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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…mehr
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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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.
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.
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