UK – MHRA and NICE awarded £1.8m to explore regulation of digital mental health tools

The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have been awarded £1.8m in funding by Wellcome over three years to support the exploration and production of guidance on digital mental health tool regulation.

The healthcare sector has seen a considerable increase in the number of digital mental health tools made available in recent years. Despite this improvement in offering, products like this can present regulatory challenges such as clarity regarding whether they are medical devices and, if so, can often lead to a lack of defined risk classification.

As a means of providing a solution to this issue, Wellcome has invested £1.8m of funding to help improve regulatory certainty and safety in this high growth, high impact area, with a central steer on creating guidance for suitable, risk-proportionate regulation of digital mental health products…