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Innovation and protection:the future of medical device regulation

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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

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Series Title

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Call Number

344.04 MIN i

Publisher

Cambridge, United Kingdom : Cambridge University Press., 2022

Collation

xiv, 280 pages; illustration

Language

English

ISBN/ISSN

9781108975452

Classification

344.04

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Subject(s)

Congresses

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