1. 2. Assurances Condition and Maintenance of Certification Requirements
1.1. Maintenance of Certification requirements.
1.1.1. We have finalized that a health IT developer must update a Health IT Module, once certified to a certification criterion adopted in § 170.315, to all applicable revised certification criteria, including the most recently adopted capabilities and standards included in the revised certification criterion
1.1.2. We have also finalized that a health IT developer must provide all Health IT Modules certified to a revised certification criterion to its customers of such certified health IT.
1.2. Condition of Certification requirement.
1.2.1. We have finalized as a Condition of Certification that a health IT developer must provide an assurance that it will not interfere with a customer's timely access to interoperable health IT certified under the Program
2. 3. Real World Testing—Inherited Certified Status
2.1. Health IT Deveopers to include in their real world testing results report the newer version of those certified Health IT Module(s) that are updated using ICS after August 31 of the year in which the plan is submitted. This will ensure that health IT developers fully test all applicable certified Health IT Module(s) as part of their real world testing requirements.
3. 4. Insights Condition and Maintenance of Certification
3.1. Insights Condition requirements in § 170.407 in three phases over three years, where health IT developers to which the requirements apply, will be required to report on some of the measures earlier than others.
4. 5. Information Blocking Enhancements
4.1. Note: Need to add more details here
5. 1. ONC Health IT Certification Program Updates
5.1. A. “The ONC Certification Criteria for Health IT” and Discontinuing Year Themed “Editions”
5.1.1. 1. Discontinuing Year Themed “Editions”
5.1.2. 2. Definition of “Revised Certification Criterion”
5.1.3. 3. Program Oversight Related to Discontinuation of Editions
5.1.3.1. a. Records Retention
5.1.3.2. b. Records Retention—Complete EHR (term dropped)
5.2. B. Standards and Implementation Specifications
5.2.1. 1. National Technology Transfer and Advancement Act
5.2.2. 2. Compliance With Adopted Standards and Implementation Specifications
5.2.3. 3. “Reasonably Available” to Interested Parties
5.3. C. New and Revised Standards and Certification Criteria (deadlines: 2/8/24, 1/1/25, 1/1/26)
5.3.1. 1. The United States Core Data for Interoperability Version 3 (USCDI v3) **(deadline: 1/1/26)**
5.3.1.1. a. Certification Criteria That Reference USCDI
5.3.1.1.1. § 170.315 (b)(1) Transition of care
5.3.1.1.2. § 170.315 (b)(2) Clinical information and reconciliation and incorporation
5.3.1.1.3. § 170.315 (e)(1) View, download, and transmit to 3rd party
5.3.1.1.4. § 170.315 (f)(5) Transmission to public health agencies (NOT in HTI-1 list)
5.3.1.1.5. § 170.315 (g)(6) Consolidated CDA creation performance
5.3.1.1.6. § 170.315 (g)(9) Application access – all data request
5.3.1.1.7. § 170.315(g)(10) Standardized API for patient and population services
5.3.1.2. b. USCDI Standard—Data Classes and Elements Added Since USCDI v1
5.3.1.2.1. i. Social Determinants of Health (SDOH)
5.3.1.2.2. ii. Care Team Member (new elements)
5.3.1.2.3. iii. Clinical Notes
5.3.1.2.4. iv. Clinical Tests (new class)
5.3.1.2.5. v. Diagnostics Imaging (new class)
5.3.1.2.6. vi. Encounter Information (new class)
5.3.1.2.7. vii. Health Insurance Information (new class)
5.3.1.2.8. viii. Health Status Assessments (new class)
5.3.1.2.9. ix. Laboratory (existing class)
5.3.1.2.10. x. Medications (existing class)
5.3.1.2.11. xi. Patient Demographics/Information (existing class renamed)
5.3.1.2.12. xii. Problems (existing class)
5.3.1.2.13. xiii. Procedures (existing class)
5.3.1.2.14. xiv. Updated Versions of Vocabulary Standard Code Sets
5.3.1.2.15. xv. Unique Device Identifier(s) for a Patient's Implantable Device(s) ( NO CHANGES - JUST A COMMENT IN FR)
5.3.1.2.16. xvi. Vital Signs ( NO CHANGES - JUST A COMMENT IN FR)
5.3.2. 2. C–CDA Companion Guide Updates (deadline: 1/1/26)
5.3.2.1. CHANGES: HL7 CDA® R2 Implementation Guide: C-CDA Templates for Clinical Notes STU Companion Guide Release 4.1 **(click on attachment link for details)**
5.3.3. 3. “Minimum Standards” Code Sets Updates **(deadline: 1/1/26)**
5.3.3.1. Affected Code Sets
5.3.3.1.1. § 170.207(o) from “sexual orientation and gender identity” to “sexual orientation and gender information”
5.3.3.2. Affected Criteria
5.3.3.2.1. § 170.315 (a)(5) Demographics
5.3.3.2.2. § 170.315 (a)(12) Family health histor
5.3.3.2.3. § 170.315 (a)(15) Social, psychological, and behavioral data
5.3.3.2.4. § 170.315 (b)(1) Transition of care
5.3.3.2.5. § 170.315 (b)(3) Electronic prescribing
5.3.3.2.6. b.6 iis expired
5.3.3.2.7. § 170.315 (b)(9) Care Plan
5.3.3.2.8. § 170.315 (c)(4) Clinical quality measures—filter
5.3.3.2.9. § 170.315 (f)(1) Transmission to immunization registries—
5.3.3.2.10. § 170.315 (f)(3) Transmission to public health agencies
5.3.3.2.11. § 170.315 (f)(4) Transmission to cancer registries
5.3.3.2.12. § 170.315 (f)(5) Transmission to public health agencies – electronic case reporting
5.3.3.2.13. § 170.315 (g)(6) Consolidated CDA creation performance
5.3.3.2.14. § 170.315 (g)(9) Application access—all data request.
5.3.4. 4. Electronic Case Reporting (NOW STANDARDS BASED) **(deadline: 1/1/26)**
5.3.4.1. Criteria description change
5.3.4.1.1. From "§ 170.315(f)(5) an electronic case report” to "§ 170.315(f)(5) a case report for electronic transmission"
5.3.4.2. Adopt consensus-based, industry-developed electronic standards and implementation guides (IGs)
5.3.4.2.1. . HL7® FHIR® Implementation Guide: Electronic Case Reporting (eCR) - US Realm 2.1.0 – STU 2 US (HL7 FHIR eCR IG)
5.3.4.2.2. .HL7 CDA® R2 Implementation Guide: Public Health Case Report - the Electronic Initial Case Report (eICR) Release 2, STU Release 3.1 - US Realm (HL7 CDA eICR IG)
5.3.4.2.3. HL7® CDA® R2 Implementation Guide: Reportability Response, Release 1, STU Release 1.1 - US Realm (HL7 CDA RR IG) (incorporated by reference, see § 170.299).
5.3.4.2.4. Reportable Conditions Trigger Codes Value Set for Electronic Case Reporting. RCTC OID: 2.16.840.1.114222.4.11.7508, Release March 29, 2022 (incorporated by reference, see § 170.299)
5.3.4.3. Affected functional requirements
5.3.4.3.1. (i) create a case report for electronic transmission based on matched trigger
5.3.4.3.2. (ii) receive, consume, and process a case report response
5.3.4.3.3. (iii) Transmit a case report electronically to a system capable of receiving a case report.
5.3.5. 5. Decision Support Interventions and Predictive Models (REPLACING a.9 CDS - Base EHR) (deadline: 1/1/25)
5.3.5.1. b.11 DSI Detailed Requirements **(click on attachment link for details)**
5.3.6. 6. Synchronized Clocks Standard **(deadline: 1/1/26)**
5.3.6.1. Removed rstandard: Network Time Protocol (NTP v4 of RFC 5905), BUT it can still be used.
5.3.6.2. any Network Time Protocol (NTP) standard that can ensure a system clock has been synchronized and meets time accuracy requirements. The applicable certification criteria that either reference the NTP standard
5.3.6.3. Affected criteria:
5.3.6.3.1. 170.315(d)(2)
5.3.6.3.2. § 170.315(d)(3)
5.3.6.3.3. § 170.315(d)(10)
5.3.6.3.4. § 170.315(e)(1)
5.3.7. Standardized API for Patient and Population Services. CHANGES: § 170.315(g)(10) **(deadlnes: 2/8/24,1/1/25, 1/1/26)**
5.3.7.1. Standard update: (SMART) App Launch Implementation Guide Release 2.0.0 (SMART v2 Guide) (deadline: 1/1/26)
5.3.7.2. All Health IT Modules certified to § 170.315(g)(10) must be able to revoke authorized application’s access within 1 hour of the request and attest to that functionality as of the HTI-1 Final Rule effective date on **February 8, 2024.**
5.3.7.3. Standard update: FHIR US Core Implementation Guide STU version 6.1.0 (deadline: 1/1/26)
5.3.7.4. Change: 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. **(deadline: 1/1/26)**
5.3.7.5. Certified API Developers with patient-facing APIs 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. We have finalized that these service base URLs must conform to a specific data format **(deadline: 1/1/25)**
5.3.8. 8 Patient Demographics and Observations Certification Criterion in § 170.315(a)(5) ( **deadline: 1/1/26)**
5.3.8.1. Adoption of USCDIv3: Sex, Sexual Orientation, and Gender Identity
5.3.8.1.1. Note: USCDv1 can be used until 12/31/25. USCDv3 required starting 1/1/26
5.3.8.2. Name change: from “demographics” to “patient demographics and observations.”
5.3.8.3. New elements: Sex Parameter for Clinical Use, Name to Use,Pronouns (pronouns will use LOINC minimimum standard version)
5.3.9. 9. Updates to Transitions of Care Certification Criterion in § 170.315(b)(1) (to support USCDIv3, ** deadline: 1/1/26)**
5.3.9.1. Affect document types: "Transition of Care", "Referral Summary", "Discharge Summary"
5.3.9.2. "Sex" is no longer a fixed USCDI value, but any valid SNOMED (minimum version) code set value
5.3.10. 10. Patient Requested Restrictions Certification Criterion **(deadline: 1/1/26)**
5.3.10.1. e.1 Patient Identify data not to share
5.3.10.2. Patients (and their authorized representatives) must be able to use an internet-based method to request a restriction to be applied for any data expressed in USCDIv3
5.3.10.3. No prescribed standard at this time but could implement using standards like DS4P data segementation.
5.3.10.4. **NOTE:** Jim is unclear as to whether the required support for these "internet based requests" ineed to be applied in e.1 - i.e. filter out requested information from View, Download, and Transmit.
5.3.11. 11. Requirement for Health IT Developers To Update Their Previously Certified Health IT
5.3.12. NOTE: Criteria Affected
5.3.12.1. Revised Criteria - Functionality
5.3.12.1.1. a5
5.3.12.1.2. a9 (replaced by b11)
5.3.12.1.3. b1
5.3.12.1.4. e1
5.3.12.1.5. f5
5.3.12.1.6. g10
5.3.12.2. Revised Criteria - Standards
5.3.12.2.1. a12
5.3.12.2.2. b2
5.3.12.2.3. b6
5.3.12.2.4. b9
5.3.12.2.5. c4
5.3.12.2.6. f1
5.3.12.2.7. f3
5.3.12.2.8. f4
5.3.12.2.9. g3
5.3.12.2.10. g6
5.3.12.2.11. g9
5.3.12.3. New Criteria
5.3.12.3.1. b11