Scientists indicate HIPAA privacy rule has had negative influence on health research

November 13, 2007

About two-thirds of clinical scientists surveyed report that the HIPAA Privacy Rule for patients has had a negative influence on the conduct of health research, often adding uncertainty, cost and delays, according to a study in the November 14 issue of JAMA.

The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule was intended to strike a balance between protecting the privacy of individually identifiable health information and preserving the legitimate use and disclosure of this information for important social goals, according to background information in the article. However, many researchers have expressed concerns that since implementation in April 2003, the Privacy Rule has adversely affected the progress of biomedical research.

Roberta B. Ness, M.D., M.P.H., of the University of Pittsburgh, Penn., and colleagues with the Joint Policy Committee, Societies of Epidemiology, conducted a survey to determine the degree, type, and variability of influence from the HIPAA Privacy Rule experienced by epidemiologists conducting research on U.S. human subjects (participants). Thirteen societies of epidemiology distributed a national Web-based survey and 1,527 eligible professionals anonymously answered questions.

The researchers found that regarding general perceptions of the HIPAA Privacy Rule, a majority of respondents reported that the degree to which the rule made research easier was low, at 1 to 2 (84.1 percent) on a 5-point scale (with 1 = none, 5 = a great deal), and that the degree to which the rule made research more difficult was high (67.8 percent), at 4 to 5 on the scale. Almost 40 percent indicated that the Privacy Rule increased research costs in the high range of 4 to 5, and half indicated that the additional time added by the rule to complete research projects was high.

Almost half indicated that the Privacy Rule had affected research related to public health surveillance at the high level. The perceived benefit of the rule with respect to strengthening public trust was reported as high by only 10.5 percent of respondents, and only 25.9 percent believed that the rule had enhanced participant confidentiality/privacy in the high range of 4 to 5.

Respondents also indicated that the proportion of institutional review board applications in which the Privacy Rule had a negative influence on human subjects (participants) protection was significantly greater than the proportion in which it had a positive influence.

(JAMA. 2007;298(18):2164-2170. Available pre-embargo to the media at

Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Editorial: The Dysregulation of Human Subjects Research

Norman Fost, M.D., M.P.H., of the University of Wisconsin School of Medicine and Public Health, Madison, and Robert J. Levine, M.D., of the Yale University School of Medicine, New Haven, Conn., highlight some of the issues and problems in the current national system for protecting human research participants.

"The sources of these problems include Office for Human Research Protection and the FDA because they appear to threaten institutions with draconian penalties for minor infractions; institutional (university and other) administrators acting out of fear that their institution could be the next to have its entire research operation suspended by 'getting caught' in one of these minor infractions; and credentialing and certifying agencies for supporting these excesses by including them in their criteria for accreditation. A satisfactory resolution for this situation is urgently required. Resolution will necessarily require participation by federal oversight agencies, institutional officials, representatives of credentialing and certifying agencies, researchers, and research participants."

(JAMA. 2007;298(18):2196-2198. Available pre-embargo to the media at

Editor's Note: Please see the article for additional information, including financial disclosures, funding and support, etc.

The JAMA Network Journals

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