Consolidated CDA (C-CDA)
4.0.0 - STU4 United States of America flag

This page is part of the CCDA: Consolidated CDA Release (v4.0.0: CCDA 4.0) generated with FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Logical Model: Product Instance

Official URL: http://hl7.org/cda/us/ccda/StructureDefinition/ProductInstance Version: 4.0.0
Draft as of 2025-06-20 Computable Name: ProductInstance
Other Identifiers: OID:2.16.840.1.113883.10.20.22.4.37

This clinical statement represents a particular device that was placed in a patient or used as part of a procedure or other act. This provides a record of the identifier and other details about the given product that was used. For example, it is important to have a record that indicates not just that a hip prostheses was placed in a patient but that it was a particular hip prostheses number with a unique identifier.

The FDA Amendments Act specifies the creation of a Unique Device Identification (UDI) System that requires the label of devices to bear a unique identifier that will standardize device identification and identify the device through distribution and use.

The FDA permits an issuing agency to designate that their Device Identifier (DI) + Production Identifier (PI) format qualifies as a UDI through a process of accreditation. Currently, there are three FDA-accredited issuing agencies that are allowed to call their format a UDI. These organizations are GS1, HIBCC, and ICCBBA. For additional information on technical formats that qualify as UDI from each of the issuing agencies see the UDI Appendix.

When communicating only the issuing agency device identifier (i.e., subcomponent of the UDI), the use of the issuing agency OID is appropriate. However, when communicating the unique device identifier (DI + PI), the FDA OID (2.16.840.1.113883.3.3719) must be used. When sending a UDI, populate the participantRole/id/@root with the FDA OID (2.16.840.1.113883.3.3719) and participantRole/id/@extension with the UDI.

When sending a DI, populate the participantRole/id/@root with the appropriate assigning agency OID and participantRole/id/@extension with the DI. The scopingEntity/id should correspond to FDA or the appropriate issuing agency.

Usages:

Changes since version 3.0.0:

  • No changes

    • Formal Views of Template Content

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

    This structure is derived from ParticipantRole

    NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
    .. ParticipantRole ParticipantRole XML Namespace: urn:hl7-org:v3
    Elements defined in Ancestors:@nullFlavor, realmCode, typeId, templateId, @classCode, id, sdtcIdentifiedBy, code, addr, telecom, playingDevice, playingEntity, scopingEntity
    Instance of this type are validated by templateId
    Logical Container: ClinicalDocument (CDA Class)
    ... Slices for templateId 1..* II Slice: Unordered, Open by value:root
    .... templateId:product-instance 1..1 II
    ..... @root 1..1 oid, uuid, ruid Required Pattern: 2.16.840.1.113883.10.20.22.4.37
    ..... @extension 0..0
    ... @classCode 1..1 cs Fixed Value: MANU
    ... id 1..* II
    .... code 0..1 CE
    ... scopingEntity 1..1 Entity
    .... id 1..* II

    doco Documentation for this format

    Constraints

    IdGradePath(s)DetailsRequirements
    should-codewarningParticipantRole.playingDeviceSHOULD contain code
    : code.exists()
    NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
    .. ParticipantRole C 1..1 ParticipantRole XML Namespace: urn:hl7-org:v3
    Elements defined in Ancestors:@nullFlavor, realmCode, typeId, templateId, @classCode, id, sdtcIdentifiedBy, code, addr, telecom, playingDevice, playingEntity, scopingEntity
    Base for all types and resources
    Instance of this type are validated by templateId
    Logical Container: ClinicalDocument (CDA Class)
    Constraints: role-choice
    ... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    ... realmCode 0..* CS
    ... typeId C 0..1 II Constraints: II-1
    .... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    .... @assigningAuthorityName 0..1 st
    .... @displayable 0..1 bl
    .... @root 1..1 oid, uuid, ruid Fixed Value: 2.16.840.1.113883.1.3
    .... @extension 1..1 st
    .... templateId:product-instance 1..1 II
    ..... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    ..... @assigningAuthorityName 0..1 st
    ..... @displayable 0..1 bl
    ..... @root 1..1 oid, uuid, ruid Required Pattern: 2.16.840.1.113883.10.20.22.4.37
    ... @classCode 1..1 cs Binding: CDARoleClassRoot (required)
    Fixed Value: MANU
    ... id 1..* II
    ... sdtcIdentifiedBy 0..* IdentifiedBy XML Namespace: urn:hl7-org:sdtc
    XML: identifiedBy (urn:hl7-org:sdtc)
    ... code 0..1 CE Binding: CDARoleCode (example)
    ... addr 0..* AD
    ... telecom 0..* TEL
    ... (Choice of one) 0..1
    .... playingDevice C 1..1 Device Constraints: should-code
    ..... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    ..... realmCode 0..* CS
    ..... typeId C 0..1 II Constraints: II-1
    ...... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    ...... @assigningAuthorityName 0..1 st
    ...... @displayable 0..1 bl
    ...... @root 1..1 oid, uuid, ruid Fixed Value: 2.16.840.1.113883.1.3
    ...... @extension 1..1 st
    ..... templateId 0..* II
    ..... @classCode 0..1 cs Binding: EntityClassDevice (required)
    ..... @determinerCode 0..1 cs Binding: EntityDeterminer (required)
    Fixed Value: INSTANCE
    ..... code 0..1 CE Binding: CDAEntityCode (example)
    ..... manufacturerModelName 0..1 SC Binding: Manufacturer Model Name Example (example)
    ..... softwareName 0..1 SC Binding: Software Name Example (example)
    .... playingEntity 0..1 PlayingEntity
    ... scopingEntity 1..1 Entity
    .... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    .... realmCode 0..* CS
    .... typeId C 0..1 II Constraints: II-1
    ..... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    ..... @assigningAuthorityName 0..1 st
    ..... @displayable 0..1 bl
    ..... @root 1..1 oid, uuid, ruid Fixed Value: 2.16.840.1.113883.1.3
    ..... @extension 1..1 st
    .... templateId 0..* II
    .... @classCode 0..1 cs Binding: EntityClassRoot (required)
    .... @determinerCode 0..1 cs Binding: EntityDeterminer (required)
    Fixed Value: INSTANCE
    .... id 1..* II
    .... code 0..1 CE Binding: CDAEntityCode (example)
    .... desc 0..1 ED

    doco Documentation for this format

    Terminology Bindings

    PathConformanceValueSet / CodeURI
    ParticipantRole.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    ParticipantRole.typeId.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    ParticipantRole.templateId:product-instance.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    ParticipantRole.classCoderequiredFixed Value: MANU
    http://hl7.org/cda/stds/core/ValueSet/CDARoleClassRoot
    ParticipantRole.codeexampleCDARoleCode
    http://hl7.org/cda/stds/core/ValueSet/CDARoleCode
    ParticipantRole.playingDevice.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    ParticipantRole.playingDevice.typeId.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    ParticipantRole.playingDevice.classCoderequiredEntityClassDevice
    http://terminology.hl7.org/ValueSet/v3-EntityClassDevice
    ParticipantRole.playingDevice.determinerCoderequiredFixed Value: INSTANCE
    http://terminology.hl7.org/ValueSet/v3-EntityDeterminer
    ParticipantRole.playingDevice.codeexampleCDAEntityCode
    http://hl7.org/cda/stds/core/ValueSet/CDAEntityCode
    ParticipantRole.playingDevice.manufacturerModelNameexampleManufacturerModelNameExample
    http://terminology.hl7.org/ValueSet/v3-ManufacturerModelNameExample
    ParticipantRole.playingDevice.softwareNameexampleSoftwareNameExample
    http://terminology.hl7.org/ValueSet/v3-SoftwareNameExample
    ParticipantRole.scopingEntity.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    ParticipantRole.scopingEntity.typeId.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    ParticipantRole.scopingEntity.classCoderequiredEntityClassRoot
    http://terminology.hl7.org/ValueSet/v3-EntityClassRoot
    ParticipantRole.scopingEntity.determinerCoderequiredFixed Value: INSTANCE
    http://terminology.hl7.org/ValueSet/v3-EntityDeterminer
    ParticipantRole.scopingEntity.codeexampleCDAEntityCode
    http://hl7.org/cda/stds/core/ValueSet/CDAEntityCode

    Constraints

    IdGradePath(s)DetailsRequirements
    II-1errorParticipantRole.typeId, ParticipantRole.playingDevice.typeId, ParticipantRole.scopingEntity.typeIdAn II instance must have either a root or an nullFlavor.
    : root.exists() or nullFlavor.exists()
    role-choiceerrorParticipantRoleplayingDevice and playingEntity are mutually exclusive
    : (playingDevice | playingEntity).count() <= 1
    should-codewarningParticipantRole.playingDeviceSHOULD contain code
    : code.exists()
    NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
    .. ParticipantRole C 1..1 ParticipantRole XML Namespace: urn:hl7-org:v3
    Elements defined in Ancestors:@nullFlavor, realmCode, typeId, templateId, @classCode, id, sdtcIdentifiedBy, code, addr, telecom, playingDevice, playingEntity, scopingEntity
    Base for all types and resources
    Instance of this type are validated by templateId
    Logical Container: ClinicalDocument (CDA Class)
    Constraints: role-choice
    ... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    ... realmCode 0..* CS
    ... typeId C 0..1 II Constraints: II-1
    .... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    .... @assigningAuthorityName 0..1 st
    .... @displayable 0..1 bl
    .... @root 1..1 oid, uuid, ruid Fixed Value: 2.16.840.1.113883.1.3
    .... @extension 1..1 st
    .... templateId:product-instance 1..1 II
    ..... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    ..... @assigningAuthorityName 0..1 st
    ..... @displayable 0..1 bl
    ..... @root 1..1 oid, uuid, ruid Required Pattern: 2.16.840.1.113883.10.20.22.4.37
    ... @classCode 1..1 cs Binding: CDARoleClassRoot (required)
    Fixed Value: MANU
    ... id 1..* II
    ... sdtcIdentifiedBy 0..* IdentifiedBy XML Namespace: urn:hl7-org:sdtc
    XML: identifiedBy (urn:hl7-org:sdtc)
    ... code 0..1 CE Binding: CDARoleCode (example)
    ... addr 0..* AD
    ... telecom 0..* TEL
    ... (Choice of one) 0..1
    .... playingDevice C 1..1 Device Constraints: should-code
    ..... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    ..... realmCode 0..* CS
    ..... typeId C 0..1 II Constraints: II-1
    ...... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    ...... @assigningAuthorityName 0..1 st
    ...... @displayable 0..1 bl
    ...... @root 1..1 oid, uuid, ruid Fixed Value: 2.16.840.1.113883.1.3
    ...... @extension 1..1 st
    ..... templateId 0..* II
    ..... @classCode 0..1 cs Binding: EntityClassDevice (required)
    ..... @determinerCode 0..1 cs Binding: EntityDeterminer (required)
    Fixed Value: INSTANCE
    ..... code 0..1 CE Binding: CDAEntityCode (example)
    ..... manufacturerModelName 0..1 SC Binding: Manufacturer Model Name Example (example)
    ..... softwareName 0..1 SC Binding: Software Name Example (example)
    .... playingEntity 0..1 PlayingEntity
    ... scopingEntity 1..1 Entity
    .... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    .... realmCode 0..* CS
    .... typeId C 0..1 II Constraints: II-1
    ..... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    ..... @assigningAuthorityName 0..1 st
    ..... @displayable 0..1 bl
    ..... @root 1..1 oid, uuid, ruid Fixed Value: 2.16.840.1.113883.1.3
    ..... @extension 1..1 st
    .... templateId 0..* II
    .... @classCode 0..1 cs Binding: EntityClassRoot (required)
    .... @determinerCode 0..1 cs Binding: EntityDeterminer (required)
    Fixed Value: INSTANCE
    .... id 1..* II
    .... code 0..1 CE Binding: CDAEntityCode (example)
    .... desc 0..1 ED

    doco Documentation for this format

    Terminology Bindings

    PathConformanceValueSet / CodeURI
    ParticipantRole.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    ParticipantRole.typeId.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    ParticipantRole.templateId:product-instance.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    ParticipantRole.classCoderequiredFixed Value: MANU
    http://hl7.org/cda/stds/core/ValueSet/CDARoleClassRoot
    ParticipantRole.codeexampleCDARoleCode
    http://hl7.org/cda/stds/core/ValueSet/CDARoleCode
    ParticipantRole.playingDevice.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    ParticipantRole.playingDevice.typeId.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    ParticipantRole.playingDevice.classCoderequiredEntityClassDevice
    http://terminology.hl7.org/ValueSet/v3-EntityClassDevice
    ParticipantRole.playingDevice.determinerCoderequiredFixed Value: INSTANCE
    http://terminology.hl7.org/ValueSet/v3-EntityDeterminer
    ParticipantRole.playingDevice.codeexampleCDAEntityCode
    http://hl7.org/cda/stds/core/ValueSet/CDAEntityCode
    ParticipantRole.playingDevice.manufacturerModelNameexampleManufacturerModelNameExample
    http://terminology.hl7.org/ValueSet/v3-ManufacturerModelNameExample
    ParticipantRole.playingDevice.softwareNameexampleSoftwareNameExample
    http://terminology.hl7.org/ValueSet/v3-SoftwareNameExample
    ParticipantRole.scopingEntity.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    ParticipantRole.scopingEntity.typeId.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    ParticipantRole.scopingEntity.classCoderequiredEntityClassRoot
    http://terminology.hl7.org/ValueSet/v3-EntityClassRoot
    ParticipantRole.scopingEntity.determinerCoderequiredFixed Value: INSTANCE
    http://terminology.hl7.org/ValueSet/v3-EntityDeterminer
    ParticipantRole.scopingEntity.codeexampleCDAEntityCode
    http://hl7.org/cda/stds/core/ValueSet/CDAEntityCode

    Constraints

    IdGradePath(s)DetailsRequirements
    II-1errorParticipantRole.typeId, ParticipantRole.playingDevice.typeId, ParticipantRole.scopingEntity.typeIdAn II instance must have either a root or an nullFlavor.
    : root.exists() or nullFlavor.exists()
    role-choiceerrorParticipantRoleplayingDevice and playingEntity are mutually exclusive
    : (playingDevice | playingEntity).count() <= 1
    should-codewarningParticipantRole.playingDeviceSHOULD contain code
    : code.exists()

    This structure is derived from ParticipantRole

    Summary

    Mandatory: 8 elements
    Fixed: 1 element
    Prohibited: 1 element

    Slices

    This structure defines the following Slices:

    • The element 1 is sliced based on the value of ParticipantRole.templateId

    Differential View

    This structure is derived from ParticipantRole

    NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
    .. ParticipantRole ParticipantRole XML Namespace: urn:hl7-org:v3
    Elements defined in Ancestors:@nullFlavor, realmCode, typeId, templateId, @classCode, id, sdtcIdentifiedBy, code, addr, telecom, playingDevice, playingEntity, scopingEntity
    Instance of this type are validated by templateId
    Logical Container: ClinicalDocument (CDA Class)
    ... Slices for templateId 1..* II Slice: Unordered, Open by value:root
    .... templateId:product-instance 1..1 II
    ..... @root 1..1 oid, uuid, ruid Required Pattern: 2.16.840.1.113883.10.20.22.4.37
    ..... @extension 0..0
    ... @classCode 1..1 cs Fixed Value: MANU
    ... id 1..* II
    .... code 0..1 CE
    ... scopingEntity 1..1 Entity
    .... id 1..* II

    doco Documentation for this format

    Constraints

    IdGradePath(s)DetailsRequirements
    should-codewarningParticipantRole.playingDeviceSHOULD contain code
    : code.exists()

    Key Elements View

    NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
    .. ParticipantRole C 1..1 ParticipantRole XML Namespace: urn:hl7-org:v3
    Elements defined in Ancestors:@nullFlavor, realmCode, typeId, templateId, @classCode, id, sdtcIdentifiedBy, code, addr, telecom, playingDevice, playingEntity, scopingEntity
    Base for all types and resources
    Instance of this type are validated by templateId
    Logical Container: ClinicalDocument (CDA Class)
    Constraints: role-choice
    ... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    ... realmCode 0..* CS
    ... typeId C 0..1 II Constraints: II-1
    .... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    .... @assigningAuthorityName 0..1 st
    .... @displayable 0..1 bl
    .... @root 1..1 oid, uuid, ruid Fixed Value: 2.16.840.1.113883.1.3
    .... @extension 1..1 st
    .... templateId:product-instance 1..1 II
    ..... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    ..... @assigningAuthorityName 0..1 st
    ..... @displayable 0..1 bl
    ..... @root 1..1 oid, uuid, ruid Required Pattern: 2.16.840.1.113883.10.20.22.4.37
    ... @classCode 1..1 cs Binding: CDARoleClassRoot (required)
    Fixed Value: MANU
    ... id 1..* II
    ... sdtcIdentifiedBy 0..* IdentifiedBy XML Namespace: urn:hl7-org:sdtc
    XML: identifiedBy (urn:hl7-org:sdtc)
    ... code 0..1 CE Binding: CDARoleCode (example)
    ... addr 0..* AD
    ... telecom 0..* TEL
    ... (Choice of one) 0..1
    .... playingDevice C 1..1 Device Constraints: should-code
    ..... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    ..... realmCode 0..* CS
    ..... typeId C 0..1 II Constraints: II-1
    ...... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    ...... @assigningAuthorityName 0..1 st
    ...... @displayable 0..1 bl
    ...... @root 1..1 oid, uuid, ruid Fixed Value: 2.16.840.1.113883.1.3
    ...... @extension 1..1 st
    ..... templateId 0..* II
    ..... @classCode 0..1 cs Binding: EntityClassDevice (required)
    ..... @determinerCode 0..1 cs Binding: EntityDeterminer (required)
    Fixed Value: INSTANCE
    ..... code 0..1 CE Binding: CDAEntityCode (example)
    ..... manufacturerModelName 0..1 SC Binding: Manufacturer Model Name Example (example)
    ..... softwareName 0..1 SC Binding: Software Name Example (example)
    .... playingEntity 0..1 PlayingEntity
    ... scopingEntity 1..1 Entity
    .... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    .... realmCode 0..* CS
    .... typeId C 0..1 II Constraints: II-1
    ..... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    ..... @assigningAuthorityName 0..1 st
    ..... @displayable 0..1 bl
    ..... @root 1..1 oid, uuid, ruid Fixed Value: 2.16.840.1.113883.1.3
    ..... @extension 1..1 st
    .... templateId 0..* II
    .... @classCode 0..1 cs Binding: EntityClassRoot (required)
    .... @determinerCode 0..1 cs Binding: EntityDeterminer (required)
    Fixed Value: INSTANCE
    .... id 1..* II
    .... code 0..1 CE Binding: CDAEntityCode (example)
    .... desc 0..1 ED

    doco Documentation for this format

    Terminology Bindings

    PathConformanceValueSet / CodeURI
    ParticipantRole.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    ParticipantRole.typeId.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    ParticipantRole.templateId:product-instance.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    ParticipantRole.classCoderequiredFixed Value: MANU
    http://hl7.org/cda/stds/core/ValueSet/CDARoleClassRoot
    ParticipantRole.codeexampleCDARoleCode
    http://hl7.org/cda/stds/core/ValueSet/CDARoleCode
    ParticipantRole.playingDevice.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    ParticipantRole.playingDevice.typeId.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    ParticipantRole.playingDevice.classCoderequiredEntityClassDevice
    http://terminology.hl7.org/ValueSet/v3-EntityClassDevice
    ParticipantRole.playingDevice.determinerCoderequiredFixed Value: INSTANCE
    http://terminology.hl7.org/ValueSet/v3-EntityDeterminer
    ParticipantRole.playingDevice.codeexampleCDAEntityCode
    http://hl7.org/cda/stds/core/ValueSet/CDAEntityCode
    ParticipantRole.playingDevice.manufacturerModelNameexampleManufacturerModelNameExample
    http://terminology.hl7.org/ValueSet/v3-ManufacturerModelNameExample
    ParticipantRole.playingDevice.softwareNameexampleSoftwareNameExample
    http://terminology.hl7.org/ValueSet/v3-SoftwareNameExample
    ParticipantRole.scopingEntity.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    ParticipantRole.scopingEntity.typeId.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    ParticipantRole.scopingEntity.classCoderequiredEntityClassRoot
    http://terminology.hl7.org/ValueSet/v3-EntityClassRoot
    ParticipantRole.scopingEntity.determinerCoderequiredFixed Value: INSTANCE
    http://terminology.hl7.org/ValueSet/v3-EntityDeterminer
    ParticipantRole.scopingEntity.codeexampleCDAEntityCode
    http://hl7.org/cda/stds/core/ValueSet/CDAEntityCode

    Constraints

    IdGradePath(s)DetailsRequirements
    II-1errorParticipantRole.typeId, ParticipantRole.playingDevice.typeId, ParticipantRole.scopingEntity.typeIdAn II instance must have either a root or an nullFlavor.
    : root.exists() or nullFlavor.exists()
    role-choiceerrorParticipantRoleplayingDevice and playingEntity are mutually exclusive
    : (playingDevice | playingEntity).count() <= 1
    should-codewarningParticipantRole.playingDeviceSHOULD contain code
    : code.exists()

    Snapshot View

    NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
    .. ParticipantRole C 1..1 ParticipantRole XML Namespace: urn:hl7-org:v3
    Elements defined in Ancestors:@nullFlavor, realmCode, typeId, templateId, @classCode, id, sdtcIdentifiedBy, code, addr, telecom, playingDevice, playingEntity, scopingEntity
    Base for all types and resources
    Instance of this type are validated by templateId
    Logical Container: ClinicalDocument (CDA Class)
    Constraints: role-choice
    ... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    ... realmCode 0..* CS
    ... typeId C 0..1 II Constraints: II-1
    .... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    .... @assigningAuthorityName 0..1 st
    .... @displayable 0..1 bl
    .... @root 1..1 oid, uuid, ruid Fixed Value: 2.16.840.1.113883.1.3
    .... @extension 1..1 st
    .... templateId:product-instance 1..1 II
    ..... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    ..... @assigningAuthorityName 0..1 st
    ..... @displayable 0..1 bl
    ..... @root 1..1 oid, uuid, ruid Required Pattern: 2.16.840.1.113883.10.20.22.4.37
    ... @classCode 1..1 cs Binding: CDARoleClassRoot (required)
    Fixed Value: MANU
    ... id 1..* II
    ... sdtcIdentifiedBy 0..* IdentifiedBy XML Namespace: urn:hl7-org:sdtc
    XML: identifiedBy (urn:hl7-org:sdtc)
    ... code 0..1 CE Binding: CDARoleCode (example)
    ... addr 0..* AD
    ... telecom 0..* TEL
    ... (Choice of one) 0..1
    .... playingDevice C 1..1 Device Constraints: should-code
    ..... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    ..... realmCode 0..* CS
    ..... typeId C 0..1 II Constraints: II-1
    ...... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    ...... @assigningAuthorityName 0..1 st
    ...... @displayable 0..1 bl
    ...... @root 1..1 oid, uuid, ruid Fixed Value: 2.16.840.1.113883.1.3
    ...... @extension 1..1 st
    ..... templateId 0..* II
    ..... @classCode 0..1 cs Binding: EntityClassDevice (required)
    ..... @determinerCode 0..1 cs Binding: EntityDeterminer (required)
    Fixed Value: INSTANCE
    ..... code 0..1 CE Binding: CDAEntityCode (example)
    ..... manufacturerModelName 0..1 SC Binding: Manufacturer Model Name Example (example)
    ..... softwareName 0..1 SC Binding: Software Name Example (example)
    .... playingEntity 0..1 PlayingEntity
    ... scopingEntity 1..1 Entity
    .... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    .... realmCode 0..* CS
    .... typeId C 0..1 II Constraints: II-1
    ..... @nullFlavor 0..1 cs Binding: CDANullFlavor (required)
    ..... @assigningAuthorityName 0..1 st
    ..... @displayable 0..1 bl
    ..... @root 1..1 oid, uuid, ruid Fixed Value: 2.16.840.1.113883.1.3
    ..... @extension 1..1 st
    .... templateId 0..* II
    .... @classCode 0..1 cs Binding: EntityClassRoot (required)
    .... @determinerCode 0..1 cs Binding: EntityDeterminer (required)
    Fixed Value: INSTANCE
    .... id 1..* II
    .... code 0..1 CE Binding: CDAEntityCode (example)
    .... desc 0..1 ED

    doco Documentation for this format

    Terminology Bindings

    PathConformanceValueSet / CodeURI
    ParticipantRole.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    ParticipantRole.typeId.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    ParticipantRole.templateId:product-instance.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    ParticipantRole.classCoderequiredFixed Value: MANU
    http://hl7.org/cda/stds/core/ValueSet/CDARoleClassRoot
    ParticipantRole.codeexampleCDARoleCode
    http://hl7.org/cda/stds/core/ValueSet/CDARoleCode
    ParticipantRole.playingDevice.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    ParticipantRole.playingDevice.typeId.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    ParticipantRole.playingDevice.classCoderequiredEntityClassDevice
    http://terminology.hl7.org/ValueSet/v3-EntityClassDevice
    ParticipantRole.playingDevice.determinerCoderequiredFixed Value: INSTANCE
    http://terminology.hl7.org/ValueSet/v3-EntityDeterminer
    ParticipantRole.playingDevice.codeexampleCDAEntityCode
    http://hl7.org/cda/stds/core/ValueSet/CDAEntityCode
    ParticipantRole.playingDevice.manufacturerModelNameexampleManufacturerModelNameExample
    http://terminology.hl7.org/ValueSet/v3-ManufacturerModelNameExample
    ParticipantRole.playingDevice.softwareNameexampleSoftwareNameExample
    http://terminology.hl7.org/ValueSet/v3-SoftwareNameExample
    ParticipantRole.scopingEntity.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    ParticipantRole.scopingEntity.typeId.nullFlavorrequiredCDANullFlavor
    http://hl7.org/cda/stds/core/ValueSet/CDANullFlavor
    ParticipantRole.scopingEntity.classCoderequiredEntityClassRoot
    http://terminology.hl7.org/ValueSet/v3-EntityClassRoot
    ParticipantRole.scopingEntity.determinerCoderequiredFixed Value: INSTANCE
    http://terminology.hl7.org/ValueSet/v3-EntityDeterminer
    ParticipantRole.scopingEntity.codeexampleCDAEntityCode
    http://hl7.org/cda/stds/core/ValueSet/CDAEntityCode

    Constraints

    IdGradePath(s)DetailsRequirements
    II-1errorParticipantRole.typeId, ParticipantRole.playingDevice.typeId, ParticipantRole.scopingEntity.typeIdAn II instance must have either a root or an nullFlavor.
    : root.exists() or nullFlavor.exists()
    role-choiceerrorParticipantRoleplayingDevice and playingEntity are mutually exclusive
    : (playingDevice | playingEntity).count() <= 1
    should-codewarningParticipantRole.playingDeviceSHOULD contain code
    : code.exists()

    This structure is derived from ParticipantRole

    Summary

    Mandatory: 8 elements
    Fixed: 1 element
    Prohibited: 1 element

    Slices

    This structure defines the following Slices:

    • The element 1 is sliced based on the value of ParticipantRole.templateId

     

    Other representations of profile: CSV, Excel