The Future of Medical Device Regulation

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 Lynee 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.