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intended uses, benefits, limitations, and evidence
of those it aims to support. The project developed through input from a range of voices: Lived experience Input from people with lived experience of mental health challenges ensured that digital solutions addressed real needs, protected privacy, and respected dignity. Healthcare professionals Clinicians provided perspective on how digital products integrate with existing care pathways and highlighted practical concerns around usability and effectiveness. Industry and developers Tech innovators shared insights on product lifecycle, development hurdles, and the fast-moving pace
supporting digital products. Classification A framework for classifying digital products, considering factors like intended use, data processing, and the degree of clinician involvement and whether the product supports diagnosis. In essence, the guidance is co- created, living, and responsive to the shifting realities of the digital health landscape.
The project also explores:
Evidence and efficacy standards Requirements for demonstrating clinical validity, safety, and ongoing benefit, ensuring products are both effective and safe for users. Stakeholder engagement Mechanisms for ongoing dialogue with subject matter experts through lived experience, patients, healthcare professionals, technology developers, and policy developers across the ecosystem to ensure guidance remains relevant and responsive. Post-market surveillance (PMS) Impact of updated regulatory requirements for monitoring products after they reach the market, including incident reporting and real- world data collection. Bringing the cast together: stakeholder- driven development No project succeeds without collaboration, and the Digital Mental Health Project is fundamentally a joint effort. From the outset, the MHRA recognised that regulation written in isolation risked missing the lived realities
of digital health innovation. Academics and researchers
Experts contributed frameworks for evaluating efficacy, structuring trials, and gathering evidence in the digital domain. Regulators and policymakers Those charged with upholding safety and trust shaped regulatory approaches to be both robust and agile. Workshops, public consultations, and iterative feedback cycles shaped the process. Guidance was drafted iteratively and in collaboration with stakeholders, published and opened for feedback. This not only built legitimacy but fostered a sense of shared stewardship over the future of digital mental health. From guidance to action: updates to post- market surveillance As the digital mental health landscape matured, so too did the need for vigilant oversight. Traditional approaches to
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