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TWIHL: Innovation and Protection: The Future of Medical Device Regulation, Episode 3

This is the last 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.

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, Associate Professor at the University of Copenhagen, Faculty of Law and Associate Director of CeBIL about her paper “Regulation of Digital Health Technologies in the EU: Intended vs. Actual Use.”

Minssen returns to talk with Janos Meszaros, Postdoctoral Research Fellow at Taiwan’s National Academy of Science about “Challenges 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?”

Finally, Christopher Robertson discusses “Preventing Medical Device-Borne Disease Outbreaks: Improving High-Level Disinfection Policies for Scopes and Probes,” with author Preeti Mehrotra, Attending Physician, Beth Israel Deaconess Medical Center and Instructor of Medicine, Harvard Medical School.

The Week in Health Law Podcast from Nicolas Terry is a commuting-length discussion about some of the more thorny issues in health law and policy. Subscribe at Apple Podcasts or Google Play, listen at Stitcher Radio, SpotifyTunein or Podbean.

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find me on Twitter @nicolasterry or @WeekInHealthLaw.

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New TWIHL: Ethical Issues in Development of a COVID-19 Vaccine

This episode is the first of a series of shows dealing with health care and research ethics related to COVID-19.

Here, Tara Sklar from The University of Arizona James E. Rogers College of Law introduces Arthur Caplan, the Drs. William F. and Virginia Connolly Mitty Professor, Founding Head of the Division of Medical Ethics, and Co-Chair of the Working Group on Compassionate Use and Preapproval Access (CUPA) at NYU Grossman School of Medicine. Dr. Caplan discusses ethical issues in development of a COVID-19 vaccine.

The series is co-sponsored by the NYU Grossman School of Medicine Division of Medical Ethics and the University of Arizona Health Law and Policy Program.

The Week in Health Law Podcast from Nicolas Terry is a commuting-length discussion about some of the more thorny issues in health law and policy. Subscribe at Apple Podcasts or Google Play, listen at Stitcher Radio, SpotifyTunein or Podbean.

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find me on Twitter @nicolasterry or @WeekInHealthLaw.

The Week in Health Law podcast logo twihl.com

New TWIHL 182: Abortion Exceptionalism During COVID-19

By Nicolas Terry

I welcome three excellent guests this week. Our discussion centers around new abortion restrictions issued as part of state responses to COVID-19. For example, in Texas, Gov. Greg Abbott issued an executive order banning nonessential medical services. Subsequently, his attorney general interpreted that order as applying to all abortions. Planned Parenthood successfully applied for a temporary restraining order in the district court, only for the Fifth Circuit to lift the stay.

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New TWIHL with Wendy Mariner and Michael Ulrich

My guests are Wendy Mariner and Michael Ulrich. At Boston University School of Public Health, Mariner is the Edward R. Utley Professor of Health Law, Professor in the Center for Health Law, Ethics & Human Rights, Professor in the Department of Health Law, Policy & Management, and Director of the JD-MPH dual degree program. She is also a Professor of Law at Boston University School of Law and Professor of Medicine at Boston University School of Medicine.

Ulrich is a Professor of Health Law, Ethics, & Human Rights at the Boston University School of Public Health. His scholarship focuses on the intersection of public health, constitutional law, bioethics, and social justice, with an emphasis on the role of law in the health outcomes of vulnerable and underserved populations. Previously he was a Senior Fellow in Health Law, & Lecturer in Law at Yale Law School and a bioethicist in the Division of AIDS at the National Institutes of Health.

Our discussion concentrates on two aspects of the COVID-19 pandemic: (1) where the healthcare system is as far as capacity and resources, the impact of new federal legislation, and what else is needed and (2) what is the legal valence (if any) of terms such as “shelter in place” or “quarantine” and how will we calibrate more serious infringements on liberty such as lockdowns.

The Week in Health Law Podcast from Nicolas Terry is a commuting-length discussion about some of the more thorny issues in health law and policy. Subscribe at Apple Podcasts or Google Play, listen at Stitcher Radio, SpotifyTunein or Podbean.

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find me on Twitter @nicolasterry or @WeekInHealthLaw.

The Week in Health Law podcast logo twihl.com

New TWIHL with Françoise Baylis

I welcome Dr. Françoise Baylis, University Research Professor at the NTE Impact Ethics interdisciplinary research team based at the Faculty of Medicine, Dalhousie University in Halifax Canada. She is a member of the Order of Canada and the Order of Nova Scotia, as well as a Fellow of the Royal Society of Canada and a Fellow of the Canadian Academy of Health Sciences. In 2017 she was awarded the Canadian Bioethics Society Lifetime Achievement Award. She is a distinguished researcher and prolific scholar with 200 or so books, refereed publications and chapters to her name. Her latest book published by Harvard University Press is Altered Inheritance: CRISPR and the Ethics of Human Genome Editing. At the time of recording we knew the book had been nominated for an Association of American Publishers Professional and Scholarly Excellence (or PROSE) award, which it subsequently won!

The Week in Health Law Podcast from Nicolas Terry is a commuting-length discussion about some of the more thorny issues in health law and policy. Subscribe at Apple Podcasts or Google Play, listen at Stitcher Radio, SpotifyTunein or Podbean.

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find me on Twitter @nicolasterry or @WeekInHealthLaw.