Medical Privacy and Medical Research — Judging the New Federal Regulations

Americans support both protecting the privacy of medical records and encouraging medical research. Thus, it is not surprising that a move to change practices in these two areas has generated attention and comment. The new federal regulations, promulgated under the authority of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), were adopted to protect the privacy of medical records. They were not specifically designed to facilitate or limit medical research. Nonetheless, the regulations have prompted strong objections from the biotechnology industry and from academic medicine. The Association of American Medical Colleges and the Biotechnology Industry Organization have argued that the regulations will make it more difficult, if not impossible, to conduct research involving the use of medical records. Kulynych and Korn discuss some of these objections elsewhere in this issue of the Journal. In this article, I summarize the new regulations, outline the debate over them, and suggest directions for changes.