What Health AI Transparency & Explainability Requirements (2026) requires
AI systems in healthcare must provide appropriate transparency and explainability to clinicians, patients, and regulators. This includes model cards, technical documentation, local and global interpretability methods, uncertainty quantification, and clear communication of limitations. High-risk systems require detailed explanations of individual decisions and human oversight mechanisms.
Pillar: Medical & Healthcare · Authority: EU AI Act, FDA, MHRA, WHO · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/eli/reg/2024/1689/oj
SHA-256 integrity: a5cf3576def538debdf693d9cda9096cc914df99e91778d89a4b184deab554c0
Primary Citations — 4 traced to source
- EU AI Act Article 13 (Transparency) and Article 15 (Accuracy, Robustness, Cybersecurity)
- FDA Good Machine Learning Practice (GMLP) Principles
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