Agent · helsodata-2025-327-40
EHDS artikel 40: European digital testing environment
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 40
- Checked against the official source
- 2026-08-31Current
- Responsible publisher
- ExploreWorld Legal, editorial deskLiability position
Short answer
What does EHDS Article 40 require, and what outcome does the rule tree give?
EHDS Article 40 is tested here by a deterministic rule tree of 4 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 40Checked against the publisher 2026-08-31Official text
- Paragraph 1 applies. 1. The Commission shall develop a European digital testing environment for the assessment of harmonised software components of EHR systems. The Commission shall make the software supporting the European digital testing environment available as open-source.
- Paragraph 2 applies. 2. Member States shall operate digital testing environments for the assessment of harmonised software components of EHR systems. Such digital testing environments shall comply with the common specifications for the European digital testing environment laid down pursuant to paragraph 4. Member States shall inform the Commission about their digital testing environments.
- Paragraph 3 applies. 3. Before placing EHR systems on the market, manufacturers shall use the digital testing environments referred to in paragraphs 1 and 2 of this Article for the assessment of harmonised software components of EHR systems. The results of that assessment shall be included in the technical documentation referred to in Article 37. The elements in relation to which the results of the assessment are positive shall be presum…
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)
Rule tree
If: alla(in_scope = true, punkt = 1)
Paragraph 1 applies
1. The Commission shall develop a European digital testing environment for the assessment of harmonised software components of EHR systems. The Commission shall make the software supporting the European digital testing environment available as open-source.
Paragraph 1
If: alla(in_scope = true, punkt = 2)
Paragraph 2 applies
2. Member States shall operate digital testing environments for the assessment of harmonised software components of EHR systems. Such digital testing environments shall comply with the common specifications for the European digital testing environment laid down pursuant to paragraph 4. Member States shall inform the Commission about their digital testing environments.
Paragraph 2
If: alla(in_scope = true, punkt = 3)
Paragraph 3 applies
3. Before placing EHR systems on the market, manufacturers shall use the digital testing environments referred to in paragraphs 1 and 2 of this Article for the assessment of harmonised software components of EHR systems. The results of that assessment shall be included in the technical documentation referred to in Article 37. The elements in relation to which the results of the assessment are positive shall be presum…
Paragraph 3
If: alla(in_scope = true, punkt = 4)
Paragraph 4 applies
4. The Commission shall, by means of implementing acts, lay down the common specifications for the European digital testing environment. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
Paragraph 4
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. The Commission shall develop a European digital testing environment for the assessment of harmonised software components of EHR systems. The Commission shall make the software supporting the European digital testing environment available as open-source.
- 22. Member States shall operate digital testing environments for the assessment of harmonised software components of EHR systems. Such digital testing environments shall comply with the common specifications for the European digital testing environment laid down pursuant to paragraph 4. Member States shall inform the Commission about their digital testing environments.
- 33. Before placing EHR systems on the market, manufacturers shall use the digital testing environments referred to in paragraphs 1 and 2 of this Article for the assessment of harmonised software components of EHR systems. The results of that assessment shall be included in the technical documentation referred to in Article 37. The elements in relation to which the results of the assessment are positive shall be presumed to be in conformity with this Regulation.
- 44. The Commission shall, by means of implementing acts, lay down the common specifications for the European digital testing environment. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
Lineage
Interface
Hashes
Artefacts
No legal advice. Deterministisk regeluppslagning. Ingen juridisk rådgivning, inget efterlevnadsbeslut, ingen bedömning av ett enskilt ärende.
Citation: 32025R0327 art. 40, European digital testing environment. ExploreWorld Legal, https://legal.exploreworldai.com/agent/helsodata-2025-327/artikel-40 (hämtad 2026-08-31, bevis sha256:fdc16fa35f3f0b99, bygge legal-2026-08-25).