Risk-Based Approach

A regulatory method that categorises AI applications into risk tiers (unacceptable, high, limited, minimal) based on their potential to cause harm to health, safety, or fundamental rights, and prescribes measures proportionate to those risks across design, training, deployment, and monitoring stages.

An evaluative framework that classifies AI projects by their potential impact on rights, liberties, and institutional interests, and that tailors assessment, testing, and control measures proportionally to assessed risk levels. The Program must apply this approach during intake, procurement, and lifecycle monitoring to prioritize mitigations.

A regulatory principle that prioritises assessment, mitigation and oversight measures proportional to the severity and likelihood of adverse impacts to human rights, democracy and the rule of law, guiding obligations for high-risk uses and compliance efforts.

A methodology for assessing the potential impact of AI in specific uses and applications, allowing for tailored mitigation strategies based on the identified appetite for risk.

The risk-based approach is a core principle of the EU AI Act, classifying AI systems into different risk categories: unacceptable, high, limited, and minimal/no risk. This approach ensures that regulatory burdens are proportionate to the potential risks posed by an AI system, with the most stringent requirements applied to high-risk systems and outright prohibitions for unacceptable risks.