MHRA publishes patient-reported outcome resources for digital mental health technologies

What Changed

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a resource collection on using patient-reported outcomes (PROs) in digital mental health technologies (DMHTs). Presented as research and analysis, it addresses incorporating PROs into evidence generation and routine monitoring.

The publication covers symptom severity, health-related quality of life, functional status, and personal recovery and goal attainment. Its disclaimer states that the listed resources and papers provide information and operational support; they do not constitute formal regulatory policy, guidance or statutory instructions approved by the MHRA or NICE.

Who Is Affected

The collection primarily targets DMHT developers. It also addresses considerations relevant to manufacturers, researchers designing studies with PRO endpoints, and teams implementing these technologies in routine care.

The MHRA emphasises selecting measures that meet clearly defined PRO objectives and are valid and appropriate for the target population and clinical setting. Ideally, measures should be standardised and capture those used in clinical practice.

Regulatory and Technical Implications

The publication points to existing MHRA guidance on device characterisation, regulatory qualification and classification. Its summary states that a DMHT with a medical purpose of helping diagnose, monitor or treat, and considered high functionality, is likely to qualify as software as a medical device (SaMD). It does not state that every digital PRO tool is a medical device.

Ethical and technical considerations include participant burden, accessibility, usability testing and clarity about who accesses PRO data and why. Research protocols should specify whether and how data will be monitored in real time, with a clear response plan for high-risk findings.

Manufacturer Actions

Developers can use the collection to structure PRO-specific research questions, justify instrument selection and measurement properties, establish assessment schedules, and plan strategies to minimise missing data. The publication highlights SPIRIT-PRO for protocols, CONSORT-PRO for transparent reporting, and PROTEUS-Practice for routine care implementation.

Assessment frequency and reminders should be balanced against participant fatigue or distress. The resources also address involving service users with lived experience in selecting and implementing PROs. For research involving high-risk findings, the response plan should form part of the ethics submission.

The publication reiterates adverse event reporting obligations for DMHTs used in clinical investigations. For marketed DMHTs qualifying as SaMD, safety concerns or events causing harm or distress can be reported through the MHRA Yellow Card scheme. Worsening PRO scores may indicate adverse events and warrant vigilance.

Confirmed Dates

The source page gives a publication date of 9 October 2026. It does not specify a separate effective date or compliance deadline for this resource collection.

Official Source

MHRA: Patient reported outcomes (PROs) resources for digital mental health technologies (DMHTs). The page lists a four-page, 234 KB PDF.

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