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Drawing on her dual perspective as a regulator and nurse, Holly Coole reveals how the MHRA is charting a new course in digital mental healthcare regulation, evaluation, and education by co-creating guidance with those who use and deliver care.
The advent of digital mental health
entering the market, it became important to clarify responsibilities and set consistent standards. Who ensures that these tools are truly safe? How do we know they work? And who is responsible if they don’t? Stakeholders, patients, clinicians, developers, and regulators found themselves navigating a digital Wild West. The Digital Mental Health Project brings together different perspectives – including from patients, clinicians, developers and regulators – to help develop clear, evidence-based guidance. Its aim is to support transparent, effective regulation and evaluation of digital mental health solutions. Guidance as a beacon: summarising the framework With the Digital Mental Health Project, the MHRA and its partners set out to publish guidance and resources to help all stakeholders
There is a story unfolding at the intersection of technology and wellbeing, a story that is quietly shaping how people access support. It starts in clinics, homes, and on the screens of smartphones, where individuals in search of mental health support encounter a new generation of digital tools. These are not just apps or algorithms; they are companions, guides, and sometimes, lifelines in the tumultuous journey towards better mental health. As digital tools become part of everyday mental health care, clear frameworks are essential to make sure they’re safe, effective, and actually work for the people who need them. At the heart of this growing field is the Digital Mental Health Project, an initiative funded by Wellcome and designed to guide, oversee, and empower the safe development and use of digital mental health technologies in the UK. This project, led by the Medicines and Healthcare products Regulatory Agency (MHRA) and in collaboration with National Institute for Health and Care Excellence (NICE), stands at the forefront of efforts to shape how digital health tools are evaluated and supported. This work is a response to a clear need: with rising mental health concerns and more digital tools
safely navigate the digital mental health landscape. The published guidance offers a map, highlighting:
Definitions and scope A clear articulation of what constitutes a digital mental health product, including distinctions between wellness apps and software as a medical device (SaMD). Transparency and accountability Obligations for manufacturers to openly communicate
Holly Coole Senior Manager Digital Mental Health, Medicines and Healthcare Products Regulatory Agency Registered Mental Health Nurse
holly-coole gov.uk/mhra
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