A \u00a31 million boost to the Medicines and Healthcare products Regulatory Agency\u2019s (MHRA) pioneering AI Airlock programme will expand access to a first-of-its-kind regulatory testing ground where companies can work directly with regulators to safely test new AI-powered medical devices and explore how to bring them to patients faster, through streamlined regulations.<\/p>\n
Applications for the second round of the programme open today (23 June 2025) and follow a successful pilot phase that saw four breakthrough AI technologies, including software that could help doctors create personalised cancer treatment plans, and a tool to help hospitals, AI developers, and regulators monitor AI performance in real time, tested in a regulatory \u2018sandbox\u2019 environment.<\/p>\n
Similar to an airlock on a spacecraft, the \u2018sandbox\u2019 testing space creates a boundary between experimental AI and fully approved medical technology used in the real world.<\/p>\n
This initiative builds on commitments in the Government\u2019s AI Opportunities Action Plan<\/a>\u00a0and the government response to the Regulatory Horizons Council report on regulation of AI as a medical device<\/a>\u00a0to enable safe AI innovation through strategic guidance to regulators and enhance their AI capabilities.<\/p>\n This programme 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 cutting unnecessary red tape and 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.<\/p>\n Science Minister, Lord Vallance, said:<\/p>\n \u201cBacking innovation means backing better regulation \u2013 and that\u2019s what the RIO is here to do.<\/p>\n \u201cSmarter, faster approaches like the AI Airlock are helping to cut red tape, bring safe new technologies to patients quicker, and ease pressure on our NHS \u2013 fuelling the Government\u2019s Plan for Change.\u201d<\/p>\n Health Minister, Baroness Merron, said:<\/p>\n \u201cAI has huge potential to improve healthcare, and we need to use it safely and responsibly. The AI Airlock programme is a great example of how we can test new technology thoroughly while still moving quickly.<\/p>\n \u201cThis \u00a31 million investment will help bring new medical tools to patients faster and strengthen the UK\u2019s position as a global leader in healthcare innovation.\u201d<\/p>\n Those selected for the next round of the AI Airlock programme will be able to test their AI healthcare products under careful supervision allowing for regulatory challenges to be identified early and adjustments made.<\/p>\n James Pound, MHRA Interim Executive Director, Innovation and Compliance, said:<\/p>\n \u201cTraditional regulatory pathways weren\u2019t designed with AI\u2019s unique characteristics in mind \u2013 including its capacity to analyse large quantities of data and help automate existing manual processes. The AI Airlock programme helps address this gap by creating a supervised testing ground where these novel technologies and challenge areas can be safely investigated.<\/p>\n \u201cThe technologies and devices which have been evaluated to date have shown the limitless potential of AI to improve patient outcomes, free up NHS resources, and enhance the accuracy and efficiency of healthcare services.<\/p>\n \u201cWith AI, we must balance robust oversight with flexibility that doesn\u2019t stifle innovation, and this programme achieves that balance.\u201d<\/p>\n Four projects were selected for the inaugural AI Airlock cohort, each focused on addressing critical healthcare challenges using AI. Among them was health technology multinational Philips\u2019 Radiology Auto Impression project which tested the use of generative AI to automate the writing of radiologists\u2019 final impressions \u2013 a critical section of radiology reports that summarises key findings from imaging procedures.<\/p>\n Working directly with MHRA experts through weekly meetings, the team gained valuable insights about the need to involve their end users \u2013 radiologists \u2013 to help define testing strategies. As Yinnon Dolev, Philips\u2019 Advanced Development NLP (Natural Language Processing) Tech Lead noted, the collaboration with regulators was \u201calmost unheard of\u201d and provided \u201ca catalyst for meaningful progress expediting our development activities.\u201d<\/p>\n OncoFlow, another first round project, looked at the use of AI to help healthcare professionals create personalised management plans for cancer patients, with the potential to reduce waiting times for cancer appointments, leading to earlier treatment and the possibility of significantly increasing patients\u2019 chances of survival. Co-founder Aruni Ghose said the Airlock programme provided his team with the chance to validate the product in a simulated clinical setting and \u201cpressure-test it against real regulatory standards\u201d which has helped the company accelerate its progress \u201cfrom idea to a validated MVP (Minimum Viable Product).\u201d<\/p>\n Rounding out the cohort have been two projects; one by Automedica Ltd, investigating the regulatory advantages of using retrieval-augmented generation (RAG) technologies with verified knowledge bases and Large Language Models (LLMs); and the other by health tech startup Newton\u2019s Tree testing its Federated AI Monitoring Service (FAMOS) to identify and mitigate AI risks in clinical settings, including performance drift or safety issues.<\/p>\n Results from all four pilot projects will be published later this year, providing valuable insights that will shape the AI Airlock programme moving forward and help inform broader regulatory approaches to the effective and safe use AI in healthcare.<\/p>\n Eligible candidates for the second cohort must demonstrate that their AI-powered medical device has the potential to deliver significant benefits to patients and the NHS, presents a new treatment approach, and offers a regulatory challenge ready to be tested in the Airlock programme.<\/p>\n Applications for cohort two open on 23 June 2025 and will close on 14 July 2025.<\/p>\n Notes to editors<\/p>\n Applications for the AI Airlock programme\u2019s second cohort are open from 23 June \u2013 14 July 2025. More information can be found at AI Airlock: the regulatory sandbox for AIaMD – GOV.UK<\/a>.<\/p>\n<\/li>\n The programme was launched in Spring 2024 and is the MHRA\u2019s first regulatory sandbox for AI as a Medical Device (AIaMD) products.<\/p>\n<\/li>\n The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All work is underpinned by robust and fact-based judgements to ensure that benefits justify any risks.<\/p>\n<\/li>\n The MHRA is an executive agency of the Department of Health and Social Care.<\/p>\n<\/li>\n\n