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 HIPAA, plaintiffs in civil court can use the rule as a standard for privacy protection even before April 2003, when both criminal and civil penalties for violations can be applied. But the rule's effect on medical researchers remains an unanswered question.

"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...

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