Harmonizing medical data sharing frameworks is challenging. Data collection and formats follow local solutions in individual hospitals; thus, interoperability is not guaranteed. The German Medical Informatics Initiative (MII) aims to provide a Germany-wide, federated, large-scale data sharing network. In the last five years, numerous efforts have been successfully completed to implement the regulatory framework and software components for securely interacting with decentralized and centralized data sharing processes. 31 German university hospitals have today established local data integration centers that are connected to the central German Portal for Medical Research Data (FDPG). Here, we present milestones and associated major achievements of various MII working groups and subprojects which led to the current status. Further, we describe major obstacles and the lessons learned during its routine application in the last six months.

ABIDE_MI is a complementary funded 18 months project within the German Medical Informatics Initiative (MII), which aims to align IT infrastructures and regulatory/governance structures between biobanks/biobanking IT and the MII data integration centres (DIC) at German university hospitals. A major task in 2021 was the systematic collection of all documents describing rules, as well as proposal/contract templates for data and biosample use and access at each of the participating 24 university hospitals and their comparison with MII-wide consented data sharing principles, documents and governance structures. This comparison revealed large heterogeneity across the ABIDE_MI sites and further, redundant structures/regulations currently established at the German university hospitals. A second task was the design and stepwise development of an IT network infrastructure with central components (data and biosample query portal) and decentralized standardized FHIR servers to capture the standardized FHIR-based core data set modules (resources) defined within the MII working group “Interoperability”. Subsequent steps in the project are the harmonization of the data and biosample sharing governance/regulation frameworks at each ABIDE_MI site, creating synergies for the research infrastructures at the German university hospitals and to link those resources to the German Portal for Medical Research Data and with the BBMRI-ERIC Directory and Negotiator tools.