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    Data Governance (AI/ML)

    Policies, controls, and documentation for the data used to train, tune, and validate medical AI models.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    Covers data provenance, consent, de-identification, demographic representativeness, labeling quality, version control, and audit trails. EU AI Act Article 10 codifies many of these as legal requirements for high-risk systems.

    What this means in practice

    Weak training-data governance is the most common reason medical AI submissions stall; reviewers want to see lineage as clearly as a DHF traces design.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    European Parliament·1FDA·1IMDRF·1
    1. 1
      EU AI Act Article 10
      Verified
      European Parliamentartificialintelligenceact.eu
    2. 2
      FDA - AI/ML-Enabled Medical Devices
      Verified
      FDAfda.gov
    3. 3
      IMDRF - Software as a Medical Device
      Verified
      IMDRFimdrf.org

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