Monday, September 13, 2004

Release: Privacy rule builds biomedical research bottleneck

According to participants at a conference in Boston today, the HIPAA privacy rule is having an adverse impact upon clinical studies and biomedical research:

Privacy rule builds biomedical research bottleneck:

"Complicated regulations hinder basic science and clinical studies

CONTACT: BOSTON, Sept. 13 &em; The Privacy Rule implemented as part of the Health Insurance Portability and Accountability Act (HIPAA) of 1996 is constraining researchers in the United States and slowing the progress of a wide range of clinical studies and biomedical research. Unless fundamental rule changes are addressed, many studies may simply move offshore, warns Roberta Ness, M.D., M.P.H., professor and chair of the department of epidemiology at the University of Pittsburgh's Graduate School of Public Health (GSPH).

Dr. Ness is moderating a policy forum discussion on 'Confidentiality and HIPAA: What's a Researcher to Do?' today during the annual meeting of the American College of Epidemiology. Scientific sessions take place through Sept. 14 at the Boston Park Plaza Hotel.

'HIPAA has had substantial negative effects on our ability to recruit individuals to participate in research,' says Dr. Ness, whose expertise is in women's health-related research, including preeclampsia, ovarian cancer, vaginal microbiology, pelvic inflammatory disease and pregnancy outcomes. 'The way that HIPAA has hurt research, I believe, is a classic example of the law of unintended consequences.' ..."

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