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.

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.

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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.

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

Please read the USCDI v3 standard document and the ONC Standards Bulletin 22-2 for details. Consistent with EO 14168 and OPM guidance, ASTP/ONC is exercising enforcement and issuing certification guidance for the ONC Health IT Certification Program with respect to certain data elements in USCDI v3. For more information see https://www.healthit.gov/topic/uscdi-v3-data-elements-enforcement-discretion.

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 V3.1

Please read the USCDI v3.1 standard document and the ONC Standards Bulletin 22-2 for details. USCDI version 3.1 updates USCDI version 3 with the following changes: consistent with Executive Order 14168, the Sex, Sexual Orientation, and Gender Identity data elements have been removed or updated in the Patient Demographics/Information Data Class.

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.

Information that guides 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.

 Usage notes: Orders convey a provider’s intent to have a service performed on or for a patient, or to give instructions on future care.

Information that guides 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 V6

ASTP/ONC published USCDI v6 on July 24, 2025, which includes 6 new data elements. Please read the USCDI v6 Standard Document and the ASTP/ONC Standards Bulletin 25-2 for details. ASTP/ONC welcomes input on future versions during the USCDI feedback period, open through September 29, 2025, at 11:59 PM ET. During this time, ASTP/ONC is accepting new data element submissions through ONDEC, and comments on existing data elements may be entered via the updated commenting feature on the USCDI data element pages.

Harmful or undesired physiological responses associated with exposure to a substance.

Information that guides treatment of the patient and recommendations for future treatment.

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.

Family member health condition(s) that are relevant to a patient's 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.

Provider-authored request for the delivery of patient care services.

 Usage notes: Orders convey a provider’s intent to have a service performed on or for a patient, or to give instructions on future care.

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.

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.

 Usage notes: Orders convey a provider’s intent to have a service performed on or for a patient, or to give instructions on future care.

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.

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.

Provider-authored request for the delivery of patient care services.

 Usage notes: Orders convey a provider’s intent to have a service performed on or for a patient, or to give instructions on future care.

Information that guides 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.

 

All 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

Pathology reports

This field is for general comments on the USCDI. I think you should reconsider having Pathology reports as part of this data set.  One part of the elements says that it should be easily read and understood, neither of which a pathology report is.  I know version two is just moving them from clinical notes to their own pathology category, but I feel these are reports that can cause a patient to panic and then maybe not be able to get into their provider right away.  Please reconsider these being part of the set.

Thank you.

Do you intend the USCDI to support a multiaxial heirarchy?

If you make Orders a Data Class, then you need to decide if you will allow notions to be categorized in more than one place or not.  For example, orders for laboratory, pathology, and diagnostic imaging tests, should those data elements be covered in those respective data classes, or should those data elements be shown within the Orders data class?  Or should they show in both places?

Do you intend the USCDI to support a multiaxial heirarchy?

If you make Orders a Data Class, then you need to decide if you will allow notions to be categorized in more than one place or not.  For example, orders for laboratory, pathology, and diagnostic imaging tests, should those data elements be covered in those respective data classes, or should those data elements be shown within the Orders data class?  Or should they show in both places?

Do you intend the USCDI to support a multiaxial heirarchy?

If you make Orders a Data Class, then you need to decide if you will allow notions to be categorized in more than one place or not.  For example, orders for laboratory, pathology, and diagnostic imaging tests, should those data elements be covered in those respective data classes, or should those data elements be shown within the Orders data class?  Or should they show in both places?

Referral Data Class

The Referral Data Class is much more mature than this Comment level characterizes.  The Referral Note document type has been recommended for Certified EHR Technology along with CCD and Discharge Summary since Meaningful Use Stage 1.  Further more, the IHE 360X Profile has been demonstrating it's use of multiple years at HIMSS Show Case demonstrations and other ONC, IHE  and DirectTrust events.  This March at the IHE Connectathon three well known EHRs and one HIE solution vendor successfully tested/demonstrated their support of the 360X profile and they were generating Referral Note documents containing all the proposed data elements within:  

 

Referral Coverage information in really "insurance information" typically categorized as "Payer Information"  in the C-CDA paradigm.  This data element faces challenges because to date there is not a national identification system to indicate what health plan is providing the coverage. Until this larger problem gets solved, representing coverage information will be challenging.

 

I've now review draft…

I've now review draft version two of the USCDI document you sent and thank you for the opportunity. My overall my main recommendation is that somewhere there needs to be a very clear indication of functional assessment. Function in terms of the ability to do ADLs and  IADLs  and what we, with IHI refer to as the 4M assessment of  age friendly health systems which includes “what matters mentation medication and  mobility. The opportunity to have interoperability is critical and this work is vital. I am always concerned when we focus on conditions instead of the capacity a person has within the context of conditions. Lots of people have heart failure and some are playing tennis while others are lying in bed.

So functional assessment.

This field is for general…

I've now review draft version two of the USCDI document you sent and thank you for the opportunity. My overall my main recommendation is that somewhere there needs to be a very clear indication of functional assessment. Function in terms of the ability to do ADLs and  IADLs  and what we, with IHI refer to as the 4M assessment of  age friendly health systems which includes “what matters mentation medication and  mobility. The opportunity to have interoperability is critical and this work is vital. I am always concerned when we focus on conditions instead of the capacity a person has within the context of conditions. Lots of people have heart failure and some are playing tennis while others are lying in bed.

So functional assessment. 

 

 

CMS Comment on USCDI draft V2

On behalf of The Centers for Medicare and Medicaid Services (CMS) and The Center for Clinical Standards and Quality (CCSQ) we submit comment on the USCDI draft version 2, attached.

 

CMS supports a broader vision for the USCDI, where the USCDI standard serves as the central mechanism for exposing usable, standardized interoperable data for multiple use cases, including quality measurement. We are committed to working collaboratively with ONC to ensure the USCDI meets stakeholder needs. We specifically urge ONC to add additional data elements to USCDI version 2 that are critical for data sharing and addressing emerging public health needs as well as health equity, highlighted in the attached comment response.

USCDI Draft Version 2 CMS Public Comment Responsev1.pdf

USCDI Draft v2: Comments from Patient & Carepartner Perspective

General Overview

  • Based on the comments and feedback received to date on this entire body of work, what is the approximate percentage of responses by stakeholder category? For example, how much feedback and guidance has been received from vendors, payors, representatives from the government, clinicians, and actual patients, carepartners, and respective patient, non-profit advocacy groups? A simple pie chart would be helpful in defining this with more transparency. The suggestion, prioritization, and implementation of new data classes and data elements will be a direct consequence of the representation of stakeholders. If patients, carepartners, and advocates have not been well represented, the USCDI expansion will not be inclusive of diverse voices nor represent the unmet needs of patients and their families. 
  • When presenting USCDI draft versions for feedback from the public, v2 or future versions moving forward, it would be helpful, on pages 5-14, to see specific examples of how each respective data class and data element is represented using synthetic data.
  • Disability status or need for accessibility support is not captured. Over 61 million (roughly 1 in 4) adults in the United States live with a disability. https://www.cdc.gov/ncbddd/disabilityandhealth/infographic-disability-impacts-all.html#:~:text=61%20million%20adults%20in%20the,is%20highest%20in%20the%20South. If we are going to improve the lives and care of individuals living with disabilities, we must prioritize capturing and sharing this data accordingly.
  • Page 4:  Does not list Data Class "Goals" and Data Element "Patient Goals"; page 8 does.
  • Imaging and pathology are recognized as data elements. Where are surgical/operative reports/notes reflected?
  • It is gravely concerning to see that critical end-of-life care information, such as Advance Directives, Do Not Resuscitate (DNR) orders, Physician Orders for Life-Sustaining Treatment (POLST), are not included in the USCDI draft v2. These are essential to be documented. Throughout the COVID-19 pandemic, we witnessed reports of potential needs to ration care due to surging numbers of COVID-19 positive patients. Many patients with life-altering, life-limiting conditions were strongly encouraged to have their end-of-life wishes documented as a precaution. Pandemic and beyond, it is unethical that end-of-life care information that has the power to actionably communicate an individual's wishes at their end of life not only does not appear in draft v2 but also is only prioritized at level 1. By not including end-of-life care information, such as Advance Directives, DNRs, and POLST, the draft document sends the message that USCDI is prioritizing vendor and billing priorities rather than data elements and data classes that have universal applicability to every human being and doing right by the patient.
  • The element "Diagnostic Imaging Narrative" as a separate entity from "Diagnostic Imaging Report" is unclear and confusing. Diagnostic Imaging Reports often have "Impressions," "Findings," "Summary," or "Observations" noted and should be referred to as such for consistency when discussed in the USCDI work. Impressions, Findings, Summaries, and Observations should not be codified to enable extraction from an imaging report without other essential elements of the respective report as this is not only counterproductive but can cause harm to inpatient care. Elements
  • There are 61 data elements in total listed in USCDI draft v2; 25 data elements (41%)  have no applicable standards listed. Some of these elements are self-explanatory and straightforward, while others have more room for interpretation and are vague, such as Patient's Goals, Date of Resolution, Care Team Members. Applicable, available standards should be assigned, and any remaining vagueness directly addressed so as to avoid amplifying confusion on implementation. The following do not have standards listed as of yet: 
    1. Assessment and Plan of Treatment
    2. Care Team Members
    3. Provider Name
    4. Provider Identifier
    5. Encounter Type
    6. Encounter Time
    7. Patient's Goals
    8. Health Concerns
    9. Values/Results
    10. Laboratory Report Narrative
    11. Pathology Report Narrative
    12. First Name
    13. Last Name
    14. Previous Name
    15. Middle Name
    16. Suffix
    17. Date of Birth
    18. Current Address
    19. Previous Address
    20. Phone Number Type
    21. Email Address
    22. Date of Diagnosis
    23. Date of Resolution
    24. Author Time Stamp
    25. Author Organization

Specific Feedback

Allergies & Intolerance: Many people are allergic to things that are not a medication that they can encounter in a clinical setting, such as latex. This won't have a medication name or drug class.

Assessment & Plan of Treatment: Is this only capturing the clinical treatment plan? Is this capturing social determinants of health (SDoH)? If a health professional is not aware of various prominent barriers a patient is living with, the clinical treatment plan that is documented will fully fail the patient. For example, prescribing an expensive infusion treatment that is not covered by a patient's insurance company may cause significant harm to the patient as treatment is not affordable or accessible. If this is not understood before the patient leaves the clinic, a patient may learn about the treatment being not covered and simply not come back to the clinic and give up. This leads to disease progression and exacerbation of symptoms with the potential for eventually needing emergency room care. By understanding what SDoH factors may negatively impact a clinical treatment plan, adjustments may be made proactively as well as connecting the patient to community support and financial assistance resources. Recommend building a framework to capture elements of social determinants of health (SDoH) for future draft versions for prioritization from level 2.

Care Team Members: Is this only capturing clinical care team members? To be progressive, we must capture and include a patient's primary carepartner, advocate, executor of their estate, personal representative, etc. as the majority of care, especially in the chronic, life-altering, life-limiting settings, happens outside of the four walls of medicine requiring the support of non-clinical care team members. The Care Team Members Data Class and Data Element need more detail in the USCDI draft v2 description on page 6 to clarify ambiguity.

Clinical Notes: Operative notes are critical to patient continuity of care and patient safety. It is important to emphasize that operative notes are one of the only pieces of information that alert patients and their carepartners to the fact that tissue and biological samples may have been harvested during surgery and have been submitted for pathology and/or laboratory analysis. Operative notes need to be included under Clinical Notes in draft v2.

Diagnostic Imaging Narrative: An Imaging Narrative should not be available to be extracted without all the accompanying essential components of the imaging report. The concept of an Imaging Narrative is also unclear. Data Elements should be reflective of the wording used in the real world. An Imaging Narrative is typically referred to as the Findings/Impressions/Summary section of the imaging report and should be referred to as such for consistency.

Immunizations: Essential public health safety, reporting, and information exchange throughout the pandemic & for post-pandemic public health monitoring.

  • Date- Include in draft v2 to monitor COVID19 vaccination doses and potential boosters
  • Type- Consider adding vaccine type (brand/manufacturer) to draft v2 as COVID-19 vaccines requiring at least two doses currently can not be mixed and matched until clinical trial data proves heterologous prime-boost is safe and effective.

Laboratory:

  • Laboratory Report Narrative- It is unclear what exactly a laboratory narrative is. A Laboratory Narrative should not be available to be extracted without all the accompanying essential components of the laboratory report.
  • Pathology Report Narrative- A Pathology Report Narrative should not be available to be extracted without all the accompanying essential components, such as the microscopic analysis and diagnosis, of the laboratory report.
  • Units of Measure- Laboratory values/results must have units of measure included. Draft v2 should include units of measure if Values/Results do not include them.
  • Autopsy Report- This is an essential piece of reporting to bring peace and closure to families grieving the loss of loved ones, as well as essential information for public health and scientific understanding of the COVID-19 pandemic. Draft v2 should include information from autopsy reports

Medications:

  • Dose- This is critical for patient safety, prevention of medication errors, and continuity of care purposes. Draft v2 should include medication dose; add to USCDI v2
  • Prescribed By- Medications often have the most variation and inconsistency in documentation as prescriptions are frequently discontinued for numerous reasons. Patients may have 20+ medications in their medication history but may only be actively currently taking 2 or 3. There is currently no way to flag a medication as discontinued. Patients are frequently told by their care team that if they did not prescribe the medication, they could not delete or remove it from their medication list in the EHR. Medication corrections are a frequent reason for patients wanting to correct their medical records. Inaccurate medication lists upon patient intake, at patient discharge, and in pre-admission for surgery can be tedious/impossible for staff and patients to review and may endanger patient safety. Draft v2 should include information on who prescribed a medication; add to USCDI v2.
  • Status- This is critical for patient safety, prevention of medication errors, and a frequent request for medical record addendums that would be of great importance to address proactively. Draft v2 should include information on whether a medication is active or discontinued. Add to USCDI v2

Problems: Date of Resolution is not broadly applicable to people living with chronic illness, life-altering, life-limiting conditions, disability, rare disease, terminal illness, and active death care and end-of-life. This is a vague data element that can bring great harm to patients should it be documented incorrectly or incompletely. The TF must be conscious of the potentially severe negative impact on patients' lives with respect to matters such as disability benefits should the data element be captured incorrectly or not comprehensively. Recommend removing from USCDI draft v2.

Procedures: Do surgical/operative reports/notes currently fall under this category?

Smoking Status: Tobacco Use more accurately describes the spectrum of individual behavior being captured in a less stigmatizing manner. TF should consider revising the data class and element name to "Tobacco Use".

Other:

  • End of Life Care- End of Life Care is often intentionally distinct from routine care and should be reflected as such. Recommend adding "End of Life Care" as a distinct new data class.
  • Advance Directive- Pandemic and beyond, it is unethical that end-of-life care information that has the power to actionably communicate an individual's wishes at their end of life not only does not appear in draft v2 but also is only prioritized at level 1. By not including end-of-life care information, such as Advance Directives, DNRs, and POLST, the draft document sends the message that USCDI is prioritizing vendor and billing priorities rather than data elements and data classes that have universal applicability to every human being and doing right by the patient. Recommend moving from L1 to draft v2.
  • Blood Type- Blood type is an essential laboratory test that is often repetitively ordered throughout women's lives due to pregnancy and the lives of patients, such as those in need of a transfusion. It would be beneficial to capture this and reduce the need for repeat testing.
  • Coverage Type- Due to the pandemic, millions of individuals have lost health coverage. In order to connect people to public resources as quickly as possible to ensure people have affordable, meaningful access to health care, information on Health Insurance Coverage Type must be prioritized.

 

 

 

 

 

 

 

Kaiser Permanente Comments on USCDI Version 2

Overall Comments

-- Definitions: ONC should more clearly define data elements in the USCDI master document (both USCDI v1 and USCDI v2). ONC does not provide any ‘data dictionary’ reference for data elements.  Also, having no applicable standard reduces the value of the USCDI and creates confusion in how health care organizations interpret each data element.  Thus, we strongly recommend that ONC develop and publish specific, detailed definitions for every data element in the USCDI.  We also recommend that ONC identify applicable standards for elements currently lacking them.  As an example, when implementing USDCI v1, we had trouble interpreting what qualifies as a progress note, what’s required for provenance, and other definitional issues. The USCDI seems to assume there is a common set of terminology used across the industry that is universally understood.  As we discovered, that is not the case.  Being that USCDI is now intended for the masses, it would be great if it could be made easier to use by including definitions.  Organizations shouldn’t have to depend on health care coding experts to understand what is required.

-- Coordination: We are concerned about the relationship among the ONC ISA, the USCDI, and requirements for eHI (electronic health information) into the future. According to final regulations, the USCDI will be superseded by eHI starting October 2022, when it is likely ONC would have issued a Version 3 of the USCDI.  ONC should address the relationship between these newer versions and the eHI.

-- ONDEC submission system improvements and USCDI Portal:  There is valuable information included in the new proposed data classes and data elements (a use case description, estimated number of stakeholders using data element, health care aims, applicable standards, additional specifications). However, all that information seems to get lost when the data element becomes part of the formal USCDI Version.  Additionally, it is worth noting that the URL links of several data classes and data elements in the USCDI portal under “V2” and “Level 2” sections do not work.

-- Submission Evaluation Criteria: ONC and HITAC considered four main criteria to evaluate each of the data classes/data elements submitted for consideration: 1) Maturity of Current Standards; 2) Maturity of Current Use; 3) Maturity of Current Exchange; and 4) Use Cases (# Stakeholders Impacted). The threshold for classifying data classes and data elements as Level 1 or Level 2 is too low. For example, limited production in 1 or 2 systems, or exchange between 2 or 3 organizations with different EHRs will get a data class/element to become classified as Level 1; and in production in more than 2 systems, or exchange between 4 or more organizations with different EHRs would get a data class/element to be classified as Level 2.  Those thresholds should be much higher, particularly for Level 2 elements (as a suggestion, consider for Level 1, Data Classes/Data Elements with limited production in 9 or 10 systems, or exchange between at least 10 organizations with different EHRs; and for Level 2, Data Classes/Data Elements in production in more than 10 systems, or exchange between 11 or more organizations with different EHRs).  We also recommend ONC consider the value of data elements for the end users, including consumers, primarily, but also providers, public health, health plans and others).

-- Recommendations regarding Version 3 submission cycle: We are concerned that the evolution of the USCDI is moving too fast to allow appropriate stakeholder consideration, transition, implementation, and evaluation.  We are also concerned with the possible regulatory adoption of a future version of USCDI and the jump from Version 1 to a Version 3 or Version 4 (as an example) will be quite significant, costly, and unduly burdensome.  Lastly, we are concerned that the new Diagnostic Imaging and Encounter Information data classes will be complex to enable the functionality needed, time consuming and costly.

Question 1 – Was the extent and scope of the proposed change appropriate? 

Changes to USCDI v2

-- New “Diagnostic Imaging” Class and Data Elements:  The data class seems to be appropriate, as it is available from systems.  With respect to the data elements, the difference between Diagnostic Imaging Narrative and Diagnostic Imaging Report is not clear. Thus, we recommend ONC clarify the difference between the two. If there is no difference, ONC should combine these into a single element.

-- New “Encounter Information” Class and Data Elements: We have no concerns about adding this new class; however, we are concerned about the Encounter Type element, as the proposal includes multiple different types of applicable code standards (SNOMED, ICD-10, HL7 Value Set, Discharge Disposition code set, VSAC code set).  Mapping encounter types across organizations will be challenging. For Encounter Time, it will be important to clarify if this will be the start time, length of appointment, scheduled time versus actual time, or scheduled length versus actual length. It will also be important to clarify what does Encounter time look like for Inpatient, ED and Ambulatory.

-- New data elements under “Care Team Member(s)” data class: Under “Provider Identifier” there are two separate and unrelated applicable standards referenced: 1) NPI and 2) Provider Taxonomy.  These two codes refer to two distinct characteristics of providers and should not be combined within a single element.  Also, we want to point out that displaying the correct taxonomy code of a provider will require complex logic, given that many providers have multiple taxonomy codes, due to multiple specialty services they provide.

-- New data elements under “Problems” data class: As we noted above in our overall comments, the data element, “Problem,” does not have a definition that covers both past and current problems.  In many instances, organizations distinguish these; the “Current Problem” list is readily available as having more immediate clinical relevance. It will be important to add a definition to the data element “Problem” and clarify whether it includes past and present conditions.

Level 2 Data Classes and Data Elements

-- We are concerned with the significant expansion of data classes and data elements in the Level 2 category, described as “data classes/elements that demonstrate extensive use in systems and exchange between systems, use cases that show significant value to current and potential users, and would clearly improve nationwide interoperability.”  While some of the classes and elements may be valuable in specific cases, they currently have limited collection, use, and exchange in existing systems (e.g., travel information, social history, social determinants of health, health insurance).

-- We reiterate our concern that all classes and elements should have clear definitions.

Level 1 and Comment Sections

No comments at this time.

Question 2 – Were the right data classes and elements added in the proposed new version? 

-- The two new classes, and the reclassification of certain clinical notes into other classes are appropriate

Question 3 – Are any of the proposed additional data classes, elements, or standards problematic?

-- Our primary concerns are that some elements lack clear definition, and there is no mapping between the applicable standard and the documentation in the electronic system of the organization.  For example, organizations have noted difficulties interpreting what qualifies as a clinical note (a progress note, for example), what is required for provenance, etc.

-- Diagnostic Imaging and Encounter Information Data classes need detailed information for an Organization to implement the technical solution. Current information and standard provided is not enough for achieving a successful implementation.

Question 4 – Are there additional data classes or elements that have been categorized by ONC as Level 2 or even Level 1 that you believe should be added to USCDI V2? 

None at this time.

 

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