Invited commentary: Population-based human subjects research in the era of enhanced privacy regulation.

Privacy seems to be of increasing public concern, as evidenced by the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, a regulatory framework that appears to hinder access to data and thus to limit population-based research. A 2009 Institute of Medicine (IOM) report urged Congress, via the US Department of Health and Human Services (HHS), to develop a new approach to protecting privacy that would not employ the HIPAA Privacy Rule. In an accompanying article in the Journal, Nattinger et al. (Am J Epidemiol. 2010;172(6):637-644) employ one of the constructs recommended in the IOM report: use of a centralized honest broker. Unfortunately, Nattinger et al.'s approach would not be acceptable to all institutional review boards. The IOM report also urged the HHS to reduce variability in interpretations of the HIPAA Privacy Rule by privacy boards through revised and expanded guidance and harmonization. HHS Secretary Kathleen Sebalius has not acted upon any of the IOM report recommendations. The need to remove major barriers to human health research cannot be forgotten. At risk is America's progress in finding solutions to our most pressing health concerns.