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Colombia · Resolution

Telemedicine resolution: AI use

In forceMinSalud Res. 1644/2026

Summary

Allows AI in telemedicine as support, never as a substitute for clinical judgment. Requires prior notice to the patient, traceability, documented technical and clinical validation, and INVIMA registration when the tool is a medical device.

Who it applies to

Healthcare providers, community-based organizations, health insurers (EPS), occupational risk insurers for health activities and local authorities.

Penalties

Health system enforcement regime, applied by the National Health Superintendency and local health departments.

Official name
Resolución 1644 de 2026 del Ministerio de Salud y Protección Social (telesalud y telemedicina), artículo 23
Official reference
Resolución 1644 de 2026, 31 de julio de 2026; Diario Oficial 53.618, 7 de septiembre de 2026; deroga la Resolución 2654 de 2019
Regulator
Ministry of Health and Social Protection; National Health Superintendency
Official source
Check the sourceHow we verify sources

Key dates

Obligations and dates

Obligations table
ObligationArticle or citationStatusDateWho it applies toVerification
Tell patients before using AI in telemedicineRes. MinSalud 1644 de 2026, art. 23.1In forceJuly 31, 2026Healthcare providers, health insurers (EPS), occupational risk insurers (for health activities) and local authorities that use AI in telemedicine.Verified in the official source on November 2, 2026
AI does not replace clinical judgmentRes. MinSalud 1644 de 2026, art. 23.1 y 23.4In forceJuly 31, 2026Providers that use AI to support diagnosis, triage or other clinical decisions in telemedicine.Verified in the official source on November 2, 2026
Traceability and audit of AI outputsRes. MinSalud 1644 de 2026, art. 23.2 y 23.6In forceJuly 31, 2026Providers that use AI in telemedicine.Verified in the official source on November 2, 2026
Technical and clinical validation, and INVIMA registration if it is a medical deviceRes. MinSalud 1644 de 2026, art. 23.3 y 23.5In forceJuly 31, 2026Providers that use AI with clinical impact in telemedicine.Verified in the official source on November 2, 2026

Tell patients before using AI in telemedicine

Res. MinSalud 1644 de 2026, art. 23.1In force

Applies from July 31, 2026

When it relates
Healthcare providers, health insurers (EPS), occupational risk insurers (for health activities) and local authorities that use AI in telemedicine.
What the rule provides
  • Tell the user, beforehand and clearly, that AI is used, what it can do, its limitations and who is responsible.
Typical evidence
  • Patient notice text and where it is shown
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.

AI does not replace clinical judgment

Res. 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.

Traceability and audit of AI outputs

Res. MinSalud 1644 de 2026, art. 23.2 y 23.6In force

Applies from July 31, 2026

When it relates
Providers that use AI in telemedicine.
What the rule provides
  • Log system outputs so they can be audited, especially after incidents or adverse events, and record them in the medical record where relevant.
  • The provider is responsible for the technologies it uses and for protecting clinical data.
Typical evidence
  • Audit logs and incident reports
Related base documents
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

Res. 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.

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