| Description |
1 online resource (xiv, 280 pages) : illustrations |
| Contents |
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 |
| Summary |
"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"-- Provided by the publisher |
| Notes |
Based on papers that were to be presented at the Petrie-Flom Center Annual Conference: Innovation and Protection: The Future of Medical Device Regulation, scheduled to be held on May 8, 2020, but were presented as podcasts due to Covid-19 |
| Bibliography |
Includes bibliographical references |
| Notes |
Description based on online resource; title from digital title page (viewed on April 11, 2022) |
| Subject |
Medical instruments and apparatus -- Law and legislation -- United States -- Congresses
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Medical instruments and apparatus -- Law and legislation -- European Union countries -- Congresses
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Medical instruments and apparatus -- Law and legislation
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United States
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European Union countries
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| Genre/Form |
proceedings (reports)
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Conference papers and proceedings
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Conference papers and proceedings.
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Actes de congrès.
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| Form |
Electronic book
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| Author |
Cohen, I. Glenn, editor.
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Minssen, Timo, editor.
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Price, W. Nicholson, II, editor
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Robertson, Christopher T., 1975- editor.
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Shachar, Carmel, 1985- editor.
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| LC no. |
2021058397 |
| ISBN |
9781108975452 |
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1108975453 |
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