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High-risk AI systems are AI applications that pose significant risks to fundamental rights, safety, or health. The concept covers classification, governance, risk assessment and mandatory conformity measures. It aims to ensure robustness, transparency and human-centric safeguards throughout the system lifecycle. Organizations must combine processes, technica…
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High-risk AI systems are applications whose purpose, context, and potential impact create heightened requirements for safety and fundamental rights.
The term emerged with risk-based AI regulation, classifying systems by possible harm rather than technical novelty. The exact classification depends on the applicable law and use case.
Risk is not determined by the model alone: purpose, affected people, decision impact, and human oversight also matter. Systems used for safety-critical or consequential decisions need evidence about data, accuracy, monitoring, and accountability. Risk category is therefore a governance property of deployment.
Purpose and context determine the consequences an AI system may have.
Assessment considers possible harm to safety, health, or fundamental rights.
Responsible people must monitor, understand, and if needed override system behavior.
The classification guides procurement, documentation, testing, monitoring, and accountability. It is jurisdiction-specific and should be checked against current regulation before production use.
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