New Federal Privacy Rules Stump Researchers

A new federal rule designed to protect patients' privacy rights could handicap researchers and prompt legal challenges, according to health policy experts. The privacy rule in the Health Insurance Portability and Accountability Act of 1996 (HIPAA)--for which the Department of Health and Human Services released guidelines in July--requires that researchers who use the nation's tissue banks obtain authorizations when they use patient-specific information, such as medical histories. According to HI

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"The rule will have substantial effects on conduct of medical and health sciences research," says David Korn, senior vice president of biomedical and health sciences research for the Association of Academic Medical Centers. "The effect of some of its provisions will, we fear, be most unfortunate." Korn, a research pathologist and past dean of Stanford Medical School, is particularly concerned that the enormous archives of human-tissue samples in the nation's hospitals and academic medical centers may be at risk. These banked tissues have become an increasingly valuable resource with the introduction of new techniques such as the use of monoclonal antibodies and PCR.

Courtesy of Davis Wwright Tremain LLP

Carol Pratt

Historically, human tissue samples removed for medical reasons are archived with a standard consent form that grants permission to use the tissue for any research in the future. "This is no longer valid," says Carol Pratt, health care attorney who ...

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