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May 8, 2020, 8:30 AM - 5:00 PM

Innovation and Protection: The Future of Medical Device Regulation, Episode 1
Innovation and Protection: The Future of Medical Device Regulation, Episode 2
Innovation and Protection: The Future of Medical Device Regulation, Episode 3

Notice of Revision

In light of developments with COVID-19, we converted our annual conference into a series of podcasts interviewing our contributors.Check out the episodes on This Week in Health Law:

Conference Description

Medical devices have historically been less regulated than their drug and biologic counterparts, both before and after coming to market. A benefit of this less demanding regulatory regime is facilitating innovation by making new devices available to consumers in a timely fashion. Nevertheless, there is increasing concern that this approach raises serious public health and safety issues.

Furthermore, there is increased awareness that the nature of medical devices is rapidly changing as the market shifts from hardware-only devices to increasing numbers of hybrids of hardware and software, or even software as a medical device (SaMD).

New regulations in the EU and the experiences of the FDA in the United States suggest that medical device regulation overall faces some global challenges, including the correct balance between patient protection and avoiding stifling business and innovation, the changing nature of medical devices to become increasingly software-based, and the difficulties of post-market surveillance. This conference will explore how these concerns can be expressed and successfully addressed in a variety of countries, each with a different medical device market.

This year’s conference is organized in collaboration with Timo Minssen, University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law (CeBIL); Nicholson Price, University of Michigan School of Law; and Christopher Robertson, James E. Rogers College of Law of the University of Arizona. This year’s conference is 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.

Agenda

9:00 - 9:15am, Welcome and Introduction

  • I. Glenn Cohen, James A. Attwood and Leslie Williams Professor of Law and Faculty Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School
  • Carmel Shachar, Executive Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School
  • 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

9:15 - 10:45am, AI and Data as Medical Devices

  • Kerstin N. Vokinger, Assistant Professor for Public Law and Digitalization, Health Legislation and Health Policy, University of Zurich (Switzerland) (with Thomas J. Hwang and Aaron S. Kesselheim) - Lifecycle Regulation of Artificial Intelligence and Machine Learning-Based Software in Medicine: Implications to Optimize Premarket and Postmarket Review by the FDA
  • Arti K. Rai, Elvin R. Latty Professor of Law, Duke University School of Law (with Barbara J. Evans) - Product Liability Risks and Defenses for FDA-Regulated AI/ML Software
  • Craig Konnoth, Associate Professor of Law, University of Colorado-Boulder School of Law - Are Electronic Health Records Medical Devices?
  • Elisabetta Biasin, Researcher, Centre for IT & IP Law, KU Leuven (Belgium) (with Erik Kamenjasevic) - Medical Devices and Cybersecurity: Legal Framework, Regulatory Challenges and Ethical Concerns
  • Tara Sklar, Professor of Health Law and Director, Health Law & Policy Program, University of Arizona James E. Rogers College of Law (with Mikey Sklar) - Wellness Devices of Uncertain Value: Citizen Science Advances in the Absence of Regulatory Action
  • Moderator: Nicholson Price, Professor of Law, University of Michigan School of Law

10:45 - 11:00am, Break

11:00am - 12:15pm, International (non-US) Regulation of Medical Devices

  • Hannah van Kolfschooten, Researcher, European Health Law, Amsterdam Law School, University of Amsterdam (the Netherlands) - Self-Monitoring Mobile Health Apps: Improving Health Data Protection in mHealth Apps through Self-Regulation by App Stores in the European Union
  • Janos Meszaros, Postdoctoral Research Fellow, National Academy of Science, Taiwan (with Marcelo Corrales Compagnucci and Timo Minssen) - 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?
  • Barry Solaiman, Assistant Professor, Hamad bin Khalifa University Law School (Qatar) (with Mark G. Bloom) - “Doctor on the Wrist”: AI Innovations in Health Care Delivery and Safeguarding Patient Safety in the EU: Towards a Science-Focused Regulatory Model
  • Helen Yu, Associate Professor and Associate Director of the Center for Advanced Studies in Biomedical Innovation Law (CeBIL), University of Copenhagen, Faculty of Law - Regulation of Digital Health Technologies in the EU: Intended vs. Actual Use
  • Moderator: 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

12:15 - 1:00pm, Lunch

1:00 - 2:00pm, Designing Medical Device Regulations

  • Mateo Aboy, Senior Research Scholar, Centre for Law, Medicine and Life Sciences, University of Cambridge; Visiting Scholar, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School; Affiliated Professor and Fellow, Center for Advanced Studies in Biomedical Innovation Law, University of Copenhagen Faculty of Law (with Jacob S. Sherkow) - Medical Device Premarketing Pathways and Intellectual Property Considerations: FDA De Novo Classification, 501(k) Submissions, and Medical Device IP
  • Christoper J. Buccafusco, Professor of Law; Director, Intellectual Property & Information Law Program; and Associate Dean for Faculty Development, Benjamin N. Cardozo School of Law, Yeshiva University - Laws of Design: What the Modern Wheelchair Can Tell Us About the Future of Medical Device Regulation
  • Matthew Herder, Director, Health Law Institute; Associate Professor, Department of Pharmacology, Faculty of Medicine; cross-appointed in Law, Dalhousie University (with Nathan Cortez and Colleen M. Flood) - A 'DESI' Designed for Devices: Insights from the FDA's Drug Efficacy Study Implementation Program Initiated during the 1960s for the Improved Regulation of Medical Devices Today
  • Moderator: I. Glenn Cohen, James A. Attwood and Leslie Williams Professor of Law and Faculty Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School

2:00 - 3:30pm, The Impact of Medical Device Regulation on Patients and Markets

  • Ross D. Silverman, Professor of Health Policy and Management, Indiana University Richard M. Fairbanks School of Public Health and Professor of Public Health Law, Indiana University Robert H. McKinney School of Law, IUPUI (with Jody L. Madeira, Barbara Andraka-Christou, and Danielle Atkins) - Crisis Equals Opportunity and Danger: The Opioid Epidemic, Problem-Solving Courts, and the Manufacture of a New Medical Device Market
  • Wendy Netter Epstein, Professor of Law and Faculty Director, Mary and Michael Jaharis Health Law Institute, DePaul University College of Law - Disrupting the Market for Ineffective Medical Devices: A Role for Payors
  • Preeti Mehrotra, Attending Physician, Beth Israel Deaconess Medical Center and Instructor of Medicine, Harvard Medical School (with Ameet Sarpatwari) - Preventing Medical Device-Borne Disease Outbreaks: Improving High-Level Disinfection Policies for Scopes and Probes
  • Katherine L. Kraschel, Lecturer in Law, Clinical Lecturer in Law, Research Scholar in Law, and Executive Director of the Solomon Center for Health Law and Policy, Yale Law School - Regulating Devices that Create Life: The Food and Drug Administration and Assisted Reproductive Technology Devices
  • Moderator: Christopher Robertson, Professor of Law and Associate Dean for Research and Innovation, James E. Rogers College of Law, University of Arizona

3:30 - 3:45pm, Break

3:45 - 5:00pm, Medical and Legal Oversight of Medical Devices

  • Sanket Dhruva, Assistant Clinical Professor, UCSF Department of Medicine (with Rita Redberg) - Revoking Regulatory Approval and Payer Coverage: Underutilized Mechanisms to Protect Patient Safety in Use of Medical Devices
  • Efthimios Parasidis, Professor of Law and Public Health, Moritz College of Law and the College of Public Health and faculty affiliate, Center for Bioethics, College of Medicine, The Ohio State University (with Daniel B. Kramer) - Compulsory Medical Device Registries: Legal and Ethical Issues
  • Anthony P. Weiss, Senior Vice President and Chief Medical Officer, Beth Israel Deaconess Medical Center; Associate Professor of Psychiatry, Harvard Medical School; Faculty Member, Center for Bioethics, Harvard Medical School (with Barak D. Richman) - Professional Self-Regulation in Medicine: Will the Rise of Intelligent Tools Mean the End of Peer Review?
  • Megan Wright, Assistant Professor, Penn State Law at University Park; Assistant Professor, Departments of Humanities and Public Health Sciences, Penn State College of Medicine; Affiliate Faculty, The Rock Ethics Institute and the Department of Sociology & Criminology, Pennsylvania State University; Adjunct Assistant Professor of Medical Ethics, Weill Cornell Medical College (with Joseph Fins) - Regulating Post-Trial Access to In-Dwelling Class III Medical Devices
  • David Rosenberg, Lee S. Kreindler Professor of Law, Harvard Law School (with Adeyemi Adediran) - To Better Control Medical Device Risks, Employ First-part Insurer Monitoring Combined with a New Regulatory Rule of Strict Liability
  • Moderator: Carmel Shachar, Executive Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School

5:00pm, Closing Remarks

  • Nicholson Price, Professor of Law, University of Michigan School of Law
  • Christopher Robertson, Professor of Law and Associate Dean for Research and Innovation, James E. Rogers College of Law, University of Arizona

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, with support from the Oswald DeN. Cammann Fund at Harvard University. Co-sponsored by the University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law (CeBIL) and the University of Arizona Health Law Program. This event is supported in part by a Novo Nordisk Foundation grant for a Collaborative Research Programme (grant agreement number NNF17SA0027784).

Innovation and Protection: The Future of Medical Device Regulation, Episode 1
Innovation and Protection: The Future of Medical Device Regulation, Episode 2
Innovation and Protection: The Future of Medical Device Regulation, Episode 3

Tags

artificial intelligence   bioethics   biotechnology   fda   health information technology   health law policy   innovation   international   medical devices   medical safety   pharmaceuticals   public health   regulation