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. (shrink)

BackgroundHuman 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 textAs 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.ConclusionsIt 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. (shrink)

With recent advancements in systems engineering and artificial intelligence, autonomous agents are increasingly being called upon to execute tasks that have normative relevance. These are tasks that directly—and potentially adversely—affect human well-being and demand of the agent a degree of normative-sensitivity and -compliance. Such norms and normative principles are typically of a social, legal, ethical, empathetic, or cultural nature. Whereas norms of this type are often framed in the abstract, or as high-level principles, addressing normative concerns in concrete applications of (...) autonomous agents requires the refinement of normative principles into explicitly formulated practical rules. This paper develops a process for deriving specification rules from a set of high-level norms, thereby bridging the gap between normative principles and operational practice. This enables autonomous agents to select and execute the most normatively favourable action in the intended context premised on a range of underlying relevant normative principles. In the translation and reduction of normative principles to SLEEC rules, we present an iterative process that uncovers normative principles, addresses SLEEC concerns, identifies and resolves SLEEC conflicts, and generates both preliminary and complex normatively-relevant rules, thereby guiding the development of autonomous agents and better positioning them as normatively SLEEC-sensitive or SLEEC-compliant. (shrink)

With recent advancements in systems engineering and artificial intelligence, autonomous agents are increasingly being called upon to execute tasks that have normative relevance. These are tasks that directly—and potentially adversely—affect human well-being and demand of the agent a degree of normative-sensitivity and -compliance. Such norms and normative principles are typically of a social, legal, ethical, empathetic, or cultural (‘SLEEC’) nature. Whereas norms of this type are often framed in the abstract, or as high-level principles, addressing normative concerns in concrete applications (...) of autonomous agents requires the refinement of normative principles into explicitly formulated practical rules. This paper develops a process for deriving specification rules from a set of high-level norms, thereby bridging the gap between normative principles and operational practice. This enables autonomous agents to select and execute the most normatively favourable action in the intended context premised on a range of underlying relevant normative principles. In the translation and reduction of normative principles to SLEEC rules, we present an iterative process that uncovers normative principles, addresses SLEEC concerns, identifies and resolves SLEEC conflicts, and generates both preliminary and complex normatively-relevant rules, thereby guiding the development of autonomous agents and better positioning them as normatively SLEEC-sensitive or SLEEC-compliant. (shrink)

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. (shrink)