Harmonized Component

Standarized functionality of EHR systems to enable the EHDS goals

In short: EHR systems shall have a number of harmonized components to enable the goals of EHDS.

The EHDS regulation describes a number of harmonized components of EHR systems and mandates that these be supported for the priority categories of data. From Article 25: EHR systems shall include a European interoperability software component for EHR systems and a European logging software component for EHR systems.

The European interoperability software component shall support the EEHRxF format as specified in Article 15.

Additional requirements for these harmonized components can be found in Annex II.

Comments/Discussion

'European interoperability software component' means a software component of the EHR system which provides and receives personal electronic health data under a priority category for primary use established under the EHDS Regulation in the European electronic health record exchange format provided for in the Regulation and which is independent of the European logging software component for EHR systems. Internationally recognized standards will provide the foundation for the implementings acts, particularly leveraging HL7 FHIR and DICOM, which serve as the foundational framework for interoperability in EHR systems.

'European logging software component' means a software component of the EHR system which provides logging information related to access by health professionals or other individuals to priority categories of personal electronic health data defined in article 14 of the EHDS Regulation, in the format defined in point 3.2. of Annex II of the EHDS Regulation, and which is independent of the European interoperability software component for EHR systems.

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Ringholm bv is a group of European experts in the field of messaging standards and systems integration in healthcare IT. We provide the industry's most advanced training courses and consulting on healthcare information exchange standards.