| Regulation / Form | Revision Date | Download |
|---|---|---|
| Smart Healthcare Committee Charter | 2025-01-16 | |
| Medical-AI Implementation Regulation | 2025-01-16 | |
| Medical-AI Software Trial Application Form | 2025-01-16 | docx |
| Medical-AI Software Trial Application — Guidelines | 2025-01-16 | |
| Medical-AI Software Production Application Form | 2025-01-16 | docx |
| Medical-AI Software Production Application — Guidelines | 2025-01-16 | |
| Medical-AI Software Nine-Point Transparency Disclosure Form | 2025-01-16 | docx |
| Medical-AI Software Nine-Point Transparency Disclosure — Guidelines | 2025-01-16 | |
| AI-on-HIS FHIR Implementation Guide | 2024-05-29 | |
| Information-System Security Baseline Self-Assessment | 2025-01-10 | xlsx |
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