Framework for Assessing Digital Health Technologies
This framework helps evaluate digital health technologies like apps and AI tools by looking at how well they work, their costs, safety, and impact on patients and healthcare systems. It's designed to handle the unique challenges of digital tools that older health assessment methods don't fully cover.
At a glance
Use when
Assessing digital health applications, planning HTA of DHTs, developing new assessment tools, or adapting existing HTA processes for digital technologies
Avoid when
Evaluating non-digital health interventions, when a disease-specific or technology-specific validated tool already exists and is sufficient
Inputs
Characteristics of the digital health technology (e.g., functionality, target condition, data use), evidence on performance and outcomes, cost data, implementation context
Outputs
Structured assessment across HTA domains, identification of evidence gaps, recommendations for adaptation or further evaluation
How it works
Derived from a scoping review of 60 frameworks, this assessment approach is aligned with the EUnetHTA Core Model domains. It provides structured guidance for evaluating digital health technologies (DHTs), with emphasis on technical characteristics, clinical effectiveness, and evidence requirements. The framework supports modular adaptation based on DHT type and highlights gaps in ethical, legal, and organizational considerations across existing models.
- HTA domains
- Clinical Effectiveness, Costs & Economic Evaluation, Patient and Social Aspects
- Categories
- AppraisalContext & ImplementationRWE
- Assumptions
- Digital health technologies require tailored assessment approaches due to rapid evolution, data dependency, and unique implementation challenges compared to traditional health interventions
- Strengths
- Based on a comprehensive scoping review following PRISMA-ScR and JBI methodology,Aligned with established HTA domains (EUnetHTA Core Model),Supports modular customization for different DHT types
- Limitations
- Limited focus on emerging technologies like AI in current frameworks,Ethical, legal, and organizational aspects are underrepresented,Heterogeneity across frameworks may limit direct comparability
- Also known as
- DHT Assessment Framework, Digital Health Technology Assessment Framework
Questions this answers
- › How can digital health technologies be systematically assessed across key HTA domains?
- › What domains are commonly covered in existing DHT assessment frameworks?
- › How do current frameworks address evidence requirements for DHTs?
- › What gaps exist in the assessment of ethical, legal, and organizational aspects of DHTs?
- › How can assessment frameworks be adapted for different types of digital health technologies?
- › What role does modularity play in improving the applicability of DHT assessment frameworks?
References & sources
Related methods
- Used withData-driven FMEA approach for hazard identification and risk evaluation in digital health
- RelatedPolicy sandbox approach for HTA guidance development
- AlternativeEvidence Matrix for Digital Medical Devices
- Used withCommon European Classification Grid for DMDs (CEUGrid-DMD)
- RelatedAI4People Ethical Framework
- RelatedFederated Learning for Digital Health
Similar by meaning
Beta record. Based on the original catalogue summary; primary-source enrichment pending.

