NICE and the MHRA have been awarded £1.8m in funding by Wellcome over three years to explore and create guidance on regulating digital mental health tools.
In the last few years, there has been a large increase in the number of digital mental health tools on the market. However, these products face regulatory challenges surrounding if they are medical devices and which risk clarification they would fall under.
To explore this, Wellcome will provide £1.8m funding to improve regulatory certainty and safety in this high-growth, high-impact area, and create guidelines for appropriate, risk-proportionate regulation of digital mental health products.
“This work is one way both organisations can simplify and streamline the process of getting wide-scale adoption of safe, clinical and cost-effective digital mental health products,” commented Mark Salmon, programme director for Information Services at NICE.
Reviewing existing standards
The project will review key elements of medical device regulations to produce guidance that will support these mental health tools in multiple significant areas. This includes establishing what qualifies as a medical device, the risk classification it would come under, and reviewing the current evidence for these devices.
“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,” added Johan Ordish, head of Software and AI at the MHRA.
Creating new guidance for digital mental health tools
The team of experts will engage and learn from people with lived experience, subject experts and patients to inform their conclusions. They will also work with international partners to encourage shared learning in digital mental health regulations globally.
The team are hoping that certain mental health software will be regulated correctly as a medical device, allowing the public can access effective and safe products to improve their mental health.
Mark Salmon, programme director for Information Services at NICE, said, “this work is one way both organisations can simplify and streamline the process of getting wide-scale adoption of safe, clinical and cost-effective digital mental health products into the hands of the people who need them and help ease the pressure on the NHS.”
Dr Miranda Wolpert, director of Mental Health at Wellcome, said, “as an increasing number of people turn to digital tools for support with mental health problems, we believe that getting the right level of regulation is vital.
“At Wellcome, we support the development of new and improved interventions for mental health, which includes digital interventions. One of the ways that we can encourage the development of tools that genuinely help and support as many people as possible will be through risk-appropriate guidance and regulation.
“The MHRA will be engaging with and learning from people with lived experience of mental health conditions, helping to ensure that that the regulation is at the right level, relevant and robust.”
