Article 15
European electronic health record exchange format
In short: The technical specifications for the priority categories (known as the EEHRxF, or European electronic health record exchange format) are comprised of
data sets, coding sets and technical interoperability specifications.
- By 26 March 2027, the Commission shall, by means of [Article 15(1)] 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).
- 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).
- 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).
- 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.
From the EU FAQ, March 2025:
One of the main obstacles to ensuring interoperability and seamless exchange of health information for providing
treatment is the use of different and often incompatible file formats for data - for example, hospitals are often technically not able to
import reports from other hospitals into their own systems. This is a problem particularly in cross-border situations but is also common within the same Member State.
The European electronic health record exchange format (EEHRxF) is designed to address the challenges of interoperability and enable the seamless
exchange of health information for the priority categories of personal electronic health data across different healthcare systems within the EU.
It provides a common European format for describing the priority categories. EHR systems will have to be able to import and
export data in this format. This will be an important step forward for interoperability of electronic health information. In simple words: the
EEHRxF will be a common language that EHR systems must be able to speak to one another.
The detailed specifications will be set out by the Commission through an implementing act, to be adopted within two years of entry into force of
the EHDS Regulation, that is to say by 26 March 2027 (see Article 15 EHDS).
The specifications are expected to build on the work of the XT-EHR Joint Action that in turn builds on the results of previous EU-funded projects
such as XpanDH, x-eHealth, and epSOS, as well as
on Commission Recommendation (EU) 2019/243
on a European Electronic Health Record exchange format.
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