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Introduction: To support research projects that require medical data from multiple sites is one of the goals of the German Medical Informatics Initiative (MII). The data integration centers (DIC) at university medical centers in Germany provide patient data via FHIR® in compliance with the MII core data set (CDS). Requirements for data protection and other legal bases for processing prefer decentralized processing of the relevant data in the DICs and the subsequent exchange of aggregated results for cross-site evaluation., Methods: Requirements from clinical experts were obtained in the context of the MII use case INTERPOLAR. A software architecture was then developed, modeled using 3LGM2, finally implemented and published in a github repository., Results: With the CDS tool chain, we have created software components for decentralized processing on the basis of the MII CDS. The CDS tool chain requires access to a local FHIR endpoint and then transfers the data to an SQL database. This is accessed by the DataProcessor component, which performs calculations with the help of rules (input repo) and writes the results back to the database. The CDS tool chain also has a frontend module (REDCap), which is used to display the output data and calculated results, and allows verification, evaluation, comments and other responses. This feedback is also persisted in the database and is available for further use, analysis or data sharing in the future., Discussion: Other solutions are conceivable. Our solution utilizes the advantages of an SQL database. This enables flexible and direct processing of the stored data using established analysis methods. Due to the modularization, adjustments can be made so that it can be used in other projects. We are planning further developments to support pseudonymization and data sharing. Initial experience is being gathered. An evaluation is pending and planned.

Introduction: NFDI4Health is a consortium funded by the German Research Foundation to make structured health data findable and accessible internationally according to the FAIR principles. Its goal is bringing data users and Data Holding Organizations (DHOs) together. It mainly considers DHOs conducting epidemiological and public health studies or clinical trials., Methods: Local data hubs (LDH) are provided for such DHOs to connect decentralized local research data management within their organizations with the option of publishing shareable metadata via centralized NFDI4Health services such as the German central Health Study Hub. The LDH platform is based on FAIRDOM SEEK and provides a complete and flexible, locally controlled data and information management platform for health research data. A tailored NFDI4Health metadata schema for studies and their corresponding resources has been developed which is fully supported by the LDH software, e.g. for metadata transfer to other NFDI4Health services., Results: The SEEK platform has been technically enhanced to support extended metadata structures tailored to the needs of the user communities in addition to the existing metadata structuring of SEEK., Conclusion: With the LDH and the MDS, the NFDI4Health provides all DHOs with a standardized and free and open source research data management platform for the FAIR exchange of structured health data.

Introduction: The Local Data Hub (LDH) is a platform for FAIR sharing of medical research (meta-)data. In order to promote the usage of LDH in different research communities, it is important to understand the domain-specific needs, solutions currently used for data organization and provide support for seamless uploads to a LDH. In this work, we analyze the use case of microneurography, which is an electrophysiological technique for analyzing neural activity., Methods: After performing a requirements analysis in dialogue with microneurography researchers, we propose a concept-mapping and a workflow, for the researchers to transform and upload their metadata. Further, we implemented a semi-automatic upload extension to odMLtables, a template-based tool for handling metadata in the electrophysiological community., Results: The open-source implementation enables the odML-to-LDH concept mapping, allows data anonymization from within the tool and the creation of custom-made summaries on the underlying data sets., Discussion: This concludes a first step towards integrating improved FAIR processes into the research laboratory's daily workflow. In future work, we will extend this approach to other use cases to disseminate the usage of LDHs in a larger research community.

Introduction: The German Medical Text Project (GeMTeX) is one of the largest infrastructure efforts targeting German-language clinical documents. We here introduce the architecture of the de-identification pipeline of GeMTeX., Methods: This pipeline comprises the export of raw clinical documents from the local hospital information system, the import into the annotation platform INCEpTION, fully automatic pre-tagging with protected health information (PHI) items by the Averbis Health Discovery pipeline, a manual curation step of these pre-annotated data, and, finally, the automatic replacement of PHI items with type-conformant substitutes. This design was implemented in a pilot study involving six annotators and two curators each at the Data Integration Centers of the University Hospitals Leipzig and Erlangen., Results: As a proof of concept, the publicly available Graz Synthetic Text Clinical Corpus (GRASSCO) was enhanced with PHI annotations in an annotation campaign for which reasonable inter-annotator agreement values of Krippendorff's α ≈ 0.97 can be reported., Conclusion: These curated 1.4 K PHI annotations are released as open-source data constituting the first publicly available German clinical language text corpus with PHI metadata.

The interoperability Working Group of the Medical Informatics Initiative (MII) is the platform for the coordination of overarching procedures, data structures, and interfaces between the data integration centers (DIC) of the university hospitals and national and international interoperability committees. The goal is the joint content-related and technical design of a distributed infrastructure for the secondary use of healthcare data that can be used via the Research Data Portal for Health. Important general conditions are data privacy and IT security for the use of health data in biomedical research. To this end, suitable methods are used in dedicated task forces to enable procedural, syntactic, and semantic interoperability for data use projects. The MII core dataset was developed as several modules with corresponding information models and implemented using the HL7® FHIR® standard to enable content-related and technical specifications for the interoperable provision of healthcare data through the DIC. International terminologies and consented metadata are used to describe these data in more detail. The overall architecture, including overarching interfaces, implements the methodological and legal requirements for a distributed data use infrastructure, for example, by providing pseudonymized data or by federated analyses. With these results of the Interoperability Working Group, the MII is presenting a future-oriented solution for the exchange and use of healthcare data, the applicability of which goes beyond the purpose of research and can play an essential role in the digital transformation of the healthcare system., (© 2024. The Author(s).)

The largest publicly funded project to generate a German-language medical text corpus will start in mid-2023. GeMTeX comprises clinical texts from information systems of six university hospitals, which will be made accessible for NLP by annotation of entities and relations, which will be enhanced with additional meta-information. A strong governance provides a stable legal framework for the use of the corpus. State-of-the art NLP methods are used to build, pre-annotate and annotate the corpus and train language models. A community will be built around GeMTeX to ensure its sustainable maintenance, use, and dissemination.

Secondary use of electronic health record (EHR) data requires a detailed description of metadata, especially when data collection and data re-use are organizationally and technically far apart. This paper describes the concept of the SMITH consortium that includes conventions, processes, and tools for describing and managing metadata using common standards for semantic interoperability. It deals in particular with the chain of processing steps of data from existing information systems and provides an overview of the planned use of metadata, medical terminologies, and semantic services in the consortium.