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Medicines and Healthcare products Regulatory Agency gov.uk

Research: Patient reported outcomes (PROs) resources for digital mental health technologies (DMHTs)

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This summary provides developers with resources on integrating patient-reported outcomes (PROs) into the evidence generation and routine monitoring for digital mental health technologies (DMHTs).

PROs can provide valuable information from the individual’s perspective on outcomes such as:

  • Symptom severity (e.g. PHQ-9 for depression and PANSS for psychosis)
  • Health-related quality of life or health status (e.g. EQ-5D)
  • Functional status (e.g. Work and Social Adjustment Scale)
  • Personal recovery and goal attainment (e.g. Goal Based Outcome Tool)

    • It is important for developers to demonstrate that chosen PRO measures address clearly defined PRO objectives, are valid and appropriate for use in the target population in the specific clinical setting. Ideally, PROs should be standardised and should capture measures used in clinical practice.

    The following considerations are intended to help support incorporating PROs in a manner that supports high-quality evidence and user safety.

  • MHRA guidance on DMHT: device characterisation, regulatory qualification and classification clarifies when DMHTs, including those that incorporate or digitise PROs, qualify as software as a medical device (SaMD) and therefore need to be compliant with the medical device regulations. In summary if a DMHT has a medical purpose of helping diagnose, monitor or treat and is considered high functionality, it is likely considered SaMD.
  • MHRA guidance on clinical investigations clarify when clinical studies involving medical devices need to be reported to the MHRA as a clinical investigation. 

    • This is an extract. The publication continues at the source.

    Contains public sector information licensed under the Open Government Licence v3.0. Licence

    Read the original at the source: https://www.gov.uk/government/publications/patient-reported-outcomes-pros-resources-for-digital-mental-health-technologies-dmhts

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    Medicines and Healthcare products Regulatory Agency — imported from official source
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    https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency.atom ATOM
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    October 09, 2026 11:01
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    https://www.gov.uk/government/publications/patient-reported-outcomes-pros-resources-for...

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