UK MHRA unveils new regulatory sandbox for testing AI

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced what it describes as a ‘regulatory sandbox’ where artificial intelligence products are set to be tested.

Dubbed the AI Airlock, the tool is intended to allow developers a safe and isolated set of systems on which AI healthcare tools can be tested and demonstrated, before being implemented in a real-world setting.

The AI Airlock is intended to ensure that medical device manufacturers can understand and deliver what is required to ensure the real-world viability of their products, as well as offering a collaborative approach between different developers.

Paul Campbell, MHRA 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.”

It comes after UK Prime Minister Rishi Sunak vowed to tackle fears surrounding AI’s potential uses and after the Department of Health and Social Care set aside £21m in funding to roll AI tools out across the UK’s National Health System (NHS).

The AI Airlock service will be intended for launch in April 2024 and will allow AI developers and medical device firms to test their AI tools in front of and with input from regulators, academics and approved government bodies, as well as other developers.

Research carried out by GlobalData found that the global AI market for healthcare is set to reach $18.8bn by 2027, up from $4.8bn in 2022. Additionally, a 2022 survey carried out by GlobalData found that 66.7% of respondents identified AI as one of the most likely disruptive technologies in the healthcare space.

In the same survey over half of respondents believe drug development and discovery has the most potential to be impacted in some way by generative AI, at 54%, with impact on clinical trials following behind with 22%.

Campbell added: “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.” Medical Device Network