor both of protecting and
not protecting information about the deceased. Considering that one of
the underlying purposes of health information confidentiality is to
encourage a person seeking treatment to be frank in the interest of
obtaining care, there is good reason for protecting information even
after death. Federal agencies and others sometimes withhold sensitive
information, such as health information, to protect the privacy of
surviving family members. At the same time, perpetual confidentiality
has serious drawbacks. If information is needed for legitimate
purposes, the consent of a living person legally authorized to grant
such consent must be obtained, and the further from the date of death,
the more difficult it may be to identify the person. The administrative
burden of perpetual protection may eventually outweigh the privacy
interests served.
While various State laws have been passed specifically addressing
privacy of genetic information, there is currently no federal
legislation that deals with these issues. We considered extending the
two-year period for genetic and hereditary information, but were unable
to construct criteria for protecting the possible privacy interests of
living children without creating extensive burden for information
holders and hampering health research. We invite comments on whether
further action is needed in this area and what types of practical
provisions may be appropriate to protect genetic and hereditary health
information.
8. Uses and Disclosures With Individual Authorization (Sec. 164.508)
Covered entities would be required to obtain individual
authorization to use individually identifiable health information for
purposes other than those allowed under the rule. Activities requiring
authorization include, for example, marketing. Costs will be ongoing
for staffing and administrative activities related to obtaining
authorization from individuals.
Our proposal is based on the precept that a combination of strict
limits on how covered entities can use and disclose protected health
information, adequate notice to individuals about how their information
will be used, and guaranteeing individuals' rights to inspect, copy and
amend their health records will provide patients with better privacy
protection and more effective control over their information than
alternative approaches to privacy protection.
This section addresses the requirements that we are proposing when
protected health information is disclosed pursuant to the individual's
explicit authorization. The regulation would require that covered
entities have authorization from individuals before using or disclosing
their protected health information for any purpose not otherwise
recognized by this regulation. Circumstances where an individual's
protected health information could be used or disclosed without
authorization are discussed in connection with proposed Secs. 164.510
and 164.522 below.
This section proposes different conditions governing such
authorizations in two situations in which individuals commonly
authorize covered entities to disclose information:
Where the individual initiates the authorization because
he or she wants a covered entity to disclose his or her record, and
Where a covered entity asks an individual to authorize it
to disclose or use information for purposes other than treatment,
payment or health care operations.
The requirements proposed in this section are not intended to
interfere with normal uses and disclosures of information in the health
care delivery or payment process, but only to allow control of uses
extraneous to health care. The restrictions on disclosure that the
regulation would apply to covered entities may mean that some existing
uses and disclosures of information could take place only if the
individual explicitly authorized them under this section.
We considered requiring a uniform set of requirements for all
authorizations, but concluded that it would be appropriate to treat
authorizations initiated by the individual differently from
authorizations sought by covered entities. There are fundamental
differences, in the uses of information and in the relationships and
understandings among the parties, in these two situations. When
individuals initiate authorizations, they are more likely to understand
the purpose of the release and to benefit themselves from the use or
disclosure. When a covered entity asks the individual to authorize
disclosure, we believe the entity should make clear what the
information will be used for, what the individual's rights are, and how
the covered entity would benefit from the requested disclosure.
We are proposing several requirements that would have to be met in
the authorization process when the individual has initiated the
authorization. We understand that the requirements that we are imposing
here would make it quite unlikely that an individual could actually
initiate a completed authorization, because few individuals would know
to include all of these elements in a request for information. In most
instances, individuals authorize a use or disclosure by completing a
form provided by a third party, either the ultimate recipient of the
information (who may have a form authorizing them to obtain the records
from the record holders) or a health care provider or health plan
holding the records (who may have a form that documents a request for
the release of records to a third party). For this reason, we do not
believe that our proposal would create substantial new burdens on
individuals or covered entities in cases when an individual is
initiating an authorized release of information. We invite comment on
whether we are placing new burdens on individuals or covered entities.
We also invite comment on whether the approach that we have proposed
provides sufficient protection to individuals who seek to have their
protected health information used or disclosed.
We are proposing that when covered entities initiate the
authorization by asking individuals to authorize disclosure, the
authorization be required to include all of the items required above as
well as several additional items. We are proposing additional
[[Page 60027]]
requirements when covered entities initiate the request for
authorization, because in many cases it could be the covered entity,
and not the individual, that achieves the primary benefit of the
disclosure. We considered permitting covered entities to request
authorizations with only the basic features proposed for authorizations
initiated by the individual, for the sake of simplicity and
consistency. However, we believe that additional protections are
merited when the entity that provides or pays for health care requests
authorizations to avert possible coercion.
We also acknowledge that there will be costs related to moving away
from a blanket authorization system. These costs will be discussed more
explicitly in the sections on allowable disclosures (both with and
without authorization).
Covered entities and third parties that wish to have information
disclosed to them will prepare forms for individuals to use to
authorize use or disclosure. A model authorization form is displayed in
Appendix A to this proposed rule. We considered presenting separate
model forms for the two different types of authorizations (initiated by
the individual and not initiated by the individual). However, this
approach could be subject to misuse and be confusing to covered
entities and individuals, who may be unclear as to which form is
appropriate in specific situations. The model in the appendix
accordingly is a unitary model, which includes all of the requirements
for both types of authorization. By following such a model, covered
entities, particularly small entities, could avoid the legal and
administrative expenses that would be necessary to develop an
authorization form that complies with the rule's requirements. The
proposed rule does not prevent entities from developing or modifying
their own authorization forms. The alternative to providing this model
was to simply state that an authorization would be required and allow
entities to develop the authorization independently. While we would
specify some information required in the authorization in this
alternative, we would not give an actual form. This was considered to
be an unnecessary burden for entities.
Finally, we are proposing that an individual be permitted to revoke
an authorization at any time except to the extent that action has been
taken in reliance on the authorization. See proposed Sec. 164.508(e).
9. Uses and Disclosures Permitted Without Individual Authorization
(Sec. 164.510)
This section describes uses and disclosures of protected health
information that covered entities could make for purposes other than
treatment, payment, and health care operations without individual
authorization, and the conditions under which such uses and disclosures
could be made. We propose to allow covered entities to use or disclose
protected health information without individual authorization for such
purposes if the use or disclosure would comply with the applicable
requirements of this section.
Covered entities could need to reevaluate and modify their
operating procedures to comply with the proposed rule's prohibition on
disclosing individually identifiable health information without patient
authorization for any purpose other than treatment, payment, health
care operations, or those situations explicitly identified as
permissible disclosures under this proposed rule. Many entities could
already do this. Entities that do not do this would need to alter
information management systems and implement administrative policies
and procedures to prevent inappropriate disclosures. Entities would
also have to determine whether or not an authorization is necessary for
each disclosure beyond treatment, payment, and health care operations
that is not explicitly defined as a permissible disclosure under this
proposed rule. It should be noted that the minimum necessary principle
is an important component of the costs related to any disclosure. We
expect that there would be significant initial and ongoing costs.
If an entity chooses to disclose protected health information
without authorization from individuals, there would be a number of new
provisions that it would have to comply with. For example, if a
disclosure is to researchers outside of the organization, the entity
must obtain written documentation indicating that the research has been
approved by an institutional review board (IRB) or equivalent process
by a privacy board. This requirement is associated with ongoing
administrative costs. We note that any such costs are optional unless
other requirements (state laws, mandatory reporting systems, etc.)
mandate these disclosures. In order to minimize the burden of these
costs for mandatory disclosures, we have tried to apply as few business
partner requirements as possible in areas where these mandatory
disclosures are possible. However, in cases where the disclosure is
optional, entities would have higher costs if they choose to use these
disclosures. We expect that entities would consider these costs before
making any such disclosure and determine if the benefits to their
business of disclosure are greater than the costs related to making the
disclosure. Additionally, other than the new requirements for
disclosures for research, most of the disclosures are simply
recognizing current practices and would not require large new costs.
We considered permitting uses and disclosures only where law
affirmatively requires the covered entity to use or disclose protected
health information. However, because the activities described below are
so important to the population as a whole, we decided to permit a
covered entity to use or disclose information to promote those
activities even when such activities are not legally mandated. In some
cases, however, we would permit a use or disclosure only when such use
or disclosure is authorized by other law. The requirements for
verification of legal authority are discussed in section II.G.3.
Disclosures that are required by current law would only require
minimal additional costs to entities. The only cost directly
attributable to this proposed requirement would be the additional cost
of noting these disclosures on the accounting of uses and disclosures.
However, disclosures required by this proposed regulation should be
considered new costs. These mandatory disclosures would be extremely
rare. For example, we expect that the Department would limit the number
of compliance audits conducted. In these cases, some of the more
expensive activities, including the minimum necessary principle and
determining whether or not to make the disclosure, would not be
applicable.
We would restrict the discussion of discretionary disclosures to
the general principles behind such disclosures rather than a detailed
description of each allowable disclosure. More elaborate discussion of
options for individual classes of disclosures can be found in the
preamble. These disclosures are optional disclosures and therefore, any
costs related to making these disclosures would incur optional costs.
We do not have a complete understanding of how often these disclosures
are currently made, nor do we understand what procedures are currently
in place. We also do not understand how often these disclosures would
be made given the new costs associated with such disclosures. Note
[[Page 60028]]
that the degree of new costs imposed if an entity opts to use a
disclosure varies dramatically depending on the type of disclosure. For
example, a disclosure of directory information in a hospital would
probably not involve significant additional costs, while research that
is not subject to the common could would have significant new costs
involved. These disclosures, and thus these costs, are optional under
this proposed rule. While they may be mandated under other law, such
mandated disclosures are already being made, so there would be no
additional costs. In this case there are only marginal new costs
related to these disclosures.
10. Clearinghouses and the Rights of Individuals
The rights described below would apply with respect to protected
health information held by health care providers and health plans. We
are proposing that clearinghouses not be subject to all of these
requirements. We believe that as business partners of covered plans and
providers, clearinghouses would not usually initiate or maintain direct
relationships with individuals. The contractual relationship between a
clearinghouse (as a business partner) and a covered plan or provider
would bind the clearinghouse to the notice of information practices
developed by the plan or provider and it would include specific
provisions regarding inspection, copying, amendment and correction.
Therefore, we do not believe that clearinghouses should be required to
provide a notice or provide access for inspection, copying, amendment
or correction. We would require clearinghouses to provide an accounting
of any disclosures for purposes other than treatment, payment and
health care operations to individuals upon request. See proposed
Sec. 164.515. It is our understanding that the vast majority of the
clearinghouse function falls within the scope of treatment, payment,
and health care operations and therefore we do not believe providing
this important right to individuals would impose a significant burden
on the industry. We invite comment on whether or not we should require
clearinghouses to comply with all of the provisions of the individual
rights section.
11. Rights and Procedures for a Written Notice of Information Practices
(Sec. 164.512)
We are proposing that individuals have a right to an adequate
notice of the information practices of covered plans and providers. The
notice would be intended to inform individuals about what is done with
their protected health information and about any rights they may have
with respect to that information. Federal agencies must adhere to a
similar notice requirement pursuant to the Privacy Act of 1974 (5
U.S.C. 552a(e)(3)).
We are not proposing that business partners (including health care
clearinghouses) be required to develop a notice of information
practices because, under this proposed rule, they would be bound by the
information practices of the health plan or health care provider with
whom they are contracting.
The rule requires covered entities to prepare and make available a
notice that informs patients about their privacy rights and the
entity's actions to protect privacy. Entities that do not already
comply with the rule's requirements would incur one-time legal and
administrative costs in preparing and making the notice available. In
addition, plans would incur ongoing costs related to the dissemination
of the notice at least once every three years, and all covered entities
would have ongoing costs related to preparation of new notices as
disclosure practices change, dissemination to new individuals who
receive services, and requests for copies of the notice. Entities would
also incur ongoing costs related to answering questions stemming from
the notice. In addition to requiring a basic notice, we considered
requiring a longer more detailed notice, that would be available to
individuals on request. However, we decided that making information
available on request, and letting the covered entity decide how best to
provide such information, is a more balanced approach. We felt that it
would be overly burdensome to all entities, especially small entities,
to require two notices.
We considered requiring covered plans or providers to obtain a
signed copy of the notice form (or some other signed indication of
receipt) when they give the form to individuals. There are advantages
to including such a requirement. A signed acknowledgment would provide
evidence that the notice form has been provided to the individual.
Further, the request to the individual to formally acknowledge receipt
would highlight the importance of the notice, providing additional
encouragement for the individual to read it and ask questions about its
content.
We are concerned, however, that requiring a signed acknowledgment
would significantly increase the administrative and paperwork burden of
this provision. We also are unsure of the best way for health plans to
obtain a signed acknowledgment because plans often do not have face-to-
face contact with enrollees. It may be possible to collect an
acknowledgment at initial enrollment, for example by adding an
additional acknowledgment to the enrollment form, but it is less clear
how to obtain it when the form is revised. We solicit comment on
whether we should require a signed acknowledgment. Comments that
address the relative advantages and burdens of such a provision would
be most useful. We also solicit comment on the best way to obtain
signed acknowledgments from health plans if such a provision is
included in the final rule. We also solicit comments on other
strategies, not involving signed acknowledgments, to ensure that
individuals are effectively informed about the information practices of
covered plans or providers.
We believe that the proposed rule appropriately balances a
patient's need for information and assurances regarding privacy with
the covered entities' need for flexibility in describing their
operations and procedures to protect patient privacy. Instead of a
model notice, we have included a sample notice to guide the development
of notices. We felt that this would be an appropriate way to reduce the
burden on all entities including those classified as small.
In Sec. 164.512, we propose the categories of information that
would be required in each notice of information practices, the specific
types of information that would have to be included in each category,
and general guidance as to the presentation of written materials. A
sample notice is provided at Appendix A of this preamble.
In a separate section of this proposed rule, we would require
covered plans or providers to develop and document policies and
procedures relating to use, disclosure, and access to protected health
information. See proposed Sec. 164.520. We intend for the documentation
of policies and procedures to be a tool for educating the entity's
personnel about its policies and procedures. In addition, the
documentation would be the primary source of information for the notice
of information practices. We intend for the notice to be a tool for
educating individuals served by the covered plan or provider about the
information practices of that entity. The information contained in the
notice would not be as comprehensive as the documentation, but rather
would provide a clear and concise summary of relevant policies and
procedures.
[[Page 60029]]
We considered prescribing specific language that each covered plan
or provider would include in its notice. The advantages of this
approach would be that the recipient would get exactly the same
information from each covered plan or provider in the same format, and
that it would be convenient for covered plans or providers to use a
uniform model notice.
There are, however, several disadvantages to this approach. First,
and most important, no model notice could fully capture the information
practices of every covered plan or provider. Large entities would have
different information practices than small entities. Some health care
providers, for example academic teaching hospitals, may routinely
disclose identifiable health information for research purposes. Other
health care providers may rarely or never make such disclosures. To be
useful to individuals, each entity's notice of information practices
should reflect its unique privacy practices.
Another disadvantage of prescribing specific language is that it
would limit each covered plan or provider's ability to distinguish
itself in the area of privacy protections. We believe that if
information on privacy protections were readily available, individuals
might compare and select plans or providers based on their information
practices. In addition, a uniform model notice could easily become
outdated. As new communication methods or technologies are introduced,
the content of the notices might need to reflect those changes.
In proposed Sec. 164.512, we would require each covered plan and
provider to include in the notice an explanation of how it uses and
discloses protected health information. The explanation must be
provided in sufficient detail as to put the individual on notice of the
uses and disclosures expected to be made of his or her protected health
information. As explained above in section II.C.7, covered plans and
providers may only use and disclose protected health information for
purposes stated in this notice.
We considered requiring the notice to include not only a discussion
of the actual disclosure practices of the covered entity, but also a
listing or discussion of all additional disclosures that are authorized
by law. We considered this approach because, under this proposed rule,
covered plans or providers would be permitted to change their
information practices at any time, and therefore individuals would not
be able to rely on the entity's current policies alone to understand
how their protected health information may be used in the future. We
recognize that in order to be fully informed, individuals need to
understand when their information could be disclosed.
We rejected this approach because we were concerned that a notice
with such a large amount of information could be burdensome to both the
individuals receiving the notices and the entities required to prepare
and distribute them. There are a substantial number of required and
permitted disclosures under State or other applicable law, and this
rule generally would permit them to be made.
Alternatively, we considered requiring that the notice include all
of the types of permissible disclosures under this rule (e.g., public
health, research, next-of-kin). We rejected that approach for two
reasons. First, we felt that providing people with notice of the
intended or likely disclosures of their protected health information
was more useful than describing all of the potential types of
disclosures. Second, in many States and localities, different laws may
affect the permissible disclosures that an entity may make, in which
case a notice only discussing permissible disclosures under the federal
rule would be misleading. While it would be possible to require covered
plans or providers to develop notices that discuss or list disclosures
that would be permissible under this rule and other law, we were
concerned that such a notice may be very complicated because of the
need to discuss the interplay of federal, State or other law for each
type of permissible disclosure. We invite comments on the best approach
to provide most useful information to the individuals without
overburdening either covered plans or providers or the recipients of
the notices.
In Sec. 164.520, we are proposing to require all covered entities
to develop and document policies and procedures for the use of
protected health information. The notice would simply summarize those
documented policies and procedures and therefore would entail little
additional burden.
It is critical to the effectiveness of this proposed rule that
individuals be given the notice often enough to remind them of their
rights, but without overburdening covered plans or providers. We
propose that all covered plans and providers would be required to make
their notice available to any individual upon request, regardless of
whether the requestor is already a patient or enrollee. We believe that
broad availability would encourage individuals or organizations to
compare the privacy practices of plans or providers to assist in making
enrollment or treatment choices. We also propose additional
distribution requirements for updating notices, which would be
different for health plans and health care providers. The requirements
for health plans and health care providers are different because we
recognize that they have contact with individuals at different points
in time in the health care system.
We considered a variety of combinations of distribution practices
for health plans and are proposing what we believe is the most
reasonable approach. We would require health plans to distribute the
notice by the effective date of the final rule, at enrollment, within
60 days of a material change to the plan's information practices, and
at least once every three years.
We considered requiring health plans to post the notice either in
addition to or instead of distribution. Because most individuals rarely
visit the office of their health plan, we do not believe that this
would be an effective means of communication. We also considered either
requiring distribution of the notice more or less frequently than every
three years. As compared to most health care providers, we believe that
health plans often are larger and have existing administrative systems
to cost effectively provide notification to individuals. Three years
was chosen as a compromise between the importance of reminding
individuals of their plans' information practices and the need to keep
the burden on health plans to the minimum necessary to achieve this
objective. We are soliciting comment on whether requiring a notice
every three years is reasonable for health plans.
We propose to require that covered health care providers provide a
copy of the notice to every individual served at the time of first
service delivery, that they post the notice in a clear and prominent
location where it is reasonable to expect individuals seeking service
from the provider to be able to read the notice, and that copies be
available on-site for individuals to take with them. In addition, we
propose to require that covered health care providers provide a copy of
the notice to individuals they are currently serving at their first
instances of service delivery within a year of the effective date of
the final rule.
We would not require providers to mail or otherwise disseminate
their notices after giving the notice to individuals at the time of the
first service delivery. Providers' patient lists may include
individuals they have not
[[Page 60030]]
served in decades. It would be difficult for providers to distinguish
between "active" patients, those who are seen rarely, and those who
have moved to different providers. While some individuals would
continue to be concerned with the information practices of providers
who treated them in the distant past, overall the burden of an active
distribution requirement would not be outweighed by improved individual
control and privacy protection.
If a provider wishes to make a material change in the information
practices addressed in the notice, it would be required to revise its
notice in advance. After making the revision, the provider would be
required to post the new notice promptly. We believe that this approach
creates the minimum burden for providers consistent with giving
individuals a clear source of accurate information.
12. Rights and Procedures for Access for Inspection and Copying
(Sec. 164.514)
In Sec. 164.514, we are proposing that, with very limited
exceptions, individuals have a right to inspect and copy protected
health information about them maintained by a covered health plan or
health care provider in a designated record set. Individuals would also
have a right of access to protected health information in a designated
record set that is maintained by a business partner of a covered plan
or provider when such information is not a duplicate of the information
held by the plan or provider, including when the business partner is
the only holder of the information or when the business partner has
materially altered the protected health information that has been
provided to it.
In Sec. 164.506(e), we are proposing that covered plans and
providers include specific terms in their contract with each business
partner. One of the required terms would be that the business partner
must provide for inspection and copying of protected health information
as provided in this section. Because our authority is limited by HIPAA
to the covered entities, we must rely upon covered plans and providers
to ensure that all of the necessary protected health information
provided by the individual to the plan or provider is available for
inspection and copying. We would require covered plans and providers to
provide access to information held in the custody of a business partner
when it is different from information maintained by the covered plan or
provider. We identified two instances where this seemed appropriate:
when the protected health information is only in the custody of a
business partner and not in the custody of the covered plan or
provider; and when protected health information has been materially
altered by a business partner. We are soliciting comment on whether
there are other instances where access should be provided to protected
health information in the custody of a business partner.
Other than in their capacity as business partners, we are not
proposing to require clearinghouses to provide access for inspection
and copying. As explained above in section II.C.5, clearinghouses would
usually be business partners under this proposed rule and therefore
they would be bound by the contract with the covered plan or provider.
See proposed Sec. 164.506(e). We carefully considered whether to
require clearinghouses to provide access for inspection and copying
above and beyond their obligations as a business partner, but
determined that the typical clearinghouse activities of translating
record formats and batching transmissions do not involve setting up
designated record sets on individuals. Although the data maintained by
the clearinghouse is protected health information, it is normally not
accessed by individual identifier and an individual's records could not
be found except at great expense. In addition, although clearinghouses
process protected health information and discover errors, they do not
create the data and make no changes in the original data. They,
instead, refer the errors back to the source for correction. Thus,
individual access to clearinghouse records provides no new information
to the individual but could impose a significant burden on the
industry.
We are proposing that covered plans and providers be required to
provide access for as long as the entity maintains the protected health
information. We considered requiring covered plans and providers to
provide access for a specific period or defining a specific retention
period. We rejected that approach because many laws and professional
standards already designate specific retention periods and we did not
want to create unnecessary confusion. In addition, we concluded that
individuals should be permitted to have access for as long as the
information is maintained by the covered plan or provider. We are
soliciting comments on whether we should include a specific duration
requirement in this proposed rule.
Proposed Sec. 164.514 would permit denial of inspection and copying
under very limited circumstances. The categories of denials would not
be mandatory; the entity could always elect to provide all of the
requested health information to the individual. For each request by an
individual, the entity could provide all of the information requested
or it could evaluate the requested information, consider the
circumstances surrounding the individual's request, and make a
determination as to whether that request should be granted or denied.
We intend to create narrow exceptions to the stated rule of open access
and we would expect covered plans and providers to employ these
exceptions rarely, if at all.
We considered whether entities should be permitted to deny access
to information based on a number of factors. For more specific
discussion of access denials, please refer to earlier preamble text.
For the purposes of the economic impacts, it is important to note that
these denials are optional and, therefore, any costs associated with
utilizing these denials are optional.
In Sec. 164.514(c) and (d), we are proposing that covered plans and
providers be required to have procedures that enable individuals to
exercise their rights to inspect and obtain a copy of protected health
information as explained above.
We considered whether this proposed rule should include detailed
procedures governing a individual's request for inspection and copying.
Because this proposed rule would affect such a wide range of entities,
we concluded that it should only provide general guidelines and that
each entity should have the discretion to develop procedures consistent
with its own size, systems, and operations.
In Sec. 164.514(d)(2), we are proposing that the covered plans and
providers would take action upon the request as soon as possible but
not later than 30 days following receipt of the request. We considered
the possibility of not including a time limitation but rather imposing
a "reasonableness" requirement on the covered plans or providers. We
concluded that the individual is entitled to know when to expect a
response. This is particularly important in the context of health
information, where an individual could need access to his or her
information in order to make decisions about care. Therefore, in order
to determine what would be "reasonable," we examined the time
limitations provided in the Privacy Act, the Freedom of Information Act
(FOIA), and several State laws.
The Privacy Act requires that upon receipt of a request for
amendment (not access), the agency would send an acknowledgment to the
individual
[[Page 60031]]
within 10 working days. (5 U.S.C. 552a (d)(2)). We considered several
options that included such an acknowledgment requirement. An
acknowledgment would be valuable because it would assure the individual
that their request was received. Despite the potential value of
requiring an acknowledgment, we concluded that it could impose a
significant administrative burden on some of the covered plans and
providers. This proposed rule would cover a wide range of entities with
varying capacities and therefore, we are reluctant to create
requirements that would overwhelm smaller entities or interfere too
much with procedures already in place. We would encourage plans and
providers to have an acknowledgment procedure in place, but would not
require it at this point. We are soliciting comment on whether this
proposed rule should require such an acknowledgment.
We also considered whether to include specific procedures governing
"urgent" or "emergency" requests. Such procedures would require
covered plans and providers to respond in a shorter time frame. We
recognize that circumstances could arise where an individual would
request inspection and copying on an expedited basis and we encourage
covered plans or providers to have procedures in place for handling
such requests. We are not proposing additional regulatory time
limitations to govern in those circumstances. The 30-day time
limitation is intended to be an outside deadline, rather than an
expectation. Rather, we would expect a plan or provider to always be
attentive to the circumstances surrounding each request and respond in
an appropriate time frame, not to exceed 30 days.
Finally, we considered including a section governing when and how
an entity could have an extension for responding to a request for
inspection and copying. For example, the FOIA provides that an agency
could request additional time to respond to a request if the agency
needs to search for and collect the requested records from facilities
that are separate from the office processing the request; to search
for, collect, and appropriately examine a voluminous amount of separate
and distinct records; and to consult with another entity or component
having a substantial interest in the determination of the request. We
determined that the criteria established in the FOIA are tailored to
government information systems and therefore could not be appropriate
for plans and providers covered by this proposed rule. Furthermore, we
determined that the 30-day time period would be sufficient for
responding to requests for inspection and copying and that extensions
should not be necessary. We are soliciting comments on whether a
structured extension procedure should be included in this proposed
rule.
In Sec. 164.514(d)(3), we are proposing that covered plans or
providers be required to notify the individual of the decision to
provide access and of any steps necessary to fulfill the request. In
addition we propose that the entity provide the information requested
in the form or format requested if it is readily producible in such
form or format. Finally, if the covered plan or provider accepts an
individual's request, it would be required to facilitate the process of
inspection and copying.
In proposed Sec. 164.514(d)(3)(iv), we would permit a covered plan
or provider to charge a reasonable, cost-based fee for copying health
information provided pursuant to this section. We considered whether we
should follow the practice in the FOIA and include a structured fee
schedule. We concluded that the FOIA was developed to reflect the
relatively uniform government costs and that this proposed rule would
apply to a broader range of entities. Depending on the size of the
entity, copying costs could vary significantly. Therefore, we propose
that the entity simply charge a reasonable, cost-based fee.
In Sec. 164.514(d)(4), we propose that a covered plan or provider
that denies an individual's request for inspection and copying in whole
or in part be required to provide the individual with a written
statement in plain language explaining the reason for the denial. The
statement could include a direct reference to the section of the
regulation relied upon for the denial, but the regulatory citation
alone would not sufficiently explain the reason for the denial. The
statement would need to include the name and number of the contact
person or office within the entity who is responsible for receiving
complaints. In addition, the statement would need to include
information regarding the submission of a complaint with the Department
pursuant to Sec. 164.522(b).
We considered proposing that covered plans and providers provide a
mechanism for appealing a denial of inspection and copying. We believe,
however, that the requirement proposed in Sec. 164.518(d) that covered
plans and providers have complaint procedures to address patient and
enrollee privacy issues generally would allow the individual to raise
the issue of a denial with the covered plan or provider. We would
expect the complaint procedures to be scalable; for example, a large
plan might develop a standard complaint process in each location where
it operates whereas, a small practice might simply refer the original
request and denial to the clinician in charge for review. We would
encourage covered plans and providers to institute a system of appeals,
but would not require it by regulation. In addition, the individual
would be permitted to file a complaint with the Department pursuant to
Sec. 164.522(b).
13. Rights and Procedures With Respect to an Accounting of Disclosures
(Sec. 164.515)
In this proposed rule, we propose that individuals have a right to
receive an accounting of all instances where protected health
information about them is disclosed by a covered entity for purposes
other than treatment, payment, and health care operations, subject to
certain time-limited exceptions for disclosures to law enforcement and
oversight agencies as discussed below. Providing such an accounting
would allow individuals to understand how their health information is
shared beyond the basic purposes of treatment, payment and health care
operations.
We considered whether to require covered entities to account for
all disclosures, including those for treatment, payment and health care
operations. We rejected this approach because it would be burdensome
and because it would not focus on the disclosures of most interest to
individuals. Upon entering the health care system, individuals are
generally aware that their information would be used and shared for the
purpose of treatment, payment and health care operations. They have the
greatest interest in an accounting of circumstances where the
information was disclosed for other purposes that are less easy to
anticipate. For example, an individual might not anticipate that his or
her information would be shared with a university for a research
project, or would be requested by a law enforcement agency.
We are not proposing that covered entities include uses and
disclosures for treatment, payment and health care operations in the
accounting. We believe that it is appropriate for covered entities to
monitor all uses and disclosures for treatment, payment and health care
operations, and they would be required to do so for electronically
maintained information by the Security Standard. However, we do not
believe that covered entities should be required to provide an
accounting of the uses and disclosures for treatment payment and health
care operations.
[[Page 60032]]
This proposed rule would not specify a particular form or format
for the accounting. In order to satisfy the accounting requirement, a
covered entity could elect to maintain a systematic log of disclosures
or it could elect to rely upon detailed record keeping that would
permit the entity to readily reconstruct the history when it receives a
request from an individual. We would require that covered entities be
able to respond to a request for accounting within a reasonable time
period. In developing the form or format of the accounting, covered
entities should adopt policies and procedures that would permit them to
respond to requests within the 30-day time period in this proposed
rule.
We also considered whether or not the disclosure history should be
a formal document that is constantly maintained or whether we should
give more flexibility to entities in this regard. We decided that since
our ultimate goal is that individuals have access to a disclosure
history of their records upon request, it would be reasonable to
require only that they be able to do this. We are not prescribing how
they fulfill the requirement. We also believe that it is less
burdensome to require that they be able to create a disclosure history
than to require that they have a specific format for maintaining a
disclosure history.
We are proposing that the accounting include all disclosures for
purposes other than treatment, payment, and health care operations,
subject to certain exceptions for disclosures to law enforcement and
oversight agencies, discussed below. This would also include
disclosures that are authorized by the individual. The accounting would
include the date of each disclosure; the name and address of the
organization or person who received the protected health information;
and a brief description of the information disclosed. For all
disclosures that are authorized by the individual, we are proposing
that the covered entity maintain a copy of the authorization form and
make it available to the individual with the accounting.
We considered whether the accounting of disclosures should include
the name of the person who authorized the disclosure of information.
The proposed Security Standard would require covered entities to have
an audit mechanism in place to monitor access by employees. We
concluded that it would be unnecessary and inappropriate to require the
covered entity to include this additional information in the
accounting. If the individual identifies an improper disclosure by an
entity, he or she should hold the entity not the employee of the entity
accountable. It is the responsibility of the entity to train its
workforce about its policies and procedures for the disclosure of
protected health information and to impose sanctions if such policies
and procedures are violated.
14. Rights and Procedures for Amendment and Correction (Sec. 164.516)
This proposed rule would provide an individual with the right to
request a covered plan or provider to amend or correct protected health
information relating to the individual. A covered plan or provider
would be required to accommodate requests with respect to any
information that the covered plan or provider determines to be
erroneous or incomplete, that was created by the plan or provider, and
that would be available for inspection and copying under proposed
Sec. 164.514.
We are concerned about the burden that requests for amendment or
correction could place on covered plans and providers and have tried to
limit the process to those situations where amendment or correction
would appear to be most important. We invite comment on whether our
approach reasonably balances burden with adequately protecting
individual interests.
We propose to require a covered plan or provider to accommodate a
request for amendment or correction if the plan or provider created the
information in dispute. We considered requiring covered plans and
providers to amend or correct any erroneous or incomplete information
it maintains, regardless of whether it created the information. Under
this approach, if the plan or provider did not create the information,
then it would have been required to trace the information back to the
original source to determine accuracy and completeness. We rejected
this option because we concluded that it would not be appropriate to
require the plan or provider that receives a request to be responsible
for verifying the accuracy or completeness of information that it did
not create. We also were concerned about the burden that would be
imposed on covered plans and providers if they were required to trace
the source of any erroneous or incomplete information transmitted to
them.
We would rely on a combination of three other requirements to
ensure that protected health information remains as accurate as
possible as it travels through the health care system. First, we are
proposing that a covered plan or provider that makes an amendment or
correction be required to notify any relevant persons, organizations,
or other entities of the change or addition. Second, we are proposing
that other covered plans or providers that receive such a notification
be required to incorporate the necessary amendment or correction.
Finally, we are proposing that covered plans or providers require their
business partners who receive such notifications to incorporate any
necessary amendments or corrections. See the discussion in section
II.F.4. We are soliciting comments whether this approach would
effectively ensure that amendments and corrections are communicated
appropriately.
We are proposing that covered plans and providers be required to
accommodate requests for amendment or correction for as long as the
entity maintains the protected health information. We considered
requiring covered plans and providers to accommodate requests for a
specific period or defining a specific retention period. We rejected
that approach because many laws and professional standards already
designate specific retention periods and we did not want to create
confusion. In addition, we concluded that individuals should be
permitted to request amendments or corrections for as long as the
information is maintained by the covered plan or provider. We are
soliciting comments on whether we should include a specific duration
requirement in this proposed rule.
In Sec. 164.516, we are proposing that covered plans and providers
be required to have procedures that enable individuals to exercise
their rights to request amendment or correction, including a means by
which individuals could request amendment or correction of protected
health information about them. We considered whether this proposed rule
should include detailed procedures governing an individual's request.
But as with the procedures for requesting inspection and copying, we
are only providing a general requirement and permitting each plan or
provider to develop procedures in accordance with its needs. Once the
procedures are developed, the plan or provider would document them in
accordance with section Sec. 164.520 and include a brief explanation in
the notice that is provided to individuals pursuant to section
Sec. 164.512.
We are proposing that the covered plan or provider would take
action on a request for amendment or correction as quickly as the
circumstances require, but not later than 60 days following the
[[Page 60033]]
request. The justification for establishing a time limitation for
amendment and correction is virtually identical to that provided for
the time limitation for inspection and copying. We concluded that the
entity should be provided with some additional flexibility in this
context. Depending on the nature of the request, an amendment or
correction could require significantly more time than a request for
inspection and copying. If a covered plan or provider needed more than
30 days to make a decision, we would encourage, but not require, it to
send an acknowledgment of receipt to the individual including an
explanation of the reasons for the delay and a date when the individual
could expect a final decision.
In Sec. 164.516(c)(3), we are proposing that, upon accepting an
amendment or correction, the covered plan or provider would be required
to make reasonable efforts to notify relevant persons, organizations,
or other entities of the change or addition. An entity would be
required to notify such persons that the individual identifies, or that
the covered plan or provider identifies as (1) a recipient of the
erroneous or incomplete information, and (2) a person who:
Has relied upon that information to the detriment of the
individual; or
Is a person who could foreseeably rely on such erroneous
or incomplete information to the detriment of the individual.
We are concerned about the potential burden that this notification
requirement would impose on covered plans and providers. We do not,
however, anticipate that a significant number of requests would be
submitted to any entity and therefore the need for such notifications
would be rare. In addition, we determined that because health
information can travel so quickly and efficiently in the modern health
care system, the need for notification outweighed the potential burden.
It is important to note that a reasonableness standard should be
applied to the notification process--if the recipient has not relied
upon the erroneous or incomplete information to the detriment of the
individual or if it is not foreseeable that the recipient would do so,
then it would not be reasonable for the covered plan or provider to
incur the time and expense of notification. If, however, if the
incorrect information is reasonably likely to be used to the detriment
of the individual, the entity should make every effort to notify the
recipients of the information of the changes as quickly as possible.
We discussed a number of options regarding the notification of
other entities. We considered only requiring that the entity provide
the individual with a listing of who else could have received the
information. This would place the burden of notification in the hands
of the individual rather than the entity. Because individuals would not
have the same contacts and relationship with other entities as the
original covered entity, we decided that placing the burden on
individuals would be more cumbersome for both individuals and the
secondary entities receiving the requests. We also considered not
including a notification requirement. However, this would mean that
individuals would need to both figure out where the information had
gone to and make separate requests for amendment or correction to every
entity. This also appeared to be overly difficult. We believe that the
option we are proposing is fair to both individuals and covered
entities.
In proposed Sec. 164.516(c)(4), we would require a covered plan or
provider to provide the individual with a written statement in plain
language of the reason for the denial and permit the individual to file
a written statement of disagreement with the decision to deny the
request.
If the individual chooses to file a statement of disagreement, then
the covered plan or provider must retain a copy of the statement with
the protected health information in dispute. The covered plan or
provider could require that the statement be a reasonable length,
provided that the individual has reasonable opportunity to state the
nature of the disagreement and offer his or her version of accurate and
complete information. In all subsequent disclosures of the information
requested to be amended or corrected, the covered plan or provider
would be required to include a copy of its statement of the basis for
denial and, if provided by the individual, a copy of his or her
statement of disagreement. If the statement submitted by the individual
is unreasonably long, the covered plan or provider could include a
summary in subsequent disclosures which reasonably explains the basis
of the individual's position. The covered plan or provider would also
be permitted to provide a rebuttal to the individual's statement of
disagreement and include the rebuttal statement in any subsequent
disclosures.
We considered requiring the covered plan or provider to provide a
mechanism for appealing denials of amendment or correction but
concluded that it would be too burdensome. We are soliciting comment on
whether the approach we have adopted reasonably balances the burdens on
covered plans or providers with the rights of individuals.
If a covered plan or provider receives a notification of erroneous
or incomplete protected health information as provided in proposed
Sec. 164.516(d), we are proposing that the covered plan or provider or
be required to make the necessary amendment or correction to protected
health information in its custody that would be available for
inspection and copying. This affirmative duty to incorporate amendments
and corrections would be necessary to ensure that individuals'
protected health information is as accurate and complete as possible as
it travels through the health care system.
15. Administrative Requirements (Sec. 164.518)
We propose that covered entities be required to implement five
basic administrative requirements to safeguard protected health
information: Designation of a privacy official, the provision of
privacy training, establishment of safeguards, a complaint process, and
establishment of sanctions. Implementation of these requirements would
vary depending on a variety of different factors such as type of entity
(e.g., provider or plan), size of entity (e.g., number of employees,
number of patients), the level of automation within the entity (e.g.,
electronic medical records), and organization of the entity (e.g.,
existence of an office of information systems, affiliation with a
medical school).
a. Designation of a Privacy Official (Sec. 164.518(a))
In proposed Sec. 164.518(a), we would require covered entities to
designate an employee or other person to serve as the official
responsible for the development of policies and procedures for the use
and disclosure of protected health information. The designation of an
official would focus the responsibility for development of privacy
policy.
We considered whether covered entities should be required to
designate a single official or an entire board. We concluded that a
single official would better serve the purposes of focusing the
responsibility and providing accountability within the entity. The
implementation of this requirement would depend on the size of the
entity. For example, a small physician's practice might designate the
office manager as the privacy official, and he or she would assume this
as one of his or her broader administrative responsibilities. A large
entity might appoint a person whose sole
[[Page 60034]]
responsibility is privacy policy, and he or she might choose to convene
a committee representing several different components of the entity to
develop and implement privacy policy.
b. Training (Sec. 164.518(b))
In proposed Sec. 164.518(b), we would require covered entities to
provide training on the entities policies and procedures with respect
to protected health information. Each entity would be required to
provide initial training by the date on which this proposed rule
becomes applicable. After that date, each covered entity would have to
provide training to new members of the workforce within a reasonable
time period after joining the entity. In addition, we are proposing
that when a covered entity makes material changes in its privacy
policies or procedures, it would be required to retrain those members
of the workforce whose duties are directly affected by the change
within a reasonable time of making the change.
The entities would be required to train all members of the
workforce (e.g., all employees, volunteers, trainees, and other persons
under the direct control of all persons working on behalf of the
covered entity on an unpaid basis who are not business partners) who
are likely to have contact with protected health information.
Upon completion of the training, the person would be required to
sign a statement certifying that he or she received the privacy
training and would honor all of the entity's privacy policies and
procedures. Entities would determine the most effective means of
communicating with their workforce. For example, in a small physician
practice, the training requirement could be satisfied by providing each
new member of the workforce with a copy of the practice's information
policies and requiring members of the workforce to acknowledge that
they have reviewed the policies. A large health plan could provide for
a training program with live instruction, video presentations or
interactive software programs. The small physician practice's solution
would not protect the large plan's data, and the plan's solution would
be neither economically feasible nor necessary for the small physician
practice.
At least once every three years after the initial training, covered
entities would be required to have each member of the workforce sign a
new statement certifying that he or she would honor all of the entity's
privacy policies and procedures. The initial certification would be
intended to make members of the workforce aware of their duty to adhere
to the entity's policies and procedures. By requiring a recertification
every three years, they would be reminded of this duty.
We considered several different options for recertification. We
considered proposing that members of the workforce be required to
recertify every six months, but concluded that such a requirement would
be too burdensome. We considered proposing that recertification be
required annually consistent with the recommendations of The American
Health Information Management Association (Brandt, Mary D., Release and
Disclosure: Guidelines Regarding Maintenance and Disclosure of Health
Information, 1997). We concluded that annual recertification could also
impose a significant burden on covered entities.
We also considered requiring that the covered entity provide
"refresher" training every three years in addition to the
recertification. We concluded that our goals could be achieved by only
requiring recertification once every three years, and retraining in the
event of material changes in policy. We are soliciting comment on this
approach.
c. Safeguards (Sec. 164.518(c))
In proposed Sec. 164.518(c), we would require covered entities to
put in place administrative, technical, and physical safeguards to
protect against any reasonably anticipated threats or hazards to the
privacy of the information, and unauthorized uses or disclosures of the
information. We proposed similar requirements for certain electronic
information in the Notice of Proposed Rulemaking entitled the Security
and Electronic Signature Standards (HCFA-0049-P), which can be found at
63 FR 43241. We are proposing parallel and consistent requirements for
safeguarding the privacy of protected health information.
i. Verification procedures.
As noted in section II.E., for many permitted disclosures the
covered entity would be responding to a request for disclosure of
protected health information. For most categories of permitted
disclosures, when the request for disclosure of protected health
information is from a person with whom the covered entity does not
routinely do business, we would require the covered entity to verify
the identity of the requestor. In addition, for certain categories of
disclosures, covered entities would also be required to verify the
requestor's legal authority to make the request.
Under Sec. 164.514, a covered entity would be required to give
individuals access to protected health information about them (under
most circumstances). The covered entity would also be required to take
reasonable steps to verify the identity of the individual making the
request for access. We do not propose to mandate particular
identification requirements (e.g., drivers licence, photo ID, etc), but
rather would leave this to the discretion of the covered entity.
We considered specifying the type of documentation or proof that
would be acceptable, but decided that the burden of such specific
regulatory requirements on covered entities would be unnecessary.
Therefore, we propose only a general requirement for reasonable
verification of identity and legal authority.
d. Internal Complaint Process (Sec. 164.518(d))
In proposed Sec. 164.518(d), we would require covered plans and
providers to have some mechanism for receiving complaints from
individuals regarding the covered plan's or provider's compliance with
the requirements of this proposed rule. The covered plan or provider
would be required to accept complaints about any aspect of their
practices regarding protected health information. We would not require
that the entity develop a formal appeals mechanism, nor that "due
process" or any similar standard be applied. We would not require that
covered entities respond in any particular manner or time frame. We are
proposing two basic requirements for the complaint process. First, the
covered plan or provider would be required to identify a contact person
or office in the notice of information practices for receiving
complaints. This person or office could either be responsible for
handling the complaints or could put the individual in touch with the
appropriate person within the entity to handle the particular
complaint. See proposed Sec. 164.512. This person could, but would not
have to be, the entity's privacy official. See proposed
Sec. 164.518(a)(2). Second, the covered plan or provider would be
required to maintain a record of the complaints that are filed and a
brief explanation of the resolution, if any.
We considered requiring covered plans and providers to provide a
formal internal appeal mechanism, but rejected that option as too
costly and burdensome for some entities. We also considered eliminating
this requirement entirely, but rejected that option because a complaint
process would give covered plans or providers a way to learn about
potential problems with privacy policies or practices, or training
[[Page 60035]]
issues. We also hope that providing an avenue for covered plans or
providers to address complaints would lead to increased consumer
satisfaction. We believe this approach strikes a reasonable balance
between allowing covered plans or providers flexibility and
accomplishing the goal of promoting attention to improvement in privacy
practices. If an individual and a covered plan or provider are able to
resolve the individual's complaint, there could be no need for the
individual to file a complaint with the Secretary under proposed
Sec. 164.522(b). However, an individual has the right to file a
complaint with the Secretary at any time. An individual could file a
complaint with the Secretary before, during, after, or concurrent with
filing a complaint with the covered plan or provider or without filing
a complaint with the covered plan or provider.
We are considering whether modifications of these complaint
procedures for intelligence community agencies could be necessary to
address the handling of classified information and solicit comment on
the issue.
e. Sanctions (Sec. 164.518(e))
In proposed Sec. 164.518(e), we would require all covered entities
to develop and apply when appropriate sanctions for failure to comply
with policies or procedures of the covered entity or with the
requirements of this proposed rule. All members of the workforce who
have regular contact with protected health information should be
subject to sanctions, as would the entity's business partners. Covered
entities would be required to develop and impose sanctions appropriate
to the nature of the issue. The type of sanction applied would vary
depending on factors such as the severity of the violation, whether the
violation was intentional or unintentional, and whether the violation
indicates a pattern or practice of improper use or disclosure of
protected health information. Sanctions could range from a warning to
termination.
We considered specifying particular sanctions for particular kinds
of violations of privacy policy, but rejected this approach for several
reasons. First, the appropriate sanction would vary with the entity's
particular policies. Because we cannot anticipate every kind of privacy
policy in advance, we cannot predict the response that would be
appropriate when that policy is violated. In addition, it is important
to allow covered entities to develop the sanctions policies appropriate
to their business and operations.
We expect that sanctions would be more formally described and
consistently carried out in larger, more sophisticated entities.
Smaller, less sophisticated entities would be given more latitude and
flexibility. For such smaller entities and less sophisticated entities,
we would not expect a prescribed sanctions policy, but would expect
that actions be taken if repeated instances of violations occur.
f. Sanctions (Sec. 164.518(f))
We propose in Sec. 164.518(f) that covered entities be required to
have procedures for mitigating, to the extent practicable, any
deleterious effect of a use or disclosure of protected health
information by their members of their workforce or business partners.
With respect to business partners, we also propose that covered
entities have an affirmative duty to take reasonable steps in response
to breaches of contract terms.
16. Development and Documentation of Policies and Procedures
(Sec. 164.520)
In proposed Sec. 164.520, we would require covered entities to
develop and document their policies and procedures for implementing the
requirements of this proposed rule. This requirement is intended as a
tool to facilitate covered entities' efforts to develop appropriate
policies to implement this proposed rule, to ensure that the members of
its workforce and business partners understand and carry out expected
privacy practices, and to assist covered entities in developing a
notice of information practices.
The scale of the policies developed should be consistent with the
size of the covered entity. For example, a smaller employer could
develop policies restricting access to health plan information to one
designated employee, empowering that employee to deny release of the
information to corporate executives and managers unless required for
health plan administration. Larger employers could have policies that
include using contractors for any function that requires access to
protected health information or requiring all reports they receive for
plan administration to be de-identified unless individual authorization
is obtained.
We are proposing general guidelines for covered entities to develop
and document their own policies and procedures. We considered a more
uniform, prescriptive approach but concluded that a single approach
would be neither effective in safeguarding protected health information
nor appropriate given the vast differences among covered entities in
size, business practices and level of sophistication. It is important
that each covered entity's internal policies and procedures for
implementing the requirements of this regulation are tailored to the
nature and number of its business arrangements, the size of its patient
population, its physical plant and computer system, the size and
characteristics of its workforce, whether it has one or many locations,
and similar factors. The internal policies and procedures appropriate
for a clearinghouse would not be appropriate for a physician practice;
the internal policies and procedures appropriate for a large, multi-
state health plan would not be appropriate for a smaller, local health
plan.
After evaluating the requirements of federal, State, or other
applicable laws, covered entities should develop policies and
procedures that are appropriate for their size, type, structure, and
business arrangements. Once a covered plan or provider has developed
and documented all of the policies and procedures as required in this
section, it would have compiled all of the information needed to
develop the notice of information practices required in Sec. 164.512.
The notice is intended to include a clear and concise summary of many
of the policies and procedures discussed in this section. Further, if
an individual has any questions about the entity's privacy policies
that are not addressed by the notice, a representative of the entity
could easily refer to the documented policies and procedures for
additional information.
Before making a material change in a policy or procedure, the
covered entity would, in most instances, be required to make the
appropriate changes to the documentation required by this section
before implementing the change. In addition, covered plans and
providers would be required to revise their notice of information
practices in advance. Where the covered entity determines that a
compelling reason exists to take an action that is inconsistent with
its documentation or notice before making the necessary changes, it
could take such action if it documents the reasons supporting the
action and makes the necessary changes within 30 days of taking such
action.
In an attempt to ensure that large entities develop coordinated and
comprehensive policies and procedures as required by this section, we
considered proposing that entities with annual receipts greater than $5
[[Page 60036]]
million \40\ be required to have a privacy board review and approve the
documentation of policies and procedures. As originally conceived, the
privacy board would only serve to review research protocols as
described in Sec. 164.510(j). We believe that such a board could also
serve as "privacy experts" for the covered entity and could review
the entity's documented policies and procedures. In this capacity, the
overriding objective of the board would be to foster development of up-
to-date, individualized policies that enable the organization to
protect health information without unnecessarily interfering with the
treatment and payment functions or business needs. This type of review
is particularly important for large entities who would have to
coordinate policies and procedures among a large staff, but smaller
organizations would be encouraged, but not required, to take a similar
approach (i.e., have a widely representative group participate in the
development and/or review of the organization's internal privacy
policies and the documentation thereof). We solicit comment on this
proposal.
---------------------------------------------------------------------------
\40\ The Small Business Administration defines small businesses
in the health care field as those generating less than $5 million
annually. Small businesses represent approximately 85% of health
care entities.
---------------------------------------------------------------------------
We also considered requiring the covered entity to make its
documentation available to persons outside the entity upon request. We
rejected this approach because covered entities should not be required
to share their operating procedures with the public, or with their
competitors.
We recognize that the documentation requirement in this proposed
rule would impose some paperwork burden on covered plans and providers.
However, we believe that it is necessary to ensure that covered plans
and providers establish privacy policies and procedures in advance of
any requests for disclosure, authorization, or subject access. It is
also necessary to ensure that covered entities and members of their
workforce have a clear understanding of the permissible uses and
disclosures of protected health information and their duty to protect
the privacy of such information under specific circumstances.
17. Compliance and Enforcement
The rules proposed below at Sec. 164.522 would establish several
requirements designed to enable the Secretary to monitor and seek to
ensure compliance with the provisions of this subpart. The general
philosophy of this section is to provide a cooperative approach to
obtaining compliance, including use of technical assistance and
informal means to resolve disputes. However, in recognition of the fact
that it would not always be possible to achieve compliance through
cooperation, the section also would provide the Secretary with tools
for carrying out her statutory mandate to achieve compliance.
Proposed Sec. 164.522(a) would establish the principle that the
Secretary would seek the cooperation of covered entities in obtaining
compliance. Section 164.522(a)(2) provides that the Secretary could
provide technical assistance to covered entities to help them come into
compliance with this subpart. It is clearly in the interests of both
the covered entities and the individuals they serve to minimize the
costs of compliance with the privacy standards. To the extent that the
Department could facilitate this by providing technical assistance, it
would endeavor to do so.
V. Initial Regulatory Flexibility Analysis
A. Introduction
Pursuant to the Regulatory Flexibility Act 5 U.S.C. 601 et. seq.,
HHS must prepare a regulatory flexibility analysis if the Secretary
certifies that a proposed rule would have a significant economic impact
on a substantial number of small entities.
This analysis addresses six issues: (1) Reasons for promulgating
the rule; (2) the proposed rule's objectives and legal basis; (3) the
number and types of small entities affected by the proposed rule; (4)
the specific activities and costs associated with compliance; (5)
options that HHS considered to minimize the rule's economic burdens or
increase its benefits for small entities; and (6) the relevant Federal
rules that could duplicate, overlap, or conflict with the proposed
rule. The following sections provide details on each of these issues.
Reasons for Promulgating the Rule
This proposed rule is being promulgated primarily because we have
been statutorily mandated to do so under section 264 of Public Law 104-
191. Additional information on the reasons for promulgating the rule
can be found in earlier preamble discussions (section I.).
Objectives and Legal Basis
This information can be found in earlier preamble discussions
(section I.).
Relevant Federal Provisions
This information can be found in earlier preamble discussions
(section I.B.)
B. Economic Effects on Small Entities
1. Number and Types of Small Entities Affected
The Small Business Administration defines small entities in the
health care sector as those organizations with less than $5 million in
annual revenues. \41\ Nonprofit organizations are also considered small
entities; however, individuals and States are not included in the
definition of a small entity. Similarly, small government jurisdictions
with a population of less than 50,000 are considered small entities.
---------------------------------------------------------------------------
\41\ We have used two different data sources for our estimates
of the number of entities. In the regulatory impact analysis (RIA),
we chose to use the same numbers as we used in other Administrative
Simplification rules. In the regulatory flexibility analysis (RFA),
we used the most recent data available from the Small Business
Administration (SBA).
We chose to use the Administrative Simplification estimates in
the RIA because we wanted our analysis to be as consistent as
possible with those regulations and also believe that because it is
higher than the more recent SBA data, it was the more conservative
data source.
We chose to use the SBA data in the RFA because we wanted our
analysis to be as consistent to SBA definitions as possible to give
the greatest accuracy for the RFA purposes.
---------------------------------------------------------------------------
Small health entities affected include: Nonprofit health plans,
hospitals, and skilled nursing facilities (SNFs); small businesses
providing health coverage; small physician practices; pharmacies;
laboratories; and durable medical equipment (DME) suppliers; health
care clearinghouses; billing companies; and vendors that supply
software applications to health care entities.
The U.S. Small Business Administration reports that as of 1996,
there were 1,078,020 small health care establishments \42\ classified
within the SIC codes we have designated (Table A).
---------------------------------------------------------------------------
\42\ Establishments are the physical location where an
enterprise conducts business. An entrprise may conduct business in
more than one establishment.
[[Page 60037]]
Table A.--Number of Health Care Entities That Meet SBA Size Standards, 1996 \1\
----------------------------------------------------------------------------------------------------------------
Total Number of Percent of
Number of Entities that Entities that
Standard Industrial Code (SIC) Industry Health Care Meet SBA Size Meet
SBA Size
Entities Standards \2\ Standards \2\
----------------------------------------------------------------------------------------------------------------
5910................................... Drug Stores & Proprietary 44,062 23,771 53.9
Stores.
6320................................... Accident & Health 3,346 428 12.8
Insurance & Medical
Service Plans (Accident &
Health Insurance and
Hospital & Medical
Service Plans).
8010................................... Offices & Clinics of 188,508 171,750 91.1
Doctors of Medicine.
8020................................... Offices & Clinics of 113,965 113,141 99.3
Dentists.
8030................................... Offices & Clinics of 9,168 9,000 98.2
Doctors of Osteopathy.
8040................................... Offices & Clinics of Other 85,326 83,563 97.9
Health Practitioners.
8050................................... Nursing & Personal Care 24,246 11,736 48.4
Facilities.
8060................................... Hospitals................. 7,284 837 11.5
8070................................... Medical & Dental 15,354 12,322 80.3
Laboratories.
8080................................... Home Health Care Services. 16,218 9,238 57.0
8090................................... Miscellaneous Health & 20,986 12,712 60.6
Allied Services.
------------------------------------------------------------------------
N/A.................................... Total..................... 528,463 448,498 84.9
----------------------------------------------------------------------------------------------------------------
\1\ Source: Office of Advocacy, U.S. Small Business Administration, from data provided by the
Bureau of the
Census, Statistics of U.S. Businesses, 1996.
\2\ Less than $5,000,000 in annual revenue.
These small businesses represent 83.8% of all health care entities
we have examined.\43\ Small businesses represent a significant portion
of the total number of health care entities but a small portion of the
revenue stream for all health care entities. In 1996, the small
businesses represented generated approximately $235 million in annual
receipts, or 22.2% of the total revenue generated by small health care
entities (Table B). \44\ The following sections provide estimates of
the number of small health care entities that will be required to
comply with the rule. We should note, however, that the SBA's published
annual receipts of health care industries differs substantially from
the National health expenditure data that the Health Care Finance
Administration (HCFA) maintains. HCFA's data are generally considered
more accurate because the data are validated by several sources.
---------------------------------------------------------------------------
\43\ Office of Advocacy, U.S. Small Business Administration,
from data provided by the Bureau of the Census, Statistics of U.S.
Businesses, 1996.
\44\ Op. cit. 1996
Table B.--Annual Receipts of Health Care Entities, 1996 \1\
----------------------------------------------------------------------------------------------------------------
Revenue Percent of
generated by total revenue
Standard Industrial Code (SIC) Industry Total revenue small entities generated
by
\2\ small entities
----------------------------------------------------------------------------------------------------------------
5910.................................. Drug Stores & $91,701,331 $23,762,195 25.9
Proprietary Stores.
6320.................................. Accident & Health 225,866,321 657,074 0.3
Insurance & Medical
Service Plans (Accident
& Health Insurance and
Hospital & Medical
Service Plans).
8010.................................. Offices & Clinics of 186,598,097 102,355,549 54.9
Doctors of Medicine.
8020.................................. Offices & Clinics of 46,131,244 44,811,866 97.1
Dentists.
8030.................................. Offices & Clinics of 4,582,835 3,992,558 87.1
Doctors Of Osteopathy.
8040.................................. Offices & Clinics of 25,053,745 21,891,338 87.4
Other Health
Practitioners.
Other Health 29,636,580 25,883,896 87.3
Practitioners (8030 and
8040).
8050.................................. Nursing & Personal Care 63,625,522 14,672,710 23.1
Facilities.
8060.................................. Hospitals............... 343,314,509 2,021,845 0.6
8070.................................. Medical & Dental 16,543,625 4,976,094 30.1
Laboratories.
8080.................................. Home Health Care 27,690,537 7,960,035 28.7
Services.
8090.................................. Miscellaneous Health & 26,036,633 7,697,264 29.6
Allied Services.
[[Page 60038]]
Other Health Care 70,270,795 20,633,393 29.4
Services
(8070,8080,8090).
-----------------------------------------------
N/A................................... Total Receipts.......... 1,057,144,399 234,798,528 22.2
----------------------------------------------------------------------------------------------------------------
\1\ Source: Office of Advocacy, U.S. Small Business Administration, from data provided by the
Bureau of the
Census, Statistics of U.S. Businesses, 1996.
\2\ The SBA defines a small business as those businesses with less than $5,000,000 in annual
revenue. For
consistency with the Regulation, we employ the term "entity" in place of "business".
The Small Business Administration reports that approximately 80
percent of the 15,000 medical laboratories and dental laboratories in
the U.S. are small entities.\45\ Furthermore, based on HCFA data, we
estimate that 98 percent of the 160,000 durable medical equipment
suppliers in the U.S. are small entities. Over 90 percent of health
practitioner offices are small businesses.\46\ Doctor offices (91%),
dentist offices (99%), osteopathy (98%) and other health practitioner
offices (98%) are primarily considered small businesses.
---------------------------------------------------------------------------
\45\ Office of Advocacy, U.S. Small Business Administration,
from data provided by the Bureau of the Census, Statistics of U.S.
Businesses, 1996.
\46\ Op.cit., 1996
---------------------------------------------------------------------------
There are also a small number of hospitals, home health agencies,
non-profit nursing facilities, and skilled nursing facilities that will
be affected by the proposed rule. According to the American Hospital
Association, there are approximately 3,131 nonprofit hospitals
nationwide. Additionally, there are 2,788 nonprofit home health
agencies in the U.S. The Health Care Finance Administration reports
that there are 591 nonprofit nursing facilities and 4,280 nonprofit
skilled nursing facilities.\47\
---------------------------------------------------------------------------
\47\ Health Care Finance Administration, OSCAR
---------------------------------------------------------------------------
While it is difficult to calculate the number of clearinghouses
that meet the definition of a small business, we believe that a
significant portion of the 80 health care clearinghouses that process
health care claims in the U.S. have annual revenues of less than $5
million annually.\48\ We believe that all of the 4,500 billing
companies \49\ that provide administrative and billing services for
physicians' offices have annual revenues below $5 million per year.
---------------------------------------------------------------------------
\48\ Faulkner & Gray's Health Data Directory, 1999
\49\ International Billing Association, 1999
---------------------------------------------------------------------------
Some contractors that work with health care entities will be
required to adopt policies and procedures to protect information. We do
not expect that the additional burden placed on contractors will be
significant. We have not estimated the effect of the proposed rule on
these entities because we cannot reasonably anticipate the number or
type of contracts affected by the proposed rule. We also do not know
the extent to which contractors would be required to modify their
policy practices as a result of the rule's implementation.
2. Activities and Costs Associated with Compliance
For a summary of the basic activities that a small entity would
need to do to comply with this rule, please refer to section III of the
preamble. This discussion summarizes some of the specific activities
that covered entities must undertake to comply with the proposed rule's
provisions and options considered that would reduce the burden to small
entities. In developing this proposed rule, we considered a variety of
alternatives for minimizing the economic burden that it will create for
small entities. We could not exempt small businesses from the entire
proposed rule because they represent such a large and critical
proportion of the health care industry (84 percent).
The guiding principle in our considerations of how to address the
burden on small entities has been to make provisions scalable. To the
extent possible, we have allowed for entities to determine how
extensively they will address certain issues. This ability to adapt
provisions to minimize burden has been addressed in earlier preamble
language and will be briefly discussed again in the following section.
Before discussing specific provisions, it is important to note some
of the broader questions that were addressed in formulating this
proposed rule. We considered extending the compliance period for small
entities but decided that because they represent such a large portion
of the health care market, such an extension would be inappropriate.
However, HIPAA does create an extended compliance time of 36 months for
small plans. For all other time limit questions, we also considered
giving small entities the same sort of extensions. For example,
entities are required to either approve or deny a request to inspect
and copy information within 20 days. We considered allowing small
entities a longer response time. Rather than giving small entities
extensions, we decided to establish time limits that we believe are
reasonable for affected entities of all sizes, with the understanding
that larger entities may not need as much time as they have been
allocated in certain situations.
While we considered the needs of small entities during our
discussions of provisions for this proposed rule, we are highlighting
the most significant discussions in the following sections:
a. Scalability. Covered entities of all types and sizes would be
required to comply with the proposed privacy standards outlined below.
The proposed standards would not impose particular mechanisms or
procedures that covered entities must adopt to implement the standards.
Instead, we would require that each affected entity assess its own
needs and devise, implement, and maintain appropriate privacy policies,
procedures, and documentation to address its business requirements. How
each privacy standard would be satisfied would be business decisions
that each entity would have to make. This allows the privacy standards
to establish a stable baseline, yet remain flexible enough to take
advantage of developments and methods for protecting privacy that will
evolve over time.
Because the privacy standards would need to be implemented by all
covered entities, from the smallest provider to the largest, multi-
state health plan, a single approach to implementing these standards
would be neither economically feasible nor effective in safeguarding
health information privacy. For example, in a small physician practice
the office manager might be designated to serve as the privacy official
as one of many duties (see proposed Sec. 164.518(a)) whereas at a large
health plan, the privacy official may constitute a full time position
and
[[Page 60039]]
have the regular support and advice of a privacy staff or board.
In taking this approach, we intend to strike a balance between the
need to maintain the confidentiality of protected health information
and the economic cost of doing so. Health care entities must consider
both aspects in devising their solutions. This approach is similar to
the approach we proposed in the Notice of Proposed Rulemaking for the
administrative simplification security and electronic signature
standards.
We decided to use this scaled approach to minimize the burden on
all entities with an emphasis on small entities.
b. Minimum necessary use and disclosure. The decisions called for
in determining what would be the minimum necessary information to
accomplish an allowable purpose should include both a respect for the
privacy rights of the subjects of the medical record and the reasonable
ability of covered entities to delimit the amount of individually
identifiable health information in otherwise permitted uses and
disclosures. For example, a large enterprise that makes frequent
electronic disclosures of similar data would be expected to remove
identifiers or to limit the data fields that are disclosed to fit the
purpose of the disclosure. An individual physician's office would not
be expected to have the same capabilities to limit the amount of
information disclosed, although, in the cases of disclosures involving
a small number of records, such an office could be expected to hide
identifiers or to limit disclosures to certain pages of the medical
record that are relevant to the purpose of the disclosure.
We understand that the requirements outlined in this section do not
create a bright line test for determining the minimum necessary amount
of protected health information appropriate for most uses or
disclosures. Because of this lack of precision, we considered
eliminating the requirement altogether. We also considered merely
requiring covered entities to address the concept within their internal
privacy procedures, with no further guidance as to how each covered
entity would address the issue. These approaches were rejected because
minimizing both the amount of protected health information used and
disclosed within the health care system and the number of persons who
have access to such information is vital if we are to successfully
enhance the confidentiality of people's personal health information. We
invite comments on the approach that we have adopted and on alternative
methods of implementing the minimum necessary principle.
c. Right to restrict. We propose to permit in Sec. 164.506(c) that
individuals be able to request that a covered entity restrict further
uses and disclosures of protected health information for treatment,
payment, or health care operations, and if the covered entity agrees to
the requested restrictions, the covered entity may not make uses or
disclosures for treatment, payment or health care operations that are
inconsistent with such restrictions, unless such uses or disclosures
are mandated by law. This provision would not apply to health care
provided to an individual on an emergency basis.
It should be noted that there is nothing in this proposed rule that
requires a health care provider to agree to a request to restrict uses
or disclosures for treatment, payment, or health care operations.
Providers who do not wish to, or due to contractual obligations cannot,
restrict further use or disclosure are not obligated to treat an
individual making a request under this provision.
If small entities view this proposed provision as overly
burdensome, they would not have to provide treatment to individuals
requesting restrictions. We considered requiring that providers conform
to requests to restrict use or disclosures. We rejected this approach
due to the potential ethical conflicts these restrictions could pose to
health care professionals and the possible burden to providers.
Providers comprise a large proportion of the small businesses covered
under this proposed regulation.
d. Creation of de-identified information. In this rule we are
proposing that covered entities and their business partners be
permitted to use protected health information to create de-identified
health information. Covered entities would be permitted to further use
and disclose such de-identified information in any way, provided that
they do not disclose the key or other mechanism that would enable the
information to be re-identified, and provided that they reasonably
believe that such use or disclosure of de-identified information will
not result in the use or disclosure of protected health information.
This means that a covered entity could not disclose de-identified
information to a person if the covered entity reasonably believes that
the person would be able to re-identify some or all of that
information, unless disclosure of protected health information to such
person would be permitted under this proposed rule. In addition, a
covered entity could not use or disclose the key to coded identifiers
if this rule would not permit the use or disclosure of the identified
information to which the key pertains. If a covered entity re-
identifies the de-identified information, it may only use or disclose
the re-identified information consistent with these proposed rules, as
if it were the original protected health information. See proposed
Sec. 164.506(d)(1).
As with other components of this proposed rule, removal of
identifiers from data could be scaled. Small entities without the
resources to determine at what point information is truly de-identified
could remove the full list of possible identifiers listed in this
regulation. Unless they have reason to believe that the information
could still be linked to an individual, this proposed requirement would
be fulfilled. However, larger, more sophisticated entities, could
choose to determine independently what information needs to be removed.
Furthermore, efforts to remove identifiers from information would
be optional. If an entity believes that removing identifiers would be
excessively burdensome, it could choose not to release the information
or to obtain an authorization from individuals before releasing any
information.
e. Uses and disclosures with individual authorization. Covered
entities must obtain individual authorization to use protected health
information for purposes other than those allowed under the proposed
rule. Activities requiring authorization would include, for example,
marketing and eligibility determinations for health coverage or
employment. Costs would be ongoing for staffing and administrative
activities related to obtaining authorization from individuals.
In establishing the requirement for covered entities to obtain
patient authorization to use individually identifiable health
information for purposes other than those allowed under the proposed
rule, we decided to include in the proposed rule a model "request for
authorization." By following such a model, covered entities,
particularly small entities, could avoid the legal and administrative
expenses that would be necessary to develop an authorization form that
complies with the proposed rule's standards. The proposed rule would
not prevent entities from developing their own patient authorization
forms or from modifying existing forms in a manner consistent with the
model.
[[Page 60040]]
The alternative to providing this model would be to state that an
authorization would be required and allow entities to develop the
authorization. We believe that providing no guidance in this area would
have caused unnecessary difficulties and burdens for small entities.
f. Uses and disclosures permitted without authorization. This
proposed rule would not require any uses or authorizations other than
to the subject individual and to the Secretary for compliance. If small
entities believe that the costs of making such discretionary
disclosures are considered too high, they could choose not to make such
disclosures. We would allow all covered entities, but particularly
small entities, to base their decisions about these disclosures on any
criteria that they believe to be important. We expect that the
additional costs related to these disclosures would be factored into
their decisions.
In cases where uses or disclosures without authorization are
required by other law, we would attempt to minimize costs by not
requiring application of the minimum necessary principle.
g. Notice to individuals of rights and procedures. The proposed
rule would require covered entities to prepare and make available a
notice that informs patients about their privacy rights and the
entity's actions to protect privacy. Entities that do not already
comply with the proposed rule's requirements would incur one-time legal
and administrative costs. In addition, plans would incur ongoing costs
related to the dissemination of the notice at least once every three
years, and all covered entities would have ongoing costs related to
dissemination to new individuals requesting services and requests for
copies of the notice. Entities would also incur ongoing costs related
to answering questions that are associated with the notice.
In discussing the requirement for covered entities to prepare and
make available a notice regarding patient privacy rights and the
entity's privacy practices, we considered exempting small businesses.
Because this would exempt 84 percent of firms, we decided not to create
this exemption. The second option would be to exempt extremely small
entities. One discussion defined small entities as those with fewer
than 10 employees. We decided that informing consumers of their privacy
rights and of the activities of covered entities with which they
conduct business was too important to exempt any entities.
In addition to requiring a basic notice, we considered requiring a
longer more detailed notice that would be available to individuals on
request. However, we decided that making information available on
request and allowing the covered entity to decide how best to provide
such information represents a more balanced approach. We believe that
it would be overly burdensome to all entities, especially small
entities, to require two notices.
We considered prescribing specific language that each covered plan
or provider would include in its notice. The advantages of this
approach would be that the recipient would receive exactly the same
information from each covered plan or provider in the same format and
that it would be convenient for covered entities to use a uniform model
notice.
There are, however, several disadvantages to this approach. First,
and most importantly, no model notice could fully capture the
information practices of every covered plan or provider. Large entities
will have information practices different from those of small entities.
Some health care providers, for example, academic teaching hospitals,
might routinely disclose identifiable health information for research
purposes. Other health care providers might rarely or never make such
disclosures. To be useful to individuals, each entity's notice of
information practices should reflect its unique privacy practices.
Another disadvantage of prescribing specific language is that it
would limit each covered plan or provider's ability to distinguish
itself in the area of privacy protections. We believe that if
information on privacy protections becomes readily available,
individuals might compare and select plans or providers based on their
information practices. In addition, a uniform model notice could easily
become outdated. As new communication methods or technologies are
introduced, the content of the notices might need to reflect those
changes.
We believe that the proposed rule appropriately balances a
patient's need for information and assurances regarding privacy with
the covered entities' need for flexibility in describing their
operations and procedures to protect patient privacy. Instead of a
model notice, we have included a sample notice to guide the development
of notices. We believe that this is an appropriate way to reduce the
burden on all entities including those classified as small.
h. Administrative requirements for covered entities. We propose
that covered entities be required to implement five basic
administrative requirements to safeguard protected health information:
designation of a privacy official, the provision of privacy training,
establishment of safeguards, a complaint process, and establishment of
sanctions. Implementation of these requirements would vary depending on
a variety of different factors such as type of entity (e.g., provider
or plan), size of entity (e.g., number of employees, number of
patients), the level of automation within the entity (e.g., electronic
medical records), and organization of the entity (e.g., existence of an
office of information systems, affiliation with a medical school).
In proposed Sec. 164.518(a), we would require covered plans and
providers to designate a privacy official to be responsible for the
development of policies for the use and disclosure of protected health
information and for the supervision of personnel with respect to use
and disclosure of protected health information. The designation of a
privacy official would focus the responsibility for development of
privacy policy.
The implementation of this requirement would depend on the size of
the entity. For example, a small physician's practice might designate
the office manager as the privacy official, and he or she would assume
this as one of his or her broader administrative responsibilities. A
large entity might appoint an individual whose sole responsibility is
privacy policy, and that individual could choose to convene a committee
representing several different components of the entity to develop and
implement privacy policy.
In proposed Sec. 164.518(b), we would require covered entities to
provide training on the their policies and procedures with respect to
protected health information. Entities would determine the most
effective means of communicating with their workforce. For example, in
a small physician practice, the training requirement could be satisfied
by providing each new member of the workforce with a copy of the
practice's information policies and requiring members of the workforce
to acknowledge that they have reviewed the policies. A large health
plan could provide for a training program with live instruction, video
presentations or interactive software programs. The small physician
practice's solution would not protect the large plan's data, and the
plan's solution would be neither economically feasible nor necessary
for the small physician practice.
In proposed Sec. 164.518(c), we would require covered entities to
put in place
[[Page 60041]]
administrative, technical, and physical safeguards to protect against
any reasonably anticipated threats or hazards to the privacy of the
information, and unauthorized uses or disclosures of the information.
In proposed Sec. 164.518(d), we would require covered plans and
providers to have some mechanism for receiving complaints from
individuals regarding the covered plan's or provider's compliance with
the requirements of this proposed rule. We considered requiring covered
plans and providers to provide a formal internal appeal mechanism, but
rejected that option as too costly and burdensome for some entities. We
also considered eliminating this requirement entirely, but rejected
that option because a complaint process would give covered plans or
providers a way to learn about potential problems with privacy policies
or practices, or training issues. We also hope that providing an avenue
for covered plans or providers to address complaints would lead to
increased consumer satisfaction. We believe this approach strikes a
reasonable balance between allowing covered plans or providers
flexibility and accomplishing the goal of promoting attention to
improvement in privacy practices.
We expect that sanctions would be more formally described and
consistently carried out in larger, more sophisticated entities.
Smaller, less sophisticated entities would be given more latitude and
flexibility. For such smaller entities and less sophisticated entities,
we would not expect a prescribed sanctions policy, but would expect
that actions be taken if repeated instances of violations occur. In
proposed Sec. 164.518(e), we would require all covered entities to
develop and apply when appropriate sanctions for failure to comply with
policies or procedures of the covered entity or with the requirements
of this proposed rule.
i. Documentation requirements for covered entities. We are
proposing that covered entities be required to document policies and
procedures in several important areas. These areas would include use
within the entity; informing business partners; disclosures with and
without authorization; limitations on use and disclosure for self-pay;
inspection and copying; amendment or correction; accounting for uses
and disclosures; notice development, maintenance, and dissemination;
sanctions; and complaint procedures. We considered whether formal
documentation of these policies would be necessary. A key factor in
making this decision was determining the burden on entities,
particularly the burden on small entities. We also considered whether
it would be reasonable to exempt very small entities from this
provision. For example, entities with fewer than ten employees could be
able to effectively communicate policies and procedures verbally. We
decided that we needed to include all entities in the provision because
these documentation requirements are intended as tools to educate the
management, employees, and business partners about the consideration
that should be given to protecting the privacy of health information.
3. The Burden on a Typical Small Business.
We expect that small entities will face a cost burden as a result
of complying with the proposed regulation. We estimate that the burden
of developing privacy policies and procedures is lower in dollar terms
for small businesses than for large businesses, but we recognize that
the cost of implementing privacy provisions will be a larger burden to
small entities as a proportion of total revenue. Due to these concerns,
we rely on the principle of scalability stated in the proposed rule,
and have based our cost estimates on the expectation that small
entities will develop less expensive and less complex privacy measures
than large entities.
In many cases, we have specifically considered the impact that the
proposed rule may have on solo practitioners or rural providers. Where
these providers do not have large technical systems, it is possible
that the regulation may not apply to small providers, or that small
providers will not be required to change their business practices other
than adhering to the basic requirements that they state their privacy
policies and notify patients of their privacy rights. For both
activities, the proposed regulation accounts for the activities and
size of the practice. Scalability implies that in developing policies
and procedures to comply with the proposed regulation, businesses
should consider their basic functions and the amount of health
information exchanged electronically. All covered entities must take
appropriate steps to address privacy concerns, and in determining the
scope and extent of their compliance activities, businesses should
weigh the costs and benefits of alternative approaches and should scale
their compliance activities to their structure, functions, and
capabilities.
Our analysis of the costs to small businesses is divided into three
sections: (1) Initial start-up costs associated with development of
privacy policy; (2) initial start-up costs associated with system
change; and (3) ongoing costs, including notification of privacy
policies.
Overall, our analysis suggests that the average start-up cost of
complying with the proposed rule is $396 per entity. This includes the
cost of developing privacy policies and systems compliance changes
(Table C). The ongoing costs of privacy compliance are approximately
$337 per entity in the first year and $343 every year thereafter (Table
D). The total cost of implementing initial and ongoing costs of the
proposed regulation in the first year is $733 per entity. After the
first year, the total compliance cost to the entity is $343 per year.
We estimate that the relative average cost of initial compliance is
approximately 0.12 percent of a small entity's annual expenditures in
the first year. The relative average cost of ongoing privacy compliance
is approximately 0.05 percent of a small entity's annual expenditures.
Our cost calculations are based on several assumptions. The cost of
developing privacy policies is based on figures from the regulatory
impact analysis that accompanied the HIPAA National Provider Identifier
(63 FR 25320). The cost of initial systems compliance is based on
current assumptions about market behavior; including the assumption
that a relatively small proportion of the total cost of system
compliance (20%) will be absorbed by small covered entities. We
evaluated the ongoing costs of an entity's privacy protection by
calculating that privacy protection costs should be proportional to the
number of patients served by the business. For example, the cost of
notifying patients of privacy practices will be directly proportional
to the number of patients served. We then multiplied the proportion of
small entities by the total ongoing costs of privacy compliance.
Initial Costs
Table C shows the results of our calculations of the cost of
initial compliance. We calculated initial privacy policy costs separate
from initial system compliance costs because we made different
assumptions about the cost of each. To calculate initial privacy policy
costs per small entity, we multiplied the estimated cost of developing
privacy policies (per entity) by the number of establishments. We then
averaged these costs and computed that the average cost of developing
privacy policies is $334.31 per small entity. The average cost of
implementing privacy policies is greater
[[Page 60042]]
than the $300 cost we assume most health care provider offices will
pay, because we assume that small health plans, hospitals, and nursing
and patient care services will spend between $500-$1,000 to implement
privacy policies. Calculating the cost of system compliance per entity
required us to estimate the percent of total system costs that each
type of entity would incur. We used the $90 million figure (cited in
the RIA) as the basis for distributing system compliance costs across
various types of entities affected by the proposed rule. We estimated
how this cost would be divided between small and large entities, and
among plans, providers and clearinghouses.
Table C.--Annual Cost of Implementing Provisions of the Proposed Privacy
Regulation In the First Year
----------------------------------------------------------------------------------------------------------------------
----------------------------------
Initial costs Ongoing costs
Total costs
----------------------------------------------------------------------------------------------------------------------
-
Annual
Initial Initial First year amendment
Total Total
privacy system Notice Total notice and Annual
annual annual
Industry policy compliance development initial issuance correction
written ongoing initial and
costs cost cost, per compliance costs for cost to
authorization cost in the ongoing
incurred by incurred by small cost, per small small cost to
small first year, cost in the
small small entity small entities, entities, entities, per
per small first year,
entities, entities entity \2\ per small per small small entity
entity per small
per entity \1\, per entity entity
entity
--------------------------------------------------entity-------------------------------------------------------------
-----------------------------------
Drug Stores & Proprietary Stores $300 $131.19 $59.40 $490.58 $118.26
$768.64 $102.55 $989.45 $1,480.03
\3\............................
Accident & Health Insurance & 1,000 1,939.86 203.91 3,143.77 314.02
127.60 17.02 458.65 3,602.41
Medical Service Plans \3\
(Accident & Health Insurance
and Hospital & Medical Service
Plans).........................
Offices & Clinics Of Doctors Of 300 21.04 21.20 342.24 42.21
260.93 34.81 337.96 680.20
Medicine.......................
Offices & Clinics Of Dentists... 300 7.43 13.25 320.68 26.39 163.11
21.76 211.26 531.94
Offices & Clinics Of Other 300 11.10 17.82 328.92 35.47 219.29
29.26 284.02 612.94
Health Practitioners...........
Nursing & Personal Care 1,500 117.15 49.63 1,666.79 98.82
610.88 81.50 791.20 2,457.99
Facilities.....................
Hospitals....................... 1,500 7,362.22 79.65 8,941.87 158.59 980.36
130.80 1,269.75 10,211.62
Home Health Care Services....... 300 58.06 30.66 388.72 61.05 377.38
50.35 488.77 877.49
Other Health Care Services 300 19.83 10.84 330.68 21.59 133.47
17.81 172.87 503.55
including Lab Services.........
----------------------------------------------------------------------------------------------------------------------
-
Average Cost................ 334.31 40.13 21.17 395.61 42.05 260.23
34.72 337.00 732.61
----------------------------------------------------------------------------------------------------------------------
----------------------------------
\1\ The SBA defines small health care entities as those with annual revenue under $5,000,000.
\2\ Total Initial Compliance Cost includes policy implementation and systems compliance costs.
\3\ Includes some entities not covered by this regulation. Pharmacies are the only component of
Drug Stores and Proprietary Stores covered by the
regulation. Accident and workers compensation insurance are not covered by the regulation.
Table D.--Annual Cost of Implementing Provisions of the Proposed Privacy Regulation, After
the First Year
----------------------------------------------------------------------------------------------------------------
Ongoing Costs
------------------------------------------------------------------
Annual
Annual amendment Annual Total
notice and Annual ongoing annual
Industry issuance correction written costs for ongoing
costs after cost to authorization paperwork cost after
the first small cost to small and the first
year, per entities, entities, per training, year, per
small per small small entity per small small
entity entity entity entity
----------------------------------------------------------------------------------------------------------------
Drug Stores & Proprietary Stores \1\......... 73.26 768.64 102.55 20 964.45
Accident & Health Insurance & Medical Service 314.02 127.60 17.02 60
518.65
Plans \2\ (Accident & Health Insurance and
Hospital & Medical Service Plans)...........
Offices & Clinics Of Doctors Of Medicine..... 26.15 260.93 34.81 20
341.90
Offices & Clinics Of Dentists................ 16.35 163.11 21.76 20 221.22
Offices & Clinics Of Other Health 21.97 219.29 29.26 20 290.52
Practitioners...............................
Nursing & Personal Care Facilities........... 61.22 610.88 81.50 100 853.59
Hospitals.................................... 98.24 980.36 130.80 100 1,309.40
Home Health Care Services.................... 37.82 377.38 50.35 20 485.54
Other Health Care Services including Lab 13.38 133.47 17.81 20
184.65
Services....................................
------------------------------------------------------------------
Average Cost............................. 26.16 260.23 34.72 22.28 343.39
----------------------------------------------------------------------------------------------------------------
\1\ The SBA defines small health care entities as those with annual revenue under $5,000,000.
\2\ Includes some entities not covered by this regulation. Pharmacies are the only component of
Drug Stores and
Proprietary Stores covered by the regulation. Accident and workers compensation insurance are
not covered by
the regulation.
Our calculations regarding division of costs are based on two
assumptions: (1) System costs are principally fixed costs associated
with the purchase of hardware and software \50\; and (2) large entities
will continue to invest more heavily in hardware and software
expenditures than small entities. We estimate that 80 percent of the
system costs will be born by large entities. The remaining 20 percent
of total systems costs will be absorbed by small entities. To calculate
the effect on small businesses, we multiplied the system compliance
costs cited in the RIA by the proportion of the costs we expect small
entities to incur (20 percent of total). We then multiplied the total
cost of system compliance for small entities by the percentage of
health care revenue by industry and calculated a cost per entity.
---------------------------------------------------------------------------
\50\ We are not suggesting that these investments are
exclusively computer-related. They may also include costs for
personnel training, reorganization, and contract negotiations with
outside entities.
---------------------------------------------------------------------------
We used HCFA's estimate of total national health expenditures to
calculate the percent of total health care business that is represented
by types of health care entities. We calculated the proportion of
business transacted by a type of health care entity (by SIC code) and
multiplied this by the total expenditures ($1.084 billion total) \51\.
National expenditure data is a useful measure for allocating system
compliance costs for two reasons. Even though system compliance costs
are primarily fixed costs, we assume that they bear some relationship
to the size and level of the activity of the entity.
[[Page 60043]]
Similarly, national expenditures vary according to both size and level
of activity. Second, in contrast to the annual receipts compiled by the
Business Census Survey, national expenditure information compares its
data to other sources in order to validate its results. Thus, we
decided that the national expenditure data are a more reliable source
of overall business activity for our purposes. Based on these
assumptions, we believe that the total cost of system compliance for
all small health care entities will be approximately 18 million.
Dividing costs by the number of small entities suggests that the
average cost of system compliance is $40.13 per entity.
---------------------------------------------------------------------------
\51\ Health Care Finance Administration, 1996 https://
www.hcfa.gov/stats/nheoact/tables/t10.htm
---------------------------------------------------------------------------
The cost of notice development is approximately $21 per small
entity. We assume that many small providers will receive assistance
developing their notice policies from professional associations. Thus,
the overall cost of developing compliant notices is significant, but
the cost per entity is small. The cost to small entities of developing
notices is based on the proportion of expenditures generated by small
entities. We recognize that this may not adequately capture the costs
of developing a provider or plan's notice of their privacy policies,
and invite comment on our approach.
We added the per-entity cost of privacy policy implementation to
the cost of systems compliance to determine the total average cost of
start-up compliance. Our figures indicate that initial compliance will
cost an average of $396 per small entity. These costs vary across
entity type (Table C). For example, small hospitals have a much higher
cost of compliance than the average cost for all small entities,
whereas dentists' offices tend to have initial compliance costs that
are lower than the average for small entities. Most small practitioner
offices have low costs ($320 per dentist office), whereas small
hospitals ($8,942 per entity) and small insurance companies have much
higher costs ($3,144 per entity) than other health care entities.
Finally, we attempted to estimate the impact of compliance costs on
small entities by comparing the cost of complying with the proposed
rule to an entity's annual expenditures (Table E). We computed the
percent of small entity expenditures as a percent of national
expenditures by calculating the proportion of small business receipts
(from census data compiled for the SBA) that apply to segments of the
health care market. Although we believe that the SBA data understates
the amount of annual receipts, we assumed that the underestimates are
consistent across all entities. Thus, although the dollar amounts
reported by the SBA are incorrect, our assumption is that the
proportion of small entity receipts relative to total annual receipts
is correct.
Applying the percent of small entity receipts to the national
expenditure data allows us to estimate the percent of national
expenditures represented by small entities. We then considered the
total compliance cost (initial and ongoing cost) as a percent of small
business expenditures. Our estimates suggest that the cost of complying
with the proposed rule represent approximately 0.12 percent of total
annual expenditures for a small health care entity in the first year.
The relative cost of complying with the proposed rule is substantially
lower in subsequent years, representing 0.04 percent of an entity's
annual expenditures. The relative cost of complying with the proposed
regulation cost of complying is highest for small health insurers (1.03
percent of expenditures). These costs will be higher due to the volume
and complexity of health plan billing systems; health plans are
required to implement more policies and procedures to protect health
information because they handle so much personally identifiable
information. Because health plan costs are higher and there is a
smaller number of plans than other type of entities affected by the
regulation, these costs result in a higher annual cost per small health
plan. Table E further illustrates the cost impact by type of entity in
the first year.
Table E.--Small Entity Business Expenditures and Proportion of Annual Expenditures
Represented by Initial and
Ongoing Compliance Costs in the First Year*
----------------------------------------------------------------------------------------------------------------
Compliance
Total annual cost as a
initial and Annual percentage of
Industry ongoing costs expenditure a small
in the first per small entity's
year, per entity \1\ annual
small entity expenditures
----------------------------------------------------------------------------------------------------------------
Drug Stores & Proprietary Stores \2\............................ $1,480.03 $2,046,199 0.07
Accident & Health Insurance & Medical Service Plans \2\ 3,602.41 350,467
1.03
(Accident & Health Insurance and Hospital & Medical Service
Plans).........................................................
Offices & Clinics Of Doctors Of Medicine........................ 680.20 695,560 0.10
Offices & Clinics Of Dentists................................... 531.94 434,260 0.12
Offices & Clinics Of Other Health Practitioners................. 612.94 583,805 0.10
Nursing & Personal Care Facilities.............................. 2,457.99 1,629,755 0.15
Hospitals....................................................... 10,211.62 2,660,215 0.38
Home Health Care Services....................................... 877.49 1,003,475 0.09
Other Health Care Services including Lab Services............... 503.55 351,146
0.14
-----------------------------------------------
Average Cost................................................ 732.61 625,992 0.12
----------------------------------------------------------------------------------------------------------------
* The SBA defines small health care entities as those with annual revenue under
$5,000,000.
** Total Initial Compliance Cost includes policy implementation and systems
compliance costs
\1\ Based on the assumption that the proportion of revenue generated by small businesses
approximates the
proportion of expenditures faced by small businesses
\2\ Includes some entities not covered by this regulation. Pharmacies are the only component of
Drug Stores and
Proprietary Stores covered by the regulation. Accident and workers compensation insurance are
not covered by
the regulation.
Ongoing Costs
In this section, we evaluate the ongoing costs of providing patient
notices, the annual cost of amending and correcting medical
information, the cost of providing written authorizations, and the
ongoing cost of paperwork and training. We estimated the ongoing costs
of compliance through calculations
[[Page 60044]]
similar to those used for our systems compliance estimates. Ongoing
costs are most heavily influenced by the size of the business.
Therefore, we assume that the number of patients an entity serves is
directly proportional to its ongoing compliance costs.
We estimated market share using Small Business Administration data
estimating total receipts.\52\ We divided the small entity receipts by
total receipts and arrived at an estimate that 22 percent of the
revenue generated by the health care classifications we examined is
from small businesses. Using annual receipts to estimate cost burden is
more accurate than using information on the number of health care
entities. The size of the small entity is more likely to be correlated
with the number of patients served than the number of businesses, and
therefore, the amount of business conducted by an entity. Because it is
difficult to find a single good estimate of market share, we considered
estimating market share over a range, using the proportion of annual
receipts as a lower bound and number of entities as the higher bound.
We concluded that even if the SBA data does not capture the total
amount of health care receipts accurately, estimating market share by
examining receipts would be much more accurate than using the number of
entities.
---------------------------------------------------------------------------
\52\ Office of Advocacy, U.S. Small Business Administration,
from data provided by the Bureau of the Census, Statistics of U.S.
Businesses, 1996.
---------------------------------------------------------------------------
We multiplied the percent total receipts by the total ongoing costs
(by entity type) to obtain a range of ongoing costs for small entities.
We were then able to divide these costs by the number of small entities
by type of entity. We estimated ongoing costs in the first year that
the proposed rule takes effect separately from our estimate of ongoing
cost in the following years. The estimates were approximately the same;
$337 and $343 respectively.
We estimate that the ongoing cost of compliance will be
approximately 0.05 percent of a small entity's annual expenditures.
This cost burden is fairly consistent across all types of entities.
Clearinghouses and Nonprofit Entities
We should note that the above discussion does not consider health
care clearinghouses, nonprofit hospitals, home health agencies, or
nursing and skilled nursing facilities. To the extent that
clearinghouses and nonprofit facilities have annual receipts of less
than $5 million, they were included in the preceding analysis.
Although we do not have precise information on the number of
clearinghouses that qualify as small entities under the RFA, we believe
that approximately half would meet the criteria. As noted in the
regulatory impact analysis, as long as clearinghouses perform the
function of merely reformatting information they receive and
transmitting the data to other entities, the cost of complying with the
proposed rule should be minimal.
A similar logic applies for nonprofit health plans and hospitals.
We do know how many nonprofit organizations currently exist in the
U.S., but do not have reliable revenue and expenditure data for these
entities. In the absence of such data, we assume that nonprofit
entities have a similar ratio of revenues to expenditures as the for-
profit entities we have examined. Thus, we believe that the impact of
complying with the proposed rule should be similar to that described
for-profit plans and hospitals.
The preceding analysis indicates that the expected burden on small
entities of implementing the proposed rule would be minimal. However,
by necessity, the analysis is based on average costs, and as such, they
may not reflect the actual burden on some or even a substantial number
of small entities. Therefore, the Secretary does not certify that the
proposed rule will not have a significant impact on a substantial
number of small entities.
VI. Unfunded Mandates
The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires
cost-benefit and other analyses for rules that would cost more than
$100 million in a single year. The proposed rule qualifies as a
significant rule under the statute. DHHS has carried out the cost-
benefit analysis in sections D and E of this document, which includes a
discussion of unfunded costs to the states resulting from this
regulation.
A. Future Costs
DHHS estimates some of the future costs of the proposed rule in
Section E of the Preliminary Regulatory Impact Analysis of this
document. The reported costs include costs incurred during the
compliance period and up to 5 years after the effective date. The same
section also includes some qualitative discussion of costs that would
occur beyond that time period. Most of the costs of the proposed rule,
however, would occur in the years immediately after the publication of
a final rule. Future costs beyond the five year period will continue
but will not be as great as the initial compliance costs.
B. Particular Regions, Communities, or Industrial Sectors.
The proposed rule applies to the health care industry and would,
therefore, affect that industry disproportionately. Any long-run
increase in the costs of health care services would largely be passed
on to the entire population of consumers.
C. National Productivity and Economic Growth
The proposed rule is not expected to substantially affect
productivity or economic growth. It is possible that productivity and
growth in certain sectors of the health care industry could be slightly
lower than otherwise because of the need to divert research and
development resources to compliance activities. The diversion of
resources to compliance activities would be temporary. Moreover, DHHS
anticipates that, because the benefits of privacy are large, both
productivity and economic growth would be higher than in the absence of
the proposed rule. In section I.A. of this document, DHHS discusses its
expectation that this proposed rule would increase communication among
consumers, health plans, and providers and that implementation of
privacy protections will lead more people to seek health care. The
increased health of the population will lead to increased productivity
and economic growth.
D. Full Employment and Job Creation.
Some of the human resources devoted to delivery of health care
services would be redirected by the proposed rule. The proposed rule
could lead to some short-run changes in employment patterns as a result
of the structural changes within the health care industry. The growth
of employment (job creation) for the roles typically associated with
the health care profession could also be temporarily change but be
balanced by an increased need for those who can assist entities with
complying with this proposed rule. Therefore, while there could be a
temporary slowing of growth in traditional health care professions,
that will be offset by a temporary increase in growth in fields that
may assist with compliance with this proposed rule (e.g. legal
professionals, and management consultants).
E. Exports
Because the proposed rule does not mandate any changes in products,
current export products will not be required to change in any way.
VII. Environmental Impact
The Department has determined under 21 CFR 25.30(K) that this
action
[[Page 60045]]
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
VIII. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995 (PRA), agencies are
required to provide a 60-day notice in the Federal Register and solicit
public comment before a collection of information requirement is
submitted to the Office of Management and Budget (OMB) for review and
approval. In order to fairly evaluate whether an information collection
should be approved by OMB, section 3506(c)(2)(A) of the PRA requires
that we solicit comment on the following issues:
Whether the information collection is necessary and useful
to carry out the proper functions of the agency;
The accuracy of the agency's estimate of the information
collection burden;
The quality, utility, and clarity of the information to be
collected; and
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
Under the PRA, the time, effort, and financial resources necessary
to meet the information collection requirements referenced in this
section are to be considered. Due to the complexity of this regulation,
and to avoid redundancy of effort, we are referring readers to Section
IV (Regulatory Impact Analysis) above, to review the detailed cost
assumptions associated with these PRA requirements. We explicitly seek,
and will consider public comment on our cost assumptions, as they
relate to the PRA requirements summarized in this section.
Summary PRA Burden Hours
------------------------------------------------------------------------
Burden (in
Provision hours)
------------------------------------------------------------------------
Sec. 160.204 Process for requesting exceptions...... 160
Sec. 164.506 General standards and implementation * TBD
specifications for uses and disclosures of protected
health information...................................
Sec. 164.508 Standards and implementation 3,561,076
specifications for uses and disclosures for which
individual authorization would be required...........
Sec. 164.510 Standards and implementation 8,903
specifications for uses and disclosures for which
individual authorization would not be required.......
Sec. 164.512 Notice of privacy practices; rights and 7,273,952
procedures...........................................
Sec. 164.514 Access to protected health information; * TBD
rights and procedures................................
Sec. 164.515 Accounting for uses and disclosures of * TBD
protected health information.........................
Sec. 164.516 Amendment and correction; rights and *TBD
procedures ..........................................
Sec. 164.520 Development and documentation of 2,927,000
policies and procedures..............................
Sec. 164.522 Compliance and Enforcement............. 2,500
-----------------
Total Hours....................................... 13,773,591
------------------------------------------------------------------------
* Burden to be determined based upon public comment.
Section 160.204 Process for Requesting Exceptions.
Section 160.204 would require States to: (1) Submit a written
request, that meets the requirements of this section, to the Secretary
to except a provision of State law from preemption under Sec. 160.203;
(2) submit a new request to the Secretary, should there be any changes
to the standard, requirement, or implementation specification or
provision of State law upon which an exception previously was granted,
and (3) submit a written request for an extension of the exception
prior to the end of the three-year approval period for a given
exception. In addition, Sec. 160.204 would require a State to submit a
written request for an advisory opinion to the Secretary that meets the
requirements of Sec. 160.204.
The burden associated with these requirements is the time and
effort necessary for a State to prepare and submit the written request
for preemption or advisory opinion to HCFA for approval. On an annual
basis it is estimated that it will take 10 States 16 hours each to
prepare and submit a request. The total annual burden associated with
this requirement is 160 hours.
Section 164.506 General Standards and Implementation Specifications
for Uses and Disclosures of Protected Health Information
Given that the burden associated with the following information
collection requirements will differ significantly, by the type and size
of plan or provider, we are explicitly soliciting comment on the burden
associated with the following requirements:
Except for disclosures of protected health information by
a covered entity that is a health care provider to another health care
provider for treatment purposes, Sec. 160.204(e) would require a
covered entity to maintain documentation demonstrating that they have
entered into a contract that meets the requirements of this part with
each of their business partners;
A covered entity would have to make all reasonable efforts
not to use or disclose more than the minimum amount of protected health
information necessary to accomplish the intended purpose of the use or
disclosure;
A covered entity could use protected health information to
create de-identified information if the individually identifiable
information has been removed, coded, encrypted, or otherwise eliminated
or concealed.
Section 164.508 Standards and Implementation Specifications for Uses
and Disclosures for Which Individual Authorization Would Be Required
Pursuant to the conditions set forth in this section, a covered
entity would need to obtain a written request from an individual,
before it uses or discloses protected health information of an
individual. A copy of the model form which appears in Appendix to
Subpart E of Part 164, or a form that contains the elements listed in
paragraphs (c) or (d) of this section, as applicable, would need to be
accepted by the covered entity.
The burden associated with these proposed requirements is the time
and effort necessary for a covered entity to obtain written
authorization prior to the disclosure of identifiable information. On
an annual basis it is estimated that it will take 890,269 entities, a
range of 0 to 80 hours per entity to obtain and
[[Page 60046]]
maintain authorization documentation on an annual basis. Given that we
believe the majority of the covered entities will be minimally affected
by this requirement, we estimate the annual average burden per entity
to be 4 hours for a total annual burden of 3,561,076 hours. Collecting
such authorization should have costs on the order of those associated
with providing access to records (not on a per page basis). Since the
proposed requirement does not apply to treatment and payment, assuming
1% of the 543 million health care encounters might be reasonable. At a
cost of about $10 each, the aggregate cost would be about $54 million.
Therefore, on average the cost per entity would be about $60, with many
entities receiving no requests and thus having no costs.
Section 164.510 Standards and Implementation Specifications for Uses
and Disclosures for Which Individual Authorization Would Not Be
Required
A covered entity could disclose protected health information to a
health researcher for health research purposes subject to 45 CFR part
46 and purposes other than those subject to 45 CFR part 46, provided
that the covered entity has obtained written documentation
demonstrating that the applicable requirements proposed in this section
have been met.
The burden associated with these proposed requirements is the time
and effort necessary for a covered entity to maintain documentation
demonstrating that they have obtained institutional review board or
privacy board approval, which meet the requirements of this section. On
an annual basis it is estimated that this proposed requirement will
affect 1 % or 8,903 of covered entities. We further estimate that it
will take an average of 1 hour per entity to meet these proposed
requirements on an annual basis. Therefore, the total estimated annual
burden associated with this proposed requirement is 8,903 hours.
Section 164.512 Notice of Privacy Practices; Rights and Procedures
Section 164.512 would require covered entities to provide written
notice of the entities' privacy practices, rights, and procedures that
meet the requirements of this section to affected parties upon request
and as summarized below.
Health plans would provide a copy of the notice to an individual
covered by the plan at enrollment and whenever the content of the
notice is significantly altered thereafter, but no less frequently than
once every three years. Total notice counts are estimated to be about
230 million, assuming plans choose to send them out annually rather
than keeping track of duration since last notice. The average number of
notices per plan per year would be about 1,200. For the approximately
19,000 plans issuing notices, the number of notices can be as few as
1,000 for a small self-insured self-administered employer, or as many
as a million or more for a large commercial insurer or HMO. We further
estimate that it will require each plan, on average, 8 hours to
disseminate the required notices. This estimate is based upon the
assumption that the required notice will be incorporated and
disseminated with a plan's annual policy materials. The total burden
associated with this requirement is calculated to be 151,800 hours.
Health care providers would provide a copy of the notice to an
individual at the time of first service delivery to the individual,
provide as promptly as possible a copy of the notice to an individual
served by the provider whenever the content of the notice is
significantly altered, post a copy of the notice in a location where it
is reasonable to expect individuals seeking services from the provider
to be able to read the notice, and date each version of the notice.
Total notices in the first year are estimated to be about 700 million
(based on annual patient contacts with hospitals, physicians, and other
providers), with subsequent year counts of 350 million. Small providers
could be providing 400 or fewer notices (based on 150 million persons
with ambulatory physician contacts per year and approximately 370,000
physician offices). The overall average will also be close to that
amount, since the bulk of providers are small entities. Large providers
could be sending out 3,000 or more notices (based on 20 million persons
with hospitalizations and approximately 6600 hospitals). We further
estimate that it will require each provider, on average, 8 hours to
disseminate the required notices. This estimate is based upon the
assumption that the required notice will be incorporated into and
disseminated with other patient materials. The total burden associated
with this requirement is calculated to be 7,122,152 hours.
Section 164.514 Access of Individuals to Protected Health Information
Given that the burden associated with the following information
collection requirements will differ significantly, by the type and size
of plan or provider, we are explicitly soliciting comment on the burden
associated with the following proposed requirements:
An individual has a right of access to, which includes a
right to inspect and obtain a copy of, his or her protected health
information in a designated record set of a covered entity that is a
health plan or a health care provider, including such information in a
business partner's designated record set that is not a duplicate of the
information held by the provider or plan, for so long as the
information is maintained;
Where the request is denied in whole or in part, the
health plan or a health care provider would provide the individual with
a written statement of the basis for the denial and a description of
how the individual may complain to the covered entity pursuant to the
complaint procedures established in Sec. 164.518 or to the Secretary
pursuant to the procedures established in Sec. 164.522 of this subpart.
Section 164.515 Accounting for Uses and Disclosures of Protected
Health Information
Given that the burden associated with maintaining records to
facilitate the recreation of disclosures will differ significantly, be
the type and size of plan or provider, we are explicitly soliciting
comment on the burden associated with the following proposed record
keeping requirement:
A covered entity that is a plan or provider would need to
be able to give individuals an accurate accounting of all uses and
disclosures that are for purposes other than treatment, payment, and
health care operations; except that such procedures would provide for
the exclusion from such accounting of protected health information
which is disclosed to a health oversight or law enforcement agency, if
the health oversight or law enforcement agency provides a written
request stating that the exclusion is necessary because disclosure
would be reasonably likely to impede the agency's activities and
specifies the time for which such exclusion is required.
Section 164.516 Amendment and Correction
Given that burden will associated with the following information
collection requirements will differ significantly, by the type and size
of plan or provider, we are explicitly soliciting comment on the burden
associated with the following proposed requirements:
An individual would have the right to request amendment or
correction of his or her protected health information in designated
records created by a covered entity that is a health plan or health
care provider, where the
[[Page 60047]]
individual asserts that the information is not accurate or complete and
where the error or omission may have an adverse effect on the
individual.
Where the request is denied , provide the individual with
a written statement of the basis for the denial, a description of how
the individual may file a statement of disagreement with the denial, a
description of how the individual may file a complaint with the covered
entity, including the name and telephone number of a contact person
within the covered entity who can answer questions concerning the
denial and the complaint process; and a description of how the
individual may file a complaint with the Secretary pursuant to
Sec. 164.522 of this subpart.
Section 164.520 Internal Privacy Practices; Standards and Procedures
A covered entity would need to ensure that all employees who have
access to protected health information have received appropriate
training about the entity's policies for use and disclosure of such
information. Upon completion of the training and at least once every
three years thereafter, covered entities would require each employee to
sign a statement that he or she received the privacy training and will
honor all of the entity's privacy policies and procedures.
The burden associated with these requirements is the time and
effort necessary for a covered entity to obtain and maintain
certification documentation demonstrating that applicable employees
have received privacy training and will honor all of the entity's
privacy policies and procedures. It is estimated that it will take
890,269 entities, a range of 1 hour to 40 hours per entity to obtain
and maintain documentation on an annual basis. Given that we believe
the majority of the covered entities will be minimally affected by this
requirement, we estimate the annual average burden to be 3 hours per
entity for a total annual burden of 2,700,000 hours. Using previous
calculations, 900,000 (rounded) entities break down to about 95% small,
5% various types of large, and 1 burden hour for 95%, and 40 burden
hours for 5%, the average burden would be 3 hours.
In addition, this section would require a covered entity that is a
health plan or health care provider to develop and document its
policies and procedures for implementing the requirements of this
proposed rule, and amend the documentation to reflect any change to a
policy or procedure.
The burden associated with these requirements is the time and
effort necessary for a covered entity to maintain documentation
demonstrating that they have implemented procedures that meet the
requirements of this proposed rule. It is estimated that it will take
890,269 entities a range of 15 minutes to 1 hour per entity to maintain
procedural documentation on an annual basis. We believe the majority
(95%) of the covered entities will be minimally affected by this
requirement. Using the 95% small/5% large, the average burden is 17
minutes. Multiplying by 890,269, results in a total annual burden of
256,000 hours (see discussion below).
Since the requirements for developing formal processes and
documentation of procedures mirror what will already have been required
under the HIPAA security regulations, the burden and additional costs
should be small. To the extent that national or state associations will
develop guidelines or general sets of processes and procedures which
will be reviewed by individual member entity, the costs would be
primarily those of the individual reviewers. Assuming this process
occurs, we believe that entities will review information from
associations in each state and prepare a set of written policies to
meet their needs. Our estimates are based on assumed costs for
providers ranging from $300 to $3000, with the average being about
$375. The range correlates to the size and complexity of the provider.
With less than 1 million provider entities, the aggregate cost would be
on the order of $300 million. For plans and clearinghouses, our
estimate assumes that the legal review and development of written
policies will be more costly because of the scope of their operations.
They are often dealing with a large number of different providers and
may be dealing with requirements from multiple states. We believe the
costs for these entities will range from $300 for smaller plans to
$15,000 for the largest plans. Because there are very few large plans
in relation to the number of small plans, the average implementation
costs will be about $3050.
Section 164.522 Compliance and Enforcement
An individual who believes that a covered entity is not complying
with the requirements of this subpart may file a complaint with the
Secretary within 180 days from the date of the alleged non-compliance,
unless the time for filing is extended by the Secretary. The complaint
would describe in detail the acts or omissions believed to be in
violation of the requirements of this subpart.
The burden associated with these requirements is the time and
effort necessary for an individual to prepare and submit a written
complaint to the Secretary. On an annual basis it is estimated that
10,000 complaints will be filed on an annual basis. We further estimate
that it will take an average of 15 minutes per individual to submit a
complaint. Therefore, the total estimated annual burden associated with
this requirement is 2,500 hours.
A covered entity would need to maintain documentation necessary for
the Secretary to ascertain whether the covered entity has complied or
is complying with the requirements of this subpart. While this section
is subject to the PRA, the burden associated with this requirement is
addressed under sections referenced above, which discuss specific
record keeping requirements.
We have submitted a copy of this proposed rule to OMB for its
review of the information collection requirements in Secs. 160.204,
164.506, 164.508, 164.510, 164.512, 164.514, 164.515, 164.516, 164.520,
and Sec. 164.522. These requirements are not effective until they have
been approved by OMB.
If you comment on any of these information collection and record
keeping requirements, please mail copies directly to the following:
Health Care Financing Administration, Office of Information Services,
Information Technology Investment Management Group, Division of HCFA
Enterprise Standards, Room C2-26-17, 7500 Security Boulevard,
Baltimore, MD 21244-1850. ATTN: John Burke HIPAA Privacy-P
Office of Information and Regulatory Affairs, Office of Management and
Budget, Room 10235, New Executive Office Building, Washington, DC
20503. ATTN: Allison Herron Eydt, HCFA Desk Officer.
IX. Executive Order 12612: Federalism
The Department has examined the effects of provisions in the
proposed privacy regulation on the relationship between the Federal
government and the States, as required by Executive Order 12612 on
"Federalism." The agency concludes that preempting State or local
proposed rules that provide less stringent privacy protection
requirements than Federal law is consistent with this Executive Order.
Overall, the proposed rule attempts to balance both the autonomy of the
States with the necessity to create a Federal benchmark to preserve the
privacy of personally identifiable health information.
[[Page 60048]]
It is recognized that the States generally have laws that relate to
the privacy of individually identifiable health information. The HIPAA
statute dictates the relationship between State law and this proposed
rule. Except for laws that are specifically exempted by the HIPAA
statute, State laws continue to be enforceable, unless they are
contrary to Part C of Title XI of the standards, requirements, or
implementation specifications adopted or pursuant to subpart x.
However, under section 264(c)(2), not all contrary provisions of State
privacy laws are preempted; rather, the law provides that contrary
provisions that are also "more stringent" than the federal regulatory
requirements or implementation specifications will continue to be
enforceable.
Section 3(b) of Executive Order 12612 recognizes that Federal
action limiting the discretion of State and local governments is
appropriate "where constitutional authority for the action is clear
and certain and the national activity is necessitated by the presence
of a problem of national scope." Personal privacy issues are widely
identified as a national concern by virtue of the scope of interstate
health commerce. HIPAA's provisions reflect this position. HIPAA
attempts to facilitate the electronic exchange of financial and
administrative health plan transactions while recognizing challenges
that local, national, and international information sharing raise to
confidentiality and privacy of health information.
Section 3(d)(2) of the Executive Order 12612 requires that the
Federal government refrain from "establishing uniform, national
standards for programs and, when possible, defer to the States to
establish standards." HIPAA requires HHS to establish standards, and
we have done so accordingly. This approach is a key component of the
proposed privacy rule, and it adheres to Section 4(a) of Executive
Order 12612, which expressly contemplates preemption when there is a
conflict between exercising State and Federal authority under Federal
statute. Section 262 of HIPAA enacted Section 1178 of the Social
Security Act, developing a "general rule" that State laws or
provisions that are contrary to the provisions or requirements of Part
C of Title XI, or the standards or implementation specifications
adopted, or established thereunder are preempted. Several exceptions to
this rule exist, each of which is designed to maintain a high degree of
State autonomy.
Moreover, Section 4(b) of the Executive Order authorizes preemption
of State law in the Federal rule making context when there is "firm
and palpable evidence compelling the conclusion that the Congress
intended to delegate to the * * * agency the authority to issue
regulations preempting State law." Section 1178 (a)(2)(B) of HIPAA
specifically preempts State laws related to the privacy of individually
identifiable health information unless the State law is more stringent.
Thus, we have interpreted State and local laws and regulations that
would impose less stringent requirements for protection of individually
identifiable health information as undermining the agency's goal of
ensuring that all patients who receive medical services are assured a
minimum level of personal privacy. Particularly where the absence of
privacy protection undermines an individual's access to health care
services, both the personal and public interest is served by
establishing Federal rules.
The proposed rule would establish national minimum standards with
respect to the collection, maintenance, access, transfer, and
disclosure of personally identifiable health information. The Federal
law will preempt State law only where State and Federal laws are
"contradictory" and the Federal regulation is judged to establish
"more stringent" privacy protections than State laws.
As required by the Executive Order, States and local governments
will be given, through this notice of proposed rule making, an
opportunity to participate in the proceedings to preempt State and
local laws (section 4(e) of Executive Order 12612). However, it should
be noted that the preemption of state law is based on the HIPAA
statute. The Secretary will also provide a review of preemption issues
upon requests from States. In addition, under the Order, appropriate
officials and organizations will be consulted before this proposed
action is implemented (section 3(a) of Executive Order 12612).
Finally, we have considered the cost burden that this proposed rule
would impose on State-operated health care entities, Medicaid, and
other State health benefits programs. We do not have access to reliable
information on the number of State-operated entities and programs, nor
do we have access to data on the costs these entities and programs
would incur in order to comply with the proposed rule. A discussion of
possible compliance costs that covered entities may incur is contained
in the Unfunded Mandates section above. We believe that requiring State
health care entities covered by the proposed rule to comply with the
proposed rule would cost less than one percent of a State's annual
budget.
The agency concludes that the policy proposed in this document has
been assessed in light of the principles, criteria, and requirements in
Executive Order 12612; that this policy is not inconsistent with that
Order; that this policy will not impose significant additional costs
and burdens on the States; and that this policy will not affect the
ability of the States to discharge traditional State governmental
functions.
During our consultation with the States, representatives from
various State agencies and offices expressed concern that the proposed
regulation would pre-empt all State privacy laws. As explained in this
section, the regulation would only pre-empt state laws where there is a
direct conflict between state laws and the regulation, and where the
regulation provides more stringent privacy protection than State law.
We discussed this issue during our consultation with State
representatives, who generally accepted our approach to the preemption
issue. During the consultation, we requested further information from
the States about whether they currently have laws requiring that
providers have a "duty to warn" family members or third parties about
a patient's condition other than in emergency circumstances. Since the
consultation, we have not received additional comments or questions
from the States.
X. Executive Order 13086: Consultation and Coordination with Indian
Tribal Governments
In drafting the proposed rule, the Department consulted with
representatives of the National Congress of American Indians and the
National Indian Health Board, as well as with a representative of the
self-governance Tribes. During the consultation, we discussed issues
regarding the application of Title II of HIPAA to the Tribes, and
potential variations based on the relationship of each Tribe with the
IHS for the purpose of providing health services. Participants raised
questions about the status of Tribal laws regarding the privacy of
health information.
List of Subjects in 45 CFR Parts 160 and 164
Employer benefit plan, Health, Health care, Health facilities,
Health insurance, Health records, Medicaid, Medical
[[Page 60049]]
research, Medicare, Privacy, Reporting and recordkeeping requirements,
security measures.
Note to reader: This proposed rule is one of several proposed
rules that are being published to implement the Administrative
Simplification provisions of the Health Insurance Portability and
Accountability Act of 1996. We propose to establish a new 45 CFR
subchapter C, parts 160 through 164. Part 160 will consist of
general provisions, part 162 will consists of the various
Administrative Simplification regulations relating to transactions
and identifiers, and part 164 will consists of the regulations
implementing the security and privacy requirements of the
legislation. Proposed part 160, consisting of two subparts (Subpart
A General Provisions, and Subpart B--Preemption of State Law) will
be exactly the same in each rule, unless we add new sections or
definitions to incorporate additional general information in the
later rules.
Dated: October 26, 1999.
Donna Shalala,
Secretary.
Appendix to the Preamble: Sample Contact of Provider Notice
PROVIDER NOTICE OF INFORMATION PRACTICES (as of 1/1/1999)
Uses and Disclosures of Health Information
We use health information about you for treatment, to obtain
payment for treatment, for administrative purposes, and to evaluate
the quality of care that you receive.
We may use or disclose identifiable health information about you
without your authorization for several other reasons. Subject to
certain requirements, we may give out health information without
your authorization for public health purposes, for auditing
purposes, for research studies, and for emergencies. We provide
information when otherwise required by law, such as for law
enforcement in specific circumstances. In any other situation, we
will ask for your written authorization before using or disclosing
any identifiable health information about you. If you choose to sign
an authorization to disclose information, you can later revoke that
authorization to stop any future uses and disclosures.
We may change our policies at any time. Before we make a
significant change in our policies, we will change our notice and
post the new notice in the waiting area and in each examination
room. You can also request a copy of our notice at any time. For
more information about our privacy practices, contact the person
listed below.
Individual Rights
In most cases, you have the right to look at or get a copy of
health information about you that we use to make decisions about
you. If you request copies, we will charge you $0.05 (5 cents) for
each page. You also have the right to receive a list of instances
where we have disclosed health information about you for reasons
other than treatment, payment or related administrative purposes. If
you believe that information in your record is incorrect or if
important information is missing, you have the right to request that
we correct the existing information or add the missing information.
You may request in writing that we not use or disclose your
information for treatment, payment and administrative purposes
except when specifically authorized by you, when required by law, or
in emergency circumstances. We will consider your request but are
not legally required to accept it.
Complaints
If you are concerned that we have violated your privacy rights,
or you disagree with a decision we made about access to your
records, you may contact the person listed below. You also may send
a written complaint to the U.S. Department of Health and Human
Services. The person listed below can provide you with the
appropriate address upon request.
Our Legal Duty
We are required by law to protect the privacy of your
information, provide this notice about our information practices,
and follow the information practices that are described in this
notice.
If you have any questions or complaints, please contact: Office
Administrator, 111 Main Street, Suite 101, Anytown, OH 41111. Phone:
(111) 555-6789, Email: admin@docshop.com.
For the reasons set forth in the preamble, it is proposed to amend
45 CFR subtitle A by adding a new subchapter C, consisting of parts 160
through 164, to read as follows:
SUBCHAPTER C--ADMINISTRATIVE DATA STANDARDS AND RELATED
REQUIREMENTS
Part
160--GENERAL ADMINISTRATIVE REQUIREMENTS
161-163--[RESERVED]
164--SECURITY AND PRIVACY
PART 160--GENERAL ADMINISTRATIVE REQUIREMENTS
Subpart A--General Provisions
Sec.
160.101 Statutory basis and purpose
160.102 Applicability
160.103 Definitions
160.104 Effective dates of a modification to a standard or
implementation specification
Subpart B--Preemption of State Law
160.201 Applicability
160.202 Definitions
160.203 General rule and exceptions
160.204 Process for requesting exception determinations or advisory
opinions
Authority: 42 U.S.C. 1320d-2 and 1320d-4.
Subpart A--General Provisions
Sec. 160.101 Statutory basis and purpose.
The requirements of this subchapter implement sections 1171 through
1179 of the Social Security Act, as amended, which require HHS to adopt
national standards to enable the electronic exchange of health
information in the health care system. The requirements of this
subchapter also implement section 264 of Pub. L 104-191, which requires
that HHS adopt national standards with respect to the privacy of
individually identifiable health information transmitted in connection
with the transactions described in section 1173(a)(1) of the Social
Security Act. The purpose of these provisions is to promote
administrative simplification.
Sec. 160.102 Applicability.
Except as otherwise provided, the standards, requirements, and
implementation specifications adopted or designated under the parts of
this subchapter apply to any entity that is:
(a) A health plan;
(b) A health care clearinghouse; and
(c) A health care provider who transmits any health information in
electronic form in connection with a transaction covered by this
subchapter.
Sec. 160.103 Definitions.
Except as otherwise provided, the following definitions apply to
this subchapter:
Act means the Social Security Act, as amended.
Covered entity means an entity described in Sec. 160.102.
Health care means the provision of care, services, or supplies to a
patient and includes any:
(1) Preventive, diagnostic, therapeutic, rehabilitative,
maintenance, or palliative care, counseling, service, or procedure with
respect to the physical or mental condition, or functional status, of a
patient or affecting the structure or function of the body;
(2) Sale or dispensing of a drug, device, equipment, or other item
pursuant to a prescription; or
(3) Procurement or banking of blood, sperm, organs, or any other
tissue for administration to patients.
Health care clearinghouse means a public or private entity that
processes or facilitates the processing of nonstandard data elements of
health information into standard data elements. The entity receives
health care transactions from health care providers or other entities,
translates the data from a given format into one acceptable to the
intended payer or payers, and forwards the processed transaction to
appropriate payers and clearinghouses. Billing services, repricing
companies, community health management information systems, community
health information systems, and "value-added"
[[Page 60050]]
networks and switches are considered to be health care clearinghouses
for purposes of this part, if they perform the functions of health care
clearinghouses as described in the preceding sentences.
Health care provider means a provider of services as defined in
section 1861(u) of the Act, a provider of medical or health services as
defined in section 1861(s) of the Act, and any other person or
organization who furnishes, bills, or is paid for health care services
or supplies in the normal course of business.
Health information means any information, whether oral or recorded
in any form or medium, that:
(1) Is created or received by a health care provider, health plan,
public health authority, employer, life insurer, school or university,
or health care clearinghouse; and
(2) Relates to the past, present, or future physical or mental
health or condition of an individual, the provision of health care to
an individual, or the past, present, or future payment for the
provision of health care to an individual.
Health plan means an individual or group plan that provides, or
pays the cost of, medical care. Such term includes, when applied to
government funded or assisted programs, the components of the
government agency administering the program. "Health plan" includes
the following, singly or in combination:
(1) A group health plan, defined as an employee welfare benefit
plan (as currently defined in section 3(1) of the Employee Retirement
Income and Security Act of 1974, 29 U.S.C. 1002(1)), including insured
and self-insured plans, to the extent that the plan provides medical
care (as defined in section 2791(a)(2) of the Public Health Service
Act, 42 U.S.C. 300gg-91(a)(2)), including items and services paid for
as medical care, to employees or their dependents directly or through
insurance or otherwise, that:
(i) Has 50 or more participants; or
(ii) Is administered by an entity other than the employer that
established and maintains the plan.
(2) A health insurance issuer, defined as an insurance company,
insurance service, or insurance organization that is licensed to engage
in the business of insurance in a State and is subject to State or
other law that regulates insurance.
(3) A health maintenance organization, defined as a federally
qualified health maintenance organization, an organization recognized
as a health maintenance organization under State law, or a similar
organization regulated for solvency under State law in the same manner
and to the same extent as such a health maintenance organization.
(4) Part A or Part B of the Medicare program under title XVIII of
the Act.
(5) The Medicaid program under title XIX of the Act.
(6) A Medicare supplemental policy (as defined in section
1882(g)(1) of the Act, 42 U.S.C. 1395ss).
(7) A long-term care policy, including a nursing home fixed-
indemnity policy.
(8) An employee welfare benefit plan or any other arrangement that
is established or maintained for the purpose of offering or providing
health benefits to the employees of two or more employers.
(9) The health care program for active military personnel under
title 10 of the United States Code.
(10) The veterans health care program under 38 U.S.C. chapter 17.
(11) The Civilian Health and Medical Program of the Uniformed
Services (CHAMPUS), as defined in 10 U.S.C. 1072(4).
(12) The Indian Health Service program under the Indian Health Care
Improvement Act (25 U.S.C. 1601, et seq.).
(13) The Federal Employees Health Benefits Program under 5 U.S.C.
chapter 89.
(14) An approved State child health plan for child health
assistance that meets the requirements of section 2103 of the Act.
(15) A Medicare Plus Choice organization as defined in 42 CFR
422.2, with a contract under 42 CFR part 422, subpart K.
(16) Any other individual or group health plan, or combination
thereof, that provides or pays for the cost of medical care.
Secretary means the Secretary of Health and Human Services and any
other officer or employee of the Department of Health and Human
Services to whom the authority involved has been delegated.
Small health plan means a health plan with annual receipts of $5
million or less.
Standard means a prescribed set of rules, conditions, or
requirements concerning classification of components, specification of
materials, performance or operations, or delineation of procedures, in
describing products, systems, services or practices.
State includes the 50 States, the District of Columbia, the
Commonwealth of Puerto Rico, the Virgin Islands, and Guam.
Transaction means the exchange of information between two parties
to carry out financial or administrative activities related to health
care. It includes the following:
(1) Health claims or equivalent encounter information;
(2) Health care payment and remittance advice;
(3) Coordination of benefits;
(4) Health claims status;
(5) Enrollment and disenrollment in a health plan;
(6) Eligibility for a health plan;
(7) Health plan premium payments;
(8) Referral certification and authorization;
(9) First report of injury;
(10) Health claims attachments; and
(11) Other transactions as the Secretary may prescribe by
regulation.
Sec. 160.104 Effective dates of a modification to a standard or
implementation specification.
The Secretary may modify a standard or implementation specification
after the first year in which the standard or implementation
specification is required to be used, but not more frequently than once
every 12 months. If the Secretary adopts a modification to a standard
or implementation specification, the implementation date of the
modified standard or implementation specification may be no earlier
than 180 days following the adoption of the modification. The Secretary
will determine the actual date, taking into account the time needed to
comply due to the nature and extent of the modification. The Secretary
may extend the time for compliance for small health plans.
Subpart B--Preemption of State Law
Sec. 160.201 Applicability.
The provisions of this subpart apply to determinations and advisory
opinions issued by the Secretary pursuant to 42 U.S.C. 1320d-7.
Sec. 160.202 Definitions.
For the purpose of this subpart, the following terms have the
following meanings:
Contrary, when used to compare a provision of State law to a
standard, requirement, or implementation specification adopted under
this subchapter, means:
(1) A party would find it impossible to comply with both the State
and federal requirements; or
(2) The provision of State law stands as an obstacle to the
accomplishment and execution of the full purposes and objectives of
part C of title XI of the Act or section 264 of Pub. L. 104-191, as
applicable.
More stringent means, in the context of a comparison of a provision
of State
[[Page 60051]]
law and a standard, requirement, or implementation specification
adopted under subpart E of part 164 of this subchapter, a law which
meets one or more of the following criteria, as applicable:
(1) With respect to a use or disclosure, provides a more limited
use or disclosure (in terms of the number of potential recipients of
the information, the amount of information to be disclosed, or the
circumstances under which information may be disclosed).
(2) With respect to the rights of individuals of access to or
amendment of individually identifiable health information, permits
greater rights or access or amendment, as applicable, provided,
however, that nothing in this subchapter shall be construed to preempt
any State law to the extent that it authorizes or prohibits disclosure
of protected health information regarding a minor to a parent, guardian
or person acting in loco parentis of such minor.
(3) With respect to penalties, provides greater penalties.
(4) With respect to information to be provided to an individual
about a proposed use, disclosure, rights, remedies, and similar issues,
provides the greater amount of information.
(5) With respect to form or substance of authorizations for use or
disclosure of information, provides requirements that narrow the scope
or duration, increase the difficulty of obtaining, or reduce the
coercive effect of the circumstances surrounding the authorization.
(6) With respect to recordkeeping or accounting requirements,
provides for the retention or reporting of more detailed information or
for a longer duration.
(7) With respect to any other matter, provides greater privacy
protection for the individual.
Relates to the privacy of individually identifiable health
information means, with respect to a State law, that the State law has
the specific purpose of protecting the privacy of health information or
the effect of affecting the privacy of health information in a direct,
clear, and substantial way.
State law means a law, decision, rule, regulation, or other State
action having the effect of law.
Sec. 160.203 General rule and exceptions.
General rule. A standard, requirement, or implementation
specification adopted under or pursuant to this subchapter that is
contrary to a provision of State law preempts the provision of State
law. This general rule applies, except where one or more of the
following conditions is met:
(a) A determination is made by the Secretary pursuant to
Sec. 160.204(a) that the provision of State law:
(1) Is necessary:
(i) To prevent fraud and abuse;
(ii) To ensure appropriate State regulation of insurance and health
plans;
(iii) For State reporting on health care delivery or costs; or
(iv) For other purposes related to improving the Medicare program,
the Medicaid program, or the efficiency and effectiveness of the health
care system; or
(2) Addresses controlled substances.
(b) The provision of State law relates to the privacy of health
information and is more stringent than a standard, requirement, or
implementation specification adopted under subpart E of part 164 of
this subchapter.
(c) The provision of State law, or the State established
procedures, are established under a State law providing for the
reporting of disease or injury, child abuse, birth, or death, or for
the conduct of public health surveillance, investigation, or
intervention.
(d) The provision of State law requires a health plan to report, or
to provide access to, information for the purpose of management audits,
financial audits, program monitoring and evaluation, facility licensure
or certification, or individual licensure or certification.
Sec. 160.204 Process for requesting exception determinations or
advisory opinions.
(a) Determinations. (1) A State may submit a written request to the
Secretary to except a provision of State law from preemption under
Sec. 160.203(a). The request must include the following information:
(i) The State law for which the exception is requested;
(ii) The particular standard(s), requirement(s), or implementation
specification(s) for which the exception is requested;
(iii) The part of the standard or other provision that will not be
implemented based on the exception or the additional data to be
collected based on the exception, as appropriate;
(iv) How health care providers, health plans, and other entities
would be affected by the exception;
(v) The length of time for which the exception would be in effect,
if less than three years;
(vi) The reasons why the State law should not be preempted by the
federal standard, requirement, or implementation specification,
including how the State law meets one or more of the criteria at
Sec. 160.203(a); and
(vii) Any other information the Secretary may request in order to
make the determination.
(2) Requests for exception under this section must be submitted to
the Secretary at an address which will be published in the Federal
Register. Until the Secretary's determination is made, the standard,
requirement, or implementation specification under this subchapter
remains in effect.
(3) The Secretary's determination under this paragraph will be made
on the basis of the extent to which the information provided and other
factors demonstrate that one or more of the criteria at Sec. 160.203(a)
has been met. If it is determined that the federal standard,
requirement, or implementation specification accomplishes the purposes
of the criterion or criteria at Sec. 160.203(a) as well as or better
than the State law for which the request is made, the request will be
denied.
(4) An exception granted under this paragraph is effective for
three years or for such lesser time as is specified in the
determination granting the request.
(5) If an exception is granted under this paragraph, the exception
has effect only with respect to transactions taking place wholly within
the State for which the exception was requested.
(6) Any change to the standard, requirement, or implementation
specification or provision of State law upon which an exception was
granted requires a new request for an exception. Absent such a request
and a favorable determination thereon, the standard, requirement, or
implementation specification remains in effect. The responsibility for
recognizing the need for and making the request lies with the original
requestor.
(7) The Secretary may seek changes to a standard, requirement, or
implementation specification based on requested exceptions or may urge
the requesting State or other organizations or persons to do so.
(8) Determinations made by the Secretary pursuant to this paragraph
will be published annually in the Federal Register.
(b) Advisory opinions.--(1) The Secretary may issue advisory
opinions as to whether a provision of State law constitutes an
exception under Sec. 160.203(b) to the general rule of preemption under
that section. The Secretary may issue such opinions at the request of a
State or at the Secretary's own initiative.
(2) A State may submit a written request to the Secretary for an
advisory opinion under this paragraph. The
[[Page 60052]]
request must include the following information:
(i) The State law for which the exception is requested;
(ii) The particular standard(s), requirement(s), or implementation
specification(s) for which the exception is requested;
(iii) How health care providers, health plans, and other entities
would be affected by the exception;
(iv) The reasons why the State law should not be preempted by the
federal standard, requirement, or implementation specification,
including how the State law meets the criteria at Sec. 160.203(b); and
(v) Any other information the Secretary may request in order to
issue the advisory opinion.
(3) The requirements of paragraphs (a)(2), (a)(5)-(a)(7) of this
section apply to requests for advisory opinions under this paragraph.
(4) The Secretary's decision under this paragraph will be made on
the basis of the extent to which the information provided and other
factors demonstrate that the criteria at Sec. 160.203(b) are met.
(5) Advisory opinions made by the Secretary pursuant to this
paragraph will be published annually in the Federal Register.
PARTS 161-163--[RESERVED]
PART 164--SECURITY AND PRIVACY
Subpart A--General Provisions
Sec.
164.102 Statutory basis
164.104 Applicability
Subparts B-D--[Reserved]
Subpart E--Privacy of Individually Identifiable Health Information
164.502 Applicability
164.504 Definitions
164.506 Uses and disclosures of protected health information:
general rules
164.508 Uses and disclosures for which individual authorization is
required
164.510 Uses and disclosures for which individual authorization is
not required
164.512 Notice to individuals of information practices
164.514 Access of individuals to protected health information
164.515 Accounting for disclosures of protected health information
164.516 Amendment and correction
164.518 Administrative requirements
164.520 Documentation of policies and procedures
164.522 Compliance and enforcement
164.524 Effective date
Appendix to Subpart E of Part 164--Model Authorization Form
Authority: 42 U.S.C. 1320d-2 and 1320d-4.
Subpart A--General Provisions
Sec. 164.102 Statutory basis.
The provisions of this part are adopted pursuant to the Secretary's
authority to prescribe standards, requirements, and implementation
standards under part C of title XI of the Act and section 264 of Public
Law 104-191.
Sec. 164.104 Applicability.
Except as otherwise provided, the provisions of this part apply to
covered entities: health plans, health care clearinghouses, and health
care providers who transmit health information in electronic form in
connection with any transaction referred to in section 1173(a)(1) of
the Act.
Subpart B-D--[Reserved]
Subpart E--Privacy of Individually Identifiable Health Information
Sec. 164.502 Applicability.
In addition to the applicable provisions of part 160 of this
subchapter and except as otherwise herein provided, the requirements,
standards, and implementation specifications of this subpart apply to
covered entities with respect to protected health information.
Sec. 164.504 Definitions.
As used in this subpart, the following terms have the following
meanings:
Business partner means, with respect to a covered entity, a person
to whom the covered entity discloses protected health information so
that the person can carry out, assist with the performance of, or
perform on behalf of, a function or activity for the covered entity.
"Business partner" includes contractors or other persons who receive
protected health information from the covered entity (or from another
business partner of the covered entity) for the purposes described in
the previous sentence, including lawyers, auditors, consultants, third-
party administrators, health care clearinghouses, data processing
firms, billing firms, and other covered entities. "Business partner"
excludes persons who are within the covered entity's workforce, as
defined in this section.
Designated record set means a group of records under the control of
a covered entity from which information is retrieved by the name of the
individual or by some identifying number, symbol, or other identifying
particular assigned to the individual and which is used by the covered
entity to make decisions about the individual. For purposes of this
paragraph, the term record means any item, collection, or grouping of
protected health information maintained, collected, used, or
disseminated by a covered entity.
Disclosure means the release, transfer, provision of access to, or
divulging in any other manner of information outside the entity holding
the information.
Health care operations means the following activities undertaken by
or on behalf of a covered entity that is a health plan or health care
provider for the purpose of carrying out the management functions of
such entity necessary for the support of treatment or payment:
(1) Conducting quality assessment and improvement activities,
including outcomes evaluation and development of clinical guidelines;
(2) Reviewing the competence or qualifications of health care
professionals, evaluating practitioner and provider performance, health
plan performance, conducting training programs in which undergraduate
and graduate students and trainees in areas of health care learn under
supervision to practice as health care providers, accreditation,
certification, licensing or credentialing activities;
(3) Insurance rating and other insurance activities relating to the
renewal of a contract for insurance, including underwriting, experience
rating, and reinsurance, but only when the individuals are already
enrolled in the health plan conducting such activities and the use or
disclosure of protected health information relates to an existing
contract of insurance (including the renewal of such a contract);
(4) Conducting or arranging for medical review and auditing
services, including fraud and abuse detection and compliance programs;
and
(5) Compiling and analyzing information in anticipation of or for
use in a civil or criminal legal proceeding.
Health oversight agency means an agency, person or entity,
including the employees or agents thereof,
(1) That is:
(i) A public agency; or
(ii) A person or entity acting under grant of authority from or
contract with a public agency; and
(2) Which performs or oversees the performance of any audit;
investigation; inspection; licensure or discipline; civil, criminal, or
administrative proceeding or action; or other activity necessary for
appropriate oversight of the health care system, of government benefit
programs for which health information is relevant to beneficiary
eligibility, or of government regulatory programs for which health
information is necessary
[[Page 60053]]
for determining compliance with program standards.
Individual means the person who is the subject of protected health
information, except that:
(1) "Individual" includes:
(i) With respect to adults and emancipated minors, legal
representatives (such as court-appointed guardians or persons with a
power of attorney), to the extent to which applicable law permits such
legal representatives to exercise the person's rights in such contexts.
(ii) With respect to unemancipated minors, a parent, guardian, or
person acting in loco parentis, provided that when a minor lawfully
obtains a health care service without the consent of or notification to
a parent, guardian, or other person acting in loco parentis, the minor
shall have the exclusive right to exercise the rights of an individual
under this subpart with respect to the protected health information
relating to such care.
(iii) With respect to deceased persons, an executor, administrator,
or other person authorized under applicable law to act on behalf of the
decedent's estate.
(2) "Individual" excludes:
(i) Foreign military and diplomatic personnel and their dependents
who receive health care provided by or paid for by the Department of
Defense or other federal agency, or by an entity acting on its behalf,
pursuant to a country-to-country agreement or federal statute; and
(ii) Overseas foreign national beneficiaries of health care
provided by the Department of Defense or other federal agency, or by a
non-governmental organization acting on its behalf.
Individually identifiable health information is information that is
a subset of health information, including demographic information
collected from an individual, and that:
(1) Is created by or received from a health care provider, health
plan, employer, or health care clearinghouse; and
(2) Relates to the past, present, or future physical or mental
health or condition of an individual, the provision of health care to
an individual, or the past, present, or future payment for the
provision of health care to an individual, and
(i) Which identifies the individual, or
(ii) With respect to which there is a reasonable basis to believe
that the information can be used to identify the individual.
Law enforcement official means an officer of an agency or authority
of the United States, a State, a territory, a political subdivision of
a State or territory, or an Indian tribe, who is empowered by law to
conduct:
(1) An investigation or official proceeding inquiring into a
violation of, or failure to comply with, any law; or
(2) A criminal, civil, or administrative proceeding arising from a
violation of, or failure to comply with, any law.
Payment means:
(1) The activities undertaken by or on behalf of a covered entity
that is:
(i) A health plan, or by a business partner on behalf of a health
plan, to obtain premiums or to determine or fulfill its responsibility
for coverage under the health plan and for provision of benefits under
the health plan; or
(ii) A health care provider or health plan, or a business partner
on behalf of such provider or plan, to obtain reimbursement for the
provision of health care.
(2) Activities that constitute payment include:
(i) Determinations of coverage, improving methods of paying or
coverage policies, adjudication or subrogation of health benefit
claims;
(ii) Risk adjusting amounts due based on enrollee health status and
demographic characteristics;
(iii) Billing, claims management, and medical data processing;
(iv) Review of health care services with respect to medical
necessity, coverage under a health plan, appropriateness of care, or
justification of charges; and
(v) Utilization review activities, including precertification and
preauthorization of services.
Protected health information means individually identifiable health
information that is or has been electronically transmitted or
electronically maintained by a covered entity and includes such
information in any other form.
(1) For purposes of this definition,
(i) "Electronically transmitted" includes information exchanged
with a computer using electronic media, such as the movement of
information from one location to another by magnetic or optical media,
transmissions over the Internet, Extranet, leased lines, dial-up lines,
private networks, telephone voice response, and "faxback" systems.
(ii) "Electronically maintained" means information stored by a
computer or on any electronic medium from which information may be
retrieved by a computer, such as electronic memory chips, magnetic
tape, magnetic disk, or compact disc optical media.
(2) "Protected health information" excludes:
(i) Individually identifiable health information in education
records covered by the Family Educational Right and Privacy Act, as
amended, 20 U.S.C. 1232g; and
(ii) Individually identifiable health information of inmates of
correctional facilities and detainees in detention facilities.
Public health authority means an agency or authority of the United
States, a State, a territory, a political subdivision of a State or
territory, or an Indian tribe that is responsible for public health
matters as part of its official mandate.
Research means a systematic investigation, including research
development, testing and evaluation, designed to develop or contribute
to generalizable knowledge. "Generalizable knowledge" is knowledge
related to health that can be applied to populations outside of the
population served by the covered entity.
Treatment means the provision of health care by, or the
coordination of health care (including health care management of the
individual through risk assessment, case management, and disease
management) among, health care providers; the referral of a patient
from one provider to another; or the coordination of health care or
other services among health care providers and third parties authorized
by the health plan or the individual.
Use means the employment, application, utilization, examination, or
analysis of information within an entity that holds the information.
Workforce means employees, volunteers, trainees, and other persons
under the direct control of a covered entity, including persons
providing labor on an unpaid basis.
Sec. 164.506 Uses and disclosures of protected health information:
general rules.
(a) Standard. A covered entity may not use or disclose an
individual's protected health information, except as otherwise
permitted or required by this part or as required to comply with
applicable requirements of this subchapter.
(1) Permitted uses and disclosures. A covered entity is permitted
to use or disclose protected health information as follows:
(i) Except for research information unrelated to treatment, to
carry out treatment, payment, or health care operations;
(ii) Pursuant to an authorization by the individual that complies
with Sec. 164.508; or
(iii) As permitted by and in compliance with this section or
Sec. 164.510.
[[Page 60054]]
(2) Required disclosures. A covered entity is required to disclose
protected health information:
(i) To an individual, when a request is made under Sec. 164.514; or
(ii) When required by the Secretary under Sec. 164.522 to
investigate or determine the entity's compliance with this part.
(b)(1) Standard: Minimum necessary. A covered entity must make all
reasonable efforts not to use or disclose more than the minimum amount
of protected health information necessary to accomplish the intended
purpose of the use or disclosure. This requirement does not apply to
uses or disclosures that are:
(i) Made in accordance with Secs. 164.508(a)(1), 164.514, or
Sec. 164.522;
(ii) Required by law and permitted under Sec. 164.510;
(iii) Required for compliance with applicable requirements of this
subchapter; or
(iv) Made by a covered health care provider to a covered health
plan, when the information is requested for audit and related purposes.
(2) Implementation specification: Procedures. To comply with the
standard in this paragraph, a covered entity must have procedures to:
(i) Identify appropriate persons within the entity to determine
what information should be used or disclosed consistent with the
minimum necessary standard;
(ii) Ensure that the persons identified under paragraph (b)(2)(i)
of this section make the minimum necessary determinations, when
required;
(iii) Within the limits of the entity's technological capabilities,
provide for the making of such determinations individually.
(3) Implementation specification: Reliance. When making disclosures
to public officials that are permitted under Sec. 164.510 but not
required by other law, a covered entity may reasonably rely on the
representations of such officials that the information requested is the
minimum necessary for the stated purpose(s).
(c)(1) Standard: Right of an individual to restrict uses and
disclosures. (i) A covered entity that is a health care provider must
permit individuals to request that uses or disclosures of protected
health information for treatment, payment, or health care operations be
restricted, and, if the requested restrictions are agreed to by the
provider, not make uses or disclosures inconsistent with such
restrictions.
(ii) This requirement does not apply:
(A) To uses or disclosures permitted under Sec. 164.510;
(B) When the health care services provided are emergency services
or the information is requested pursuant to Sec. 164.510(k) and
(C) To disclosures to the Secretary pursuant to Sec. 164.522.
(iii) A provider is not required to agree to a requested
restriction.
(2) Implementation specifications. A covered entity must have
procedures that:
(i) Provide individuals an opportunity to request a restriction on
the uses and disclosures of their protected health information;
(ii) Provide that restrictions that are agreed to by the entity are
reduced to writing or otherwise documented;
(iii) Enable the entity to honor such restrictions; and
(iv) Provide for the notification of others to whom such
information is disclosed of such restriction.
(d)(1) Standard: use or disclosure of de-identified protected
health information. The requirements of this subpart do not apply to
protected health information that a covered entity has de-identified,
provided, however, that:
(i) Disclosure of a key or other device designed to enable coded or
otherwise de-identified information to be re-identified constitutes
disclosure of protected health information; and
(ii) If a covered entity re-identifies de-identified information,
it may use or disclose such re-identified information only in
accordance with this subpart.
(2) Implementation specifications. (i) A covered entity may use
protected health information to create de-identified information by
removing, coding, encrypting, or otherwise eliminating or concealing
the information that makes such information individually identifiable.
(ii) Information is presumed not to be individually identifiable
(de-identified), if:
(A) The following identifiers have been removed or otherwise
concealed:
(1) Name;
(2) Address, including street address, city, county, zip code, and
equivalent geocodes;
(3) Names of relatives;
(4) Name of employers;
(5) Birth date;
(6) Telephone numbers;
(7) Fax numbers;
(8) Electronic mail addresses;
(9) Social security number;
(10) Medical record number;
(11) Health plan beneficiary number;
(12) Account number;
(13) Certificate/license number;
(14) Any vehicle or other device serial number;
(15) Web Universal Resource Locator (URL);
(16) Internet Protocol (IP) address number;
(17) Finger or voice prints;
(18) Photographic images; and
(19) Any other unique identifying number, characteristic, or code
that the covered entity has reason to believe may be available to an
anticipated recipient of the information; and
(B) The covered entity has no reason to believe that any
anticipated recipient of such information could use the information,
alone or in combination with other information, to identify an
individual.
(iii) Notwithstanding paragraph (d)(2)(ii) of this section,
entities with appropriate statistical experience and expertise may
treat information as de-identified, if they include information listed
in paragraph (d)(2)(ii) of this section and they determine that the
probability of identifying individuals with such identifying
information retained is very low, or may remove additional information,
if they have a reasonable basis to believe such additional information
could be used to identify an individual.
(e)(1) Standards: Business partners. (i) Except for disclosures of
protected health information by a covered entity that is a health care
provider to another health care provider for consultation or referral
purposes, a covered entity may not disclose protected health
information to a business partner without satisfactory assurance from
the business partner that it will appropriately safeguard the
information.
(ii) A covered entity must take reasonable steps to ensure that
each business partner complies with the requirements of this subpart
with respect to any task or other activity it performs on behalf of the
entity, to the extent the covered entity would be required to comply
with such requirements.
(2) Implementation specifications. (i) For the purposes of this
section, satisfactory assurance means a contract between the covered
entity and the business partner to which such information is to be
disclosed that establishes the permitted and required uses and
disclosures of such information by the partner. The contract must
provide that the business partner will:
(A) Not use or further disclose the information other than as
permitted or required by the contract;
(B) Not use or further disclose the information in a manner that
would violate the requirements of this subpart, if done by the covered
entity;
[[Page 60055]]
(C) Use appropriate safeguards to prevent use or disclosure of the
information other than as provided for by its contract;
(D) Report to the covered entity any use or disclosure of the
information not provided for by its contract of which it becomes aware;
(E) Ensure that any subcontractors or agents to whom it provides
protected health information received from the covered entity agree to
the same restrictions and conditions that apply to the business partner
with respect to such information;
(F) Make available protected health information in accordance with
Sec. 164.514(a);
(G) Make its internal practices, books, and records relating to the
use and disclosure of protected health information received from the
covered entity available to the Secretary for purposes of determining
the covered entity's compliance with this subpart;
(H) At termination of the contract, return or destroy all protected
health information received from the covered entity that the business
partner still maintains in any form and retain no copies of such
information; and
(I) Incorporate any amendments or corrections to protected health
information when notified pursuant to Sec. 164.516(c)(3).
(ii) The contract required by paragraph (e)(2)(i) of this section
must:
(A) State that the individuals whose protected health information
is disclosed under the contract are intended third party beneficiaries
of the contract; and
(B) Authorize the covered entity to terminate the contract, if the
covered entity determines that the business partner has violated a
material term of the contract required by this paragraph.
(iii) A material breach by a business partner of its obligations
under the contract required by paragraph (e)(2)(i) of this section will
be considered to be noncompliance of the covered entity with the
applicable requirements of this subpart, if the covered entity knew or
reasonably should have known of such breach and failed to take
reasonable steps to cure the breach or terminate the contract.
(f) Standard: Deceased individuals. A covered entity must comply
with the requirements of this subpart with respect to the protected
health information of a deceased individual for two years following the
death of such individual. This requirement does not apply to uses or
disclosures for research purposes.
(g) Standard: uses and disclosures consistent with notice. Except
as provided by Sec. 164.520(g)(2), a covered entity that is required by
Sec. 164.512 to have a notice may not use or disclose protected health
information in a manner inconsistent with such notice.
Sec. 164.508 Uses and disclosures for which individual authorization
is required.
(a) Standard. An authorization executed in accordance with this
section is required in order for the covered entity to use or disclose
protected health information in the following situations:
(1) Request by individual. Where the individual requests the
covered entity to use or disclose the information.
(2) Request by covered entity. (i) Where the covered entity
requests the individual to authorize the use or disclosure of the
information. The covered entity must request and obtain an
authorization from the individual for all uses and disclosures that are
not:
(A) Except as provided in paragraph (a)(3) of this section,
compatible with or directly related to treatment, payment, or health
care operations;
(B) Covered by Sec. 164.510;
(C) Covered by paragraph (a)(1) of this section; or
(D) Required by this subpart.
(ii) Uses and disclosures of protected health information for which
individual authorization is required include, but are not limited to,
the following:
(A) Use for marketing of health and non-health items and services
by the covered entity;
(B) Disclosure by sale, rental, or barter;
(C) Use and disclosure to non-health related divisions of the
covered entity, e.g., for use in marketing life or casualty insurance
or banking services;
(D) Disclosure, prior to an individual's enrollment in a health
plan, to the health plan or health care provider for making eligibility
or enrollment determinations relating to the individual or for
underwriting or risk rating determinations;
(E) Disclosure to an employer for use in employment determinations;
and
(F) Use or disclosure for fundraising purposes.
(iii) A covered entity may not condition the provision to an
individual of treatment or payment on the provision by the individual
of a requested authorization for use or disclosure, except where the
authorization is requested in connection with a clinical trial.
(iv) Except where required by law, a covered entity may not require
an individual to sign an authorization for use or disclosure of
protected health information for treatment, payment, or health care
operations purposes.
(3) Authorization required: Special cases. (i) Except as otherwise
required by this subpart or permitted under Sec. 164.510, a covered
entity must obtain the authorization of the individual for the
following uses and disclosures of protected health information about
the individual:
(A) Use by a person other than the creator, or disclosure, of
psychotherapy notes; and
(B) Use or disclosure of research information unrelated to
treatment.
(ii) The requirements of paragraphs (b) through (e) of this section
apply to such authorizations, as appropriate.
(iii) A covered entity may not condition treatment, enrollment in a
health plan, or payment on a requirement that the individual authorize
use or disclosure of psychotherapy notes relating to the individual.
(iv) For purposes of this section:
(A) Psychotherapy notes means notes recorded (in any medium) by a
health care provider who is a mental health professional documenting or
analyzing the contents of conversation during a private counseling
session or a group, joint, or family counseling session. For purposes
of this definition, "psychotherapy notes" excludes medication
prescription and monitoring, counseling session start and stop times,
the modalities and frequencies of treatment furnished, results of
clinical tests, and any summary of the following items: diagnosis,
functional status, the treatment plan, symptoms, prognosis and progress
to date.
(B) Research information unrelated to treatment means health
information that is received or created by a covered entity in the
course of conducting research, for which there is insufficient
scientific and medical evidence regarding the validity or utility of
the information such that it should not be used for the purpose of
providing health care, and with respect to which the covered entity has
not requested payment from a third party payor.
(b) General implementation specifications for authorizations.--(1)
General requirements. A copy of the model form which appears in
Appendix A hereto, or a document that contains the elements listed in
paragraphs (c) or (d) of this section, as applicable, must be accepted
by the covered entity.
(2) Defective authorizations. There is no "authorization" within
the meaning of this section, if the submitted form has any of the
following defects:
(i) The expiration date has passed;
(ii) The form has not been filled out completely;
[[Page 60056]]
(iii) The authorization is known by the covered entity to have been
revoked;
(iv) The form lacks an element required by paragraph (c) or (d) of
this section, as applicable;
(v) The information on the form is known by the covered entity to
be false.
(3) Compound authorizations. Except where authorization is
requested in connection with a clinical trial, an authorization for use
or disclosure of protected health information for purposes other than
treatment or payment may not be in the same document as an
authorization for or consent to treatment or payment.
(c) Implementation specifications for authorizations requested by
an individual.--(1) Required elements. Before a covered entity may use
or disclose protected health information of an individual pursuant to a
request from the individual, it must obtain a completed authorization
for use or disclosure executed by the individual that contains at least
the following elements:
(i) A description of the information to be used or disclosed that
identifies the information in a specific and meaningful fashion;
(ii) The name of the covered entity, or class of entities or
persons, authorized to make the requested use or disclosure;
(iii) The name or other specific identification of the person(s) or
entity(ies), which may include the covered entity itself, to whom the
covered entity may make the requested use or disclosure;
(iv) An expiration date;
(v) Signature and date;
(vi) If the authorization is executed by a legal representative or
other person authorized to act for the individual, a description of his
or her authority to act or relationship to the individual;
(vii) A statement in which the individual acknowledges that he or
she has the right to revoke the authorization, except to the extent
that information has already been released under the authorization; and
(viii) A statement in which the individual acknowledges that
information used or disclosed to any entity other than a health plan or
health care provider may no longer be protected by the federal privacy
law.
(2) Plain language requirement. The model form at appendix A to
this subpart may be used. If the model form at appendix A to this
subpart is not used, the authorization form must be written in plain
language.
(d) Implementation specifications for authorizations for uses and
disclosures requested by covered entities.--(1) Required elements.
Before a covered entity may use or disclose protected health
information of an individual pursuant to a request that it has made, it
must obtain a completed authorization for use or disclosure executed by
the individual that meets the requirements of paragraph (c) of this
section and contains the following additional elements:
(i) Except where the authorization is requested for a clinical
trial, a statement that it will not condition treatment or payment on
the individual's providing authorization for the requested use or
disclosure;
(ii) A description of the purpose(s) of the requested use or
disclosure;
(iii) A statement that the individual may:
(A) Inspect or copy the protected health information to be used or
disclosed as provided in Sec. 164.514; and
(B) Refuse to sign the authorization; and
(iv) Where use or disclosure of the requested information will
result in financial gain to the entity, a statement that such gain will
result.
(2) Required procedures. In requesting authorization from an
individual under this paragraph, a covered entity must:
(i) Have procedures designed to enable it to request only the
minimum amount of protected health information necessary to accomplish
the purpose for which the request is made; and
(ii) Provide the individual with a copy of the executed
authorization.
(e) Revocation of authorizations. An individual may revoke an
authorization to use or disclose his or her protected health
information at any time, except to the extent that the covered entity
has taken action in reliance thereon.
Sec. 164.510 Uses and disclosures for which individual authorization
is not required.
A covered entity may use or disclose protected health information,
for purposes other than treatment, payment, or health care operations,
without the authorization of the individual, in the situations covered
by this section and subject to the applicable requirements provided for
by this section.
(a) General requirements. In using or disclosing protected health
information under this section:
(1) Verification. A covered entity must comply with any applicable
verification requirements under Sec. 164.518(c).
(2) Health care clearinghouses. A health care clearinghouse that
uses or discloses protected health information it maintains as a
business partner of a covered entity may not make uses or disclosures
otherwise permitted under this section that are not permitted by the
terms of its contract with the covered entity under Sec. 164.506(e).
(b) Disclosures and uses for public health activities.--(1)
Permitted disclosures. A covered entity may disclose protected health
information for the public health activities and purposes described in
this paragraph to:
(i) A public health authority that is authorized by law to collect
or receive such information for the purpose of preventing or
controlling disease, injury, or disability, including, but not limited
to, the reporting of disease, injury, vital events such as birth or
death, and the conduct of public health surveillance, public health
investigations, and public health interventions;
(ii) A public health authority or other appropriate authority
authorized by law to receive reports of child abuse or neglect;
(iii) A person or entity other than a governmental authority that
can demonstrate or demonstrates that it is acting to comply with
requirements or direction of a public health authority; or
(iv) A person who may have been exposed to a communicable disease
or may otherwise be at risk of contracting or spreading a disease or
condition and is authorized by law to be notified as necessary in the
conduct of a public health intervention or investigation.
(2) Permitted use. Where the covered entity also is a public health
authority, the covered entity is permitted to use protected health
information in all cases in which it is permitted to disclose such
information for public health activities under paragraph (b)(1) of this
section.
(c) Disclosures and uses for health oversight activities.--(1)
Permitted disclosures. A covered entity may disclose protected health
information to a health oversight agency for oversight activities
authorized by law, including audit, investigation, inspection, civil,
criminal, or administrative proceeding or action, or other activity
necessary for appropriate oversight of:
(i) The health care system;
(ii) Government benefit programs for which health information is
relevant to beneficiary eligibility; or
(iii) Government regulatory programs for which health information
is necessary for determining compliance with program standards.
(2) Permitted use. Where a covered entity is itself a health
oversight agency, the covered entity may use protected health
information for health oversight activities described by paragraph
(c)(1) of this section.
(d) Disclosures and uses for judicial and administrative
proceedings.--(1) Permitted disclosures. A covered entity may disclose
protected health
[[Page 60057]]
information in the course of any judicial or administrative proceeding:
(i) In response to an order of a court or administrative tribunal;
or
(ii) Where the individual is a party to the proceeding and his or
her medical condition or history is at issue and the disclosure is
pursuant to lawful process or otherwise authorized by law.
(2) Permitted use. Where the covered entity is itself a government
agency, the covered entity may use protected health information in all
cases in which it is permitted to disclose such information in the
course of any judicial or administrative proceeding under paragraph
(d)(1) of this section.
(3) Additional restriction. (i) Where the request for disclosure of
protected health information is accompanied by a court order, the
covered entity may disclose only that protected health information
which the court order authorizes to be disclosed.
(ii) Where the request for disclosure of protected health
information is not accompanied by a court order, the covered entity may
not disclose the information requested unless a request authorized by
law has been made by the agency requesting the information or by legal
counsel representing a party to litigation, with a written statement
certifying that the protected health information requested concerns a
litigant to the proceeding and that the health condition of such
litigant is at issue at such proceeding.
(e) Disclosures to coroners and medical examiners. A covered entity
may disclose protected health information to a coroner or medical
examiner, consistent with applicable law, for the purposes of
identifying a deceased person or determining a cause of death.
(f) Disclosures for law enforcement purposes. A covered entity may
disclose protected health information to a law enforcement official if:
(1) Pursuant to process. (i) The law enforcement official is
conducting or supervising a law enforcement inquiry or proceeding
authorized by law and the disclosure is:
(A) Pursuant to a warrant, subpoena, or order issued by a judicial
officer that documents a finding by the judicial officer;
(B) Pursuant to a grand jury subpoena; or
(C) Pursuant to an administrative request, including an
administrative subpoena or summons, a civil investigative demand, or
similar process authorized under law, provided that:
(1) The information sought is relevant and material to a legitimate
law enforcement inquiry;
(2) The request is as specific and narrowly drawn as is reasonably
practicable; and
(3) De-identified information could not reasonably be used.
(ii) For the purposes of this paragraph, "law enforcement inquiry
or proceeding" means:
(A) An investigation or official proceeding inquiring into a
violation of, or failure to comply with, law; or
(B) A criminal, civil, or administrative proceeding arising from a
violation of, or failure to comply with, law.
(2) Limited information for identifying purposes. The disclosure is
for the purpose of identifying a suspect, fugitive, material witness,
or missing person, provided that, the covered entity may disclose only
the following information:
(i) Name;
(ii) Address;
(iii) Social security number;
(iv) Date of birth;
(v) Place of birth;
(vi) Type of injury or other distinguishing characteristic; and
(vii) Date and time of treatment.
(3) Information about a victim of crime or abuse. The disclosure is
of the protected health information of an individual who is or is
suspected to be a victim of a crime, abuse, or other harm, if the law
enforcement official represents that:
(i) Such information is needed to determine whether a violation of
law by a person other than the victim has occurred; and
(ii) Immediate law enforcement activity that depends upon obtaining
such information may be necessary.
(4) Intelligence and national security activities. The disclosure
is:
(i) For the conduct of lawful intelligence activities conducted
pursuant to the National Security Act (50 U.S.C. 401, et seq.);
(ii) Made in connection with providing protective services to the
President or other persons pursuant to 18 U.S.C. 3056; or
(iii) Made pursuant to 22 U.S.C. 2709(a)(3).
(5) Health care fraud. The covered entity believes in good faith
that the information disclosed constitutes evidence of criminal
conduct:
(i) That arises out of and is directly related to:
(A) The receipt of health care or payment for health care,
including a fraudulent claim for health care;
(B) Qualification for or receipt of benefits, payments, or services
based on a fraudulent statement or material misrepresentation of the
health of the individual;
(ii) That occurred on the premises of the covered entity; or
(iii) Was witnessed by a member of the covered entity's workforce.
(5) Urgent circumstances. The disclosure is of the protected health
information of an individual who is or is suspected to be a victim of a
crime, abuse, or other harm, if the law enforcement official represents
that:
(i) Such information is needed to determine whether a violation of
law by a person other than the victim has occurred; and
(ii) Immediate law enforcement activity that depends upon obtaining
such information may be necessary.
(g) Disclosures and uses for governmental health data systems.--(1)
Permitted disclosures. A covered entity may disclose protected health
information to a government agency, or private entity acting on behalf
of a government agency, for inclusion in a governmental health data
system that collects health data for analysis in support of policy,
planning, regulatory, or management functions authorized by law.
(2) Permitted uses. Where a covered entity is itself a government
agency that collects health data for analysis in support of policy,
planning, regulatory, or management functions, the covered entity may
use protected health information in all cases in which it is permitted
to disclose such information for government health data systems under
paragraph (g)(1) of this section.
(h) Disclosures of directory information. (1) Individuals with
capacity. For individuals with the capacity to make their own health
care decisions, a covered entity that is a health care provider may
disclose protected health information for directory purposes, provided
that, the individual has agreed to such disclosure.
(2) Incapacitated individuals. For individuals who are
incapacitated, a covered entity that is a health care provider may, at
its discretion and consistent with good medical practice and any prior
expressions of preference of which the covered entity is aware,
disclose protected health information for directory purposes.
(3) Information to be disclosed. The information that may be
disclosed for directory purposes pursuant to paragraphs (h)(1) and (2)
of this section, is limited to:
(i) Name of the individual;
(ii) Location of the individual in the health care provider's
facility; and
(iii) Description of the individual's condition in general terms
that do not
[[Page 60058]]
communicate specific medical information about the individual.
(i) Disclosures for banking and payment processes. A covered entity
may disclose, in connection with routine banking activities or payment
by debit, credit, or other payment card, or other payment means, the
minimum amount of protected health information necessary to complete a
banking or payment activity to:
(1) Financial institutions. An entity engaged in the activities of
a financial institution (as defined in section 1101 of the Right to
Financial Privacy Act of 1978); or
(2) Entities acting on behalf of financial institutions. An entity
engaged in authorizing, processing, clearing, settling, billing,
transferring, reconciling, or collecting payments, for an entity
described in paragraph (i)(1) of this section.
(j) Uses and disclosures for research purposes. A covered entity
may use or disclose protected health information for research,
regardless of the source of funding of the research, provided that, the
covered entity has obtained written documentation of the following:
(1) Waiver of authorization. A waiver, in whole or in part, of
authorization for use or disclosure of protected health information
that has been approved by either:
(i) An Institutional Review Board, established in accordance with 7
CFR 1c.107, 10 CFR 745.107, 14 CFR 1230.107, 15 CFR 27.107, 16 CFR
1028.107, 21 CFR 56.107, 22 CFR 225.107, 28 CFR 46.107.32 CFR 219.107,
34 CFR 97.107, 38 CFR 16.107, 40 CFR 26.107.45 CFR 46.107, 45 CFR
690.107, or 49 CFR 11.107; or
(ii) A privacy board that:
(A) Has members with varying backgrounds and appropriate
professional competency as necessary to review the research protocol;
(B) Includes at least one member who is not affiliated with the
entity conducting the research or related to a person who is affiliated
with such entity; and
(C) Does not have any member participating in a review of any
project in which the member has a conflict of interest.
(2) Date of approval. The date of approval of the waiver, in whole
or in part, of authorization by an Institutional Review Board or
privacy board.
(3) Criteria. The Institutional Review Board or privacy board has
determined that the waiver, in whole or in part, of authorization
satisfies the following criteria:
(i) The use or disclosure of protected health information involves
no more than minimal risk to the subjects;
(ii) The waiver will not adversely affect the rights and welfare of
the subjects;
(iii) The research could not practicably be conducted without the
waiver;
(iv) Whenever appropriate, the subjects will be provided with
additional pertinent information after participation;
(v) The research could not practicably be conducted without access
to and use of the protected health information;
(vi) The research is of sufficient importance so as to outweigh the
intrusion of the privacy of the individual whose information is subject
to the disclosure;
(vii) There is an adequate plan to protect the identifiers from
improper use and disclosure; and
(viii) There is an adequate plan to destroy the identifiers at the
earliest opportunity consistent with conduct of the research, unless
there is a health or research justification for retaining the
identifiers.
(4) Required signature. The written documentation must be signed by
the chair of, as applicable, the Institutional Review Board or the
privacy board.
(k) Uses and disclosures in emergency circumstances.--(1) Permitted
disclosures. A covered entity may, consistent with applicable law and
standards of ethical conduct and based on a reasonable belief that the
use or disclosure is necessary to prevent or lessen a serious and
imminent threat to the health or safety of an individual or the public,
use or disclose protected health information to a person or persons
reasonably able to prevent or lessen the threat, including the target
of the threat.
(2) Presumption of reasonable belief. A covered entity that makes a
disclosure pursuant to paragraph (k)(1) of this section is presumed to
have acted under a reasonable belief, if the disclosure is made in good
faith based upon a credible representation by a person with apparent
knowledge or authority (such as a doctor or law enforcement or other
government official).
(l) Disclosures to next-of-kin.--(1) Permitted disclosures. A
covered entity may disclose protected health information to a person
who is a next-of-kin, other family member, or close personal friend of
an individual who possesses the capacity to make his or her own health
care decisions, if:
(i) The individual has verbally agreed to the disclosure; or
(ii) In circumstances where such agreement cannot practicably or
reasonably be obtained, only the protected health information that is
directly relevant to the person's involvement in the individual's
health care is disclosed, consistent with good health professional
practices and ethics.
(2) Next-of-kin defined. For purposes of this paragraph, "next-of-
kin" is defined as defined under applicable law.
(m) Uses and disclosures for specialized classes.--(1) Military
purposes. A covered entity that is a health care provider or health
plan providing health care to individuals who are Armed Forces
personnel may use and disclose protected health information for
activities deemed necessary by appropriate military command authorities
to assure the proper execution of the military mission, where the
appropriate military authority has published by notice in the Federal
Register the following information:
(i) Appropriate military command authorities;
(ii) The circumstances for which use or disclosure without
individual authorization would be required; and
(iii) Activities for which such use or disclosure would occur in
order to assure proper execution of the military mission.
(2) Department of Veterans Affairs. The Department of Veterans
Affairs may use and disclose protected health information among
components of the Department that determine eligibility for or
entitlement to, or that provide, benefits under laws administered by
the Secretary of Veterans Affairs.
(3) Intelligence community. A covered entity may disclose protected
health information of an individual who is an employee of the
intelligence community, as defined in section 4 of the National
Security Act, 50 U.S.C. 401a, and his or her dependents, if such
dependents are being considered for posting abroad, to intelligence
community agencies, where authorized by law.
(4) Department of State. The Department of State may use protected
health information about the following individuals for the following
purposes:
(i) As to applicants to the Foreign Service, for medical clearance
determinations about physical fitness to serve in the Foreign Service
on a worldwide basis, including about medical and mental conditions
limiting assignability abroad; determinations of conformance to
occupational physical standards, where applicable; and determinations
of suitability.
[[Page 60059]]
(ii) As to members of the Foreign Service and other United States
Government employees assigned to serve abroad under Chief of Mission
authority, for medical clearance determinations for assignment to posts
abroad, including medical and mental conditions limiting such
assignment; determinations of conformance to occupational physical
standards, where applicable; determinations about continued fitness for
duty, suitability, and continuation of service at post (including
decisions on curtailment); separation medical examinations; and
determinations of eligibility of members of the Foreign Service for
disability retirement (whether on application of the employee or the
Secretary of State).
(iii) As to eligible family members of Foreign Service or other
United States Government employees, for medical clearance
determinations as described in paragraph (m)(4)(ii) of this section to
permit eligible family members to accompany employees to posts abroad
on Government orders; determinations regarding family members remaining
at post; and separation medical examinations.
(n) Uses and disclosures otherwise required by law. A covered
entity may use or disclose protected health information where such use
or disclosure is required by law and the use or disclosure meets all
relevant requirements of such law. This paragraph does not apply to
uses or disclosures that are covered by paragraphs (b) through (m) of
this section.
Sec. 164.512 Notice to individuals of information practices.
(a) Standard. An individual has a right to adequate notice of the
policies and procedures of a covered entity that is a health plan or a
health care provider with respect to protected health information.
(b) Standard for notice procedures. A covered entity that is a
health plan or health care provider must have procedures that provide
adequate notice to individuals of their rights and the procedures for
exercising their rights under this subpart with respect to protected
health information about them.
(c) General implementation specification. A covered entity that has
and follows procedures that meet the requirements of this section will
be presumed to have provided adequate notice under this section.
(d) Implementation specifications: content of notice.--(1) Required
elements. Notices required to be provided under this section must
include in plain language a statement of each of the following
elements:
(i) Uses and disclosures. The uses and disclosures, and the
entity's policies and procedures with respect to such uses and
disclosures, must be described in sufficient detail to put the
individual on notice of the uses and disclosures expected to be made of
his or her protected health information. Such statement must:
(A) Describe the uses and disclosures that will be made without
individual authorization; and
(B) Distinguish between those uses and disclosures the entity makes
that are required by law and those that are permitted but not required
by law.
(ii) Required statements. State that:
(A) Other uses and disclosures will be made only with the
individual's authorization and that such authorization may be revoked;
(B) An individual may request that certain uses and disclosures of
his or her protected health information be restricted, and the covered
entity is not required to agree to such a request;
(C) An individual has the right to request, and a description of
the procedures for exercising, the following with respect to his or her
protected health information:
(1) Inspection and copying;
(2) Amendment or correction; and
(3) An accounting of the disclosures of such information by the
covered entity;
(D) The covered entity is required by law to protect the privacy of
its individually identifiable health information, provide a notice of
its policies and procedures with respect to such information, and abide
by the terms of the notice currently in effect;
(E) The entity may change its policies and procedures relating to
protected health information at any time, with a description of how
individuals will be informed of material changes; and
(F) Individuals may complain to the covered entity and to the
Secretary if they believe that their privacy rights have been violated.
(iii) Contact. The name and telephone number of a contact person or
office required by Sec. 164.518(a)(2).
(iv) Date. The date the version of the notice was produced.
(2) Revisions. A covered health plan or health care provider may
change its policies or procedures required by this subpart at any time.
When a covered health plan or health care provider materially revises
its policies and procedures, it must update its notice as provided for
by Sec. 164.520(g).
(e) Implementation specifications: Provision of notice. A covered
entity must make the notice required by this section available:
(1) General requirement. On request; and
(2) Specific requirements. As follows:
(i) Health plans. Health plans must provide a copy of the notice to
an individual covered by the plan:
(A) As of the date on which the health plan is required to be in
compliance with this subpart;
(B) After the date described in paragraph (e)(2)(i)(A) of this
section, at enrollment;
(C) After enrollment, within 60 days of a material revision to the
content of the notice; and
(D) No less frequently than once every three years.
(ii) Health care providers. A health care provider must:
(A) During the one year period following the date by which the
provider is required to come into compliance with this subpart, provide
a copy to individuals currently served by the provider at the first
service delivery to such individuals during such period, provided that,
where service is not provided through a face-to-face contact, the
provider must provide the notice in an appropriate manner within a
reasonable period of time following first service delivery;
(B) After the one year period provided for by paragraph
(e)(2)(ii)(A) of this section, provide a copy to individuals served by
the provider at the first service delivery to such individuals,
provided that, where service is not provided through a face-to-face
contact, the provider must provide the notice in an appropriate manner
within a reasonable period of time following first service delivery;
and
(C) Post a copy of the notice in a clear and prominent location
where it is reasonable to expect individuals seeking service from the
provider to be able to read the notice. Any revision to the notice must
be posted promptly.
Sec. 164.514 Access of individuals to protected health information
(a) Standard: Right of access. An individual has a right of access
to, which includes a right to inspect and obtain a copy of, his or her
protected health information in designated record sets of a covered
entity that is a health plan or a health care provider, including such
information in a business partner's designated record set that is not a
duplicate of the information held by the provider or plan, for so long
as the information is maintained.
(b) Standard: denial of access to protected health information.--
(1) Grounds. Except where the protected
[[Page 60060]]
health information to which access is requested is subject to 5 U.S.C.
552a, a covered entity may deny a request for access under paragraph
(a) of this section where:
(i) A licensed health care professional has determined that, in the
exercise of reasonable professional judgment, the inspection and
copying requested is reasonably likely to endanger the life or physical
safety of the individual or another person;
(ii) The information is about another person (other than a health
care provider) and a licensed health care professional has determined
that the inspection and copying requested is reasonably likely to cause
substantial harm to such other person;
(iii) The information was obtained under a promise of
confidentiality from someone other than a health care provider and such
access would be likely to reveal the source of the information;
(iv) The information was obtained by a covered entity that is a
health care provider in the course of a clinical trial, the individual
has agreed to the denial of access when consenting to participate in
the trial (if the individual's consent to participate was obtained),
and the clinical trial is in progress; or
(v) The information was compiled in reasonable anticipation of, or
for use in, a legal proceeding.
(2) Other information available. Where a denial of protected health
information is made pursuant to paragraph (b)(1) of this section, the
covered entity must make any other protected health information
requested available to the individual to the extent possible consistent
with the denial.
(c) Standard: procedures to protect rights of access. A covered
entity that is a health plan or a health care provider must have
procedures that enable individuals to exercise their rights under
paragraph (a) of this section.
(d) Implementation specifications: Access to protected health
information. The procedures required by paragraph (c) of this section
must:
(1) Means of request. Provide a means by which an individual can
request inspection or a copy of protected health information about him
or her.
(2) Time limit. Provide for taking action on such requests as soon
as possible but not later than 30 days following receipt of the
request.
(3) Request accepted. Where the request is accepted, provide:
(i) For notification of the individual of the decision and of any
steps necessary to fulfill the request;
(ii) The information requested in the form or format requested, if
it is readily producible in such form or format;
(iii) For facilitating the process of inspection and copying; and
(iv) For a reasonable, cost-based fee for copying health
information provided pursuant to this paragraph, if deemed desirable by
the entity.
(4) Request denied. Where the request is denied in whole or in
part, provide the individual with a written statement in plain language
of:
(i) The basis for the denial; and
(ii) A description of how the individual may complain to the
covered entity pursuant to the complaint procedures established in
Sec. 164.518(d)(2) or to the Secretary pursuant to the procedures
established in Sec. 164.522(b). The description must include:
(A) The name and telephone number of the contact person or office
required by Sec. 164.518(a)(2) of this subpart; and
(B) Information relevant to filing a complaint with the Secretary
under Sec. 164.522(b).
Sec. 164.515 Accounting for disclosures of protected health
information.
(a) Standard: Right to an accounting of disclosures of protected
health information. An individual has a right to receive an accounting
of all disclosures of protected health information made by a covered
entity as long as such information is maintained by the entity, except
for disclosures:
(1) For treatment, payment and health care operations; and
(2) To health oversight or law enforcement agencies, if the health
oversight or law enforcement agency has provided a written request
stating that the exclusion is necessary because disclosure would be
reasonably likely to impede the agency's activities and specifying the
time for which such exclusion is required.
(b) Standard: Procedures for accounting. A covered entity must have
procedures to give individuals an accurate accounting of disclosures
for which an accounting is required by paragraph (a) of this section.
(c) Implementation specifications: Accounting procedures. The
procedures required by paragraph (b) of this section must:
(1) Provide for an accounting of the following:
(i) The date of each disclosure;
(ii) The name and address of the organization or person who
received the protected health information;
(iii) A brief description of the information disclosed;
(iv) For disclosures other than those made at the request of the
individual, the purpose for which the information was disclosed; and
(v) Provision of copies of all requests for disclosure.
(2) Provide the accounting to the individual as soon as possible,
but no later than 30 days of receipt of the request therefor.
(3) Provide for a means of accounting for as long as the entity
maintains the protected health information.
(4) Provide for a means of requiring business partners to provide
such an accounting upon request of the covered entity.
Sec. 164.516 Amendment and correction.
(a) Standard: right to request amendment or correction.--(1) Right
to request. An individual has the right to request a covered entity
that is a health plan or health care provider to amend or correct
protected health information about him or her in designated record sets
of the covered entity for as long as the covered entity maintains the
information.
(2) Grounds for denial of request. A covered entity may deny a
request for amendment or correction of the individual's protected
health information, if it determines that the information that is the
subject of the request:
(i) Was not created by the covered entity;
(ii) Would not be available for inspection and copying under
Sec. 164.514 or
(iii) Is accurate and complete.
(b) Standard: Amendment and correction procedures. A covered entity
that is a health plan or health care provider must have procedures to
enable individuals to request amendment or correction, to determine
whether the requests should be granted or denied, and to disseminate
amendments or corrections to its business partners and others to whom
erroneous information has been disclosed.
(c) Implementation specifications: Procedures. The procedures
required by paragraph (b) of this section must provide that the covered
entity will:
(1) Means of request. Provide a means by which an individual can
request amendment or correction of his or her protected health
information.
(2) Time limit. Take action on such request within 60 days of
receipt of the request;
(3) Request accepted. Where the request is accepted in whole or in
part:
(i) As otherwise required by this part, make the appropriate
amendments or corrections;
(ii) As otherwise required by this part, identify the challenged
entries as
[[Page 60061]]
amended or corrected and indicate their location;
(iii) Make reasonable efforts to notify:
(A) Persons, organizations, or other entities the individual
identifies as needing to be notified; and (B) Persons, organizations,
or other entities, including business partners, who the covered entity
knows have received the erroneous or incomplete information and who may
have relied, or could foreseeably rely, on such information to the
detriment of the individual; and (iv) Notify the individual of the
decision to correct or amend the information.
(4) Request denied. Where the request is denied in whole or in
part:
(i) Provide the individual with a written statement in plain
language of:
(A) The basis for the denial;
(B) A description of how the individual may file a written
statement of disagreement with the denial; and
(C) A description of how the individual may complain to the covered
entity pursuant to the complaint procedures established in
Sec. 164.518(d) or to the Secretary pursuant to the procedures
established in Sec. 164.522(b). The description must include:
(1) The name and telephone number of the contact person or office
required by Sec. 164.518(a)(2); and
(2) Information relevant to filing a complaint with the Secretary
under Sec. 164.522(b).
(ii) The procedures of the covered entity must:
(A) Permit the individual to file a statement of the individual's
disagreement with the denial and the basis of such disagreement.
(B) Provide for inclusion of the covered entity's statement of
denial and the individual's statement of disagreement with any
subsequent disclosure of the information to which the disagreement
relates, provided, however, that the covered entity may establish a
limit to the length of the statement of disagreement, and may summarize
the statement of disagreement if necessary.
(C) Permit the covered entity to provide a rebuttal to the
statement of disagreement in subsequent disclosures under paragraph
(c)(4)(ii)(B) of this section.
(d) Standard: Effectuating a notice of amendment or correction. Any
covered entity that receives a notice of amendment or correction must
have procedures in place to make the amendment or correction in any of
its designated record sets and to notify its business partners, as
appropriate, of necessary amendments or corrections of protected health
information.
(e) Implementation specification: effectuating a notice of
amendment or correction. The procedures required by paragraph (d) of
this section must specify the process for correction or amendment of
information in all appropriate designated record sets maintained by the
covered entity and its business partners.
Sec. 164.518 Administrative requirements.
Except as otherwise provided, a covered entity must meet the
requirements of this section.
(a) Designated privacy official: standard.--(1) Responsibilities of
designated privacy official. A covered entity must designate a privacy
official who is responsible for the development and implementation of
the privacy policies and procedures of the entity.
(2) Contact person or office. A covered entity must designate a
contact person or office who is responsible for receiving complaints
under this section and who is able to provide further information about
matters covered by the notice required by Sec. 164.512. If a covered
entity designates a contact person, it may designate the privacy
official as the contact person.
(b) Training.--(1) Standard. All members of the covered entity's
workforce who, by virtue of their positions, are likely to obtain
access to protected health information must receive training on the
entity's policies and procedures required by this subpart that are
relevant to carrying out their function within the entity.
(2) Implementation specification. A covered entity must train all
members of its workforce who, by virtue of their positions, are likely
to obtain access to protected health information. Such training must
meet the following requirements:
(i) The training must occur:
(A) For members of the covered entity's workforce as of the date on
which this subpart becomes applicable to such entity, by such date; and
(B) For persons joining the covered entity's workforce after the
date in paragraph (b)(2)(i)(A) of this section, within a reasonable
period after the person joins the workforce.
(ii) The covered entity must require members of its workforce
trained as required by this section to sign, upon completing training,
a certification. The certification must state:
(A) The date of training; and
(B) That the person completing the training will honor all of the
entity's policies and procedures required by this subpart.
(iii) The covered entity must require members of its workforce
trained as required by this section to sign, at least once every three
years, a statement certifying that the person will honor all of the
entity's policies and procedures required by this subpart.
(iv) The covered entity must provide all members of its workforce
with access to protected health information within the entity with
further training, as relevant to their function within the entity,
whenever the entity materially changes its privacy policies or
procedures.
(c) Safeguards.--(1) Standard. A covered entity must have in place
appropriate administrative, technical, and physical safeguards to
protect the privacy of protected health information.
(2) Implementation specification: Verification procedures. A
covered entity must have administrative, technical, and physical
procedures in place to protect the privacy of protected health
information. Such procedures must include adequate procedures for
verification of the identity and/or authority, as required by this
subpart, of persons requesting such information, where such identity or
authority is not known to the entity, as follows:
(i) The covered entity must use procedures that are reasonably
likely to establish that the individual or person making the request
has the appropriate identity for the use or disclosure requested,
except for uses and disclosures that are:
(A) Permitted by this subpart and made on a routine basis to
persons or other entities with which the covered entity interacts in
the normal course of business or otherwise known to the covered entity;
or
(B) Covered by paragraphs (c)(2)(ii), (iii), or (iv) of this
section.
(ii) When the request for information is made by a government
agency under Sec. 164.510(b), Sec. 164.510(c), Sec. 164.510(e),
Sec. 164.510(f), Sec. 164.510(g), Sec. 164.510(m), Sec. 164.510(n), or
Sec. 164.522, and the identity and/or authority are not known to the
covered entity, the covered entity may not disclose such information
without reasonable evidence of identity and/or authority to obtain the
information.
(A) For purposes of this paragraph, "reasonable evidence of
identity" means:
(1) A written request on the agency's letterhead;
(2) Presentation of an agency identification badge or official
credentials; or
(3) Similar proof of government status.
(B) For purposes of this paragraph, reasonable evidence of
authority means:
[[Page 60062]]
(1) A written statement of the legal authority under which the
information is requested; a request for disclosure made by official
legal process issued by a grand jury or a judicial or administrative
body is presumed to constitute reasonable legal authority; or
(2) Where the request is made orally, an oral statement of such
authority.
(iii) When the request for information is made by a person or
entity acting on behalf of a government agency under Sec. 164.510(b),
Sec. 164.510(c), Sec. 164.510(g), or Sec. 164.510(n), and the identity
and/or authority are not known to the covered entity, the covered
entity may not disclose such information without reasonable evidence of
identity and/or authority to obtain the information.
(A) For the purposes of this paragraph, reasonable evidence of
identity means:
(1) A written statement from the government agency, on the agency's
letterhead, that the person or entity is acting under the agency's
authority; or
(2) Other evidence or documentation, such as a contract for
services, memorandum of understanding, or purchase order, that
establishes that the person or entity is acting on behalf of or under
the agency's authority.
(B) For the purposes of this paragraph, "reasonable evidence of
authority" means a statement that complies with paragraph (c)(ii)(B)
of this section.
(iv) For uses and disclosures under Sec. 164.510(d),
Sec. 164.510(h), or Sec. 164.510(j), compliance with the applicable
requirements of those sections constitutes adequate verification under
this section.
(v)(A) A covered entity may reasonably rely on evidence of identity
and legal authority that meets the requirements of this paragraph.
(B) Where presentation of particular documentation or statements
are required by this subpart as a condition of disclosure, a covered
entity may reasonably rely on documentation or statements that on their
face meet the applicable requirements.
(3) Implementation specification: Other safeguards. A covered
entity must have safeguards to ensure that information is not used in
violation of the requirements of this subpart or by members of its
workforce or components of the entity or employees and other persons
associated with, or components of, its business partners who are not
authorized to access the information.
(4) Implementation specification: Disclosures by whistleblowers. A
covered entity is not considered to have violated the requirements of
this subpart where a member of its workforce or an employee or other
person associated with a business partner discloses protected health
information that such member or other person believes is evidence of a
violation of law to:
(i) The law enforcement official or oversight agency authorized to
enforce such law; or
(ii) An attorney, for the purpose of determining whether a
violation of law has occurred or assessing what remedies or actions at
law may be available to the employee.
(d) Complaints to the covered entity--(1) Standard. A covered
entity that is a health plan or health care provider must provide a
process whereby individuals may make complaints concerning the entity's
compliance with the requirements established by this subpart.
(2) Implementation specifications. A covered entity that is a
health plan or health care provider must develop and implement
procedures under which an individual may file a complaint alleging that
the covered entity failed to comply with one or more requirements of
this subpart. Such procedures must provide for:
(i) The identification of the contact person or office required by
paragraph (a)(2) of this section; and
(ii) Maintenance by the covered entity of a record of all
complaints and their disposition, if any.
(e) Sanctions: Standard. A covered entity must develop and apply
when appropriate sanctions against members of its workforce who fail to
comply with the policies and procedures of the covered entity or the
requirements of this subpart in connection with protected health
information held by the covered entity or its business partners.
(f) Duty to mitigate: standard. A covered entity must have
procedures for mitigating, to the extent practicable, any deleterious
effect of a use or disclosure of protected health information in
violation of this subpart.
Sec. 164.520 Documentation of policies and procedures.
(a) Standard. A covered entity must adequately document its
compliance with the applicable requirements of this subpart.
(b) Implementation specification: General. A covered entity must
document its policies and procedures for complying with the applicable
requirements of this subpart. Such documentation must include, but is
not limited to, documentation that meets the requirements of paragraphs
(c) through (g) of this section.
(c) Implementation specification: Uses and disclosures. With
respect to uses by the covered entity or its business partners of
protected health information, a covered entity must document its
policies and procedures regarding:
(1) Uses and disclosures of such information, including:
(i) Uses and disclosures with authorization, including for
revocation of authorizations; and
(ii) Uses and disclosures without authorization, including:
(A) For treatment, payment, and health care operations;
(B) For disclosures to business partners, including monitoring and
mitigation; and
(C) For uses and disclosures pursuant to Sec. 164.510.
(2) For implementation of the minimum necessary requirement of
Sec. 164.506(b).
(3) For implementation of the right to request a restriction under
Sec. 164.506(c), including:
(A) Who, if anyone, in the covered entity is authorized to agree to
such a request; and
(B) How restrictions agreed to are implemented.
(4) For creation of de-identified information in accordance with
Sec. 164.506(d).
(d) Implementation specification: Individual rights. A covered
entity must document its policies and procedures under Secs. 164.512,
164.514, 164.515, and 164.516, as applicable, including:
(1) How notices will be disseminated in accordance with
Sec. 164.512;
(2) Designated record sets to which access will be granted under
Sec. 164.514;
(3) Grounds for denying requests for access under Sec. 164.514;
(4) Copying fees, if any;
(5) Procedures for providing accounting pursuant to Sec. 164.515;
(6) Procedures for accepting or denying requests for amendment or
correction under Sec. 164.516;
(7) How other entities will be notified of amendments or
corrections accepted under Sec. 164.516; and
(8) Identification of persons responsible for making decisions or
otherwise taking action, including serving as a contact person, under
Secs. 164.512, 164.514, 164.515, and 164.516.
(e) Implementation specification: Administrative requirements. A
covered entity must provide documentation of its procedures for
complying with Sec. 164.518, including:
(1) Identification of the persons or offices required by
Sec. 164.518(a) and their duties;
(2) Training provided as required by Sec. 164.518(b);
[[Page 60063]]
(3) How access to protected health information is regulated by the
covered entity and its business partners, including safeguards required
by Sec. 164.518(c);
(4) For a covered entity that is a health plan or health care
provider, for receiving complaints under Sec. 164.518(d);
(5) Sanctions, and the application thereof, required by
Sec. 164.518(e); and
(6) Procedures for mitigation under Sec. 164.518(f).
(f) Implementation specification: Specific documentation required.
A covered entity must retain documentation of the following for six
years from when the documentation is created, unless a longer period
applies under this subpart:
(1) Restrictions agreed to pursuant to Sec. 164.506(c);
(2) Contracts pursuant to Sec. 164.506(e);
(3) Authorization forms used pursuant to Sec. 164.508;
(4) Samples of all notices issued pursuant to Sec. 164.512;
(5) Written statements required by Sec. 164.514;
(6) The accounting required by Sec. 164.515;
(7) Documents relating to denials of requests for amendment and
correction pursuant to Sec. 164.516;
(8) Certifications under Sec. 164.518(b); and
(9) Complaints received and any responses thereto pursuant to
Sec. 164.518(d).
(g) Implementation specification: Change in policy or procedure.
(1) Except as provided in paragraph (g)(2) of this section, a covered
entity may not implement a change to a policy or procedure required or
permitted under this subpart until it has made the appropriate changes
to the documentation required by this section and the notice required
by Sec. 164.512.
(2) Where the covered entity determines that a compelling reason
exists to make a use or disclosure or take another action permitted
under this subpart that its notice and policies and procedures do not
permit, it may make the use or disclosure or take the other action if:
(1) It documents the reasons supporting the use, disclosure, or
other action; and
(2) Within 30 days of the use, disclosure, or other action, changes
its notice, policies and procedures to permit such use, disclosure, or
other action.
Sec. 164.522 Compliance and enforcement.
(a) Principles for achieving compliance.--(1) Cooperation. The
Secretary will, to the extent practicable, seek the cooperation of
covered entities in obtaining compliance with the requirements
established under this subpart.
(2) Assistance. The Secretary may provide technical assistance to
covered entities to help them comply voluntarily with this subpart.
(b) Individual complaints to the Secretary. An individual who
believes that a covered entity is not complying with the requirements
of this subpart may file a complaint with the Secretary, provided that,
where the complaint relates to the alleged failure of a covered entity
to amend or correct protected health information pursuant to
Sec. 164.516, the Secretary may determine whether the covered entity
has followed procedures that comply with Sec. 164.516, but will not
determine whether the information involved is accurate, complete, or
whether errors or omissions might have an adverse effect on the
individual.
(1) Requirements for filing complaints. Complaints under this
section must meet the following requirements:
(i) A complaint must be filed in writing, either on paper or
electronically.
(ii) A complaint should name the entity that is the subject of the
complaint and describe in detail the acts or omissions believed to be
in violation of the requirements of this subpart.
(iii) The Secretary may prescribe additional requirements for the
filing of complaints, as well as the place and manner of filing, by
notice in the Federal Register.
(2) Investigation. The Secretary may investigate complaints filed
under this section. Such investigation may include a review of the
pertinent policies, practices, and procedures of the covered entity and
of the circumstances regarding any alleged acts or omissions concerning
compliance.
(c) Compliance reviews. The Secretary may conduct compliance
reviews to determine whether covered entities are complying with this
subpart.
(d) Responsibilities of covered entities.--(1) Provide records and
compliance reports. A covered entity must keep such records and submit
such compliance reports, in such time and manner and containing such
information, as the Secretary may determine to be necessary to enable
the Secretary to ascertain whether the covered entity has complied or
is complying with the requirements of this subpart.
(2) Cooperate with periodic compliance reviews. The covered entity
shall cooperate with the Secretary if the Secretary undertakes a review
of the policies, procedures, and practices of a covered entity to
determine whether it is complying with this subpart.
(3) Permit access to information. A covered entity must permit
access by the Secretary during normal business hours to its books,
records, accounts, and other sources of information, including
protected health information, and its facilities, that are pertinent to
ascertaining compliance with this subpart. Where any information
required of a covered entity under this section is in the exclusive
possession of any other agency, institution, or person and the other
agency, institution, or person fails or refuses to furnish the
information, the covered entity must so certify and set forth what
efforts it has made to obtain the information. Protected health
information obtained in connection with a compliance review or
investigation under this subpart will not be disclosed by the
Secretary, except where necessary to enable the Secretary to ascertain
compliance with this subpart, in formal enforcement proceedings, or
where otherwise required by law.
(4) Refrain from intimidating or retaliatory acts. A covered entity
may not intimidate, threaten, coerce, discriminate against, or take
other retaliatory action against any individual for the filing of a
complaint under this section, for testifying, assisting, participating
in any manner in an investigation, compliance review, proceeding or
hearing under this Act, or opposing any act or practice made unlawful
by this subpart.
(e) Secretarial action regarding complaints and compliance
reviews.--(1) Resolution where noncompliance is indicated. (i) If an
investigation pursuant to paragraph (b)(2) of this section or a
compliance review pursuant to paragraph (c) of this section indicates a
failure to comply, the Secretary will so inform the covered entity and,
where the matter arose from a complaint, the individual, and resolve
the matter by informal means whenever possible.
(ii) If the Secretary determines that the matter cannot be resolved
by informal means, the Secretary may issue written findings documenting
the non-compliance to the covered entity and, where the matter arose
from a complaint, to the complainant. The Secretary may use such
findings as a basis for initiating action under section 1176 of the Act
or initiating a criminal referral under section 1177.
(2) Resolution where no violation is found. If an investigation or
compliance review does not warrant action pursuant
[[Page 60064]]
to paragraph (e)(1) of this section, the Secretary will so inform the
covered entity and, where the matter arose from a complaint, the
individual in writing.
Sec. 164.524 Effective date.
A covered entity must be in compliance with this subpart not later
than 24 months following the effective date of this rule, except that a
covered entity that is a small health plan must be in compliance with
this subpart not later than 36 months following the effective date of
the rule.
[[Page 60065]]
Appendix to Subpart E of Part 164--Model Authorization Form
[GRAPHIC] [TIFF OMITTED] TP03NO99.000
[FR Doc. 99-28440 Filed 10-28-99; 4:45 pm]
BILLING CODE 4150-04-C
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