Hardback
Research Handbook on Health, AI and the Law
This is an open access title available under the terms of a CC BY-NC-ND 4.0 License. It is free to read, download and share on Elgaronline, thanks to generous funding support from Hamad Bin Khalifa University (HBKU).
The Research Handbook on Health, AI and the Law explores the use of AI in healthcare, identifying the important laws and ethical issues that arise from its use. Adopting an international approach, it analyses the varying responses of multiple jurisdictions to the use of AI and examines the influence of major religious and secular ethical traditions.
The Research Handbook on Health, AI and the Law explores the use of AI in healthcare, identifying the important laws and ethical issues that arise from its use. Adopting an international approach, it analyses the varying responses of multiple jurisdictions to the use of AI and examines the influence of major religious and secular ethical traditions.
More Information
Critical Acclaim
Contents
More Information
The Research Handbook on Health, AI and the Law explores the use of AI in healthcare, identifying the important laws and ethical issues that arise from its use. Adopting an international approach, it analyses the varying responses of multiple jurisdictions to the use of AI and examines the influence of major religious and secular ethical traditions.
Bringing together a diverse range of carefully selected legal experts, the Research Handbook critically assesses the different uses of AI in healthcare and its promise to provide greater accuracy for healthcare professionals and patients by diagnosing diseases and detecting illness earlier and helping hospitals run more efficiently. It also highlights a series of legal and ethical challenges AI raises relating to bias, privacy, data security, medical liability, informed consent and intellectual property. AI governance is rigorously examined in countries across the globe spanning Asia, Europe and the US while different responses from international organisations towards AI in healthcare are also evaluated.
This Research Handbook is a key resource for scholars and law students and for those interested in current and developing legal paradigms. Its legal and practical dimensions will also be beneficial to lawyers practising in health law and internet and technology law, policymakers and medical professionals.
Bringing together a diverse range of carefully selected legal experts, the Research Handbook critically assesses the different uses of AI in healthcare and its promise to provide greater accuracy for healthcare professionals and patients by diagnosing diseases and detecting illness earlier and helping hospitals run more efficiently. It also highlights a series of legal and ethical challenges AI raises relating to bias, privacy, data security, medical liability, informed consent and intellectual property. AI governance is rigorously examined in countries across the globe spanning Asia, Europe and the US while different responses from international organisations towards AI in healthcare are also evaluated.
This Research Handbook is a key resource for scholars and law students and for those interested in current and developing legal paradigms. Its legal and practical dimensions will also be beneficial to lawyers practising in health law and internet and technology law, policymakers and medical professionals.
Critical Acclaim
‘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.’
– Simon Chesterman, National University of Singapore, Singapore
‘Solaiman and Cohen have assembled a comprehensive yet nuanced examination of how Artificial Intelligence is disrupting healthcare and medicine. This Research Handbook examines the key legal issues facing medical AI from patient consent and secular ethics to medical device regulation and algorithmic accountability. Contributions from eminent legal scholars across the globe result in a volume that is as cutting edge as it is a joy to read. This invaluable research and teaching resource effortlessly weaves together legal, ethical, political, and technical analysis. This is now the field’s essential reference point for academics, lawyers, policymakers, and healthcare professionals wanting to understand medical AI and the law.’
– Sandra Wachter, University of Oxford, UK
– Simon Chesterman, National University of Singapore, Singapore
‘Solaiman and Cohen have assembled a comprehensive yet nuanced examination of how Artificial Intelligence is disrupting healthcare and medicine. This Research Handbook examines the key legal issues facing medical AI from patient consent and secular ethics to medical device regulation and algorithmic accountability. Contributions from eminent legal scholars across the globe result in a volume that is as cutting edge as it is a joy to read. This invaluable research and teaching resource effortlessly weaves together legal, ethical, political, and technical analysis. This is now the field’s essential reference point for academics, lawyers, policymakers, and healthcare professionals wanting to understand medical AI and the law.’
– Sandra Wachter, University of Oxford, UK
Contents
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
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
