Table 1

Existing frameworks developed by HTA agencies for assessing digital health technologies in Europe, adapted from San Miguel et al16

CountryFramework for DTsAuthorYear
GermanyFast track procedure for DiGAsThe Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM)2020
UKEvidence Standards Framework for DMTsNational Institute for Health and Care Excellence2019
FranceLoi de financement de la sécurité sociale pour 2022
Guide on specific features of clinical evaluation of a connected medical device
Haute Autorité de Santé2022
FinlandDigi-HTA frameworkCentre for Health and Technology, FinCCHTA and the University of Oulu’s MIPT research group2019
NetherlandsGuidance for assessment of digital careKnowledge Centre Digital Care (Health Insurers)2021
AustriaFramework for reimbursement decisions of digital health technologiesAustrian Institute for HTA2021
  • BfArM, Federal Institute for Drugs and Medical Devices; DiGA, Digital Health Application; DMT, Digital Medical Technology; DT, Digital Technology; FinCCHTA, Finnish Coordinating Center for Health Technology Assessment; HTA, health technology assessment; MIPT, Medical Imaging, Physics and Technology.