Skip to main content Accessibility help
×
Home
Hostname: page-component-7ccbd9845f-vmftn Total loading time: 0.723 Render date: 2023-01-27T22:34:21.581Z Has data issue: true Feature Flags: { "useRatesEcommerce": false } hasContentIssue true

Contents

Published online by Cambridge University Press:  31 March 2022

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

Summary

Type
Chapter
Information
The Future of Medical Device Regulation
Innovation and Protection
, pp. vii - ix
Publisher: Cambridge University Press
Print publication year: 2022

Contents

  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

You have Access Open access

Save book to Kindle

To save this book to your Kindle, first ensure coreplatform@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about saving to your Kindle.

Note you can select to save to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be saved to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

Find out more about the Kindle Personal Document Service.

Available formats
×

Save book to Dropbox

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Dropbox.

Available formats
×

Save book to Google Drive

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Google Drive.

Available formats
×