Privacy rule builds biomedical research bottleneck

CONTACT: BOSTON, Sept. 13 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."

The Privacy Rule, which became effective in April 2003, allows patients to have access to their medical records and find out when the records are disclosed, and it restricts what health professionals can do with the information. Those who violate the rule risk large fines, and possibly jail time.

In the past, identifying patients who might potentially benefit from a clinical trial of a new drug or treatment was simply a matter of reviewing medical records for suitable candidates and then contacting them to see whether they would be interested in participating. Under HIPAA regulations, however, patient contacts now must be initiated by their physicians busy people whose understandable priority is the practice of primary or specialty patient care.


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