Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, and advisor to MedTech suppliers, promotes calls to put patient safety at the heart of AI MedTech regulation.
The Patient Safety Commissioner, Professor Henrietta Hughes, has called on the Medicines and Healthcare products Regulatory Agency (MHRA) to put patients and the public at the centre of regulatory decision-making as the agency navigates a period of rapid technological change. In a wide-ranging statement posted on the MHRA blog site, the commissioner warned that failing to listen to patients can allow avoidable harm to persist, while genuine partnership with those affected by care can transform safety outcomes.
Addressing a future where artificial intelligence and enhanced post-market surveillance play an increasingly prominent role, the commissioner said regulators must strike a careful balance between accelerating access to novel treatments and maintaining an unwavering commitment to patient safety. That balance, she argued, is becoming even more critical as devices and systems evolve after approval in ways traditional products do not.
“Patients and the public bring perspectives that no clinical trial or regulatory framework can fully capture,” the commissioner said, emphasising that lived experience reveals how medicines and medical devices perform across diverse populations, across a range of health conditions, and over many years in real-world settings. They warned that current surveillance systems risk missing subtle safety signals — particularly those affecting vulnerable groups with different risk profiles — unless post-market monitoring is substantially strengthened.
The commissioner pointed to recent work on The Safety Gap report, involving patients with sensory impairments, as evidence that involving patients and their representatives from the outset prevents harm and drives improvement. She said the input of patients should not be treated as a box-ticking exercise but as a genuine partnership woven into regulatory lifecycles.
Last year’s Patient Safety Principles, published by the commissioner, were highlighted as a practical framework for doing so. The principles call for a culture of safety that places patients at the heart of decisions, promotes equity and tackles health inequalities, identifies and mitigates risks proactively, demands transparency and accountability, and makes better use of data and information to improve outcomes. The commissioner urged regulators to embed these principles from strategy formation through to post-market monitoring.
The commissioner will co-chair the National Commission on the Regulation of AI in Healthcare, a body intended to bring together patients, researchers, clinicians and technology leaders to examine AI’s benefits and dangers for patients and those who care for them. The commission aims to shape policies around how AI systems are trained, how bias is identified and removed, and how outputs are validated and monitored once in use.
Misinformation and bias in AI outputs were cited as urgent threats. The highlighted previous warnings from the MHRA’s own Chief Executive, Lawrence Tallon, warned of “an age of insidious misinformation” and urged regulators to speak with authority and clarity. She welcomed recent MHRA communications on the safety of paracetamol-based products as an example of how quick, accurate messaging from a trusted regulator can protect the public.
As patients increasingly turn to AI chatbots for health advice, the commissioner stressed the need for safeguards over the content that drives algorithms and clarity about how bias and misinformation will be eliminated.
Transparency and accountability are central to the commissioner’s demands. Patients have a right to know when AI influences their care, to be told about system limitations and uncertainties, and to understand who is responsible when AI-informed decisions lead to harm — the clinician, the healthcare organisation, or the software developer.
The commissioner concluded that the future of medical regulation should not be framed as a choice between innovation and safety. True innovation, she said, serves patients best when rooted in trust, robust safety measures and genuine partnership between regulators, clinicians, industry and the people they exist to protect.
The Author used AI in preparing this article. Comments upon or questions about this article can be addressed to chris.whitehouse@whitehousecomms.com.
