Agent · helsodata-2025-327-38
EHDS artikel 38: Information sheet accompanying the EHR system
Structural tree: the article's own paragraphs, verbatim.
CELEX 32025R0327 · 2026-08-31 · Weight 70 · minimal-risk
OpenOpen reading. No metering is planned for this class.
- What this page is
- Agent, EHDS artikel 38
- Checked against the official source
- 2026-08-31Current
- Responsible publisher
- ExploreWorld Legal, editorial deskLiability position
Short answer
What does EHDS Article 38 require, and what outcome does the rule tree give?
EHDS Article 38 is tested here by a deterministic rule tree of 13 rules, built from the article's own conditions. The tree reads your facts and names the outcome that applies, starting with Paragraph 1 applies, carrying paragraph citation, content hash and read date 2026-08-31 against CELEX 32025R0327. The outcome is a machine classification, not a compliance decision.
EHDS Article 38Checked against the publisher 2026-08-31Official text
- Paragraph 1 applies. 1. EHR systems shall be accompanied by an information sheet that includes concise, complete, correct and clear information that is relevant, accessible and comprehensible to professional users.
- Paragraph 2 applies. 2. The information sheet referred to in paragraph 1 shall specify:
- Paragraph 3 applies. (a)
A source reference, not legal advice.
Jurisdiction
The same agent, read through one country's lens.
Inputs
- in_scopeThe article applies to the situationboolean
- punktParagraph of the articleenum (1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13)
Rule tree
If: alla(in_scope = true, punkt = 1)
Paragraph 1 applies
1. EHR systems shall be accompanied by an information sheet that includes concise, complete, correct and clear information that is relevant, accessible and comprehensible to professional users.
Paragraph 1
If: alla(in_scope = true, punkt = 2)
Paragraph 2 applies
2. The information sheet referred to in paragraph 1 shall specify:
Paragraph 2
If: alla(in_scope = true, punkt = 3)
Paragraph 3 applies
(a)
Paragraph 3
If: alla(in_scope = true, punkt = 4)
Paragraph 4 applies
the identity, registered trade name or registered trademark, and contact details of the manufacturer and, where applicable, of its authorised representative;
Paragraph 4
If: alla(in_scope = true, punkt = 5)
Paragraph 5 applies
(b)
Paragraph 5
If: alla(in_scope = true, punkt = 6)
Paragraph 6 applies
the name and version of the EHR system and date of its release;
Paragraph 6
If: alla(in_scope = true, punkt = 7)
Paragraph 7 applies
(c)
Paragraph 7
If: alla(in_scope = true, punkt = 8)
Paragraph 8 applies
the intended purpose of the EHR system;
Paragraph 8
If: alla(in_scope = true, punkt = 9)
Paragraph 9 applies
(d)
Paragraph 9
If: alla(in_scope = true, punkt = 10)
Paragraph 10 applies
the categories of electronic health data that the EHR system has been designed to process;
Paragraph 10
If: alla(in_scope = true, punkt = 11)
Paragraph 11 applies
(e)
Paragraph 11
If: alla(in_scope = true, punkt = 12)
Paragraph 12 applies
the standards, formats and specifications supported by the EHR system and versions of those standards, formats and specifications.
Paragraph 12
If: alla(in_scope = true, punkt = 13)
Paragraph 13 applies
3. As an alternative to supplying the information sheet referred to in paragraph 1 of this Article with the EHR system, manufacturers may enter the information referred to in paragraph 2 of this Article into the EU database for registration of EHR systems and wellness applications referred to in Article 49.
Paragraph 13
If no rule matches: The article is not stated to apply, or no paragraph is selected. The agent abstains rather than guesses.
The article text as read
- 11. EHR systems shall be accompanied by an information sheet that includes concise, complete, correct and clear information that is relevant, accessible and comprehensible to professional users.
- 22. The information sheet referred to in paragraph 1 shall specify:
- 3(a)
- 4the identity, registered trade name or registered trademark, and contact details of the manufacturer and, where applicable, of its authorised representative;
- 5(b)
- 6the name and version of the EHR system and date of its release;
- 7(c)
- 8the intended purpose of the EHR system;
- 9(d)
- 10the categories of electronic health data that the EHR system has been designed to process;
- 11(e)
- 12the standards, formats and specifications supported by the EHR system and versions of those standards, formats and specifications.
- 133. As an alternative to supplying the information sheet referred to in paragraph 1 of this Article with the EHR system, manufacturers may enter the information referred to in paragraph 2 of this Article into the EU database for registration of EHR systems and wellness applications referred to in Article 49.
Lineage
Interface
Hashes
Artefacts
No legal advice. Deterministisk regeluppslagning. Ingen juridisk rådgivning, inget efterlevnadsbeslut, ingen bedömning av ett enskilt ärende.
Citation: 32025R0327 art. 38, Information sheet accompanying the EHR system. ExploreWorld Legal, https://legal.exploreworldai.com/agent/helsodata-2025-327/artikel-38 (hämtad 2026-08-31, bevis sha256:9bca72420f28c973, bygge legal-2026-08-25).