The MHRA has selected seven AI healthcare technologies for the second phase of its AI Airlock programme, giving medical algorithms a controlled room in which to prove they can help patients without immediately requesting a lanyard, a keynote slot and the keys to the NHS.
The programme will examine safety, effectiveness and limitations while manufacturers and regulators explore possible routes towards approval. This is regulation doing its job, rather than waiting for a confident app to diagnose the entire waiting room before asking whether it brought any evidence.
Each system must bring its claims to the door, leave unsupported certainty in the tray and explain what happens when the data is less tidy than the demonstration. The selected tools cover clinical note taking, cancer diagnosis, eye disease detection, hospital summaries and blood test interpretation. Even the spreadsheet has been told to remain calm.
‘A health tool is not clever merely because it makes a graph,’ said Professor Della Dataset, Chief Examiner of Excitable Screens. ‘The useful question is whether it works safely when a real human being is no longer standing beside it saying, “Wait, no, not like that.”’
The technologies are being tested because they might help clinicians work faster and make better informed decisions. They are not being invited to replace clinical judgement, which will reassure anyone who has watched a printer misread a straightforward form and then behave as if it had discovered a new branch of medicine.
The Airlock gives developers and regulators somewhere to inspect the difficult parts before a product arrives wearing the word “revolutionary” like a fluorescent vest. Testing can expose weak evidence, unclear limits and the precise moment when an impressive prediction turns out to be the hospital carpet.
Medical AI has a curious relationship with confidence. A screen can produce an answer in half a second, while the human team spends ten minutes asking whether that answer relates to the patient or merely resembles something the software encountered during training. The Airlock exists to keep those questions in the room, where they cannot be edited out of the launch presentation.
The work will also inform future MHRA thinking about regulation in healthcare. Thus the algorithms are being examined, the rules are being examined and the rules for examining the rules are preparing a listening exercise about whether the examination has captured the correct stakeholders.
By the time the first tool leaves the Airlock, it may have learned that evidence is not an optional accessory and that “the computer said so” is not a clinical pathway. The NHS can then welcome the machines properly, by issuing a password that expires before the algorithm has finished explaining why it needs access to everything.
Real story: Medicines and Healthcare products Regulatory Agency.
