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008 240216s2022 enk|||||o|||| 00| 0 eng d
020 _a9781108975452
040 _aSPU
049 _amain
050 0 4 _aK 3611.M45
_bF87 2022
245 0 4 _aThe future of medical device regulation : innovation and protection /
_cedited by I. Glenn Cohen, Timo Minssen, W. Nicholson Price II, Christopher Robertson, Carmel Shachar
260 _aCambridge :
_bCambridge University Press,
_c2022
300 _aonline resource
449 _a110301
500 _aTitle from publisher's bibliographic system (viewed on 31 Mar 2022)
505 0 _aIntroduction / 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
650 0 _aMEDICAL INSTRUMENTS AND APPARATUS
_xLAW AND LEGISLATION
_xCONGRESSES
_9256421
700 _aCohen, I. Glenn
_eeditor
_9256413
700 _aMinssen, Timo
_eeditor
_9256422
700 _aPrice, W. Nicholson
_eeditor
_9256423
700 _aRobertson, Christopher T.
_d1975-
_eeditor
_9256424
700 _aShachar, Carmel,
_d1985-
_eeditor
_9256419
850 _aSPU
856 _uhttps://doi.org/10.1017/9781108975452
910 _aLibrary
_bCambridge University Press
_c160224
_pEB000383
942 _2lcc
_cEBK
998 _aniparat 0224
999 _c213459