Data Strategy Briefing — July 9, 2021
ONC’s July 2021 United States Core Data for Interoperability Version 2 expands certified health IT exchange requirements to new sexual orientation, gender identity, social determinants, and care-team elements that providers must map into electronic health record workflows ahead of SVAP adoption cycles.
Executive summary. The Office of the National Coordinator for Health IT (ONC) released Version 2 of the United States Core Data for Interoperability (USCDI) on 9 July 2021, expanding the minimum dataset that certified health IT must be able to exchange to include sexual orientation, gender identity, social determinants of health, and enhanced care-team information.[1] USCDI v2 builds on Version 1’s baseline and feeds the Standards Version Advancement Process (SVAP), through which certified EHR developers can voluntarily adopt the updated dataset and make it available to providers ahead of mandatory incorporation into future certification rulemaking.[2]
Context and regulatory drivers. The 21st Century Cures Act mandates nationwide interoperability, requiring ONC to define data classes that support information exchange across providers, payers, and patients. USCDI is the curated dataset that underpins ONC Certification criteria, information blocking compliance, and federal programme alignment (CMS Promoting Interoperability, CDC public health reporting).[3] Version 2 reflects stakeholder input from the USCDI expansion process and emphasises health equity by adding data elements that enable better tracking of disparities.
Key additions in USCDI v2. The new version introduces data elements within existing classes and adds new classes:
- Demographics: Sexual orientation and gender identity (SOGI) elements allow recording of a patient’s self-identified orientation and gender identity, plus a field for recorded sex at birth.[2]
- Health status and assessments: Elements capture disability status, mental function, pregnancy status, and immunisation status.
- Clinical notes: The dataset confirms that progress notes, assessment and plan notes, and history and physical notes remain required for exchange.
- Care team members: Two new elements—Care Team Member Name and Care Team Member Role—support more precise coordination across multidisciplinary teams.
- Social determinants of health (SDOH): New data classes capture food insecurity, housing instability, transportation insecurity, and utilities, aligning with Gravity Project terminology recommendations.[4]
Implications for certified EHR technology. Certified developers must map USCDI v2 elements to standard vocabularies (LOINC, SNOMED CT, ICD-10-CM, HCPCS) and support FHIR-based exchange once ONC approves SVAP updates referencing HL7 FHIR US Core v5 or later.[5] Developers should update data models, APIs, and user interfaces to capture SOGI and SDOH fields with proper privacy controls, ensuring consistent terminology binding. Providers must plan for training and workflow changes because staff may need guidance on how to sensitively collect SOGI data and integrate SDOH screening tools.
Information blocking and patient access. The Cures Act information-blocking provisions require actors to make USCDI data available via APIs. As developers adopt USCDI v2 through SVAP, they must update API documentation, test conformance with SMART on FHIR apps, and manage version negotiation so third-party developers can request the expanded data elements. Healthcare organisations should coordinate with patient portal vendors to ensure SOGI and SDOH fields are displayed appropriately and accompanied by educational content to avoid misinterpretation.
Public health and quality reporting. USCDI v2 supports emerging public health needs, such as better tracking of pandemic impacts on vulnerable populations. Federal programmes like CMS’s Inpatient Quality Reporting and the CDC’s Data Modernization Initiative increasingly rely on standardised datasets; organisations that implement USCDI v2 can streamline reporting by reusing structured data captured in EHR workflows. SDOH elements enable risk stratification for value-based care and community health needs assessments.
Concrete implementation controls.
- Data governance charter. Update data governance policies to include ownership of SOGI and SDOH elements, define steward roles, and establish review cycles for terminology updates.
- Clinical workflow design. Embed SDOH screening questionnaires and SOGI intake forms into visit templates, requiring dual attestation (clinician and patient) for accuracy and ensuring skip logic prevents unnecessary questions.
- Access controls and privacy. Configure role-based access to sensitive data elements, requiring explicit justification for users viewing SOGI fields and logging access for audit review.
- Data quality checks. Implement automated validation rules that flag inconsistent combinations (e.g., pregnancy status for patients outside biologically plausible categories) and generate monthly data-quality scorecards.
- API contract testing. Run regression tests across FHIR endpoints whenever USCDI versions change, documenting results and remediation to satisfy certification surveillance.
Implementation roadmap.
- Quarter 1: Conduct a gap analysis comparing current EHR capabilities and data dictionaries against USCDI v2 requirements; prioritise high-impact data classes.
- Quarter 2: Prototype UI changes for SOGI and SDOH data capture, engage patient advisory councils for feedback, and pilot data collection in select clinics.
- Quarter 3: Roll out staff training on inclusive communication, update privacy notices explaining the use of SOGI/SDOH data, and integrate community resource referral platforms (e.g., Unite Us, Aunt Bertha).
- Quarter 4: Enable FHIR API updates aligned with HL7 US Core releases, conduct SVAP documentation submission, and audit data quality and access logs.
- Ongoing: Monitor ONC and CMS guidance, participate in HL7 implementation communities, and refresh assessments as new USCDI versions are proposed.
Change management and training. Collecting SOGI and SDOH data requires cultural competence. Organisations should develop training modules with scenario-based learning, emphasising patient consent, confidentiality, and respectful language. Leadership should reinforce that the data supports equitable care and is not used to deny services. Provide scripts for front-line staff and integrate prompts into patient portals so individuals can self-report data before appointments.
Health equity and analytics. USCDI v2 enables stratified quality metrics by orientation, gender identity, and SDOH risk factors. Healthcare analytics teams can incorporate these fields into dashboards to identify disparities in preventive care, chronic disease management, and telehealth access. Aligning with the Gravity Project standards facilitates data exchange with community-based organisations and payers, enabling closed-loop referrals and outcome tracking.
Privacy and patient trust considerations. Because SOGI and SDOH data can be sensitive, organisations must explain why data is collected and how it is protected. Privacy notices and consent forms should articulate usage (care coordination, quality improvement, population health). Implement opt-out options for non-mandatory data collection, and ensure de-identification procedures when using data for research or analytics to mitigate reidentification risk.
Technical interoperability requirements. Developers should leverage HL7 FHIR US Core profiles that correspond to new USCDI elements, such as the Observation resource for SOGI data with LOINC codes and the Condition or Observation resources for SDOH findings. Consistent coding ensures compatibility with federal initiatives like TEFCA and eHealth Exchange participation. Testing should include HL7 Inferno test suites and ONC-sponsored interoperability events.
Regulatory watchpoints. ONC plans to incorporate newer USCDI versions into certification updates (HTI-1 proposed rule references USCDI v3), so organisations should treat v2 adoption as a stepping stone rather than an endpoint.[6] Aligning early with v2 reduces future disruption and demonstrates commitment to interoperability compliance. Additionally, payers subject to CMS Interoperability and Patient Access rules may leverage USCDI v2 to enhance data sharing with providers.
Metrics and monitoring. Track completion rates for SOGI and SDOH fields, patient opt-out rates, data quality (null values, invalid codes), staff training completion, and number of community referrals generated from SDOH screening. Align metrics with health equity goals and incorporate them into quality committees’ dashboards.
Risks of non-compliance. Failure to adopt USCDI v2 in a timely manner can jeopardise ONC certification, limit participation in CMS incentive programmes, and expose organisations to information-blocking complaints. Conversely, poor-quality SOGI or SDOH data can erode patient trust. Robust governance, training, and technology upgrades mitigate these risks while enabling more equitable, interoperable care delivery.
Regulatory summary
The USCDI v2 standard published by ONC expands certified health IT criteria under the 21st Century Cures Act. It introduces new data classes for sexual orientation, gender identity, social determinants of health, clinical notes, and device identifiers. These elements will flow into ONC certification updates and forthcoming rulemaking, requiring EHR vendors and health information networks to support standardized exchange formats (FHIR US Core profiles) and terminology mappings. Providers participating in CMS interoperability programs should expect conformance testing and data availability obligations as the USCDI v2 elements roll into certification and TEFCA implementation.
Required controls
- Data model updates. Extend data schemas to capture new USCDI v2 classes with standardized vocabularies (LOINC, SNOMED CT, ICD-10-CM) and ensure APIs expose the fields via US Core FHIR profiles.
- Terminology services. Implement or update terminology servers to manage code set mappings for SDOH and gender identity data, with validation in clinical workflows.
- Privacy and consent management. Apply granular access controls and consent tracking for sensitive attributes such as sexual orientation and gender identity, aligning with state privacy laws and 42 CFR Part 2 considerations.
- Interoperability testing. Participate in HL7 FHIR Connectathons or use ONC-approved testing tools to validate USCDI v2 conformance for APIs and document exchange.
Implementation guidance
Workflow integration: Update EHR user interfaces to collect and display USCDI v2 data elements with patient-friendly terminology and clinical decision support where appropriate. Train clinicians on consistent capture of SDOH data and sensitive demographic fields.
API and exchange enablement: Align with HL7 US Core v4/v5 profiles referenced by USCDI v2. Ensure patient access APIs and bulk FHIR export endpoints include the new elements with proper terminology bindings, and verify that health information exchange partners can consume them.
Data quality and governance: Establish validation rules, error handling, and auditing for new data elements. Monitor completeness and accuracy metrics, and coordinate with quality reporting teams to reflect USCDI v2 data in quality measures and public health reporting pipelines.
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