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The future of medical device regulation : innovation and protection
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.
ISBN
9781108838634
1108838634
9781108972055
1108972055
9781108975452
Publication
Cambridge, United Kingdom ; New York, NY : Cambridge University Press, 2022.
Copyright Notice Date
©2022.
Physical Description
xiv, 280 pages : illustrations ; 24 cm.
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 Covid19.
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.
Other formats
Online version: Innovation and protection Cambridge, United Kingdom ; New York, NY : Cambridge University Press, 2022
Format
Books
Language
English
Added to Catalog
November 14, 2022
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.
Genre/Form
Conference papers and proceedings.
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