Working documents

This working paper (D5.1) reports on an analysis of the data elements from a number of sources to identify and to some degree align the healthcare/IPS data elements of greatest research value and proposes the data elements that could usefully be added to the existing IPS in order to maximise its value for public/population health and clinical research in addition to its primary value for healthcare. This core data element set will be subject to consultation by stakeholders, and then, aligned CDISC and HL7 FHIR implementation guides will be produced. This will set the groundwork for IPS+R and for additional health information domains, new or extended priority data categories in the EHDS.

This working paper presents nine use cases that illustrate how a common data format and a direct link between data with collected for primary use can support public health purposes. These use cases vary in terms of citizen involvement and the use of tools like the Yellow Button. They aim to address objectives such as administrative simplification, improved data quality, real-time monitoring, patient identification, and knowledge generation.

The xShare Industry Label is a voluntary certification developed to help the digital health industry align with upcoming European Health Data Space (EHDS) requirements. It provides a pathway for manufacturers to demonstrate technical compliance with interoperability standards, supporting early readiness for the EHDS and fostering cross-border health data exchange.

The European Electronic Health Record Exchange Format (European EHRxF), introduced by the European Commission in 2019, aims to ensure secure, interoperable, cross-border access to electronic health data across the EU. To enhance public understanding, “EHRxF in a Nutshell” was developed, illustrating its benefits through eight storylines based on perspectives of citizens, workforce, health system, and market.

This document summarises major current strategic and priority secondary use data collection initiatives and analyses them with the aim of bridging the gap between primary and secondary data use for better healthcare outcomes and policymaking. It documents important lessons learnt from “only once” initiatives and discusses the need of a better alignment between resources used in care, research, epidemiology and decision support.

Finland boasts comprehensive, high-quality information resources and advanced digital service infrastructure, anchored by the extensive Kanta services system. The implementation of the Act on the Secondary Use of Health and Social Data in 2019, along with the establishment of Findata as a centralized access point for secondary use of health and social data, solidifies Finland’s position as a global leader in health data management and accessibility. Moreover, its robust health information system, combined with active participation in European initiatives, positions Finland as a key player in shaping and preparing for the European Health Data Space (EHDS).

The SENTINEL and Health Hub initiatives have succeeded to create a direct connexion between primary and secondary use and have bought the users in thanks to an adapted mix of drivers, providing thus one of the very first European examples of “only once” best practices. Furthermore, the solution deployed has a very wide spectrum as it covers all medical specialties. This is thus an impressive achievement and an excellent preparation for the upcoming EHDS. However Denmark needs to urgently appropriate international standards and initiate urgently conversion of legacies. Only at this very condition, will the country be in the best position to make the best of this best practice in the context of the EHDS.

Belgium’s progress towards standardising health data systems offers both challenges and achievements. The country continues to address fragmentation by implementing national platforms and aligning with international terminology standards and data exchange formats. Efforts to centralise data collection systems, ensure semantic interoperability, and minimise data redundancy are key to improving data quality and usability. The HD4DP application can be presented as an example of Belgium’s dedication to bridging the gap between primary and secondary use. However, based on the feedback from hospitals and laboratories working with the application, it is evident that greater priority needs to be placed on using international standards and simplifying data entry for users.