high-risk AI system
regulatoryWhat It Means
A high-risk AI system is any AI application that the EU AI Act has specifically identified as posing significant risks to people's safety, rights, or well-being. These systems face the strictest regulatory requirements under the law, including mandatory risk assessments, human oversight, and extensive documentation before they can be deployed in the EU market.
Why Chief AI Officers Care
High-risk AI systems require substantial compliance investments including quality management systems, detailed documentation, conformity assessments, and ongoing monitoring - often costing hundreds of thousands of dollars per system. Non-compliance can result in fines up to 6% of global annual revenue, plus potential bans from the EU market. CAIOs must identify which of their AI systems qualify as high-risk and budget for the extensive compliance processes required.
Real-World Example
A bank's AI system that automatically approves or denies mortgage applications would be classified as high-risk because it affects access to essential services. The bank must conduct thorough bias testing, maintain detailed logs of all decisions, ensure human reviewers can override the system, and undergo third-party conformity assessments before deploying the system in any EU country.
Common Confusion
Many assume that high-risk classification depends on how sophisticated or powerful an AI system is, but it actually depends entirely on the system's intended use and application area. A simple rule-based system used in hiring could be high-risk, while a complex AI used for game development would not be.
Industry-Specific Applications
See how this term applies to healthcare, finance, manufacturing, government, tech, and insurance.
Healthcare: In healthcare, high-risk AI systems include medical devices using AI for diagnosis, treatment decisions, or patient moni...
Finance: In finance, high-risk AI systems include credit scoring algorithms, automated loan approval systems, and AI-powered insu...
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Includes:
- 6 industry-specific applications
- Relevant regulations by sector
- Real compliance scenarios
- Implementation guidance
Technical Definitions
EU AI ActEuropean Union Artificial Intelligence Act
"An AI system identified as high-risk pursuant to Article 6."Article 3(2) • Effective: August 2, 2026
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