Research Handbook on Health, AI and the Law

Edited by Barry Solaiman, Assistant Dean, Assistant Professor of Law, College of Law, Hamad Bin Khalifa University, Doha and Adjunct Assistant Professor of Medical Ethics in Clinical Medicine, Weill Cornell Medicine, Qatar 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

Contents

1 Introduction to the Research Handbook on Health, AI and the Law:
a framework for health, AI and the law 1
Barry Solaiman and I. Glenn Cohen

PART I THE USES OF AI IN HEALTH
2 AI in hospital administration and management: ethical and legal implications 21
Abeer Malik and Barry Solaiman
3 Facial recognition AI technology in healthcare and the law 41
Vera Lúcia Raposo
4 Cybersecurity of AI medical devices: risks, legislation, and challenges 57
Elisabetta Biasin, Erik Kamenjašević and Kaspar Rosager Ludvigsen
5 Regulating smart healthcare robots: the European approach 75
Tom Goffin and Sofia Palmieri

PART II THE LEGAL CONSIDERATIONS OF AI IN HEALTH
6 Algorithmic discrimination and health equity 93
Jessica L. Roberts and Peter Salib
7 AI and data protection law in health 111
Craig Konnoth
8 The legal considerations of AI-blockchain for securing health data 130
Barry Solaiman and Georgios Dimitropoulos
9 Liability for use of artificial intelligence in medicine 150
W. Nicholson Price II, Sara Gerke and I. Glenn Cohen
10 Artificial intelligence and the law of informed consent 168
I. Glenn Cohen and Andrew Slottje
11 Artificial intelligence and intellectual property in healthcare technologies 184
Charlotte A. Tschider and Cynthia M. Ho

PART III THE ETHICAL PERSPECTIVES OF AI IN HEALTH
12 Idealism, realism, pragmatism: three modes of theorising within secular
AI ethics 203
Rune Nyrup and Beba Cibralic
13 AI, medicine and Christian ethics 219
Zachary R. Calo
14 Islamic ethico-legal perspectives on medical accountability in the age of
artificial intelligence 234
Mohammed Ghaly

PART IV THE LEGAL GOVERNANCE OF AI AROUND THE WORLD
15 International organisations and the global governance of AI in health 255
Sara Kijewski, Elettra Ronchi and Effy Vayena
16 US regulation of medical artificial intelligence and machine learning
(AI/ML) research and development 272
Vasiliki Rahimzadeh
17 The state and values of AI governance in UK healthcare 290
Colm Peter McGrath
18 Governing AI in the European Union: emerging infrastructures and
regulatory ecosystems in health 309
Timo Minssen, Barry Solaiman, Lea Köttering, Jakob Wested and Abeer Malik
19 Regulating AI in health in the Middle East: case studies from Qatar,
Saudi Arabia and the United Arab Emirates 329
Barry Solaiman, Ayesha Bashir and Fama Dieng
20 Convergence in the regulation of artificial intelligence software as
medical device in the Guangdong–Hong Kong–Macao Greater Bay
Area of China 351
Calvin Wai Loon Ho
21 Legal governance of artificial intelligence in healthcare devices and
services in Singapore 369
Warren B. Chik and Haran Sugumaran
22 Regulating artificial intelligence in medical care in South Korea 388
Won Bok Lee