EU advances health data exchange regulation

EU Council and Parliament preliminary agree on EHDS regulation, aiming to improve health data access/control, facilitate reuse for public interest, and foster a unified digital health market within the EU.

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The EU Council and Parliament have agreed on a preliminary law facilitating health data exchange within the EU. The proposed European Health Data Space (EHDS) regulation aims to enhance individuals’ access and control over their electronic health data while permitting certain data reuse for public interest and research. It establishes a health-specific data environment to advance a unified digital health market. Presently, cross-border health data access in the EU varies. The new rules intend to enable scenarios where the EU citizens visiting another EU country could get a prescription or medication in another EU country.

The provisional agreement between the Council and Parliament revises the Commission’s proposal, focusing on critical areas:

  • Opt-out: Member states can allow patients to opt out of their health data use, except for public interest, policy-making, statistics, and research under strict conditions.
  • Restricted information: Patients can limit access to vital health data for healthcare professionals.
  • Sensitive data: Stricter measures for researching sensitive data, like genetic data.
  • Trusted data holders: Member states can appoint trusted entities to process access requests.
  • Clinically significant findings: Researchers must inform health data access bodies about findings affecting patients, prompting patient or professional notification.

The agreement needs approval from both Council and Parliament, followed by legal revision, before being adopted and enacted.