art_26__para_2

Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (Text with EEA relevance) · European Union

2. EHR systems that are manufactured and used within health institutions established in the Union, as well as EHR systems offered as a service as defined in Article 1(1), point (b), of Directive (EU) 2015/1535 of the European Parliament and of the Council (33) to a natural or legal person established in the Union, shall be considered as having been put into service.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-15 · Text as adopted (Official Journal); later amendments are not incorporated in this text.