A Brief Summary of the HIPAA Medical Privacy Rule
CRS Report for Congress
A Brief Summary of the HIPAA Medical
Gina Marie Stevens
American Law Division
This report provides a brief overview of the modified HIPAA Privacy rule,
“Standards for the Privacy of Individually Identifiable Health Information”(“privacy
rule”) published on August 14, 2002 by the Department of Health and Human Services1
(HHS). Issuance of the modified Privacy Rule by the Bush Administration is the
culmination of a decades long debate over access to medical records that has pitted
privacy advocates and civil libertarians against employers and much of the health care
industry. As required by the Health Insurance Portability and Accountability Act of
1996 (“HIPAA”), a privacy rule was issued in December 2000, and modified August
April 2003 for most entities. The HIPAA Privacy Rule establishes a set of basic
consumer protections and a series of regulatory permissions for uses and disclosures ofth
protected health information. S. 16, introduced in the 108 Congress by Senator
Daschle, would reverse some modifications to the rule. This report will be updated.
Background. In recent years, our society has come to rely increasingly on medical
information to perform basic functions and to make decisions about individuals.
However, a number of fundamental developments have threatened the confidentiality of
health-care information, and are the cause of a great deal of concern. The emergence of
third-party payment plans; the use of health-care information for non-health care
purposes; the growing involvement of government agencies in virtually all aspects of
health care; and the exponential increase in the use of computers and automated
information systems for health record information have combined to put substantial
pressure on traditional confidentiality protections. In addition, an increasing number of
parties involved in health care treatment, payment, and oversight have routine access to
personally identifiable health records. Greater utilization of health-care information
2 See CRS Report RS21505, Compliance with the HIPAA Medical Privacy Rule, by Gina Stevens.
Congressional Research Service ˜ The Library of Congress
coupled with inadequate confidentiality protections has increased the potential for
unauthorized uses and disclosures of medical information. The disclosure of personally
identifiable health-care information can profoundly affect people’s lives. “It affects
decisions on whether they are hired or fired; whether they can secure business licenses,
and life insurance; whether they are permitted to drive cars; whether they are placed under
police surveillance or labeled a security risk; or even whether they can get nominated for
and elected to political office.”3 Other secondary uses of health-care information, such
as the use of genetic test results for employment and insurance purposes, have the
potential to result in harm to the health-care subject if the information is disclosed for
unauthorized purposes. These factors accentuate the need for strong legal safeguards.
Medical Privacy Laws. The confidentiality of health-care information is
governed by various federal, state, and local statutes, ordinances, regulations, and case
law. Also applicable are private accreditation standards, such as those of the Joint
Commission on Accreditation of Healthcare Organizations, internal policies of particular
institutions, and ethical guidelines of professional organizations. Prior to the issuance of
the HIPAA privacy rule, federal laws did not address the confidentiality of health-care
information collected and maintained by the private sector (i.e., doctors, hospitals, health
plans, health insurers, and other health-care related entities). A major impetus for the
enactment of HIPAA’s privacy requirement was the absence of a comprehensive federal
law that protected the confidentiality of patient records in all settings.
Another impetus for the enactment of HIPAA was the lack of uniformity among
the states in their treatment of the confidentiality of health-care information. There was
substantial variation between the states on many aspects of medical records law. These
differences are becoming much more critical in the collection, maintenance, and
disclosure of health-care information as it is transmitted through interstate commerce
amongst patients, physicians, health-care facilities, employers, government agencies, and
insurers located in different states and subject to different laws. To address this disparity,
HIPAA provides that state law, except for certain specified laws (concerning public health
surveillance) and state laws that are more stringent, is preempted by the federal privacy
rule. A compendium of state laws issued July 20, 1999 and November 2002 by
Georgetown University’s Health Privacy Project, “The State of Health Privacy: An
Uneven Terrain”, identifies medical records privacy provisions from state legislative
codes. The report covers only state statutes and divides them by patient access, restrictions
on disclosure, privilege, and condition specific requirements.4
HIPAA. Several comprehensive medical records confidentiality bills were
introduced during the past decade, with the end result being passage of the medical
privacy requirements as part of the Health Insurance Portability and Accountability Act
of 1996 (“HIPAA”). The Health Insurance Portability and Accountability Act of 1996
(HIPAA), Pub. L. 104-191, 42 U.S.C. §§ 1320d et seq., was created to improve the
portability and continuity of health insurance coverage, to combat waste, fraud and abuse
in health care, to promote the use of medical savings accounts, to improve access to long
term care, and to simplify the administration of health insurance. Sections 261 through
3 A. Westin, Computers, Health Records, and Citizen’s Rights 60 (1976).
4 See, [http://www.healthprivacy.org/info-url_nocat2304/info-url_nocat.htm].
administrative simplification rule requires health care payers and providers who transmit
transactions electronically to use standardized data elements to conduct financial and
administrative transactions. Section 262 directs HHS to issue standards to facilitate the
electronic exchange of information, and to develop standards to protect the security of
such information. Section 264 of HIPAA requires HHS to submit to the Congress
detailed recommendations on standards with respect to privacy rights for individually
identifiable health information.
The Secretary made preliminary privacy recommendations to Congress in September
and enforcement/redress, to: limit the use of an individual’s health care information to
health purposes only; require organizations to provide adequate security measures to
protect information from misuse or disclosure; provide patients with new rights to control
how their health information is used, such as the ability to get copies of records and
propose corrections; hold those who misuse personal health information accountable, and
provide redress for persons harmed by its misuse through criminal and civil penalties; and
balance privacy protections with public responsibility to support national priorities,
including public health, research, quality care, and reduction of fraud and abuse, including
allowing law enforcement access to personal health information. In the 106th Congress
several proposals to protect health information were considered, but Congress did not pass
legislation. None of the bills were reported out of committee, with disagreements over
the patient’s right to sue, parental notification of minor’s access to health care, and
preemption precluding agreement. In the absence of the enactment of federal legislation,
HIPAA required HHS to issue privacy regulations.
The December 2000 Privacy Rule. The final privacy regulation was published
in the Federal Register on December 28, 2000 at 65 Fed. Reg. 82462, shortly before the
Clinton Administration left office, and after HHS received over 52,000 comments on its
initial proposal. Its original effective date of February 26, 2001 was subsequently
changed to April 14, 2001.5 Enforcement of the rule begins in April 2003, except for
small health plans (annual receipts of $5 million or less) who have until 2004 to comply.
The medical privacy rule prohibits covered entities from disclosing protected health
information to any third parties, unless the rules otherwise permit the disclosure.
Applicability. The rule covers health plans, health care providers, and health care
clearinghouses (entities that process or facilitate the processing of nonstandard data
elements of health information into standard data elements). It only covers information
that is electronically transmitted or maintained. It covers protected health information in
any form, whether oral, written or electronic.
Individual Rights. Individuals are given a right of access to their health information,
a right to receive notice of the covered entity’s privacy policies, a right to request
amendments of their information, a right to an accounting of the disclosures made, and
a right to file complaints regarding use or disclosure of their information. Individuals may
request that restrictions be placed on the disclosure of their health information.
5 66 Fed. Reg. 12433 (Feb. 26, 2001)(the delayed effective date occurred as a result of HHS’
failure to submit the rule to Congress for the required 60-day review period until February 13,
Permitted Uses and Disclosures With Consent or Authorization. The use of protected
health information for treatment, payment, or health care operations (a provider’s or
health plan’s management and other activities necessary for support of treatment or
payment) requires the prior written consent of a patient. Disclosures for purposes other
than treatment, payment, and health care operations require a prior written authorization.
Permitted Uses and Disclosures Without Consent or Authorization. Certain public
priority uses and disclosures of information do not require prior written consent or
authorization (such as health system oversight, public health activities, certain research
activities, law enforcement, judicial and administrative proceedings, emergency treatment,
and imminent threats to the health or safety of any person). Covered entities are permitted
to disclose information to law enforcement for purposes of health care oversight (i.e.,
investigations of health care fraud, government program fraud, and civil rights
investigations), for general law enforcement investigations (i.e., in response to grand jury
subpoenas and court orders), to avert a serious threat to health and safety, to coroners and
medical examiners, for investigations involving abuse, neglect, or domestic violence.
Information Practices. Disclosures of protected health information other than for
treatment purposes must use only the “minimum necessary” information. Covered
entities must enter into contracts with “business associates” requiring them to protect
individual health information, and must take action if they know of practices by their
business associates that violate the contractual agreement. Covered entities must adhere
to specific procedures in using information for fundraising or marketing. There are special
requirements that apply to both federal and privately funded research. Psychotherapy
notes may not be used or disclosed to others without explicit authorization.
Preemption. State law, except for certain specified laws (concerning public health
surveillance) and state laws that are more stringent, is preempted by the federal rule.
Enforcement. The Secretary, covered entities, and others are required to ascertain
compliance with, and enforcement of the privacy regulation. Any person may file a
complaint with the HHS Office for Civil Rights. In cases of noncompliance, the Secretary
is directed to resolve the matter by informal means. If the matter cannot be resolved
informally, the Secretary may issue written findings of non-compliance that may be used
as a basis for initiating action (civil monetary penalties) or a criminal referral.
Penalties. Violators will be subject to civil monetary penalties ($100 per violation
up to $25,000 per year), and criminal penalties (up to $250,000 and imprisonment up to
10 years) against covered entities that knowingly and improperly disclose identifiable
health information. The regulation does not authorize patients to sue. Instead, the law
provides that individuals must direct their complaints to HHS’ Office for Civil Rights
(OCR).6 OCR maintains a Web site with information on the new regulation, including
guidance at [http://www.hhs.gov/ocr/hipaa/]. HHS also recently issued a 20 page
“Summary of the HIPAA Privacy Rule.”7 HHS will enforce the civil money penalties,
and the Department of Justice will enforce the criminal penalties.
6 See [http://www.ehcca.com/presentations/hipaa6/campanelli.pdf].
The final privacy rule was criticized by some for its complexity, and for the
imposition of substantial administrative and financial burdens on the health care industry.
At the same time, the regulation was applauded by privacy advocates, consumer groups,
and some health care industry participants. The General Accounting Office found that
considerable uncertainty existed regarding the actions needed to comply with the new
privacy regulations. Major concerns among stakeholder groups and the Congress centered
on consent and authorization procedures; contractual liability and business associates;
parental access to minors’ health information (typically related to substance abuse, mental
health treatment, and reproductive care); preemption of state laws; law enforcement
access to protected health information; costs; and technical assistance.
The August 2002 Privacy Rule. The Bush Administration and HHS re-opened8
the privacy rule to additional comment on February 8, 2001, and announced that it would
accept further comments on the rule until March 30, 2001, see 66 Fed. Reg. 12378. The
scope and cost of the rule, coupled with the substantial nature of some concerns raised in
the initial comment period, led HHS to conclude that an additional comment period was
warranted. On April 12, 2001, Secretary Thompson announced that HHS would
immediately begin the process of implementing the patient privacy rule, of issuing
guidelines, and of considering any necessary modifications. Several areas were targeted
for clarification or modification: impediments to information sharing; consent and
authorization procedures; parental access to minors’ health information; uses and
disclosures for treatment, payment, and health care operations; notices of privacy
practices; minimum necessary uses and disclosures; oral communications; business
associates; uses and disclosures for marketing; parents as the personal representatives of
unemancipated minors; uses and disclosures for research purposes; uses and disclosures
for which authorizations are required; and de-identification. On July 6, 2001 HHS issued9
interpretative guidance materials on the rule. In response to numerous and extensive
comments received by HHS, along with intense lobbying efforts by various stakeholders,
in March 2002 the Bush Administration issued proposed modifications to the privacy rule
in the Federal Register at 67 Fed. Reg. 14775, and permitted a 30-day comment period
on its proposal. On August 14, 2002, HHS published in the Federal Register the privacy
rule with certain modifications, 67 Fed. Reg. 53181.10 The August 2002 modification is
virtually unchanged from the March 2002 proposal, does not require Congressional
approval, and has the force of law. A summary of significant final modifications
follows. For detailed discussion of medical privacy issues, see CRS Report RS20500,
Medical Records Privacy: Questions and Answers on the HIPAA Final Rule.
Notice. The August 2002 rule adds a new requirement for health care providers with
a direct treatment relationship, that they make a good faith effort to obtain an individual’s
written acknowledgment of receipt of the provider’s privacy notice.
8 During the 12 month period after the standards are initially adopted, the Secretary is permitted
to modify the standards only if necessary to permit compliance. After the first year of adoption,
HHS may modify the standards not more than once every 12 months. 42 U.S.C. § 1320d-3(b).
9 Available at [http://www.hhs.gov/ocr/hipaa/finalmaster.html].
10 Available at [http://www.hhs.gov/ocr/combinedregtext.pdf].
Consent and Authorization. The requirement for providers to obtain an individual’s
prior written consent to use or disclose protected health information for treatment,
payment or health care operations was eliminated. The August 2002 rule permits covered
entities to obtain consent, but does not require it. Although patient authorizations will
still be required to use and disclose information for purposes outside of treatment,
payment, and health care operations, the August 2002 rule standardizes the core
requirements in authorization forms, and allows health care groups to use a single type
of authorization to get permission to use information for a specific purpose or disclosure.
Minimum Necessary. The August 2002 rule exempts from the minimum necessary
standards any uses or disclosures for which an authorization has been received.
Incidental Use and Disclosure. The August 2002 rule explicitly permits incidental
disclosures resulting from activities such as discussions at nursing stations, the use of
sign-in sheets, calling out names in waiting rooms, etc. provided reasonable safeguards
and minimum necessary requirements are met.
Business Associates. The August 2002 rule allows covered entities, except small
health plans, up to one year beyond the April 14, 2003 enforcement date to change
existing contracts with business associates.
Marketing. The August 2002 rule requires covered entities to obtain prior patient
authorization for marketing, except for a face-to-face communication or a communication
involving a promotional gift of nominal value. The rule distinguishes between activities
that are and are not marketing. The definition of “marketing” in the new rules excludes
communications by a health care provider promoting its own goods and services.
Medical Information of Minors. The December 2000 privacy rule generally gives
control of health information about a minor to the parent, guardian, or person acting in
loco parentis. The August 2002 rule clarifies that state law governs in the area of parents
and minors, and that HIPAA does not overturn state laws that give providers discretion
to disclose or deny health information to parents.
Research. The December 2000 privacy rule provides that protected health
information may not be used or disclosed for research without either a written
authorization or a waiver of authorization approved by an Institutional Review Board or
a Privacy Board. In the August 2002 rule, HHS significantly simplified the administrative
burdens for obtaining authorizations and assessing requests for waivers of authorization.
Disclosures to Obtain Payment. The December 2000 rule prevents a provider from
disclosing protected health information to another entity for other than treatment
purposes. A covered entity is permitted to disclose protected health information to other
covered entities and to noncovered health care providers to enable for payment purposes.
Legislation. S. 16, The Equal Rights and Equal Dignity for Americans Act,
would, among other things, reverse August 2002 modifications to the privacy rule