The Future of Medical Device Regulation - Title page

pp iii-iii

Copyright page

pp iv-iv

Dedication

pp v-vi

Contents

pp vii-ix

Figures

pp x-x

Contributors

pp xii-xiii

Acknowledgments

pp xiv-xiv

Volume Introduction

pp 1-10

Part I - AI and Data as Medical Devices

pp 11-46

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

pp 13-21

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

pp 22-35

3 - Are Electronic Health Records Medical Devices?

pp 36-46

Part II - European Regulation of Medical Devices

pp 47-114

4 - Cybersecurity of Medical Devices

pp 51-62

5 - The mHealth Power Paradox

pp 63-76

6 - The Interaction of the Medical Device Regulation and the GDPR

pp 77-90

7 - AI, Explainability, and Safeguarding Patient Safety in Europe

pp 91-102

8 - Regulation of Digital Health Technologies in the European Union

pp 103-114

Part III - Designing Medical Device Regulations

pp 115-160

9 - IP and FDA Regulation of De Novo Medical Devices

pp 117-128

10 - A “DESI” for Devices?

pp 129-140

11 - Digital Home Health During the COVID-19 Pandemic

pp 141-160

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

pp 161-214

12 - Clouded Judgment

pp 165-178

13 - Disrupting the Market for Ineffective Medical Devices

pp 179-191

14 - Preventing Medical Device-Borne Outbreaks

pp 192-202

15 - Regulating Devices that Create Life

pp 203-214

Part V - Medical and Legal Oversight of Medical Devices

pp 215-216

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

pp 217-228