May 14, 2012: "Non-Consensual Access to Data for Research and Public Health"
On Monday, May 14, 2012, Professor Barbara Evans, JD, PhD, Professor of Law at the University of Houston, Co-Director of the Health Law & Policy Institute, and Director of the Center on Biotechnology and Law, spoke on "Non-Consensual Access to Data for Research and Public Health."
Recent legislation envisions heavy use of studies that "repurpose" data from patients' actual encounters with the healthcare system to generate evidence to support regulatory, policy, and clinical decision-making. Observational methodologies are poised to play an important role in 21st-century biomedical research and public health, but only if the United States comes to terms with a difficult truth: Drawing valid inferences requires access to high-quality, inclusive, longitudinally linked data resources, and creating these resources often requires at least some nonconsensual access to identifiable health information. Existing federal regulations actually allow such access but do so in a way that angers data users and privacy advocates alike. This lecture explores alternatives for strengthening and rationalizing the federal regulatory framework for managing nonconsensual access to identifiable health information.