First Do No Harm: Legal Principles Regulating the Future of Artificial Intelligence in Health Care in South Africa

Authors

DOI:

https://doi.org/10.17159/1727-3781/2022/v25ia11118

Keywords:

artificial intelligence, ethics , health care, health policies, machine learning

Abstract

What sets AI systems and AI-powered medical robots apart from all other forms of advanced medical technology is their ability to operate at least to some degree autonomously from the human health care practitioner and to use machine-learning to generate new, often unforeseen, analysis and predictions. This poses challenges under the current framework of laws, regulations, and ethical guidelines applicable to health care in South Africa. The article outlines these challenges and sets out guiding principles for a normative framework to regulate the use of AI in health care. The article examines three key areas for legal reform in relation to AI in health care. First, it proposes that the regulatory framework for the oversight of software as a medical device needs to be updated to develop frameworks for adequately regulating the use of such new technologies. Secondly, it argues that the present HPCSA guidelines for health care practitioners in South Africa adopt an unduly restrictive approach centred in the outmoded semantics of telemedicine. This may discourage technological innovation that could improve access to health care for all, and as such the guidelines are inconsistent with the national digital health strategy. Thirdly, it examines the common law principles of fault-based liability for medical negligence, which could prove inadequate to provide patients and users of new technologies with redress for harm where fault cannot clearly be attributed to the healthcare practitioner. It argues that consideration should be given to developing a statutory scheme for strict liability, together with mandatory insurance, and appropriate reform of product liability pertaining to technology developers and manufacturers. These legal reforms should not be undertaken without also developing a coherent, human-rights centred policy framework for the ethical use of AI, robotics, and related technologies in health care in South Africa.

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References

Bibliography

Literature

Alheit K "The Applicability of the EU Product Liability Directive to Software" 2001 CILSA 188-209

Ameer-Mia F, Pienaar C and Kekana N "South Africa" in Berkowitz M (ed) AI, Machine Learning and Big Data 2020 2nd ed (Global Legal Group London 2020) 248-261

Barit A "The Apps are Coming! But Will They Be Legal in South Africa?" 2019 SAMJ 150-151

Cabral TS "Liability and Artificial Intelligence in the EU: Assessing the Adequacy of the Current Product Liability Directive" 2020 MJ 615-635

Department of Health National Digital Health Strategy for South Africa 2019-2024 (Department of Health Pretoria 2019)

Department of Health National e-Health Strategy (2012-2016) (Department of Health Pretoria 2012)

Donnelly D Privacy by (re)Design: A Comparative Study of the Protection of Personal Information in the Mobile Applications Ecosystem under United States, European Union and South African Law (PhD-dissertation University of KwaZulu-Natal 2020)

Dourish P "Algorithms and Their Others: Algorithmic Culture in Context" 2016 Big Data & Society 3-6

DuBois JM, Chibnall JT and Gibbs J "Compliance Disengagement in Research: Development and Validation of a New Measure" 2016 Sci Eng Ethics 965-988

Flach P Machine Learning: The Art and Science of Algorithms that Make Sense of Data (Cambridge University Press Cambridge 2012)

Foote S "Product Liability and Medical Device Regulation: Proposal for Reform" in Ekelman K (ed) New Medical Devices: Invention, Development, and Use (National Academy Press Washington DC 1988) 73-92

Gerke S, Minssen T and Cohen G "Ethical and Legal Challenges of Artificial Intelligence-driven Healthcare" in Bohr A (ed) Artificial Intelligence in Healthcare (Elsevier London 2020) 295-336

Gowar C "Product Liability: A Changing Playing Field?" 2011 Obiter 521-536

Hagendorff T "The Ethics of AI Ethics: An Evaluation of Guidelines" 2020 Minds and Machines 99-120

Jiang F et al "Artificial Intelligence in Healthcare: Past, Present and Future" 2017 Stroke and Vascular Neurology 230-243

Jobin A, Ienca M and Vayena E "The Global Landscape of AI Ethics Guidelines" 2019 Nature Machine Intelligence 389-399

Lang M "Heart Rate Monitoring Apps: Information for Engineers and Researchers About the New European Medical Devices Regulation 2017/745" 2017 JMIR Biomed Eng 1-5

Loubser M et al The Law of Delict in South Africa 3rd ed (Oxford University Press Cape Town 2018)

Luxton D "Ethical Implications of Conversational Agents in Global Public Health" 2020 Bull World Health Organ 285-287

Mahomed S "Healthcare, Artificial Intelligence and the Fourth Industrial Revolution: Ethical, Social and Legal Considerations" 2018 SAJBL 93-95

Mahomed S "COVID-19: The Role of Artificial Intelligence in Empowering the Healthcare Sector and Enhancing Social Distancing Measures During a Pandemic" 2020 SAMJ 1-4

McQuoid-Mason D "What Constitutes Medical Negligence?" 2010 SA Heart 248-251

Morley J et al "From What to How: An Initial Review of Publicly Available AI Ethics Tools, Methods and Research to Translate Principles into Practices" 2020 Sci Eng Ethics 2141-2168

Mueller D "Addressing the Challenges of Implementing a Health Technology Assessment Policy Framework in South Africa" 2020 Int J Technol Assess Health Care 453-458

Neethling J and Potgieter JM Law of Delict 7th ed (Lexis Nexis Durban 2015)

Nöthling-Slabbert M and Pepper M "Medicine and the Law: The Consumer Protection Act: No-fault Liability of Health Care Providers" 2011 SAMJ 800-801

Nöthling Slabbert M et al "The Application of the Consumer Protection Act in the South African Health Care Context: Concerns and Recommendations" 2011 CILSA 180-181

Ormond E "The Ghost in the Machine: The Ethical Risks of AI" 2020 The Thinker 4-11

Roberts H et al "The Chinese Approach to Artificial Intelligence: An Analysis of Policy, Ethics, and Regulation" 2021 AI & Society 59-77

Schönberger D "Artificial Intelligence in Healthcare: A Critical Analysis of the Legal and Ethical Implications" 2019 Int J Law Inf Technol 171-203

Smit M and Mwale D "The Global Approach to Regulation of Medical Devices and IVDs" 2019 Without Prejudice 35-38

Townsend B "Software as Medical Devices (SaMDs): Critical Rights Issues Regarding AI Software-based Health Technologies in South Africa" 2020 TSAR 747-762

Townsend B and Thaldar D "Navigating Uncharted Waters: Biobanks and Informational Privacy in South Africa" 2019 SAJHR 329-350

Watson D et al "Clinical Applications of Machine Learning Algorithms: Beyond the Black Box" 2019 BMJ 364-373

World Health Organization Generating Evidence for Artificial Intelligence-based Medical Devices: A Framework for Training, Evaluation and Validation (WHO Geneva 2021)

World Health Organization Global Strategy on Digital Health 2020-2025 (WHO Geneva 2019)

World Health Organization Recommendations on Digital Interventions for Health System Strengthening (WHO Geneva 2019)

Case law

Afrox Healthcare Bpk v Strydom 2002 6 SA 21 (SCA)

Broude v McIntosh 1998 3 SA 60 (SCA)

Castell v De Greef 1993 3 SA 501 (C)

Castell v De Greef 1994 4 SA 408 (C)

Dube v Administrator Transvaal 1963 4 SA 260 (T)

Financial Mail (Pty) Ltd v Sage Holdings Ltd 1993 (2) SA 451 (AD)

Jansen van Vuuren v Kruger 1993 4 SA 842 (A)

Khumalo v Holomisa 2002 5 SA 401 (CC)

Michael v Linksfield Park Clinic (Pty) Ltd 2001 3 SA 1188 (SCA)

Mitchell v Dixon 1914 AD 519

National Coalition for Gay and Lesbian Equality v Minister of Justice 1999 1 SA 6 (CC)

NM v Smith 2007 5 SA 250 (CC)

Oppelt v Head: Health, Department of Health Provincial Administration: Western Cape 2016 1 SA 325 (CC)

Richter v Estate Hamman 1976 3 SA 226 (C)

S v Kramer 1987 1 SA 887 (W)

S v Mkwetshana 1965 2 SA 493 (N)

Transnet Ltd v The Owner of the Alina II 2011 6 SA 206 (SCA)

Tshabalala-Msimang v Makhanya 2008 6 SA 102 (W)

Van Wyk v Lewis 1924 AD 438

Legislation

Admiralty Jurisdiction Regulation Act 105 of 1983

Constitution of the Republic of South Africa, 1996

Consumer Protection Act 68 of 2008

Electronic Communications and Transactions Act 25 of 2002

Hazardous Substances Act 15 of 1973

Health Professions Act 56 of 1974

Medicines and Related Substances Act 101 of 1965

Medicines and Related Substances Amendment Act 14 of 2015

National Health Act 61 of 2003

Promotion of Access to Information Act 2 of 2000

Protection of Personal Information Act 4 of 2013

Government publications

GN 1212 in GG 40325 of 3 October 2016 (National Integrated ICT Policy White Paper)

GN 341-342 in GG 40772 of 7 April 2017 (National E-Government Strategy and Roadmap)

GN 343 in GG 40772 of 7 April 2017 (National E-Strategy)

GN 591 in GG 43834 of 23 October 2020 (Report of the Presidential Commission on the Fourth Industrial Revolution (4IR))

Internet sources

Access Partnership and University of Pretoria 2018 Artificial Intelligence for Africa: An Opportunity for Growth, Development, and Democratisation https://www.up.ac.za/media/shared/7/ZP_Files/ai-for-africa.zp165664.pdf accessed 14 March 2021

Academy of Science of South Africa 2018 Human Genetics and Genomics in South Africa: Ethical, Legal and Social Implications http://dx.doi.org/10.17159/assaf.2018/0033 accessed 17 March 2021

African Union 2019 The Digital Transformation Strategy for Africa (2020-2030) https://au.int/en/documents/20200518/digital-transformation-strategy-africa-2020-2030 accessed 22 April 2021

BroadReach Healthcare 2019 South Africa Leading the Way in the Fight Against HIV and AIDS https://www.broadreachcorporation.com/south-africa-leading-the-way-in-the-fight-against-hiv-and-aids/ accessed 13 February 2021

Council of Europe's Ad Hoc Committee on Artificial Intelligence 2020 Towards Regulation of AI Systems https://rm.coe.int/prems-107320-gbr-2018-compli-cahai-couv-texte-a4-bat-web/1680a0c17a accessed 13 March 2021

CIFAR date unknown Pan-Canadian AI Stragety https://cifar.ca/ai/ accessed 17 March 2021

Cleary K 2020 Special investigation: Claims of 90-90-90 Success in KZN Districts were Premature https://www.spotlightnsp.co.za/2020/03/18/special-investigation-claims-of-90-90-90-success-in-kzn-districts-were-premature/ accessed 17 February 2021

Council of the European Committees 1985 Council Directive 85/374/EEC of 25 July 1985 on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Concerning Liability for Defective Products https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31985L0374&from=EN accessed 16 February 2022

DeepMind date unknown Ethics and Society https://deepmind.com/

applied/deepmind-ethics-society/principles/ accessed 13 March 2021

European Commission 2018 Communication from the Commission: Artificial Intelligence for Europe (COM(2018) 237 final) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM%3A2018%3A237%3AFIN accessed 16 February 2022

European Commission, Directorate-General for Communications Networks, Content and Technology 2019 Ethics Guidelines for Trustworthy AI https://data.europa.eu/doi/10.2759/177365 accessed 16 February 2022

European Commission 2021 Proposal for a Regulation of the European Parliament and of the Council Laying Down Harmonised Rules on Artificial Intelligence (Artificial Intelligence Act) and Amending Certain Union Legislative Acts (COM/2021/206 final) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52021PC0206 accessed 16 February 2022

European Parliament 2016 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the Protection of Natural Persons with Regard to the Processing of Personal Data and on the Free Movement of Such Data, and Repealing Directive 95/46/EC (General Data Protection Regulation) (Text with EEA Relevance) https://eur-lex.europa.eu/eli/reg/2016/679/oj accessed 16 February 2022

European Parliament 2017 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices, Amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Reguation (EC) No 1223/2009 and Repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA Relevance) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745 accessed 16 February 2022

European Parliament 2020 Resolution of 20 October 2020 with Recommendations to the Commission on a Framework of Ethical Aspects of Artificial Intelligence, Robotics and Related Technologies 2020/2012(INL), P9_TA-PROV(2020)0275 https://www.europarl.europa.

eu/doceo/document/TA-9-2020-0275_EN.html accessed 16 February 2022

European Parliament 2020 Resolution of 20 October 2020 with Recommendations to the Commission on a Civil Liability Regime for Artificial Intelligence 2020/2014(INL), P9_TA-PROV(2020)0276 https://www.europarl.europa.eu/doceo/document/TA-9-2020-0276_EN.html accessed 16 February 2022

United States Food and Drug Administration 2021 Artificial Intelligence and Machine Learning (AI/ML) Software as a Medical Device Action Plan https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device accessed 17 February 2021

Fjeld J et al 2019 Principled Artificial Intelligence: A Map of Ethical and Rights-based Approaches https://papers.ssrn.com/sol3/

papers.cfm?abstract_id=3518482 accessed 13 March 2021

G20 2019 G20 Ministerial Statement on Trade and Digital Economy https://www.mofa.go.jp/files/000486596.pdf accessed 12 March 2021

Google AI date unknown Artificial Intelligence at Google: Our Principles https://ai.google/principles/ accessed 13 March 2021

Health Professions Council of South Africa date unknown Booklet 1: General Ethical Guidelines for Health Professions https://www.hpcsa.co.za/Uploads/Professional_Practice/Ethics_Booklet.pdf accessed 22 April 2021

HPCSA date unknown Booklet 3: National Patient's Rights Charter https://www.hpcsa.co.za/Uploads/Professional_Practice/Ethics_Booklet.pdf accessed 4 December 2020

Health Professions Council of South Africa date unknown Booklet 4: Seeking Patients' Informed Consent: The Ethical Considerations https://www.hpcsa.co.za/Uploads/Professional_Practice/Ethics_Booklet.pdf accessed 4 December 2020

Health Professions Council of South Africa date unknown Booklet 5: Confidentiality: Protecting and Providing Information https://www.hpcsa.co.za/Uploads/Professional_Practice/Ethics_Booklet.pdf accessed 4 December 2020

Health Professions Council of South Africa date unknown Booklet 10: Guidelines for the Practice of Telemedicine https://www.hpcsa.co.za/Uploads/Professional_Practice/Ethics_Booklet.pdf accessed 4 December 2020

Health Professions Council of South Africa 2020 Guidance on the Application of Telemedicine Guidelines During rhe Covid19 Pandemic https://www.hpcsa.co.za/Uploads/Events/Announcements/APPLICATION_OF_TELEMEDICINE_GUIDELINES.pdf accessed 13 February 2021

Health Professions Council of South Africa 2020 Notice to Amend Telemedicine Guidelines During COVID-19 https://www.saheart.org/cms/content/104-notice-to-amend-telemedicine-guidelines-during-covid-19-%E2%80%93-dated-3-april-2020-%7C-hpcsa-e-bulletin accessed 13 February 2021

Institute of Electrical and Electronics Engineers 2019 Ethically Aligned Design: A Vision for Prioritizing Human Well-being with Autonomous and Intelligent Systems https://standards.ieee.org/industry-connections/ec/

autonomous-systems.html accessed 13 March 2021

International Telecommunication Union 2020 Guidance on AI and Digital Technologies for COVID Health Emergency https://www.itu.int/en/ITU-T/focusgroups/ai4h/Documents/FGAI4H-DT4ER-O-001.pdf accessed 22 April 2021

International Telecommunication Union and World Health Organization date unknown Focus Group on "Artificial Intelligence for Health" https://www.itu.int/en/ITU-T/focusgroups/ai4h/Pages/default.aspx accessed 13 March 2021

Marwala T 2020 Review, Amend or Create Policy and Legislation Enabling the 4IR https://mg.co.za/article/2020-04-03-review-amend-or-create-policy-and-legislation-enabling-the-4ir/ accessed 14 March 2021

McPake R 2020 Pilot Story: Will Access to Sex-positive and Reproductive Health Information Through a Chatbot Lead to Increased Contraceptive Use Amongst Kenyan Youth? https://medium.com/frontier-technologies-hub/pilot-story-will-access-to-sex-positive-and-reproductive-health-information-through-a-chatbot-d41738947d0c accessed 14 February 2021

Microsoft date unknown Responsible AI Principles https://www.microsoft.com/en-us/ai/responsible-ai?activetab=pivot1%3aprimaryr6 accessed 13 March 2021

Microsoft 2019 Artificial Intelligence in Middle East and Africa: South Africa Outlook for 2019 and Beyond https://info.microsoft.com/rs/157-GQE-382/images/MicrosoftSouthAfricanreportSRGCM1070.pdf accessed 14 March 2021

Morley J et al 2019 The Debate on the Ethics of AI in Health Care: A Reconstruction and Critical Review https://ssrn.com/abstract=3486518 accessed 17 February 2021

Organisation for Economic Co-operation and Development 2019 Recommendation of the Council on Artificial Intelligence OECD/LEGAL/0449 https://legalinstruments.oecd.org/en/instruments/OECD-LEGAL-0449 accessed 16 February 2022

Oxford Insights 2019 Government Artificial Intelligence Readiness Index 2019 https://africa.ai4d.ai/wp-content/uploads/2019/05/ai-gov-readiness-report_v08.pdf accessed 12 March 2021

Pillay R 2019 The Future of Health in South Africa https://mg.co.za/article/2019-11-22-00-the-future-of-health-in-south-africa/ accessed 14 March 2021

Research ICT Africa 2021 RIA Technical Assistance Provider for AU's Digital Health Strategy https://researchictafrica.net/2021/02/15/ria-provides-technical-assistance-for-development-of-aus-digital-health-strategy/ accessed 18 February 2021

Singh V 2020 AI and Data in South Africa's Health Sector https://policyaction.org.za/sites/default/files/PAN_TopicalGuide_AIData6_Health_Elec.pdf accessed 14 March 2021

UNAIDS date unknown 90-90-90: Treatment for All https://www.unaids.org/en/resources/909090 accessed 17 February 2021

United Nations Educational, Scientific and Cultural Organization 2017 Report of COMEST on Robotics Ethics (SHS/YES/COMEST-10/17/2 REV) https://unesdoc.unesco.org/ark:/48223/pf0000253952 accessed 16 February 2022

United Nations Educational, Scientific and Cultural Organization 2019 Steering AI and Advanced ICTs for Knowledge Societies: A Rights, Openness, Access, and Multi-stakeholder Perspective https://unesdoc.unesco.org/ark:/48223/pf0000374014 accessed 12 March 2021

United Nations Educational, Scientific and Cultural Organization 2021 Artificial Intelligence Needs Assessment Survey in Africa https://unesdoc.unesco.org/ark:/48223/pf0000375322 accessed 12 March 2021

United Nations Educational, Scientific and Cultural Organization 2021 Recommendation on the Ethics of Artificial Intelligence https://unesdoc.unesco.org/ark:/48223/pf0000380455 accessed 17 February 2022

Vawda YA and Shozi B 2020 Eighteen Years After Doha: An Analysis of the Use of Public Health TRIPS Flexibilities in Africa https://ssrn.com/abstract=3559478 accessed 16 February 2022

Walch K 2020 AI Laws are Coming https://www.forbes.com/

sites/cognitiveworld/2020/02/20/ai-laws-are-coming/ accessed 12 March 2021

Wiegand T et al date unknown Whitepaper for the ITU/WHO Focus Group on Artificial Intelligence for Health https://www.itu.int/en/ITU-T/focusgroups/ai4h/Documents/FG-AI4H_Whitepaper.pdf accessed 13 March 2021

World Medical Association 2017 Declaration of Geneva Adopted by the 2nd General Assembly of the World Medical Association, Geneva, Switzerland, September 1948 and Last Amended by the 68th General Assembly, Chicago, United States, October 2017 https://www.wma.net/policies-post/wma-declaration-of-geneva/ accessed 16 February 2022

Zeng Y, Lu E and Huangfu C 2018 Linking Artificial Intelligence Principles https://arxiv.org/ftp/arxiv/papers/1812/1812.04814.pdf accessed 13 March 2021

Published

2022-04-07

How to Cite

Donnelly, D.-L. (2022). First Do No Harm: Legal Principles Regulating the Future of Artificial Intelligence in Health Care in South Africa. Potchefstroom Electronic Law Journal, 25, (Published 7 April 2022) pp 1 – 43. https://doi.org/10.17159/1727-3781/2022/v25ia11118

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Section

Articles