Speed, safety and trust: The blueprint for regulating AI in healthcare

Digital Health Unplugged returns as host Jordan Sollof is joined by Lawrence Tallon, chief executive at the Medicines and Healthcare products Regulatory Agency (MHRA), to discuss the newly published blueprint for regulating AI in healthcare. The National Commission into the Regulation of AI in Healthcare published its recommendations today (10 September), setting out how the UK can give patients faster, safer access to AI in their care. Tallon discusses some of the key recommendations and what they could mean for patients, clinicians and developers of AI-enabled medical devices. Among the proposals is a staged, “L-plates” style approach to authorising new AI models, designed to enable promising technologies to reach patients more quickly while evidence about their safety and effectiveness continues to develop. Sollof asks Tallon how the proposed system would work and, crucially, how regulators could ensure that speeding up access does not expose patients to greater risk. The discussion also explores the commission’s call for continuous, real-world monitoring of AI-enabled medical devices throughout their working lives, including who would be responsible for monitoring systems once they are deployed and why a single point of approval may no longer be sufficient for AI technologies that can change over time. Tallon is questioned on proposals to make safety information about individual AI-enabled medical devices easier to access, whether patients should be told every time AI is involved in their care and what happens if someone does not want an AI system to be used. The episode also tackles one of the biggest questions surrounding the growing use of healthcare AI: who is accountable when something goes wrong? Sollof then asks what stronger powers proposed for the MHRA could allow the regulator to do when an AI system falls short of expected standards, and whether the commission’s recommendations could address concerns about AI scribes and ambient voice technology after reports of errors appearing in patients’ medical records. Guest: Lawrence Tallon, chief executive, the MHRA