Kit Fotheringham

This article contributes to the ongoing debate about legal liability and responsibility for patient harm in scenarios where artificial intelligence (AI) is used in healthcare.We note that due to the structure of negligence liability in England and Wales, it is likely that clinicians would be held solely negligent for patient harms arising from software defects, even though AI algorithms will share the decision-making space with clinicians.Drawing on previous research, we argue that the traditional model of negligence liability for clinical malpractice cannot be relied upon to offer justice for clinicians and patients. There is a pressing need for law reform to consider the use of risk pooling, alongside detailed professional guidance for the use of AI in healthcare spaces.

Here, we provide a response to the UK Government's March 2023 white paper "A pro-innovation approach to AI regulation". We challenge the white paper's claims that it puts forward a balanced, pragmatic, proportionate, contextualised, and agile model that leverages the capabilities and skills of existing regulators to foster AI innovation. We also challenge the claims that the model is underpinned by a set of principles providing a clear, unified, and flexible framework that improves upon the current ‘complex patchwork of legal requirements’.

Artificially intelligent systems (AISs) are in development to aid the clinicians and patients of the United Kingdom’s National Health Service. We assess the statutory requirements for product liability claims against producers of defective AISs in clinical use and set out the criteria for bringing a successful claim against a producer to the courts of England and Wales. We argue that the mismatch between product liability and safety regulation leaves patients, and consumers more generally, without an adequate remedy for the consequences of AIS defects. We also discuss the intertwinement of the consumer Protection Act 1987 and the Medical Devices Regulations 2002. Recent developments such as United Kingdom’s withdrawal from the European Union and the updated Medicines and Medical Devices Act 2021 are discussed. In addition, we offer novel discussion regarding the tort of ‘breach of statutory duty’ as provided for by the Medicines and Medical Devices Act 2021.

This article theorises, within the context of the law of England and Wales, the potential outcomes in negligence claims against clinicians and software development companies (SDCs) by patients injured due to AI system (AIS) use with human clinical supervision. Currently, a clinician will likely shoulder liability via a negligence claim for allowing defects in an AIS’s outputs to reach patients. We question if this is ‘fair, just and reasonable’ to clinical users: we argue that a duty of care to patients ought to be recognised on the part of SDCs as well as clinicians. As an alternative to negligence claims, we propose ‘risk pooling’ which utilises insurance. Here, a fairer construct of shared responsibility for AIS use could be created between the clinician and the SDC; thus, allowing a rapid mechanism of compensation to injured patients via insurance.