The European Health Data Space (EHDS) is the first common European data space under the European Data Strategy. The EHDS Regulation came into effect on 26 March 2025 and is being applied through phases between 2027 and 2031. 

The EHDS established 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 aims to improve the flow of health data to improve the standard of health and social care that individuals receive and better facilitate other uses of health data, including research, innovation and policy-making, known as secondary use of information. 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. 

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

• Open the full legal text for the EHDS Regulation (external website)
• Visit the HealthData@EU Central Platform (external website)
• Visit the Department of Health’s HealthData@IE webpage (external link)
• Visit the TEHDAS website (external link): The Second Joint Action Towards the European Health Data Space (TEHDAS2) supports bodies to prepare for secondary use of health data under the 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.  
• Visit the QUANTUM website (external link): 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. 

Under the European Health Data Space (EHDS), each EU Member State has to set up one or more health data access bodies (HDABs). A HDAB will securely connect health data users, such as researchers and policy-makers, with health datasets. Access to health datasets through HDAB services will be subject to a strict and transparent decision-making process with legal, technical and ethical controls in place, in line with the requirements set out nationally and 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.

We coordinate three programmes of work within the HealthData@IE project. Each programme of work coordinated by HIQA is supported by a Working Group. The Working Group contributes to completing successful and timely key milestones and outputs through expert advice, reviewing and providing feedback and supporting stakeholder engagement at key stages. 

• Engagement, Dissemination and Training: This programme of work is focused on engaging with stakeholders and providing relevant information, training and support for health data holders, data users and the public. A Public and Patient Involvement (PPI) panel is in place to help ensure materials are clear, relevant and accessible to the public.
  • Open the Dissemination, Training and Support (WP2) Working Group Membership (opens new tab)
• 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.
  • Open the National Health Dataset Catalogue (nHDsC) (WP6) Working Group membership (opens new tab)
• Health data quality enhancement: This programme of work is focused on developing tools and resources to enhance health data quality and interoperability (the ability of different systems or devices to operate together effectively) to support safe, reliable secondary use of data for research and policy and ensure organisations are prepared for implementing the EHDS.
  • Open the Health data quality enhancement (WP8) Working Group membership (opens new tab)
  • Open the Technical Sub-Group for National Interoperability Framework (WP8.4) Working Group membership (opens new tab)

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.

• Open our Readiness Assessment Report (opens new tab): This report sets out the findings of an assessment which examines how prepared health data holders are for the establishment of HDAB services. It also outlines the steps needed to ensure health data holders can meet future responsibilities under the EHDS Regulation.
• Download our National Interoperability Framework Review (PDF): This review identified and summarised available approaches in other jurisdictions or countries, and in other relevant organisations, that facilitate the exchange of health-related data for secondary use purposes to inform developing a National Interoperability Framework for HDAB services in Ireland.
• Open our International Review of Engagement, Education and Data Quality Enhancement in relation to Health Data Access Bodies (opens new tab): A review of international best practices in engaging, educating and enhancing data quality in the context of the secondary use of health data and HDAB services.
• Open our HealthData@IE Engagement and Education Strategic Plan 2024–2027 (opens new tab): An overview of HIQA's plan for engaging, informing, training and educating in relation to establishing HDAB services in Ireland.
• Open our Programme Plan for Work Package 8—Health Data Quality Enhancement: Improving quality and interoperability of data for secondary use (opens new tab): A detailed overview of tasks included in Work Package 8 on Health Data Quality Enhancement, along with their associated outputs. 

• Open our Guidance for Data Holders: Preparing for the establishment of HDAB services in Ireland under the EHDS (opens new tab): This document outlines key aspects of the secondary use of health data under the regulation, and the implications for health data holders in Ireland.
• Open our Readiness Assessment Protocol, Use Cases and Survey: Preparing for the establishment of HDAB services in Ireland under the EHDS (opens new tab): This document describes the overall approach to the readiness assessment, how data will be collected and analysed and the expected outputs.
• Open our HealthData@IE Training and Education Resources Portfolio (opens new tab): This is 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.