Serious Incident
An AI system incident or malfunction that directly or indirectly causes death, serious health harm, major infrastructure disruption, fundamental‑rights infringements, or serious property/environmental damage.
How the laws define this
Regulatory frameworks uniformly characterize a serious incident as an event linked to an AI system that involves severe harm, such as death, injury, property or economic loss, and fundamental rights breaches. Every definition agrees that such an event triggers mandatory reporting obligations, regulatory oversight, and potential corrective enforcement actions. The primary area of divergence centers on whether potential harm qualifies or if realized impact is strictly required. Under Regulation (EU) 2024/1689 — Artificial Intelligence Act (applies in Germany as EU regulation) and Regulation (EU) 2024/1689 - Artificial Intelligence Act (applies in Slovakia as EU regulation), an incident encompasses events that may lead to or could cause severe adverse effects. Conversely, Regulation (EU) 2024/1689 — Artificial Intelligence Act and Proyecto de Ley (Boletín 15869-19) — Regula los sistemas de inteligencia artificial, la robótica y tecnologías conexas (Bill to regulate AI systems, robotics and related technologies) limit qualifying incidents to events that actually result in or materially contribute to harm.
Synthesised from the 4 statutory definitions below. Each one is quoted in full, with its source.
What it triggers
- Under Regulation (EU) 2024/1689 — Artificial Intelligence Act, such incidents trigger reporting obligations, corrective actions and potential enforcement by competent authorities.
- Under Regulation (EU) 2024/1689 — Artificial Intelligence Act, such incidents trigger mandatory reporting duties, remediation and cooperation with competent authorities.
- Under Regulation (EU) 2024/1689 - Artificial Intelligence Act, such incidents trigger mandatory reporting, post-market monitoring obligations and may lead to corrective measures, recalls or enforcement actions by competent authorities.
- In Chile, under the Bill to regulate AI systems, robotics and related technologies, such incidents trigger mandatory reporting within specified timeframes to enable regulatory response and market surveillance.source
Definitions (4)
An event involving an AI system that results in or materially contributes to death, bodily injury, significant economic loss, substantial impairment of fundamental rights, or other serious harms; such incidents trigger mandatory reporting within specified timeframes to enable regulatory response and market surveillance.
An incident related to the use of an AI system that has led or may lead to death, serious injury, a severe adverse effect on health or safety, serious damage to property, or a serious breach of fundamental rights; such incidents trigger reporting obligations, corrective actions and potential enforcement by competent authorities.
An adverse event related to the use of an AI system that results in death, serious physical or mental injury, significant damage to property, or a substantial impairment of fundamental rights; such incidents trigger mandatory reporting duties, remediation and cooperation with competent authorities under the Act.
An event involving an AI system that causes or could cause significant adverse effects to health, safety or fundamental rights, which triggers mandatory reporting, post‑market monitoring obligations and may lead to corrective measures, recalls or enforcement actions by competent authorities.
Not to be confused with
An AI Incident is a broader event where an AI system causes or nearly causes harm, malfunction, or violation of requirements warranting investigation, while a Serious Incident specifically involves death, serious harm, or other severe consequences triggering mandatory reporting.
Questions and answers
What reporting is required for a serious incident under the EU AI Act?
Serious incidents trigger reporting obligations to competent authorities, along with corrective actions, remediation, cooperation, post-market monitoring, and potential measures like recalls or enforcement. This applies when the incident leads to death, serious injury, damage, or rights breaches.
Does Chile's AI bill require reporting serious incidents?
Yes, the bill under review would require mandatory reporting of serious incidents within specified timeframes to enable regulatory response and market surveillance.
What counts as a serious incident in the EU AI Act?
It includes events related to AI use that result in or may lead to death, serious injury, severe health effects, property damage, or serious fundamental rights breaches.
Related Terms
AI Incident
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High-Risk AI System
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Post-Market Monitoring
Ongoing surveillance of AI system performance after deployment in the market....
Market Surveillance
Ongoing monitoring and enforcement of AI compliance by national authorities....