ETHICS AND GOVERNANCE OF ARTIFICIAL INTELLIGENCE FOR HEALTH ETHICS AND GOVERNANCE OF ARTIFICIAL INTELLIGENCE FOR HEALTH WHO GUIDANCE 1 ETHICS AND GOVERNANCE OF ARTIFICIAL INTELLIGENCE FOR HEALTH Ethics and governance of artificial intelligence for health: WHO guidance ISBN 978-92-4-002920-0 (electronic version) ISBN 978-92-4-002921-7 (print version) © World Health Organization 2021 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. 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Graphic design: The New Division 2 ETHICS AND GOVERNANCE OF ARTIFICIAL INTELLIGENCE FOR HEALTH CONTENTS Foreword..................................................................................................................................................... v Acknowledgements................................................................................................................................ vii Abbreviations and acronyms............................................................................................................... x Executive summary................................................................................................................................. xi 1. Introduction.......................................................................................................................................... 1 2. Artificial intelligence.......................................................................................................................... 4 3. Applications of artificial intelligence for health...................................................................... 6 3.1 In health care................................................................................................................ 6 3.2 In health research and drug development............................................................. 11 3.3 In health systems management and planning...................................................... 12 3.4 In public health and public health surveillance..................................................... 12 3.5 The future of artificial intelligence for health......................................................... 15 4. Laws, policies and principles that apply to use of artificial intelligence for health.... 17 4.1 Artificial intelligence and human rights................................................................... 17 4.2 Data protection laws and policies............................................................................. 19 4.3 Existing laws and policies related to health data................................................... 19 4.4 General principles for the development and use of artificial intelligence....... 20 4.5 Principles for use of artificial intelligence for health............................................. 21 4.6 Bioethics laws and policies......................................................................................... 21 4.7 Regulatory considerations.......................................................................................... 22 5. Key ethical principles for use of artificial intelligence for health...................................... 23 5.1 Protect autonomy......................................................................................................... 25 5.2 Promote human well-being, human safety and the public interest.................. 26 5.3 Ensure transparency, explainability and intelligibility........................................... 26 5.4 Foster responsibility and accountability.................................................................. 28 5.5 Ensure inclusiveness and equity................................................................................ 29 5.6 Promote artificial intelligence that is responsive and sustainable.................... 30 6. Ethical challenges to use of artificial intelligence for health care.................................... 31 6.1 Assessing whether artificial intelligence should be used.................................... 31 6.2 Artificial intelligence and the digital divide.............................................................. 34 6.3 Data collection and use............................................................................................... 35 6.4 Accountability and responsibility for decision-making with artificial intelligence...................................................................................................... 41 6.5 Autonomous decision-making................................................................................... 45 6.6 Bias and discrimination associated with artificial intelligence............................ 54 6.7 Risks of artificial intelligence technologies to safety and cybersecurity........... 57 iii3 ETHICS AND GOVERNANCE OF ARTIFICIAL INTELLIGENCE FOR HEALTH 6.8 Impacts of artificial intelligence on labour and employment in health and medicine................................................................................................ 58 6.9 Challenges in commercialization of artificial intelligence for health care........ 61 6.10 Artificial intelligence and climate change................................................................ 64 7. Building an ethical approach to use of artificial intelligence for health......................... 65 7.1 Ethical, transparent design of technologies........................................................... 65 7.2 Engagement and role of the public and demonstration of trustworthiness to providers and patients......................................................... 69 7.3 Impact assessment...................................................................................................... 72 7.4 Research agenda for ethical use of artificial intelligence for health care........ 74 8. Liability regimes for artificial intelligence for health............................................................ 76 8.1 Liability for use of artificial intelligence in clinical care......................................... 76 8.2 Are machine-learning algorithms products?.......................................................... 77 8.3 Compensation for errors............................................................................................ 78 8.4 Role of regulatory agencies and pre-emption....................................................... 79 8.5 Considerations for low- and middle-income countries........................................ 79 9. Elements