People across the UK will have better access to high quality,
safe and effective digital mental health support, thanks to
extended funding for clearer regulation and evaluation of these
technologies.
The Medicines and Healthcare products Regulatory Agency (MHRA)
and the National Institute for Health and Care Excellence (NICE)
have secured a £2 million funding boost from Wellcome to continue
its joint work on clearer, more consistent regulation and
evaluation of digital mental health technologies. Running to
Autumn 2028, the renewed support builds on activities already
underway to help people across the UK access safe and effective
digital mental health technologies.
From symptom-tracking apps to AI-powered assessments and virtual
reality therapy, digital mental health technologies are
increasingly used by individuals and across the NHS to support
mental health. Research from the UK suggests they can provide real benefits
for some people, in managing depression, anxiety and stress,
alongside other forms of care. As these technologies become more
embedded in everyday care, clear standards and reliable evidence
are essential so users, clinicians and services can trust how
they work and what they offer.
Although certain digital mental health technologies fall under
medical device regulations and must meet the same strict safety
standards as other medical devices, new research from
Woodnewton suggests that many people do not realise they can
report problems with digital mental health tools in the same way,
via the Yellow Card scheme,
reinforcing the need for clearer guidance and communication.
Since launching in 2023, the
programme has focused on introducing clearer, risk-proportionate
regulation and evaluation to a fast-moving area, working closely
with people with lived
experience, mental health specialists, developers and
international partners.
The next phase will build on current work in the software and
artificial intelligence (AI) team, including to:
- Establish a digital mental health technology AI airlock
- Explore international reliance and mutual recognition for the
regulation of digital mental health technologies
- Drive increased quality and evidence for digital mental
health technologies on the UK market
- Consider challenges in transporting evidence across
international settings
For the public and clinicians, this will mean better access to
high quality, safe and effective digital mental health
technologies and clearer information about what they do, how they
have been assessed, and the evidence behind them. For developers,
this will provide a clearer framework that supports both
innovation and safety.
This funding is part of Wellcome's
commitment to drive transformation in early intervention for
anxiety, depression and psychosis, to create a world where no one
is held back by mental health problems.
Lawrence Tallon, Chief Executive of the MHRA,
said:
“Digital mental health support is becoming part of daily life for
many people. 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. This funding helps us continue that work.
By creating clear, practical guidance for both users and
developers, we can give people confidence in the tools they use
and help responsible innovation reach the public more quickly.”
Dr Samantha Roberts, Chief Executive of NICE,
said:
“As digital mental health technologies play an increasingly
important role in people's lives and NHS care, it's vital that we
have robust frameworks in place to evaluate their effectiveness
and safety.
“We welcome this extended funding which allows us to continue our
collaboration with the MHRA and other partners to ensure that
high-quality, evidence based digital mental health support is
available when and where people need it.
“This work will also provide developers with clearer pathways for
their innovations that support patients and ease some of the
pressure on NHS services.”
Professor Miranda Wolpert, Director of Mental Health at
Wellcome:
“Our partnership with the MHRA and NICE over the next few years
is a great example of how our research funding and policy work is
fostering collaboration to bring more pathways to earlier
interventions for anxiety, depression and psychosis.
“They will be creating practical tools that help regulators and
developers work together on safe and effective solutions,
supporting regulators to build a clearer global picture of
frameworks and evidence. This will help get the best digital
interventions into the hands of people with mental health
problems.”
Notes to editors
- More information about the project can be accessed through
the Digital mental health
technology hub.
