HIPAA Privacy Rule Impacts Badly On Health Research, Say Two-thirds Of Clinical Scientists

Editor's Choice
Main Category: Biology / Biochemistry
Also Included In: Clinical Trials / Drug Trials;  Public Health
Article Date: 13 Nov 2007 - 13:00 PDT

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A survey revealed that approximately two-thirds of clinical scientists believe the HIPAA (Health Insurance Portability and Accountability Act) Privacy Rule for patients has impacted negatively on the way health research is carried out - making it prone to delays, higher costs and confusion, according to an article published in the Journal of the American Medical Association (JAMA), November 14th issue.

The HIPAA Privacy Rule aimed to strike a balance between protecting the privacy of individually identifiable health information and preserving the rightful use and disclosure of this information for important social goals, explain the authors.

However, numerous researchers say that since the Act was implemented, April 2003, the effect on the progress of biomedical research has been negative.

Roberta B. Ness, M.D., M.P.H., University of Pittsburgh, Penn., and team with the Joint Policy Committee, Societies of Epidemiology, carried out a survey to find out the extent, type and variability of influence from the HIPAA Privacy Rule experienced by epidemiologists who carry out research on American human participants. A nationwide Web-based survey was distributed by 13 epidemiology societies - 1,527 eligible professionals responded anonymously.

The respondents had to rate, from 1 to 5, how the HIPAA influenced their research (1 = not at all, 5 = a great deal). 84.1% gave either 1 or 2 points when asked whether the Act made research easier, while 67.8% said it had made their research more difficult. Approximately 40% said the Privacy Rule upped their research costs, while about 50% said the rule had resulted in them having to spend longer getting things done.

The respondents also said that the proportion of institutional review board applications in which the Privacy Rule had a negative impact on participants' protection was substantially larger than the proportion in which it had a positive impact.

Editorial

"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," Norman Fost, M.D., M.P.H., 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., wrote in an Editorial.

JAMA. Article - 2007;298(18):2164-2170
JAMA. Editorial - 2007;298(18):2196-2198

http://jama.ama-assn.org

Written by - Christian Nordqvist
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