Healthcare regulator MHRA is fast-tracking new AI tools that promise to dramatically improve patient care.
The wait for medical test results can stretch from days, to weeks, or even months. That wait period is often filled with worry and it always feels like an eternity. But what if that wait could be cut from weeks down to just a few minutes?
In the next phase of its ‘AI Airlock’ programme, the Medicines and Healthcare products Regulatory Agency (MHRA) is evaluating seven new technologies designed to tackle some of healthcare’s most pressing challenges.
The innovations being trialled could slash the time for bowel cancer test results to mere minutes and enable earlier detection of skin cancer and genetic eye diseases. The AI Airlock initiative provides a secure, controlled environment for manufacturers to test these sophisticated systems. This “regulatory sandbox” allows for evaluation of the AI’s effectiveness and limitations, helping to forge a clear path towards eventual regulatory approval and deployment within the health service.
The insights gained from this real-world testing will directly inform the MHRA’s future regulations for AI as a medical device and feed into the National Commission into the Regulation of AI in Healthcare. This commission brings together a diverse group of patient advocates, clinicians, regulators, and technology companies to advise the agency.
The seven selected technologies include AI-powered clinical note-taking to reduce administrative burdens on doctors, advanced cancer diagnostics, sophisticated eye disease detection, and tools that can summarise a patient’s entire hospital stay or interpret complex blood tests. The ultimate goal is to use AI to support clinicians, helping them to make faster and better-informed care decisions for their patients.
Health Innovation Minister Zubir Ahmed 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.
“Through our ten year health plan we will drive for the NHS to be the most AI-enabled healthcare system in the world.”
Pioneering a path for safe AI healthcare innovation
The evolution of AI presents unique challenges for regulators tasked with ensuring patient care safety.
Lawrence Tallon, MHRA Chief Executive, commented: “As the first country to create a dedicated regulatory environment, or ‘sandbox’, specifically for AI medical devices, we’re pioneering solutions to the unique challenges of regulating these emerging healthcare technologies.
“The first phase of AI Airlock demonstrated the value of close collaboration between innovators and regulators. I look forward to seeing the results of this new cohort and how their technologies will shape the next generation of safe, effective AI tools in healthcare.”
This second phase builds upon the success of the initial pilot. The MHRA has published four reports detailing the key findings from the first group of participants, which included innovative companies like Philips and OncoFlow.
Working with the initial cohort, the AI Airlock programme identified several areas for regulatory improvement. These included better methods for validating synthetic data used to train AI models, ensuring the decisions made by an AI are “explainable” to a clinician, and developing novel approaches to tackle emerging risks such as AI “hallucinations,” where a model generates incorrect or nonsensical information.
Yinnon Dolev, Gen AI Product Owner at Philips Medical Systems, said: “Participating in the AI Airlock sandbox was a very positive experience. The chance for a R&D representative to impact the regulatory strategy with the regulator is almost unheard of.
“The interaction with the team and experts was exceptional. They provided invaluable insights and support, making the entire process smooth and productive. Meeting with the MHRA on a weekly basis throughout the pilot was also a catalyst for meaningful progress expediting our development activities.”
A clinician’s perspective of using AI tools for patient care
For frontline medical staff, the promise of AI is coupled with a healthy dose of caution. Sir Andrew Goddard, Chairman of the AI Airlock Governance Board and a Consultant Gastroenterologist at Royal Derby Hospital, emphasised the programme’s role in building trust.
“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,” explained Sir Goddard. “This programme goes a long way to embedding safety and rapid development of these new technologies in our health service.”
By bringing innovators and regulators together at an early stage, the AI Airlock will help to deliver the next wave of medical technology to improve patient care, but in a manner that is also safe, reliable, and worthy of the trust of both patients and doctors.
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