For Immediate Release

Washington, August 21, 2001-In testimony before the National Committee on Vital and Health Statistics's (NCVHS) Subcommittee on Privacy and Confidentiality, the Association of American Medical Colleges (AAMC) stated its objections to certain provisions in the Health Insurance Portability and Accountability Act's (HIPAA) final medical privacy rule. The Subcommittee serves as an advisory committee to the Secretary of Health and Human Services.

During the hearing, the AAMC pointed out that while it strongly supports measures to protect the privacy rights of research participants, the Association believes that some of the standards outlined in the HIPAA rule would constrict the researchers' access to essential medical information, and create significant obstacles to the conduct of research.

"This rule needlessly intrudes upon the current IRB system of research oversight, burdening biomedical and behavioral research with onerous procedures, ambiguous regulations and extensive new liability concerns", said Jennifer Kulynych J.D., Ph.D., a director in the AAMC's Division of Biomedical and Health Sciences Research.

The AAMC's main concern with the privacy rule is that it will impose new civil and criminal liability upon hospitals, health plans and providers who use or disclose data for research purposes, even when such uses or disclosures are approved by Institutional Review Boards (IRBs), independent panels responsible for reviewing federally regulated research. The Association believes the existing federal requirements effectively address the privacy needs of participants in federally regulated research because IRBs must review all risks to participants--including risks to privacy.

In its testimony, the AAMC emphasized that, according to a 1997 report from the NCVHS to the Secretary of Health and Human Services, there was no evidence of documented breaches of privacy of research participants. If additional safeguards are necessary, the AAMC contends that modifying the criteria of the current regulation-the Common Rule-would be a better solution. The AAMC urged the Secretary to:

• Exempt research currently subject to IRB oversight from the authorization, waiver, "minimum necessary," and "accounting for disclosures" provisions of the privacy rule.
• Create a de-identification standard for IRB-approved research that requires removal of direct identifiers only, and permits IRBs to determine when data are sufficiently "de- identified" for disclosure in authorized research.
• Instruct the federal Office of Human Research Protections to produce new educational materials that will help IRBs fulfill their mandate to evaluate safeguards for protecting the privacy of research participants and the confidentiality of research data.

In addition to today's testimony, the AAMC and various organizations representing the research community recently expressed their concerns about the federal privacy rule in a letter to HHS Secretary Tommy Thompson.

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The Association of American Medical Colleges represents the 125 accredited U.S. medical schools; the 16 accredited Canadian medical schools; some 400 major teaching hospitals, including 74 Veterans Administration medical centers; 91 academic and professional societies representing over 100,000 faculty members; and the nation's 67,000 medical students and 102,000 residents.

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