art_48__para_1

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

1. Manufacturers of wellness applications may claim interoperability with an EHR system, provided that the relevant common specifications and essential requirements referred to in Article 36 and Annex II, respectively, are met. In the event of such claim, those manufacturers shall duly inform users of the interoperability of such wellness applications and the effects of such interoperability.

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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.