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The Future of Medical Device Regulation: Innovation and Protection

Edited by: I. Glenn Cohen, Timo Minssen, W. Nicholson Price II, Christopher Robertson, Carmel Shachar

ISBN13: 9781108972055
Published: April 2022
Publisher: Cambridge University Press
Country of Publication: USA
Format: Paperback
Price: £34.99

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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.

Medical Law and Bioethics
I. Glenn Cohen, Timo Minssen, W. Nicholson Price, Christopher Robertson and Carmel Shachar
Part I. AI and Data as Medical Devices:
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:
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:
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:
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