Official Digital Health Technology Assessment Guidelines: An International Comparative Review and Analysis
Abstract
Objectives: To systematically identify and comparatively analyze official digital health technology assessment (DHTA) guidelines worldwide, examining their methodological quality, domain coverage, and cross-national patterns to inform international standardization.
Methods: A systematic review was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020. Official DHTA guidelines issued by national authorities between 2019 and 2025 were identified through structured searches of PubMed and gray literature. Methodological quality was appraised using the AGREE II instrument, and domain coverage was analyzed based on the European Network for Health Technology Assessment Core Model to enable cross-country comparison.
Results: Twelve official DHTA guidelines from 10 countries across 4 continents were included. Overall methodological quality was moderate (mean AGREE II score: 65%), with substantial cross-national variation (range: 53%-73%), particularly in Rigor of Development and Stakeholder Involvement. Guidelines covered an average of 61% of the 11 European Network for Health Technology Assessment domains. Clinical effectiveness (91.7%), patient and social aspects (91.7%), technical description (83.3%), and safety (83.3%) were widely incorporated, whereas legal (25%), organizational (41.7%), and ethical (41.7%) domains were less frequently addressed.
Conclusions: Official DHTA guidelines are becoming increasingly institutionalized…
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