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Published online 14 November 2007 | Nature 450, 332 (2007) | doi:10.1038/450332d
News in Brief
Patient privacy rules hamper US research
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WHY I NO LONGER DO CLINICAL RESEARCH. John M. Freeman M.D. Professor emeritus, Johns Hopkins Medical Institutions, Baltimore Bully for Dr. Ness! HIPAA regulations and the attendant increasingly stringent IRB rules have, I believe, had an important negative impact on a physician's ability to ask and answer clinical questions. Prior to HIPAA I spent my academic medical career asking questions about my patients and stimulating my residents to do likewise. Asking, and seeking answers, is the intellectual stimulus for improving clinical medicine. On rounds, as a fellow at Columbia in 1962 I was asked about the long-term neurologic sequellae of Sydenham’s chorea. Another fellow and I went to medical records and identified approximately 50 patients diagnosed with the disease 30 years earlier. We were able to find them by telephone, interview most, and establish that there were no neurologic sequellae. However, we found a continued increase in rheumatic heart disease leading to more prolonged antibiotic prophylaxis, and found psychological sequellae leading to obsessive-compulsive disorders (and new research on PANDAS). None of this could have been accomplished under current HIPAA regulations. Never could we have located patients in New York City 30 years after discharge to ask their physician’s permission to interview them. Recently at Johns Hopkins, with IRB approval we treated patients with Rasmussen’s Encephalitis with hemispherectomy and reported the outcome. When we wished to follow up our own patients years later to evaluate longer term problems, we found HIPAA regulations and IRB demands to be so cumbersome that we decided not to conduct the study. No longer could I pick up the phone and call former patients, even my own, without much red tape. I feel very sorry for our young trainees interested in doing clinical research. I regret the difficulty they will have in asking questions and validating or changing their clinical therapies. I have retired, partly because I can no longer ask, or teach trainees to ask, meaningful clinical questions. Epidemiologists may have been the easiest individuals to study, but the ramifications of the HIPAA regulations extend far beyond the epidemiologists surveyed; they affect all of clinical medicine. The regulations are major inhibiting factors in training residents to think and to challenge. If HIPAA rules had a more demonstrable benefit, the restrictions might be tolerable, but what is their benefit to damage ratio? My guess is that it is not very high. I thank Dr. Ness and the Institute of Medicine for starting to document this appalling situation.