Artificial intelligence (AI) tools that could transform patient care \u2013 from reducing bowel cancer test times from weeks to minutes, to detecting skin cancer and genetic eye diseases sooner \u2013 are being tested in the next phase of the Medicines and Healthcare products Regulatory Agency\u2019s (MHRA) AI Airlock programme.\u00a0<\/p>\n
Seven manufacturers developing novel AI-powered healthcare technologies have been selected for the second phase of the programme, which provides a controlled environment to trial AI tools safely, ensure their effectiveness, identify limitations and challenges around the use of AI as a medical device, and explore potential pathways towards regulatory approval.\u00a0<\/p>\n
The in-depth insights from testing real-world technologies through the Airlock will inform future MHRA work on the regulation of AI, including recommendations to the MHRA\u2019s National Commission into the Regulation of AI in Healthcare<\/a> \u2013 which brings together patient advocates, clinicians, regulators, and tech companies to advise the MHRA on AI regulation in healthcare.\u00a0<\/p>\n The chosen technologies span AI-powered clinical note taking, advanced cancer diagnostics, eye disease detection, hospital stay summaries, and blood test interpretation \u2013 targeting critical challenges across the healthcare system and supporting clinicians to make faster, more informed decisions for patients.\u00a0<\/p>\n Health Innovation Minister Zubir Ahmed said:\u00a0<\/p>\n \u201cThe AI revolution is here and we want our NHS staff to be the first in the queue, armed with rigorously tested and evidenced clinical AI tools\u00a0<\/p>\n \u201cThe AI airlock programme is a great example of how we can test new innovations thoroughly while still moving at pace, as we seek to deliver on our promise to shift healthcare from analogue to digital.\u00a0<\/p>\n \u201cThrough our ten year health plan we will drive for the NHS to be the most AI-enabled healthcare system in the world.\u201d\u00a0<\/p>\n Lawrence Tallon, MHRA Chief Executive, said:\u00a0<\/p>\n \u201cAI technologies offer important opportunities to transform healthcare, but they also create new regulatory complexities, due to the rapid pace at which they are evolving.\u00a0<\/p>\n \u201cAs the first country to create a dedicated regulatory environment, or \u2018sandbox\u2019, specifically for AI medical devices, we\u2019re pioneering solutions to the unique challenges of regulating these emerging healthcare technologies.\u00a0\u00a0\u00a0<\/p>\n \u201cThe first phase of AI Airlock demonstrated the value of close collaboration between innovators and regulators. I look forward to seeing the results of this new cohort and how their technologies will shape the next generation of safe, effective AI tools in healthcare.\u201d\u00a0<\/p>\n Sir Andrew Goddard, AI Airlock Governance Board Chairman and Consultant Gastroenterologist at Royal Derby Hospital, said:\u00a0<\/p>\n \u201cAI holds enormous potential for the NHS to become faster and better at managing health and illness.\u00a0\u00a0<\/p>\n \u201cKeeping patients safe whilst allowing access to the most up to date innovations is a critical part of what the MHRA does, and I am really excited by the progress the AI Airlock is making in achieving this.\u00a0\u00a0<\/p>\n \u201cThe results of the first year of the programme published today show what can be achieved with collaborative working between the MHRA and industry. The second phase partners have been selected with current challenges facing the NHS in mind.\u00a0\u00a0<\/p>\n \u201cMany clinicians, like myself, are keen to see AI find its place in the NHS but are worried by over-promise on results and lack of reassurance with regards to patient safety. This programme goes a long way to embedding safety and rapid development of these new technologies in our health service.\u201d\u00a0<\/p>\n Phase two of the programme builds on the success of the pilot phase. Four reports published today<\/a> capture the key insights from the initial cohort, including a programme report and three workshop reports. These provide a blueprint for how the regulatory sandbox can accelerate safe AI innovation and support the Government\u2019s bold vision for the NHS to be the world\u2019s most AI-enabled healthcare system<\/a>.<\/p>\n Working with four innovative companies \u2013 Philips, Newton\u2019s Tree, OncoFlow, and Automedica Ltd \u2013 the AI Airlock programme identified a number of potential regulatory improvements and recommendations to enhance patient safety and support innovation. These included improvements for synthetic data validation, AI decision explainability, and innovative approaches to tackle emerging risks like AI hallucinations.\u00a0<\/p>\n Yinnon Dolev, Gen AI Product Owner at Philips Medical Systems, said:\u00a0<\/p>\n \u201cParticipating in the AI Airlock sandbox was a very positive experience. The chance for a R&D representative to impact the regulatory strategy with the regulator is almost unheard of.\u00a0<\/p>\n \u201cThe interaction with the team and experts was exceptional. They provided invaluable insights and support, making the entire process smooth and productive. Meeting with the MHRA on a weekly basis throughout the pilot was also a catalyst for meaningful progress expediting our development activities.\u201d\u00a0<\/p>\n Notes to editors\u00a0<\/p>\n The MHRA AI Airlock was launched in Spring 2024 and is the MHRA\u2019s first regulatory sandbox for AI as a Medical Device (AIaMD) products. Applications for the second round of the programme opened on 23 June 2025 and closed on 14 July 2025.\u00a0<\/p>\n For more information on the AI Airlock programme, visit: AI Airlock: the regulatory sandbox for AIaMD – GOV.UK<\/a>\u00a0<\/p>\n AI Airlock is backed by the Government\u2019s new Regulatory Innovation Office (RIO), which is supporting regulators to test more agile, flexible ways of working that can keep pace with emerging technologies like AI. By making the UK a more innovation-friendly environment, the RIO is helping to deliver the Government\u2019s Plan for Change \u2013 backing high-growth industries, supporting NHS innovation, and accelerating technologies that can make a real difference to people\u2019s lives.\u00a0<\/p>\n