The Future of Medical Device Regulation

Innovation and Protection

I. Glenn Cohen , Timo Minssen, W. Nicholson Price II , Christopher Robertson

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English

Cambridge University Press
07 April 2022

IT & Communications law; Regulation of medicines & medical devices; Medicine; Medical ethics & professional conduct; Forensic medicine; Impact of science & technology on society

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.

Edited by: I. Glenn Cohen , Timo Minssen, W. Nicholson Price II, Christopher Robertson , Carmel Shachar
Imprint: Cambridge University Press
Country of Publication: United Kingdom
Edition: New edition
Dimensions: Height: 228mm, Width: 152mm, Spine: 16mm
Weight: 439g
ISBN: 9781108972055
ISBN 10: 1108972055
Pages: 350
Publication Date: 07 April 2022
Audience: College/higher education , Further / Higher Education
Format: Paperback
Publisher's Status: Active

I. Glenn Cohen is James A. Attwood and Leslie Williams Professor of Law, Deputy Dean, and Faculty Director in the Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics, Harvard Law School. Timo Minssen is Professor of Law is Director of the Center for Advanced Studies in Biomedical Innovation Law (CeBIL) in the Faculty of Law, University of Copenhagen, Denmark. W. Nicholson Price II is Professor of Law in the University of Michigan School of Law. Christopher Robertson is Professor and N. Neal Pike Scholar of Health and Disability Law in the School of Law, Boston University. Carmel Shachar is Executive Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.