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    ONC HTI-1 / HTI-2

    ONC certification rules adding transparency and risk-management requirements to certified health IT, including AI/predictive DSI.

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

    Definition

    HTI-1 (final 2024) introduced the Decision Support Intervention criterion requiring source attributes and intervention risk management for predictive models in certified EHRs. HTI-2/HTI-3 extend transparency, interoperability, and information-blocking requirements.

    What this means in practice

    Even non-EHR vendors are affected: model 'nutrition labels' are increasingly expected by HDOs procuring AI-enabled tools.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ONC·1FDA·2
    1. 1
      ONC HTI-1
      Verified
      ONChealthit.gov
    2. 2
      FDA - Software as a Medical Device (SaMD)
      Verified
      FDAfda.gov
    3. 3
      FDA - AI/ML-Enabled Medical Devices
      Verified
      FDAfda.gov

    Inline markers like [1] jump to the matching reference above.