Data & Privacy
- Data Act
- Data Governance Act
- EHDS
- ePrivacy Directive
- GDPR
AI & Trust
- Artificial Intelligence Act
- Product Liability Directive
Cybersecurity
- Cyber Resilience Act
- Cybersecurity Act
- DORA
- NIS2
Digital Services & Media
- Digital Markets Act
- Digital Services Act
- European Media Freedom Act
European Health Data Space Regulation
- Recitals
CHAPTER I
GENERAL PROVISIONSArticles 1 — 2
CHAPTER II
PRIMARY USEArticles 3 — 24
CHAPTER III
EHR SYSTEMS AND WELLNESS APPLICATIONSArticles 25 — 49
CHAPTER IV
SECONDARY USEArticles 50 — 81
CHAPTER V
ADDITIONAL ACTIONSArticles 82 — 91
CHAPTER VI
EUROPEAN GOVERNANCE AND COORDINATIONArticles 92 — 96
CHAPTER VII
DELEGATION OF POWERS AND COMMITTEE PROCEDUREArticles 97 — 98
CHAPTER VIII
MISCELLANEOUSArticles 99 — 104
CHAPTER IX
DEFERRED APPLICATION, TRANSITIONAL AND FINAL PROVISIONSArticles 105 — 105
ANNEXES
EHDS Article 15. European electronic health record exchange format
- 1.By 26 March 2027, the Commission shall, by means of implementing acts, lay down the technical specifications for the priority categories of personal electronic health data referred to in Article 14(1), setting out the European electronic health record exchange format. Such format shall be commonly used, machine-readable and allow transmission of personal electronic health data between different software applications, devices and healthcare providers. Such format shall support transmission of structured and unstructured health data and shall include the following elements:
- (a)harmonised datasets containing electronic health data and defining structures, such as data fields and data groups for the representation of clinical content and other parts of the electronic health data;
- (b)coding systems and values to be used in datasets containing electronic health data;
- (c)technical interoperability specifications for the exchange of electronic health data, including its content representation, standards and profiles.
The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the examination procedure referred to in Article 98(2).
- 2.The Commission shall, by means of implementing acts, provide regular updates of the European electronic health record exchange format to integrate relevant revisions of the healthcare coding systems and nomenclatures. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
- 3.The Commission may, by means of implementing acts, lay down technical specifications to extend the European electronic health record exchange format to additional categories of personal electronic health data referred to in Article 14(1), third subparagraph. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
- 4.Member States shall ensure that the priority categories of personal electronic health data referred to in Article 14 are issued in the European electronic health record exchange format referred to in paragraph 1 of this Article. Where such data are transmitted by automated means for primary use, the receiving provider shall accept the format of the data and be able to read them.
Relevant Recitals for this Article
The level of availability of personal health and genetic data in an electronic format varies between Member States. The EHDS should make it easier for natural persons to have those data available in electronic format and to control better the access to and sharing of their personal electronic health data. This would also contribute to the achievement of the target of 100 % of Union citizens having access to their electronic health records by 2030, as referred to in Decision (EU) 2022/2481 of the European Parliament and of the Council . In order to make electronic health data accessible and transmissible, such data should be accessed and transmitted in an interoperable common European electronic health record exchange format, at least for certain categories of electronic health data such as patient summaries, electronic prescriptions and dispensations, medical imaging studies and related imaging reports, medical test results and discharge reports, subject to transition periods. Where personal electronic health data are made available to a healthcare provider or a pharmacy by a natural person, or are transmitted by another controller in the European electronic health record exchange format, that format should be accepted, and the recipient should be able to read the data and use them for the provision of healthcare or for dispensation of a medicinal product, thus supporting the provision of the healthcare services or the dispensation of the electronic prescription. The European electronic health record exchange format ought to be designed in a way that facilitates translation of electronic health data communicated using that format into the official languages of the Union, to the extent possible. Commission Recommendation (EU) 2019/243 provides the foundations for such a common European electronic health record exchange format. The interoperability of the EHDS should contribute to having European health datasets of a high quality. The use of a European electronic health record exchange format should become more widespread at Union and national level. The European electronic health record exchange format could allow for different profiles for its use at the level of EHR systems and at the level of the national contact points for digital health in MyHealth@EU for cross-border data exchange.
While EHR systems are widespread, the level of digitalisation of health data varies in Member States depending on data categories and on the coverage of healthcare providers that register health data in electronic format. In order to support the application of data subjects’ rights of access to and exchange of electronic health data, Union action is needed to avoid further fragmentation. In order to contribute to a high quality and continuity of healthcare, certain categories of health data should be registered in electronic format systematically and in accordance with specific data quality requirements. The European electronic health record exchange format should form the basis for specifications related to the registration and exchange of electronic health data.