Report: HIPAA hinders health research
"Research was not intended to be governed by the HIPAA privacy rule, but neither was it exempted from the regulation," the report authors wrote. "However, the new constructs and restrictions on information mandated by the rule have had untold consequences for the conduct of research and the advance of science and discovery in the United States.
The AAHC has called for changes to the rule, and has recommended options to address the issue based on evidence from a limited number of focus groups conducted with researchers throughout the United States in 2007.
“The growing elderly population, the challenging economy, the regulatory environment and the increasing demands for new treatments and cures for disease and illness require a reexamination of the impact of the HIPAA Privacy Rule, not only on the institutions and research personnel sustaining the nation’s research enterprise, but also on the patients who participate in research studies,” the report said.
The association also recommended that research be exempt from the privacy rule and be solely governed by the Common Rule, which requires research on human subjects funded or conducted by a federal agency be approved by an institutional review board.
"However, the prevailing practice of academic health centers is to require all research conducted at their institution to comply with the Common Rule regardless of funding source," according to the report.
The association also recommended revising the Common Rule to add more explicit standards for the privacy of health information and accommodate new technologies against new threats to safety and privacy.
View the report, "The HIPAA Privacy Rule: Lacks Patient Benefit, Impedes Research Growth.”