Medicines and Healthcare products Regulatory Agency (MHRA) have selected five innovative technologies for the AI Airlock, a pilot scheme to better understand how artificial intelligence (AI) powered medical devices can work as quickly and safely as possible.
Having the potential to significantly improve the diagnosis and care of patients, these new medical devices include devices for cancer and radiology services, among others.
AI technology is particularly difficult to prove that it is safe to be used in healthcare settings, including the fact that the medical device changes as it learns.
AI Airlock is a regulatory “sandbox”: a study where manufacturers can best explore how to collect evidence that could later be used to support the approval of their product, which is carried out under MHRA supervision in a virtual or simulated setting. This will help the manufacturer and the MHRA better understand the challenge of regulating AI in medical devices, and paving the way for quicker NHS and patient access to potentially transformative AI technologies.
Laura Squire, MedTech regulatory reform lead and chief officer at the MHRA, said: “New AI medical devices have the potential to increase the accuracy of healthcare decisions, save time and improve efficiency, leading to better outcomes for the NHS and patients across all healthcare settings.
“But we need to be confident that AI-powered medical devices introduced into the NHS are safe, and stay safe and perform as intended through their lifetime of use.
“By examining the technologies announced today in a safe setting, in partnership with technology specialists, developers and the NHS, we can test and improve the rules for AI-powered medical devices, helping get products like these to the hospitals and patients who need them sooner.”
Karin Smyth, minister of state for health (secondary care) said: “As part of our 10 Year Health Plan, we’re shifting NHS care from analogue to digital and this project will help bring the most promising technology to patients.
“AI has the power to revolutionise care by supporting doctors to diagnose diseases, automating time-consuming admin tasks and reducing hospital admissions by predicting future ill health allowing targeted, preventative action.”
Science minister, Lord Vallance said: “AI Airlock is a great example of government working with businesses to enable them to turn ideas into products that improve lives. This shows how good regulation can facilitate emerging technologies for the benefit of the UK and our economy.”
For full information on the five selected technologies, please visit here.
