Revise HIPAA: Health researchers
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) linkurl:report;http://www.aahcdc.org/policy/reddot/AAHC_HIPAA_Creating_Barriers.pdf released yesterday (Jun 16). This sentiment echoes linkurl:concerns;http://www.the-scientist.
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) linkurl:report;http://www.aahcdc.org/policy/reddot/AAHC_HIPAA_Creating_Barriers.pdf released yesterday (Jun 16). This sentiment echoes linkurl:concerns;http://www.the-scientist.com/blog/display/53866/ previously voiced by US epidemiologists, who linkurl:said;http://jama.ama-assn.org/cgi/reprint/298/18/2164.pdf 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 linkurl:genetic datasets.;http://www.the-scientist.com/news/display/53554/ 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 linkurl:mutations;http://www.the-scientist.com/news/display/38329/ 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.
June 18, 2008
As the article states, the goal of HIPAA is a proper one. However, a very large problem is that the language in HIPAA regs is subject to inconsistent interpretation across individual institutions, with some Institutional Review Boards taking an excessively restrictive approach. In a clinical study that required age at diagnosis and age at treatment data for statistical analyses, one major midwest center repeatedly insisted that they could not provide date of birth, date of diagnosis, or even age at diagnosis because those could be used as "identifiers" and would violate HIPAA. This, despite the fact that the records were extracted and completely anonymized before being transmitted to the sponsor, so it would be impossible to trace back to a specific individual. That lack of data would have rendered those subjects useless for the study, so that site was dropped. Whose interests were served by that?
June 19, 2008
I think the problem is that there are too many bioethicists with not enough to do. Idle hands are the Devil's workshop, and I think that consciously or unconsciously these people need to show some output. As a result, we have the continuing discovery of additional and increasingly improbable needs for protection. \n\nUnfortunately, the greatest risk of all may be attempting to achieve a no-risk society. The people who die because a new drug is not developed or is delayed by absurd HIPAA regulations or interpretations are never counted. \n\nAs the first poster said, the intent is proper. However, as we know from recent news articles, even with all these protections in place, the records of celebreties routinely manage to find their way to the press.