Edited by Barry Solaiman, Affiliate, HMS Center for Bioethics and I. Glenn Cohen, Deputy Dean, James A. Attwood and Leslie Williams Professor of Law, Harvard Law School, Harvard University and Faculty Director, Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics, Harvard Law School, Harvard University, US

‘From drug discovery to personalised medicine, or merely easing the administrative load of overstretched medical professionals, artificial intelligence can make healthcare more effective and efficient. Yet the ethical and legal perils of “automated medicine” are easily seen. This Research Handbook surveys the diversity of practices, ethical frameworks, and emergent laws in this space. It will be of interest to practitioners and scholars, as well as anyone seeking to understand how AI can reshape a profession and its norms.’

• Contents1 Introduction to the Research Handbook on Health, AI and the Law:a framework for health, AI and the law 1Barry Solaiman and I. Glenn CohenPART I THE USES OF AI IN HEALTH2 AI in hospital administration and management: ethical and legal implications 21Abeer Malik and Barry Solaiman3 Facial recognition AI technology in healthcare and the law 41Vera Lúcia Raposo4 Cybersecurity of AI medical devices: risks, legislation, and challenges 57Elisabetta Biasin, Erik Kamenjašević and Kaspar Rosager Ludvigsen5 Regulating smart healthcare robots: the European approach 75Tom Goffin and Sofia PalmieriPART II THE LEGAL CONSIDERATIONS OF AI IN HEALTH6 Algorithmic discrimination and health equity 93Jessica L. Roberts and Peter Salib7 AI and data protection law in health 111Craig Konnoth8 The legal considerations of AI-blockchain for securing health data 130Barry Solaiman and Georgios Dimitropoulos9 Liability for use of artificial intelligence in medicine 150W. Nicholson Price II, Sara Gerke and I. Glenn Cohen10 Artificial intelligence and the law of informed consent 168I. Glenn Cohen and Andrew Slottje11 Artificial intelligence and intellectual property in healthcare technologies 184Charlotte A. Tschider and Cynthia M. HoPART III THE ETHICAL PERSPECTIVES OF AI IN HEALTH12 Idealism, realism, pragmatism: three modes of theorising within secularAI ethics 203Rune Nyrup and Beba Cibralic13 AI, medicine and Christian ethics 219Zachary R. Calo14 Islamic ethico-legal perspectives on medical accountability in the age ofartificial intelligence 234Mohammed GhalyPART IV THE LEGAL GOVERNANCE OF AI AROUND THE WORLD15 International organisations and the global governance of AI in health 255Sara Kijewski, Elettra Ronchi and Effy Vayena16 US regulation of medical artificial intelligence and machine learning(AI/ML) research and development 272Vasiliki Rahimzadeh17 The state and values of AI governance in UK healthcare 290Colm Peter McGrath18 Governing AI in the European Union: emerging infrastructures andregulatory ecosystems in health 309Timo Minssen, Barry Solaiman, Lea Köttering, Jakob Wested and Abeer Malik19 Regulating AI in health in the Middle East: case studies from Qatar,Saudi Arabia and the United Arab Emirates 329Barry Solaiman, Ayesha Bashir and Fama Dieng20 Convergence in the regulation of artificial intelligence software asmedical device in the Guangdong–Hong Kong–Macao Greater BayArea of China 351Calvin Wai Loon Ho21 Legal governance of artificial intelligence in healthcare devices andservices in Singapore 369Warren B. Chik and Haran Sugumaran22 Regulating artificial intelligence in medical care in South Korea 388Won Bok Lee

Edited by Barry Solaiman, Affiliate, HMS Center for Bioethics and I. Glenn Cohen, Deputy Dean, James A. Attwood and Leslie Williams Professor of Law, Harvard Law School, Harvard University and Faculty Director, Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics, Harvard Law School, Harvard University, US

‘From drug discovery to personalised medicine, or merely easing the administrative load of overstretched medical professionals, artificial intelligence can make healthcare more effective and efficient. Yet the ethical and legal perils of “automated medicine” are easily seen. This Research Handbook surveys the diversity of practices, ethical frameworks, and emergent laws in this space. It will be of interest to practitioners and scholars, as well as anyone seeking to understand how AI can reshape a profession and its norms.’

• Contents1 Introduction to the Research Handbook on Health, AI and the Law:a framework for health, AI and the law 1Barry Solaiman and I. Glenn CohenPART I THE USES OF AI IN HEALTH2 AI in hospital administration and management: ethical and legal implications 21Abeer Malik and Barry Solaiman3 Facial recognition AI technology in healthcare and the law 41Vera Lúcia Raposo4 Cybersecurity of AI medical devices: risks, legislation, and challenges 57Elisabetta Biasin, Erik Kamenjašević and Kaspar Rosager Ludvigsen5 Regulating smart healthcare robots: the European approach 75Tom Goffin and Sofia PalmieriPART II THE LEGAL CONSIDERATIONS OF AI IN HEALTH6 Algorithmic discrimination and health equity 93Jessica L. Roberts and Peter Salib7 AI and data protection law in health 111Craig Konnoth8 The legal considerations of AI-blockchain for securing health data 130Barry Solaiman and Georgios Dimitropoulos9 Liability for use of artificial intelligence in medicine 150W. Nicholson Price II, Sara Gerke and I. Glenn Cohen10 Artificial intelligence and the law of informed consent 168I. Glenn Cohen and Andrew Slottje11 Artificial intelligence and intellectual property in healthcare technologies 184Charlotte A. Tschider and Cynthia M. HoPART III THE ETHICAL PERSPECTIVES OF AI IN HEALTH12 Idealism, realism, pragmatism: three modes of theorising within secularAI ethics 203Rune Nyrup and Beba Cibralic13 AI, medicine and Christian ethics 219Zachary R. Calo14 Islamic ethico-legal perspectives on medical accountability in the age ofartificial intelligence 234Mohammed GhalyPART IV THE LEGAL GOVERNANCE OF AI AROUND THE WORLD15 International organisations and the global governance of AI in health 255Sara Kijewski, Elettra Ronchi and Effy Vayena16 US regulation of medical artificial intelligence and machine learning(AI/ML) research and development 272Vasiliki Rahimzadeh17 The state and values of AI governance in UK healthcare 290Colm Peter McGrath18 Governing AI in the European Union: emerging infrastructures andregulatory ecosystems in health 309Timo Minssen, Barry Solaiman, Lea Köttering, Jakob Wested and Abeer Malik19 Regulating AI in health in the Middle East: case studies from Qatar,Saudi Arabia and the United Arab Emirates 329Barry Solaiman, Ayesha Bashir and Fama Dieng20 Convergence in the regulation of artificial intelligence software asmedical device in the Guangdong–Hong Kong–Macao Greater BayArea of China 351Calvin Wai Loon Ho21 Legal governance of artificial intelligence in healthcare devices andservices in Singapore 369Warren B. Chik and Haran Sugumaran22 Regulating artificial intelligence in medical care in South Korea 388Won Bok Lee

Edited by Barry Solaiman, Affiliate, HMS Center for Bioethics and I. Glenn Cohen, Deputy Dean, James A. Attwood and Leslie Williams Professor of Law, Harvard Law School, Harvard University and Faculty Director, Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics, Harvard Law School, Harvard University, US

‘From drug discovery to personalised medicine, or merely easing the administrative load of overstretched medical professionals, artificial intelligence can make healthcare more effective and efficient. Yet the ethical and legal perils of “automated medicine” are easily seen. This Research Handbook surveys the diversity of practices, ethical frameworks, and emergent laws in this space. It will be of interest to practitioners and scholars, as well as anyone seeking to understand how AI can reshape a profession and its norms.’

• Contents1 Introduction to the Research Handbook on Health, AI and the Law:a framework for health, AI and the law 1Barry Solaiman and I. Glenn CohenPART I THE USES OF AI IN HEALTH2 AI in hospital administration and management: ethical and legal implications 21Abeer Malik and Barry Solaiman3 Facial recognition AI technology in healthcare and the law 41Vera Lúcia Raposo4 Cybersecurity of AI medical devices: risks, legislation, and challenges 57Elisabetta Biasin, Erik Kamenjašević and Kaspar Rosager Ludvigsen5 Regulating smart healthcare robots: the European approach 75Tom Goffin and Sofia PalmieriPART II THE LEGAL CONSIDERATIONS OF AI IN HEALTH6 Algorithmic discrimination and health equity 93Jessica L. Roberts and Peter Salib7 AI and data protection law in health 111Craig Konnoth8 The legal considerations of AI-blockchain for securing health data 130Barry Solaiman and Georgios Dimitropoulos9 Liability for use of artificial intelligence in medicine 150W. Nicholson Price II, Sara Gerke and I. Glenn Cohen10 Artificial intelligence and the law of informed consent 168I. Glenn Cohen and Andrew Slottje11 Artificial intelligence and intellectual property in healthcare technologies 184Charlotte A. Tschider and Cynthia M. HoPART III THE ETHICAL PERSPECTIVES OF AI IN HEALTH12 Idealism, realism, pragmatism: three modes of theorising within secularAI ethics 203Rune Nyrup and Beba Cibralic13 AI, medicine and Christian ethics 219Zachary R. Calo14 Islamic ethico-legal perspectives on medical accountability in the age ofartificial intelligence 234Mohammed GhalyPART IV THE LEGAL GOVERNANCE OF AI AROUND THE WORLD15 International organisations and the global governance of AI in health 255Sara Kijewski, Elettra Ronchi and Effy Vayena16 US regulation of medical artificial intelligence and machine learning(AI/ML) research and development 272Vasiliki Rahimzadeh17 The state and values of AI governance in UK healthcare 290Colm Peter McGrath18 Governing AI in the European Union: emerging infrastructures andregulatory ecosystems in health 309Timo Minssen, Barry Solaiman, Lea Köttering, Jakob Wested and Abeer Malik19 Regulating AI in health in the Middle East: case studies from Qatar,Saudi Arabia and the United Arab Emirates 329Barry Solaiman, Ayesha Bashir and Fama Dieng20 Convergence in the regulation of artificial intelligence software asmedical device in the Guangdong–Hong Kong–Macao Greater BayArea of China 351Calvin Wai Loon Ho21 Legal governance of artificial intelligence in healthcare devices andservices in Singapore 369Warren B. Chik and Haran Sugumaran22 Regulating artificial intelligence in medical care in South Korea 388Won Bok Lee