The Medicines and Healthcare products Regulatory Agency (MHRA) is planning to launch a ‘regulatory sandbox’ to support the development of AI services in the sector.
Named the AI-Airlock, it is scheduled for release in April 2024 and will provide a monitored virtual area for developers to generate robust evidence for their advanced technologies.
The plan has been promised funding from the Government as one of a number of projects receiving support under its £118 million AI skills based programme announced this week.
MHRA said means patients could benefit from faster access to developing technologies such as improved diagnostics or precision medicine.
Development of AI-Airlock will involve a partnership between government, regulators and industry will see advanced AI technology used in NHS settings, with strict safety controls, ahead of navigating regulatory approval.
It will help developers work within the current regulatory system, identify where their products need to build more evidence for a safety and efficacy assessment and help resolve these issues. This will involve a robust process, so manufacturers of software and AI medical devices understand and deliver what is required to ensure the real world viability of these devices.
MHRA said that further information will be made public when the AI-Airlock opens.
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Dr Paul Campbell, MHRA’s head of software and AI said: “Building on the success of the regulatory sandbox, we are excited to deliver a new, world leading methodology to support safe early access to AI for patients and healthcare.
“We need to ensure that AI is safe and properly regulated, but in a way that doesn’t stifle innovation and access to the latest of medical technologies to improve patient care.
“The deployment of AI and machine learning enabled med-tech devices is challenging, given the level of complexity of these products.
“However, by moving beyond conventional product concepts and associated regulations, sandboxes like the AI-Airlock offer a unique and safe learning space for manufacturers to work with regulators and other parties to explore new, cutting-edge solutions to help resolve these challenges.
“The new AI-Airlock scheme run by the MHRA will give us answers about how best to provide safe and effective products, such as AI-driven medical devices, to the NHS and patients.”
