DIGAs (Digitale Gesundheitsanwendungen / Digital Health Applications) are digital health applications, often referred to as “apps on prescription,” which are certified medical devices designed to support patients in the treatment, monitoring, and management of various physical and mental health conditions.
These applications can be smartphone apps, web-based applications, or software for desktop use.
APPLICATIONS
They cover a wide range of medical fields such as diabetology, cardiology, psychotherapy, physiotherapy, and more. DIGAs help patients by providing information, guiding exercises, symptom tracking, and sometimes enabling electronic data transfer to healthcare providers with patient consent.
RULES
DIGAs must undergo a strict approval process by the German Federal Institute for Drugs and Medical Devices (BfArM), ensuring they meet high standards for safety, functionality, data protection, and demonstrate a positive healthcare effect. Once approved, they are listed in the official DiGA directory, and patients insured under Germany’s statutory health insurance can receive them via prescription or health insurance approval, with costs covered by the insurer.
HISTORY
Regarding their existence internationally, DIGAs were first introduced and are currently established in Germany, where the legal framework was set by the Digital Healthcare Act (Digitale-Versorgung-Gesetz) in 2019. Germany is recognized as a pioneer in integrating digital health applications into standard healthcare reimbursement.
COUNTRIES
Following Germany’s lead, other countries have begun developing similar systems for digital health applications.
Notably, France and Belgium have established special approval processes for digital health applications, aiming to integrate them into their healthcare systems.
Austria has also been advancing efforts to incorporate DIGA-like applications into regular care since around 2020. Italy is also exploring the introduction of similar digital health application frameworks.
In Portugal a Whitepapers discovers detailed insights into the Portuguese digital health ecosystem and reimbursement mechanisms, provided by a panel of experts.
SUMMARY
What are DIGA?
Certified digital medical devices (apps/web applications) prescribed to support detection, monitoring, treatment, and management of diseases and disabilities, reimbursed by statutory health insurance in Germany.
Where do DIGA exist?
Primarily in Germany, with emerging or developing frameworks in France, Belgium, Austria, and Italy following Germany’s pioneering model.
This model is considered innovative and is setting standards internationally for digital health integration into healthcare systems.
SOURCES
https://gesund.bund.de/en/digital-health-applications-diga
https://digitalversorgt.de/wp-content/uploads/2025/03/SVDGV-DiGA-Report24-DE.pdf
https://digitalversorgt.de/wp-content/uploads/2024/01/DiGA-Report-2023-eng.pdf https://quickbirdmedical.com/en/belgium-digital-health-reimbursement/
