MHRA issues guidance for people using mental health apps

As an increasing number of people turn to mental health apps and technologies for support, the Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on how to use the tools safely.

Not all digital mental health technologies are regulated as medical devices – some are instead classed as wellbeing or lifestyle products, which means they may not have been through the same checks.

MHRA and NHS England have developed free online resources for the public, parents, carers and professionals which use short animations and real-world examples to show what safe, well-evidenced digital mental health technologies look like, and explain how to report concerns through the MHRA Yellow Card scheme.

Professor Anthony Harnden, chair of the MHRA and professor of primary care at the University of Oxford, said: “When someone turns to a tool to help with their mental health, they need to know it is safe, effective, and built on reliable evidence.

“Our aim is to give people clear, practical advice they can use in everyday life, so they understand what good looks like and when to speak up if something doesn’t feel right.

“As a GP, I’ve seen how patients can benefit from accessing digital tools alongside traditional forms of care. This guidance supports better conversations between clinicians and patients and helps everyone ask the right questions about whether a tool is right for them.”

The resources were developed in partnership with NHS England’s MindEd Technology Enhanced Learning programme as part of a Wellcome-funded project to support the safe and effective use of digital mental health technologies.

Matthew Brown, head of digital technology, discovery research and mental health at Wellcome, said: “As more people turn to digital mental health technologies for support, we need practical ways for regulators, developers, and healthcare providers to work together so that safe, effective interventions reach those who need them.

“These technologies offer transformative opportunities, and we need better evidence to understand what works, for whom, and in which contexts.

“Our partnership with MHRA and NICE [National Institute for Health and care Excellence] over the coming years reflects this commitment, bringing research, policy, and innovation together to create earlier and more effective support for anxiety, depression, and psychosis.”

Dr Nick Crabb, chief scientific officer at NICE, said: “These new resources will help people ask the right questions and make informed choices.

“This matters now more than ever, as the government’s 10 year health plan expands NICE’s technology appraisal process to cover devices, diagnostics and digital products for the first time.”

The guidance follows the launch of GenAI tools for healthcare from OpenAI, Anthropic and Google in the US this month, which can analyse medical records and data from health apps to give personalised healthcare advice.

Pritesh Mistry, fellow in digital technologies at The King’s Fund, explores the implications of GenAI tools for healthcare in the UK in this opinion piece.

Learn more about the Wellcome-funded project on digital mental health technologies in this episode of the Digital Health Unplugged podcast.