USCDI Export for the Public

Type of the event itself in relation to the subject

adverse events are mapped to MedDRA terminology

The suspected agent causing the adverse event

adverse events are mapped to MedDRA terminology

The NIAAA Single-Item Screener is a single question that may be used to screen men and women (separately) for unhealthy alcohol use. It has been validated in primary care settings; the specific language for men and women appears below. Men: How many times in the past year have you had five or more drinks in a day? Women: How many times in the past year have you had four or more drinks in a day?

Most of the requested data elements are in LOINC, as per the codes below. We have requested the addition of the NIAAA Single-Item Screener and the diagnosis of Alcohol Use Disorder to LOINC. AUDIT-C : 72109-2 Ethanol in blood: 5640-8 Ever drink alcohol: 69721-9 Average daily alcohol intake: 74013-4 Alcohol binge episodes/month: 11286-2 Alcohol abuse or dependence: 74043-1 Alcohol help during pregnancy: 64718-0

The AUDIT-C is a three-item measure to screen for alcohol-related problems. Questions and answers include: 1. How often do you have a drink containing alcohol? (Response choices: Never/Monthly or less/2-4 times per month/2-3 times per week/4 or more times per week) 2. How many standard drinks containing alcohol do you have on a typical day? (Response choices: 1-2/3-4/5-6/7-9/10 or more) 3. How often do you have six or more drinks on one occasion? (Response choices: Daily or almost daily/Weekly/Monthly/Less than monthly/Never)

Most of the requested data elements are in LOINC, as per the codes below. We have requested the addition of the NIAAA Single-Item Screener and the diagnosis of Alcohol Use Disorder to LOINC. AUDIT-C : 72109-2 Ethanol in blood: 5640-8 Ever drink alcohol: 69721-9 Average daily alcohol intake: 74013-4 Alcohol binge episodes/month: 11286-2 Alcohol abuse or dependence: 74043-1 Alcohol help during pregnancy: 64718-0

This data element describes whether an individual sought help for alcohol-related problems during pregnancy

Most of the requested data elements are in LOINC, as per the codes below. We have requested the addition of the NIAAA Single-Item Screener and the diagnosis of Alcohol Use Disorder to LOINC. AUDIT-C : 72109-2 Ethanol in blood: 5640-8 Ever drink alcohol: 69721-9 Average daily alcohol intake: 74013-4 Alcohol binge episodes/month: 11286-2 Alcohol abuse or dependence: 74043-1 Alcohol help during pregnancy: 64718-0

Date the claim was adjudicated

NUBC, CPT, HCPCS, HIPPS, ICD-9, ICD-10, DRGs, NDC, POS, NCPDP codes, and X12 codes.

Data State, in context of data lifecycle. States should include: origination (capture, collection), update (from previous content/value), verification (of data sourced by others (e.g., transcriptionist, scribe, student) or from automated device), transformation (e.g., from source system internal representation to exchange artifact (such as HL7 message, CDA document or FHIR resource), from exchange artifact to receiver internal representation). Provenance set includes the who, what, when, where and why as metadata for USCDI data classes and data elements. Data State is part of “what”. Data State must be associated with each USCDI dataset or data element that has a unique provenance set. Occurs when data is originated (captured, collected or sourced), updated, verified, attested, transformed (e.g., to/from exchange artifact such as HL7 v2 message, document or FHIR resource instance). Note that Data State is intrinsic to what the source EHR/HIT system already knows, thus it does not require extra data collection (burden) by the clinician or other end user.

Location where action was taken and/or where dataset or data element was collected (captured, sourced). Location should include room (within) building (within) organization. Provenance set includes the who, what, when, where and why as metadata for USCDI data classes and data elements. Physical Location is part of “where”. Physical Location must be associated with each USCDI dataset or data element that has a unique provenance set. Occurs when data is originated (captured, collected or sourced), updated, verified, attested, transformed (e.g., to/from exchange artifact such as HL7 v2 message, document or FHIR resource instance). Note that Physical Location is intrinsic to what the source EHR/HIT system already knows, thus it does not require extra data collection (burden) by the clinician or other end user.

Network Address where dataset or data element was originated (collected, captured, sourced), updated, verified, attested, transformed... Provenance set includes the who, what, when, where and why as metadata for USCDI data classes and data elements. Network Address is part of “where”. Network Address must be associated with each USCDI dataset or data element that has a unique provenance set. Occurs when data is originated (captured, collected or sourced), updated, verified, attested, transformed (e.g., to/from exchange artifact such as HL7 v2 message, document or FHIR resource instance). Note that Network Address is intrinsic to what the source EHR/HIT system already knows, thus it does not require extra data collection (burden) by the clinician or other end user.

Rationale describes why an action was taken (i.e., the action during which the dataset and/or data element was originated (collected, captured, sourced)). Provenance set includes the who, what, when, where and why as metadata for USCDI data classes and data elements. Rationale is part of “why”. Rationale should be associated with each USCDI dataset or data element that has a unique provenance set. Occurs when action-related data is originated (captured, collected or sourced), updated, verified, attested, transformed (e.g., to/from exchange artifact such as HL7 v2 message, document or FHIR resource instance). Note that Rationale may be intrinsic to what the source EHR/HIT system already knows, thus it will not require extra data collection (burden) by the clinician or other end user.

Purpose of Capture describes why a dataset or data elements were originated (collected, captured, sourced), updated, verified, attested, transformed... Often needed to ensure Purpose of Capture is equivalent or compatible with each potential Purpose of Use. Provenance set includes the who, what, when, where and why as metadata for USCDI data classes and data elements. Purpose of Capture is part of “why”. Purpose of Capture should be associated with each USCDI dataset or data element that has a unique provenance set. Occurs when data is originated (captured, collected or sourced), updated, verified, attested, transformed (e.g., to/from exchange artifact such as HL7 v2 message, document or FHIR resource instance). Note that Purpose of Capture may be intrinsic to what the source EHR/HIT system already knows, thus it will not require extra data collection (burden) by the clinician or other end user.

A Policy tag is the 0..1 component of a Security Label that conforms to follows the HL7 Healthcare Privacy and Security Classification System (HCS), Release 1 syntax to represent the policy governing of the information assigned a Security Label. The policy represented by this code is the authoritative source of the type of information deemed sensitive and the level of confidentiality protection to be provided. Policies may pertain to privacy, security, research, trust, etc., and may be issued by a jurisdiction, an organization, or an individual, e.g., by a consent directive. In addition, the policy may limit the permissible purposes of use, and the obligations and prohibited actions which may be taken by senders and receivers, which are conveyed using other types of tags in the Security Label representing a specific policy. HL7 recommends creating a value set of Policy codes to value the Policy tag, which are specific to priority US policies as discussed in the HL7 Cross-Paradigm US Regulatory Security Labeling Implementation Guide, which is under development. For example, the US Controlled Unclassified Information (CUI) policy 32 CFR Part 2002, established the executive branch’s CUI Program, policy for designating, handling, and decontrolling information that qualifies as CUI, and the security mechanisms by which the confidentiality of CUI is enforced. This rule affects Federal executive branch agencies that handle CUI and all organizations (sources) that handle, possess, use, share, or receive CUI—or which operate, use, or have access to Federal information and information systems on behalf of an agency. https://www.archives.gov/cui/about As a result, most entities exchanging health information in the US will likely either mark CUI or receive CUI, and will be required to comply with this regulation. CUI exchanged using HL7 standards will need to indicate that the recipient must comply with this regulation using a security label with a Policy tag for 32 CFR Part 2002. HL7 Cross Paradigm US Security Labeling IG is under development to standardize CUI labeling for use with HL7 Version 2, CDA, and FHIR specifications. For Policy codes used to populate Security Label Policy tags, see HL7 PolicyType value set at: https://build.fhir.org/ig/HL7/UTG/ValueSet-v3-ActPolicyType.html

HL7 v3 code systems and value sets, and HL7 standards listed in the Data Elements above, and discussed in the use cases. All be the Cross Paradigm for US Regulatory Security Labeling, FHIR US Regulatory Security Labeling IG, and the FHIR DS4P IG are normative.

A Refrain tag is the 0..* component of a Security Label that conforms to follows the HL7 Healthcare Privacy and Security Classification System (HCS), Release 1 syntax to convey a prohibited action that an information custodian, receiver, or user must not perform. For HL7 Refrain tags see the Refrain value set at: https://build.fhir.org/ig/HL7/UTG/ValueSet-v3-RefrainPolicy.html

HL7 v3 code systems and value sets, and HL7 standards listed in the Data Elements above, and discussed in the use cases. All be the Cross Paradigm for US Regulatory Security Labeling, FHIR US Regulatory Security Labeling IG, and the FHIR DS4P IG are normative.

An Obligation tag is the 0..* component of a Security Label that conforms to follows the HL7 Healthcare Privacy and Security Classification System (HCS), Release 1 syntax to convey the mandated action that an information custodian, receiver, or user must perform. For HL7 Obligation tags see ObligationPolicy at: https://build.fhir.org/ig/HL7/UTG/ValueSet-v3-ObligationPolicy.html

HL7 v3 code systems and value sets, and HL7 standards listed in the Data Elements above, and discussed in the use cases. All be the Cross Paradigm for US Regulatory Security Labeling, FHIR US Regulatory Security Labeling IG, and the FHIR DS4P IG are normative.

A Sensitivity tag is the 0..* component of a Security Label that conforms to the HL7 Healthcare Privacy and Security Classification System (HCS), Release 1 syntax to represent the type of information deemed by policy to require a specified level of Confidentiality protection. HL7 recommends creating a value set of Sensitivity codes to value the Sensitivity tag, which are specific to priority US policies as discussed in the HL7 Cross-Paradigm US Regulatory Security Labeling Implementation Guide, which is under development. For HL7 v3 Sensitivity codes see _ActInformationSensitivityPolicy in the ActCode value set. For background on the use of Sensitivity codes, see Sensitive Information Security Label Privacy Tag Used if required by governing policy in HL7 Implementation Guide: Data Segmentation for Privacy (DS4P), Release 1, in the HL7 Version 2.9 BHS, FHS, MSH, and ARV Segments, and in the FHIR Data Segmentation for Privacy IG.

HL7 v3 code systems and value sets, and HL7 standards listed in the Data Elements above, and discussed in the use cases. All be the Cross Paradigm for US Regulatory Security Labeling, FHIR US Regulatory Security Labeling IG, and the FHIR DS4P IG are normative.

Data element capturing the refugee status of a patient

Veteran Status: Z56.82 Military deployment status Farmworker Status: ICD: Z57.2 Occupational exposure to dust Z57.3 Occupational exposure to other air contaminants Z57.4 Occupational exposure to toxic agents in agriculture Z57.6 Occupational exposure to extreme temperature Z57.8 Occupational exposure to other risk factors Agricultural/animal husbandry worker (occupation) - SNOMED: 106390009 Refugee Status: Refugee family (social concept) - SNOMED: 413323004 Refugee (person) - SNOMED: 446654005 Are you a refugee? - LOINC: 93027-1 Refugee - LOINC: LA29153-6

Data element capturing seasonal or migrant farm work status.

Veteran Status: Z56.82 Military deployment status Farmworker Status: ICD: Z57.2 Occupational exposure to dust Z57.3 Occupational exposure to other air contaminants Z57.4 Occupational exposure to toxic agents in agriculture Z57.6 Occupational exposure to extreme temperature Z57.8 Occupational exposure to other risk factors Agricultural/animal husbandry worker (occupation) - SNOMED: 106390009 Refugee Status: Refugee family (social concept) - SNOMED: 413323004 Refugee (person) - SNOMED: 446654005 Are you a refugee? - LOINC: 93027-1 Refugee - LOINC: LA29153-6

Military service in the armed forces of the United States or other nations, including the length and branch of service, the military occupation, the location and type of duty (e.g., in the United States or abroad with combat, combat support, or noncombat duties), and any ongoing illness, injury, limitation, or disability that began during military service. (Institute of Medicine, Capturing Social and Behavioral Domains in Electronic Health Records, Phase 2, p. 297 (2014).)

Yes, a vocabulary/terminology standard and/or technical specification exists for each proposed data element. The Gravity Project attaches a letter with an overview. For (1) Food Insecurity: LOINC, SNOMED-CT, ICD-10-CM, and CPT/HCPCS terminologies are specified by value set in NLM’s Value Set Authority Center (VSAC). For (2) Housing Instability and Homelessness, (3) Inadequate Housing, (4) Transportation Insecurity, (5), Financial Strain, (6) Social Isolation, (7) Stress, (8) Interpersonal Violence, (9) Education, (10) Employment, and (11) Veteran Status: • The corresponding value sets are under development by the Gravity Project; • The value sets will be complete prior to publishing of USCDI v2.0; • Even if a particular value set might be incomplete, the value set will be citable. The technical specifications for value sets under each data element are described below: • Assessments: LOINC • Health Concerns/Problems/Diagnoses: SNOMED-CT, ICD-10-CM • Goals: LOINC • Procedures/Interventions: SNOMED-CT (clinical), CPT/HCPCS (billing) • Outcomes: LOINC (NCQA measures) • Consent (where needed): based on existing HL7 code systems

The area of social risk documented for a patient (e.g., housing insecurity, alcohol use, transportation security). When exchanging a domain, the following constituent data components should be included: - Source/Assessment: The specific survey, questionnaire, or question set(s) used to calculate the patient’s risk value for the domain, if applicable. If a particular assessment was not used to calculate the patient’s risk value, just the risk value may be exchanged. - Risk Value: The category of risk that applies to a patient for the domain (e.g., “high risk,” “moderate risk,” “low risk,” or “unknown”). - Date: The date the assessment was completed.

LOINC can be used to express a number of assessments used to evaluate a patient’s social determinants of health. SNOMED CT can be used to document a clinical observation stemming from an assessment when it is appropriate.

Medicare Beneficiary Identifiers (MBI) used to uniquely identify Medicare patients.

MBI format specifications: https://www.cms.gov/Medicare/New-Medicare-Card/Understanding-the-MBI.pdf HL7 Identifier type value set, see MC (http://hl7.org/fhir/R4/v2/0203/index.html)