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Agent · helsodata-2025-327-40

EHDS artikel 40: European digital testing environment

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Structural tree: the article's own paragraphs, verbatim.

Also searched as: Regulation (EU) 2025/327 article 40

CELEX 32025R0327 · 2026-08-31 · Weight 70 · minimal-risk

OpenOpen reading. No metering is planned for this class.

EHDSOfficial source

What this page is
Agent, EHDS artikel 40
Checked against the official source
2026-08-31Expired
Responsible publisher
ExploreWorld Legal, editorial deskLiability position

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Jurisdiction

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Inputs

  • in_scopeThe article applies to the situationboolean
  • punktParagraph of the articleenum (1 | 2 | 3 | 4)

Rule tree

  1. If: alla(in_scope = true, punkt = 1)

    Paragraph 1 addressed to the Commission, no direct obligation for businesses

    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

  2. If: alla(in_scope = true, punkt = 2)

    Paragraph 2 addressed to the Member States, no direct obligation for businesses

    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

  3. 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

  4. If: alla(in_scope = true, punkt = 4)

    Paragraph 4 addressed to the Commission, no direct obligation for businesses

    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

  1. 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.
  2. 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.
  3. 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.
  4. 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

treatyTFEU art. 288 (förordning)
act32025R0327
chapter-
article40
paragraphs4
jurisdictionEuropean Union (EU)
supervisor-
national-

Interface

callhttps://legal.exploreworldai.com/api/public/v1/agents/helsodata-2025-327-40/run
methodGET
outputmatched, outcome, trace, missing, hash
Quota60 anrop per minut och adress, utan nyckel
stabilityRegelträdet versioneras. En ändring byter artefakthash, aldrig adress.

Hashes

textsha256:f36ab7466333420cdcc914c465caeba53d8387e7fd63c710cd16e7043b6d581b
scriptsha256:27a7b4467d4f9a89bbc0e9a683a9a30ea6d600b00786ee79952add23c740f6df
enginesha256:0a4bd50d21f8ec9be383fc091511008b76ad61909cbfb674eab56fe567fbd7a0
agentsha256:7dd615a532eb65dbba36bf1bf8bc57485d61b37d4d8c3f2793ca306b87a47313
versionagent-engine-1+legal-2026-11-03 / 7dd615a532eb65db

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. NovaCopilot, https://legal.exploreworldai.com/agent/helsodata-2025-327/artikel-40 (hämtad 2026-08-31, bevis sha256:3ac9e7c9fd467624, bygge legal-2026-11-03).