The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a funding boost of £1 million for its AI Airlock regulatory sandbox program.
What is the AI Airlock?
A regulatory sandbox is a framework that enables businesses to test and experiment with innovative products and services under the supervision of a regulatory body.
Funding Purpose
This funding aims to:
- Enhance access to a regulatory testing environment.
- Facilitate direct collaboration between companies and regulators for safe testing of AI-powered medical devices.
Application Timeline
Applications for the second round of the program are open from 23 June 2025 to 14 July 2025.
Ministerial Insights
Baroness Merron, health minister, emphasized the importance of AI in healthcare, stating:
“AI has huge potential to improve healthcare, and we need to use it safely and responsibly. The AI Airlock program is a great example of how we can test new technology thoroughly while still moving quickly.”
She added that this investment will expedite the delivery of new medical tools to patients and bolster the UK’s position in healthcare innovation.
Program Background
The AI Airlock program was launched in Spring 2024 to tackle regulatory challenges associated with AI medical devices. The inaugural cohort included:
- Philips: A Radiology Auto Impression project utilizing generative AI for automating radiologists’ final impressions.
- OncoFlow: A project aimed at helping healthcare professionals develop personalized cancer management plans.
- Automedica Ltd: Investigating regulatory advantages of retrieval-augmented generation technologies.
- Newton’s Tree: Testing a Federated AI Monitoring Service to identify and mitigate AI risks in clinical settings.
Future Insights
Results from these pilot projects are expected to be published in 2025, providing valuable insights to refine the AI Airlock program and inform broader regulatory strategies for AI in healthcare.
Regulatory Challenges
James Pound, interim executive director at MHRA, noted:
“Traditional regulatory pathways weren’t designed with AI’s unique characteristics in mind. The AI Airlock program helps address this gap by creating a supervised testing ground for these novel technologies.”
He emphasized the need for a balance between oversight and flexibility to foster innovation.
Government Support
The AI Airlock initiative aligns with the government’s AI Opportunities Action Plan, announced by Prime Minister Keir Starmer in January 2025, and is supported by the Regulatory Innovation Office.