anx_II__table__4 — Regulation (EU) 2025/327 of the European Parliament and of the Council of 11…

anx_IItable4

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

| 1.4. | The harmonised software components of an EHR system that is intended to be operated together with other products, including medical devices, shall be designed and manufactured in such a way that interoperability and compatibility are reliable and secure, and personal electronic health data can be shared between the device and the EHR system in relation to those harmonised software components of an EHR system.

← anx_II__table__3 · All articles · 2. Requirements for interoperability →

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