DiGAs in der Orthopädie – aktueller Stand und Aussicht
摘要
The introduction of Digital Health Applications (DiGAs) through the Digital Healthcare Act (DVG) has initiated a paradigm shift in German healthcare and opened new therapeutic pathways for orthopedics and trauma surgery. As prescribable and reimbursable medical devices classified as risk classes I–IIb, DiGAs are subject to a strict regulatory framework overseen by the German Federal Institute for Drugs and Medical Devices (BfArM) through a “fast-track” process. This procedure imposes high standards for data protection, cybersecurity, and interoperability, while allowing for provisional approval based on an evaluation concept—leading to ongoing debates around evidence requirements and pricing. This article analyzes the current state of DiGAs in orthopedics, classifies digital health applications using a pyramid model, explains the approval and prescription process, and provides an overview of available orthopedic DiGAs. A critical appraisal of clinical evidence shows that some applications have demonstrated efficacy in randomized controlled trials, while methodological challenges and the quality of approval studies remain points of contention. Major limitations include low prescription rates due to knowledge gaps, lack of integration into clinical workflows, and structural barriers such as limited interoperability. Looking ahead, the future of DiGAs is shaped by artificial intelligence, sensor technology, and integration with the telematics infrastructure. This evolution calls for a transformation in the role of orthopedic specialists into digital therapy managers and requires active involvement from professional societies.