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Brazil · Resolution

Federal Council of Medicine resolution on AI use in medicine

In forceCFM Res. 2,454/2026

Summary

It governs how physicians and health institutions use AI. AI supports but does not replace the medical decision. Institutions must assess and classify each system's risk and have governance processes; if they adopt their own AI, an AI and Telemedicine Commission. Patients must be informed and AI use is recorded in the medical record. Documents submitted to the ANPD or other Brazilian regulators must be in Portuguese.

Who it applies to

Physicians and public and private health institutions (hospitals, clinics and similar) in Brazil, including AI already in use.

Penalties

Professional ethics sanctions imposed by the Regional Medical Councils.

Official name
Resolução CFM nº 2.454, de 11 de fevereiro de 2026 – Normatiza o uso da inteligência artificial na medicina
Official reference
Resolução CFM nº 2.454/2026, DOU 27-feb-2026; en vigor el 26-ago-2026
Regulator
Federal Council of Medicine (CFM) and Regional Medical Councils
Official source
Check the sourceHow we verify sources

Key dates

Obligations and dates

Obligations table
ObligationArticle or citationStatusDateWho it applies toVerification
Preliminary risk assessment and classification, with continuous monitoringRes. CFM 2.454/2026In forceAugust 26, 2026If you are a hospital, clinic or other health institution that develops or uses AI.Verified in the official source on November 2, 2026
AI and Telemedicine CommissionRes. CFM 2.454/2026In forceAugust 26, 2026If your health institution adopts its own AI systems.Verified in the official source on November 2, 2026
Clinical use rules: physician decision, patient notice and recordsRes. CFM 2.454/2026In forceAugust 26, 2026If physicians use AI to support care, diagnosis or treatment.Verified in the official source on November 2, 2026

Preliminary risk assessment and classification, with continuous monitoring

Res. CFM 2.454/2026In force

Applies from August 26, 2026

When it relates
If you are a hospital, clinic or other health institution that develops or uses AI.
What the rule provides
  • Carry out a preliminary risk assessment and classify each system as low, medium, high or unacceptable risk.
  • Set up internal safety, quality and ethics governance processes, including for AI already in use.
  • Implement continuous audit and monitoring mechanisms; for high-risk systems, regular audits.
  • Tell patients the risk level of the system used in their care.
Typical evidence
  • Inventory with risk classification.
  • Governance procedures.
  • Monitoring plan and audit records.
Verification
Verified in the official source on November 2, 2026Checked on the CFM's official portal: published in the DOU on Feb 27, 2026 and in force on Aug 26, 2026 (180 days). Adopted Feb 11, 2026 and corrected Mar 5, 2026 per secondary sources. Correction to the notes: the CFM requires an AI and Telemedicine Commission only for institutions that adopt their own AI systems. Ten health organizations asked for it to be suspended; no ruling suspending it was found as of Nov 2, 2026. Review Nov 2, 2026: Mayer Brown summary (Mar 2026) confirms the preliminary assessment with four levels and the institutional duty of continuous audit and monitoring. The full DOU text could not be extracted (scanned PDF).

AI and Telemedicine Commission

Res. CFM 2.454/2026In force

Applies from August 26, 2026

When it relates
If your health institution adopts its own AI systems.
What the rule provides
  • Create an AI and Telemedicine Commission coordinated by a physician and reporting to the technical director.
Typical evidence
  • Charter and meeting minutes.
Related base documents
Supporting documents
Verification
Verified in the official source on November 2, 2026Checked on the CFM's official portal: published in the DOU on Feb 27, 2026 and in force on Aug 26, 2026 (180 days). Adopted Feb 11, 2026 and corrected Mar 5, 2026 per secondary sources. Correction to the notes: the CFM requires an AI and Telemedicine Commission only for institutions that adopt their own AI systems. Ten health organizations asked for it to be suspended; no ruling suspending it was found as of Nov 2, 2026.

Clinical use rules: physician decision, patient notice and records

Res. CFM 2.454/2026In force

Applies from August 26, 2026

When it relates
If physicians use AI to support care, diagnosis or treatment.
What the rule provides
  • Keep the final decision with the physician, who may accept or reject suggestions and refuse unvalidated systems.
  • Inform patients when AI is a relevant support and respect their informed refusal.
  • Do not delegate communication of diagnoses, prognoses or treatment decisions to AI.
  • Record AI use as decision support in the medical record.
Typical evidence
  • Clinical use policy and medical record entries.
Verification
Verified in the official source on November 2, 2026Checked on the CFM's official portal: published in the DOU on Feb 27, 2026 and in force on Aug 26, 2026 (180 days). Adopted Feb 11, 2026 and corrected Mar 5, 2026 per secondary sources. Correction to the notes: the CFM requires an AI and Telemedicine Commission only for institutions that adopt their own AI systems. Ten health organizations asked for it to be suspended; no ruling suspending it was found as of Nov 2, 2026.

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