The Health Information and Quality Authority (HIQA) has today published reports of two new tools it has developed by engaging with health data holders in Ireland prepare for secondary use of data for the upcoming European Health Data Space (EHDS). 

Through the HealthData@IE project, HIQA is working in partnership with the Department of Health, and other key stakeholders to support the health and social care system in Ireland to prepare for making data available for secondary use by March 2029. Information management and data quality are fundamental to the success of the EHDS so data users can confidently rely on data to inform important decisions such as policy making, planning and management of health services and research.  

HIQA has engaged with data holders to develop two tools to support EHDS readiness:

• a self-assessment tool, called the Information Management Maturity Assessment Tool (IMMAT) to support health data holders in identifying their level of maturity compared to other data holders in Ireland, enabling organisations to identify and prioritise changes that are required to enhance maturity, and be ready to comply with the EHDS by 2029. 
• a tool to assess compliance with information management and data quality, aligned to EHDS requirements. The Compliance Assessment Framework (CAF) tool clearly outlines what steps need to be taken to enhance data quality ensuring it is of high quality. 

The reports of these two new tools, published today, show that while participating data holders had measures in place to manage data quality and information, findings identified gaps in digital infrastructure, governance, staff capacity and consistency of assessments. 

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

“The findings show that while Ireland has strong foundations, significant work is needed to prepare the Irish health system for making data available for secondary use under the EHDS. These two tools will play a central role in supporting health data holders to meet their obligations, and our reports provide valuable insights to shape this rapidly evolving area for data holders. 

Strengthening governance, improving processes and associated documentation, as well as building digital capability will be essential to ensure Ireland can fully comply with and benefit from the EHDS.”

An updated data quality assessment framework and supporting guidance are expected to be published in 2027, and a digital version of the IMMAT will be rolled out to priority data holders. HIQA also has a wider programme of work to support data holders in their preparations over the coming years. 

ENDS 

Notes:  

• The European Health Data Space (EHDS) (opens new website) Regulation aims to create a standardised health data space across the EU, allowing individuals to control and utilise their health data at home or in other Member States. It also aims to enhance the use of data for secondary purposes across the EU by making it possible for researchers, innovators and policymakers to use this data in a trusted and secure way that preserves privacy. Secondary use of health data is the practice of reusing information originally gathered for direct patient care and medical treatment for other purposes, such as scientific research, public health tracking, and healthcare policy-making. 
• Between 2029 and 2031, EU Member States are required to establish secondary data access services, under EHDS Regulation. To achieve this, Health Data Access Body (HDAB) services 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. 
• The implementation of a comprehensive legal framework, including the Health Information Act 2026 and the EHDS Implementing Acts in 2027, will be a critical step in promoting the effective use of health data in Ireland. 
• Under the EU4Health programme, EU funding has been awarded to the Department of Health to facilitate the establishment of Health Data Access Body (HDAB) services. The grant-funded project (HealthData@IE, opens new webiste) is being led by the Department of Health in partnership with HIQA, the Health Research Board (HRB) and the Central Statistics Office (CSO). The project involves developing a national Health Dataset Catalogue (nHDC) to facilitate data discovery, as well as a Data Access Application Management System (DAAMS) to receive, track and process applications, to issue permits, and secure processing environments (SPEs) to ensure the secure processing of health data. 
• To comply with the EHDS Regulation, data holders must identify if they are required to make datasets available for secondary use and if they need to complete the data quality and utility label; publish descriptions of relevant datasets through the nHDC; update dataset information on the nHDC annually; report on data quality through the Data Quality and Utility Label annually; submit datasets through HDAB services when requested. 
• National guidance, dedicated resources and the implementation of a unified strategy are also required to standardise data sharing, in line with semantic interoperability and data exchange standards. This will ensure a consistent approach to making data readily available and fit-for-purpose when requested. 
• In 2024, HIQA published National Standards for Information Management in Health and Social Care (opens new webpage) that aim to contribute to safer better care by improving the management of health and social care information. These standards will support Ireland’s health and social care system meet requirements set out under forthcoming health information legislation at both national and European level including the Health Information Bill and the European Health Data Space. The standards will also support the implementation of the Department of Health’s strategy, Digital for Care: A Digital Health Framework for Ireland 2024-2030.  
• In 2025, HIQA published a guidance document (PDF) for data holders to outline what the EHDS Regulation is, with a particular focus on what it will mean for the secondary use of health data and the implications for Ireland. 
• In 2026 HIQA published a readiness assessment (PDF) on health data holders in Ireland and the secondary use of health data under the European Health Data Space (EHDS) Regulation.  
• HIQA frequently updates a catalogue (opens new webpage) of National data collections in Ireland promoting the maximum use of existing national data collections to drive improvements in the quality and safety of our health and social care services in Ireland. The catalogue is being developed into a digital tool to support regular updates and discoverability of data aligned with European requirements.

About HIQA 

The Health Information and Quality Authority (HIQA) is the independent body that promotes safety and quality in the provision of health and social care services in Ireland.  

Through its regulation, standard setting and evidence to inform decision-making functions, HIQA supports health and social care services to consistently deliver excellent standards of care and the best possible health and social care outcomes for all.