Data Strategy Briefing — April 18, 2023
ONC’s HTI-1 proposed rule entered the Federal Register, advancing USCDI v3 adoption, algorithm transparency attestations, and decision support monitoring requirements for certified health IT.
Executive briefing: The Office of the National Coordinator for Health IT published its Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing proposed rule (HTI-1) in the Federal Register on 18 April 2023. The proposal aligns certification criteria with USCDI v3, introduces a decision support interventions framework, and expands information blocking exceptions to cover insights generated by predictive tools.
Key interoperability checkpoints
- Certification roadmap. Review proposed timelines for adopting USCDI v3, FHIR Release 4.0.1, and bulk data requirements across certified modules.
- Algorithm transparency. Inventory predictive and AI-powered clinical decision support that would require source descriptions, risk management artefacts, and performance monitoring disclosures.
- Insights sharing. Update information blocking governance to handle requests for decision support outputs covered by new exception language.
Operational priorities
- Comment preparation. Coordinate clinical, compliance, and vendor teams to submit feedback before the June 2023 deadline.
- Product assessments. Evaluate EHR vendor release plans for HTI-1 updates and budget for implementation testing once the rule is finalised.
- Risk management. Develop model inventory and validation controls to evidence safe, effective decision support in line with proposed transparency artifacts.
Enablement moves
- Embed HTI-1 milestones into interoperability steering committee scorecards alongside TEFCA and API mandates.
- Launch cross-functional reviews of machine learning governance to align with ONC’s decision support expectations.
Sources
Zeph Tech helps provider and developer teams prepare for HTI-1 with certification gap analyses, algorithm governance frameworks, and information blocking updates.