The future of medical device regulation : (Record no. 38450)
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| 000 -LEADER | |
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| fixed length control field | 05103nam a2200385 i 4500 |
| 001 - CONTROL NUMBER | |
| control field | CR9781108975452 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | UkCbUP |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20240508141513.0 |
| 006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS | |
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| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION | |
| fixed length control field | cr|||||||||||| |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 200813s2022||||enk o ||1 0|eng|d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781108975452 (ebook) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Canceled/invalid ISBN | 9781108838634 (hardback) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Canceled/invalid ISBN | 9781108972055 (paperback) |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | UkCbUP |
| Language of cataloging | eng |
| Description conventions | rda |
| Transcribing agency | UkCbUP |
| 050 04 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | K3611.M45 |
| Item number | F98 2022 |
| 082 00 - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 344.04/1 |
| Edition number | 23/eng/20220202 |
| 245 04 - TITLE STATEMENT | |
| Title | The future of medical device regulation : |
| Remainder of title | innovation and protection / |
| Statement of responsibility, etc. | edited by I. Glenn Cohen, Timo Minssen, W. Nicholson Price II, Christopher Robertson, Carmel Shachar. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Place of production, publication, distribution, manufacture | Cambridge : |
| Name of producer, publisher, distributor, manufacturer | Cambridge University Press, |
| Date of production, publication, distribution, manufacture, or copyright notice | 2022. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 1 online resource (xiv, 280 pages) : |
| Other physical details | digital, PDF file(s). |
| 336 ## - CONTENT TYPE | |
| Content type term | text |
| Content type code | txt |
| Source | rdacontent |
| 337 ## - MEDIA TYPE | |
| Media type term | computer |
| Media type code | c |
| Source | rdamedia |
| 338 ## - CARRIER TYPE | |
| Carrier type term | online resource |
| Carrier type code | cr |
| Source | rdacarrier |
| 500 ## - GENERAL NOTE | |
| General note | Title from publisher's bibliographic system (viewed on 31 Mar 2022). |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | Introduction / Glenn Cohen, Timo Minssen, W. Nicholson Price, Christopher Robertson, Carmel Shachar -- Lifecycle regulation and evaluation of artificial intelligence and machine learning-based medical devices / Kerstin N. Vokinger, Thomas J. Hwang, & Aaron S. Kesselheim -- Product liability suits for FDA-regulated AI/ML Software / Barbara Evans & Frank Pasquale -- Are electronic health records medical devices? / Craig Konnoth -- Cybersecurity of medical devices : regulatory challenges in the EU / Elisabetta Biasin & Erik Kamenjasevic -- The mHealth power paradox : improving data protection in health apps through self-regulation in the European Union / Hannah van Kolfschooten -- The interaction of the medical device regulation and the GDPR : do European rules on privacy and scientific research impair the safety & performance of AI medical devices? / Janos Meszaros, Marcelo Corrales Compagnucci, & Timo Minssen -- AI, explainability, and safeguarding patient safety in Europe : towards a science-focused regulatory model / Barry Solaiman & Mark G. Bloom -- Regulation of digital health technologies in the EU : intended versus actual use / Helen Yu -- IP and FDA regulation of De Novo medical devices / Mateo Aboy & Jacob S. Sherkow -- A "DESI" for devices? Can a Pharmaceutical Program from the 1960s improve FDA oversight of medical devices? / Matthew Herder & Nathan Cortez -- Digital home health during the COVID-19 Pandemic : challenges to safety, liability, and informed consent, and the way to move forward / Sara Gerke -- Clouded judgment : preventing conflicts of interest in problem-solving courts / Jody Lynee Madeira, Barbara Andraka-Christou, Lori Ann Eldridge, & Ross D. Silverman -- Disrupting the market for ineffective medical devices / Wendy Netter Epstein -- Preventing medical device-borne outbreaks : the case of high-level disinfection policy for duodenoscopes / Preeti Mehrotra, David J. Weber, & Ameet Sarpatwari -- Regulating devices that create life / Katherine Kraschel -- Ensuring patient safety and benefit in use of medical devices granted expedited approval / Sanket S. Dhruva, Jonathan J. Darrow, Aaron S. Kesselheim, & Rita F. Redberg -- Compulsory medical device registries : legal and regulatory issues / Efthimios Parasidis & Daniel B. Kramer -- Professional self-regulation in medicine : will the rise of intelligent tools mean the end of peer review? / Anthony P. Weiss & Barak D. Richman -- Regulating post-trial access to in-dwelling Class III neural devices / Megan S. Wright & Joseph J. Fins -- Strengthening the power of health care insurers to regulate medical device risks / David Rosenberg & Adeyemi Adediran. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | 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. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Medical instruments and apparatus |
| General subdivision | Law and legislation |
| Form subdivision | Congresses. |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Cohen, I. Glenn, |
| Relator term | editor. |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Minssen, Timo, |
| Relator term | editor. |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Price, W. Nicholson, |
| Numeration | II, |
| Relator term | editor. |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Robertson, Christopher T. |
| Dates associated with a name | 1975- |
| Relator term | editor. |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Shachar, Carmel, |
| Dates associated with a name | 1985- |
| Relator term | editor. |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Relationship information | Print version: |
| International Standard Book Number | 9781108838634 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="https://doi.org/10.1017/9781108975452">https://doi.org/10.1017/9781108975452</a> |
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