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How Can Law and Policy Advance Quality in Genomic Analysis and Interpretation for Clinical Care?
Barbara J Evans1, Gail Javitt1, Ralph Hall1
1Barbara J. Evans, Ph.D., J.D., LL.M., is the Mary Ann and Lawrence E. Faust Professor of Law and Professor, Electrical and Computer Engineering at the University of Houston. Gail Javitt, J.D., is a Member of the Firm at Hyman, Phelps, and McNamara, P.C. Ralph Hall, J.D., is a Principal at Leavitt Partners and a Professor of Practice at the University of Minnesota Law School. Megan Robertson, J.D., is an Associate in the Health Care and Life Sciences practice, Epstein Becker & Green, P.C. Pilar Ossorio, Ph.D., J.D., is Professor of Law and Bioethics at the University of Wisconsin Law School and Ethics Scholar-in-Residence at the Morgridge Institute for Research. Susan M. Wolf, J.D., is McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre Baker Daniels Professor of Law; Professor of Medicine; and Chair of the Consortium on Law and Values in Health, Environment & the Life Sciences at the University of Minnesota. Thomas Morgan, M.D., F.A.C.M.G., is Associate Professor of Pediatrics in Medical Genetics at the Vanderbilt University School of Medicine. Ellen W. Clayton, M.D., J.D., is Craig-Weaver Professor of Pediatrics and Professor of Law at Vanderbilt University Medical Center and Vanderbilt University.
Abstract:
Delivering high quality genomics-informed care to patients requires accurate test results whose clinical implications are understood. While other actors, including state agencies, professional organizations, and clinicians, are involved, this article focuses on the extent to which the federal agencies that play the most prominent roles - the Centers for Medicare and Medicaid Services enforcing CLIA and the FDA - effectively ensure that these elements are met and concludes by suggesting possible ways to improve their oversight of genomic testing.
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