Člen 61 Uredbe (EU) 2024/1689 — Informirana privolitev pri testiranju v realnih razmerah. Uradno besedilo, praktična razlaga, ključne obveznosti in posledice za skladnost.
Člen 61 določa prag privolitve za testiranje visokotveganih sistemov UI v realnih razmerah po členu 60: nihče ne sodeluje brez prostovoljne, informirane privolitve. Logiko kliničnih preskušanj prenaša v testiranje UI.
Povzetek uradnega besedila
- Privolitev se pridobi pred vsakim sodelovanjem, po jasnih in razumljivih informacijah o naravi, ciljih, pogojih, pričakovanem trajanju in pravicah udeleženca
- Udeleženec lahko kadar koli zavrne ali odstopi, brez utemeljitve in brez škode
- Privolitev je datirana in dokumentirana; udeleženec ali njegov zakoniti zastopnik prejme izvod
Časovnica skladnosti
Uporablja se od 2. avgusta 2026; digitalni omnibus 2026 je preložil vsebinske obveznosti visokega tveganja (Prilogo III na 2. december 2027, Prilogo I na 2. avgust 2028), te določbe pa ni premaknil.
Official AI Act Compliance Deadline Calendar
Updated · Sources: Regulation (EU) 2024/1689 and the 2026 Digital Omnibus on AI.
| Obligation | Applies to | Original date | New date | Status | Countdown | Legal basis |
|---|---|---|---|---|---|---|
| Prohibited Practices (Art. 5) | All providers and deployers | active | — | AI Act Art. 5 | ||
| GPAI Rules (Chapter 5) | GPAI model providers | active | — | AI Act Art. 51-56 | ||
| AI-Generated Content Marking | Providers of generative GPAI systems | active | — | AI Act Art. 50(2) | ||
| Regulatory Sandboxes | National competent authorities | active | — | AI Act Art. 57 | ||
| High-risk AI — Annex III (standalone) | Providers of standalone Annex III systems | deferred | — | AI Omnibus 2026 Art. 6(2) | ||
| High-risk AI — Annex I (embedded) | AI embedded in Annex I regulated products | deferred | — | AI Omnibus 2026 Art. 6(1) |
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