Introduction / Glenn Cohen, Timo Minssen, W. Nicholson Price, Christopher Robertson, Carmel Shachar
Lifecycle regulation and evaluation of artificial intelligence and machine learning-based medical devices / Kerstin N. Vokinger, Thomas J. Hwang, & Aaron S. Kesselheim
Product liability suits for FDA-regulated AI/ML Software / Barbara Evans & Frank Pasquale
Are electronic health records medical devices? / Craig Konnoth
Cybersecurity of medical devices : regulatory challenges in the EU / Elisabetta Biasin & Erik Kamenjasevic
The mHealth power paradox : improving data protection in health apps through self-regulation in the European Union / Hannah van Kolfschooten
The interaction of the medical device regulation and the GDPR : do European rules on privacy and scientific research impair the safety & performance of AI medical devices? / Janos Meszaros, Marcelo Corrales Compagnucci, & Timo Minssen
AI, explainability, and safeguarding patient safety in Europe : towards a science-focused regulatory model / Barry Solaiman & Mark G. Bloom
Regulation of digital health technologies in the EU : intended versus actual use / Helen Yu
IP and FDA regulation of De Novo medical devices / Mateo Aboy & Jacob S. Sherkow
A "DESI" for devices? Can a Pharmaceutical Program from the 1960s improve FDA oversight of medical devices? / Matthew Herder & Nathan Cortez
Digital home health during the COVID-19 Pandemic : challenges to safety, liability, and informed consent, and the way to move forward / Sara Gerke
Clouded judgment : preventing conflicts of interest in problem-solving courts / Jody Lyneé Madeira, Barbara Andraka-Christou, Lori Ann Eldridge, & Ross D. Silverman
Disrupting the market for ineffective medical devices / Wendy Netter Epstein
Preventing medical device-borne outbreaks : the case of high-level disinfection policy for duodenoscopes / Preeti Mehrotra, David J. Weber, & Ameet Sarpatwari
Regulating devices that create life / Katherine Kraschel
Ensuring patient safety and benefit in use of medical devices granted expedited approval / Sanket S. Dhruva, Jonathan J. Darrow, Aaron S. Kesselheim, & Rita F. Redberg
Compulsory medical device registries : legal and regulatory issues / Efthimios Parasidis & Daniel B. Kramer
Professional self-regulation in medicine : will the rise of intelligent tools mean the end of peer review? / Anthony P. Weiss & Barak D. Richman
Regulating post-trial access to in-dwelling Class III neural devices / Megan S. Wright & Joseph J. Fins
Strengthening the power of health care insurers to regulate medical device risks / David Rosenberg & Adeyemi Adediran.