The EHDS EHR system: information sheet

Revised 2026-10-26.

This is the information sheet of the EHR system that FerroEHR and FerroBRIDGE form together. A copy accompanies each release of either product, free of charge for the user, as the EHDS (Regulation (EU) 2025/327) asks: each EHR system is “accompanied, free of charge for the user, by the information sheet provided for in Article 38 and clear and complete instructions for use” (Art. 30(1)(d)). Article 38(1) asks for “concise, complete, correct and clear information that is relevant, accessible and comprehensible to professional users”, and Article 38(2) lists what the sheet specifies. Each section below is one point of that list. The instructions for use accompany it.

Note

This page holds what stays true from one release to the next. The copy a release carries is cut from the revision of this page that the release pins, and the release lane appends that release’s own facts under the heading “This copy”: the version of each product, the release date and the version of each standard in the table under (e). Read the copy of the release you run. The quotations are from the Official Journal text of the EHDS. No conformity assessment has been carried out and no EU declaration of conformity exists; nothing on this sheet says that the EHR system meets the Regulation.

(a) The manufacturer

EHDS Art. 38(2)(a): “the identity, registered trade name or registered trademark, and contact details of the manufacturer and, where applicable, of its authorised representative”.

Cadasto B.V. is the manufacturer of both products and of every other FerroHEALTH product (the manufacturer).

(b) Name, version and release date

EHDS Art. 38(2)(b): “the name and version of the EHR system and date of its release”.

• Name: FerroEHR with FerroBRIDGE, the EHR system Cadasto B.V. declares. FerroEHR, the openEHR Clinical Data Repository, ships the European logging software component. FerroBRIDGE, the bridge from openEHR to HL7 FHIR and to the OMOP Common Data Model, ships the European interoperability software component. The two are separate products on their own release lines and meet only over the openEHR REST API (how the products fit together).
• Version: the release of the product this copy accompanies, with the oldest release of the other product it is tested against. A copy attached to a FerroEHR release names that FerroEHR release and the oldest FerroBRIDGE release FerroEHR is tested against; a copy attached to a FerroBRIDGE release names it the other way round. “This copy” at the end of the copy states both.
• Release date: the date of the release this copy accompanies, as its product’s changelog heads that release. “This copy” states it.
• Support period: only the newest release of each product is supported. Cadasto B.V. commits to keep publishing security fixes for at least five years after each release and ships them only in the newest release (security, the Cyber Resilience Act). The end month of that commitment is in the notes of each release.

(c) Intended purpose

EHDS Art. 38(2)(c): “the intended purpose of the EHR system”.

The EHR system stores, versions and queries the structured health records of one healthcare provider, records every access to them, and exchanges them with other systems in HL7 FHIR and, for research and analytics, as rows of the OMOP Common Data Model. FerroEHR holds the records and serves them through the openEHR REST API and AQL to the software the provider’s health professionals and patients use, and records every access in its access log. FerroBRIDGE reads and writes FerroEHR over that API and maps the records to FHIR and to the OMOP Common Data Model, driven by mapping specifications the deployment loads. Neither product has a clinical user interface, and the system is not intended for any medical device purpose. Each product runs one instance per organisation.

The full statement, with the users and what the intended purpose excludes, is the intended purpose. Each product’s book carries its own part of it.

(d) The categories of electronic health data

EHDS Art. 38(2)(d): “the categories of electronic health data that the EHR system has been designed to process”.

• Clinical content: the priority categories of EHDS Art. 14(1), “(a) patient summaries; (b) electronic prescriptions; (c) electronic dispensations; (d) medical imaging studies and related imaging reports; (e) medical test results, including laboratory and other diagnostic results and related reports; and (f) discharge reports”, and any category a Member State adds in national law, as far as the operational templates the deploying organisation loads describe them. FerroEHR stores this content. Imaging studies are held as attachments or as references to an imaging archive; neither product implements DICOM image transfer. FerroBRIDGE maps the same content to FHIR resources and to OMOP Common Data Model rows as it passes, and the readiness record names which category has a mapping today (readiness).
• Identities: FerroEHR holds persons, organisations and roles, and their identifiers, in a separate demographic domain, and the link between a record and its subject in a separate linkage domain. FerroBRIDGE keeps the correspondence between the FHIR identifiers it serves and the openEHR identifiers they stand for.
• The access log: FerroEHR records who accessed which record, when, from which origin and in which priority category, naming health professionals and patients.

(e) Standards, formats and specifications

EHDS Art. 38(2)(e): “the standards, formats and specifications supported by the EHR system and versions of those standards, formats and specifications”.

The table names each standard and the product that supports it. The versions move with each release, so the release lane of each product appends the versions of its own release under “This copy”, read from the pins of that release.

The European electronic health record exchange format of EHDS Art. 15 has not been adopted; when it is, FerroBRIDGE carries it. Each product measures its conformance to the specifications it implements and publishes the record in its own book; those records measure the specifications, not the EHDS.

This copy

The release lane appends this section to the copy it attaches: the product and release the copy accompanies, its release date, the oldest release of the other product it is tested against, and the version of each standard above for that release. This page in the book carries no such facts.