The European Health Data Space in communicable diseases surveillance and monitoring of medicines and vaccines: achievements of a pilot project examining the user journey

Abstract

The future European Health Data Space (EHDS), a network for secure cross-border data use, could be beneficial for public health initiatives. The HealthData@EU pilot project evaluated possibilities of secondary data use based on five use cases and established a pilot IT infrastructure. This article reports overarching experiences from two public health use cases and the IT development. Experiences were reported by the Users' Journey steps (data discovery, application, use, and finalization) elaborated in the context of the European Health Data Space (TEHDAS), the first conceptual EHDS project. The European Medicines Agency's use case analysed coagulopathy-related events in COVID-19 patients, the one led by the European Centre for Disease Prevention and Control assessed the feasibility of HealthData@EU to support antimicrobial resistance surveillance. The IT work package developed the infrastructure for information exchange. The use cases indicated that standardized procedures, wherever available, were considered highly beneficial. In the application phase, node-specific requirements slowed down the progress. A distributed approach in combination with the use of Secure Processing Environments (SPE) was successfully conducted. The IT infrastructure was piloted, tested, and published as open source. It supports data discovery and applications in the future. The HealthData@EU pilot project has achieved major steps regarding data discoverability and accessibility, where a need for more standardized procedures was detected in the use cases. Distributed analyses in combination with SPE use may be possible approaches for the data use phase, which require further investigation in TEHDAS2 and other initiatives.

Figure 1.

Diagram showing the steps of the EMA use case (UC) journey.

Figure 2.

Diagram showing the steps of the ECDC use case (UC).