In order for digital healthcare processes to develop their full potential, diagnostic data - in particular laboratory results and other in-vitro diagnostics data - must be structured, interoperable and available across all sectors. This is the only way to effectively implement digital applications, automated processes, AI-based evaluations and European connectivity in the sense of the European Health Data Space (EHDS). The Verband der Diagnostica-Industrie e.V. (VDGH) therefore welcomes the objective of the draft bill for a law for data and digital innovation in healthcare (GeDIG). This provides for the Social Code V with its care-oriented regulations to be expanded to include a data- and digital-based regulatory framework. A series of extensive changes, particularly in the areas of telematics infrastructure, gematik, electronic patient records, interoperability and data usage, will introduce a fundamental structural change to the digital healthcare architecture.
At the same time, the VDGH sees a need for adjustments to the draft law in several areas, as it falls short of the announcements and goals of the Federal Ministry of Health's digitalization strategy "Gemeinsam digital 2026" in key points.
