Part IAI and Data as Medical DevicesIntroduction

W. Nicholson Price II

1. 1Lifecycle Regulation and Evaluation of Artificial Intelligence and Machine Learning-Based Medical Devices

   Kerstin N. Vokinger, Thomas J. Hwang, and Aaron S. Kesselheim

2. 2Product Liability Suits for FDA-Regulated AI/ML Software

   Barbara J. Evans and Frank Pasquale

3. 3Are Electronic Health Records Medical Devices?

   Craig Konnoth

Part IIEuropean Regulation of Medical DevicesIntroduction

Timo Minssen

1. 4Cybersecurity of Medical Devices: Regulatory Challenges in the European Union

   Elisabetta Biasin and Erik Kamenjasevic

2. 5The mHealth Power Paradox: Improving Data Protection in Health Apps through Self-Regulation in the European Union

   Hannah van Kolfschooten

3. 6The 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

4. 7AI, Explainability, and Safeguarding Patient Safety in Europe: Toward a Science-Focused Regulatory Model

   Barry Solaiman and Mark G. Bloom

5. 8Regulation of Digital Health Technologies in the European Union: Intended versus Actual Use

   Helen Yu

Part IIIDesigning Medical Device RegulationsIntroduction

I. Glenn Cohen

1. 9IP and FDA Regulation of De Novo Medical Devices

   Mateo Aboy and Jacob S. Sherkow

2. 10A “DESI” for Devices? Can a Pharmaceutical Program from the 1960s Improve FDA Oversight of Medical Devices?

   Matthew Herder and Nathan Cortez

3. 11Digital Home Health During the COVID-19 Pandemic: Challenges to Safety, Liability, and Informed Consent, and the Way to Move Forward

   Sara Gerke

Part IVThe Impact of Medical Device Regulation on Patients and MarketsIntroduction

Christopher Robertson

1. 12Clouded Judgment: Preventing Conflicts of Interest in Drug Courts

   Jody Lyneé Madeira, Barbara Andraka-Christou, Lori Ann Eldridge, and Ross D. Silverman

2. 13Disrupting the Market for Ineffective Medical Devices

   Wendy Netter Epstein

3. 14Preventing Medical Device-Borne Outbreaks: The Case of High-Level Disinfection Policy for Duodenoscopes

   Preeti Mehrotra, David J. Weber, and Ameet Sarpatwari

4. 15Regulating Devices that Create Life

   Katherine L. Kraschel

Part VMedical and Legal Oversight of Medical DevicesIntroduction

Carmel Shachar

1. 16Ensuring 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

2. 17Compulsory Medical Device Registries: Legal and Regulatory Issues

   Efthimios Parasidis and Daniel B. Kramer

3. 18Professional Self-Regulation in Medicine: Will the Rise of Intelligent Tools Mean the End of Peer Review?

   Anthony P. Weiss and Barak D. Richman

4. 19Regulating Posttrial Access to In-Dwelling Class III Neural Devices

   Megan S. Wright and Joseph J. Fins

5. 20Strengthening the Power of Health Care Insurers to Regulate Medical Device Risks

   David Rosenberg and Adeyemi Adediran