The future of medical device regulation : innovation and protection / edited by I. Glenn Cohen, Timo Minssen, W. Nicholson Price II, Christopher Robertson, Carmel Shachar.

Title from publisher's bibliographic system (viewed on 31 Mar 2022).

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 Lynee 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.

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.