A new review published in DIGITAL HEALTH examines how regulatory approaches will need to evolve as artificial intelligence becomes increasingly embedded in digital mental health technologies.
Drawing on insights from a multidisciplinary symposium convened by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), the paper brings together perspectives from regulators, clinicians, researchers, developers, policymakers and people with lived experience. It explores both the significant opportunities presented by AI — from personalised care and earlier detection to increased health system capacity — and the distinctive risks of applying rapidly evolving technologies in mental health.
Key takeaways include:
- Human oversight remains critical, particularly where AI informs clinical decisions or directly interacts with people seeking mental health support.
- Safety needs to extend across the entire AI lifecycle, including robust real-world monitoring for adverse events, model drift and emerging risks.
- Equity must be built in from the outset, with diverse datasets, bias mitigation and meaningful co-creation with people with lived experience.
- Regulation needs to keep pace with rapidly evolving technology, while providing clear, proportionate pathways that support responsible innovation.
- Greater international regulatory alignment could help reduce fragmentation and support equitable access to safe and effective AI-enabled mental health technologies.
The authors argue that effective regulation should enable innovation while keeping safety, transparency, accountability, equity and human values at the centre. Achieving this will require ongoing collaboration between regulators, developers, clinicians, researchers, health systems and people with lived experience as both AI capabilities and their applications in mental health continue to evolve.
Read the full paper: Artificial intelligence in digital mental health technology: Considerations for regulation.
