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.

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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 by the Medicines and Medical Devices Act 2021.