Donnelly Dusty-Lee
School of Law, University of Kwa-Zulu Natal, South Africa.
Potchefstroom Electron Law J. 2022 Jan 11;25. doi: 10.17159/1727-3781/2022/v25ia11118. Epub 2022 Apr 7.
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.
人工智能系统和由人工智能驱动的医疗机器人与所有其他形式的先进医疗技术的不同之处在于，它们至少在一定程度上能够独立于人类医疗从业者运行，并利用机器学习生成新的、往往不可预见的分析和预测。这在适用于南非医疗保健的现行法律法规和道德准则框架下带来了挑战。本文概述了这些挑战，并提出了一个规范框架的指导原则，以规范人工智能在医疗保健中的使用。本文探讨了与医疗保健领域人工智能相关的法律改革的三个关键领域。首先，它建议更新将软件作为医疗设备进行监管的框架，以制定充分规范此类新技术使用的框架。其次，它认为南非目前针对医疗从业者的卫生专业人员委员会指南采取了一种过度限制的方法，该方法以过时的远程医疗语义为中心。这可能会阻碍能够改善全民医疗保健可及性的技术创新，因此这些指南与国家数字健康战略不一致。第三，它审视了基于过错的医疗过失责任普通法原则，在过错无法明确归咎于医疗从业者的情况下，这一原则可能不足以让新技术的患者和使用者获得损害赔偿。它主张应考虑制定一项严格责任法定计划，同时实行强制保险，并对与技术开发者和制造商相关的产品责任进行适当改革。在南非医疗保健领域对人工智能、机器人技术及相关技术进行道德使用时，在没有制定一个连贯的、以人权为中心的政策框架的情况下，不应进行这些法律改革。
