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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 for by the Medicines and Medical Devices Act 2021.
Smith et al. (Tue,) studied this question.