The Government recognises that artificial intelligence (AI) in clinical decision-making has significant potential to improve patient outcomes and efficiency, while raising important questions about accountability and patient safety.
Existing legal and regulatory frameworks provide a strong basis for allocating responsibility for potential harms. These include clinical negligence law, professional standards, product liability regimes, and oversight from regulators such as the Medicines and Healthcare products Regulatory Agency (MHRA), the Care Quality Commission, the Information Commissioner and the National Institute for Health and Care Excellence.
Responsibility for patient care decisions remain with clinicians, who must exercise professional judgement when using AI tools. As AI becomes more embedded in clinical pathways, in the event of an incident, this would likely involve multiple parties and responsibilities would likely be apportioned accordingly, depending on the circumstances.
The Government recognises that AI introduces novel considerations around the distribution of responsibility between manufacturers, software licensors, and users. The Department has commissioned work from NHS Resolution to assess how existing liability frameworks apply to AI use cases and to provide greater clarity.
This is further supported by recent research from the MHRA’s National Commission into the Regulation in Healthcare, which highlights strong support for AI in healthcare provided there are robust safeguards, clear accountability, and ongoing monitoring and performance.
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