This article provides a comprehensive analysis of the various dimensions in South African law applicable to personal genomic sequence data. This analysis includes property rights, personality rights, and intellectual property rights. Importantly, the under-investigated question of whether personal genomic sequence data are capable of being owned is investigated and answered affirmatively. In addition to being susceptible of ownership, personal genomic sequence data are also the object of data subjects’ personality rights, and can also be the object of intellectual property rights: whether on their own qua trade secret or as part of a patented invention or copyrighted dataset. It is shown that personality rights constrain ownership rights, while the exploitation of intellectual property rights is constrained by both personality rights and ownership rights. All of these rights applicable to personal genomic sequence data should be acknowledged and harmonized for such data to be used effectively.

The idea of a data transfer agreement (DTA) template for the South African (SA) research community is receiving increasing attention. Whiledeveloping such a DTA template is certainly a worthwhile project, questions regarding the project’s practical execution should be addressed,including how to best operationalise the envisioned DTA template, and the content of the envisioned DTA template. It is proposed that anempowerment approach be followed in operationalising the envisioned DTA template, which is contrasted with the regulatory approachfollowed with the material transfer agreement that the Minister of Health promulgated in 2018. While the regulatory approach would entailgovernment making the use of the envisioned DTA template compulsory regardless of the quality of such a template, the empowermentapproach, by contrast, entails a focus on developing a high-quality, professionally drafted DTA template for the SA research community andmaking the use thereof a matter of own choice. Regarding the content of the envisioned DTA template, four hot-button content provisionsare analysed, and it is argued that SA research institutions and researchers should be empowered to: (i) have clarity and legal certaintyregarding their ownership of data, where relevant; (ii) be able to commercialise their research findings without unnecessary contractualconstraints; (iii) avoid falling into the trap of unlawful benefit sharing with research participants; and (iv) be aware that their legal role asresponsible parties, where relevant, cannot be contracted out via a DTA.

Despite the tremendous promise offered by artificial intelligence (AI) for healthcare in South Africa, existing policy frameworks are inadequate for encouraging innovation in this field. Practical, concrete and solution-driven policy recommendations are needed to encourage the creation and use of AI systems. This article considers five distinct problematic issues which call for policy development: (i) outdated legislation; (ii) data and algorithmic bias; (iii) the impact on the healthcare workforce; (iv) the imposition of liability dilemma; and (v) a lack of innovation and development of AI systems for healthcare in South Africa. The adoption of a national policy framework that addresses these issues directly is imperative to ensure the uptake of AI development and deployment for healthcare in a safe, responsible and regulated manner.

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.