The Future of Medical Device Regulation: Innovation and Protection

doi:10.1017/9781108975452

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The Future of Medical Device Regulation

The Future of Medical Device Regulation

Innovation and Protection

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This Book has been cited by the following publications. This list is generated based on data provided by Crossref.

Compagnucci, Marcelo Corrales Fenwick, Mark Minssen, Timo and Aboy, Mateo 2024. The Law and Ethics of Data Sharing in Health Sciences. p. 1.

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Edited by I. Glenn Cohen, Harvard Law School, Massachusetts, Timo Minssen, University of Copenhagen, W. Nicholson Price II, University of Michigan, Ann Arbor, Christopher Robertson, Boston University, Carmel Shachar, Harvard Law School, Massachusetts

Publisher:: Cambridge University Press
Online publication date:: March 2022
Print publication year:: 2022
Online ISBN:: 9781108975452
DOI:: https://doi.org/10.1017/9781108975452
Creative Commons:: This content is Open Access and distributed under the terms of the Creative Commons Attribution licence CC-BY-NC-ND 4.0 https://creativecommons.org/creativelicenses

Subjects:: Medico-Legal, Bioethics and Health Law, Law, Medicine, Medical Law, Ethics and forensic Medicine

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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. For medical providers, policymakers, and other stakeholders, the book offers a framework for the opportunities and challenges on the horizon for medical device regulation. Readers will gain a nuanced overview of the latest developments in patient privacy and safety, innovation, and new regulatory laws. This book is also available as Open Access on Cambridge Core.

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