A rule meant to protect the privacy of medical patients impedes critical health research by limiting access to stored tissue and genetic datasets and by hampering research participant recruitment, according to an Association of Academic Health Centers (AAHC) report released yesterday (Jun 16). This sentiment echoes concerns previously voiced by US epidemiologists, who said the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA) has made their research more difficult to conduct since its enactment in 2003.

The AAHC convened focus groups at several US academic medical centers, and researchers and administrators there said that HIPAA increased administrative burden with additional paperwork, created confusion over the rule's ambiguous wording, and made it harder for investigators to identify eligible study participants by reviewing their medical records.

The red tape created by the rule was particularly detrimental to studies involving stored tissues and genetic datasets. Because HIPAA makes it more difficult to track patients after a study is completed, investigators may be unable to find and inform study participants of treatments for genetic mutations that made them eligible for past studies. Additionally, community health providers and other community researchers might be shying away from participating in broad-scale clinical studies because of potential liability issues raised by HIPAA, the report states.

The AAHC recommends that the US Department of Health and Human Services revise HIPAA in a way that continues to protect the privacy of clinical research participants while making studies easier to conduct. The organization also calls on Congress to enact a national genetic privacy act that will not limit access to genetic datasets or tissue banks in the way that HIPAA now does.