Which coverage area does this briefing belong to?

This briefing falls under Zeph Tech's Data Strategy coverage pillar, which tracks regulatory developments, technical standards, and operational guidance relevant to data strategy professionals.

Data Strategy — Healthcare interoperability

Q: What sources does this briefing cite?

The analysis draws on 8 authoritative sources including: Health Data, Technology, and Interoperability (HTI-1) Proposed Rule, HTI-1 Proposed Rule Fact Sheet, HTI-1 Proposed Rule.

ONC's HTI-1 proposed rule in April 2023 updated health IT certification requirements. Decision support, USCDI v3, and real-time benefit tools. Healthcare IT certification continued evolving.

Kodi C.

Editor & Research Lead

Verified for technical accuracy — Kodi C.

Data strategy, stewardship, and privacy briefings

The US Office of the National Coordinator for Health IT (ONC) released the Health Data, Technology, and Interoperability (HTI-1) proposed rule to advance nationwide health information exchange, mandate adoption of USCDI v3 data classes, and require transparency around certified health IT that uses predictive decision support. The proposal updates certification criteria, codifies reporting metrics from the 21st Century Cures Act, and follows the Trusted Exchange Framework and Common Agreement (TEFCA) to promote secure, standards-based interoperability. Health systems, payers, and health IT developers need to mobilize cross-functional teams to modernize data models, document algorithmic risks, and prepare for expanded public reporting obligations.

ONC’s rule introduces the decision support intervention (DSI) framework that broadens existing clinical decision support requirements to include machine learning, predictive risk scoring, and other advanced analytics embedded in certified health IT. Developers must supply “source attributes” detailing training data, evaluation procedures, performance characteristics, and appropriate use guidance so clinicians and patients can assess trustworthiness. The rule also updates information blocking regulations, adds a TEFCA participation metric to the Certified Health IT Developer program, and proposes a new Insights Condition to standardize data export capabilities.

Capability expansion and impact

The HTI-1 rule accelerates capabilities across five domains:

Data interoperability. Adoption of USCDI v3 introduces data classes for sexual orientation, gender identity, social determinants of health, and personal health records, enabling richer population analytics and equity dashboards.
Algorithm transparency. The DSI framework demands lifecycle documentation—intended use, limitations, validation settings, known risks—that helps providers to implement AI responsibly and enables regulators to scrutinise high-risk models.
Public health readiness. Updated certification criteria require electronic case reporting, bulk FHIR export, and support for Health Level Seven (HL7) FHIR R4 capabilities, improving response during outbreaks and national emergencies.
Patient helpment. Enhanced electronic health information export requirements and performance reporting metrics give individuals faster access to longitudinal records and visibility into how their data supports care coordination.
Compliance assurance. Information blocking updates clarify that actors must respond to patient and provider requests within specific timeframes and maintain auditable logs, elevating accountability for data sharing practices.

Collectively, these capabilities create a blueprint for interoperable, trustworthy digital health ecosystems, but they demand significant investment in data governance, vendor collaboration, and change management.

Adoption timeline

Teams should structure setup across four coordinated tracks:

USCDI v3 data readiness. Conduct gap analyzes between current data dictionaries and USCDI v3 classes, prioritizing structured capture of social determinants, sexual orientation, and gender identity data. Update EHR templates, terminology services, and patient intake workflows to support consistent coding and privacy controls.
Decision support governance. Inventory all AI- and rules-based interventions embedded in clinical workflows. For each, build DSI documentation packages covering input features, intended user, evaluation metrics (sensitivity, specificity, fairness), and monitoring plans. set up a multidisciplinary review board (clinicians, data scientists, ethicists) to approve deployment and retraining cycles.
TEFCA and bulk exchange enablement. Align with TEFCA Qualified Health Information Network (QHIN) onboarding requirements by upgrading identity proofing, security tokens, and consent management. Enhance FHIR bulk export tooling to meet the proposed Insights Condition and support payer-to-payer exchange mandated by CMS interoperability rules.
Information blocking compliance. Update request management systems so patients, providers, and public health agencies can track information sharing requests end-to-end. Automate exception evaluation, logging, and disclosure to satisfy ONC’s expanded documentation expectations.

Each track should integrate change management plans that include clinician education, patient communications, and vendor coordination. Align capital budgets with the rule’s phased timelines—most provisions anticipate compliance within 24 months of finalization, while reporting metrics may require earlier pilot submissions.

Responsible governance and oversight

HTI-1 pushes leaders to strengthen governance across clinical, technical, and ethical dimensions:

Board and executive engagement. Include interoperability readiness and algorithm transparency on quality and compliance committee agendas. Track progress using balanced scorecards that measure USCDI adoption, TEFCA connectivity, and DSI documentation completeness.
Risk management integration. Incorporate algorithmic harm scenarios into enterprise risk registers. Align with FDA’s software as a medical device guidance and forthcoming joint ONC-FDA-OCR AI oversight principles to avoid misclassification of high-risk DSIs.
Ethics and equity safeguards. Embed bias assessment checkpoints into model development, using representative datasets and auditing demographic performance. Document mitigation strategies and communicate them through DSI transparency artifacts.
Vendor accountability. Update contracts with health IT developers to mandate timely delivery of DSI documentation, USCDI updates, and interface changes. Require attestation that code updates will be provided ahead of regulatory deadlines.

Governance structures should ensure patients are represented in decision-making, especially when models influence diagnosis, triage, or care management. Public reporting obligations will expose laggards, so preventive transparency is essential.

Tailored approaches

Health systems. Establish interoperability command centers to coordinate EHR upgrades, TEFCA onboarding, and clinician training. Integrate DSI evaluation with medical staff credentialing and quality improvement programs.
Health plans. Synchronize HTI-1 requirements with CMS interoperability and prior authorization rules. Build FHIR-based member data repositories that support payer-to-payer exchange, risk adjustment analytics, and utilization management transparency.
Health IT developers. prioritize roadmap items for USCDI v3 support, bulk FHIR export, DSI documentation tooling, and TEFCA integration. Offer sandbox environments and APIs so clients can test workflows before deploying updates.
Public health agencies. Use the proposed funding and standards alignment to modernize surveillance platforms, ensuring they can consume EHR exports, reconcile data across jurisdictions, and feed analytics back to providers during emergencies.

Measurement and continuous improvement

Teams should develop metrics and evidence packages that show compliance and value realization:

USCDI coverage. Percentage of encounters capturing new USCDI v3 elements, completeness scores for social determinants fields, and audit trails for patient consent related to sensitive data.
DSI transparency maturity. Share of deployed decision support tools with complete documentation, cadence of performance monitoring, and number of bias mitigation actions executed per quarter.
Exchange performance. TEFCA transaction volume, average response time for patient-initiated information requests, and uptime of FHIR APIs measured against ONC reporting metrics.
Information blocking responsiveness. Average time to fulfil requests, exception utilization rates, and issue resolution aging.
Clinical impact. Quality measures (readmissions, preventive care adherence) correlated with deployment of DSIs and improved data sharing, demonstrating value beyond compliance.

Maintain a compliance binder containing certification attestations, DSI documentation, board minutes, and performance dashboards. Refresh quarterly to respond to ONC audits, payer due diligence, or accreditation surveys.

Partnering with digital health leaders to operationalize HTI-1 requirements through interoperability roadmaps, AI transparency toolkits, and value-tracking dashboards.

Visit pillar hub

Latest guides

Data Strategy Operating Model Guide
Design a data strategy operating model that satisfies the EU Data Act, EU Data Governance Act, U.S. Evidence Act, and Singapore Digital Government policies with measurable…
Data Interoperability Engineering Guide
Engineer interoperable data exchanges that satisfy the EU Data Act, Data Governance Act, European Interoperability Framework, and ISO/IEC 19941 portability requirements.
Data Stewardship Operating Model Guide
Establish accountable data stewardship programmes that meet U.S. Evidence Act mandates, Canada’s Directive on Service and Digital, and OECD data governance principles while…

Coverage intelligence

Published: April 18, 2023
Coverage pillar: Data Strategy
Source credibility: 76/100 — medium confidence
Topics: Healthcare interoperability · AI governance · US regulation
Sources cited: 8 sources (federalregister.gov, healthit.gov, hhs.gov, cms.gov)
Reading time: 5 min

Cited sources

Health Data, Technology, and Interoperability (HTI-1) Proposed Rule — Office of the National Coordinator for Health IT
HTI-1 Proposed Rule Fact Sheet — Office of the National Coordinator for Health IT
HTI-1 Proposed Rule — Office of the National Coordinator for Health IT
ONC advances AI transparency in HTI-1 proposed rule — ONC Buzz Blog
HHS proposes rule to strengthen health data interoperability — U.S. Department of Health and Human Services
United States Core Data for Interoperability (USCDI) Version 3 — ONC Interoperability Standards Advisory
CMS interoperability and prior authorization final rule — Centers for Medicare & Medicaid Services
FDA issues guidance on software functions including AI/ML-enabled devices — U.S. Food and Drug Administration

Comments

Community

We publish only high-quality, respectful contributions. Every submission is reviewed for clarity, sourcing, and safety before it appears here.

First name

Last name (optional)

Comment

Submissions showing "Awaiting moderation" are in review. Spam, low-effort posts, or unverifiable claims will be rejected. We verify submissions with the email you provide, and we never publish or sell that address.

Verification

Complete the CAPTCHA to submit.