Skip to content
AI Policy Generator

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.

Risk classification

JurisdictionLevelDateNote
ColombiaSector rulesSeptember 7, 2026Ministry of Health Resolution 1644/2026 (telemedicine, Art. 23): prior patient notice, technical and clinical validation, traceability and INVIMA registration if it is a device.

Obligations related to this use case

AI does not replace clinical judgment

MinSalud Res. 1644/2026Res. MinSalud 1644 de 2026, art. 23.1 y 23.4In force

Applies from July 31, 2026

When it relates
Providers that use AI to support diagnosis, triage or other clinical decisions in telemedicine.
What the rule provides
  • Make sure the health professional keeps control of the decision and can review, validate or reject what the AI suggests.
Typical evidence
  • Clinical oversight procedure and log of validations or rejections
Verification
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

MinSalud Res. 1644/2026Res. MinSalud 1644 de 2026, art. 23.3 y 23.5In force

Applies from July 31, 2026

When it relates
Providers that use AI with clinical impact in telemedicine.
What the rule provides
  • Have a documented technical and clinical validation covering performance, bias, data quality, cybersecurity, human oversight and change management.
  • If the tool is a medical device for diagnostic or clinical support, hold the INVIMA registration or permit.
Typical evidence
  • Validation file and INVIMA registration, if applicable
Verification
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.

Related base documents

Related kits

Includes 5 documents

Healthcare Kit

Technical and clinical validation, DPIA for health data, clinician oversight, in-use monitoring and a model card for clinical AI tools.

USD 139USD 215

Complete kit · available to buy

Find out what applies to you (free)Colombia