| Description |
1 online resource (xiv, 280 pages) : illustrations |
| Note |
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 Covid19. |
| Bibliography |
Includes bibliographical references. |
| 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 |
"It may seem counterintuitive to open a book on medical devices with chapters on software and data, but these are the frontiers of new medical device regulation and law. Physical devices are still crucial to medicine, but they - and medical practice as a whole - are embedded in and permeated by networks of software and caches of data. Those software systems are often mindbogglingly complex and largely inscrutable, involving artificial intelligence and machine learning. Ensuring that such software works effectively and safely remains a substantial challenge for regulators and policymakers. Each of the three Chapters in this Section examines different aspects of how best to meet this challenge, focusing on review by drug regulators and, crucially, what aspects of oversight fall outside that purview"-- Provided by publisher. |
| Note |
Description based on online resource; title from digital title page (viewed on April 11, 2022). |
| Local Note |
Cambridge University Press Cambridge Open Access Books and Elements |
| Subject |
Medical instruments and apparatus -- Law and legislation -- Congresses.
|
|
Medical instruments and apparatus -- Law and legislation.
(OCoLC)fst01014213
|
| Genre/Form |
Conference papers and proceedings. (OCoLC)fst01423772
|
| Added 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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| Other Form: |
Print version: Innovation and protection Cambridge, United Kingdom ; New York, NY : Cambridge University Press, 2022 9781108838634 (DLC) 2021058396 |
| ISBN |
9781108975452 electronic book |
|
1108975453 electronic book |
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9781108838634 hardcover |
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9781108972055 paperback |
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