Diagnosis, triage or clinical support in Colombia: related rules
AI that helps diagnose, prioritize patients, recommend treatments, read medical images or draft clinical notes. Errors affect health, so clinical validation, medical oversight, patient transparency and, if it is a medical device, sanitary registration are required.
Ministry of Health Resolution 1644/2026 (telemedicine, Art. 23): prior patient notice, technical and clinical validation, traceability and INVIMA registration if it is a device.
Verified in the official source on November 2, 2026Official text checked in the MinTIC legal database. Correction: the resolution applies from issuance (Jul 31, 2026), not from Official Gazette publication (Sep 7, 2026); providers that already had telemedicine enabled have 12 months (art. 43) to comply, i.e., until about Jul 31, 2027.
Technical and clinical validation, and INVIMA registration if it is a medical device
Verified in the official source on November 2, 2026Official text checked in the MinTIC legal database. Correction: the resolution applies from issuance (Jul 31, 2026), not from Official Gazette publication (Sep 7, 2026); providers that already had telemedicine enabled have 12 months (art. 43) to comply, i.e., until about Jul 31, 2027.