- EU AI Act
High-risk AI system
An AI system with significant risk to health, safety or fundamental rights. It must meet strict EU AI Act rules: conformity assessment, human oversight and documentation.
Regulation: EU AI Act
Definition
High-risk AI systems fall into two groups. The first are safety components of products already covered by EU law, such as machinery, medical devices, toys and lifts. The second are systems used in sensitive areas: biometric identification, critical infrastructure, education, employment, law enforcement and the administration of justice.
Key obligations for providers
- A risk management system
- Data governance and dataset quality
- Technical documentation
- Logging and record-keeping
- Transparency and information for deployers
- Human oversight
- Conformity assessment
- Registration in the EU database
- Post-market monitoring
- Reporting serious incidents
Related terms
- EU AI Act
AI system
A machine-based system that works with some autonomy and generates predictions, recommendations, decisions or content.
- EU AI Act
Conformity assessment
The process that shows a high-risk AI system meets EU AI Act requirements.
- GDPR
Data protection impact assessment (DPIA)
A structured assessment for high-risk processing of personal data.
Start with your most complex regulatory problem
- 01Initial meeting
- 02Demonstration on your case
- 03Deployment in weeks