ADVANCING THE ASSESSMENT OF DIGITAL HEALTH TECHNOLOGIES: VALIDATING THE ASSESS DHT FRAMEWORK
Author(s)
Felix Broghammer, Dr. rer. medic.1, Julian Stein, M.Sc.1, Yui Hidaka, PhD2, Gregor Goetz, PhD2, Claudia Wild, PhD2, Carmen Fourier, PhD3, Annika Bergman, MSc3, Elisabet Ekvärn, PhD3, Alba Ruiz-Ramos, PhD4, Juan Antonio Blasco, MD, MSc4, Juan Carlos Rejon-Parrilla, MSc, PhD4, Anastasia Chalkidou, PhD5, Lirije Hyseni, MSc6, Antonia Elizabeth Needham-Taylor, BSc, MSc6, Zoe Garrett, MPhil, MRes6, Peter Schwarz, Prof.1.
1Department of Prevention and Care of Diabetes, Department of Medicine III, Faculty of Medicine Carl Gustav Carus, Technical University Dresden, Dresden, Germany, 2Austrian Institute for Health Technology Assessment (AIHTA), Vienna, Austria, 3The Dental and Pharmaceutical Benefits Agency (TLV), Stockholm, Sweden, 4Andalusian Regional Department of Health (area of HTA, AETSA), Sevilla, Spain, 5National Institute for Health and Care Excellence (NICE), London, United Kingdom, 6National Institute for Health and Care Excellence (NICE), Manchester, United Kingdom.
1Department of Prevention and Care of Diabetes, Department of Medicine III, Faculty of Medicine Carl Gustav Carus, Technical University Dresden, Dresden, Germany, 2Austrian Institute for Health Technology Assessment (AIHTA), Vienna, Austria, 3The Dental and Pharmaceutical Benefits Agency (TLV), Stockholm, Sweden, 4Andalusian Regional Department of Health (area of HTA, AETSA), Sevilla, Spain, 5National Institute for Health and Care Excellence (NICE), London, United Kingdom, 6National Institute for Health and Care Excellence (NICE), Manchester, United Kingdom.
OBJECTIVES: The Horizon Europe project ASSESS-DHT aims to harmonize the assessment of Digital Health Technologies (DHT) through a comprehensive, lifecycle-based framework covering HTA core domains and novel topics. This study explores external user testing of the framework, using interactions with DHT developers and Health Technology Assessment body (HTAb) feedback to validate content and inform its future direction.
METHODS: Framework robustness was evaluated via four 12-month case studies of diverse DHTs (e.g., telehealth, AI-assisted radiology) to generate simulated HTA reports and empirical feedback. An open call further engaged external developers and HTAbs as early users of updated framework components. Tested content (e.g., DHT classification, evidence requirements) was derived from the ASSESS-DHT interim manual and other consortium outputs. Mixed-methods feedback was systematically collected through questionnaires, including usability/utility Likert-scale ratings (5-point; 1=low, 5=high) and narrative reflections for thematic qualitative analysis.
RESULTS: Core HTA domains adapted for DHTs received high usefulness ratings (developers: 4.2/5; HTAbs: 3.8/5), though stakeholders emphasized the need for streamlined, practical guidance. Feedback highlighted the importance of explicitly linking taxonomic and lifecycle categorisations to HTA evidence requirements. Novel topics (e.g., AI validation, cybersecurity) demanded substantial additional evidence provision and evaluation effort, and insights revealed a need to better align these technical criteria with HTA remits versus traditional regulatory boundaries. These learnings directly informed ongoing usability tests with 7 AI-enabled DHT developers and 5 external HTAbs, with full results presented at the conference.
CONCLUSIONS: ASSESS-DHT aims to fill a critical gap in DHT evaluation of by providing a structured, lifecycle-informed framework. Initial piloting emphasized the importance of streamlining components and aligning advanced technical topics with institutional remits. Insights generated through case studies and ongoing usability testing are refining the final framework, ensuring its practical relevance, methodological robustness, and usability for both developers and assessors.
METHODS: Framework robustness was evaluated via four 12-month case studies of diverse DHTs (e.g., telehealth, AI-assisted radiology) to generate simulated HTA reports and empirical feedback. An open call further engaged external developers and HTAbs as early users of updated framework components. Tested content (e.g., DHT classification, evidence requirements) was derived from the ASSESS-DHT interim manual and other consortium outputs. Mixed-methods feedback was systematically collected through questionnaires, including usability/utility Likert-scale ratings (5-point; 1=low, 5=high) and narrative reflections for thematic qualitative analysis.
RESULTS: Core HTA domains adapted for DHTs received high usefulness ratings (developers: 4.2/5; HTAbs: 3.8/5), though stakeholders emphasized the need for streamlined, practical guidance. Feedback highlighted the importance of explicitly linking taxonomic and lifecycle categorisations to HTA evidence requirements. Novel topics (e.g., AI validation, cybersecurity) demanded substantial additional evidence provision and evaluation effort, and insights revealed a need to better align these technical criteria with HTA remits versus traditional regulatory boundaries. These learnings directly informed ongoing usability tests with 7 AI-enabled DHT developers and 5 external HTAbs, with full results presented at the conference.
CONCLUSIONS: ASSESS-DHT aims to fill a critical gap in DHT evaluation of by providing a structured, lifecycle-informed framework. Initial piloting emphasized the importance of streamlining components and aligning advanced technical topics with institutional remits. Insights generated through case studies and ongoing usability testing are refining the final framework, ensuring its practical relevance, methodological robustness, and usability for both developers and assessors.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA135
Topic
Health Technology Assessment, Medical Technologies, Methodological & Statistical Research
Topic Subcategory
Value Frameworks & Dossier Format
Disease
No Additional Disease & Conditions/Specialized Treatment Areas