HIPAA’s chilling effect’ on biomedical research
An editorial in the February issue of the Annals of Epidemiology expresses concern that HIPAA’s efforts to enhance patient confidentiality by restricting access to medical records is slowing the progress of critical biomedical research.
University of Pittsburgh Graduate School of Public Health professor Roberta Ness reports a significant "chilling effect" of the regulations after documenting trends in recruitment of research subjects to the Prenatal Exposures and Preeclampsia Program Project, an ongoing prospective study of women followed throughout pregnancy at Magee-Women's Hospital of the University of Pittsburgh Medical Center, for which she is a co-investigator.
The ultimate aim of the study is to determine the cause of preeclampsia, a complication that affects up to 7% of first pregnancies and can be fatal to mother and baby.
The first phase of the study took place from 1997 to 2001, before HIPAA implementation, with an average of 12.4 women recruited each week, he says. But after HIPAA, due to restrictions on researchers’ ability to identify potentially eligible subjects, recruitment fell to an average of 2.5 to 5.7 women a week.
Inconsistencies among academic institutions concerning interpretation of HIPAA regulations remains a potent threat to a wide range of clinical and biomedical research studies, Ness adds. The University of Pittsburgh’s Institutional Review Board first disallowed waivers of the rule, she says. Investigators may seek a waiver to allow them easier access to protected health information, but waiver criteria vary among universities. At Pitt, a waiver was granted in 2003 and rescinded in 2004.
"Recruitment with a HIPAA waiver decreased by half, and recruitment without a HIPAA waiver fell by half again," Ness explains. Internal university efforts continue to resolve these kinds of conflicts for researchers, she says, but modifications to the rule itself would go a long way toward standardizing the way institutions view it.
"The post-HIPAA era brought an unwillingness on the part of the University of California system to continue its 16-year-long rapid cancer case reporting relationship with the California State Cancer Registry," Ness adds.
"For well over a year, researchers were barred from access to large numbers of recently diagnosed cancer patients in a case that also briefly engaged the state’s court system. Fortunately, the University of California reversed its stance," she notes.
The American College of Epidemiology has called on Health and Human Services (HHS) to address the issue. "An HHS advisory committee has proposed HIPAA modifications that include harmonizing HIPAA with the common rule that determines other Institutional Review Board activities, among others," Ness says. "We can only hope that the new secretary of Health and Human Services will adopts these modifications."
An editorial in the February Annals of Epidemiology expresses concern that HIPAAs efforts to enhance patient confidentiality by restricting access to medical records is slowing the progress of critical biomedical research.
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