AI breakthroughs expand the MHRA’s ‘Airlock’ testing programme to accelerate AI-powered healthcare innovation
The Medicines and Healthcare products Regulatory Agency (MHRA) has secured a £1 million investment to expand its AI Airlock programme. This initiative offers a unique regulatory testing space where companies collaborate directly with regulators to safely trial new AI-powered medical devices and explore faster patient access through streamlined regulations.
Applications for the programme’s second round opened on 23 June 2025, following a successful pilot phase. The initial cohort tested four innovative AI technologies, including software designed to assist doctors in creating personalised cancer treatment plans and a monitoring tool that enables hospitals, AI developers, and regulators to track AI performance in real time within a controlled ‘sandbox’ environment.
What is the AI Airlock programme?
Named after the airlock system in spacecraft, this regulatory ‘sandbox’ creates a protective boundary between experimental AI technologies and fully approved medical devices used in clinical settings. This approach builds on government commitments to support safe AI innovation through strategic guidance and enhanced regulatory capabilities, as outlined in the AI Opportunities Action Plan and the Regulatory Horizons Council report on AI as a medical device.
The AI Airlock programme is supported by the Government’s Regulatory Innovation Office (RIO), which promotes agile and flexible regulatory methods to keep pace with emerging technologies like AI. By reducing unnecessary bureaucracy, RIO aims to create a more innovation-friendly environment in the UK, supporting NHS innovation and accelerating technologies that improve patient outcomes.
Voices from leadership
Science Minister Lord Vallance emphasised the link between innovation and regulation, stating: “Smarter, 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.”
Health Minister Baroness Merron highlighted the programme’s role in balancing safety and speed: “AI has huge potential to improve healthcare, and we need to use it safely and responsibly. This £1 million investment will help bring new medical tools to patients faster and strengthen the UK’s position as a global leader in healthcare innovation.”
Benefits for participants
Selected companies gain access to a supervised testing environment where regulatory challenges can be identified early and addressed effectively. James Pound, MHRA Interim Executive Director for Innovation and Compliance, noted that traditional regulatory frameworks were not designed with AI’s unique capabilities in mind. The AI Airlock fills this gap by providing a controlled space to safely investigate novel AI technologies and regulatory issues.
He added, “The evaluated technologies have shown AI’s potential to improve patient outcomes, free up NHS resources, and enhance healthcare delivery. The programme balances robust oversight with flexibility to avoid stifling innovation.”
Insights from the inaugural cohort
- Philips’ Radiology Auto Impression Project: This initiative tested generative AI to automate the critical section of radiology reports summarising imaging findings. Close collaboration with MHRA experts helped Philips better involve radiologists in defining testing strategies. Philips’ NLP Tech Lead, Yinnon Dolev, described the regulator partnership as “almost unheard of,” accelerating their development process.
- OncoFlow: Using AI to support personalised cancer management plans, OncoFlow aims to reduce waiting times and improve survival chances. Co-founder Aruni Ghose praised the Airlock for allowing validation in a simulated clinical environment and “pressure-testing” against real regulatory standards, speeding progress from concept to a validated minimum viable product.
- Automedica Ltd: Explored regulatory benefits of retrieval-augmented generation (RAG) combined with verified knowledge bases and Large Language Models (LLMs).
- Newton’s Tree: Tested their Federated AI Monitoring Service (FAMOS) to detect and mitigate AI risks in clinical settings, such as performance drift or safety concerns.
Results from these pilot projects will be published later this year, providing insights to refine the AI Airlock and inform wider regulatory strategies for AI in healthcare.
How to apply for the second cohort
Eligible applicants must demonstrate that their AI-powered medical device offers significant benefits to patients and the NHS, presents a novel treatment approach, and poses regulatory challenges suitable for the Airlock environment.
Applications for the second cohort are open from 23 June to 14 July 2025. More details and application guidance can be found on the Complete AI Training website.
Background
The AI Airlock programme launched in Spring 2024 as the MHRA’s first regulatory sandbox focused on AI as a medical device (AIaMD) products. The MHRA regulates medicines and medical devices in the UK, ensuring they are safe and effective through evidence-based assessments. The agency operates under the Department of Health and Social Care.
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