United States Core Data for Interoperability (USCDI)
The United States Core Data for Interoperability (USCDI) is a standardized set of health data classes and constituent data elements for nationwide, interoperable health information exchange. Review the USCDI Fact Sheet to learn more.
A USCDI Data Class is an aggregation of Data Elements by a common theme or use case.
A USCDI Data Element is a piece of data defined in USCDI for access, exchange or use of electronic health information.
USCDI ONC New Data Element & Class (ONDEC) Submission System
USCDI V1
Please reference the USCDI version 1 document to the left for applicable standards versions associated with USCDI v1.
Harmful or undesired physiological responses associated with exposure to a substance.
Health professional’s conclusions and working assumptions that will guide treatment of the patient.
Information about a person who participates or is expected to participate in the care of a patient.
Narrative patient data relevant to the context identified by note types.
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- Usage note: Clinical Notes data elements are content exchange standard agnostic. They should not be interpreted or associated with the structured document templates that may share the same name.
Desired state to be achieved by a patient.
Health related matter that is of interest, importance, or worry to someone who may be the patient, patient’s family or patient’s health care provider.
Record of vaccine administration.
Analysis of clinical specimens to obtain information about the health of a patient.
Pharmacologic agents used in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Data used to categorize individuals for identification, records matching, and other purposes.
Activity performed for or on a patient as part of the provision of care.
The metadata, or extra information about data, regarding who created the data and when it was created.
Representing a patient’s smoking behavior.
Unique identifier(s) for a patient's implantable device(s).
Physiologic measurements of a patient that indicate the status of the body’s life sustaining functions.
USCDI V2
The USCDI v2 contains data classes and elements from USCDI v1 and new data classes and elements submitted through the ONDEC system. Please reference the USCDI Version 2 document to the left for applicable vocabulary standards versions associated with USCDI v2 and to the ONC Standards Bulletin 21-3 for more information about the process to develop USCDI v2 and future versions.
Harmful or undesired physiological responses associated with exposure to a substance.
Health professional’s conclusions and working assumptions that will guide treatment of the patient.
Information about a person who participates or is expected to participate in the care of a patient.
Narrative patient data relevant to the context identified by note types.
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- Usage note: Clinical Notes data elements are content exchange standard agnostic. They should not be interpreted or associated with the structured document templates that may share the same name.
Non-imaging and non-laboratory tests performed that result in structured or unstructured findings specific to the patient to facilitate the diagnosis and management of conditions.
Tests that result in visual images requiring interpretation by a credentialed professional.
Information related to interactions between healthcare providers and a patient.
Desired state to be achieved by a patient.
Health related matter that is of interest, importance, or worry to someone who may be the patient, patient’s family or patient’s health care provider.
Record of vaccine administration.
Analysis of clinical specimens to obtain information about the health of a patient.
Pharmacologic agents used in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Data used to categorize individuals for identification, records matching, and other purposes.
Condition, diagnosis, or reason for seeking medical attention.
Activity performed for or on a patient as part of the provision of care.
The metadata, or extra information about data, regarding who created the data and when it was created.
Representing a patient’s smoking behavior.
Unique identifier(s) for a patient's implantable device(s).
Physiologic measurements of a patient that indicate the status of the body’s life sustaining functions.
USCDI V3
USCDI v3 contains data classes and elements from USCDI v2 and new data classes and elements submitted through the ONDEC system. Please reference the USCDI Version 3 document to the left for applicable vocabulary standards versions associated with USCDI v3 and to the ONC Standards Bulletin 22-2 for more information about the process to develop USCDI v3 and future versions.
Harmful or undesired physiological responses associated with exposure to a substance.
Health professional’s conclusions and working assumptions that will guide treatment of the patient.
Information about a person who participates or is expected to participate in the care of a patient.
Narrative patient data relevant to the context identified by note types.
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- Usage note: Clinical Notes data elements are content exchange standard agnostic. They should not be interpreted or associated with the structured document templates that may share the same name.
Non-imaging and non-laboratory tests performed that result in structured or unstructured findings specific to the patient to facilitate the diagnosis and management of conditions.
Tests that result in visual images requiring interpretation by a credentialed professional.
Information related to interactions between healthcare providers and a patient.
Desired state to be achieved by a patient.
Data related to an individual’s insurance coverage for health care.
Assessments of a health-related matter of interest, importance, or worry to a patient, patient’s family, or patient’s healthcare provider that could identify a need, problem, or condition.
Record of vaccine administration.
Analysis of clinical specimens to obtain information about the health of a patient.
Pharmacologic agents used in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Data used to categorize individuals for identification, records matching, and other purposes.
Condition, diagnosis, or reason for seeking medical attention.
Activity performed for or on a patient as part of the provision of care.
The metadata, or extra information about data, regarding who created the data and when it was created.
Unique identifier(s) for a patient's implantable device(s).
Physiologic measurements of a patient that indicate the status of the body’s life sustaining functions.
USCDI V4
USCDI v4 added 20 data elements and one data class to USCDI v3. Please reference the USCDI v4 standard document and the ONC Standards Bulletin 23-2 for details. To review the prioritization criteria ONC used to select the USCDI v4 data elements, refer to the ONC Standards Bulletin 22-2.
Harmful or undesired physiological responses associated with exposure to a substance.
Information about a person who participates or is expected to participate in the care of a patient.
Narrative patient data relevant to the context identified by note types.
-
- Usage note: Clinical Notes data elements are content exchange standard agnostic. They should not be interpreted or associated with the structured document templates that may share the same name.
Non-imaging and non-laboratory tests performed that result in structured or unstructured findings specific to the patient to facilitate the diagnosis and management of conditions.
Tests that result in visual images requiring interpretation by a credentialed professional.
Information related to interactions between healthcare providers and a patient.
Physical place of available services or resources.
Desired state to be achieved by a person or a person’s elections to guide care.
Data related to an individual’s insurance coverage for health care.
Assessments of a health-related matter of interest, importance, or worry to a patient, patient’s family, or patient’s healthcare provider that could identify a need, problem, or condition.
Record of vaccine administration.
Analysis of clinical specimens to obtain information about the health of a patient.
An instrument, machine, appliance, implant, software or other article intended to be used for a medical purpose.
Pharmacologic agents used in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Data used to categorize individuals for identification, records matching, and other purposes.
Conclusions and working assumptions that will guide treatment of the patient, and recommendations for future treatment.
Condition, diagnosis, or reason for seeking medical attention.
Activity performed for or on a patient as part of the provision of care.
The metadata, or extra information about data, regarding who created the data and when it was created.
Physiologic measurements of a patient that indicate the status of the body’s life sustaining functions.
USCDI V5
USCDI v5 was published on July 16, 2024, and includes 16 new data elements and two new data classes. Please read the USCDI v5 standard document and the ONC Standards Bulletin 24-2 for details.
Harmful or undesired physiological responses associated with exposure to a substance.
Information about a person who participates or is expected to participate in the care of a patient.
Narrative patient data relevant to the context identified by note types.
-
- Usage note: Clinical Notes data elements are content exchange standard agnostic. They should not be interpreted or associated with the structured document templates that may share the same name.
Non-imaging and non-laboratory tests performed that result in structured or unstructured findings specific to the patient to facilitate the diagnosis and management of conditions.
Tests that result in visual images requiring interpretation by a credentialed professional.
Information related to interactions between healthcare providers and a patient.
Physical place of available services or resources.
Desired state to be achieved by a person or a person’s elections to guide care.
Data related to an individual’s insurance coverage for health care.
Assessments of a health-related matter of interest, importance, or worry to a patient, patient’s family, or patient’s healthcare provider that could identify a need, problem, or condition.
Record of vaccine administration.
Analysis of clinical specimens to obtain information about the health of a patient.
An instrument, machine, appliance, implant, software or other article intended to be used for a medical purpose.
Pharmacologic agents used in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Findings or other clinical data collected about a patient during care.
Provider-authored request for the delivery of patient care services.
Data used to categorize individuals for identification, records matching, and other purposes.
Conclusions and working assumptions that will guide treatment of the patient, and recommendations for future treatment.
Condition, diagnosis, or reason for seeking medical attention.
Activity performed for or on a patient as part of the provision of care.
The metadata, or extra information about data, regarding who created the data and when it was created.
Physiologic measurements of a patient that indicate the status of the body’s life sustaining functions.
Draft USCDI V6
ASTP/ONC published Draft USCDI v6 on January 14, 2025, and proposes to add 6 new data elements. Please read the Draft USCDI v6 standard document and the ASTP Standards Bulletin 25-1 for details. ASTP/ONC is accepting comments here through May 12, 2025, at 11:59 PM ET.
Harmful or undesired physiological responses associated with exposure to a substance.
Information about a person who participates or is expected to participate in the care of a patient.
Narrative patient data relevant to the context identified by note types.
-
- Usage note: Clinical Notes data elements are content exchange standard agnostic. They should not be interpreted or associated with the structured document templates that may share the same name.
Non-imaging and non-laboratory tests performed that result in structured or unstructured findings specific to the patient to facilitate the diagnosis and management of conditions.
Tests that result in visual images requiring interpretation by a credentialed professional.
Information related to interactions between healthcare providers and a patient.
Physical place of available services or resources.
Desired state to be achieved by a person or a person’s elections to guide care.
Data related to an individual’s insurance coverage for health care.
Assessments of a health-related matter of interest, importance, or worry to a patient, patient’s family, or patient’s healthcare provider that could identify a need, problem, or condition.
Record of vaccine administration.
Analysis of clinical specimens to obtain information about the health of a patient.
An instrument, machine, appliance, implant, software or other article intended to be used for a medical purpose.
Pharmacologic agents used in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Findings or other clinical data collected about a patient during care.
Provider-authored request for the delivery of patient care services.
Data used to categorize individuals for identification, records matching, and other purposes.
Conclusions and working assumptions that will guide treatment of the patient, and recommendations for future treatment.
Condition, diagnosis, or reason for seeking medical attention.
Activity performed for or on a patient as part of the provision of care.
The metadata, or extra information about data, regarding who created the data and when it was created.
Physiologic measurements of a patient that indicate the status of the body’s life sustaining functions.
- Represented by a terminology standard or SDO-balloted technical specification or implementation guide.
- Data element is captured, stored, or accessed in multiple production EHRs or other HIT modules from more than one developer.
- Data element is electronically exchanged between more than two production EHRs or other HIT modules of different developers using available interoperability standards.
- Use cases apply to most care settings or specialties.
Level 2
Harmful or undesired physiological responses associated with exposure to a substance.
Material substance originating from a biological entity intended to be transplanted or infused into another (possibly the same) biological entity.
Tests that result in visual images requiring interpretation by a credentialed professional.
Physical place of available services or resources.
Data related to an individual’s insurance coverage for health care.
Record of vaccine administration.
An instrument, machine, appliance, implant, software or other article intended to be used for a medical purpose.
Pharmacologic agents used in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Provider-authored request for the delivery of patient care services.
Data used to categorize individuals for identification, records matching, and other purposes.
Conclusions and working assumptions that will guide treatment of the patient, and recommendations for future treatment.
Condition, diagnosis, or reason for seeking medical attention.
Activity performed for or on a patient as part of the provision of care.
Physiologic measurements of a patient that indicate the status of the body’s life sustaining functions.
- Represented by a terminology standard or SDO-balloted technical specification or implementation guide.
- Data element is captured, stored, or accessed in at least one production EHR or HIT module.
- Data element is electronically exchanged between two production EHRs or other HIT modules using available interoperability standards.
- Use cases apply to several care settings or specialties.
Level 1
Material substance originating from a biological entity intended to be transplanted or infused into another (possibly the same) biological entity.
Narrative patient data relevant to the context identified by note types.
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- Usage note: Clinical Notes data elements are content exchange standard agnostic. They should not be interpreted or associated with the structured document templates that may share the same name.
Physical place of available services or resources.
Assessments of a health-related matter of interest, importance, or worry to a patient, patient’s family, or patient’s healthcare provider that could identify a need, problem, or condition.
Analysis of clinical specimens to obtain information about the health of a patient.
Pharmacologic agents used in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Data used to categorize individuals for identification, records matching, and other purposes.
The metadata, or extra information about data, regarding who created the data and when it was created.
Physiologic measurements of a patient that indicate the status of the body’s life sustaining functions.
- Not represented by a terminology standard or SDO-balloted technical specification or implementation guide.
- Data element is captured, stored, or accessed in limited settings such as a pilot or proof of concept demonstration.
- Data element is electronically exchanged in limited environments, such as connectathons or pilots.
- Use cases apply to a limited number of care settings or specialties, or data element represents a specialization of other, more general data elements.
Level 0
Harmful or undesired physiological responses associated with exposure to a substance.
Material substance originating from a biological entity intended to be transplanted or infused into another (possibly the same) biological entity.
Information about a person who participates or is expected to participate in the care of a patient.
Narrative patient data relevant to the context identified by note types.
-
- Usage note: Clinical Notes data elements are content exchange standard agnostic. They should not be interpreted or associated with the structured document templates that may share the same name.
Non-imaging and non-laboratory tests performed that result in structured or unstructured findings specific to the patient to facilitate the diagnosis and management of conditions.
Tests that result in visual images requiring interpretation by a credentialed professional.
Information related to interactions between healthcare providers and a patient.
Health data as reflected in a patient's Explanation of Benefits (EOB) statements, typically derived from claims and other administrative data.
Desired state to be achieved by a patient.
Desired state to be achieved by a person or a person’s elections to guide care.
Data related to an individual’s insurance coverage for health care.
Assessments of a health-related matter of interest, importance, or worry to a patient, patient’s family, or patient’s healthcare provider that could identify a need, problem, or condition.
Record of vaccine administration.
Analysis of clinical specimens to obtain information about the health of a patient.
An instrument, machine, appliance, implant, software or other article intended to be used for a medical purpose.
Pharmacologic agents used in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Findings or other clinical data collected about a patient during care.
Provider-authored request for the delivery of patient care services.
Data used to categorize individuals for identification, records matching, and other purposes.
Conclusions and working assumptions that will guide treatment of the patient, and recommendations for future treatment.
Condition, diagnosis, or reason for seeking medical attention.
Activity performed for or on a patient as part of the provision of care.
The metadata, or extra information about data, regarding who created the data and when it was created.
Physiologic measurements of a patient that indicate the status of the body’s life sustaining functions.
The USCDI ONC New Data Element and Class (ONDEC) Submission System supports a predictable, transparent, and collaborative process, allowing health IT stakeholders to submit new data elements and classes for future versions of USCDI. Click here for more information and to submit new data elements.
The USCDI standard will follow the Standards Version Advancement Process described in the Cures rule to allow health IT developers to update their systems to newer version of USCDI and provide these updates to their customers.
Comment
Submitted by RGold on
Vizient Inc. Comments on Draft USCDI v6
Attached please find comments from Vizient Inc. on Draft USCDI v6
Submitted by Robert Hussey on
Comments from Wolters Kluwer on USCDI v6
Attached are comments from Wolters Kluwer on USCDI v6. Thanks for allowing us to share our views.
Submitted by NCQA on
NCQA Comments on Draft USCDI v6
The National Committee for Quality Assurance (NCQA) thanks ASTP for the opportunity to provide feedback on the draft version 6 of the US Core Data for Interoperability (USCDI).
NCQA is a private, 501(c)(3) not-for-profit, independent organization dedicated to improving health care quality through our Accreditation and measurement programs. We are a national leader in quality oversight and a pioneer in quality measurement. Leveraging our strengths as a trusted third party, we are committed to helping organizations navigate the challenges associated with improving the health care system. Our mission to improve the quality of health for all Americans propels our daily work.
NCQA is pleased to provide the following comments, summarized below and detailed in the attached letter, on the proposals and considerations for USCDI v6.
- Comments on ASTP requested items: Care Plan, Diagnostic Imaging
- Support the addition of the Care Plan element to USCDI and applaud the inclusion of goals as a minimum required component to support person-centered care plans.
- Support adding additional detail to the Diagnostic Imaging data class including adding terminology requirements to the structured components of the Diagnostic Imaging Report data element to support exchange of clinical interpretation of results.
- Additional recommendations for Final USCDI v6
- Add additional required components to the Discharge Summary data element to align industry requirements and support high quality care transitions.
- Expand the Smoking Status data element to include all tobacco products or add a new Tobacco Use Status data element to the Health Status Assessments data class.
- Other comments
- Support for the Department of Veterans Affairs recommendation to add Veteran Status data element to the Patient Demographic data class.
- Recommend early alignment of the Race and Ethnicity data elements to the updated OMB SPD 15 standard to support clear, aligned standards requirements across the industry.
- Continue to recommend ASTP add the Carin Blue Button (BB) Common Payer Consumer Data Set (CPCDS) elements to USCDI to align requirements across payers and health IT.
Submitted by hantran on
CAP Comments on Draft USCDI v6
Please see attached comments from the College of American Pathologists (CAP) on Draft USCDI v6.
Submitted by Aarthi Shanmugavel on
American Dental Association comments on Draft USCDI V6
ADA appreciates the opportunity to present comments on Draft USCDI V6.
Submitted by Aarthi Shanmugavel on
American Dental Association comments on USCDI V6
The American Dental Association appreciates the opportunity to provide feedback on Draft USCDI v6.
Submitted by kari.guida@sta… on
The Minnesota Department of…
The Minnesota Department of Health (MDH) requests that the pronouns, sexual orientation, and gender identity data elements be part of USCDI v6. Removing these data elements from USCDI v6 is harmful to the people we serve. EHRs capturing this information, and other social determinants of health and patient demographic information allows providers, patients, and public health to better understand factors affecting health, provide better person-centered care, and implement evidence-based health policy. This removal will limit MDH’s response to current and emerging health concerns, thus making people less healthy and care more expensive.
The removal of these important data elements also invalidates the development and implementation work done across the country. In Minnesota, the Minnesota e-Health Standards and Interoperability Workgroup met in November of 2014 to assess e-health health and social determinants of health that are captured in EHRs. This was at the request of the Minnesota Commissioner of Health to fulfil part of a legislative study. This work has continued as providers, the community, and other partners recognize and benefit value from the collection, use, and sharing of these data elements; they meet the information and care needs.
The removal of pronouns, sexual orientation, and gender identity from the Patient Demographic/Information Data Class in draft USCDI v6 is a step backwards for ASTP; limiting our nation’s progress on achieving the technical and policy foundation needed for the access, exchange, and use of electronic health information to support nationwide interoperable health information exchange.
Submitted by mashafa on
Academy of Nutrition and Dietetics comments on draft USCDI v6
The Academy of Nutrition and Dietetics appreciates and is grateful for the inclusion of the new Nutrition Order data element under the Orders data class and strongly supports its inclusion in the upcoming USCDI v6. This new data element is essential for ensuring comprehensive and coordinated care across all care settings, as Nutrition Order is a fundamental component of patient management that impacts all patients, regardless of their healthcare environment.
The inclusion of Nutrition Order will permit the streamlining of other data elements within the Nutrition and Diet class. Additionally, Nutrition Order effectively captures terminology components such as SNOMED CT and the International Dysphagia Diet Standardisation Initiative (IDDSI) level classifications for food and drinks, which support standardized documentation and data exchange.
Nutrition Order, already embedded in daily healthcare workflows, has been rigorously tested by the PACIO (Post-Acute Care Interoperability) community in recent HL7 FHIR Connectathons. These tests have demonstrated its interoperability and readiness for widespread adoption, and it has been formally included in the PACIO Implementation Guide. Moreover, the FHIR NutritionOrder standard is actively being implemented as searchable and readable data within commonly used large electronic medical record (EMR) systems and malnutrition software solutions, underscoring its practical utility and emphasizing the demand for standardization across healthcare systems.
By adopting Nutrition Order in USCDI v6, healthcare providers can significantly enhance interoperability through structured documentation of diet modifications, including therapeutic diets, texture-modified diets, and culturally significant diets (e.g., Halal, Kosher). This adoption will substantially improve the ability of care teams to share critical nutritional information, promote continuity of care, and ensure patient safety.
Including Nutrition Order in USCDI v6 directly addresses the often-overlooked yet universally impactful nature of nutrition-related orders, thus advancing care coordination, improving patient outcomes, and enhancing interoperability of nutrition data across the healthcare continuum.
Submitted by jennifermar on
Comments on Proposed USCDI v6 Valley Medical Center
We appreciate the opportunity to provide feedback on Draft USCDI Version 6, published in January 2025. As a leading healthcare organization committed to advancing interoperability, patient care, and data security, we commend the Office of the National Coordinator for Health Information Technology (ONC) and the Assistant Secretary for Technology Policy (ASTP) for their ongoing efforts to refine and expand the USCDI standards. Below, we address the key areas outlined in the public comment request, offering detailed insights, concerns, and recommendations to support the development of the final USCDI v6.
1. Feedback on Data Elements
The proposed data elements in Draft USCDI v6 represent a significant step forward in standardizing health information exchange (HIE) across care settings, aligning with clinical, public health, and behavioral health priorities. We support the addition of new data elements such as Facility Address, Unique Device Identifier, Portable Medical Order, Care Plan, Date of Onset, and Family Health History, as they address critical gaps in interoperability and enhance patient care coordination. These elements are particularly valuable for:
- Improving health outcomes: Elements like Care Plan and Family Health History enable coordinated care across providers, especially for patients with chronic conditions or complex medical histories, facilitating personalized treatment plans.
- Enhancing public health reporting: Facility Address and Unique Device Identifier support population health management and device-related safety monitoring, respectively, by providing granular data for tracking and analysis.
- Supporting end-of-life care: Portable Medical Order ensures that critical care preferences (e.g., POLST, MOLST) are accessible across settings, improving decision-making for patients with serious life-limiting conditions.
However, we identify several areas where additional data elements or clarifications could strengthen USCDI v6:
- Missing Elements:
- Mental Health Crisis Indicators: While Mental/Cognitive Status is included under Health Status Assessments, we recommend adding specific data elements for mental health crisis indicators (e.g., suicide risk assessment scores, acute psychosis flags). These are critical for timely interventions and integration with behavioral health systems, particularly given the emphasis on behavioral health integration in the policy priorities.
- Genomic Data: As precision medicine advances, including basic genomic data elements (e.g., genetic variants, pharmacogenomic markers) could support tailored treatments and align with emerging clinical workflows. This would build on Family Health History to provide a more comprehensive view of patient risk.
- Patient-Reported Outcomes (PROs): Incorporating structured PROs (e.g., pain scales, quality-of-life assessments) would enhance patient-centered care and align with value-based care models, which prioritize patient-reported data.
- Clarifications Needed:
- Sex Parameter for Clinical Use: The removal of pronouns, sexual orientation, and gender identity data elements (noted on page 4) raises concerns about the ability to provide culturally competent care. We recommend clarifying how Sex Parameter for Clinical Use will capture nuanced clinical observations (e.g., hormone levels, anatomic characteristics) without losing critical identity data that impacts care delivery, such as transgender health needs.
- SDOH Assessments and Interventions: While SDOH Assessment and SDOH Interventions are included, their definitions and usage notes could be expanded to include specific examples of standardized screening tools (e.g., PRAPARE, AHC HRSN) and intervention tracking metrics to ensure consistency across systems.
These additions and clarifications would minimize ambiguity, reduce implementation burden, and improve the utility of USCDI v6 for patient care and HIE.
2. Implementation Challenges
Implementing Draft USCDI v6 presents several challenges for our organization, which operates a network of hospitals, clinics, and certified health IT systems. We anticipate the following barriers and propose potential solutions:
- Technical Integration Complexity:
- Challenge: Integrating new data elements like Unique Device Identifier and Portable Medical Order requires updates to existing electronic health record (EHR) systems, interfaces, and data mapping processes. This may strain resources, especially for legacy systems not originally designed for these standards.
- Solution: Leverage ONC’s Health IT Certification Program resources, such as the Standards Version Advancement Process (SVAP), to adopt USCDI v6 incrementally. Partner with health IT vendors to develop modular APIs and FHIR-based interfaces that streamline data element integration. Additionally, provide detailed implementation guides and testing tools specific to these new elements.
- Vocabulary Standard Alignment:
- Challenge: The requirement to use multiple vocabulary standards (e.g., LOINC, SNOMED CT, RxNorm) for data elements like Clinical Tests and Medications may create inconsistencies if our systems or external partners use different or outdated versions. Mapping to the specified versions (e.g., LOINC 2.78, SNOMED CT U.S. Edition September 2024) could be resource-intensive.
- Solution: ONC could collaborate with standards development organizations (SDOs) to create crosswalks or mapping tools for transitioning between vocabulary versions. Offering training and certification programs for health IT developers on these standards would also mitigate adoption barriers.
- Workforce Training:
- Challenge: Staff and clinicians may require extensive training to understand and utilize new data elements, such as Care Plan and SDOH Interventions, in workflows. This could disrupt operations and increase costs.
- Solution: Develop ONC-supported training modules, webinars, and best practice guides tailored to clinical and IT staff. Partner with academic institutions and professional associations to integrate USCDI v6 education into continuing education programs.
- Cost and Resource Allocation:
- Challenge: The financial and human resource investment required for system upgrades, testing, and compliance with regulatory timelines (e.g., HTI-1, HTI-2) could strain budgets, particularly for smaller healthcare organizations.
- Solution: ONC could offer grants or funding opportunities through HHS programs (e.g., HRSA, CMS) to support implementation. Additionally, creating a centralized repository of case studies and lessons learned from early adopters would help organizations prioritize resources effectively.
By addressing these challenges with targeted resources and partnerships, ONC can facilitate a smoother transition to USCDI v6.
3. Patient Privacy and Data Security
Our organization is deeply committed to safeguarding patient information, aligning with federal regulations such as HIPAA and the 21st Century Cures Act. We support the USCDI v6’s role in enhancing interoperability but have concerns about privacy and security:
- Data Sensitivity:
- Certain new data elements, such as Family Health History, SDOH Assessments, and Portable Medical Orders, may contain sensitive information (e.g., genetic risks, socioeconomic status, end-of-life preferences). Unauthorized disclosure could lead to discrimination or privacy breaches, particularly if shared across untrusted networks or with third parties.
- Alignment with Our Commitment: We ensure compliance with HIPAA’s minimum necessary standard and implement role-based access controls, encryption, and audit trails to protect patient data. USCDI v6’s structured data elements should be accompanied by robust security guidance to prevent misuse or over-sharing.
- Interoperability Risks:
- Expanding data exchange through USCDI v6 increases the attack surface for cyberattacks, such as ransomware or data breaches, especially if health IT systems lack consistent security protocols.
- Alignment with Our Commitment: We employ advanced cybersecurity measures, including multi-factor authentication, regular vulnerability assessments, and participation in TEFCA™-compliant networks, which require stringent security standards. We recommend ONC include specific security requirements (e.g., FHIR API encryption standards, audit logging for data access) in USCDI v6 implementation guidance to align with our practices.
- Consent and Granularity:
- The removal of pronouns, sexual orientation, and gender identity data (page 4) may limit patients’ ability to control how their identity data is shared, potentially undermining trust. We suggest clarifying how patients can opt-in or opt-out of sharing specific data elements, ensuring transparency and consent.
- Alignment with Our Commitment: We prioritize patient consent and provide granular data-sharing preferences through our MyChart portal. We recommend ONC develop patient-facing resources to explain USCDI v6 data elements and consent options, reinforcing trust in interoperability initiatives.
To address these concerns, ONC could collaborate with HHS and NIST to publish security frameworks tailored to USCDI v6, ensuring alignment with our organization’s privacy-first approach.
4. Overall Impact
Draft USCDI v6 has the potential to significantly enhance healthcare interoperability by standardizing a broader set of data elements critical for coordinated care, public health, and value-based outcomes. We foresee the following impacts on our organization and the broader healthcare system:
- Positive Impacts:
- Improved Care Coordination: Elements like Care Plan, Family Health History, and Portable Medical Order will enable seamless care transitions across settings, reducing duplication of services and improving outcomes for patients with complex needs, such as those in radiation oncology or chronic disease management.
- Enhanced Public Health: Facility Address and Unique Device Identifier will support real-time disease surveillance and device safety monitoring, strengthening our ability to respond to public health emergencies (e.g., pandemics, recalls).
- Behavioral Health Integration: The focus on behavioral health data (e.g., Mental/Cognitive Status, SDOH Assessments) aligns with our efforts to integrate primary and behavioral care, improving holistic patient care.
- Potential Hindrances:
- Implementation Burden: As noted earlier, the technical and financial challenges of adopting new data elements and vocabulary standards could delay interoperability gains, particularly for smaller providers in our network.
- Data Overload: The expanded scope of USCDI v6 may lead to information overload for clinicians if systems lack robust filtering and prioritization tools, potentially hindering decision-making efficiency.
- Inconsistent Adoption: Variability in health IT vendor readiness and provider uptake could create interoperability gaps, especially if some organizations lag in implementing USCDI v6 or use non-compliant systems.
To maximize benefits and minimize hindrances, we recommend ONC prioritize phased implementation timelines, vendor certification incentives, and clinician usability testing to ensure USCDI v6 delivers on its interoperability promise.
5. Additional Recommendations
To enhance USCDI v6 and promote better patient outcomes, we offer the following recommendations:
- Expand Behavioral Health Data: Include specific mental health crisis indicators (e.g., suicide risk scores, crisis flags) and substance use severity scales to support timely interventions and integration with primary care, aligning with the policy priority of behavioral health integration.
- Incorporate Precision Medicine Elements: Add basic genomic data (e.g., genetic variants, pharmacogenomic markers) to support precision medicine, reflecting advancements in clinical genomics and personalized care.
- Provide Implementation Templates: Develop standardized FHIR profiles, implementation guides, and mapping tools for new data elements (e.g., Unique Device Identifier, Portable Medical Order) to reduce technical barriers and ensure consistency across systems.
- Enhance Patient Engagement: Include patient-reported outcomes (PROs) and patient-generated health data (e.g., wearable device metrics) to empower patients and align with value-based care models, improving engagement and outcomes.
- Strengthen SDOH Guidance: Provide detailed usage notes and standardized tools for SDOH Assessments and SDOH Interventions, including specific screening instruments and intervention tracking metrics, to ensure uniform adoption and impact on health equity.
- Address Equity and Inclusion: Reconsider the removal of pronouns, sexual orientation, and gender identity data, offering guidance on capturing these elements securely and optionally to support culturally competent care without compromising privacy.
We appreciate ONC’s commitment to stakeholder engagement and look forward to collaborating on finalizing USCDI v6. These recommendations aim to ensure the standard meets the diverse needs of healthcare organizations, enhances patient outcomes, and drives meaningful interoperability across the U.S. healthcare ecosystem.
Sincerely,
Jennifer Hornbuckle, Senior Quality Analytics Analyst, Information Services
Valley Medical Center
Submitted by RGold on
Vizient Inc. Comments on Draft USCDI v6
We thank ASTP for the opportunity to share recommendations related to Draft USCDI v6. In our comments, we respond to issues raised in SB25-1 and offer our recommendations to constructively improve Draft USCDI v6. However, Vizient believes it is important that additional clarification on several data elements be provided before Draft USCDI v6 is finalized. In addition, we offer recommendations for future iterations of USCDI.
Suggestions for Improvement in the Data Classes or Elements in Draft USCDI v6
As described below, Vizient offers several suggestions related to the data classes or elements included in Draft USCDI v6. Notably, Vizient is generally supportive of several of the data elements and classes proposed to be added to USCDI v6, as we believe they will help support more robust and accurate data collection for hospitals and other providers.
Should Other Data Elements, Already Classified as Level 2 on the USCDI Web Pages, be Added to USCDI v6 Instead, or in Addition to Those in Draft USCDI v6? If so, why?
Vizient recommends adding the below Level 2 data elements to USCDI v6. In support of these additions, use cases are also provided for consideration:
• Medications
•Vital Signs
Data Elements for Future Consideration after USCDI v6
Vizient appreciates ASTP’s efforts to build upon USCDI by providing new versions and additional clarity. For future versions of USCDI, Vizient encourages ASTP to consider further clarifying the following elements and classes:
• Class: Encounter Information
• Class: Patient Demographics / Information
• Class: Medication
Are there Significant Barriers to Development, Implementation, or Use for Any of These Data Elements that Warrant a Change in Definition, or Removal from Draft USCDI v6?
Vizient notes that, as of the time of our comments, we did not encounter barriers to adding to the selected elements. We encourage ASTP to include the elements from the draft USCDI v6 in the final version.
Applicable Vocabulary Standards for Race and Ethnicity Data Elements
In Draft USCDI v6, under the Patient Demographics/Information data class, the applicable vocabulary standards for both race and ethnicity require the use of both the 1997 Office of Management and Budget (OMB) Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity[1] and the Centers for Disease Control and Prevention (CDC) Race and Ethnicity Code Set Version 1.3.[2] As ASTP is aware, the OMB Standards were updated in 2024[3] and these revisions were not incorporated in the amended CDC code set. However, CDC indicates[4] these code sets will be aligned in the future. Vizient appreciates the ongoing process of updates to the vocabulary standards and encourages ASTP to continue to use the most recent CDC Race and Ethnicity Code Set in future iterations of USCDI.
New and Updated Data Elements Included in Draft USCDI v6
Facility Address
In Draft USCDI v6, ASTP adds the new data element “Facility Address”, which includes the physical location of available services or resources, to be used to differentiate specific service locations, link data to track care quality and health outcomes and monitor facility level capacity, such as hospital bed and ventilator availability. Vizient is supportive of the addition of “Facility Address” as a data element because many hospitals currently include this field in their EHRs to share this data for quality and safety purposes including, tracking the patient journey through different sites of care, patient outcomes and to support quality improvement efforts.
Date of Onset
In USCDI v6, ASTP adds the new data element “Date of Onset” as the date or estimated date when signs or symptoms of a condition began to provide more information about the course of disease or other condition providing in existing data elements (e.g., Date of Diagnosis and Date of Resolution). While Vizient supports the addition of this data element to help provide clarity about the progression of the patient’s condition, we believe the data element can be further refined. Vizient suggests clarifying that this data element reflects the onset of symptoms as provided by the patient to allow for more accurate documentation. In addition, such clarification will support communication between providers by providing clear, consistent information about the patient's condition, particularly if patients switch providers or are transferred to different care settings.
Medical Devices Data Element Unique Device Identifier (UDI)– Implantable
ASTP is updating the Medical Devices data element Unique Device Identifier - Implantable to broaden its scope to include all other medical devices, including non-implantable devices. Vizient supports expanding this data element to include non-implantable devices because of the important need for providers to exchange information to effectively identify and report on all device-related patient safety events, improve clinical decision-making to enhance patient treatment, respond to device safety recalls and strengthen the monitoring of medical devices to help ensure their ongoing safety and effectiveness. Additionally, Vizient appreciates ASTP broadening this data element as one data point captured in a single standardized field that recognizes the device identifier, as this will help hospitals manage device information more efficiently and reduce the likelihood of adverse events. For example, if a patient needs to change to a different hospital or provider due to a change in their insurance, the new provider can easily pull their records and link the patient to the device they are using. This will help providers manage device information more efficiently, inform their treatment decisions and improve patient care.
Conclusion
Vizient’s clients include a wide variety of hospitals ranging from independent, community-based hospitals to large, integrated health care systems that serve acute and non-acute care needs. Additionally, many hospitals are specialized, including academic medical centers and pediatric facilities. Individually, our members are integral partners in their local communities, and many are ranked among the nation’s top health care providers. In closing, on behalf of Vizient, I would like to thank ASTP for providing us with the opportunity to comment on USCDI v6. Please feel free to contact me, or Randi Gold at Randi.Gold@vizientinc.com, if you have any questions or if Vizient may provide any assistance as you consider these recommendations.
Respectfully submitted,
Shoshana Krilow
Senior Vice President of Public Policy and Government Relations
Vizient, Inc.
USCDI V6 Comments Final_1.pdf