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EHR Vendors: HTI-1 Certification Deadlines and Compliance Checklist

EHR Vendor HTI-1 Certification - Dynamic Health IT

April 17, 2025ONC (Office of National Coordinator)

Summary

EHR vendors must prepare for ONC requirements through 2025, accelerating preparations for HTI-1 certification. Key requirements include updating standards like FHIR and C-CDA, implementing data restriction features in patient portals, and ensuring bi-directional electronic care reporting (FHIR/CDA eICR) for public health reporting.

Details

EHR vendors must update and provide certified health IT by December 31, 2025, conforming to new standards and certification criteria included in the HTI-1 Final Rule. This process involves several technical changes. First, support for USCDIv3 data elements is mandatory, alongside updates to major standards such as C-CDA templates, FHIR US Core IG 6.1.0, and FHIR R4.0.1. Furthermore, patient portals must allow patients to restrict the sharing of certain classes of data (§ 170.315 (e)(1)). Additionally, public health reporting requires bi-directional standards-based electronic care reporting using FHIR or CDA eICR. Vendors must also begin capturing key metrics—such as system performance and clinical impact—to satisfy the Insight Condition and Maintenance of Certification Requirements. Separately, changes to patient demographics requirements starting in 2025 exempt certified health IT modules from recording specific data elements like sexual orientation, gender identity, or sex parameters for clinical use.

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