1. 2. Assurances Condition and Maintenance of Certification Requirements
2. 3. Real World Testing—Inherited Certified Status
3. 4. Insights Condition and Maintenance of Certification
4. 5. Information Blocking Enhancements
5. 1. ONC Certification Program Updates
5.1. A. “The ONC Certification Criteria for Health IT” and Discontinuing Year Themed “Editions”
5.1.1. No more year themes
5.1.2. Persistent name: "ONC Certification Criteria for Health IT"
5.2. B. New and Revised Standards and Certification Criteria (1/1/25, 1/1/26)
5.2.1. I. The United States Core Data for Interoperability Standard Version 3 (USCDI v3)
5.2.1.1. Affected Criteria (HTI-1 List is incomplete)
5.2.1.1.1. § 170.315 (b)(1) Transition of care
5.2.1.1.2. § 170.315 (b)(2) Clinical information and reconciliation and incorporation
5.2.1.1.3. § 170.315 (e)(1) View, download, and transmit to 3rd party
5.2.1.1.4. § 170.315 (f)(5) Transmission to public health agencies (NOT in HTI-1 list)
5.2.1.1.5. § 170.315 (g)(6) Consolidated CDA creation performance
5.2.1.1.6. § 170.315 (g)(9) Application access – all data request
5.2.1.1.7. § 170.315(g)(10) Standardized API for patient and population services
5.2.1.2. USCDIv3 Classes/Elements
5.2.1.3. New in USCDIv3 (compared to USCDIv1)
5.2.1.3.1. I. Social Determinants of Health (SDOH) new elements
5.2.1.3.2. II. Care Team Member (existing class)
5.2.1.3.3. III. Clinical Notes (existing class)
5.2.1.3.4. IV. Clinical Tests (new data class)
5.2.1.3.5. V. Diagnostics Imaging (new data class)
5.2.1.3.6. VI. Encounter Information (new data class)
5.2.1.3.7. VII. Health Insurance Information (new data class)
5.2.1.3.8. VIII. Health Status Assessments (new data class)
5.2.1.3.9. IX. Laboratory (existing class)
5.2.1.3.10. X. Medications (existing class)
5.2.1.3.11. XI. Patient Demographics/Information (existing class)
5.2.1.3.12. XII. Problems
5.2.1.3.13. XIII. Procedures
5.2.1.3.14. XIV. ALL VOCABULARY CODE SETS STANDARDS Updated to the new "Minimum Standards"
5.2.2. II. HL7 C-CDA Companion Guide Updates
5.2.2.1. CHANGES: HL7 CDA® R2 Implementation Guide: C-CDA Templates for Clinical Notes STU Companion Guide Release 4.1
5.2.3. III. “Minimum Standards” Code Sets Updates
5.2.3.1. Affected Code Sets
5.2.3.1.1. § 170.207(o) from “sexual orientation and gender identity” to “sexual orientation and gender information”
5.2.3.2. Affected Criteria
5.2.3.2.1. § 170.315 (a)(5) Demographics
5.2.3.2.2. § 170.315 (a)(12) Family health histor
5.2.3.2.3. § 170.315 (b)(1) Transition of care
5.2.3.2.4. § 170.315 (c)(4) Clinical quality measures—filter
5.2.3.2.5. § 170.315 (f)(1) Transmission to immunization registries—
5.2.3.2.6. § 170.315 (f)(3) Transmission to public health agencies
5.2.3.2.7. § 170.315 (f)(4) Transmission to cancer registries
5.2.4. IV. Electronic Case Reporting§ 170.315(f)(5) Electronic Case Reporting (NOW STANDARDS BASED)
5.2.4.1. Adopt consensus-based, industry-developed electronic standards and implementation guides (IGs)
5.2.4.2. Affected functional requirements
5.2.4.2.1. (i) create a case report for electronic transmission
5.2.4.2.2. (ii) consume and process a case report response
5.2.4.2.3. (iii) consume and process electronic case reporting trigger codes and parameters
5.2.4.3. WE NEED TO DEEP DIVE ON THIS TOPIC. A LOT TO UNCOVER HERE.
5.2.5. V. Decision Support Interventions and Predictive Models (REPLACING a.9 CDS - Base EHR)
5.2.5.1. § 170.315(b)(11) Decision Support Intervention
5.2.5.2. Optional Predictive Support enabled
5.2.5.2.1. Enable user to review predictive DSI “source attributes"
5.2.5.2.2. Employ “intervention risk management” practices.
5.2.5.3. Enable users to provide feedback regarding DSI information displayed through the Health IT Module
5.2.5.3.1. Export in computable format
5.2.5.4. Other changes / Additions
5.2.5.5. b.11 DSI Detailed Requirements
5.2.6. VI. Synchronized Clocks Standard
5.2.6.1. ANY NTP standard and version
5.2.7. VII. Standardized API for Patient and Population Services. CHANGES: § 170.315(g)(10)
5.2.7.1. Refresh Tokens: valid for a period of no less than three months and will apply to all applications using the “confidential app” profile for both first time and subsequent connections.
5.2.7.2. FHIR US Core IG v6.0.0 (NOTE ABOUT if avalailable)
5.2.7.3. API Condition and Maintenance
5.2.7.3.1. Requirement that Certified API Developers with patient-facing apps must publish their service base URLs for all customers, regardless of whether the certified Health IT Modules are centrally managed by the Certified API Developer or locally deployed by an API Information Source, according to a specified format.
5.2.7.4. We also propose to revise the requirement in § 170.315(g)(10)(vi) to specify that Health IT Modules presented for certification that allow short-lived access tokens to expire, in lieu of immediate access token revocation, must have such access tokens expire within one hour of the request.
5.2.7.5. We propose to adopt the Substitutable Medical Applications, Reusable Technologies (SMART) Application Launch Framework Implementation Guide Release 2.0.0 (SMART v2 Guide)
5.2.7.6. NEED TO DEEP DIVE ON THIS TOPIC
5.2.8. VIII. Patient Demographics and Observations Certification Criterion in § 170.315(a)(5)
5.2.9. IX. Updates to Transitions of Care Certification Criterion in § 170.315(b)(1) (to support USCDIv3, **1/1/26)**
5.2.10. X. Patient Requested Restrictions Certification Criterion (1/1/26?)
5.2.10.1. (NEW) § 170.315(d)(14)
5.2.10.2. e.1 and other affected criteria
5.2.11. XI. Requirement for Health IT Developers To Update Their Previously Certified Health IT