214. Technological Advancements & Medical Device Regulation. Guests, Nicholson Price, Craig Konnoth, Carmel Shachar, Anthony P. Weiss, and Barbara Evans.

This is the second of three episodes of “Innovation and Protection: The Future of Medical Device Regulation,” a podcast miniseries created to replace the 2020 Petrie-Flom Center Annual Conference in light of the COVID-19 pandemic. These episodes highlight a selection of papers that were written for the conference, which was organized in collaboration with the University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law (CeBIL) and the University of Arizona Health Law Program. All of the papers will be published in an edited volume. First, Nicholson Price, Professor at the University of Michigan School of Law, interviews Craig Konnoth, Associate Professor of Law at University of Colorado-Boulder School of Law, about his paper, “Are Electronic Health Records Medical Devices?” Next, Petrie-Flom Center Executive Director Carmel Shachar and Anthony P. Weiss, Senior Vice President and Chief Medical Officer at the Beth Israel Deaconess Medical Center, discuss his paper, “Professional Self-Regulation in Medicine: Will the Rise of Intelligent Tools Mean the End of Peer Review?” Then Price returns to talk with Barbara Evans, Mary Ann & Lawrence E. Faust Professor of Law at the University of Houston Law Center, about “Product Liability Risks and Defenses for FDA-Regulated AI/ML Software.”