Influence of the HIPAA Privacy Rule on Health Research

Abstract

ABSTRACT

The aim of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule is to achieve a balance between protecting the privacy of health information while at the same time maintaining the ability to use the information to achieve important research and social goals. The rule allows health care provider organizations to disclose individually identifiable health information for research purposes if the patient has authorized this action in writing or, at the least, the researcher has obtained a waiver of authorization from an institutional review board. In this national Web-based survey, 1527 professionals from 13 societies of epidemiology were asked about their experiences with the HIPAA Privacy Rule.

Just over two-thirds of respondents expressed a belief that the Privacy Rule has made research more difficult at a level of 4 to 5 on a Likert scale, where 5 indicated substantial added cost and time to complete the study in question. Slightly more than half the respondents identified a particular protocol that was most affected by the Privacy Rule. Respondents believed that the proportion of institutional review board applications in which the Privacy Rule had a negative influence on protecting research subjects was significantly greater than the proportion in which it had a positive influence (P < 0.001).

A number of themes emerged when respondents were asked to tell about their experiences with HIPAA: