by Alexander Fenkiw | Nov 25, 2025 | diga-whitepaper, Unkategorisiert
What is the point of a DiGA if it does not improve patients’ lives? There is none! This is why DiGAs are only justified when their positive supply effect has been proven. Only then do you have a chance of being permanently included in the BfArM register....
by author1 | Oct 16, 2025 | Unkategorisiert
Those who develop digital offerings for health promotion or prevention often face the question: How can these be financed through health insurance companies? Many software manufacturers are familiar with the reimbursement options available through DiGA. Much less well...
by Sabine | May 15, 2025 | diga-whitepaper, Unkategorisiert
In 2020, Germany became the first country to establish DiGA in regular healthcare. This means that digital health applications can be approved in a structured, transparent process. Once approved, DiGA can then be prescribed by doctors in a similar way to medication....
by Daniel Lange | Feb 5, 2025 | medical-software-whitepaper, Unkategorisiert
Over the past ten years, we have learned a great deal about the development of software medical devices. We are pleased to share this expertise in our technical articles with (prospective) developers of Software as a Medical Device (SaMD) so that not everyone has to...
by Alexander Fenkiw | Jan 9, 2025 | medical-software-whitepaper, Unkategorisiert
At the beginning of the development of a software medical device, the central question is: Which risk class applies to my product? Risk classification has serious implications and significantly influences the cost and time frame of product development. In extreme...
by Alexander Fenkiw | Sep 18, 2024 | Unkategorisiert
On December 19, 2019, the Digital Care Act (DVG) made it possiblethat doctors can now prescribe digital health applications (DiGA) to patients in a standardized way for the first time. A counterpart to this has also been created for nursing care: digital care...