TY - DATA AU - Cohen, I. Glenn AU - Minssen, Timo AU - Price, W. Nicholson AU - Robertson, Christopher T. AU - Shachar, Carmel, TI - The future of medical device regulation : innovation and protection SN - 9781108975452 AV - K 3611.M45 F87 2022 PY - 2022/// CY - Cambridge PB - Cambridge University Press KW - MEDICAL INSTRUMENTS AND APPARATUS KW - LAW AND LEGISLATION KW - CONGRESSES N1 - Title from publisher's bibliographic system (viewed on 31 Mar 2022); 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 UR - https://doi.org/10.1017/9781108975452 ER -