Burna AI's design reflects three controls the EU AI Act sets for high-risk AI systems. The Act, Regulation (EU) 2024/1689, includes requirements for record-keeping (Article 12), transparency and information for deployers (Article 13) and human oversight (Article 14). In Burna AI, a clinician reviews and signs every grade before it becomes a record; every grade carries the CTCAE criterion and the line in the medical record that produced it; attribution uses named algorithms, WHO-UMC and Kramer, with the reasoning shown; and every access to patient data is logged. Patient data is stored in the United States.
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