DiGA price negotiations with the GKV-Spitzenverband
The development of a digital health application (DiGA) costs time and money and involves many regulatory hurdles. As a manufacturer, you naturally have an interest in ensuring that this effort pays off in the end. You probably already know that even if your...
DiGAV and DVG: Important Links
Here you will find the most important links to the Digital Healthcare Act (DVG) and the Digital Health Applications Ordinance (DiGAV). This list is intended to help you access the relevant documents more quickly for regular reference. This page also provides an...
Interoperability for digital health applications (DiGA)
We would like to quickly introduce the topic of interoperability in DiGA development with a small example: “Μια DiGA πρέπει να πληροί ορισμένες απαιτήσεις διαλειτουργικότητας.” Do you understand this sentence? Unless you speak Greek, probably not. You therefore need...
The Digital Act (DigiG): Guide for DiGA manufacturers
The new Digital Act of the Federal Ministry of Health was passed on February 2, 2024. It touches on a wide range of topics relating to modern healthcare, such as the electronic patient file (ePA) and regulations on the telematics infrastructure. With regard to DiGA,...
DiGA Guide: History of all changes
The BfArM updates the DiGA guidelines regularly. Unfortunately, there is no detailed change history available for this yet. We therefore continuously review all changes to the DiGA guidelines and prepare them for you. We present all changes here in a clear format with...
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