Masterarbeit

Comparative Analysis of Evaluation and Reimbursement Pathways for Digital Health Applications in Germany, France, and Belgium - Current Status and Outlook for the EU ***

Michael Link (2024)

Summary
Language: English
In light of the ubiquitous presence of smartphones for over two decades, and the concomitant rise in the value of these devices in our daily lives, coupled with a growing market of tens of thousands of health-oriented apps, it is becoming increasingly important to be able to identify secure and beneficial health-related apps.
Despite the availability of these apps for over 15 years, formal review and reimbursement processes are not yet uniformly established across the EU. However, this thesis demonstrates that a considerable number of steps have already been taken in the three exemplary countries, namely Germany, France and Belgium, with the introduction of evaluation and reimbursement pathways for digital health applications, and other EU countries are following them. Nevertheless, several challenges and problems remain to be addressed: Firstly, there are legal uncertainties due to evolving legislation and evaluation procedures. Secondly, there are divergent definitions and requirements for digital health applications across EU countries, making it difficult to develop EU-wide applications. Thirdly, the evaluation processes involving multiple stakeholders are complex and resource intensive. Finally, fundamental differences in national healthcare and reimbursement systems affect the integration of digital health applications into the respective country systems.
The thesis concludes that while there has been significant progress in the acceptance and integration of digital health applications into the German, French, and Belgian healthcare systems, a more harmonised EU-wide approach is still required. A stepwise approach is suggested to achieve this goal: starting with the harmonization of nomenclature and definitions, followed by the alignment of non-clinical and then clinical requirements, enabling data sharing between member states, recognition of evaluations from other member states, and concluding with the harmonisation of socio-economic requirements and value assessments. This harmonisation would facilitate the development and deployment of digital health applications, thereby ensuring better patient care and structural efficiency in the healthcare sector.
The ongoing EU projects and initiatives aimed at harmonising evaluation and reimbursement processes are promising, but their impact remains uncertain. It will therefore be important to consolidate their conclusions. Ultimately, to benefit from the full potential of digital health applications, it is crucial that a regulatory framework is developed which is capable of keeping pace with the rapid advancements in digital technologies.
Pages: 88
Annexes: 4, Pages: 12