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.

  •  
  • 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.

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.

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.

  •  
  • 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.

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.

USCDI V3.1

Please read the USCDI v3.1 standard document and the ONC Standards Bulletin 22-2 for details.

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.

  •  
  • 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 April 14, 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.

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.

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.

Conclusions and working assumptions that will guide treatment of the patient, and recommendations for future treatment.

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.

Level 2 data elements meet the following criteria:
  • 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.

Data related to an individual’s insurance coverage for health care.

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.

Level 1 data elements meet the following criteria:
  • 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.

  •  
  • 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.

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.

Level 0 data elements meet the following criteria:
  • 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.

Tests that result in visual images requiring interpretation by a credentialed professional.

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.

Findings or other clinical data collected about a patient during care.

Conclusions and working assumptions that will guide treatment of the patient, and recommendations for future treatment.

Condition, diagnosis, or reason for seeking medical attention.

Physiologic measurements of a patient that indicate the status of the body’s life sustaining functions.

 

Previous USCDI Versions

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

ADVION Advocates comments on Draft USCDI v6

 

 

May 12, 2025  

Acting Assistant Secretary Steve Posnack, MS, MHS  
Assistant Secretary for Technology Policy and Office of the National Coordinator for Health Information Technology (ASTP/ONC)  

U.S. Department of Health and Human Services  
330 C Street SW, 7th Floor  
Washington, DC 20201  

 

       Submitted Electronically Via HealthIT.gov  

 

RE: United States Core Data for Interoperability Draft Version 6  

 

Dear Mr. Posnack:  

ADVION is writing to provide public comment on the Draft United States Core Data for Interoperability (USCDI) Version 6, particularly regarding its implications for long-term post-acute care providers, health information technology vendors that serve post-acute care providers and rehabilitation specialists.   

ADVION is a trade association representing the providers of ancillary care and services for the long-term and post-acute care (LTPAC) sector. Our members include rehabilitation therapy companies; providers of clinical laboratory and portable x-ray services; suppliers of complex medical equipment and other specialized supplies; and health information technology (health IT) vendors that develop and distribute full clinical electronic health records (EHRs), billing and point-of-care health IT systems and other software solutions serving the majority of LTPAC providers (i.e., assisted living facilities, Home Health Agencies (HHAs), Inpatient Rehabilitation Facilities (IRFs), Long Term Care Hospitals (LTCHs) and Skilled Nursing Facilities (SNFs)). ADVION is a founding member of the Long Term & Post-Acute Care Health IT Collaborative, which was formed in 2005 to advance health IT issues by encouraging coordination among provider organizations, policymakers, vendors, payers and other stakeholders.    

For providers and vendors in the long-term care sector, the integration of standardized data elements is crucial to enhancing interoperability and improving patient outcomes. The proposed additions in USCDI Version 6, such as the inclusion of Facility Information and Unique Device Identifier, are significant to LTPAC providers. These new data elements will facilitate better tracking of patient care across various settings and improve communication among care providers, thereby streamlining transitions of care for our patients.  

However, the requirement to code and implement these new data elements into our Electronic Health Records (EHRs) presents substantial challenges to LTPAC vendors and providers. LTPAC providers will need to allocate resources to update their EHR systems, ensuring that the systems can accurately capture and report the new standards. This may involve not only technical adjustments but also comprehensive training for staff to familiarize them with the new coding requirements and data entry processes.  

In particular, the inclusion of the Unique Device Identifier (UDI) poses usability and workflow integration challenges. Nursing home and SNF teams do not routinely capture UDIs at the bedside, and current EHR interfaces may not support structured entry, scanning, or FHIR-based exchange of device information. Vendors would benefit from implementation guidance regarding device types most relevant to LTPAC and appropriate timing of UDI capture during transitions of care.  

The Portable Medical Orders element (e.g., POLST, MOLST) is highly relevant to LTPAC but varies significantly across states. LTPAC vendors will need guidance on how to consistently support interoperable exchange of portable medical orders in both structured and scanned formats. Furthermore, integration into workflow, especially when forms are received externally, must account for role-based documentation practices that often differ from hospital settings.  

While we support the emphasis on standardized Patient Summary and Care Plan elements, it is important to recognize that existing regulatory assessments such as Minimum Data Set (MDS 3.0), required by Medicare for residents of skilled nursing facilities, already include many of these data points. If not aligned, these new requirements may introduce documentation duplication or conflict with federally mandated formats.  

From the perspective of an IT vendor, most LTPAC EHRs are not ONC-certified, as they are not currently subject to federal certification mandates. As such, any interoperability expectations stemming from USCDI must account for the technical and financial limitations of these systems. One possible approach could be to establish a pathway for modular compliance or offer certification incentives, which may help vendors gradually align with ONC goals without requiring complete system overhauls. 

We also note that the proposed new Social Determinants of Health (SDOH) and cognitive/functional assessment elements overlap with MDS and therapy evaluations. Ensuring that these can be mapped and reused, rather than manually re-entered, will be critical for workflow efficiency. There is also a need for education and standardization of coding practices, as LTPAC staff may not be accustomed to using LOINC or SNOMED for daily clinical documentation.  

Finally, consistent with our prior concerns, we reiterate the risk associated with the removal of pronouns, sexual orientation, and gender identity (SOGI) as noted on page 4 of the draft USCDI v6. These elements are critical for providing respectful, person-centered care in the LTPAC setting, particularly for vulnerable LGBTQ+ populations. Their removal could lead to the loss of essential identity-related information that enables inclusive care and helps reduce disparities. From an IT perspective, LTPAC vendors who have already built support for these elements may face uncertainty and additional costs to reconfigure systems or rely on custom, non-standard data fields. This creates challenges for interoperability and consistent data exchange across care settings. Moreover, the absence of these standardized fields impedes efforts to track and address equity in care delivery. The implementation burden of new standards, especially when paired with the removal of valuable identity data, highlights the need for consistent guidance, flexibility, and support across the LTPAC sector.  

We must also highlight the potential implementation burden associated with these new data requirements. Ensuring that providers are supported through adequate funding and resources is essential to implementing these new standards effectively.  

We urge you to consider the unique challenges faced by LTPAC providers, vendors and rehabilitation specialists as you finalize the USCDI v6. The successful implementation of these data standards offers the potential to enhance patient care significantly, but it must be accompanied by thoughtful consideration of the resources and training required for effective adoption.  

Thank you for the opportunity to provide input on this important matter. I am available to provide additional input or clarification and can be reached at 202 803-2385 or Cynthia@ADVIONadvocates.org.  

Sincerely,  

 

Cynthia K.  Morton, MPA 

Chief Executive Officer 

 

CMS-CCSQ Supports new ONDEC submissions

CMS-CCSQ supports the ONDEC submission for the new VA Status data element

Recommendation: CMS CCSQ recommends the Veteran Status data element be included in the Patient Demographics/Information data class in Level 2 of USCDI. The VA will be submitting an ONDEC form proposing this as a new data element.

Rationale: CMS CCSQ is requesting that Veteran Status be added to Level 2 of the USCDI under the Patient Demographics/Information data class. Veteran Status is a critical data element that identifies individuals who have served in active military, naval, or air service under conditions other than dishonorable discharge, as defined by 13 CFR § 125.11. This data is essential for recognizing the unique healthcare needs of Veterans and their eligibility for specialized programs, such as behavioral health screenings and military toxic exposure evaluations under initiatives like the Promise to Address Comprehensive Toxics (PACT) Act. The inclusion of this data in USCDI would ensure that Veterans receive the necessary care and services, particularly when receiving care outside of Veterans Administration (VA) facilities. Veteran Status can be captured via patient self-declaration or verified in real time through authoritative, standards-based APIs, such as the VA-Developed Veteran Confirmation API.
Including Veteran Status in USCDI aligns with the broader goals of improving care for underserved populations, as it enables clinicians to tailor interventions to the specific needs of Veterans. By incorporating this data into the Patient Demographics category, providers will be able to leverage it for clinical decision support, such as triggering specialized interventions or referrals. Additionally, it supports administrative workflows like benefit eligibility reporting and quality measure assessments. The ability to track and stratify Veteran Status ensures that Veterans receive appropriate care regardless of their care setting, whether transitioning from a VA facility to a community hospital or receiving care from multiple providers. This inclusion will also enhance interoperability, ensuring that Veteran Status is accurately exchanged across disparate healthcare systems, promoting coordinated care and continuity.
Technically, Veteran Status is supported by established standards, including the “US Veteran” extension in HL7 FHIR, which enhances interoperability and facilitates the exchange of this data across various healthcare systems. This data element has already been implemented in production environments, such as Epic and Oracle Cerner, proving its broad applicability. By formalizing Veteran Status in USCDI, we not only ensure Veterans receive the care they are entitled to but also support the ongoing efforts to reduce healthcare disparities and improve overall care quality for this underserved population.

 

CMS-CCSQ supports the ONDEC submission for the new Disability Accommodations data element

Recommendation: Add a new data element entitled Disability Accommodations to USCDI Level 0 in the Patient Demographics/Information data class. OMH will be submitting an ONDEC form proposing this as a new data element.

Rationale: CMS CCSQ supports the inclusion of the Disability Accommodations data element in Level 0 of the USCDI as a critical step in improving healthcare access for individuals with disabilities. Approximately 27% of U.S. adults live with some form of disability (CDC, 2023), facing significant health disparities, including higher rates of chronic conditions and limited access to healthcare providers. Additionally, an estimated 70 million Americans experience challenges with self-care, independent living, mobility, and cognition (CDC, 2024). Among these, older adults report the highest disability prevalence, often compounded by decreased social and community engagement, which in turn contributes to further health conditions, such as depression.
While the Disability Status data element (draft v6) identifies whether a patient has a disability, the Disability Accommodations data element goes further by specifying the exact accommodations required. These can include physical adjustments or policy modifications, allowing healthcare providers to tailor services to each patient’s unique needs. It’s important to note that disability itself is not a health outcome, but rather a factor in how individuals experience aspects of life, such as hearing, seeing, processing information, and self-care.
Documenting this information raises the awareness of disability accommodation needs, enabling healthcare providers to support and meet the documented needs of patients. This support may also be required to meet certain legal requirements such as those outlined in the Americans with Disabilities Act (ADA), the Rehabilitation Act, and Section 1557 of the Affordable Care Act (ACA). The most frequently requested accommodations include communication-based (e.g., assistive listening devices, large print materials), cognitive-based (e.g., support for decision-making), and mobility-based (e.g., assistance with transfers, fine motor support) accommodations (Joint Commission Journal, 2023). 
Moreover, this data plays a crucial role in advancing interoperability across healthcare systems. Disability accommodation data is already being exchanged in PAC QRPs, including the Functional Assessment Standardized Items (FASI), which are used in IRFs, LTCHs, skilled nursing facilities (SNFs), and other PAC facilities. FASI includes standardized data elements related to accommodation, such as the "Assistive Devices for Everyday Activities" section (Item ID GG0125). This section covers a variety of devices, including canes, crutches, walkers, shower/commode chairs, communication devices, ramps, oxygen, and more (Item IDs GG0125A through GG0125Z). Recent FHIR standards have established a framework for standardizing this data across different systems (HL7 FHIR, 2024). Furthermore, the ONC Health Information Technology Advisory Committee (HITAC) has recommended adding an "Accommodations" data element to the USCDI, emphasizing the importance of standardized data in fostering patient-centered and inclusive care (Health Information Technology Advisory Committee, 2022).


References:
    i. Centers for Disease Control and Prevention (CDC). (2023). Disability impacts all of us. Retrieved from the CDC website.
    ii. Centers for Disease Control and Prevention (CDC). (2024). Disability and Health Data Now. Retrieved from the CDC website.
    iii. HL7 FHIR. (2024). Extension: National Directory of Healthcare Providers & Services (NDH) Accessibility. Retrieved from the HL7 FHIR website.
    iv. Buning, G., James, T. E., Richards, B., & McKee, M. M. (2024). Self-reported accommodation needs for patients with disabilities in primary care. The Joint Commission Journal on Quality and Patient Safety, 49(12), 776–786. Retrieved from ScienceDirect online database.
    v. Morris, M. (2024). Documentation of disability status and accommodation needs in the electronic health record: A qualitative study of health care organizations’ current practices. The Joint Commission Journal on Quality and Patient Safety.
    vi. Health Information Technology Advisory Committee (HITAC). (2022). Interoperability Standards Workgroup: Phase 1 recommendations report. U.S. Department of Health and Human Services. Retrieved from the Health Information Technology (HealthIT) Government website.

APHL Comments on USCDI V6

The Association of Public Health Laboratories (APHL) welcomes the opportunity to comment on USCDI v6. Please find our comments attached. 

APHL USCDI V6 Comments 20250512.pdf

JPHIT USCDIv6 Comments

The Joint Public Health Informatics Taskforce (JPHIT) welcomes the opportunity to comment on USCDI v6. Please find our comments attached below. 

USCDIV6 JPHIT Feedback_0.pdf

FEHRM Feedback on Draft USCDI V6

May 9, 2025

 

Mr. Steven Posnack

Acting Assistant Secretary for Technology Policy

Office of the Assistant Secretary for Technology Policy and Office of the National Coordinator for Health Information Technology (ASTP/ONC)

Department of Health and Human Services

Hubert Humphrey Building, Suite 729

200 Independence Avenue SW

Washington, DC 20201

Re: ASTP’s Request for Comments on United States Core Data for Interoperability Version 6

 

Acting Assistant Secretary Posnack,

 

The Federal Electronic Health Records Modernization (FEHRM) Program Office appreciates this opportunity to review and provide feedback on ASTP/ONC’s United States Core Data for Interoperability Version 6. The FEHRM surveyed subject matter experts at the Department of Defense (DOD) and the Veteran’s Administration (VA) in compiling these comments.

Please consider adding the following considerations for the revised data classes and elements in this version of USCDI:

1. Recommend there be two data elements, (Unique Device Identifier—Implantable and Unique Device Identifier—Non-implantable), to ensure clinicians receive the most specific information as possible.

Use Case: A clinician is sorting through a patient's chart for the types of medical devices. Rather than sort through numerous devices, the distinction of implantable versus non-implantable will allow the clinician to filter through the data more efficiently.

2. Recommend adding Allergy Severity as a separate data element or a sub-category to the Allergy Reaction. Additionally, recommend adding Allergy Criticality as a new data element. Both recommended data elements are commonly exchanged in the industry and valuable clinical information.

Use Case: A patient has a severe allergy to latex. However, without allergy severity the clinician is unable to document and must use a free-text comment field. The receiving system does not display free-text comments and the receiving system's clinicians do not receive the patient's allergy severity. The same can be said for criticality.

3. Recommend support with an additional consideration of inpatient/outpatient situations (e.g., bedside, patient wearable)

Use Case: If patient diabetic wearable reading and also a lab draw reading, how to differentiate.

4. Recommend a clear definition of the segments of the Unique Identification (ID) (e.g., National Drug Code) with segments clearly identifying manufacture device, type, serial number, model, etc.

Use Case: an operational /clinical/regulatory user can parse the ID for expanded focused reports that identifies a specific company, device type, device model, etc.

5. Recommend a standardized set of section labels so that Artificial Intelligence (AI) and Natural Language Processing (NLP) can parse appropriately. The value of codified data will inform actionable insights

Use Case: NLP can locate a section data element label for the consistent reporting and analysis.

6. Recommend a SNOMED CT identifier for Date of Onset. To be practical, there is a need to define a default date format if patient reported date is not exact. Guidance is needed on format of a default date (e.g., 01/01/2025)

Use Case: the patient is asked for the date of onset of leg pain that started in 2025 but does not remember the exact date.

7. Recommend a codified structure for family health history to support future AI and NLP requirements (e.g., standardized data labels)

Use Case: by identifying the data element with a data label, AI algorithms can identify trends in chronic diseases across the family members.

8. Recommend constraining the applicable vocabulary standards in the Family History class to only SNOMED CT. As the draft notes in its submission text, “Current users of 552 products of health information technology certified to the ONC 2015 or Cures Update to 2015 certification criteria: The health IT permits users to record, change, and access a patient’s family health history according to the September 2015 Release of SNOMED CT®, U.S. Edition.” Adding ICD-10-CM as an applicable standard significantly increases the inbound (receiver side) interoperability burden, typically requiring the receiving systems to implement and maintain maps and rules, while not materially improving the coverage of likely family history data.

We appreciate the opportunity to comment on this updated version of USCDI. Please feel free to contact us if you have any questions or would like any further information.

 

 

Regards,

 

Charles Gabrial

Digital Health Standards Lead

Federal Electronic Health Record Modernization (FEHRM) Office

 

Veeva Comments on Draft USCDI V6

On behalf of Veeva Systems, please see the attached comments. 

Veeva_USCDI_v6_Comments.pdf

Tennessee Department of Health

May 9, 2025

Steven Posnack, MS, MHS
Acting Assistant Secretary for Technology Policy, Acting National Coordinator for Health Information Technology
Department of Health and Human Services
Hubert Humphrey Building, Suite 729
200 Independence Avenue SW
Washington, DC 20201

RE: Draft USCDI Version 6

Dear Mr. Posnack, 

The Tennessee Department of Health (TDH) Office of Informatics and Analytics (TDH-OIA) appreciates the opportunity to share comments on Version 6 the United States Core Data for Interoperability Version 6 (USCDI v6). TDH is the primary public health agency responsible for public health in Tennessee. The department oversees eighty-nine rural county health departments and works closely with six metropolitan health departments under local governance to carry out the provision of public health services to people in Tennessee. Each county in Tennessee is served by a county health department providing direct and indirect services to Tennessee residents and visitors. TDH staff participates in many health care and health IT industry organizations, associations, workgroups, and task forces to ensure the needs of public health programs including those that conduct surveillance, outbreak investigations and event response, laboratory testing, and prevention of communicable and non-communicable diseases and conditions in Tennessee are heard. 

The mission of the Tennessee Department of Health is to protect, promote and improve the health and prosperity of people in Tennessee. The TDH has a great deal of interest in the widespread adoption and use of nationally accepted standards and requirements that increase data sharing, improves timely reporting and accuracy, that enforces information sharing between the clinical sector and public health. TDH can appreciate ONC’s effort for its development of the USCDI as the foundation of data elements and classes that all electronic health record technology should be able to collect, analyze and share between providers. Once broadly adopted, the USCDI will lead to improved interoperability and health data exchange, enabling better care coordination, improved health for patients and lower costs. 

TDH-OIA strongly supports comments submitted by the Council of State and Territorial Epidemiologists (CSTE). Specifically, we support the previous CSTE comments regarding confusion with including “intent” in the “Pregnancy Status” data element definition. We recommend considering a separate data element to capture information regarding pregnancy intent more accurately.

Additionally, we support the newly proposed addition of Facility Address and Facility Information.

We would also like to offer for consideration the addition of data elements “Ordering Facility” and “Performing Facility” to increase clarity when reviewing information related to lab specimens. This information is especially important for public health programs that use the details for reporting and investigations.

Again, TDH-OIA is appreciative of ASTP’s efforts and are thankful for the opportunity to comment. If there are any questions or concerns, please reach us at TDH.Informatics@tn.gov.

CDISC Response on ASTP USCDI v6 Draft

CDISC welcomes the opportunity to submit comments on ASTP's draft USCDI v6. Please see the attached comments.

CDISC Response to ASTP USCDI v6.0_2025-05-08.pdf

AHIP Comments on Draft USCDI V6

Dear Mr. Posnack: 

AHIP appreciates the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology’s (ASTP/ONC) ongoing work to advance the interoperability of health information through the United States Core Data for Interoperability (USCDI). We agree that a common set of data classes and elements is essential to achieving interoperability between consumers, doctors, hospitals, health plans, and other stakeholders. Patients deserve high-quality, equitable, and affordable care delivered by health care providers and health plans who are working together— that includes sharing the data patients and their doctors need to make informed health care decisions. With this goal in mind we are pleased to offer the following comments on the draft USCDI v6. 

Data Class: Health Insurance Information

We continue to be concerned that several data elements in the Health Insurance Information data class do not exist or risk exposing personally identifiable information without providing value to consumers. 

The USCDI should not contain elements that have no associated value set or national standard, but rather only include information that is feasible to collect and has a specific use case. ONC should remove the payer identifier data element as there is no broadly used national standard for this data element.

The privacy and security of member data is a paramount responsibility and a major concern for health plans and the consumers they serve. While this information may be robustly protected when held by a physician, hospital, or health insurance provider, the data are outside the reach of the Health Insurance Portability and Accountability Act (HIPAA) once shared through the API to third-party applications per the ONC Cures Act Rule or the Centers for Medicare & Medicaid Services Interoperability and Patient Access Rule. Moreover, all USCDI data elements are required to be shared with the selected third-party applications under the CMS rules— there is no data segmentation opportunity to pull out elements that the patient may consider sensitive. 

For the Health Insurance Information data class, the data elements include identifiers (ID) of not only the patient but also their spouse or parent (if they are the subscriber) and where they are employed. While the patient ID may be useful in the EHR to match information with practice management systems or payer claims information, this sort of detailed benefit information does not provide clinically relevant or even intelligible information for third party applications unless the identifier is also the patient’s social security number. Moreover, it is information consumers already know, so they do not need to access it through a third party. However, in the hands of third-party applications via the Patient Access API, the information could be used to identify someone in a different data set, make associations with other people in other data sets, or even re-identify a de-identified data set. Thus, while there may be important reasons to share some of this data among HIPAA covered entities, sharing it with entities outside of HIPAA exposes patients to risk without material benefit. 

To remedy this threat CMS and ASTP/ONC should reconsider the automatic link between the USCDI and the Patient Access API. Instead, each data element for the purposes of standardizing EHR data should be weighed separately from whether it should be shared with third-party applications that are not covered by HIPAA. Otherwise, we are providing patients with a false choice: access the data they need to make informed choices, or risk potential exposure of sensitive information. Until then, ONC should remove the following data elements to protect consumer privacy

  • Member identifier,
  • Subscriber identifier, 
  • Relationship to subscriber, 
  • Group identifier. 

ONC could focus the Health Insurance Information data class, in the meantime, on higher level elements such as whether the person has insurance coverage and the type of coverage. This could help third-party applications determine if information and support is available from a health insurer or whether, for example, cost estimates for the uninsured would be of use. 

Data Class: Facility Information 

We support the addition of the Facility Address data element. This data element will provide important information necessary to identify facilities and link service and outcome data to a specific physical institution or facility. Currently, it can be challenging to differentiate specific service locations and link data or records for purposes such as quality measurement. Accurate facility information, including name, address, and identifier will facilitate the transition to digital quality measurement and help public payers and health plans more accurately understand the quality of care offered at specific facilities, rather than overall quality at a system level. 

Data Class: Problems

AHIP supports the addition of the Date of Onset data element. This data element will capture important information about the onset of symptoms, timing, and potential triggers to support better diagnosis and case management. This data element also serves an important public health function to help track disease outbreaks.   

We are concerned about the addition of the Family Health History Data element.  While we appreciate the impact of genetics and the potential clinical value of this information, we are concerned that including this data element in USCDI could jeopardize patient privacy and the privacy of a patient’s family members who may not have consented to having this information shared. 

As noted above, AHIP continues to be concerned about the risk to patient privacy posed by third-party applications that are not covered by HIPAA. These new entities can be collecting, using, disclosing, and disseminating consumer health data for the purpose of monetizing it, and yet consumers are generally unaware that the data are outside these regulatory protection frameworks. AHIP continues to be very concerned about the potential for bad actors to exploit data gained via the APIs and the potential consequences for patients and their families. This risk grows exponentially as additional data elements are required to be shared with third-party apps not governed by the health care privacy legal requirements. For example, sensitive patient data, at an individually identifiable level, shared by a payer with an app developer under CMS required policies can be freely sold or disclosed as long as it is noted in the consumer terms and agreement provided by the app (which can be changed at any time).

The privacy and security of member data is a paramount responsibility and a major concern for health plans and the consumers they serve. Until more robust privacy protections are extended to third-party applications ASTP/ONC should be judicious about adding data elements to USCDI. As noted above, ASTP/ONC should also consider that instead of adopting versions of the USCDI wholesale for sharing via the CMS required APIs, CMS and ASTP/ONC should consider the contribution of each data element and whether it is necessary to share through the Patient Access API and expose to the risk of passing to a third-party app that is not covered by HIPAA.

Future Directions: Support Digital Quality Measurement

We appreciate ASTP/ONC’s efforts to coordinate with the Core Quality Measures Collaborative (CQMC) and build on the CQMC’s work when developing the USCDI+ Quality. Aligned measures based on interoperable data have the potential to reduce the burden on clinicians and providers while providing all stakeholders more robust information on performance. We strongly encourage ASTP/ONC to continue to collaborate with the CQMC when updating the USCDI+ Quality in the future and prioritize the data elements necessary to calculate the CQMC core measures for future versions. However, ASTP/ONC should also add data elements necessary to calculate digital quality measures in the baseline USCDI to ensure they are available for all payers and health care providers to use. 

Additionally, we urge ASTP/ONC to include data elements for high-value measures beyond CMS programs in the USCDI and the USCDI+ Quality. For example, ASTP/ONC should add data elements to support the exchange of data to support the National Committee for Quality Assurance (NCQA)’s HEDIS measures to support aligned measures across public and private payers. ASTP/ONC should also prioritize high-value but high burden measures such as patient experience measures, patient-reported outcomes-based performance measures (PRO-PMs), and social needs screening measures where digital measurement could materially advance their use and facilitate the exchange of person-centered data. Promoting the interoperability of patient-generated data could allow for it to be used across the system while reducing the response burden on patients. 

AHIP and its members look forward to working with ASTP/ONC to continue to advance interoperability to empower patients and support patient care. If you have any questions, please contact me at dlloyd@ahip.org

Sincerely, 

Danielle A. Lloyd, MPH 

Senior Vice President, Private Market Innovations and Quality Initiatives

Regenstrief Institute Comments on Draft USCDI v6

The Regenstrief Institute welcomes the opportunity to submit the attached comments on ASTP’s Draft United States Core Data for Interoperability (USCDI) Version 6 and related data classes standards and elements.  Our comments for USCDI v6, are intended to augment the USCDI with critical input and support its use in facilitating information exchange and interoperability goals.  We appreciate and look forward to continued collaboration with ASTP.

USCDI v6 Cover Letter, Comments_Regenstrief_2025-05-07_FINAL.pdf