Digital mental health tool funding announced

Wellcome has awarded £1.8 million of funding to the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) over three years to explore digital mental health tools.

The funding has also been awarded to improve regulatory certainty and safety in the digital mental health tools field. There has been an increase in availability of the tools, but there remains a lack of clarity around whether they are medical devices, and therefore which risk classification they fall under.

The funding will focus on providing guidance for "appropriate, risk-proportionate regulation of digital mental health products".

Medical device regulations will be reviewed and new guidance will be produced on what qualifies as a medical devices and the risk classification they would fall under, as well as a review of the current evidence base for these devices.

Minister for Mental Health, Dr Caroline Johnson, said: "Digital mental health tools can be incredibly useful to help build resilience and prevent problems worsening, but it’s crucial these are regulated properly.

"This funding will help us to better understand these products and give us the tools to make sure everyone who uses them has access to safe, effective support."

Johan Ordish, Head of Software and AI at the MHRA said: "Digital mental health tools offer millions of people vital support and guidance to explore and help manage their mental health issues every day.

"However, there are a number of regulatory complexities in establishing when these products should be regulated and what evidence they must have to demonstrate safety and effectiveness.

"We need to make sure that we are able to answer these questions, to ensure that patients can be confident in the choices they make to support their mental health."


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