The future of medical device regulation : innovation and protection /

The future of medical device regulation : innovation and protection

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Bibliographic Details
Corporate Author: Cambridge University Press ()
Other Authors: Cambridge University Press (), (), (), (), ()
Language:English
Published: Cambridge : Cambridge University Press, 2022.
Subjects:
Zagadnienia prawa administracyjnego państw obcych
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Online Access:Zobacz publikację w Cambridge Core (Open Access)
Description:
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.


Table of Contents:
  • Cohen, I. Glenn Minssen, Timo Price, W. Nicholson II Robertson, Christopher Shachar, Carmel Volume Introduction (s. 1-10) https://doi.org/10.1017/9781108975452.001
  • Vokinger, Kerstin N. Hwang, Thomas J. Kesselheim, Aaron S. Lifecycle Regulation and Evaluation of Artificial Intelligence and Machine Learning-Based Medical Devices (s. 13-21) https://doi.org/10.1017/9781108975452.002
  • Price, W. Nicholson II Part I - AI and Data as Medical Devices : Introduction (s. 11-12) https://doi.org/10.1017/9781108975452
  • Evans, Barbara J. Pasquale, Frank Product Liability Suits for FDA-Regulated AI/ML Software (s. 22-35) https://doi.org/10.1017/9781108975452.003
  • Konnoth, Craig Are Electronic Health Records Medical Devices? (s. 36-46) https://doi.org/10.1017/9781108975452.004
  • Minssen, Timo Part II - European Regulation of Medical Devices (s. 47-50) https://doi.org/10.1017/9781108975452
  • Biasin, Elisabetta Kamenjasevic, Erik Cybersecurity of Medical Devices : Regulatory Challenges in the European Union (s. 51-62) https://doi.org/10.1017/9781108975452.005
  • Kolfschooten, Hannah van The mHealth Power Paradox : Improving Data Protection in Health Apps through Self-Regulation in the European Union (s. 63-76) https://doi.org/10.1017/9781108975452.006
  • Meszaros, Janos Corrales Compagnucci, Marcelo Minssen, Timo The Interaction of the Medical Device Regulation and the GDPR : Do European Rules on Privacy and Scientific Research Impair the Safety and Performance of AI Medical Devices? (s. 77-90) https://doi.org/10.1017/9781108975452.007
  • Solaiman, Barry Bloom, Mark G. AI, Explainability, and Safeguarding Patient Safety in Europe : Toward a Science-Focused Regulatory Model (s. 91-102) https://doi.org/10.1017/9781108975452.008
  • Yu, Helen Regulation of Digital Health Technologies in the European Union : Intended versus Actual Use (s. 103-114) https://doi.org/10.1017/9781108975452.009
  • Cohen, I. Glenn Part III - Designing Medical Device Regulations : Introduction (s. 115-116) https://doi.org/10.1017/9781108975452
  • Aboy, Mateo Sherkow, Jacob S. IP and FDA Regulation of De Novo Medical Devices (s. 117-128) https://doi.org/10.1017/9781108975452.010
  • Herder, Matthew Cortez, Nathan A “DESI” for Devices? : Can a Pharmaceutical Program from the 1960s Improve FDA Oversight of Medical Devices? (s. 129-140) https://doi.org/10.1017/9781108975452.011
  • Gerke, Sara Digital Home Health During the COVID-19 Pandemic : Challenges to Safety, Liability, and Informed Consent, and the Way to Move Forward (s. 141-160) https://doi.org/10.1017/9781108975452.012
  • Robertson, Christopher Part IV - The Impact of Medical Device Regulation on Patients and Markets : Introduction (s. 161-163) https://doi.org/10.1017/9781108975452
  • Madeira, Jody Lynée Andraka-Christou, Barbara Eldridge, Lori Ann Silverman, Ross D. Clouded Judgment : Preventing Conflicts of Interest in Drug Courts (s. 165-178) https://doi.org/10.1017/9781108975452.013
  • Epstein, Wendy Netter Disrupting the Market for Ineffective Medical Devices (s. 179-191) https://doi.org/10.1017/9781108975452.014
  • Mehrotra, Preeti Weber, David J. Sarpatwari, Ameet Preventing Medical Device-Borne Outbreaks : The Case of High-Level Disinfection Policy for Duodenoscopes (s. 192-202) https://doi.org/10.1017/9781108975452.015
  • Kraschel, Katherine L. Regulating Devices that Create Life (s. 203-214) https://doi.org/10.1017/9781108975452.016
  • Shachar, Carmel Part V - Medical and Legal Oversight of Medical Devices (s. 215-216) https://doi.org/10.1017/9781108975452
  • Dhruva, Sanket S. Darrow, Jonathan J. Kesselheim, Aaron S. Redberg, Rita F. Ensuring Patient Safety and Benefit in Use of Medical Devices Granted Expedited Approval (s. 217-228) https://doi.org/10.1017/9781108975452.017
  • Parasidis, Efthimios Kramer, Daniel B. Compulsory Medical Device Registries : Legal and Regulatory Issues (s. 229-243) https://doi.org/10.1017/9781108975452.018
  • Weiss, Anthony P. Richman, Barak D. Professional Self-Regulation in Medicine : Will the Rise of Intelligent Tools Mean the End of Peer Review? (s. 244-255) https://doi.org/10.1017/9781108975452.019
  • Wright, Megan S. Fins, Joseph J. Regulating Posttrial Access to In-Dwelling Class III Neural Devices (s. 256-267) https://doi.org/10.1017/9781108975452.020
  • Rosenberg, David Adediran, Adeyemi Strengthening the Power of Health Care Insurers to Regulate Medical Device Risks (s. 268-280) https://doi.org/10.1017/9781108975452.021