ASTP Standards Bulletin 2022-2

ONC Standards Bulletin 2022-2 (SB22-2) discusses the development and finalization of the latest version of the United States Core Data for Interoperability (USCDI), Version 3 (USCDI v3), which was released on July 19, 2022. Stakeholders across the healthcare system benefit from the USCDI, which sets the technical foundation for the access, exchange, and use of electronic health information to support patient care. The USCDI defines the baseline set of data to inform interoperable implementations for stakeholders such as federal agencies supporting health and health care, hospitals, research organizations, clinician offices, and software developers. ONC updates the USCDI annually to keep pace with medical, technology, and policy changes.

SB22-2 describes ONC’s continued expansion of USCDI, including the prioritization approach for USCDI Version 4. This bulletin reflects ONC’s consideration of stakeholder feedback and the ONC Health IT Advisory Committee (HITAC) recommendations on Draft USCDI v3 released in January 2022.

What’s New in USCDI v3

Building on USCDI v2, USCDI v3 added 24 data elements across the following data classes: Health Insurance Information, Health Status/Assessments, Laboratory, Medications, Patient Demographics/Information, and Procedures.

Medications Data Elements

ONC received significant input during USCDI v3’s public feedback cycle urging ONC to add medication- related data elements to the existing data class in USCDI v3, even though they were not part of Draft USCDI v3. In response to this input, we evaluated level 2 classified data elements and added Dose, Dose Unit of Measure, Indication, and Fill Status to the Medications data class. The additional data elements are necessary for certain CMS reporting programs and are also required elements in ONC certification criteria, including electronic prescribing. Additionally, we added National Drug Codes (NDC) as an optional terminology for the Medications data element.

Health Status/Assessments Data Elements

USCDI Draft v3 included a new data class, Health Status. In response to stakeholder input to make the description/scope of this data class clearer and more representative of the types of data that could be included, USCDI v3 refers to this data class as Health Status/Assessments. This new data class represents assessments of health-related matters performed during care that could identify a need or problem. The new data elements in this data class are Disability Status, Mental/Cognitive Status (Mental Status in Draft v3), Functional Status, and Pregnancy Status. Pregnancy Status is of particular importance to those who provide care for women who may be or seek to become pregnant. It is also a substantive data element for lab testing and public health reporting, as noted by ONC’s prior federal advisory committees.[1] The Health Status/Assessments data class provides a broader context than the USCDI v2 Health Concerns data class, therefore we also moved Health Concerns into this new data class.

Health Insurance Information Data Elements

USCDI v3 also includes a new data class Health Insurance Information, which provides an opportunity for health IT (not just electronic health record systems) to capture and exchange key health care insurance coverage information in a consistent and standardized way. This data class includes seven new elements: Coverage Status, Relationship to Subscriber, Member Identifier, Subscriber Identifier, Payer Identifier, Group Identifier, and Coverage Type. We received feedback that Coverage Type may be based on the setting and type of care provided, and we call on stakeholders to identify an applicable vocabulary standard.

Laboratory Data Elements

To address public health reporting priorities, especially those identified during the COVID-19 pandemic, ONC added Specimen Type and Result Status to the Laboratory data class.

Patient Demographics/Information Data Elements

ONC also received feedback that over time data elements in the Patient Demographics data class had expanded beyond just purely demographics. To address this feedback, we have changed the data class’s name to Patient Demographics/Information. In addition, ONC added seven new data elements to the Patient Demographics/Information data class. Related Person’s Name and Related Person’s Relationship enable linkages between maternal and child records as well as identifying other related persons, such as custodians and guardians. Date of Death supports patient matching, adverse events, public health, and vital records reporting. Occupation and Occupation Industry were added to support public health and to capture military service. Finally, Tribal Affiliation, is extensively captured by the U.S. Indian Health Service to aid in determination of eligibility for IHS services, and care-coordination with non-tribal medical facilities.

Procedures Data Element

ONC added Reason for Referral to the Procedure data class, as this data element is already part of the Certification Program requirements for Transitions of Care and is broadly implemented in health IT. We also clarified through the data class definition and scope that Reason for Referral is used in referrals and consultations and is not intended to represent the clinical indication for procedures. This concept is captured by problems or encounter diagnosis.

Vital Signs Data Element

We also changed the Vital Signs data element, Weight-for-Length Percentile, from “Birth – 36 Months” to “Birth – 24 Months.” This change reflects input from the standards, clinical, and pediatric health care communities that Weight-for-Length Percentile is not used after 24 months of age. BMI Percentile (2 – 20 Years) is used after 24 months of age. Changing the age range of Weight-for-Length Percentile does not change the way it is used.

Other Updates Within USCDI v3

To address the need for flexibility in the way certain data elements are represented in health IT, and the rapidly changing terminology landscape around these data elements, ONC removed the references to specific value sets and codes. Instead, where appropriate, we replaced these value sets and codes with applicable vocabulary standards and will continue to use the Interoperability Standards Advisory to identify value sets or code sets that may be helpful for developers and implementers. We also updated the applicable vocabulary standards for data elements to their latest published versions and clarified the definitions and scope of many data elements to assist with implementation.

Based on ongoing standards development, we made updates to the definition for Discharge Summary Note to include admission and discharge dates and locations, discharge instructions, and reason(s) for admission. We expect the implementation burden to be minimal because this data is required in the Transitions of Care, and View, Download and Transmit to 3rd Party Certification Criteria.

Addressing Draft USCDI v3 Request for Feedback

When ONC published Draft USCDI v3 in January 2022, we asked the public to provide feedback on several existing data elements in USCDI.

We also requested input on Current Address and Previous Address and whether ONC should use the new Project US@ Technical Specification for Patient Addresses Final Version 1.0 as the applicable standard. US@ is a result of collaboration across standards development organizations and other stakeholders to develop the technical specification and a companion guide for patient address standardization. ONC received a significant amount of support for this and has defined US@ as the applicable vocabulary standard for Current Address and Previous Address in the Patient Demographics/Information data class. We believe this new standard will advance the quality and safety of patient addresses and has the potential for use in other address-related data elements in the future.

USCDI v4 Submission Period

ONC is now accepting new submissions for data classes and data elements to be considered for inclusion in the next version of USCDI, Version 4 (USCDI v4). After reviewing the USCDI website for data classes and elements that may already meet their needs, anyone can submit new data classes or elements using the ONC New Data Element and Class Submission System (ONDEC). Submitters can see how ONC evaluates new submissions using the USCDI ONDEC Submission Prep Sheet as a guide. ONC evaluates all submissions based on published leveling criteria and notifies submitters of the level of technical maturity (Comment, Level 1, or Level 2) their submissions received or if any additional information is needed. The submission period for USCDI v4 ends Friday, September 30, 2022, at 11:59pm ET.

ONC encourages stakeholders to engage and collaborate to submit comments and additional information for data elements previously submitted that are not included in USCDI v3. Additional information provided by commenters may lead to some data elements being promoted to a higher level of maturity and readiness (Level 1 or Level 2) and consideration by ONC for inclusion in USCDI v4 or future versions.