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…