AI Glossary

The use of AI for diagnostics, decision support or the processing of health data; often falling under both the medical devices regime and that for high-risk systems.

A reference to EU harmonization legislation; AI systems embedded in regulated products (e.g., medical devices, machinery) are classified as high-risk under it, with a longer transition period.

A list of areas in which standalone AI systems are considered high-risk, such as recruitment, credit scoring, education, law enforcement, migration and border management, and critical infrastructure.

The provision setting out the rules under which an AI system is considered high-risk, including exemptions for systems that do not pose a significant risk of harm.