Back to Annual Meeting Page		American Public Health Association 133rd Annual Meeting & Exposition December 10-14, 2005 Philadelphia, PA

Abstract #105363

Deborah Klein Walker, EdD, Abt. Associates, Inc., 55 Wheeler St., Cambridge, MA 02138, 617-349-2390, Debbie.Walker@earthlink.net, Daniel J. Friedman, PhD, Population and Public Health Information, 12 Gorham Ave., Brookline, MA 02445, and Carol Stocks, RN, MHSA, Agency for Healthcare Research and Quality, 540 Gaither Rd., Rockville, MD 20850.

The purpose of this qualitative study, funded by the Agency for Healthcare Research and Quality, was to document (1) the initial impact of the HIPAA Privacy Rule (PR) on health services research; (2) the impact of HIPAA on health services researchers working with IRBs; (3) changes made in research design and studies abandoned; and (4) suggested actions needed, if any, to ease barriers for health services research. We conducted individual discussions with 33 senior health care researchers, privacy officers, research compliance officers and IRB directors responsible for the implementation of HIPAA and the Common Rule in a variety of health care research settings 18 months after the implementation of the HIPAA Privacy Rule. Most of the respondents reported making changes in how they plan for and conduct health services research. About half described a study that was abandoned because of the HIPAA PR requirements. Almost all of the informants (94%) stated that the HIPAA Privacy Rule had impacted the design and conduct of health services research. The two largest reported impacts were increased costs and resource expenditures (90%) and increased time periods for preparing research (87%). A majority mentioned problems with sample representation and bias, obtaining consent for individual PHI, conflicting interpretations of what is allowed under the HIPAA PR and problems satisfying requirements of multiple IRBs for multisite studies. The perceived impacts of the HIPAA Privacy Rule which have been experienced in the health services research community during the first eighteen months of the implementation of the Rule can be categorized into two types: 1) those that may be ameliorated with increased time, resources and clearer guidance and 2) those that may not be ameliorated without considering changes in the Privacy Rule itself. As has been expressed in journal and news articles both before and after the implementation of the HIPAA Privacy Rule, some of the respondents argued that the improved privacy and confidentiality of information for the patients with respect to research are more than offset by the additional burdens imposed by the HIPAA Privacy Rule; in fact, they articulated that the public welfare incurred a net loss from the HIPAA Privacy Rule since important research is being altered or stopped.

Learning Objectives:

• To understand what the HIPAA Privacy Rule specifies for health services research
• To review how the Privacy Rule has impacted the types of research being conducted

Keywords: Research, Privacy

Presenting author's disclosure statement:

I wish to disclose that I have NO financial interests or other relationship with the manufactures of commercial products, suppliers of commercial services or commercial supporters.