ONC HTI-1 Rule: What Healthcare Developers Must Know

What is the HTI-1 Final Rule?

The ONC Health Data, Technology, and Interoperability (HTI-1) Final Rule, effective 2024, updates the 21st Century Cures Act regulations. It introduces new requirements for FHIR-based data exchange, decision support transparency, and information blocking enforcement.

What Changed for FHIR APIs

HTI-1 updates the USCDI standard to version 3 (USCDI v3) as the minimum required data set for patient access APIs. This adds new data classes including health insurance information, sex parameters for clinical use, and disability status.

TEFCA and QHINs

HTI-1 formalises the Trusted Exchange Framework and Common Agreement (TEFCA). Participating health information networks become Qualified Health Information Networks (QHINs). If your platform connects to multiple EHRs and aggregates records, you may need to evaluate QHIN participation.

Predictive Decision Support (§170.315(b)(11))

New transparency requirements apply to AI/ML-based clinical decision support. If your CDS uses a predictive model to support care decisions, you must now disclose the funding source, intended use, and whether the model has been validated on diverse populations.

Information Blocking Updates

The rule tightens the information blocking definitions. Conditions to watch for developers:

• APIs must not impose unnecessary technical barriers or excessive fees on third-party access
• Response time SLAs are now an information blocking consideration
• Restricting access to data your system holds — even for "security" reasons without documented justification — may constitute information blocking

What To Do Now

Audit your FHIR API against USCDI v3. Update your CapabilityStatement to declare USCDI v3 support. Review your CDS transparency documentation. If you operate a patient access portal, verify it exposes all required data classes without friction.

Have questions about implementing this in your healthcare platform? Get in touch with the Akhester team.