OBJECTIVES: Regulatory and payment pathway guidance are emerging related to digital health technologies (DHTs). As DHT applications are commercialized, healthcare technology assessment (HTA) agencies will play an increasingly important role in assessing their potential value. The goal of this study was to identify and review available DHT value assessment frameworks.

METHODS: We conducted a targeted review using PubMed and HTA sites to identify DHT assessment frameworks from HTA authorities in North America and Europe. We prioritized DHT frameworks published in English from January 1, 2018-November 10, 2023. Frameworks limited to DHT subcategories (e.g., mobile health apps, personalized medicine solutions) were excluded. Twelve EUnetHTA HTA Core Model domains (Health problem and current use of technology; Technical technology characteristics; Safety; Clinical effectiveness; Patient and social aspects; Economics; Legality; Ethics; Organizational impact; Usability; Data security; Interoperability) informed descriptive analysis.

RESULTS: Three DHT frameworks met inclusion criteria from the US (ICER), the UK (NICE), and Finland (Digi-HTA). All 3 frameworks covered 5/12 domains: ‘safety,’ ‘clinical effectiveness,’ ‘economics,’ ‘usability,’ and ‘data security.’ ‘Technological characteristics’ (ICER, Digi-HTA), ‘patient and social aspects’ (NICE, ICER), and ‘interoperability’ (NICE, Digi-HTA) were addressed by 2/3 frameworks. ‘Health problem and current use of technology’ was covered in ICER's framework. NICE addressed both ‘legal’ and ‘ethical’ guidance. No framework covered ‘organizational impact.’ NICE's framework encompassed the most domains (9/12), followed by ICER (8/12) and Digi-HTA (7/12). Related to the ‘economics’ category, budget-impact analysis was recommended by ICER and NICE, and cost-effectiveness analysis was suggested by NICE (for costly interventions) and Digi-HTA.

CONCLUSIONS: Few HTA agencies have published broad DHT assessment frameworks. Among existing frameworks, assessment criteria vary, and domains salient to DHT evaluation—including technological characteristics, interoperability, and ethics—are not universally considered. Establishment of clear, explicit evidence standards is needed to facilitate robust DHT value assessment.