Influence of the HIPAA Privacy Rule on health research

Abstract

Context: Anecdotal reports suggest that the Health Insurance Portability and Accountability Act Privacy Rule (HIPAA Privacy Rule) may be affecting health research in the United States.

Objective: To survey epidemiologists about their experiences with the HIPAA Privacy Rule.

Design, setting, and participants: Thirteen societies of epidemiology distributed a national Web-based survey; 2805 respondents accessed the survey Web site and 1527 eligible professionals anonymously answered questions.

Main outcome measures: Responses related influences such as research delays and added cost after Privacy Rule implementation, frequency and type of Privacy Rule-related institutional review board modifications, level of difficulty obtaining deidentified data and waivers, experiences with multisite studies, and perceived participant privacy benefits under the rule. Respondents ranked their perceptions of Privacy Rule influence on 5-point Likert scales.

Results: A total of 875 (67.8%) respondents reported that the HIPAA Privacy Rule has made research more difficult at a level of 4 to 5 on a Likert scale, in which 5 indicates a great deal of added cost and time to study completion. A total of 684 (52.1%) of respondents identified a "most affected" protocol. Respondents 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 (P < .001).

Conclusion: In this national survey of clinical scientists, only a quarter perceived that the rule has enhanced participants' confidentiality and privacy, whereas the HIPAA Privacy Rule was perceived to have a substantial, negative influence on the conduct of human subjects health research, often adding uncertainty, cost, and delay.