HealthData@IE– National Project Implementing EHDS

The European Health Data Space (EHDS) will be the first common European data space under European Data Strategy. It is designed to improve both the flow of health data and access to health data for the benefit of patients, healthcare providers and researchers.

The EHDS Regulation is expected to be formally adopted as EU law in autumn 2024. Implementation deadlines fall between 2026 and 2030. There is a need for legislative and operational preparations to ensure Ireland is ready implement the EHDS.

Under the EHDS, each EU Member State will be required to establish a Health Data Access Body (HDAB). A HDAB is a service allowing data users such as researchers and policymakers to apply for access to health datasets to support research and innovation, education and training, policymaking, health service management and preparing national statistics.

Access to datasets will be on a permit basis and under supervised conditions within secure processing environments. Data users will be able to apply for access to datasets from different controllers which will be gathered and linked by the HDAB services. Data discovery will be facilitated through national health metadata catalogues maintained by the HDABs.

The Department of Health has been awarded EU funding under the EU4Health programme to support the establishment of a HDAB in Ireland. The grant-funded project will be delivered in collaboration between the Department of Health, the Health Information and Quality Authority (HIQA) and the Health Research Board (HRB).

The project will focus on the development of national infrastructures needed for data access. The data access infrastructure includes systems identified by the EU Commission as core Digital Business Capabilities for HDABs:

• A Data Access Application Management System (DAMMS) to receive, track and process applications and to issue permits.
• A national health metadata catalogue to facilitate data discovery.
• A Secure Processing Environments to ensure the secure processing of health data.

Further, the project will deliver important workstreams on:

• Data quality enhancement, to improve the quality of health data made available by HDABs.
• A structured programme of training and engagement with data users on the EHDS.

The department has established a steering committee to bring together stakeholders and national experts to oversee delivery HealthData@IE. The Steering Committee meets every 6 weeks and also considers the wider national landscape and preparations for health data access.

The HealthData@IE project is co-funded by the European Union through EU4Health 2021-2027 under grant agreement number EU4H-2023-JA-3-IBA-10.

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 HaDEA. Neither the European Union nor the granting authority can be held responsible for them.