European Union: European Health Data Space Regulation (2025/327) including provisions on third-country participation enters into force
Description
European Health Data Space Regulation (2025/327) including provisions on third-country participation enters into force
On 26 March 2035, Article 75(5) of the European Health Data Space (EHDS) Regulation (2025/327) enters into force. Third countries or international organisations may become authorised participants in HealthData@EU if they comply with the Regulation's rules and provide equivalent access to health data users in the EU. The European Commission will be responsible for assessing and determining compliance through implementing acts, ensuring that these entities meet the necessary legal, technical, and security standards. Monitoring compliance, including secure processing requirements under Article 73, will be the responsibility of the Commission. The list of approved implementing acts will be made available to the public under the procedure outlined in Article 98(2).
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