Consolidated CDA Release 2.1 StructureDefinition Publication
2.1 - CI Build United States of America flag

Consolidated CDA Release 2.1 StructureDefinition Publication, published by Health Level Seven. This is not an authorized publication; it is the continuous build for version 2.1). This version is based on the current content of https://github.com/HL7/CDA-ccda-2.1-sd/ and changes regularly. See the Directory of published versions

Logical Model: Brand Name Observation

Official URL: http://hl7.org/cda/us/ccda/StructureDefinition/BrandNameObservation Version: 2.1
Draft as of 2023-09-29 Computable Name: BrandNameObservation
Other Identifiers: id: urn:hl7ii:2.16.840.1.113883.10.20.22.4.301:2019-06-21

This template is intended to be used in addition to the Product Instance template urn:oid:2.16.840.1.113883.10.20.22.4.37 to exchange the Brand Name. The UDI-DI of the medical device may be used to retrieve the Brand Name in accessGUDID, which should be considered the source of truth.

Usage:

  • This Logical Model is not used by any profiles in this Implementation Guide

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from CDAR2.Observation

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 1..1CDAR2.ObservationXML Namespace: urn:hl7-org:v3
Elements defined in Ancestors: @classCode, @moodCode, @negationInd, realmCode, typeId, templateId, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, referenceRange
Base for all types and resources
... templateId 1..1II
.... root 1..1oid, uuid, ruidtemplate oid
Required Pattern: 2.16.840.1.113883.10.20.22.4.301
.... extension 1..1stRequired Pattern: 2019-06-21
... code 1..1CDCode for "Device Brand Name"
.... code 1..1csRequired Pattern: C71898
.... codeSystem 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.3.26.1.1
.... codeSystemName 0..1stRequired Pattern: NCI Thesaurus
.... displayName 0..1stRequired Pattern: Brand Name
... value 1..1ED

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 1..1CDAR2.ObservationXML Namespace: urn:hl7-org:v3
Elements defined in Ancestors: @classCode, @moodCode, @negationInd, realmCode, typeId, templateId, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, referenceRange
Base for all types and resources
... @classCode 1..1csBinding: ActClassObservation (required)
... @moodCode 1..1cs
... templateId 1..1II
.... @root 1..1oid, uuid, ruidtemplate oid
Required Pattern: 2.16.840.1.113883.10.20.22.4.301
.... @extension 1..1stRequired Pattern: 2019-06-21
.... @code 1..1csRequired Pattern: C71898
.... @codeSystem 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.3.26.1.1
.... @codeSystemName 0..1stRequired Pattern: NCI Thesaurus
.... @displayName 0..1stRequired Pattern: Brand Name
... value 1..1ED

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
Observation.classCoderequiredActClassObservation
Observation.codeextensibleObservationType

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 1..1CDAR2.ObservationXML Namespace: urn:hl7-org:v3
Elements defined in Ancestors: @classCode, @moodCode, @negationInd, realmCode, typeId, templateId, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, referenceRange
Base for all types and resources
... @classCode 1..1csBinding: ActClassObservation (required)
... @moodCode 1..1cs
... @negationInd 0..1bl
... realmCode 0..*CS
... typeId 0..1II
... templateId 1..1II
.... @nullFlavor 0..1csBinding: NullFlavor (required)
.... @assigningAuthorityName 0..1st
.... @displayable 0..1bl
.... @root 1..1oid, uuid, ruidtemplate oid
Required Pattern: 2.16.840.1.113883.10.20.22.4.301
.... @extension 1..1stRequired Pattern: 2019-06-21
... id 0..*II
... code 1..1CDCode for "Device Brand Name"
Binding: ObservationType (extensible)
.... @nullFlavor 0..1csBinding: NullFlavor (required)
.... @code 1..1csRequired Pattern: C71898
.... @codeSystem 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.3.26.1.1
.... @codeSystemName 0..1stRequired Pattern: NCI Thesaurus
.... @codeSystemVersion 0..1st
.... @displayName 0..1stRequired Pattern: Brand Name
.... @sdtcValueSet 0..1oidXML Namespace: urn:hl7-org:sdtc
XML: valueSet (urn:hl7-org:sdtc)
.... @sdtcValueSetVersion 0..1stXML Namespace: urn:hl7-org:sdtc
XML: valueSetVersion (urn:hl7-org:sdtc)
.... originalText 0..1ED
.... qualifier 0..*CR
.... translation 0..*CD
... derivationExpr 0..1ST
... text 0..1ED
... statusCode 0..1CSBinding: ActStatus (required)
... effectiveTime 0..1IVL_TS
... priorityCode 0..1CEBinding: ActPriority (extensible)
... repeatNumber 0..1IVL_INT
... languageCode 0..1CSBinding: HumanLanguage (required)
... value 1..1ED
... interpretationCode 0..*CEBinding: ObservationInterpretation (required)
... methodCode 0..*CEBinding: ObservationMethod (extensible)
... targetSiteCode 0..*CD
... subject 0..1Subject
... specimen 0..*Specimen
... performer 0..*Performer2
... author 0..*Author
... informant 0..*Informant
... participant 0..*Participant2
... entryRelationship 0..*EntryRelationship
... reference 0..*Reference
... precondition 0..*Precondition
... referenceRange 0..*InfrastructureRoot
.... @nullFlavor 0..1csBinding: NullFlavor (required)
.... realmCode 0..*CS
.... typeId 0..1II
.... templateId 0..*II
.... @typeCode 0..1csBinding: ActRelationshipPertains (required)
Fixed Value: REFV
.... observationRange 1..1ObservationRange

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
Observation.classCoderequiredActClassObservation
Observation.templateId.nullFlavorrequiredNullFlavor
Observation.codeextensibleObservationType
Observation.code.nullFlavorrequiredNullFlavor
Observation.statusCoderequiredActStatus
Observation.priorityCodeextensibleActPriority
Observation.languageCoderequiredHumanLanguage (a valid code from http://terminology.hl7.org/CodeSystem/ietf3066)
Observation.interpretationCoderequiredObservationInterpretation
Observation.methodCodeextensibleObservationMethod
Observation.referenceRange.nullFlavorrequiredNullFlavor
Observation.referenceRange.typeCoderequiredFixed Value: REFV

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())

This structure is derived from CDAR2.Observation

Summary

Mandatory: 6 elements

Differential View

This structure is derived from CDAR2.Observation

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 1..1CDAR2.ObservationXML Namespace: urn:hl7-org:v3
Elements defined in Ancestors: @classCode, @moodCode, @negationInd, realmCode, typeId, templateId, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, referenceRange
Base for all types and resources
... templateId 1..1II
.... root 1..1oid, uuid, ruidtemplate oid
Required Pattern: 2.16.840.1.113883.10.20.22.4.301
.... extension 1..1stRequired Pattern: 2019-06-21
... code 1..1CDCode for "Device Brand Name"
.... code 1..1csRequired Pattern: C71898
.... codeSystem 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.3.26.1.1
.... codeSystemName 0..1stRequired Pattern: NCI Thesaurus
.... displayName 0..1stRequired Pattern: Brand Name
... value 1..1ED

doco Documentation for this format

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 1..1CDAR2.ObservationXML Namespace: urn:hl7-org:v3
Elements defined in Ancestors: @classCode, @moodCode, @negationInd, realmCode, typeId, templateId, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, referenceRange
Base for all types and resources
... @classCode 1..1csBinding: ActClassObservation (required)
... @moodCode 1..1cs
... templateId 1..1II
.... @root 1..1oid, uuid, ruidtemplate oid
Required Pattern: 2.16.840.1.113883.10.20.22.4.301
.... @extension 1..1stRequired Pattern: 2019-06-21
.... @code 1..1csRequired Pattern: C71898
.... @codeSystem 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.3.26.1.1
.... @codeSystemName 0..1stRequired Pattern: NCI Thesaurus
.... @displayName 0..1stRequired Pattern: Brand Name
... value 1..1ED

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
Observation.classCoderequiredActClassObservation
Observation.codeextensibleObservationType

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 1..1CDAR2.ObservationXML Namespace: urn:hl7-org:v3
Elements defined in Ancestors: @classCode, @moodCode, @negationInd, realmCode, typeId, templateId, id, code, derivationExpr, text, statusCode, effectiveTime, priorityCode, repeatNumber, languageCode, value, interpretationCode, methodCode, targetSiteCode, subject, specimen, performer, author, informant, participant, entryRelationship, reference, precondition, referenceRange
Base for all types and resources
... @classCode 1..1csBinding: ActClassObservation (required)
... @moodCode 1..1cs
... @negationInd 0..1bl
... realmCode 0..*CS
... typeId 0..1II
... templateId 1..1II
.... @nullFlavor 0..1csBinding: NullFlavor (required)
.... @assigningAuthorityName 0..1st
.... @displayable 0..1bl
.... @root 1..1oid, uuid, ruidtemplate oid
Required Pattern: 2.16.840.1.113883.10.20.22.4.301
.... @extension 1..1stRequired Pattern: 2019-06-21
... id 0..*II
... code 1..1CDCode for "Device Brand Name"
Binding: ObservationType (extensible)
.... @nullFlavor 0..1csBinding: NullFlavor (required)
.... @code 1..1csRequired Pattern: C71898
.... @codeSystem 1..1oid, uuid, ruidRequired Pattern: 2.16.840.1.113883.3.26.1.1
.... @codeSystemName 0..1stRequired Pattern: NCI Thesaurus
.... @codeSystemVersion 0..1st
.... @displayName 0..1stRequired Pattern: Brand Name
.... @sdtcValueSet 0..1oidXML Namespace: urn:hl7-org:sdtc
XML: valueSet (urn:hl7-org:sdtc)
.... @sdtcValueSetVersion 0..1stXML Namespace: urn:hl7-org:sdtc
XML: valueSetVersion (urn:hl7-org:sdtc)
.... originalText 0..1ED
.... qualifier 0..*CR
.... translation 0..*CD
... derivationExpr 0..1ST
... text 0..1ED
... statusCode 0..1CSBinding: ActStatus (required)
... effectiveTime 0..1IVL_TS
... priorityCode 0..1CEBinding: ActPriority (extensible)
... repeatNumber 0..1IVL_INT
... languageCode 0..1CSBinding: HumanLanguage (required)
... value 1..1ED
... interpretationCode 0..*CEBinding: ObservationInterpretation (required)
... methodCode 0..*CEBinding: ObservationMethod (extensible)
... targetSiteCode 0..*CD
... subject 0..1Subject
... specimen 0..*Specimen
... performer 0..*Performer2
... author 0..*Author
... informant 0..*Informant
... participant 0..*Participant2
... entryRelationship 0..*EntryRelationship
... reference 0..*Reference
... precondition 0..*Precondition
... referenceRange 0..*InfrastructureRoot
.... @nullFlavor 0..1csBinding: NullFlavor (required)
.... realmCode 0..*CS
.... typeId 0..1II
.... templateId 0..*II
.... @typeCode 0..1csBinding: ActRelationshipPertains (required)
Fixed Value: REFV
.... observationRange 1..1ObservationRange

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
Observation.classCoderequiredActClassObservation
Observation.templateId.nullFlavorrequiredNullFlavor
Observation.codeextensibleObservationType
Observation.code.nullFlavorrequiredNullFlavor
Observation.statusCoderequiredActStatus
Observation.priorityCodeextensibleActPriority
Observation.languageCoderequiredHumanLanguage (a valid code from http://terminology.hl7.org/CodeSystem/ietf3066)
Observation.interpretationCoderequiredObservationInterpretation
Observation.methodCodeextensibleObservationMethod
Observation.referenceRange.nullFlavorrequiredNullFlavor
Observation.referenceRange.typeCoderequiredFixed Value: REFV

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())

This structure is derived from CDAR2.Observation

Summary

Mandatory: 6 elements

 

Other representations of profile: CSV, Excel