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The Future of Medical Device Regulation
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Book description

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. This book is also available as Open Access on Cambridge Core.

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Contents

Full book PDF

Page 1 of 2


  • The Future of Medical Device Regulation - Title page
    pp iii-iii
  • Innovation and Protection
  • 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
  • Part I - AI and Data as Medical Devices
    pp 11-46
  • Introduction
  • 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
  • Introduction
  • Part III - Designing Medical Device Regulations
    pp 115-160
  • Introduction
  • 9 - IP and FDA Regulation of De Novo Medical Devices
    pp 117-128
  • 13 - Disrupting the Market for Ineffective Medical Devices
    pp 179-191
  • 15 - Regulating Devices that Create Life
    pp 203-214
  • Part V - Medical and Legal Oversight of Medical Devices
    pp 215-216
  • Introduction

Page 1 of 2


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