We support new guidance from the Medicines and Healthcare Products Regulatory Agency (MHRA) on using apps and digital tools safely to support mental health and wellbeing.

The MHRA, which regulates medicines and medical devices, has worked with NHS England to develop resources to help people, parents, carers, and professionals understand what safe and effective digital mental health technologies look like. 

Rising use of digital tools

Digital mental health tools include mood trackers, mindfulness apps, guided meditation programs, and online CBT platforms.

They support mental health care but do not use AI to make decisions or adapt. They follow pre-set rules or fixed content pathways, providing structured exercises, guidance, or tracking for users

More people, including many young people, are turning these online tools to support their mental health. The new guidance will help users navigate the wide and often confusing array of digital mental health products.

It encourages people to ask five simple questions before using a digital mental health tool. These include understanding what the tool claims to do, who it is designed for, whether there is evidence it works, and how personal data is handled.

It also encourages checking whether a product is regulated as a medical device, meets UK safety standards, and how to report concerns if a tool causes harm or distress.

Regulatory gap in digital mental health support

While new guidance is welcome for apps that make medical claims, we remain concerned that many people are increasingly turning to more convenient digital platforms that fall outside this regulatory framework.

AI-powered tools that don’t claim to provide medical treatment may instead fall under broader legislation, which doesn’t specifically address their use for mental health support. This creates a gap in oversight and public understanding.

It’s important that people are aware that not all apps offering mental health advice or support are regulated, evidence-based, or subject to the same safety standards as recognised medical devices.

Why human connection matters

Martin Bell, our Head of Policy and Public Affairs said:

“While well-evidenced digital tools and apps can be beneficial, they can never replicate or replace the human touch of therapy. Human connection, authenticity, empathy, and compassion are the life and soul of successful therapy – and these require a trained human therapist.

“Advancements in digital mental health tools, apps, or AI made available through the NHS must be used alongside traditional therapy, not at the expense of investment in human-led care provided by qualified psychological professionals.”

“This guidance from the MHRA helps people access safe and effective digital mental health tools and identify options that are right for the individual and evidence based. It also provides clear advice on how to report harmful technology, which is a vital safeguard for the public.