Das neue Bewertungsverfahren zur Erstattung digitaler Gesundheitsanwendungen (DiGA) aus Sicht der gesetzlichen Krankenversicherung

Gregor-Haack, Johanna; Busse, Thorsten; Hagenmeyer, Ernst-Günther

doi:10.1007/s00103-021-03401-1

Cited by 4 publications

(1 citation statement)

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“…To prove a DiGA’s positive healthcare effect, manufacturers must provide quantitative results of a comparative study conducted in Germany as part of their application. This study needs to demonstrate the superiority of using the DiGA over not using it in terms of at least one claimed positive healthcare effect ( 9 ). The gold standard study design to prove a positive effect is a randomized control trial, however they also accept alternative study designs like Pragmatic Clinical Trials (PCT), Sequential Multiple Assignment Randomized Trial (SMART) or Multiphase Optimization Strategy (MOST), with the minimum requirement being a retrospective comparison ( 40 ).…”

Section: Resultsmentioning

confidence: 99%

International practices in health technology assessment and public financing of digital health technologies: recommendations for Hungary

Mezei,

Horváth,

Pálfi

et al. 2023

Front. Public Health

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BackgroundEvaluating and integrating digital health technologies is a critical component of a national healthcare ecosystem in the 2020s and is expected to even increase in significance.DesignThe paper gives an overview of international practices on public financing and health technology assessment of digital health technologies (DHTs) in five European Union (EU) countries and outlines recommendations for country-level action that relevant stakeholders can consider in order to support uptake of digital health solutions in Hungary. A scoping review was carried out to identify and gather country-specific classifications and international practices on the financing DHTs in five pioneering EU countries: Germany, France, Belgium, the United Kingdom and Finland.ResultsSeveral frameworks have been developed for DHTs, however there is no single, unified framework or method for classification, evaluation, and financing of digital health technologies in European context. European countries apply different taxonomy, use different assessment domains and regulations for the reimbursement of DHTs. The Working Group of the Hungarian Health Economic Society recommends eight specific points for stakeholders, importantly taking active role in shaping common clinical evidence standards and technical quality criteria across in order for common standards to be developed in the European Union single market.ConclusionSpecificities of national healthcare contexts must be taken into account in decisions to allocate public funds to certain therapies rather than others.

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Section: Resultsmentioning

confidence: 99%