UK Agencies Plan to Clarify Mental Health Tool Regulation

The UK’s National Institute for Health and Care Excellence (NICE) and the Medicines and Healthcare products Regulatory Agency (MHRA) said they aim to clarify the regulation and safety of digital mental health with the help of more than $1.9 million in funding from the Wellcome foundation.

NICE said the funding will help address the large increase in digital mental health tools on the market in recent years. The products present regulatory challenges, NICE said, including deciding whether they are medical devices and if so, under which risk classification they fall.

The funding comes from UK-based Wellcome, a foundation established in 1936 that aims to support health science.

The agencies said their aim is to review the current evidence base for these devices. “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,” said Johan Ordish, MHRA’s head of software and AI.