JMIR Publications

ABSTRACT

The ongoing development of European Health Data Space (EHDS) for the secondary use of data (known as EHDS2) by the HealthData@EU pilot is mainly based on the Towards the European Health Data Space (TEHDAS) Joint Action (JA) results and recommendations on standards, interoperability, and governance models. The TEHDAS JA also considers the real-world expertise of existing European data-driven projects in standards implementation, interoperability, and data governance. Nevertheless, as the EHDS regulations are still evolving, relevant standards are still being developed, which presents a key challenge for these projects. The main objective of this work is to create an interactive toolkit to collect the lessons learned from the European projects in standards and interoperability implementation to contribute to shaping the EHDS2 interoperability framework. Furthermore, the best practices of these projects and their approaches to tackling the existing gaps in standards are valuable inputs for upcoming projects and standards organizations. In collaboration with the EC European Standardisation Booster (HSbooster.eu) initiative, we conducted several meetings and workshops among seven data-driven projects with cancer use cases (October 2023-July 2024) to explore how the projects adopt health standards and data quality frameworks. These projects are: IDERHA, EUCAIM, ASCAPE, iHelp, Bigpicture, HealthData@EU pilot, and INCISIVE project. We first created a template for the EHDS2 interoperability framework based on the new European Interoperability Framework (EIF) to collect the projects’ expertise in implementing the health standards. Finally, we investigated the available resources for creating the interactive toolkit based on the new EIF model and principles. The interactive toolkit provides a user-friendly interface of the new EIF layers and principles. The lessons learned from the seven projects in addition to the main outputs and deliverables are mapped to the different EIF layers and principles. Moreover, the recent publications on standards development and AI Act implementation were also incorporated into the toolkit as a guiding material. The toolkit provided an interactive entry module to support current and future projects in editing and printing the project interoperability framework in alignment with the EHDS2 requirements. The best practices in standards implementation and interoperability framework of the existing projects can play a crucial role in shaping the anticipated EHDS2 interoperability framework. The current version of the toolkit is based on the results of the seven projects and the recent publications on the AI Act implementation. Other projects can also use the toolkit to share their lessons learned and best practices using the entry modules of the toolkit. Thus, the HSbooster hosts the toolkit for broader dissemination and feedback to enhance the toolkit. In this way, we can collaborate in harmonizing the implementation of the standards across the projects and ultimately shaping the EHDS2 interoperability framework.