Health care delivered by covered entities conducting clinical trials typically are subject to both the proposed rule and to Federal regulations for protection of human re search subjects (The Federal Policy for the Protection of Human Subjects, codified for the Department of Health and Human Services in Title 45 C.F.R. part 46, and/or the Food and Drug Administration’s human subject regulations for research in support of medical product applications to the Food and Drug Administration, or regulated by that agency, at 21 C.F.R. parts 50 and 56).
Current human subjects rules impose no substantive restrictions on disclosure of patient information. Institutional review boards must consider the adequacy of confidenti ality protections for subjects, and researchers must tell subjects to what extent their confi dentiality will be protected. There should be no conflict between these requirements and the proposed rules. The proposed HIPAA regulation will expand on the current human subjects requirements by requiring a more detailed description of intended use of patient information. The proposed HIPAA rule also requires additional criteria for waiver of patient authorization.