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The Future of Medical Device Regulation: Innovation and Protection

The Future of Medical Device Regulation: Innovation and Protection

Author: I. Glenn Cohen; Timo Minssen; W. Nicholson Price II; Christopher Robertson; Carmel Shachar
Publisher: Cambridge University Press
ISBN: 9781108972055
Published In: April 2022
Format: Paperback
Jurisdiction: ? Disclaimer:
Countri(es) stated herein are used as reference only

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Regulators have been more permissive for medical devices compared to their drug and biologic counterparts. While innovative products can thereby reach consumers more quickly, this approach raises serious public health and safety concerns. Additionally, the nature of medical devices is rapidly changing, as software has become as important as hardware. Regulation must keep pace with the current developments and controversies of this technology. This volume provides a multidisciplinary evaluation of the ethical, legal, and regulatory concerns surrounding medical devices in the US and EU. For medical providers, policymakers, and other stakeholders, the book offers a framework for the opportunities and challenges on the horizon for medical device regulation. Readers will gain a nuanced overview of the latest developments in patient privacy and safety, innovation, and new regulatory laws.

Introduction

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

Part I. AI and Data as Medical Devices:

Introduction

W. Nicholson Price

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

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

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

Barbara Evans and Frank Pasquale

3. Are Electronic Health Records Medical Devices?

Craig Konnoth

Part II. European Regulation of Medical Devices:

Introduction

Timo Minssen

4. Cybersecurity of Medical Devices: Regulatory Challenges in the EU

Elisabetta Biasin and Erik Kamenjasevic

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

Hannah van Kolfschooten

6. The 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

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

Barry Solaiman and Mark G. Bloom

8. Regulation of Digital Health Technologies in the EU: Intended versus Actual Use

Helen Yu

Part III. Designing Medical Device Regulations:

Introduction

I. Glenn Cohen

9. IP and FDA Regulation of De Novo Medical Devices

Mateo Aboy and Jacob S. Sherkow

10. A 'DESI' For Devices? Can a Pharmaceutical Program from the 1960s Improve FDA Oversight of Medical Devices?

Matthew Herder and Nathan Cortez

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

Sara Gerke

Part IV. The Impact of Medical Device Regulation on Patients and Markets:

Introduction

Christopher Robertson

12. Clouded Judgment: Preventing Conflicts of Interest in Problem-Solving Courts

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

13. Disrupting the Market for Ineffective Medical Devices

Wendy Netter Epstein

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

Preeti Mehrotra, David J. Weber and Ameet Sarpatwari

15. Regulating Devices that Create Life

Katherine Kraschel

Part V. Medical and Legal Oversight of Medical Devices:

Introduction: Carmel Shachar

16. Ensuring 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

17. Compulsory Medical Device Registries: Legal and Regulatory Issues

Efthimios Parasidis and Daniel B. Kramer

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

Anthony P. Weiss and Barak D. Richman

19. Regulating Post-Trial Access to In-Dwelling Class III Neural Devices

Megan S. Wright and Joseph J. Fins

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

David Rosenberg and Adeyemi Adediran

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