ONC ultimately finalized the removal of 14 certification criteria and the revision of seven others, retaining 39 criteria completely intact. In doing so, federal regulators preserved foundational privacy and security requirements, held the line on usability and quality management baselines, extended a multi-year lifeline to legacy Consolidated CDA (C-CDA) transitions of care, and decoupled federal artificial intelligence “model card” mandates from certified EHR technology.
The most closely watched policy pivot in HTI-5 centers on Decision Support Interventions (DSI) under 45 CFR § 170.315(b)(11). In the previous HTI-1 Final Rule, ONC established stringent algorithmic transparency rules requiring health IT developers to display standardized “source attributes”—effectively nutrition labels or “model cards”—for predictive decision support interventions (PDSIs), detailing training datasets, demographic validation benchmarks, and algorithmic funding sources.
Under HTI-5, ONC finalized a complete removal of these predictive model card and intervention risk management requirements:
In justifying the reversal, ONC noted that clinicians operating in high-pressure clinical workflows rarely access technical model cards, while the regulatory overhead of maintaining compliance was depressing developer investment in frontier artificial intelligence. The agency emphasized that oversight of clinical algorithmic safety is more properly anchored within the Food and Drug Administration (FDA) and civil rights non-discrimination rules (45 CFR § 92.210) rather than standard EHR certification.
While developers secured substantial relief around AI compliance, provider associations, patient advocates, and safety-net organizations successfully pushed back against proposals that threatened clinical safety and software integrity:
Recognizing that small clinics, long-term post-acute care (LTPAC) facilities, and behavioral health providers remain heavily reliant on document-based workflows, ONC restructured its transitions-of-care policies to establish an orderly runway toward an all-FHIR ecosystem:
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