Recent research, supported by ORCHA, found that 72% of countries have no organisation responsible for the safety or quality oversight of mobile health apps, and that even where regulation exists it covers only products formally classed as medical devices.
This Resource Centre explains how emerging assurance frameworks are addressing that gap, and how the ORCHA Global Baseline Review (OBR) and OBR+ have become the co-ordinating foundation for a consistent, evidence-based approach to digital-health quality and trust.
digital health apps globally
of countries have no organisation responsible for the safety or quality oversight of mobile health apps
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Across 94 identified assessment frameworks, only 8 had undergone validity testing, and almost 40 % of all criteria relied on subjective assessor judgement.
Earlier reviews in NPJ Digital Medicine (2021) and BMJ Health & Care Informatics (2022) reported the same problem - frameworks often lack inter-rater reliability and use high-level questions that invite interpretation [6][7].
Regulatory systems built for medical devices still struggle to keep pace with adaptive, software-based products [2 8].
These findings highlight the need for active, evidence-based frameworks that sit alongside regulation: transparent, repeatable, and proportionate to digital risk.
The OBR provides exactly that: a granular, criterion-level framework derived from global standards (GDPR, DCB0129, ISO 82304-2, NICE ESF) and continuously tested across tens of thousands of app reviews.
Frameworks built on the OBR use a micro-criteria structure - hundreds of precisely defined checks - ensuring that assessments are objective, repeatable, and defensible rather than reliant on interpretation.
Region: Canada
Focus: Mental health
Region: UK
Focus: Mental health
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From ORCHA Assured to international certification, our assessment frameworks turn compliance into credibility.
Suppliers get faster market access and health systems have confidence in consistency
Dynamic, evidence-based assurance model that's relevant to the realities of software-as-a-service
A single, standardised foundation that scales globally but customises locally
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Talk to us about building your own assessment or explore how ORCHA’s frameworks can support your assurance goals.
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