Holly Coole, Senior Manager for Digital Mental Health at the MHRA

The Horizon Adoption of Wellbeing Technology Toolkit project worked with Holly Coole, Senior Manager for Digital Mental Health at the Medicines and Healthcare products Regulatory Agency.  Holly leads a Wellcome-funded Digital Mental Health Technology project in collaboration with National Institute for Health and Care Excellence (NICE) and told us:

  “We hope the recently published guidance for digital mental health technology characterisation, regulatory qualification and classification will be useful for resources like the HAWT Toolkit. We recognise that mental health support is often provided through third sector organisations like charities and helping them to understand the regulations is crucial to ensure that safe and effective technologies are adopted that have been responsibly developed. We hope that clarification about what qualifies as SaMD, along with clear examples, can support decision making not just within national health services across the UK but across all sectors and we sincerely value the work that the HAWT project is doing to guide potential adopters and raise awareness of the regulations”.