The National Commission is an independent expert advisory body established by the MHRA to advise the Government. The Commission’s recommendations have been shaped by evidence, expertise and extensive engagement. This has included input from its four expert working groups and wider research and engagement with patients and the public, healthcare professionals, healthcare organisations, industry, researchers, regulators and others across the health system
Statement from Dr Rosie Benneyworth, Interim Chief Executive
“We welcome the publication of the National Commission’s report and recommendations on the regulation of AI in healthcare. Artificial Intelligence has real potential to improve patient experiences and help health and care services respond to increasing demand. However, patient safety must remain at the centre of the implementation of any new technologies. Transparency, learning and continuous improvement will be essential as AI becomes more embedded in care.
“The Commission's vision for a regulatory framework that is safe, fast and trusted reflects the need to balance innovation with patient safety, public confidence and effective oversight. We agree that, to build confidence, patients and healthcare professionals must be given clear, accessible and transparent information on how AI is being used and how safety will be ensured. They must also be able to influence the process of governance, by having easy routes to raise concerns and share their experiences.
“The focus of the recommendations on proportionate, lifecycle-based regulation and shared responsibility across the healthcare system is particularly important. Understanding and managing the safety implications of AI is not the responsibility of any one organisation. It requires collaboration between developers, healthcare providers, regulators, policymakers and healthcare professionals to ensure risks are identified and addressed appropriately. It is very positive that the Commission recognise the need to manage these risks within a framework that establishes clear lines of accountability, meaningful oversight and a commitment to learning.
“The report crucially recognises that human factors plays an integral role in the improvement of healthcare safety. We very much welcome the recommendation that the MHRA should provide guidance to manufacturers incorporating human factors considerations into the phases of development, design and testing of software and AI-enabled devices.
“We have recently launched an investigation that focuses on the use of Ambient Voice Technology in hospitals which is a good example of where AI technology is accelerating but patient safety implications not fully understood. As this work progresses, we will carefully consider the Commission's recommendations and the wider conversations taking place across the healthcare system about the safe use of AI. By improving our understanding of both the opportunities and the risks associated with these technologies, we can help support their safe adoption in ways that benefit patients, staff and the healthcare system.”
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