Information sheet

The information sheet that accompanies each FerroEHR release, free of charge, as EHDS Art. 30(1)(d) asks (Regulation (EU) 2025/327). EHDS Art. 38(1) asks for “concise, complete, correct and clear information that is relevant, accessible and comprehensible to professional users”, and Art. 38(2) lists what it specifies; each section below is one point of that list. The instructions for use accompany it.

• (a) The manufacturer
• (b) Name, version and release date
• (c) Intended purpose
• (d) The categories of electronic health data
• (e) Standards, formats and specifications

Note

This sheet is published in the book of each release, at https://ferroehr.eu/docs/vX.Y.Z/compliance/information-sheet.html, and attached to each GitHub release as ferroehr-vX.Y.Z-information-sheet.md, a plain-text Markdown file a screen reader reads as text, with that release’s version and date stamped at the top. The book at /docs/dev/ describes the code on main, which is not a release. The article texts are those vendored at docs/law/eu/ehds/text.html. No conformity assessment has been carried out and no EU declaration of conformity exists; nothing on this sheet says that FerroEHR 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”.

The running server names the manufacturer in the same words on its startup banner, in ferroehr --version and on GET /management/info (the manufacturer and the deployment report). Cadasto B.V. is the manufacturer of every FerroHEALTH product; the FerroHEALTH book describes it at https://ferrohealth.eu/docs/manufacturer.html and its post-market procedure at https://ferrohealth.eu/docs/post-market.html.

(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, one of the two products of the EHR system Cadasto B.V. declares. The other is FerroBRIDGE, which ships the European interoperability software component and publishes its own version, date and information sheet with its releases. The two meet over the openEHR REST API.
• Version: the release this sheet belongs to: the tag vX.Y.Z, the version ferroehr --version prints, and server_version on GET /ferroehr/rest/status.
• Release date: the date on the release’s heading in the changelog, ## [X.Y.Z] - YYYY-MM-DD.
• Support period: five years from the month of the release date; the end month is in the release notes and in SECURITY.md.

(c) Intended purpose

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

FerroEHR stores, versions and queries the structured health records of one healthcare provider, and serves them to the software that provider’s health professionals and patients use, through the openEHR REST API and AQL. It records every access to those records in its access log, the European logging software component. It has no clinical user interface of its own, and it is not intended for any medical device purpose. It runs one instance per organisation, operated by the organisation itself, by a processor on its behalf, or by Cadasto B.V. as a hosted service.

FerroEHR’s part of the statement, with the environment and the foreseeable misuse, is the intended purpose. The statement for the EHR system FerroEHR forms with FerroBRIDGE, with its users, is in the FerroHEALTH book at https://ferrohealth.eu/docs/ehds/intended-purpose.html.

(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. Imaging studies are held as attachments or as references to an imaging archive; FerroEHR implements no DICOM image transfer. The deployment declares which templates carry which category in the [audit.categories] map.
• Identities, in a separate demographic domain: persons, organisations and roles, and their identifiers.
• The link between a record and its subject, in a separate linkage domain.
• The access log: 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”.

Which openEHR generation a deployment serves is a configuration choice (choosing a specification generation). The conformance record measured against the openEHR specifications is on the conformance page; it measures the openEHR specifications, not the EHDS. The European electronic health record exchange format of EHDS Art. 15 has not been adopted, and FerroBRIDGE, not FerroEHR, carries it.