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Please note this is an extract of the original bulletin.

Update on pioneering initiative on regulation and evaluation of digital mental health technologies

Page summary:
An MHRA and NICE partnership, funded by Wellcome, is addressing key challenges for regulating and evaluating digital mental health technologies (DMHTs) with input from patients, the public and mental health professionals.

Change made:
First published.

Software and artificial intelligence (AI) as a medical device

Page summary:
Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD).

Change made:
Added links to Scotland and Northern Ireland incident reporting centres

MHRA launches AI Airlock to address challenges for regulating medical devices that use Artificial Intelligence

Page summary:
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (9 May 2024) launched AI Airlock, its new regulatory sandbox for AI as a Medical Device (AIaMD).

Change made:
First published.

AI Airlock: the regulatory sandbox for AIaMD

Page summary:
A proactive, collaborative, agile and the first of its kind approach to identifying and addressing the challenges faced by AI as a Medical Device (AIaMD).

Change made:
First published.

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