A company developing AI-driven medical diagnostic tools is expanding into the European market.

The EU AI Act classifies AI systems by risk, with medical diagnostics as high-risk, requiring stringent safety measures to prevent harm, such as misdiagnoses. Compliance prioritizes robust testing, validation, and monitoring to ensure safe outcomes, aligning with ISO 42001’s risk management framework. While ethics and privacy are critical, safety is the primary focus to meet regulatory thresholds and protect users. Exact extract: "The EU AI Act emphasizes implementing measures to prevent harmful outcomes and ensure AI system safety, particularly for high-risk applications like medical diagnostics." (Reference: Cyber Security for AI by SISA Study Guide, Section on EU AI Act Compliance, Page 175-178).