The head of the Medicines and Healthcare products Regulatory Agency (MHRA) has told the BBC that the United Kingdom needs fresh laws to oversee the growing use of artificial intelligence in health services.
Lawrence Tallon said AI tools will soon be a routine feature of care in the NHS and argued that existing regulatory arrangements are not sufficient to manage the risks and challenges posed by their wider adoption. His comments position the MHRA at the centre of calls for a clearer legal framework for AI-driven medical devices and clinical decision support systems.
Why regulation matters
Healthcare regulators typically assess safety, efficacy and quality for medical products, and Tallon’s intervention highlights concerns about how those responsibilities apply to software that learns and changes over time. New or updated laws could set out duties for developers, standards for clinical validation, and processes for ongoing oversight — areas Tallon suggested need formalisation as AI becomes more embedded in clinical pathways.
Context and next steps
Tallon’s remarks come as health services globally experiment with AI for diagnostics, workflow optimisation and patient-facing applications. In the UK, the debate over how to balance innovation with patient safety and data protection is expected to shape future policy discussions. The MHRA is likely to be a key participant in any legislative work aimed at defining how AI should be assessed, approved and monitored within the NHS.