Dáil Éireann Debate, Wednesday - 25 March 2026
431. Deputy Malcolm Byrne asked the Minister for Health for an update on plans for the secure use of anonymised and pseudonymised clinical data for research, policy-making, and service planning in healthcare. [23011/26]
Amharc ar fhreagraBoth the Health Information Bill and the European Health Data Space (EHDS) Regulation will provide increased access to anonymised and pseudonymised health data that can be used for secondary purposes including for research, policy making and service provision. The Health Information Bill places a focus on the primary use of data, and this will provide the legal basis for the establishment of electronic health records. A statutory duty will also be introduced to share personal health data across healthcare providers, as well as at the patient’s request. The EHDS, which came into effect in March 2025, will follow a phased implementation timeline with deadlines for Member States between 2027 and 2031. It provides a common governance framework and harmonised infrastructure for the use and reuse of electronic health information in and between EU Member States.
A key feature of the EHDS will be the establishment of national Health Data Access Bodies (HDABs). HDABs will provide governance oversight and facilitate access to anonymised and pseudonymised health data for secondary purposes. My Department has been awarded €3 million in EU funding to support the establishment of an Irish HDAB. Key deliverables include scoping requirements for a secure processing environment and data access management system, deployment of a national metadata catalogue, and development of dissemination and training materials to support HDAB stakeholders.
My Department plans to use this increased access to data to develop policy relevant research on capital planning, workforce planning, health system productivity, health system financing, drug expenditure and behavioural economics. Data will also be used for the compilation of healthcare related statistics, monitoring of health system performance and quality of care. In order to expand the numbers of clinical trials taking place in the State, data will be used to inform the development of agile and responsive systems to reduce the time taken for regulatory approvals, increase pubic and patient involvement through accurate tracking of key performance indicators to grow recognition of the importance of clinical trials throughout the health system, as well as to promote value and incentivise activity among clinical research facilities. Furthermore, pseudonymised clinical data will aid research that supports workforce planning, in addition to informing the design of future clinical trials. During these activities the appropriate mechanisms of data and patient protection will continue to be applied.
