Wellcome have provided 3 years of funding for the MHRA and NICE to collaboratively work on clarifications for the regulation and evaluation of digital mental health technologies (DMHTs). This has enabled these agencies the opportunity to engage with a wide range of stakeholders, including mental healthcare professionals, industry, researchers, international regulators and vitally those with lived experience, to ensure the outcomes help get the right tools and treatments to those who would benefit from their use. 
To date, outputs have included:
-    Two published journal articles about the challenges and areas where impact can be made (Sage Journals Digital Health and The Lancet Digital Health) 
-    One published journal article describing a conceptual framework for DMHTs (JMIR)
-    A User and public perspectives report
-    MHRA guidance on digital mental health technology: qualification and classification.
Outputs that are in progress include:   
-    AI in mental health event and article
-    Developing a standard on clinical evaluation of DMHT
-    Quality of life measure review of appropriateness for mental health
-    MHRA guidance and report on post-market surveillance of DMHT
-    Yellow Card Scheme improvements for DMHTs
-    Learning modules for healthcare professionals and the public to understand the regulation and evaluation of DMHTs to help them identify reliable, effective and acceptably safe products. 
The MHRA and NICE will explain how guidance published in February, 2025 and outputs throughout the project clarify what kind of innovations will and will not now be classed as software as a medical device (SaMD) and what the implications of these are for stakeholders in terms of evidence generation and pathways to implementation.