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Published online by Cambridge University Press:  31 March 2022

I. Glenn Cohen
Harvard Law School, Massachusetts
Timo Minssen
University of Copenhagen
W. Nicholson Price II
University of Michigan, Ann Arbor
Christopher Robertson
Boston University
Carmel Shachar
Harvard Law School, Massachusetts


The Future of Medical Device Regulation
Innovation and Protection
, pp. vii - ix
Publisher: Cambridge University Press
Print publication year: 2022
Creative Commons
Creative Common License - CCCreative Common License - BYCreative Common License - NCCreative Common License - ND
This content is Open Access and distributed under the terms of the Creative Commons Attribution licence CC-BY-NC-ND 4.0


  1. List of Figures

  2. List of Tables

  3. List of Contributors

  4. Acknowledgments

  5. Introduction

    I. Glenn Cohen, Timo Minssen, W. Nicholson Price II, Christopher Robertson, and Carmel Shachar

  6. Part IAI and Data as Medical DevicesIntroduction

    W. Nicholson Price II

    1. 1Lifecycle Regulation and Evaluation of Artificial Intelligence and Machine Learning-Based Medical Devices

      Kerstin N. Vokinger, Thomas J. Hwang, and Aaron S. Kesselheim

    2. 2Product Liability Suits for FDA-Regulated AI/ML Software

      Barbara J. Evans and Frank Pasquale

    3. 3Are Electronic Health Records Medical Devices?

      Craig Konnoth

  7. Part IIEuropean Regulation of Medical DevicesIntroduction

    Timo Minssen

    1. 4Cybersecurity of Medical Devices: Regulatory Challenges in the European Union

      Elisabetta Biasin and Erik Kamenjasevic

    2. 5The mHealth Power Paradox: Improving Data Protection in Health Apps through Self-Regulation in the European Union

      Hannah van Kolfschooten

    3. 6The Interaction of the Medical Device Regulation and the GDPR: Do European Rules on Privacy and Scientific Research Impair the Safety and Performance of AI Medical Devices?

      Janos Meszaros, Marcelo Corrales Compagnucci, and Timo Minssen

    4. 7AI, Explainability, and Safeguarding Patient Safety in Europe: Toward a Science-Focused Regulatory Model

      Barry Solaiman and Mark G. Bloom

    5. 8Regulation of Digital Health Technologies in the European Union: Intended versus Actual Use

      Helen Yu

  8. Part IIIDesigning Medical Device RegulationsIntroduction

    I. Glenn Cohen

    1. 9IP and FDA Regulation of De Novo Medical Devices

      Mateo Aboy and Jacob S. Sherkow

    2. 10A “DESI” for Devices? Can a Pharmaceutical Program from the 1960s Improve FDA Oversight of Medical Devices?

      Matthew Herder and Nathan Cortez

    3. 11Digital Home Health During the COVID-19 Pandemic: Challenges to Safety, Liability, and Informed Consent, and the Way to Move Forward

      Sara Gerke

  9. Part IVThe Impact of Medical Device Regulation on Patients and MarketsIntroduction

    Christopher Robertson

    1. 12Clouded Judgment: Preventing Conflicts of Interest in Drug Courts

      Jody Lyneé Madeira, Barbara Andraka-Christou, Lori Ann Eldridge, and Ross D. Silverman

    2. 13Disrupting the Market for Ineffective Medical Devices

      Wendy Netter Epstein

    3. 14Preventing Medical Device-Borne Outbreaks: The Case of High-Level Disinfection Policy for Duodenoscopes

      Preeti Mehrotra, David J. Weber, and Ameet Sarpatwari

    4. 15Regulating Devices that Create Life

      Katherine L. Kraschel

  10. Part VMedical and Legal Oversight of Medical DevicesIntroduction

    Carmel Shachar

    1. 16Ensuring Patient Safety and Benefit in Use of Medical Devices Granted Expedited Approval

      Sanket S. Dhruva, Jonathan J. Darrow, Aaron S. Kesselheim, and Rita F. Redberg

    2. 17Compulsory Medical Device Registries: Legal and Regulatory Issues

      Efthimios Parasidis and Daniel B. Kramer

    3. 18Professional Self-Regulation in Medicine: Will the Rise of Intelligent Tools Mean the End of Peer Review?

      Anthony P. Weiss and Barak D. Richman

    4. 19Regulating Posttrial Access to In-Dwelling Class III Neural Devices

      Megan S. Wright and Joseph J. Fins

    5. 20Strengthening the Power of Health Care Insurers to Regulate Medical Device Risks

      David Rosenberg and Adeyemi Adediran

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