by Malte Bucksch | Mar 17, 2024 | Unkategorisiert
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...
by Alexander Fenkiw | Mar 17, 2024 | Unkategorisiert
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...
by Sabine | Feb 20, 2024 | diga-whitepaper, Professional article for DiGA landing page, Unkategorisiert
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,...
by author1 | Jun 20, 2023 | Unkategorisiert
For services that serve prevention and health promotion in accordance with Section 20 SGB V, certification as a DiGA is generally ruled out – after all, this must always be based on specific existing indications. Instead, however, there is another regulatory...
by LaraBoll | May 19, 2023 | diga-whitepaper, Unkategorisiert
Having fulfilled all regulatory parameters and been entered in the central DiGA directory, have all hurdles been cleared and a successful market entry guaranteed? Unfortunately not quite. Contrary to some wishful thinking, entry in the central DiGA directory itself...
by Alexander Fenkiw | Jan 18, 2023 | Unkategorisiert
Although Switzerland is geographically located in the heart of the EU, it is not part of it. This also affects manufacturers of (software) medical devices. Is it possible for MDR medical devices to enter the Swiss market without further ado? How do Swiss manufacturers...