ARTICLE SUMMARY:
The UK device regulator MHRA wants to team up with AI medical device developers and other experts to solve vexing oversight problems for the emerging class of technologies. It plans to start accepting applications to its new AI Airlock “regulatory sandbox” this fall.
Companies developing artificial intelligence-driven medtech tools are at the vanguard of healthcare innovation but also of medical device regulation. AI/machine learning technology opens up questions that have yet to be fully answered for regulators operating under traditional device frameworks. The UK device authority wants to step out ahead to fill those knowledge gaps with a novel approach that it plans to roll out this fall.
The AI Airlock as it will be called is a “regulatory sandbox” developed by the UK Medicines and Healthcare products Regulatory Agency (MHRA), which is gearing up to start accepting applications from companies to participate in a pilot phase in the next month.
“We want to try and make this a team sport.”
The program will invite four to six makers of next-generation AI devices who are experiencing “some sort of problem” with regulatory development to work alongside regulators, approved bodies (the UK’s version of notified bodies), and the National Healthcare System (NHS) to find solutions, said Paul Campbell, head of software and AI at MHRA, in an interview. The sandbox will serve as a protected but collaborative space, he explained, where “we can all learn and understand, ‘Is there a problem? What is the problem? How do we handle the problem? Whose problem is it? What needs to be done?’”
