Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use International flag

Global Core Electronic Medicinal Product Information (ePI), published by HL7 International - Biomedical Research & Regulation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions

Resource Profile: Composition - ePI Type 1

Official URL: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type1 Version: 1.1.0
Computable Name: CompositionEpiType1

This profile represents the constraints applied to the Composition resource used in the Electronic Product Information (ePI) FHIR Implementation Guide.

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description Differentials, Snapshots, and other representations.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Composition 0..* Composition A set of resources composed into a single coherent clinical statement with clinical attestation
... id Σ 1..1 id Unique Identifier for this ePI Instance
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 1..1 code Language of the ePI content
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
... Slices for contained 0..* Resource Contained, inline Resources
Slice: Unordered, Open by type:$this
.... contained:binaryImage 0..* BinaryEpi Pure binary content defined by a format other than FHIR
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 1..* Identifier Business Identifier (e.g., Reg Number)
... status ?!Σ 1..1 code Workflow Status (e.g., preliminary, final)
Binding: CompositionStatus (required): The workflow/clinical status of the composition.
... type Σ 1..1 CodeableConcept Type of ePI document (e.g., SmPC, PIL)
Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
... subject Σ 1..* Reference(MedicinalProductDefinition) The Medicinal Product described
... date Σ 1..1 dateTime Date of Authorization or Change
... author Σ 1..* Reference(Organization (ePI)) Organization responsible for content
... title Σ 1..1 string Official Title of the ePI
... relatesTo 0..* RelatedArtifact Reference to previous versions
... section C 0..1 BackboneElement Root / Parent Section
Constraints: cmp-1, cmp-2
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... title 1..1 string Parent Section Title
.... code 1..1 CodeableConcept Parent Section Code
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.... text C 1..1 Narrative Parent Section Text
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
.... entry C 0..* Reference(Resource) A reference to data that supports this section
.... section 1..* BackboneElement Nested Content Sections
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Title of the nested section
..... code 0..1 CodeableConcept Code for the nested section
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
..... text C 0..1 Narrative Text content of the nested section
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... entry C 0..* Reference(Resource) A reference to data that supports this section

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Composition.language Base required All Languages 📍5.0.0 FHIR Std.
Composition.status Base required Composition Status 📍5.0.0 FHIR Std.
Composition.type Base preferred FHIR Document Type Codes 📍5.0.0 FHIR Std.
Composition.section.​code Base example Document Section Codes 📍5.0.0 FHIR Std.
Composition.section.​section.code Base example Document Section Codes 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
cmp-1 error Composition.section A section must contain at least one of text, entries, or sub-sections text.exists() or entry.exists() or section.exists()
cmp-2 error Composition.section A section can only have an emptyReason if it is empty emptyReason.empty() or entry.empty()
dom-2 error Composition If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Composition If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error Composition If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error Composition If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Composition A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Composition Composition
... id 1..1 id Unique Identifier for this ePI Instance
... meta
.... versionId 1..1 id Version Identifier
.... lastUpdated 1..1 instant Date Last Changed
.... profile 1..* canonical(StructureDefinition) Profile Conformity
... language 1..1 code Language of the ePI content
... Slices for contained 0..* Resource Contained, inline Resources
Slice: Unordered, Open by type:$this
.... contained:binaryImage 0..* BinaryEpi Pure binary content defined by a format other than FHIR
... identifier 1..* Identifier Business Identifier (e.g., Reg Number)
... status 1..1 code Workflow Status (e.g., preliminary, final)
... type 1..1 CodeableConcept Type of ePI document (e.g., SmPC, PIL)
... subject 1..* Reference(MedicinalProductDefinition) The Medicinal Product described
... date 1..1 dateTime Date of Authorization or Change
... author 1..* Reference(Organization (ePI)) Organization responsible for content
... title 1..1 string Official Title of the ePI
... relatesTo 0..* RelatedArtifact Reference to previous versions
... section 0..1 BackboneElement Root / Parent Section
.... title 1..1 string Parent Section Title
.... code 1..1 CodeableConcept Parent Section Code
.... text 1..1 Narrative Parent Section Text
.... section 1..* BackboneElement Nested Content Sections
..... title 0..1 string Title of the nested section
..... code 0..1 CodeableConcept Code for the nested section
..... text 0..1 Narrative Text content of the nested section

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Composition 0..* Composition A set of resources composed into a single coherent clinical statement with clinical attestation
... id Σ 1..1 id Unique Identifier for this ePI Instance
... meta Σ 0..1 Meta Metadata about the resource
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 1..1 id Version Identifier
.... lastUpdated Σ 1..1 instant Date Last Changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile Σ 1..* canonical(StructureDefinition) Profile Conformity
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 1..1 code Language of the ePI content
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
... text 1..1 Narrative Narrative Title of the ePI
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... Slices for contained 0..* Resource Contained, inline Resources
Slice: Unordered, Open by type:$this
.... contained:binaryImage 0..* BinaryEpi Pure binary content defined by a format other than FHIR
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... url Σ 0..1 uri Canonical identifier for this Composition, represented as a URI (globally unique)
... identifier Σ 1..* Identifier Business Identifier (e.g., Reg Number)
... version Σ 0..1 string An explicitly assigned identifer of a variation of the content in the Composition
... status ?!Σ 1..1 code Workflow Status (e.g., preliminary, final)
Binding: CompositionStatus (required): The workflow/clinical status of the composition.
... type Σ 1..1 CodeableConcept Type of ePI document (e.g., SmPC, PIL)
Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
... category Σ 0..* CodeableConcept Categorization of Composition
Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
... subject Σ 1..* Reference(MedicinalProductDefinition) The Medicinal Product described
... encounter Σ 0..1 Reference(Encounter) Context of the Composition
... date Σ 1..1 dateTime Date of Authorization or Change
... useContext Σ 0..* UsageContext The context that the content is intended to support
... author Σ 1..* Reference(Organization (ePI)) Organization responsible for content
... name Σ 0..1 string Name for this Composition (computer friendly)
... title Σ 1..1 string Official Title of the ePI
... note 0..* Annotation For any additional notes
... attester 0..* BackboneElement Attests to accuracy of composition
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... mode 1..1 CodeableConcept personal | professional | legal | official
Binding: CompositionAttestationMode (preferred): The way in which a person authenticated a composition.
.... time 0..1 dateTime When the composition was attested
.... party 0..1 Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization) Who attested the composition
... custodian Σ 0..1 Reference(Organization) Organization which maintains the composition
... relatesTo 0..* RelatedArtifact Reference to previous versions
... event Σ 0..* BackboneElement The clinical service(s) being documented
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... period Σ 0..1 Period The period covered by the documentation
.... detail Σ 0..* CodeableReference(Resource) The event(s) being documented, as code(s), reference(s), or both
Binding: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented.
... section C 0..1 BackboneElement Root / Parent Section
Constraints: cmp-1, cmp-2
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... title 1..1 string Parent Section Title
.... code 1..1 CodeableConcept Parent Section Code
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.... author 0..* Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section
.... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
.... text C 1..1 Narrative Parent Section Text
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
.... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
.... entry C 0..* Reference(Resource) A reference to data that supports this section
.... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
.... section 1..* BackboneElement Nested Content Sections
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Title of the nested section
..... code 0..1 CodeableConcept Code for the nested section
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
..... author 0..* Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text content of the nested section
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... section 0..* See section (Composition) Nested Section

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Composition.meta.security Base extensible All Security Labels 📍5.0.0 FHIR Std.
Composition.meta.tag Base example Common Tags 📍5.0.0 FHIR Std.
Composition.language Base required All Languages 📍5.0.0 FHIR Std.
Composition.status Base required Composition Status 📍5.0.0 FHIR Std.
Composition.type Base preferred FHIR Document Type Codes 📍5.0.0 FHIR Std.
Composition.category Base example Referenced Item Category Value Set 📍5.0.0 FHIR Std.
Composition.attester.​mode Base preferred Composition Attestation Mode 📍5.0.0 FHIR Std.
Composition.event.detail Base example v3 Code System ActCode 📦3.0.0 THO v7.0
Composition.section.​code Base example Document Section Codes 📍5.0.0 FHIR Std.
Composition.section.​orderedBy Base preferred List Order Codes 📍5.0.0 FHIR Std.
Composition.section.​emptyReason Base preferred List Empty Reasons 📍5.0.0 FHIR Std.
Composition.section.​section.code Base example Document Section Codes 📍5.0.0 FHIR Std.
Composition.section.​section.orderedBy Base preferred List Order Codes 📍5.0.0 FHIR Std.
Composition.section.​section.emptyReason Base preferred List Empty Reasons 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
cmp-1 error Composition.section A section must contain at least one of text, entries, or sub-sections text.exists() or entry.exists() or section.exists()
cmp-2 error Composition.section A section can only have an emptyReason if it is empty emptyReason.empty() or entry.empty()
dom-2 error Composition If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Composition If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error Composition If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error Composition If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Composition A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Summary

Mandatory: 10 elements(7 nested mandatory elements)

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of Composition.contained

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Composition 0..* Composition A set of resources composed into a single coherent clinical statement with clinical attestation
... id Σ 1..1 id Unique Identifier for this ePI Instance
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 1..1 code Language of the ePI content
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
... Slices for contained 0..* Resource Contained, inline Resources
Slice: Unordered, Open by type:$this
.... contained:binaryImage 0..* BinaryEpi Pure binary content defined by a format other than FHIR
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 1..* Identifier Business Identifier (e.g., Reg Number)
... status ?!Σ 1..1 code Workflow Status (e.g., preliminary, final)
Binding: CompositionStatus (required): The workflow/clinical status of the composition.
... type Σ 1..1 CodeableConcept Type of ePI document (e.g., SmPC, PIL)
Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
... subject Σ 1..* Reference(MedicinalProductDefinition) The Medicinal Product described
... date Σ 1..1 dateTime Date of Authorization or Change
... author Σ 1..* Reference(Organization (ePI)) Organization responsible for content
... title Σ 1..1 string Official Title of the ePI
... relatesTo 0..* RelatedArtifact Reference to previous versions
... section C 0..1 BackboneElement Root / Parent Section
Constraints: cmp-1, cmp-2
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... title 1..1 string Parent Section Title
.... code 1..1 CodeableConcept Parent Section Code
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.... text C 1..1 Narrative Parent Section Text
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
.... entry C 0..* Reference(Resource) A reference to data that supports this section
.... section 1..* BackboneElement Nested Content Sections
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Title of the nested section
..... code 0..1 CodeableConcept Code for the nested section
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
..... text C 0..1 Narrative Text content of the nested section
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... entry C 0..* Reference(Resource) A reference to data that supports this section

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Composition.language Base required All Languages 📍5.0.0 FHIR Std.
Composition.status Base required Composition Status 📍5.0.0 FHIR Std.
Composition.type Base preferred FHIR Document Type Codes 📍5.0.0 FHIR Std.
Composition.section.​code Base example Document Section Codes 📍5.0.0 FHIR Std.
Composition.section.​section.code Base example Document Section Codes 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
cmp-1 error Composition.section A section must contain at least one of text, entries, or sub-sections text.exists() or entry.exists() or section.exists()
cmp-2 error Composition.section A section can only have an emptyReason if it is empty emptyReason.empty() or entry.empty()
dom-2 error Composition If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Composition If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error Composition If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error Composition If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Composition A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Differential View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Composition Composition
... id 1..1 id Unique Identifier for this ePI Instance
... meta
.... versionId 1..1 id Version Identifier
.... lastUpdated 1..1 instant Date Last Changed
.... profile 1..* canonical(StructureDefinition) Profile Conformity
... language 1..1 code Language of the ePI content
... Slices for contained 0..* Resource Contained, inline Resources
Slice: Unordered, Open by type:$this
.... contained:binaryImage 0..* BinaryEpi Pure binary content defined by a format other than FHIR
... identifier 1..* Identifier Business Identifier (e.g., Reg Number)
... status 1..1 code Workflow Status (e.g., preliminary, final)
... type 1..1 CodeableConcept Type of ePI document (e.g., SmPC, PIL)
... subject 1..* Reference(MedicinalProductDefinition) The Medicinal Product described
... date 1..1 dateTime Date of Authorization or Change
... author 1..* Reference(Organization (ePI)) Organization responsible for content
... title 1..1 string Official Title of the ePI
... relatesTo 0..* RelatedArtifact Reference to previous versions
... section 0..1 BackboneElement Root / Parent Section
.... title 1..1 string Parent Section Title
.... code 1..1 CodeableConcept Parent Section Code
.... text 1..1 Narrative Parent Section Text
.... section 1..* BackboneElement Nested Content Sections
..... title 0..1 string Title of the nested section
..... code 0..1 CodeableConcept Code for the nested section
..... text 0..1 Narrative Text content of the nested section

doco Documentation for this format

Snapshot ViewView

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Composition 0..* Composition A set of resources composed into a single coherent clinical statement with clinical attestation
... id Σ 1..1 id Unique Identifier for this ePI Instance
... meta Σ 0..1 Meta Metadata about the resource
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 1..1 id Version Identifier
.... lastUpdated Σ 1..1 instant Date Last Changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile Σ 1..* canonical(StructureDefinition) Profile Conformity
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 1..1 code Language of the ePI content
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
... text 1..1 Narrative Narrative Title of the ePI
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... Slices for contained 0..* Resource Contained, inline Resources
Slice: Unordered, Open by type:$this
.... contained:binaryImage 0..* BinaryEpi Pure binary content defined by a format other than FHIR
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... url Σ 0..1 uri Canonical identifier for this Composition, represented as a URI (globally unique)
... identifier Σ 1..* Identifier Business Identifier (e.g., Reg Number)
... version Σ 0..1 string An explicitly assigned identifer of a variation of the content in the Composition
... status ?!Σ 1..1 code Workflow Status (e.g., preliminary, final)
Binding: CompositionStatus (required): The workflow/clinical status of the composition.
... type Σ 1..1 CodeableConcept Type of ePI document (e.g., SmPC, PIL)
Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
... category Σ 0..* CodeableConcept Categorization of Composition
Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
... subject Σ 1..* Reference(MedicinalProductDefinition) The Medicinal Product described
... encounter Σ 0..1 Reference(Encounter) Context of the Composition
... date Σ 1..1 dateTime Date of Authorization or Change
... useContext Σ 0..* UsageContext The context that the content is intended to support
... author Σ 1..* Reference(Organization (ePI)) Organization responsible for content
... name Σ 0..1 string Name for this Composition (computer friendly)
... title Σ 1..1 string Official Title of the ePI
... note 0..* Annotation For any additional notes
... attester 0..* BackboneElement Attests to accuracy of composition
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... mode 1..1 CodeableConcept personal | professional | legal | official
Binding: CompositionAttestationMode (preferred): The way in which a person authenticated a composition.
.... time 0..1 dateTime When the composition was attested
.... party 0..1 Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization) Who attested the composition
... custodian Σ 0..1 Reference(Organization) Organization which maintains the composition
... relatesTo 0..* RelatedArtifact Reference to previous versions
... event Σ 0..* BackboneElement The clinical service(s) being documented
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... period Σ 0..1 Period The period covered by the documentation
.... detail Σ 0..* CodeableReference(Resource) The event(s) being documented, as code(s), reference(s), or both
Binding: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented.
... section C 0..1 BackboneElement Root / Parent Section
Constraints: cmp-1, cmp-2
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... title 1..1 string Parent Section Title
.... code 1..1 CodeableConcept Parent Section Code
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.... author 0..* Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section
.... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
.... text C 1..1 Narrative Parent Section Text
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
.... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
.... entry C 0..* Reference(Resource) A reference to data that supports this section
.... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
.... section 1..* BackboneElement Nested Content Sections
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Title of the nested section
..... code 0..1 CodeableConcept Code for the nested section
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
..... author 0..* Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text content of the nested section
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
..... section 0..* See section (Composition) Nested Section

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Composition.meta.security Base extensible All Security Labels 📍5.0.0 FHIR Std.
Composition.meta.tag Base example Common Tags 📍5.0.0 FHIR Std.
Composition.language Base required All Languages 📍5.0.0 FHIR Std.
Composition.status Base required Composition Status 📍5.0.0 FHIR Std.
Composition.type Base preferred FHIR Document Type Codes 📍5.0.0 FHIR Std.
Composition.category Base example Referenced Item Category Value Set 📍5.0.0 FHIR Std.
Composition.attester.​mode Base preferred Composition Attestation Mode 📍5.0.0 FHIR Std.
Composition.event.detail Base example v3 Code System ActCode 📦3.0.0 THO v7.0
Composition.section.​code Base example Document Section Codes 📍5.0.0 FHIR Std.
Composition.section.​orderedBy Base preferred List Order Codes 📍5.0.0 FHIR Std.
Composition.section.​emptyReason Base preferred List Empty Reasons 📍5.0.0 FHIR Std.
Composition.section.​section.code Base example Document Section Codes 📍5.0.0 FHIR Std.
Composition.section.​section.orderedBy Base preferred List Order Codes 📍5.0.0 FHIR Std.
Composition.section.​section.emptyReason Base preferred List Empty Reasons 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
cmp-1 error Composition.section A section must contain at least one of text, entries, or sub-sections text.exists() or entry.exists() or section.exists()
cmp-2 error Composition.section A section can only have an emptyReason if it is empty emptyReason.empty() or entry.empty()
dom-2 error Composition If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Composition If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error Composition If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error Composition If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Composition A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Summary

Mandatory: 10 elements(7 nested mandatory elements)

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of Composition.contained

 

Other representations of profile: CSV, Excel, Schematron