UK accepts continuous monitoring plan for AI medical devices

The UK government has accepted 44 recommendations from the National Commission into the Regulation of AI in Healthcare, including a plan for the Medicines and Healthcare products Regulatory Agency, or MHRA, to continually monitor artificial intelligence-based medical devices, according to Fierce Biotech.

Fierce Biotech reported that the approach would replace the current policy of an initial check without ongoing monitoring. The government accepted the recommendations on October 6.

Continuous oversight proposed for AI devices

According to Fierce Biotech, the reforms are intended to help patients benefit from safe, effective and trusted AI while maintaining safeguards as technologies evolve. The publication reported that AI medical devices may be used inside patients and can present risks including malfunction, hacking or new forms of harm.

Fierce Biotech reported that the UK government described its objective as creating an agile approach to AI device regulation. Health Innovation Minister James Frith said that innovation must not come at the expense of patient safety and that oversight will evolve as the technology develops.

MHRA opens third AI Airlock phase

As part of the government response, the MHRA is opening applications for the third phase of its AI Airlock, a regulatory sandbox for AI-enabled medical devices, Fierce Biotech reported. Testing during that phase will be informed by the Commission recommendations.

An implementation roadmap is set to be published in spring next year, according to Fierce Biotech. The reported actions place ongoing regulatory monitoring and AI Airlock testing alongside the UK government response to the Commission recommendations.

Key developments reported by Fierce Biotech

• The UK government accepted 44 recommendations from the National Commission into the Regulation of AI in Healthcare.
• The MHRA is set to continually monitor AI-based medical devices.
• Applications are opening for the third phase of the AI Airlock.
• An implementation roadmap is set for publication in spring next year.