The Future of Medical Device Regulation

Herausgeber: Cohen, I. Glenn; Price II, W. Nicholson; Minssen, Timo

• Broschiertes Buch

Produktbeschreibung

As the nature of medical devices is rapidly changing, the legal and ethical questions around medical devices are becoming ever more complex. This volume analyses the current issues and controversies around patient privacy, innovation, and new regulatory laws in the US and EU.

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Produktdetails

• Verlag: Cambridge University Press
• Seitenzahl: 296
• Erscheinungstermin: 9. März 2022
• Englisch
• Abmessung: 229mm x 152mm x 16mm
• Gewicht: 438g
• ISBN-13: 9781108972055
• ISBN-10: 1108972055
• Artikelnr.: 62953456

Inhaltsangabe

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.