(Text with EEA relevance)

CHAPTER I GENERAL PROVISIONS CHAPTER II PRIMARY USE SECTION 1 Rights of natural persons in relation to the primary use of their personal electronic health data, and related provisions SECTION 2 Governance for primary use SECTION 3 Cross-border infrastructure for primary use of personal electronic health data CHAPTER III EHR SYSTEMS AND WELLNESS APPLICATIONS SECTION 1 Scope and general provisions for EHR systems SECTION 2 Obligations of economic operators with regard to EHR systems SECTION 3 Conformity of the harmonised software components of EHR systems SECTION 4 Market surveillance of EHR systems SECTION 5 Other provisions on interoperability SECTION 6 Registration of EHR systems and wellness applications CHAPTER IV SECONDARY USE SECTION 1 General conditions with regard to secondary use SECTION 2 Governance and mechanisms for secondary use SECTION 3 Access to electronic health data for secondary use SECTION 4 Cross-border infrastructure for secondary use SECTION 5 Health data quality and utility for secondary use SECTION 6 Complaints CHAPTER V ADDITIONAL ACTIONS CHAPTER VI EUROPEAN GOVERNANCE AND COORDINATION CHAPTER VII DELEGATION OF POWERS AND COMMITTEE PROCEDURE CHAPTER VIII MISCELLANEOUS CHAPTER IX DEFERRED APPLICATION, TRANSITIONAL AND FINAL PROVISIONS This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 11 February 2025. For the European Parliament The President R. METSOLA For the Council The President A. SZŁAPKA ELI: http://data.europa.eu/eli/reg/2025/327/oj ISSN 1977-0677 (electronic edition)

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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.