On December 13th, 2023, the HTI-1 Proposed Rule was ratified into the HTI-1 Final Rule bringing forth a new cohort of HTI-1 requirements primed to impact the compliance landscape over the next several years. More specifically, the HTI-1 Final Rule made critical updates to the following core requirements:
- USCDI Version 3 Updates
- Decision Support Intervention
- Insights Condition Reporting
- Electronic Case Reporting Update
- Patient Request for Data Restriction
- Information Blocking Update
USCDI Version 3
Starting from January 1, 2026, the ONC Health IT Certification Program will implement the United States Core Data for Interoperability (USCDI) Version 3 (v3) as its new baseline standard. Developers of certified health IT systems will have the option to transition to USCDI v3 earlier. This updated version emphasizes improving the accuracy and completeness of patient characteristics data to enhance equity, diminish disparities, and bolster public health data interoperability.
Decision Support Intervention
The HTI-1 Final Rule mandated adoption of the DSI Criterion, serving as a revision of the current CDS Criterion. This update will be enforceable by January 1,2025.
Additionally, the ONC established new definitions for “predictive decision support interventions” and “decision support interventions”.
To achieve certification, Health IT developers must adhere to specific actions outlined by the ONC, ensuring transparency and safety when incorporating DSI into certified Health IT. These actions include providing relevant technical and performance information, source attribution, adopting risk management practices, and participating in real-world testing.
Insights Condition Reporting
The Insights Condition is a new reporting mandate for Electronic Health Records (EHRs), effective from January 1, 2026. It requires the collection of data for complete annual periods, including metrics such as the number of unique individuals accessing their EHR through specific technologies. The reporting will be phased in over three years, with EHRs having six months after each reporting year to deliver their reports. The requirement applies to EHR developers with at least 50 hospital sites or 500 individual clinician users. This reporting differs from Real World Testing (RWT), aiming to provide ONC and CMS with actual usage metrics of certified capabilities.
Examples of required metrics include details about applications connecting to certified health IT deployments.
Electronic Case Reporting
The HTI-1 Proposed Rule introduced a comprehensive electronic case reporting (eCR) protocol, necessitating consensus-based electronic standards and implementation guides (IGs) from the industry to streamline case reporting. The HTI-1 Final Rule retained this requirement and specified certain standards to support the eCR process under § 170.315(f)(5), including creating an electronic initial case report (eICR) following HL7 Clinical Document Architecture (CDA) eICR implementation guide (IG) or HL7 Fast Health Interoperability Resources (FHIR®) eCR IG, and processing a reportability response (RR) following HL7 CDA RR IG or HL7 FHIR eCR IG.
Following the HTI-1 Final Rule release, the enforcement date for these requirements was shifted from January 1, 2025, to January 1, 2026.
Patient Request for Data Restrictions
The HTI-1 Proposed Rule introduced a “Request for Restrictions” mandate, obligating certified EHRs to offer patients and their representatives an online method to limit access to their healthcare data. However, the Final Rule discarded the additional data handling requirements initially proposed, leaving only the functionality for patients to request restrictions. The rule’s primary aim is to establish the capability for patient requests, which must be implemented by January 1, 2026.
Information Blocking Update
The HTI-1 Final Rule modifies definitions and exceptions related to information blocking to facilitate sharing of information. It introduces a new exception to promote secure and efficient exchange of electronic health data under the Trusted Exchange Framework and Common Agreement (TEFCA).