MHRA and NICE Open a Phase 1 Survey on Digital Mental Health Technologies
The Medicines and Healthcare products Regulatory Agency and the National Institute for Health and Care Excellence have opened a call for evidence on resources developed through the Wellcome Digital Mental Health Technologies programme. The survey is designed to assess how those materials are being received, accessed, and used, and whether they are changing understanding, confidence, decision-making, and professional practice. It closes at 11:59pm on 26 February 2027.
This is not a clinical trial, but it sits close to the regulatory edge of modern mental healthcare. Digital tools for depression, anxiety, self-management, triage, monitoring, and broader support now move into care pathways faster than many health systems can evaluate them. When guidance is weak, developers may build faster than clinicians can appraise, and patients can end up using software with uneven evidence, unclear safeguards, or poorly defined clinical purpose. A structured feedback exercise from MHRA and NICE is intended to test whether the first phase of the programme is doing its job: building usable resources for safe development, regulation, evaluation, and deployment.
The survey sits within the programme’s Phase 1 and theory-based outcome evaluation. In practical terms, that means the agencies want to know not only whether the resources exist, but whether they are being used in the real world and whether they alter behaviour. For digital mental health products, that question matters at every stage of the pathway. A developer may read a guidance document and redesign a product specification; a clinician may use the material to judge whether an app belongs in a service; a regulator may use it to frame expectations around evidence; a patient or carer may use it to understand what a safe, credible tool should look like.
One sentence captures the point: regulatory materials only matter if they change decisions.
What the survey is trying to measure
The call for evidence seeks to understand how the resources have been received, accessed, and used. It also asks whether those resources have contributed to changes in understanding, confidence, decision-making, and professional practice. That focus places the initiative squarely in implementation territory. Digital mental health technologies are not judged only by whether they are available; they are judged by whether they can be selected appropriately, integrated into care, and used with a realistic understanding of benefit and risk.
The programme materials were built to support safe development, regulation, evaluation, and use of digital mental health technologies, including mental health apps and other digital tools. Those categories are broad, and the breadth is clinically important. A mobile app that tracks mood, a digital triage platform, a therapeutic intervention delivered through software, and a remote monitoring tool do not raise identical questions. Each one creates different risks around accuracy, privacy, escalation, user engagement, clinical oversight, and evidence quality. Guidance that treats them as interchangeable would be too blunt to be useful.
MHRA and NICE are asking whether the Phase 1 outputs are meeting their intended objectives and whether the findings should shape future direction in Phase 2 of the programme. The framing suggests a classic regulatory problem: guidance can be well designed on paper yet still fail if it is inaccessible, unclear, or too distant from the realities of product development and clinical adoption. In mental health, where digital tools often aim to meet people at moments of vulnerability, the consequences of poor design can be immediate. A confusing interface can reduce engagement. A weak evidence standard can allow ineffective products into circulation. An incomplete safety framework can leave clinicians uncertain about when to recommend, monitor, or avoid a tool altogether.
Why stakeholders beyond regulators are being asked to respond
The invitation extends to developers and manufacturers, healthcare professionals, researchers, policymakers and regulators, as well as people with lived experience of mental health conditions, carers, and members of the public. That mix is deliberate. Digital mental health technologies are shaped by technical teams, purchased or commissioned by services, reviewed by researchers, scrutinized by policy teams, and used by patients and families. A resource that makes sense to a developer but not to a clinician can fail in deployment. A document that is clear to regulators but opaque to the public can miss the people most affected by the resulting decisions.
The survey also adapts to the respondent’s experience. Those familiar with many, some, or none of the resources can still take part, and only relevant questions will appear. That design lowers the barrier to participation and broadens the evidence base. For a policy exercise of this kind, breadth matters because the value of the material is partly measured by who can use it and how they use it. A professional audience may focus on evidence thresholds and regulatory language. A person with lived experience may focus on clarity, trust, and whether the resources reflect real-world needs rather than idealized assumptions.
Digital mental health is entering a phase in which evaluation cannot be an afterthought. Software can change quickly, scale rapidly, and reach patients without the usual constraints of physical distribution. Regulation therefore depends on tools that are not just technically sound but clinically intelligible. The current survey is an attempt to pressure-test whether the first phase of that work has produced material that people can actually use.
Phase 2 will depend on what comes back now
The call for evidence has a straightforward purpose: generate feedback that can be used to refine future MHRA and NICE direction in Phase 2 of the programme. There is no claim here that the resources are complete, final, or universally effective. The agencies are asking the opposite question — where the materials work, where they do not, and how they should be improved. In regulatory science, that sort of feedback can be as important as formal data because it reveals whether a framework can survive contact with the field.
For mental health services, the implications are concrete. Better evaluation resources can help separate a credible digital intervention from a superficial one. Better regulatory guidance can reduce uncertainty for clinicians deciding whether to recommend a tool. Better public-facing language can help patients and carers understand what safe digital support should offer, and what it should not promise. The survey remains open until late February 2027, leaving time for a wide range of stakeholders to respond before the next phase is shaped.