The Future of Medical Device Regulation

Timo Minssen

ISBN 10: 1108972055 / ISBN 13: 9781108972055

Published by Cambridge University Press, GB, 2022

About this Item

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.

Seller Inventory # LU-9781108972055

Bibliographic Details

• Title: The Future of Medical Device Regulation
• Publisher: Cambridge University Press, GB
• Publication Date: 2022
• Language: English
• ISBN 10: 1108972055
• ISBN 13: 9781108972055
• Binding: Paperback
• Condition: New
• Weight: 439 grams

About this title

Synopsis

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.

About the Authors

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.