Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, and advisor to MedTech suppliers, focuses on the MHRA’s programme for the development and adoption of new AI MedTech.
In a significant step toward embedding artificial intelligence into frontline healthcare, the Medicines and Healthcare products Regulatory Agency (MHRA) has selected seven emerging AI-powered technologies for the second phase of its AI Airlock programme.
Launched in 2024, the AI Airlock is the MHRA’s regulatory “sandbox” for AI as a Medical Device. Its mission is to provide a safe, structured environment where innovative AI tools can be tested in real or semi-real clinical settings. This allows researchers, developers, and regulators to observe and refine deployment pathways before full-scale clinical use.
Insights gained from testing real-world technologies through the Airlock will inform future MHRA work on AI regulation, including recommendations to the National Commission into the Regulation of AI in Healthcare. This Commission brings together patient advocates, clinicians, regulators, and technology companies to guide the MHRA’s approach to AI governance in healthcare.
The selected technologies include AI-powered clinical notetaking, advanced cancer diagnostics, eye disease detection, hospital stay summarisation, and blood test interpretation. Collectively, these tools address key challenges across the healthcare system, helping clinicians make faster, more informed decisions for patients and potentially enabling earlier disease detection.
The first phase of the programme provided important lessons, highlighting the need for stronger approaches to synthetic data validation, explainability of AI decision-making, and mitigation of risks such as AI hallucinations. The second phase will expand real-world testing and refine regulatory models to support safe and scalable adoption.
Commenting on the announcement, Health Innovation Minister, Zubir Ahmed MP, a vascular surgeon said: “The 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.”
The Author used AI in preparing this article. Comments upon or questions about this article can be addressed to [email protected].
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