Implications of HIPAA Privacy Regulations

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Korn D. AAMC Commentary: The Effect of the Privacy Rule on Teaching and Research. Washington, DC: Association of American Medical Colleges. 2001 February.
The challenge for medical information privacy regulation is to find the appropriate balance point between the competing interests of individual privacy and the public benefits derived from the use of medical information. This commentary analyzes the specific aspects of the Privacy Rule that concern the AAMC because of their potential effect on health professions education, research, and the health care delivery system.

Other Articles

Cohen JJ. Letter to the Honorable Tommy G. Thompson. March 29, 2001. Available at www.aamc.org/advocacy/testimny/research/hipaathompson.htm.
This letter is the Association of American Medical Colleges (AAMC) commentary on the Department of Health and Human services final rule entitled "Standards for the Privacy of Individually Identifiable Health Information."

Goldman J. Assessing HIPAA: How Federal Medical Record Privacy Regulations Can Be Improved. Testimony of Janlori Goldman, J.D. Director, Health Privacy Project, Institute for Health Care Research and Policy, Georgetown University, before the House Committee on Energy and Commerce, Subcommittee on Health. Washington, DC: Health Privacy Project. 2001 March 22. Available at www.healthprivacy.org/newsletter-url2306/newsletter-url_list.htm?section=HPP%20Testimony.
Ms. Goldman's testimony addresses the importance of protecting privacy in the health care arena and the genesis of the health privacy regulation. It includes a brief summary of the final regulation, describes the major areas of contention, conveys the Health Privacy Project's recommendations to Congress, and urges that there be no delay in implementing the regulation.

Health Privacy Project. Myths and Facts about the Federal Medical Privacy Regulation. Institute for Health Care Research and Policy. Georgetown University. 2001 April 4. Available at www.healthprivacy.org/info-url_nocat2303/info-url_nocat_show.htm?doc_id=53028
Using discussion of various "myths" about the regulation generated by testimony and media sources, this document seeks to clarify its intent.

Korn D. Contribution of the Human Tissue Archive to the Advancement of Medical Knowledge and the Public Health. In Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, Volume II, Commissioned Papers. Rockville, MD: National Bioethics Advisory Commission, 2000 January.
This report describes specific examples of how studies of archived tissue samples have contributed to the advancement of medicine, and often to the improvement of public health as well. Although not specifically collected for research purposes, these specimens provide an irreplaceable research resource. The debate over access to human tissue samples for research has included too little input from the scientific community, which is needed to balance the individual's expectation of the right to privacy against the public benefit from biomedical research and improved public health. As new technologies evolve that promise access to even more medical information from studies of these specimens, "public policy must continue to encourage the accumulation of the human tissue archive and facilitate its accessibility for medical research."

Korn D. Genetic Privacy, Medical Information Privacy, and the Use of Human Tissue Specimens in Research. In Genetic Testing and the Use of Information. Edited by Clarisa Long. Washington, DC: The AEI Press. 1999.
Policy issues concerning the privacy of medical and genetic information are interlinked, involving patient care, biomedical research, and public health, with competing public and private goods. The author discusses genetic privacy within the context of medical privacy, considering that the solutions to problems of access to and protection of both kinds of information must be approached together to be feasible. The chapter provides some background on the issues, and a review of legal and legislative approaches to privacy protection, and presents specific recommendations for striking a balance between private interest and the public benefit of having medical information available for research purposes. The recommendations are as follows:

Korn D. Medical Information Privacy and the Conduct of Biomedical Research. Academic Medicine. 2000 October; 75(10): 963-968.
Profound changes in the health care delivery system, the increasing pervasiveness of information technology, and dramatic advancements in research in human genetics are intensifying public concerns about the privacy of medical information. The author argues that some of these concerns, such as the fear that medical data could be used to deny health insurance or employment, are "pragmatic" and can be dealt with through the political process. But other, "ideologic" concerns tend to generate strong emotions and political positions that impede rational discourse and confound attempts to seek workable compromises. While stressing that the progress of medicine has long depended on empirical data about individuals, he discusses the federal oversight of research involving human subjects, including provisions in place to protect their privacy and maintain the confidentiality of data, while at the same time permitting necessary access to data for research. He suggests that since every individual benefits from the accumulated medical knowledge base, everyone should contribute to the ongoing expansion and renewal of that base. The author then states nine principles crafted at the Association of American Medical Colleges to guide its thinking and advocacy efforts regarding medical information privacy issues. He acknowledges that the uses of identifiable patient information within our health care and research systems are bewildering and hard to explain to the public, which is deeply concerned about privacy in general, and especially medical information privacy. How to address this concern and at the same time protect the completeness, accuracy, and integrity of the medical record? The author offers no specific answers beyond those embodied in the AAMC principles, but maintains that a satisfactory solution will come only from carefully crafted federal legislation that creates a comprehensive, uniform, and effective system of workable protections of the confidentiality of medical information, while protecting the access needed to pursue the nation's ambitious agenda in health research.

Korn D. Medical Information Privacy and the Conduct of Biomedical Research. In Privacy and Health Care. Edited by J. Humber and R. Almeder. Totowa, NJ: Humana Press. 2001: 103-129.
Protection of medical information privacy in the United States at this time is limited to State laws, which are generally regarded as fragmentary, variably effective, discordant, and dissatisfying. Why, despite broad-based public support of the need for comprehensive federal legislation, have repeated Congressional efforts in recent years to enact privacy legislation failed to get out of committee? This chapter attempts to answer this question by providing context that is often lacking in the public political discourse. The author explains the flows of identifiable medical information that are necessary for the day to day operations of the health-care system, and gives special attention to the important role played by archived medical information in supporting medical research, and improving the health of the public. He emphasizes that it is possible to provide identifiable medical information used in research with almost total protection from forcible trespass with far more confidence than is true for medical information used in providing care. He argues that everyone is a beneficiary of the knowledge accrued from studies using medical information, and that the ethical principle of justice supports the proposition that since everyone benefits, everyone is obligated to allow his or her medical information to be used in medical research.

Pritts, J, Goldman J, Hudson Z, Berenson A, Hadley E. The State of Health Privacy: An Uneven Terrain: A Comprehensive Survey of State Health Privacy Statutes. Washington, DC: Health Privacy Project. 1999 August. Available at www.healthprivacy.org/newsletter-url2306/newsletter-url_list.htm?section=HPP%20Resources.
State laws relating to health privacy have been enacted over many years to address a wide variety of uses and public health concerns. This 50-state survey of state health privacy statutes was designed to answer the question "How have states responded to the health privacy needs of their citizens?" as the debate over a comprehensive federal health privacy law was heating up. It describes the scope and context of state laws, observing that 1) states legislate and regulate health privacy by the entities that use medical information, 2) that most states presume an ethical duty to maintain confidentiality, 3) state laws have not kept pace with changes in health care delivery and technology, and 4) that remedies for violations vary widely. Major findings fall under four main categories: patient access to their own medical records, restrictions on disclosure of medical information, doctor-patient privilege, and privacy requirements for specific medical conditions. The report also summarizes the nature of state statutes with regard to remedies and penalties triggered by violations, the treatment of government-maintained records, and how access to information by researchers is regulated. It documents that there is little probability that any federal law could match the breadth and scope of existing state laws.

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