MHRA AI Airlock regulatory sandbox receives £1m investment
- 24 June 2025
- The Medicines and Healthcare products Regulatory Agency’s (MHRA) AI airlock programme has received £1 million in funding
- The funding will help expand access to a regulatory testing ground where companies can work directly with regulators to safely test new AI-powered medical devices
- Applications for the second round of the programme are now open until 14 July 2025
The Medicines and Healthcare products Regulatory Agency (MHRA) has received £1 million in funding for its AI Airlock regulatory sandbox programme.
A regulatory sandbox is a tool which allows businesses to explore and experiment with new and innovative products, services or businesses under the supervision of a regulator.
The funding will help expand access to a regulatory testing ground which allows companies to work directly with regulators to safely test new AI-powered medical devices.
Applications for the second round of the programme are open from 23 June 2025 until 14 July 2025.
Baroness Merron, health minister, said: “AI 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.
“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.
“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.”
The AI Airlock programme launched in Spring 2024 to address the challenges in regulating medical devices that use AI.
MHRA selected four AI technologies focused on addressing critical healthcare challenges, for the inaugural AI Airlock cohort, a pilot phase.
These include a Radiology Auto Impression project from Philips which tested the use of generative AI to automate the writing of radiologists’ final impressions, and OncoFlow, a project looking at the use of AI to help healthcare professionals create personalised management plans for cancer patients.
A project from Automedica Ltd, investigated the regulatory advantages of using retrieval-augmented generation technologies with verified knowledge bases and Large Language Models.
The other project by startup Newton’s Tree tested its Federated AI Monitoring Service to identify and mitigate AI risks in clinical settings, including performance drift or safety issues.
Results from the pilot projects will be published in 2025, with the aim of providing insights to shape the AI Airlock programme and help inform broader regulatory approaches to the effective and safe use AI in healthcare.
James Pound, interim executive director, innovation and compliance at MHRA, said: “Traditional regulatory pathways weren’t designed with AI’s unique characteristics in mind – 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.
“The 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.
“With AI, we must balance robust oversight with flexibility that doesn’t stifle innovation, and this programme achieves that balance.”
The AI Airlock builds on commitments in the government’s AI Opportunities Action Plan, announced by prime minister Keir Starmer in January 2025, which is backed by the government’s Regulatory Innovation Office.
