Healthcare products regulator 'to move forward' with AI HealthTech sandbox

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced it will move forward with a regulatory sandbox developed for AI healthcare tools.

MHRA said the partnership between government, regulators and industry will see advanced AI technology used in NHS settings, with strict safety controls, ahead of navigating regulatory approval.

The government agency’s AI-Airlock will provide a regulator-monitored virtual area for developers to generate robust evidence for their advanced technologies.

Noting that AI-related technologies can sometimes be challenging to test using traditional trial techniques, the watchdog said those developing such technology could benefit from the AI-Airlock project’s collaborative approach to identifying and managing evidence requirements.

Where successful, the AI-Airlock will help NHS patients to benefit earlier from emerging technologies before they are available anywhere else in the world, it added.

“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,” said Dr Paul Campbell, MHRA head of software and AI. ““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.”

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