Denis Naughten (Roscommon-Galway, Independent)
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577. To ask the Minister for Health his views on the fact that access to anonymised medical records operates to protect the vital interest of every citizen and in the public interest; and if he will make a statement on the matter. [39947/24]

Stephen Donnelly (Wicklow, Fianna Fail)
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The European Health Data Space (EHDS) Regulation, which is planned for publication in Q4 2024, will establish EU legislation governing the use and re-use of electronic health information in EU Member States for primary purposes (patient care and treatment) and secondary purposes (research and innovation, policy making, education and training). I welcome the forthcoming Regulation as a powerful driver of health services improvement and a key for unlocking the tremendous potential of health data to improve the lives of patients and health performance outcomes.

The EHDS Regulation contains a number of safeguards to ensure that patient data is protected. A key feature will be the establishment of two national supervisory bodies responsible for the governance and oversight of health data: the Digital Health Authority, for health data for primary use, and the Health Data Access Body, for health data for secondary use. In relation to the secondary use of health data, safeguard measures will require:

• Data users who want to access health data must apply for access through a Health Data Access Body.
• Access to personal electronic health data (e.g. data contained in an Electronic Health Record) can only be provided in an anonymised or pseudonymised format.
• Data user applications will be reviewed by an expert Access Review Committee hosted by the Health Data Access Body.
• Attempts to re-identify a patient through data access will result in possible penalties including:
  • fines;
  • referral to the Data Protection Commission;
  • data permit revocation (nationally and at EU level).