Data security & data protection certificates for DiGA
Digital health applications (DiGA) require the following certificates in the area of data protection and data security (in addition to many other requirements) in order to be listed in the BfArM directory: Data security certificate according to BSI TR-03161 Data...
DiPA Guide: Digital Applications for Care
On December 19, 2019, the Digital Care Act (DVG) made it possible for doctors to prescribe digital health applications (DiGA) to patients in a standardized way for the first time. With the Digital Care and Nursing Modernization Act (DVPMG), a counterpart to this was...
DiGA: Guidelines for demonstrating positive supply effects
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....
AI Act: Guidelines for medical device manufacturers according to MDR (2025)
The EU is now also regulating the use of artificial intelligence (AI) with the EU AI Act. This also affects manufacturers of software medical devices that integrate AI into their MDR medical devices. The AI Act is intended to ensure that AI systems are designed in a...
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