To date, more than 160 million people have been infected with COVID-19 worldwide. In the present study, we investigated the history of SARS-CoV-2 infection among 3067 healthcare workers (HCW) in a German COVID-19 treatment center during the early phase of the pandemic (July 2020) based on the seroprevalence of SARS-CoV-2 antibodies and self-reported previous PCR results. The results demonstrate a low prevalence of SARS-CoV-2 infection (n = 107 [3.5%]) with no increased risk for employees with a high level of patient exposure in general or working in COVID-19-confined areas in particular. This suggests that the local hygiene standards implemented in our hospital during the first wave of COVID-19 pandemic were effective in preventing patient-to-HCW transmission. No evidence for highly mobile staff serving as a vector for SARS-CoV-2 transmission could be found. In addition, impairment of smell and/or taste was strongly associated with SARS-CoV-2 history.

Background: Consistent self-management can improve symptoms and increase the quality of life of persons with cystic fibrosis (CF) who require daily care through following complex, time-consuming, and frequently changing self-management routines. However, it is challenging for many persons with CF to adhere to their self-management routines. Mobile health (mHealth) applications can support patients following and documenting daily treatment routines and medical history. Objective: This research aims to exploratively use the human-centered design approach (HCD) to identify needs and requirements to design an mHealth software concept for the disease management of persons with CF that includes secure data storage and communication with health care providers (HCP). Methods: The HCD process, as defined in ISO 9241–210, was used. Semi-structured interviews and a focus group interview were conducted with three adult persons living with CF, and two experienced CF nurses to explore the needs, challenges, and requirements for daily CF routines, nursing, and therapies. The interview transcripts were qualitatively assessed by thematic analysis, and the results were validated against previously published studies. The identified requirements were then used to design a technical software concept. Results: Participants expressed a need for patient-centered documentation that supports treatment adherence, enhances communication with their healthcare provider team, supports recalling their medical history, and overall enhances patient empowerment. The proposed features of the concept rely on daily documentation between clinic appointments, reminders and adherence checklists, a secure and direct communication channel with the healthcare provider team, medical summary reports, and customizing the application to individual user needs. This input made it possible to describe a user workflow and software functionalities using low-fidelity mockups. Based on the user workflow, a secure software architecture was developed. Prominent features are an in-person authentication process to define a trusted, secure, and direct communication channel between the self-management and HCP system. Furthermore, a clear separation of data storage and access is proposed, where the patient has full sovereignty to decide which data should be shared. Conclusion: We found that the HCD approach, particularly the use of stakeholder interviews, represents a feasible way to support the design of an mHealth software architecture in the context of CF. Further research in this domain is encouraged.

The European Health Data Space (EHDS) requires a large set of harmonized governance regulations and processes as well as a robust technological infrastructure for successful EU-wide health data sharing for secondary use. In Germany, nation-wide data sharing of real-world data from all university hospitals’ patient care documentation has been enabled by the Medical Informatics Initiative (MII) and the German Portal for Medical Research Data (FDPG). After the EU EHDS regulation went into force in March 2025, we conducted a comparison between the German MII/FDPG framework and the stipulations set out by the EU, with a particular focus on the responsibilities of data holders and data access bodies. Our results illustrate that the national secondary use research infrastructure established over one decade of MII provides an excellent basis for Germany’s path towards the EHDS.

In biomedical research, business processes, such as data-sharing or feasibility queries, span across several healthcare organizations. Due to the growing number of data-sharing projects and connected organizations, the management of distributed processes gets more complex over time. This leads to an increased need for administrating, orchestrating, and monitoring all distributed processes of a single organization. A proof of concept for a decentralized and use case agnostic monitoring dashboard was developed for the Data Sharing Framework, which most German university hospitals have deployed. The implemented dashboard can handle current, changing, and upcoming processes using only information for cross-organizational communication. This differentiates our approach from other existing use case specific content visualizations. The presented dashboard is a promising solution to provide administrators with an overview of the status of their distributed process instances. Therefore, this concept will be further developed in upcoming releases.

Introduction: The Medical Informatics Initiative enables the secondary use of clinical routine data in German university medicine through a federated FHIR-based infrastructure, with implementation guides defining the underlying data representation. Reliable validation of FHIR resources is required to ensure conformance with these specifications. However, validation in federated environments remains challenging due to heterogeneous infrastructures, limited terminology availability, and difficulties in establishing reproducible validation setups. Methods: This technical case report describes the design and implementation of a locally deployable FHIR validation service in the MII context. The system combines the HL7-maintained FHIR Validator with a configurable terminology service and a containerized deployment model. Structural and terminology validation are separated by design. Implementation guides and terminology resources are provisioned in a reproducible manner. The system supports both local terminology deployment and integration with existing institutional terminology services. Results: The proposed solution enables automated conformance testing of FHIR resource instances against MII implementation guides in local and federated environments. The service is provided as a reusable containerized validation component that can be integrated into development and data processing workflows, improving reproducibility, and reducing configuration effort across sites. Discussion: The results demonstrate that reproducible FHIR validation can be achieved through standardized deployment and controlled terminology provisioning. Remaining limitations are primarily related to incomplete or unavailable terminology content. Further work is required to evaluate the approach in production settings across data integration centers and to assess integration into data processing pipelines, including the handling and interpretation of validation results.