Last week, Germany’s Federal Ministry of Health has adjusted the rules governing Digital Health Applications (DiGA) once more. Key changes include new reporting obligations that require manufacturers to measure and document the success of their digital health apps. This reform adds notable operational pressure, while the reported outcomes will directly
Continue Reading Germany changes rules for Digital Health Applications (DiGA) – More Reporting, More Transparency, More WorkDigital Health Apps
Germany plans Health Data Use Act and stricter pricing & reimbursement rules for Digital Health Apps
By Dr. Dr. Adem Koyuncu on
At the end of June 2023, a draft Health Data Use Act (“GDNG”) and a draft Digital Act (“DigiG”) of the German Federal Ministry of Health have become public. These drafts are part of the German government’s digitalization strategy for the health sector. The Health Data Use Act plans to grant industry companies an access right to patient health data for research purposes. The Digital Act envisages significant restrictions for the pricing and reimbursement of Digital Health Apps. Below, we summarize key aspects of these two legislation proposals.
Continue Reading Germany plans Health Data Use Act and stricter pricing & reimbursement rules for Digital Health Apps