art_48__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. The interoperability of wellness applications with EHR systems shall not entail the automatic sharing of all or part of the health data from the wellness application with, or automatic transmission of all or part of such data to, the EHR system. The sharing or transmission of such data shall only be possible if it is in accordance with Article 5 and after consent is given by the natural person concerned and interoperability shall be limited exclusively to those purposes. The manufacturers of wellness applications claiming interoperability with an EHR system shall ensure that the natural person concerned is able to choose which categories of health data from the wellness application are to be inserted in the EHR system and the circumstances for the sharing or transmission of those categories of data.

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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.