The U.K.’s drug and medical technology regulatory body the MHRA will continually monitor all artificial intelligence-based devices.
This will be a major step up from the current policy, which relies on one initial check-and-done approach.
The move forms part of a new series of 44 recommendations made by the National Commission into the Regulation of AI in Healthcare, which was accepted by the U.K. government on Tuesday, October 6. An “implementation roadmap” is set to published in spring next year.
As part of this response, the MHRA is also opening the call for applications for the third phase of its so-called “AI Airlock,” its regulatory sandbox for AI-enabled medical devices, with testing informed by the Commission’s recommendations.
The idea is to create a “world-leading agile approach to AI device regulation,” said the U.K. government in an Oct. 6 release. “The reforms aim to ensure patients can benefit from safe, effective and trusted AI more quickly, while maintaining robust safeguards as technologies evolve.”
This comes amid growing trepidation more broadly in some quarters, notably within the AI industry itself, of how quickly AI is developing and how well safeguards are keeping up with the pace of development.
This is especially sensitive in the medtech world, where AI devices are used inside patients and pose risks of malfunction, hacking or potentially causing harm in new ways, which requires a newer methodology of regulation.
“We want all patients to benefit from the life-saving potential of AI, with the confidence that it is safe, effective and properly overseen,” said Health Innovation Minister James Frith in a statement.
“We also want to see the NHS harness the best new technologies to give patients faster, better care and give staff more time to focus on patients," he added. "But innovation must never come at the expense of patient safety. This will be a continually evolving process as the technology itself develops.”