Legal and ethical principles governing the use of artificial intelligence in radiology services in South Africa.

Artificial intelligence (AI) will drastically change the healthcare system. Radiology is one speciality that is most affected as AI algorithms are increasingly used in diagnostic imaging. AI-enhanced health technologies will, inter alia, increase workflow efficiency, improve diagnostic accuracy, reduce healthcare-related costs, and help alleviate medical personnel shortages in under-resourced settings. However, the development of AI-enhanced technologies in healthcare is fraught with legal, ethical, and human rights concerns. Currently, the use of AI in South African healthcare is not governed by sui generis legislation or ethical guidance focused exclusively and specifically on AI, although various provisions and principles from law and ethics find application. This article outlines these normative principles and explains their relationship with the extant legal obligations and regulatory framework as applied to the use of AI in radiology services in South Africa. The article concludes with three key recommendations for radiology practitioners using AI in South Africa. These are the need for: vigilant monitoring of AI use in practice, reforms to the liability framework, and appropriate guidance from local regulators and the Health Professions Council of South Africa on the ethical use of AI.

Future of global regulation of human genome editing: a South African perspective on the WHO Draft Governance Framework on Human Genome Editing.

WHO in 2019 established the Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing, which has recently published a Draft Governance Framework on Human Genome Editing. Although the Draft Framework is a good point of departure, there are four areas of concern: first, it does not sufficiently address issues related to establishing safety and efficacy. Second, issues that are a source of tension between global standard setting and state sovereignty need to be addressed in a more nuanced fashion. Third, it fails to meaningfully engage with the extent to which the conceptualisation of human dignity may justifiably vary between jurisdictions. Fourth, the meaning of harm to the interests of a future person requires clarity. Provided these four areas of concern can be addressed, the future of the global governance of human genome editing may hold promise.

Human genome editing: how to prevent rogue actors.

BACKGROUND: Human genome editing technologies offer much potential benefit. However, central to any conversation relating to the application of such technologies are certain ethical, legal, and social difficulties around their application. The recent misuse, or inappropriate use, by certain Chinese actors of the application of genome editing technologies has been, of late, well noted and described. Consequently, caution is expressed by various policy experts, scientists, bioethicists, and members of the public with regard to the appropriate use of human germline genome editing and its possible future effect on future generations. MAIN TEXT: As concerns about the applications of heritable genome editing have grown, so too have the questions around what is to be done to curtail 'rogue actors'. This paper explores various ways in which to regulate genomic editing that are socially beneficial, while being cognisant of legal and ethical principles and rights values. This is done by evolving regulatory frameworks across jurisdictions in an attempt to raise issues, address common principles, and set responsible standards for stewardship of the novel technology. CONCLUSIONS: It is suggested that robust and concrete regulatory measures be introduced that are culturally and contextually sensitive, inclusive, appropriate, and trustworthy - and are based on public empowerment and human rights objectives. Doing so will ensure that we are perfectly positioned to harness and promote the benefits that novel technologies have to offer, while safeguarding public health and curtailing the ambitions of rogue actors. This it is acknowledged is no easy task, so, as a point of departure, this paper sets out a path forward by means of certain, practical recommendations - by constructing genome editing regulation in a manner that both fulfils the desire to better progress human health and that can withstand legal and ethical scrutiny. The following observations and recommendations are made: Firstly, that a solution of effective, legitimate governance should consist of a combination of national and supranational legislative regulation or 'hard' law, in combination with 'soft' ethics, firmly anchored in and underpinned by human rights values. Second, that efforts to support legal and ethical solutions should be rigorous, practical, and robust, contribute to a reaffirmation of human rights in a contextually sensitive manner, and be transnational in reach. Lastly, that greater harmonisation across jurisdictions and increased public engagement be sought. This it is proposed will address the question of how to implement a normative framework which in turn can prevent future rogue actors.

Mapping the regulatory landscape of AI in healthcare in Africa.

Introduction: Artificial intelligence (AI)-enhanced technology has seen unprecedented expansion in the recent past. This growth brings with it huge opportunities for the positive transformation of the economy, business, healthcare, and society. However, a critical question is whether, and to what extent, regulatory measures and mechanisms have been implemented to safeguard its design, development, and deployment. This paper offers a scoping exercise that maps the regulatory landscape of AI in healthcare (including health research) in certain African countries. Methods: This research is conducted across 12 African countries: Botswana, Cameroon, The Gambia, Ghana, Kenya, Malawi, Nigeria, Rwanda, South Africa, Tanzania, Uganda, and Zimbabwe. As limited specific AI legislation is found in these African countries, and because AI is informed by ancillary regulatory frameworks, we include data protection, digital health, consumer protection, and intellectual property in our research. A scoping review method was applied with a manual search of digital libraries with search terms customised for each repository consisting of core search terms for the various topics, including, among others, "law," "regulation," "artificial intelligence," "data protection," "intellectual property," and "digital health". Results and discussion: Analysis of the data demonstrated that while in the African countries under investigation there is no sui generis AI regulation, recent developments were found in areas that inform AI adoption, including in digital health, data protection, consumer protection, and intellectual property. Our findings highlight the fragmentation of the African AI regulatory landscape and illustrate the importance of continued AI regulatory development to ensure that Africa is well positioned for future AI adoption in health.

Medical practitioner perspectives on AI in emergency triage.

Introduction: A proposed Diagnostic AI System for Robot-Assisted Triage ("DAISY") is under development to support Emergency Department ("ED") triage following increasing reports of overcrowding and shortage of staff in ED care experienced within National Health Service, England ("NHS") but also globally. DAISY aims to reduce ED patient wait times and medical practitioner overload. The objective of this study was to explore NHS health practitioners' perspectives and attitudes towards the future use of AI-supported technologies in ED triage. Methods: Between July and August 2022 a qualitative-exploratory research study was conducted to collect and capture the perceptions and attitudes of nine NHS healthcare practitioners to better understand the challenges and benefits of a DAISY deployment. The study was based on a thematic analysis of semi-structured interviews. The study involved qualitative data analysis of the interviewees' responses. Audio-recordings were transcribed verbatim, and notes included into data documents. The transcripts were coded line-by-line, and data were organised into themes and sub-themes. Both inductive and deductive approaches to thematic analysis were used to analyse such data. Results: Based on a qualitative analysis of coded interviews with the practitioners, responses were categorised into broad main thematic-types, namely: trust; current practice; social, legal, ethical, and cultural concerns; and empathetic practice. Sub-themes were identified for each main theme. Further quantitative analyses explored the vocabulary and sentiments of the participants when talking generally about NHS ED practices compared to discussing DAISY. Limitations include a small sample size and the requirement that research participants imagine a prototype AI-supported system still under development. The expectation is that such a system would work alongside the practitioner. Findings can be generalisable to other healthcare AI-supported systems and to other domains. Discussion: This study highlights the benefits and challenges for an AI-supported triage healthcare solution. The study shows that most NHS ED practitioners interviewed were positive about such adoption. Benefits cited were a reduction in patient wait times in the ED, assistance in the streamlining of the triage process, support in calling for appropriate diagnostics and for further patient examination, and identification of those very unwell and requiring more immediate and urgent attention. Words used to describe the system were that DAISY is a "good idea", "help", helpful, "easier", "value", and "accurate". Our study demonstrates that trust in the system is a significant driver of use and a potential barrier to adoption. Participants emphasised social, legal, ethical, and cultural considerations and barriers to DAISY adoption and the importance of empathy and non-verbal cues in patient interactions. Findings demonstrate how DAISY might support and augment human medical performance in ED care, and provide an understanding of attitudinal barriers and considerations for the development and implementation of future triage AI-supported systems.

A deliberative public engagement study on heritable human genome editing among South Africans: Study results.

This paper reports the results of a public engagement study on heritable human genome editing (HHGE) carried out in South Africa, which was conducted in accordance with a study protocol that was published in this journal in 2021. This study is novel as it is the first public engagement study on HHGE in Africa. It used a deliberative public engagement (DPE) methodology, entailing inter alia that measures were put in place to ensure that potential participants became informed about HHGE, and that deliberations between the participants were facilitated with the aim of seeking consensus. A diverse group of 30 persons was selected to participate in the DPE study, which took place via Zoom over three consecutive weekday evenings. The main results are: Provided that HHGE is safe and effective, an overwhelming majority of participants supported allowing the use of HHGE to prevent genetic health conditions and for immunity against TB and HIV/Aids, while significant majorities opposed allowing HHGE for enhancement. The dominant paradigm during the deliberations was balancing health benefits (and associated improvements in quality of life) with unforeseen health risks (such as loss of natural immunity). The seriousness of a health condition emerged as the determining factor for the policy choice of whether to allow an application of HHGE. More generally, equal access to HHGE qua healthcare service featured as an important value, and it was uncontested that the South African government should allocate resources to promote scientific research into HHGE. These results are aligned with the policy principles for regulating HHGE in South Africa suggested by Thaldar et al. They call for urgent revision of South African ethics guidelines that currently prohibit research on HHGE, and for dedicated HHGE legal regulations that provide a clear and comprehensive legal pathway for researchers who intend to conduct HHGE research and clinical trials.

The multidimensional legal nature of personal genomic sequence data: A South African perspective.

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.

A virtual deliberative public engagement study on heritable genome editing among South Africans: Study protocol.

This article outlines the protocol for a prospective study for virtual deliberative public engagement on heritable genome editing in humans. The study intends to create a platform for a diverse group of 25-30 South Africans to engage with a facilitator and each other on 15 policy questions regarding heritable genome editing, with a focus on: a) the prevention of heritable genetic conditions; b) editing for immunity; and c) editing for enhancement. The aim is to understand the views on these issues so as to inform further research and policy, and to analyse the process and effect of deliberation on opinion. Participants will be expected to study the provided resource materials and pass the entrance exam-aligning with the protocols of the Harvard Personal Genome Project. In this way, the commitment, openness and basic knowledge of the candidates will be tested to ascertain whether they are suitable participants for the deliberative engagement.