MHRA funded to oversee digital mental health product standards

Receives £1.8m funding

Hemma Visavadia
clock • 1 min read

The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have received £1.8 million to explore and produce guidance on regulating digital mental health tools.

MHRA will use the funding to improve clarity around whether mental health products should be considered medical devices and the risk classification they would fall under, as well as a review of the current evidence base for these devices. The funding, which was provided by health and wellbeing researcher Wellcome, will last for three years to "help improve regulatory certainty and safety" on digital mental health devices, which have increased in number in recent years, particularly during the Covid-19 pandemic. Dr Caroline Johnson, minister for mental health, said that while digital m...

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