ExampleGuidancev1.0.0

Diagnostic support for clinicians: no disclosure duty, still due care

A hospital deploys an interactive AI system used exclusively by properly trained health professionals to support medical diagnosis and suggest treatments. The question is whether the patient or the clinician must be told it is AI.

The official source remains authoritative. This is general information about obligations and not legal advice. See this object on the map

Address and citation

This object has an address of its own that is never renamed or reused. Store the identifier in your own file, not the title or the link.

Identifier: praxikon:eu:ai-act:example:example-artikel-50-klinisch-beslissysteem
Payload hash (sha256): 373ac7240ce91407219c0e1aa4125e839d59caee1738579bab6fc375dfa28564

Citation line

Praxikon, "Diagnostic support for clinicians: no disclosure duty, still due care", praxikon:eu:ai-act:example:example-artikel-50-klinisch-beslissysteem@1.0.0, dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.1.0 (schema 1.4.0), effective_at 2026-08-08T00:00:00.000Z, known_at 2026-08-14T00:00:00.000Z, sha256 373ac7240ce91407219c0e1aa4125e839d59caee1738579bab6fc375dfa28564

Version: 1.0.0
Legal time (effective_at): 20 July 2026
Knowledge time (known_at): 8 August 2026
Closed on: Not closed
Topics: examples

Review status: Placed against the official source (8 August 2026). Next check due by 4 February 2027. The check date is the knowledge date of this version; no later recheck has been recorded.

What this object links to

Every relation appears below as a path: from the source with its locator, through the conditions and exceptions of the object carrying the relation, to the consequence. A locator belongs to a statement in the data and not to a relation, so the source is the source anchor of the carrying object.

The obligation this hangs off

1 of 1 shown

The object belongs to this obligation. The source line it hangs off sits there.

Source
Official fact on this object, with its locator.
- Guidelines on Article 50
  Locator: Commission Guidelines C(2026) 5054 final, 20.7.2026, paragraph (45), lists with and without the obviousness exception
  praxikon:eu:ai-act:source:commission-article-50-guidelines
  Open official source
Via
No condition or exception recorded on this object.
Consequence
- ObligationArticle 50: transparency
  praxikon:eu:ai-act:obligation:article-50-transparency

What this object is about

1 of 1 shown

The object is about this role. Undifferentiated: it does not follow that the duty rests on this role.

Source
Official fact on this object, with its locator.
- Guidelines on Article 50
  Locator: Commission Guidelines C(2026) 5054 final, 20.7.2026, paragraph (45), lists with and without the obviousness exception
  praxikon:eu:ai-act:source:commission-article-50-guidelines
  Open official source
Via
No condition or exception recorded on this object.
Consequence
- ActorDeployer
  praxikon:eu:ai-act:actor:deployer

What this object states

Official fact

Attributable to a named primary source, with a locator. Where they differ, the official source prevails.

The Commission guidelines of 20 July 2026 list interactive AI systems intended only for properly trained health professionals to support medical diagnosis and suggest treatments as an example where the obviousness exception in Article 50(1) applies: for that user the AI nature is clear.
- Locator: Commission Guidelines C(2026) 5054 final, 20.7.2026, paragraph (45), lists with and without the obviousness exceptionpraxikon:eu:ai-act:source:commission-article-50-guidelinesOpen official source

Our interpretation

Our own reading. It can change without the law changing, and it is not the position of a supervisory authority.

The exception attaches to the user, not to the system. The moment the same model also speaks to patients, that ground falls away and the disclosure duty applies as normal. And an exception to Article 50 says nothing about the rest: where it is a medical device or a high-risk application, those regimes continue to apply in full.
- Locator: Commission Guidelines C(2026) 5054 final, 20.7.2026, paragraph (45), lists with and without the obviousness exceptionpraxikon:eu:ai-act:source:commission-article-50-guidelinesOpen official source

When this applies

No condition recorded on this object.

When this does not apply

No exception recorded on this object.

Referring to this object

Citation block

Copy this reference into your advice, article or file. The identifier, the version and the hash keep the statement findable later, even once the dataset has moved on.

Reference

Praxikon, "Diagnostic support for clinicians: no disclosure duty, still due care",
praxikon:eu:ai-act:example:example-artikel-50-klinisch-beslissysteem@1.0.0,
dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.1.0 (schema 1.4.0),
effective_at 2026-07-20T00:00:00.000Z, known_at 2026-08-08T00:00:00.000Z,
sha256 373ac7240ce91407219c0e1aa4125e839d59caee1738579bab6fc375dfa28564,
https://www.praxikon.com/en/verkenner/example/example-artikel-50-klinisch-beslissysteem
(https://www.praxikon.com/api/v1/entities?id=praxikon%3Aeu%3Aai-act%3Aexample%3Aexample-artikel-50-klinisch-beslissysteem&effective_at=2026-07-20&known_at=2026-08-08&lang=en, accessed 2026-08-25)

Short form

praxikon:eu:ai-act:example:example-artikel-50-klinisch-beslissysteem@1.0.0 (sha256 373ac724)

BibTeX

@misc{praxikon-eu-ai-act-example-example-artikel-50-klinisch-beslissysteem-1-0-0,
  author       = {{Praxikon}},
  title        = {Diagnostic support for clinicians: no disclosure duty, still due care},
  year         = {2026},
  version      = {1.0.0},
  number       = {praxikon:eu:ai-act:example:example-artikel-50-klinisch-beslissysteem},
  howpublished = {AI Act Change \& Evidence Graph, dataset 2.1.0, schema 1.4.0},
  note         = {effective_at 2026-07-20T00:00:00.000Z; known_at 2026-08-08T00:00:00.000Z; sha256 373ac7240ce91407219c0e1aa4125e839d59caee1738579bab6fc375dfa28564},
  url          = {https://www.praxikon.com/en/verkenner/example/example-artikel-50-klinisch-beslissysteem},
  urldate      = {2026-08-25},
  language     = {en}
}

CSL JSON

[
  {
    "id": "praxikon:eu:ai-act:example:example-artikel-50-klinisch-beslissysteem@1.0.0",
    "type": "dataset",
    "title": "Diagnostic support for clinicians: no disclosure duty, still due care",
    "container-title": "AI Act Change & Evidence Graph",
    "publisher": "Praxikon",
    "version": "1.0.0",
    "number": "praxikon:eu:ai-act:example:example-artikel-50-klinisch-beslissysteem",
    "URL": "https://www.praxikon.com/en/verkenner/example/example-artikel-50-klinisch-beslissysteem",
    "language": "en",
    "issued": {
      "date-parts": [
        [
          2026,
          8,
          8
        ]
      ]
    },
    "accessed": {
      "date-parts": [
        [
          2026,
          8,
          25
        ]
      ]
    },
    "note": "dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.1.0; schema 1.4.0; effective_at 2026-07-20T00:00:00.000Z; known_at 2026-08-08T00:00:00.000Z; sha256 373ac7240ce91407219c0e1aa4125e839d59caee1738579bab6fc375dfa28564; retrieved_from https://www.praxikon.com/api/v1/entities?id=praxikon%3Aeu%3Aai-act%3Aexample%3Aexample-artikel-50-klinisch-beslissysteem&effective_at=2026-07-20&known_at=2026-08-08&lang=en; licence https://www.praxikon.com/nl/legal/terms"
  }
]

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