Artificial intelligence (AI) tools that could transform patient care – from reducing bowel cancer test times from weeks to minutes, to detecting skin cancer and genetic eye diseases sooner – are being tested in the next phase of the Medicines and Healthcare products Regulatory Agency’s (MHRA) AI Airlock programme.
Seven manufacturers developing novel AI-powered healthcare technologies have been selected for the second phase of the programme, which provides a controlled environment to trial AI tools safely, ensure their effectiveness, identify limitations and challenges around the use of AI as a medical device, and explore potential pathways towards regulatory approval.
The in-depth insights from testing real-world technologies through the Airlock will inform future MHRA work on the regulation of AI, including recommendations to the MHRA’s National Commission into the Regulation of AI in Healthcare – which brings together patient advocates, clinicians, regulators, and tech companies to advise the MHRA on AI regulation in healthcare.
The chosen technologies span AI-powered clinical note taking, advanced cancer diagnostics, eye disease detection, hospital stay summaries, and blood test interpretation – targeting critical challenges across the healthcare system and supporting clinicians to make faster, more informed decisions for patients.
Sir Andrew Goddard, AI Airlock Governance Board Chairman and Consultant Gastroenterologist at Royal Derby Hospital, said: “AI holds enormous potential for the NHS to become faster and better at managing health and illness. Keeping patients safe whilst allowing access to the most up to date innovations is a critical part of what the MHRA does, and I am really excited by the progress the AI Airlock is making in achieving this.
“The results of the first year of the programme published today show what can be achieved with collaborative working between the MHRA and industry. The second phase partners have been selected with current challenges facing the NHS in mind. Many clinicians, like myself, are keen to see AI find its place in the NHS but are worried by over-promise on results and lack of reassurance with regards to patient safety. This programme goes a long way to embedding safety and rapid development of these new technologies in our health service.”
Phase two of the programme builds on the success of the pilot phase. Four recently published reports capture the key insights from the initial cohort, including a programme report and three workshop reports. These provide a blueprint for how the regulatory sandbox can accelerate safe AI innovation and support the Government’s vision for the NHS to be the world’s most AI-enabled healthcare system.
Working with four innovative companies – Philips, Newton’s Tree, OncoFlow, and Automedica Ltd – the AI Airlock programme identified a number of potential regulatory improvements and recommendations to enhance patient safety and support innovation. These included improvements for synthetic data validation, AI decision explainability, and innovative approaches to tackle emerging risks like AI hallucinations.
The AI Airlock Phase 2 Cohort includes:
- Nu & Aegis AI Conversational & Monitoring System - Numan
Numan’s AI system aims to aid patients to understand blood test results by providing personalised, evidence-based explanations of blood test results in accessible language. The regulatory challenge focuses on how such AI systems can offer explanatory support to patients in a way that is demonstrably safe, transparent, and validated.
- PANProfiler Colorectal (MSI/MMR) - Panakeia Technologies
Around 44,100 people in the UK are diagnosed with colorectal cancer each year, yet only 58% begin treatment within the NHS-recommended 62-day window. Treatment delays often arise because patients require additional laboratory tests for mismatch repair deficiency (MMR/MSI) which help doctors decide on the best treatment - but these tests typically take two-four weeks. PANProfiler Colorectal (MMR/MSI) uses artificial intelligence to analyse the same tissue slides pathologists use for diagnosis. The AI delivers results within minutes, without extra tests, allowing doctors to make faster treatment decisions. The technology has been validated on over 4,700 UK colorectal cancer samples, showing similar accuracy to current laboratory tests, and it has now been approved for NHS use. Regulatory challenges remain: laboratory methods vary across hospitals, tumours can behave differently, and definitions of ‘positive’ or ‘negative’ results are not fully standardised.
- Octopath
Advances in personalised medicine require increasingly complex, time-consuming diagnostic analysis to select targeted therapies, but this demand is colliding with a shrinking specialist workforce, creating unsustainable workloads and diagnostic delays. Octopath addresses this by augmenting pathologists with a state-of-the-art AI platform, delivering rapid, quantitative analysis from routine digital pathology slides. Its models provide clinically relevant outputs like mitotic index and immune cell infiltration to support faster, more consistent diagnoses. However, as an adaptive AI in-vitro diagnostic device, Octopath presents novel regulatory challenges, particularly in clinical evaluation and managing post-market updates.