MHRA issues new guidance for mental health tech
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The Medicines and Healthcare products Regulatory Agency (MHRA) has issued new guidance for people using mental health apps and technologies.

New online resources will help the public, parents, carers and health, social care and education professionals understand what safe, effective digital mental health technologies look like in practice.

The resources have been developed with NHS England.

More people, especially young people are using digital tools for mental health support. This could include symptom-tracking apps and virtual reality therapies.

However, these are not always reliable, safe, or right for an individual. The new guidance is designed to help people make informed choices.

The new online resources use short animations and real-world examples to show what safe, well-evidenced digital mental health technologies look like in practice, and explain how to report concerns through the MHRA Yellow Card scheme so action can be taken to protect others.

The guidance is aimed at those using the technologies, as well as parents and carers, and includes professionals who often recommend them, including teachers, nurses, GPs and mental health practitioners. 

MHRA Chair and professor of primary care at the University of Oxford, Professor Anthony Harnden, 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.

“Digital mental health technologies are not a replacement for professional healthcare. Anyone experiencing mental health difficulties should seek support from trained professionals.”

Chief Scientific Officer at NICE, Dr Nick Crabb, said: “Our role at NICE is to help practitioners and commissioners get the best care to people, fast, while ensuring value for the taxpayer. As digital mental health technologies become more widely used, it’s vital that people can access tools that are safe, effective and built on robust evidence.

“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. Our collaboration with the MHRA and Wellcome is helping to lay the groundwork for this – ensuring that innovation in mental health is matched by rigorous, proportionate evaluation so that the best digital tools can reach those who need them.”