HIPAA privacy law hinders clinical research
HIPAA Weekly Advisor, September 20, 2004
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Under HIPAA, researchers can no longer review medical records to look for suitable patients for trials, previously the easiest, most widely used method for finding candidates. Instead, patients' primary care physicians must initiate contact with researchers for these trials.
Physicians and scientists conducting these trials must now spend months compiling lists of patients who have authorized the release of their medical records to researchers. This process is significantly slowing down research, according to Medical News Today.
"HIPAA has substantial negative effects on our ability to recruit individuals to participate in research," Roberta Ness, MD, MPH, professor and chair of the epidemiology department at the University of Pittsburgh's School of Public Health, said at the annual meeting of the American College of Epidemiology. "The way HIPAA has hurt research, I believe, is a classic example of the law of unintended consequences."
Unless the government changes HIPAA privacy law rules regarding research, she said, clinical studies may move offshore and will no longer be subject to U.S. regulations.
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