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

Consolidated CDA (C-CDA), published by Health Level Seven. This guide is not an authorized publication; it is the continuous build for version 4.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/CDA-ccda/ and changes regularly. 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 2025-10-02 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:

You can also check for usages in the FHIR IG Statistics

Changes since version 3.0.0:

  • New Content
  • 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
    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

    Id Grade Path(s) Description Expression
    should-code warning ParticipantRole.playingDevice SHOULD contain code code.exists()
    NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
    .. ParticipantRole C 1..1 ParticipantRole XML Namespace: urn:hl7-org:v3
    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

    Path Status Usage ValueSet Version Source
    ParticipantRole.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.typeId.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.templateId:product-instance.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.classCode Base required CDARoleClassRoot 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.code Base example CDARoleCode 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.playingDevice.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.playingDevice.​typeId.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.playingDevice.​classCode Base required EntityClassDevice 📦3.0.0 THO v6.5
    ParticipantRole.playingDevice.​determinerCode Base required EntityDeterminer 📦3.0.0 THO v6.5
    ParticipantRole.playingDevice.​code Base example CDAEntityCode 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.playingDevice.​manufacturerModelName Base example Manufacturer Model Name Example 📦2.0.0 THO v6.5
    ParticipantRole.playingDevice.​softwareName Base example Software Name Example 📦2.0.0 THO v6.5
    ParticipantRole.scopingEntity.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.scopingEntity.​typeId.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.scopingEntity.​classCode Base required EntityClassRoot 📦3.0.0 THO v6.5
    ParticipantRole.scopingEntity.​determinerCode Base required EntityDeterminer 📦3.0.0 THO v6.5
    ParticipantRole.scopingEntity.​code Base example CDAEntityCode 📦2.0.1-sd Clinical Document Architecture v2.0

    Constraints

    Id Grade Path(s) Description Expression
    II-1 error ParticipantRole.typeId, ParticipantRole.playingDevice.typeId, ParticipantRole.scopingEntity.typeId An II instance must have either a root or an nullFlavor. root.exists() or nullFlavor.exists()
    role-choice error ParticipantRole playingDevice and playingEntity are mutually exclusive (playingDevice | playingEntity).count() <= 1
    should-code warning ParticipantRole.playingDevice SHOULD contain code code.exists()
    NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
    .. ParticipantRole C 1..1 ParticipantRole XML Namespace: urn:hl7-org:v3
    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

    Path Status Usage ValueSet Version Source
    ParticipantRole.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.typeId.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.templateId:product-instance.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.classCode Base required CDARoleClassRoot 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.code Base example CDARoleCode 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.playingDevice.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.playingDevice.​typeId.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.playingDevice.​classCode Base required EntityClassDevice 📦3.0.0 THO v6.5
    ParticipantRole.playingDevice.​determinerCode Base required EntityDeterminer 📦3.0.0 THO v6.5
    ParticipantRole.playingDevice.​code Base example CDAEntityCode 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.playingDevice.​manufacturerModelName Base example Manufacturer Model Name Example 📦2.0.0 THO v6.5
    ParticipantRole.playingDevice.​softwareName Base example Software Name Example 📦2.0.0 THO v6.5
    ParticipantRole.scopingEntity.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.scopingEntity.​typeId.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.scopingEntity.​classCode Base required EntityClassRoot 📦3.0.0 THO v6.5
    ParticipantRole.scopingEntity.​determinerCode Base required EntityDeterminer 📦3.0.0 THO v6.5
    ParticipantRole.scopingEntity.​code Base example CDAEntityCode 📦2.0.1-sd Clinical Document Architecture v2.0

    Constraints

    Id Grade Path(s) Description Expression
    II-1 error ParticipantRole.typeId, ParticipantRole.playingDevice.typeId, ParticipantRole.scopingEntity.typeId An II instance must have either a root or an nullFlavor. root.exists() or nullFlavor.exists()
    role-choice error ParticipantRole playingDevice and playingEntity are mutually exclusive (playingDevice | playingEntity).count() <= 1
    should-code warning ParticipantRole.playingDevice SHOULD 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
    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

    Id Grade Path(s) Description Expression
    should-code warning ParticipantRole.playingDevice SHOULD contain code code.exists()

    Key Elements View

    NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
    .. ParticipantRole C 1..1 ParticipantRole XML Namespace: urn:hl7-org:v3
    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

    Path Status Usage ValueSet Version Source
    ParticipantRole.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.typeId.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.templateId:product-instance.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.classCode Base required CDARoleClassRoot 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.code Base example CDARoleCode 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.playingDevice.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.playingDevice.​typeId.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.playingDevice.​classCode Base required EntityClassDevice 📦3.0.0 THO v6.5
    ParticipantRole.playingDevice.​determinerCode Base required EntityDeterminer 📦3.0.0 THO v6.5
    ParticipantRole.playingDevice.​code Base example CDAEntityCode 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.playingDevice.​manufacturerModelName Base example Manufacturer Model Name Example 📦2.0.0 THO v6.5
    ParticipantRole.playingDevice.​softwareName Base example Software Name Example 📦2.0.0 THO v6.5
    ParticipantRole.scopingEntity.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.scopingEntity.​typeId.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.scopingEntity.​classCode Base required EntityClassRoot 📦3.0.0 THO v6.5
    ParticipantRole.scopingEntity.​determinerCode Base required EntityDeterminer 📦3.0.0 THO v6.5
    ParticipantRole.scopingEntity.​code Base example CDAEntityCode 📦2.0.1-sd Clinical Document Architecture v2.0

    Constraints

    Id Grade Path(s) Description Expression
    II-1 error ParticipantRole.typeId, ParticipantRole.playingDevice.typeId, ParticipantRole.scopingEntity.typeId An II instance must have either a root or an nullFlavor. root.exists() or nullFlavor.exists()
    role-choice error ParticipantRole playingDevice and playingEntity are mutually exclusive (playingDevice | playingEntity).count() <= 1
    should-code warning ParticipantRole.playingDevice SHOULD contain code code.exists()

    Snapshot View

    NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
    .. ParticipantRole C 1..1 ParticipantRole XML Namespace: urn:hl7-org:v3
    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

    Path Status Usage ValueSet Version Source
    ParticipantRole.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.typeId.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.templateId:product-instance.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.classCode Base required CDARoleClassRoot 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.code Base example CDARoleCode 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.playingDevice.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.playingDevice.​typeId.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.playingDevice.​classCode Base required EntityClassDevice 📦3.0.0 THO v6.5
    ParticipantRole.playingDevice.​determinerCode Base required EntityDeterminer 📦3.0.0 THO v6.5
    ParticipantRole.playingDevice.​code Base example CDAEntityCode 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.playingDevice.​manufacturerModelName Base example Manufacturer Model Name Example 📦2.0.0 THO v6.5
    ParticipantRole.playingDevice.​softwareName Base example Software Name Example 📦2.0.0 THO v6.5
    ParticipantRole.scopingEntity.​nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.scopingEntity.​typeId.nullFlavor Base required CDANullFlavor 📦2.0.1-sd Clinical Document Architecture v2.0
    ParticipantRole.scopingEntity.​classCode Base required EntityClassRoot 📦3.0.0 THO v6.5
    ParticipantRole.scopingEntity.​determinerCode Base required EntityDeterminer 📦3.0.0 THO v6.5
    ParticipantRole.scopingEntity.​code Base example CDAEntityCode 📦2.0.1-sd Clinical Document Architecture v2.0

    Constraints

    Id Grade Path(s) Description Expression
    II-1 error ParticipantRole.typeId, ParticipantRole.playingDevice.typeId, ParticipantRole.scopingEntity.typeId An II instance must have either a root or an nullFlavor. root.exists() or nullFlavor.exists()
    role-choice error ParticipantRole playingDevice and playingEntity are mutually exclusive (playingDevice | playingEntity).count() <= 1
    should-code warning ParticipantRole.playingDevice SHOULD 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