The Medicines and Healthcare products Regulatory Agency (MHRA) has issued new guidance for the public and healthcare professionals on the use of apps and digital tools for mental health support, aiming to help people make more informed choices and “know what to do if something doesn’t feel right”.
Anthony Harnden, MHRA chair 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.”
As part of the new guidance, the agency has published online resources including animations and real-world examples demonstrating “what safe, well-evidenced digital mental health technologies look like in practice”, going on to explain how to report concerns through the MHRA Yellow Card scheme. The resources form part of a project designed to support the safe and effective use of digital mental health technologies, funded by the Wellcome Trust.
The MHRA also lists five things to check prior to using a digital mental health tool, stating that claims around medical benefits should be clearly explained and supported by evidence, that age and intended users should be clearly stated, and that “trustworthy products will explain how they have been tested or evaluated”. Users should be able to find out easily how their data is stored and used, it continues, and if a digital mental health technology is classed as a medical device, users are able to check whether the products is registered by looking for a CE or UKCA mark, or by checking the MHRA’s online public register.
Resources are split into those for the general public and resources for health and social care professionals via the MindEd website. This focuses on steps that can be taken to review the intended purpose, safety, and evidence backing for a digital mental health product, and how their safety is monitored, including how to report concerns when the use of a product “has contributed to an adverse incident”.
Nick Crabb, NICE chief scientific officer, noted how the new resources will help people to ask the right questions and make informed choices, adding: “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.”
Wider trend: Digital mental health
Innovate UK is granting £3.6 million to supplier-led projects delivering digital therapeutic solutions for mental health, focusing on extended reality (XR) tech such as virtual reality, augmented reality, mixed reality, and haptics. The Mindset XR for digital mental health programme is offering funding to 17 projects in total, that address conditions spanning ADHD, autism, generalised anxiety disorder, and PTSD, with the aim of treating more people, including those in remote or underserved areas. Selected projects are set to be developed and trialled over 12-to-18 months, with the UKRI noting their potential for widespread impact and delivering “scalable mental health solutions that could be adopted into the UK’s formal mental healthcare ecosystem”.
Thames Valley and Wessex Adult Secure Provider Collaborative has opened a preliminary market engagement exercise for a patient flow clinical information system to be used across its low and medium adult mental health services, known as Shaped for Me. The collaborative, a partnership of seven mental health service providers including NHS trusts and independent providers across five integrated care systems, is aiming to understand the market capability to deliver a digital platform to replace its current incumbent solution.
Researchers at Cambridgeshire and Peterborough NHS Foundation Trust and the University of Cambridge are to lead on a project to create a “publicly accessible platform for exploring how genes and molecules influence mental health”. The Open Psychiatry Project, has been provided with £2.3 million funding from the UK Research and Innovation Medical Research Council and the National Institute for Health and Care Research. The project aims to deliver a platform to offer data-driven support to researchers, clinicians, health partners and patients when it comes to understanding mental health conditions and how best to treat them.
