EnforcementArticle 3(49)Article 73
Incidente grave
Un incidente o malfunzionamento di un sistema di IA ad alto rischio che conduce direttamente o indirettamente alla morte di una persona o a gravi danni alla sua salute, a una grave e irreversibile interruzione della gestione di infrastrutture critiche, a una violazione degli obblighi del diritto dell’Unione a tutela dei diritti fondamentali o a gravi danni a beni o ambiente.
Termini correlati
- Penalties and FinesAdministrative fines applicable under Article 99: up to €35 million or 7% of total worldwide annual turnover for violations of prohibited AI practices; up…
- Right to ExplanationThe right under Article 86 of affected persons to obtain an explanation of the role of the AI system in a decision-making procedure and the main elements…
- Right to Lodge a ComplaintThe right of any natural or legal person to lodge a complaint with the relevant national competent authority regarding non-compliance with the Regulation,…
- AI SystemA machine-based system designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or…
- Risk-Based ApproachThe overarching regulatory framework of the EU AI Act that categorises AI systems by the level of risk they pose — prohibited, high-risk, limited-risk,…
- Placing on MarketThe first making available of an AI system or a general-purpose AI model on the Union market, in the course of a commercial activity, whether for payment…
Controlli di conformità correlati
- RK-009Incident and Near-Miss LoggingProviders and deployers must log all incidents, near-misses, and serious incidents involving the AI system, with sufficient detail to support root cause analysis and to meet the reporting obligations under Article 73.
- HO-009Escalation Procedures for AI System IssuesDeployers must define and communicate escalation procedures for situations where the AI system behaves unexpectedly, produces outputs that raise concerns, or where human overseers require additional expertise or authority to act.
- PM-004Incident Detection and Root Cause AnalysisProviders must implement automated and manual mechanisms to detect incidents and near-misses in operation, and conduct root cause analysis for significant incidents to identify systemic issues and prevent recurrence.
- PM-005Serious Incident Reporting to AuthoritiesArticle 73(1) requires providers and deployers to report serious incidents to the relevant market surveillance authority without undue delay after becoming aware of them, with initial reports submitted within the timeframes specified in Article 73(2).
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