EU Health Data API
0.1.0 - ci-build
150
EU Health Data API
0.1.0 - ci-build
150
EU Health Data API, published by HL7 Europe. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/euridice-org/eu-health-data-api/ and changes regularly. See the Directory of published versions
Source: EUR-Lex Regulation (EU) 2025/327
Published: 5 March 2025 Entered into force: 26 March 2025
Note: The essential requirements laid down in this Annex shall apply mutatis mutandis to medical devices, in vitro diagnostic medical devices, AI systems and wellness applications claiming interoperability with EHR systems.
The harmonised software components must achieve their intended performance and be designed such that during normal use, they support patient safety and fulfill their designated purpose.
The harmonised software components of the EHR system shall be designed and developed in such a way that the EHR system can be supplied and installed, taking into account the instructions and information provided by the manufacturer, without adversely affecting its characteristics and performance during its intended use.
Systems must be designed to uphold individual rights according to their intended purpose under Chapter II, maintaining interoperability, safety, and security features.
Where an EHR system operates with other products including medical devices, it must ensure reliable and secure interoperability with compatible sharing of personal health data through the harmonised components.
Where an EHR system is designed to store or intermediate personal electronic health data, it shall provide an interface enabling access to the personal electronic health data processed by it in the European electronic health record exchange format.
Systems must be able to receive personal electronic health data in the European electronic health record exchange format through the interoperability component.
Where an EHR system is designed to provide access to personal electronic health data, it shall be able to receive personal electronic health data in the European electronic health record exchange format, by means of the European interoperability software component for EHR systems.
Systems enabling structured data entry must support sufficient detail levels to enable provision of entered data in the required exchange format.
The harmonised software components of an EHR system shall not include features that prohibit, restrict or place an undue burden on authorised access, personal electronic health data sharing or use of personal electronic health data for permitted purposes.
Systems must not include features that prohibit, restrict, or unduly burden the authorised exporting of personal electronic health data when replacing one EHR system with another.
An EHR system designed to be used by health professionals shall provide reliable mechanisms for the identification and authentication of health professionals.
The logging component must record sufficient information for every access event, including:
The harmonised software components of an EHR system shall include tools or mechanisms to review and analyse the log data, or it shall support the connection and use of external software for the same purposes.
Components storing personal health data must support varying retention periods and access rights accounting for data origins and categories.
IG © 2025+ HL7 Europe.
Package hl7.fhir.eu.eu-health-data-api#0.1.0 based on FHIR 4.0.1.
Generated
2026-02-06
