Knowledge Center

Written by Robert Tennant, VP Federal Affairs, WEDI

On the eve of its annual meeting in Washington, D.C., the Office of the National Coordinator for Health Information Technology (ONC) finalized its Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) rule. Key provisions of the final rule include:

• Algorithm Transparency: The rule establishes transparency requirements for the artificial intelligence (AI) and other predictive algorithms that are part of certified health IT. ONC is seeking to promote responsible AI and make it possible for clinical users to access a consistent, baseline set of information about the algorithms they use to support their decision making and to assess such algorithms for fairness, appropriateness, validity, effectiveness, and safety.
• USCDI Version 3: The rule names the United States Core Data for Interoperability (USCDI) Version 3 (v3) as the new baseline standard within the ONC Health IT Certification Program (Certification Program) as of January 1, 2026. The rule, however, permits certified health IT developers to adopt USCDI v3 sooner. USCDI v3 includes updates that advance more accurate and complete patient characteristics data.
• Enhanced Information Blocking Requirements: The rule modifies certain information blocking definitions and exceptions and adds a new exception to encourage secure, efficient, standards-based exchange of electronic health information under the Trusted Exchange Framework and Common Agreement (TEFCA).
• New Interoperability-Focused Reporting Metrics for Certified Health IT: The rule also implements the 21^stCentury Cures Act’s requirement to adopt a Condition of Certification (the “Insights Condition”) for developers of certified health IT to report certain metrics as part of their participation in the Certification Program. ONC anticipates that these metrics will provide additional insight into how certified health IT is used in support of care delivery.

ONC will host the following information sessions to discuss the final rule:

• HTI-1 Final Rule Overview Information Session #1: Thursday, January 4, 2024 at 1pm ET. Register here.
• HTI-1 Final Rule Insights Condition Information Session: Tuesday, January 9, 2024 at 3pm ET. Register here.
• HTI-1 Final Rule Decision Support Interventions Information Session: Wednesday, January 17, 2024 at 1pm ET. Register here.
• HTI-1 Final Rule Information Blocking Information Session: Thursday, January 25, 2024 at 1pm ET. Register here.
• HTI-1 Final Rule Overview with Question & Answer Information Session #2: Thursday, February 1, 2024 at 1pm ET. Register here.

ONC has also produced the following Fact Sheets and Measurement Spec Sheets:

1. General Overview Fact Sheet [PDF – 313 KB]
2. Final Rule At-a-Glance Fact Sheet [PDF – 203 KB]
3. Decision Support Interventions and Predictive Models Fact Sheet [PDF - 281 KB]
4. Insights Condition Fact Sheet [PDF - 219 KB]
5. HTI-1 Information Blocking Fact Sheet [PDF - 167 KB]
6. HTI-1 Key Dates Fact Sheet [PDF - 193 KB]

Measurement Spec Sheets on the Final Rule

1. Individual Access Spec Sheet [PDF – 125 KB]
2. C-CDA Reconcile Spec Sheet [PDF – 266 KB]
3. Supported Apps Spec Sheet [PDF – 177 KB]
4. Use of FHIR Spec Sheet [PDF – 132 KB]
5. Use of FHIR Bulk Data Spec Sheet [PDF – 124 KB]
6. Immunization Administrations Spec Sheet [PDF – 156 KB]
7. Immunization Query Spec Sheet [PDF – 125 KB]