The future of medical device regulation : innovation and protection
- Publication/Creation:
- Cambridge, United Kingdom ; New York, NY : Cambridge University Press, 2022
- Resource Type:
- Book
More Details
Additional/Related Title Information
- Full Title:
- The future of medical device regulation : innovation and protection / edited by I. Glenn Cohen, Harvard Law School, Timo Minssen, University of Copenhagen, W. Nicholson Price II, University of Michigan, Christopher Robertson, Boston University, Carmel Shachar, Harvard Law School
Related Names
- Additional Author/Creators:
- Cohen, I. Glenn, editor
Minssen, Timo, editor
Price, W. Nicholson, II, editor
Robertson, Christopher T., 1975-, editor
Shachar, Carmel, 1985-, editor
Subjects/Genre
- Genre:
- Conference papers and proceedings
- Subjects:
- Medical instruments and apparatus--Law and legislation--Congresses
Description/Summary
- Table of Contents:
- Introduction / Glenn Cohen, Timo Minssen, W. Nicholson Price II, Christopher Robertson, Carmel Shachar -- Part I : AI and data as medical devices. Introduction / W. Nicholson Price II -- Lifecycle regulation and evaluation of artificial intelligence and machine learning-based medical devices / Kerstin N. Vokinger, Thomas J. Hwang, and Aaron S. Kesselheim -- Product liability suits for FDA-regulated AI/ML software / Barbara J. Evans and Frank Pasquale -- Are electronic health records medical devices? / Craig Konnoth -- Part II : European regulation of medical devices. Introduction / Timo Minssen -- Cybersecurity of medical devices : regulatory challenges in the European Union / Elisabetta Biasin and 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 and performance of AI medical devices? / Janos Meszaros, Marcelo Corrales Compagnucci, and Timo Minssen -- AI, explainability, and safeguarding patient safety in Europe : toward a science-focused regulatory model / Barry Solaiman and Mark G. Bloom -- Regulation of digital health technologies in the European Union : intended versus actual use / Helen Yu -- Part III : Designing medical device regulations. Introduction / I. Glenn Cohen -- IP and FDA regulation of De Novo medical devices / Mateo Aboy and Jacob S. Sherkow -- A "DESI" for devices? Can a pharmaceutical program from the 1960s improve FDA oversight of medical devices? / Matthew Herder and 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 -- Part IV : The impact of medical device regulation on patients and markets. Introduction / Christopher Robertson -- Clouded judgment : preventing conflicts of interest in drug courts / Jody Lyneé Madeira, Barbara Andraka-Christou, Lori Ann Eldridge, and 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, and Ameet Sarpatwari -- Regulating devices that create life / Katherine L. Kraschel -- Part V : Medical and legal oversight of medical devices. Introduction / Carmel Shachar -- Ensuring 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 -- Compulsory medical device registries : legal and regulatory issues / Efthimios Parasidis and Daniel B. Kramer -- Professional self-regulation in medicine : will the rise of intelligent tools mean the end of peer review? / Anthony P. Weiss and Barak D. Richman -- Regulating posttrial access to in-dwelling Class III neural devices / Megan S. Wright and Joseph J. Fins -- Strengthening the power of health care insurers to regulate medical device risks / David Rosenberg and 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"--
- Language:
- English
- Physical Type/Description:
- xiv, 280 pages : illustrations ; 24 cm
- General 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.
- Local Note:
- GOBI Library Solutions from EBSCO
Additional Identifiers
- Catalog ID (MMSID):
- 9937459947102486
- ISBN:
- 9781108838634
1108838634
9781108972055
1108972055 - OCLC Number:
- 1295617417
- Barcode:
- 200000220757
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