REGULATIONS AND FRAMEWORKS
CFM nº 2.454/2026
CFM-2454 pack with technical evaluations and manual controls, declared initiative risk classification and Annex III documentation. Results and exceptions form part of the evidence trail.
Healthcare · Professional resolution
How to use and verify
- In AI Portfolio, record the initiative and its declared CFM classification. Classification is the institution’s responsibility.
- In Audit Evidence, open the CFM-2454 pack in Controls. Review results, data gaps and manual controls.
- Use the healthcare guide to relate evidence to Annex III measures. Export the dossier and gather external institutional and clinical evidence.
What the evidence demonstrates
Records show declared content, its owners and revisions. Technical artifacts depend on available integrations, data and period. Export integrity does not confirm that a declaration is true.
Technical control thresholds are ScaleQuality methodology parameters; they must not be presented as legal minimums of the resolution.
Responsibilities and official source
Your organization determines applicability, validates information, carries out measures and obtains the necessary external opinions and assessments. Internal review or risk acceptance does not constitute certification or turn a control into compliance.
Consult official source — CFM nº 2.454/2026