The European Health Data Space (EHDS) is the first common European data space under the European Data Strategy. It aims to establish a common framework for the use and exchange of electronic health data across the EU, making it easier and safer for the public and health and social care professionals to access and share health data across EU countries. It will bring benefits for advances in medical research, innovation in medicines and healthcare technology, more informed public health policies and improved quality of care. This will make health data more accessible, secure and usable, while protecting people’s privacy. The full legal text is available through the European Health Data Space Regulation.

The EHDS Regulation entered into force on 26 March 2025 and will be implemented on a phased basis between 2027 and 2031. Implementing acts will be published by 2027 to provide detailed rules and specifications. With regard to the secondary use of data, the EHDS Regulation places an obligation on individual Member States to establish one or more Health Data Access Bodies (HDABs). A HDAB will securely connect health data users, such as researchers and policymakers, with health datasets. Access to health datasets through HDAB services will be subject to a stringent and transparent decision-making process with legal, technical and ethical controls in place, in line with national requirements and those set out in the EHDS Regulation. The majority of health datasets are to be made available through a HDAB by 2029. The remaining health datasets will be made available by 2031, including data on factors impacting on health, genomic and other molecular data, and data from clinical trials and research cohorts or surveys.

Want to explore the wider policy and technical context for HealthData@IE and the European Health Data Space? Here are links to some relevant national and European sources of information:

• EHDS Regulation
• HealthData@EU Central Platform
• Department of Health HealthData@IE page
• TEHDAS2: The TEHDAS2 joint action supports preparation for secondary use of health data under the European Health Data Space (EHDS). The TEHDAS2 joint action started in May 2024 and it will build on the work of TEHDAS1 and other European projects. TEHDAS2 provides guidance, tools, policies and case studies on governance, interoperability, data quality and technical architecture for secondary use of health data.  
• QUANTUM: HIQA is a project partner in the EU-funded QUANTUM project, which aims to create a common label system for Europe that guarantees the quality and utility of datasets for scientific and health innovation purposes. These labels will enable researchers, policymakers and healthcare professionals to identify high-quality data for research and decision making. 

HIQA coordinates three programmes of work within the HealthData@IE project. Each programme of work coordinated by HIQA is supported by a Working Group. Their role is to actively contribute to the successful and timely completion of key milestones and deliverables through providing expert advice, reviewing and providing feedback on outputs and supporting stakeholder engagement at key stages. Details of working group members are provided under each work package.

• Engagement, Dissemination and Training: this programme of work is focused on dissemination, stakeholder engagement and providing relevant training and support for health data holders, data users and the public. A Public and Patient Involvement (PPI) panel helps ensure materials are clear, relevant and accessible.
  Dissemination, Training and Support (WP2) Working Group Membership
• National Health Dataset Catalogue (nHDsC): this programme of work is focused on developing a national health dataset catalogue for the secondary use of data. It will help data users find, understand and access available health datasets across Ireland.
  National Health Dataset Catalogue (nHDsC) (WP6) Working Group membership
• Health data quality enhancement: this programme of work is focused on developing tools and resources to enhance health data quality and interoperability to support safe, reliable secondary use of data for research and policy and ensure organisations are prepared for implementation of the EHDS regulation.
  Health data quality enhancement (WP8) Working Group membership
  Technical Sub-Group for National Interoperability Framework (WP8.4) Working Group membership

Funding and Disclaimer

The HealthData@IE project is co-funded by the European Union through the EU4Health 2021-2027 health programme, grant agreement EU4H-2023-JA-3-IBA-10. Further funding is through the Irish government.

Có-mhaoinithe ag an Aontas Eorpach. Is leis an údar nó na húdair amháin a gcuid tuairimí agus barúlacha, áfach, agus ní léiríonn siad tuairimí an Aontais Eorpaigh nó na Gníomhaireachta Feidhmiúcháin Eorpaí um an tSláinte agus an Digitiú (HADEA) i gcónaí. Ní fhéadfaidh an tAontas Eorpach ná an t-údarás deonúcháin a bheith freagrach astu.

Co-funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the European Health and Digital Executive Agency (HADEA). Neither the European Union not the granting authority can be held responsible for them.

• Read our Readiness Assessment Report: The findings of a readiness assessment examining health data holders’ levels of preparedness for the establishment of HDAB services and outlines steps needed to ensure health data holders can meet future obligations under the EHDS Regulation.
• Read our National Interoperability Framework Review: This review identified and synthesised available approaches in other jurisdictions (and non-jurisdiction relevant organisations) that facilitate the exchange of health-related data for secondary use purposes to inform the development of a National Interoperability Framework (NIF) for HDAB services in Ireland.
• Read our International Review of Engagement, Education and Data Quality Enhancement in relation to Health Data Access Bodies: A review of international best practices in relation to engagement, education and data quality enhancement in the context of the secondary use of health data and HDAB services.
• Read our HealthData@IE Engagement and Education Strategic Plan 2024–2027: An overview of HIQA's plan for engagement, dissemination, training and education in relation to establishing HDAB services in Ireland.
• Read our Programme Plan for Work Package 8—Health Data Quality Enhancement: Improving quality and interoperability of data for secondary use: A detailed overview of tasks included in Work Package 8, along with their associated deliverables. 

• Read our Guidance for Data Holders: Preparing for the establishment of HDAB services in Ireland under the EHDS: It outlines key aspects of the secondary use of health data under the regulation, and the implications for health data holders in Ireland.
• Read our readiness Assessment Protocol, Use Cases and Survey: Preparing for the establishment of HDAB services in Ireland under the EHDS: This document describes the overall approach to the readiness assessment, how data will be collected and analysed and expected readiness assessment outputs.
• Read our HealthData@IE Training and Education Resources Portfolio: A repository of tools and materials in relation to the EHDS and the secondary use of health data that are developed in the EU and elsewhere.