Overview
- MHRA published new user guidance and, with NHS England, released free resources that show how to assess digital mental health tools and report concerns via the Yellow Card scheme.
- The advice notes that many products are marketed for wellbeing rather than regulated as medical devices, which means they may not carry CE or UKCA marks or have undergone equivalent checks.
- Wellcome committed £2m to MHRA and NICE through 2028 to support stronger regulatory frameworks and better evidence for digital mental health technologies.
- The next phase includes a controlled environment to test AI medical devices before NHS rollout, exploration of international regulatory reliance, and moves to raise evidence quality across the UK market.
- Research from Woodnewton indicates low public awareness of the Yellow Card reporting route, reinforcing the education push as new GenAI health tools launch in the United States.