215. Recent Advances in Medical Device Regulation. Guests, Timo Minssen, Helen Yu, Janos Meszaros, Christopher Robertson, and Preeti Mehrotra.

Published: Aug. 14, 2020, 7:51 p.m.

b'This is the last of three episodes of \\u201cInnovation and Protection: The Future of Medical Device Regulation,\\u201d 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\\u2019s 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. This third episode looks at recent advances in medical device regulation in the U.S. and abroad, and the effects of the COVID-19 pandemic on national and international medical device regulation. First, Timo Minssen, Professor of Law and Director, Center for Advanced Studies in Biomedical Innovation Law (CeBIL), University of Copenhagen and Researcher in Quantum Law, Lund University, interviews Helen Yu,\\xa0Associate Professor at the University of Copenhagen, Faculty of Law and Associate Director of CeBIL about her paper \\u201cRegulation of Digital Health Technologies in the EU: Intended vs. Actual Use.\\u201d Minssen returns to talk with Janos Meszaros,\\xa0Postdoctoral Research Fellow at Taiwan\\u2019s National Academy of Science about \\u201cChallenges at the Interface of EU Medical Device Regulation and the GDPR: Do the Rules on Privacy and Scientific Research Impair the Safety of AI Medical Devices?\\u201d Finally, Christopher Robertson discusses \\u201cPreventing Medical Device-Borne Disease Outbreaks: Improving High-Level Disinfection Policies for Scopes and Probes,\\u201d with author Preeti Mehrotra,\\xa0Attending Physician, Beth Israel Deaconess Medical Center and Instructor of Medicine, Harvard Medical School.'