Framework for reimbursement decisions of digital health technologies (mHealth) and its (retrospective) application on selected examples

Jeindl R, Wild C
Record ID 32018000893
Original Title: Framework zur Unterstützung von Refundierungsentscheidungen zu digitalen Gesundheitsanwendungen (mHealth) und dessen (retrospektive) Anwendung an ausgewählten Beispielen
Authors' objectives: The increasing use of digital health applications poses new challenges for decision makers in the evaluation of these applications. For the majority of available digital health applications there is little or no evidence of (medical, organisational or economic) benefit. Currently available assessment frameworks often do not cover all domains of a full HTA. At the same time, the thorough evaluation of a digital health application requires additional, technology-specific aspects such as software updates, questions of connectivity and compatibility, as well as digital data protection. This report aims to examine the applicability of the currently available assessment frameworks for selected digital health applications and to develop recommendations for Austria.
Authors' results and conclusions: Suggestions for study designs were described in four of six analysed frameworks. A risk classification of the digital health application to be evaluated was suggested in one of six analysed frameworks. Aspects of artificial intelligence were considered in one of six analysed frameworks. Only for two of the eleven selected digital health applications the present study design met the evidence standards of the NICE framework. Belgium, France, the Netherlands, England and Germany have different strategies for the regulation and reimbursement of digital health applications. Recent developments in these countries show that there are efforts to find regulations at the national level. There is a great heterogeneity of assessment frameworks, especially with regard to risk classification and technology-specific aspects such as data protection and artificial intelligence. Only the Evidence Standards Framework of NICE offers a precise classification into defined risk classes with correspondingly required study designs. The published evidence of digital health applications show differences in the choice of study designs. Controlled studies with comparisons of the standard of care are not always available, but are more frequent in recent (ongoing) studies.
Authors' methods: A systematic literature search in four databases and a survey of INAHTA members was conducted to identify assessment frameworks. Six assessment frameworks were exemplarily selected and analysed. A manual search was performed to identify already reimbursed digital health applications, for eleven digital health applications the published studies were identified. A hand search was conducted to describe the strategies and regulations of several countries in dealing with digital health applications.
Project Status: Completed
Year Published: 2020
URL for additional information:
English language abstract: An English language summary is available
Publication Type: Full HTA
Country: Austria
MeSH Terms
  • Health Information Systems
  • Telemedicine
  • Electronic Data Processing
  • Reimbursement Mechanisms
  • Mobile Applications
  • Digital health applications
  • health app
  • assessment frameworks
  • reimbursement
  • mHealth
  • digital health
Organisation Name: Austrian Institute for Health Technology Assessment
Contact Address: Garnisongasse 7/20, A-1090 Vienna, Austria
Contact Name:
Contact Email:
Copyright: AIHTA
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.