Existing frameworks developed by HTA agencies for assessing digital health technologies in Europe, adapted from San Miguel et al16
Country | Framework for DTs | Author | Year |
Germany | Fast track procedure for DiGAs | The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) | 2020 |
UK | Evidence Standards Framework for DMTs | National Institute for Health and Care Excellence | 2019 |
France | Loi de financement de la sécurité sociale pour 2022 Guide on specific features of clinical evaluation of a connected medical device | Haute Autorité de Santé | 2022 |
Finland | Digi-HTA framework | Centre for Health and Technology, FinCCHTA and the University of Oulu’s MIPT research group | 2019 |
Netherlands | Guidance for assessment of digital care | Knowledge Centre Digital Care (Health Insurers) | 2021 |
Austria | Framework for reimbursement decisions of digital health technologies | Austrian Institute for HTA | 2021 |
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.