Chapter VI · Measures in support of innovation
Article 61 — Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes
Official text
Each paragraph records where its wording comes from. Only text reproduced unchanged from the Official Journal is authentic; consolidated text is editorial and has no legal value. Paragraphs, subparagraphs and points each have their own link.
For the purpose of testing in real world conditions under Article 60, freely-given informed consent shall be obtained from the subjects of testing prior to their participation in such testing and after their having been duly informed with concise, clear, relevant, and understandable information regarding:
- (a)
the nature and objectives of the testing in real world conditions and the possible inconvenience that may be linked to their participation;
- (b)
the conditions under which the testing in real world conditions is to be conducted, including the expected duration of the subject or subjects’ participation;
- (c)
their rights, and the guarantees regarding their participation, in particular their right to refuse to participate in, and the right to withdraw from, testing in real world conditions at any time without any resulting detriment and without having to provide any justification;
- (d)
the arrangements for requesting the reversal or the disregarding of the predictions, recommendations or decisions of the AI system;
- (e)
the Union-wide unique single identification number of the testing in real world conditions in accordance with Article 60(4) point (c), and the contact details of the provider or its legal representative from whom further information can be obtained.
Authentic — as published in the Official Journal
The informed consent shall be dated and documented and a copy shall be given to the subjects of testing or their legal representative.
Authentic — as published in the Official Journal
The formal analysis of Article 61
Article 6 is formalised first. The remaining articles follow.
Article 61 is formalised node by node: each rule as a deontic position with its operator, each exception with its rank, each predicate resolved against the definitions in Article 3.
What members get, per article
- the rule logic: every norm as a formal position, with the defeater chain that decides which exception wins
- the competency questions and their answers, every unanswered one marked as a gap and named
- the ontology: predicates bound to AISV (AI Standardisation Vocabulary) and to the definitions they depend on, exportable as JSON-LD and OWL
- the documentation: the Article 6(4) assessment record generated from a fact set, with its derivation and the version of the law it was decided against
Built for providers claiming the 6(3) derogation, for the counsel who has to defend that claim, and for the auditor who reads it afterwards.
Access is invite-only and opening in stages. Article 6 is formalised first; the remaining articles follow.
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Commentary in preparation
The official text above is complete. The editorial layer for this article — duties, the roles bound by them, the AISV concepts that model them, and the European standards written to support them — is in preparation, in the same form as the articles already published.
See the published articles