The Health Information and Quality Authority (HIQA) has today published new analysis on health data holders in Ireland and the secondary use of health data under the European Health Data Space (EHDS) Regulation. 

“Readiness Assessment for Data Holders” was conducted as part of the ‘HealthData@IE project’, led by the Department of Health in collaboration with HIQA, the Health Research Board, and key stakeholders across the Health Service Executive and wider health system.

Between 2029 and 2031, EU Member States are required to establish secondary data access services, under the EHDS Regulation. This will allow researchers, policy-makers and health authorities to securely access anonymised health data for purposes such as research, innovation and public health planning.

To achieve this, a Health Data Access Body (HDAB) service will securely connect data users with appropriate health data to support their work, while health data holders will be required to make their data available. An example of a health data holder is the National Cancer Registry of Ireland.

HIQA’s readiness assessment examines 21 major health datasets held by 16 data holders, representing a significant portion of Ireland’s health data infrastructure. It identifies key gaps between Ireland’s current levels of preparedness and what health data holders must do to meet their obligations under the EHDS Regulation, while outlining existing areas of good practice and areas where more work is needed.

The report found that key steps must be taken across Ireland’s health and social care system to prepare for the full breadth of EHDS Regulation requirements. For data holders to comply with obligations, effective infrastructure, governance structures and data sharing practices are essential. Detailed rules and specifications will be required to support changes in practices and prepare for the establishment of a HDAB service.

Key steps that data holders must take to comply with the EHDS Regulation include:

• identifying if they are required to make datasets available for secondary use
• publishing descriptions of relevant datasets
• updating dataset information annually
• reporting on data quality annually
• submitting datasets through the HDAB service when requested.

HIQA’s Director of Health Information and Standards, Rachel Flynn, said: 

“While Ireland has a significant body of work to do, the EHDS Regulation brings with it many welcome developments for our national health information system. The aim of the EHDS is to benefit patients, health and social care providers and researchers by establishing a common framework across the EU for the use and exchange of electronic health data.

HIQA is playing a pivotal role in working with national data collections to prepare the sector for the establishment of HDAB services. We are working closely with similar grant holders across Europe, placing Ireland in a unique position to learn from the experiences of many experts at such an optimal time of planning and innovation. 

The implementation of the National Standards for Information Management in Health and Social Care, developed by HIQA and mandated by the Minister for Health in 2024, will complement the Regulation and support data holders in maintaining good data management practices to ensure data is of sufficient quality to be shared with a HDAB service.

The HealthData@IE project will further build on progress made by HIQA in recent years in this area such as developing a National Health Dataset Catalogue, enhancing data quality by developing guidance and training materials, hosting a peer-support network for health data holders on the topic of data quality, and developing a national interoperability framework. The report published today will help data holders across Ireland understand what the EHDS means for them and what their obligations are under this Regulation.”

Read the Readiness Assessment Report at the link from the top of the page.