The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have been awarded £1.8 million by the Wellcome organisation to produce guidance on regulating digital mental health tools.
MHRA said that Wellcome, which funds research and runs policy and advocacy campaigns in healthcare, has provided the money for the next three years to help ensure products are risk-proportionate, effective and safe for use.
There has been a large increase in the number of such tools over recent years but there are questions such as whether they should be regarded as medical devices and which risk classification they fall under.
The project will review key aspects of medical device regulations and the current evidence base for the use of the tools. MHRA said this will involve engaging with people who have used them and international partners.
Questions to answer
Johan Ordish, head of software and AI at MHRA, said: “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.”
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.”
