UK Medicines Regulator Calls for New Laws to Govern AI Use in Healthcare

The chief executive of the UK's Medicines and Healthcare products Regulatory Agency has told the BBC that new legislation is needed to govern the use of artificial intelligence in healthcare, warning that AI will soon be routinely used across the NHS. Lawrence Tallon explained that current regulatory frameworks were not designed to oversee AI-driven medical tools, which can learn and adapt over time in ways that traditional medical devices do not. The BBC reports that the MHRA is concerned about the safety, transparency and accountability of AI systems used in clinical decision-making, diagnostics and patient monitoring. Tallon emphasised that regulation must balance innovation with patient safety, and that clear legal frameworks are needed to define who is responsible when AI systems make errors or produce harmful outcomes.

Why this matters for UK organisations

For UK organisations operating in healthcare, life sciences or adjacent sectors, this signals that regulatory expectations around AI are tightening. The MHRA's position reflects broader concerns about how AI systems are validated, monitored and held accountable, particularly when they influence decisions that affect patient safety. This is not just a healthcare issue: the same questions about transparency, accountability and governance apply to AI use in financial services, legal services, recruitment and other regulated sectors. Organisations deploying AI tools need to understand how those systems make decisions, what data they rely on, and who is responsible when things go wrong. The call for new legislation suggests that regulatory frameworks will become more prescriptive, and that organisations should expect greater scrutiny of how AI is developed, tested and deployed. This includes understanding how AI systems are validated, how they are monitored for drift or bias, and how accountability is assigned when AI-driven decisions lead to adverse outcomes.

What to review

Review how AI systems are governed, validated and monitored within your organisation. Consider whether you have clear accountability for AI decision-making, whether AI tools are subject to the same risk management and oversight as other critical systems, and whether your organisation can explain how AI-driven decisions are made. Regulatory expectations are likely to increase, and organisations that establish clear governance now will be better positioned to meet future requirements. This includes understanding what AI systems are in use, how they are tested and validated, who is responsible for their outputs, and whether there are clear processes for monitoring performance, detecting errors and responding when AI systems produce harmful or incorrect results. For organisations in regulated sectors, this also means understanding how AI governance aligns with existing regulatory obligations around data protection, patient safety, consumer protection and professional accountability.

Source: BBC News