European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide
1.0.0 - final

Resource Profile: 05 EU EPI Composition (Labelling documents)

Official URL: http://ema.europa.eu/fhir/StructureDefinition/EUEpiCompositionLabeling Version: 1.0.0
Active as of 2026-08-26 Computable Name: EUEpiCompositionLabeling

This profile represents the constraints applied to Labelling documents.

This profile represents the constraints applied to Labelling documents.

Usages:

  • This Profile is not used by any profiles in this Specification

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

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

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Composition 0..* Composition A set of resources composed into a single coherent clinical statement with clinical attestation
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... type Σ 1..1 CodeableConcept Type of EPI document is Labelling.
Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
... date Σ 1..1 dateTime Composition editing time
... author Σ 1..* Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) Who and/or what authored the composition
... title Σ 1..1 string Human Readable name/title
... section C 1..1 BackboneElement Level 1 section heading for the whole EPI
Constraints: cmp-1, cmp-2
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code 1..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.... entry C 0..* Reference(Resource) A reference to data that supports this section
.... section 1..* BackboneElement Nested sub-section headings for level 2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... code 1..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... section 0..* BackboneElement Nested sub-section headings for level 3.
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... code 1..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
...... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section 0..* BackboneElement Nested sub-section headings for level 4.
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... code 1..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... section 0..* BackboneElement Nested sub-section headings for level 5.
........ modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........ code 1..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ 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.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.
Composition.section.​section.section.code Base example Document Section Codes 📍5.0.0 FHIR Std.
Composition.section.​section.section.section.​code Base example Document Section Codes 📍5.0.0 FHIR Std.
Composition.section.​section.section.section.​section.code Base example Document Section Codes 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression

This structure is derived from Composition

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Composition 0..* Composition A set of resources composed into a single coherent clinical statement with clinical attestation
... type 1..1 CodeableConcept Type of EPI document is Labelling.
.... coding
..... system 1..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/100000155531
..... code 1..1 code Symbol in syntax defined by the system
Required Pattern: 100000155535
... section 1..1 BackboneElement Level 1 section heading for the whole EPI
.... code 1..1 CodeableConcept Classification of section (recommended)
..... coding
...... system 1..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
...... code 1..1 code Symbol in syntax defined by the system
Binding: Labelling Codes (required)
.... section 1..* BackboneElement Nested sub-section headings for level 2
..... code 1..1 CodeableConcept Classification of section (recommended)
...... coding
....... system 1..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
....... code 1..1 code Symbol in syntax defined by the system
Binding: Labelling Codes (required)
..... section 0..* BackboneElement Nested sub-section headings for level 3.
...... code 1..1 CodeableConcept Classification of section (recommended)
....... coding
........ system 1..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
........ code 1..1 code Symbol in syntax defined by the system
Binding: Labelling Codes (required)
...... section 0..* BackboneElement Nested sub-section headings for level 4.
....... code 1..1 CodeableConcept Classification of section (recommended)
........ coding
......... system 1..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
......... code 1..1 code Symbol in syntax defined by the system
Binding: Labelling Codes (required)
....... section 0..* BackboneElement Nested sub-section headings for level 5.
........ code 1..1 CodeableConcept Classification of section (recommended)
......... coding
.......... system 1..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
.......... code 1..1 code Symbol in syntax defined by the system
Binding: Labelling Codes (required)

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Composition.section.​code.coding.code Base required Labelling Codes 📦1.0.0 This IG
Composition.section.​section.code.coding.​code Base required Labelling Codes 📦1.0.0 This IG
Composition.section.​section.section.code.​coding.code Base required Labelling Codes 📦1.0.0 This IG
Composition.section.​section.section.section.​code.coding.code Base required Labelling Codes 📦1.0.0 This IG
Composition.section.​section.section.section.​section.code.coding.​code Base required Labelling Codes 📦1.0.0 This IG
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Composition 0..* Composition A set of resources composed into a single coherent clinical statement with clinical attestation
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... 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 0..* Identifier Version-independent identifier for the Composition
... version Σ 0..1 string An explicitly assigned identifer of a variation of the content in the Composition
... status ?!Σ 1..1 code registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown
Binding: CompositionStatus (required): The workflow/clinical status of the composition.
... type Σ 1..1 CodeableConcept Type of EPI document is Labelling.
Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 0..* Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/100000155531
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
Required Pattern: 100000155535
..... display ΣC 0..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... category Σ 0..* CodeableConcept Categorization of Composition
Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
... subject Σ 0..* Reference(Resource) Who and/or what the composition is about
... encounter Σ 0..1 Reference(Encounter) Context of the Composition
... date Σ 1..1 dateTime Composition editing time
... useContext Σ 0..* UsageContext The context that the content is intended to support
... author Σ 1..* Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) Who and/or what authored the composition
... name Σ 0..1 string Name for this Composition (computer friendly)
... title Σ 1..1 string Human Readable name/title
... 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 Relationships to other compositions/documents
... 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 1..1 BackboneElement Level 1 section heading for the whole EPI
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 0..1 string Label for section (e.g. for ToC)
.... code 1..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 0..* Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
Binding: Labelling Codes (required)
...... display ΣC 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... 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 summary of the section, for human interpretation
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 sub-section headings for level 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 0..1 string Label for section (e.g. for ToC)
..... code 1..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 0..* Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..1 code Symbol in syntax defined by the system
Binding: Labelling Codes (required)
....... display ΣC 0..1 string Representation defined by the system
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... 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 summary of the section, for human interpretation
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..* BackboneElement Nested sub-section headings for level 3.
...... 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 Label for section (e.g. for ToC)
...... code 1..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... coding Σ 0..* Coding Code defined by a terminology system
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
........ version Σ 0..1 string Version of the system - if relevant
........ code ΣC 1..1 code Symbol in syntax defined by the system
Binding: Labelling Codes (required)
........ display ΣC 0..1 string Representation defined by the system
........ userSelected Σ 0..1 boolean If this coding was chosen directly by the user
....... text Σ 0..1 string Plain text representation of the concept
...... 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 summary of the section, for human interpretation
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..* BackboneElement Nested sub-section headings for level 4.
....... 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 Label for section (e.g. for ToC)
....... code 1..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding Σ 0..* Coding Code defined by a terminology system
......... id 0..1 id Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
......... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
......... version Σ 0..1 string Version of the system - if relevant
......... code ΣC 1..1 code Symbol in syntax defined by the system
Binding: Labelling Codes (required)
......... display ΣC 0..1 string Representation defined by the system
......... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
........ text Σ 0..1 string Plain text representation of the concept
....... 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 summary of the section, for human interpretation
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..* BackboneElement Nested sub-section headings for level 5.
........ 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 Label for section (e.g. for ToC)
........ code 1..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... id 0..1 id Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
......... coding Σ 0..* Coding Code defined by a terminology system
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
.......... version Σ 0..1 string Version of the system - if relevant
.......... code ΣC 1..1 code Symbol in syntax defined by the system
Binding: Labelling Codes (required)
.......... display ΣC 0..1 string Representation defined by the system
.......... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
......... text Σ 0..1 string Plain text representation of the concept
........ 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 summary of the section, for human interpretation
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.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 v7.3
Composition.section.​code Base example Document Section Codes 📍5.0.0 FHIR Std.
Composition.section.​code.coding.code Base required Labelling Codes 📦1.0.0 This IG
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.code.coding.​code Base required Labelling Codes 📦1.0.0 This IG
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.
Composition.section.​section.section.code Base example Document Section Codes 📍5.0.0 FHIR Std.
Composition.section.​section.section.code.​coding.code Base required Labelling Codes 📦1.0.0 This IG
Composition.section.​section.section.orderedBy Base preferred List Order Codes 📍5.0.0 FHIR Std.
Composition.section.​section.section.emptyReason Base preferred List Empty Reasons 📍5.0.0 FHIR Std.
Composition.section.​section.section.section.​code Base example Document Section Codes 📍5.0.0 FHIR Std.
Composition.section.​section.section.section.​code.coding.code Base required Labelling Codes 📦1.0.0 This IG
Composition.section.​section.section.section.​orderedBy Base preferred List Order Codes 📍5.0.0 FHIR Std.
Composition.section.​section.section.section.​emptyReason Base preferred List Empty Reasons 📍5.0.0 FHIR Std.
Composition.section.​section.section.section.​section.code Base example Document Section Codes 📍5.0.0 FHIR Std.
Composition.section.​section.section.section.​section.code.coding.​code Base required Labelling Codes 📦1.0.0 This IG
Composition.section.​section.section.section.​section.orderedBy Base preferred List Order Codes 📍5.0.0 FHIR Std.
Composition.section.​section.section.section.​section.emptyReason Base preferred List Empty Reasons 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression

This structure is derived from Composition

Summary

Mandatory: 4 elements(15 nested mandatory elements)

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
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... type Σ 1..1 CodeableConcept Type of EPI document is Labelling.
Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
... date Σ 1..1 dateTime Composition editing time
... author Σ 1..* Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) Who and/or what authored the composition
... title Σ 1..1 string Human Readable name/title
... section C 1..1 BackboneElement Level 1 section heading for the whole EPI
Constraints: cmp-1, cmp-2
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code 1..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
.... entry C 0..* Reference(Resource) A reference to data that supports this section
.... section 1..* BackboneElement Nested sub-section headings for level 2
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... code 1..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
..... entry C 0..* Reference(Resource) A reference to data that supports this section
..... section 0..* BackboneElement Nested sub-section headings for level 3.
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... code 1..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
...... entry C 0..* Reference(Resource) A reference to data that supports this section
...... section 0..* BackboneElement Nested sub-section headings for level 4.
....... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
....... code 1..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
....... entry C 0..* Reference(Resource) A reference to data that supports this section
....... section 0..* BackboneElement Nested sub-section headings for level 5.
........ modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
........ code 1..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ 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.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.
Composition.section.​section.section.code Base example Document Section Codes 📍5.0.0 FHIR Std.
Composition.section.​section.section.section.​code Base example Document Section Codes 📍5.0.0 FHIR Std.
Composition.section.​section.section.section.​section.code Base example Document Section Codes 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression

Differential View

This structure is derived from Composition

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Composition 0..* Composition A set of resources composed into a single coherent clinical statement with clinical attestation
... type 1..1 CodeableConcept Type of EPI document is Labelling.
.... coding
..... system 1..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/100000155531
..... code 1..1 code Symbol in syntax defined by the system
Required Pattern: 100000155535
... section 1..1 BackboneElement Level 1 section heading for the whole EPI
.... code 1..1 CodeableConcept Classification of section (recommended)
..... coding
...... system 1..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
...... code 1..1 code Symbol in syntax defined by the system
Binding: Labelling Codes (required)
.... section 1..* BackboneElement Nested sub-section headings for level 2
..... code 1..1 CodeableConcept Classification of section (recommended)
...... coding
....... system 1..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
....... code 1..1 code Symbol in syntax defined by the system
Binding: Labelling Codes (required)
..... section 0..* BackboneElement Nested sub-section headings for level 3.
...... code 1..1 CodeableConcept Classification of section (recommended)
....... coding
........ system 1..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
........ code 1..1 code Symbol in syntax defined by the system
Binding: Labelling Codes (required)
...... section 0..* BackboneElement Nested sub-section headings for level 4.
....... code 1..1 CodeableConcept Classification of section (recommended)
........ coding
......... system 1..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
......... code 1..1 code Symbol in syntax defined by the system
Binding: Labelling Codes (required)
....... section 0..* BackboneElement Nested sub-section headings for level 5.
........ code 1..1 CodeableConcept Classification of section (recommended)
......... coding
.......... system 1..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
.......... code 1..1 code Symbol in syntax defined by the system
Binding: Labelling Codes (required)

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Composition.section.​code.coding.code Base required Labelling Codes 📦1.0.0 This IG
Composition.section.​section.code.coding.​code Base required Labelling Codes 📦1.0.0 This IG
Composition.section.​section.section.code.​coding.code Base required Labelling Codes 📦1.0.0 This IG
Composition.section.​section.section.section.​code.coding.code Base required Labelling Codes 📦1.0.0 This IG
Composition.section.​section.section.section.​section.code.coding.​code Base required Labelling Codes 📦1.0.0 This IG

Snapshot 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 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... 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 0..* Identifier Version-independent identifier for the Composition
... version Σ 0..1 string An explicitly assigned identifer of a variation of the content in the Composition
... status ?!Σ 1..1 code registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown
Binding: CompositionStatus (required): The workflow/clinical status of the composition.
... type Σ 1..1 CodeableConcept Type of EPI document is Labelling.
Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 0..* Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/100000155531
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
Required Pattern: 100000155535
..... display ΣC 0..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... category Σ 0..* CodeableConcept Categorization of Composition
Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
... subject Σ 0..* Reference(Resource) Who and/or what the composition is about
... encounter Σ 0..1 Reference(Encounter) Context of the Composition
... date Σ 1..1 dateTime Composition editing time
... useContext Σ 0..* UsageContext The context that the content is intended to support
... author Σ 1..* Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) Who and/or what authored the composition
... name Σ 0..1 string Name for this Composition (computer friendly)
... title Σ 1..1 string Human Readable name/title
... 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 Relationships to other compositions/documents
... 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 1..1 BackboneElement Level 1 section heading for the whole EPI
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 0..1 string Label for section (e.g. for ToC)
.... code 1..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 0..* Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
Binding: Labelling Codes (required)
...... display ΣC 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... text Σ 0..1 string Plain text representation of the concept
.... 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 summary of the section, for human interpretation
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 sub-section headings for level 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 0..1 string Label for section (e.g. for ToC)
..... code 1..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 0..* Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..1 code Symbol in syntax defined by the system
Binding: Labelling Codes (required)
....... display ΣC 0..1 string Representation defined by the system
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... 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 summary of the section, for human interpretation
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..* BackboneElement Nested sub-section headings for level 3.
...... 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 Label for section (e.g. for ToC)
...... code 1..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... coding Σ 0..* Coding Code defined by a terminology system
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
........ version Σ 0..1 string Version of the system - if relevant
........ code ΣC 1..1 code Symbol in syntax defined by the system
Binding: Labelling Codes (required)
........ display ΣC 0..1 string Representation defined by the system
........ userSelected Σ 0..1 boolean If this coding was chosen directly by the user
....... text Σ 0..1 string Plain text representation of the concept
...... 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 summary of the section, for human interpretation
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..* BackboneElement Nested sub-section headings for level 4.
....... 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 Label for section (e.g. for ToC)
....... code 1..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
........ id 0..1 id Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
........ coding Σ 0..* Coding Code defined by a terminology system
......... id 0..1 id Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
......... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
......... version Σ 0..1 string Version of the system - if relevant
......... code ΣC 1..1 code Symbol in syntax defined by the system
Binding: Labelling Codes (required)
......... display ΣC 0..1 string Representation defined by the system
......... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
........ text Σ 0..1 string Plain text representation of the concept
....... 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 summary of the section, for human interpretation
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..* BackboneElement Nested sub-section headings for level 5.
........ 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 Label for section (e.g. for ToC)
........ code 1..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
......... id 0..1 id Unique id for inter-element referencing
......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
......... coding Σ 0..* Coding Code defined by a terminology system
.......... id 0..1 id Unique id for inter-element referencing
.......... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.......... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/200000029659
.......... version Σ 0..1 string Version of the system - if relevant
.......... code ΣC 1..1 code Symbol in syntax defined by the system
Binding: Labelling Codes (required)
.......... display ΣC 0..1 string Representation defined by the system
.......... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
......... text Σ 0..1 string Plain text representation of the concept
........ 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 summary of the section, for human interpretation
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.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 v7.3
Composition.section.​code Base example Document Section Codes 📍5.0.0 FHIR Std.
Composition.section.​code.coding.code Base required Labelling Codes 📦1.0.0 This IG
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.code.coding.​code Base required Labelling Codes 📦1.0.0 This IG
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.
Composition.section.​section.section.code Base example Document Section Codes 📍5.0.0 FHIR Std.
Composition.section.​section.section.code.​coding.code Base required Labelling Codes 📦1.0.0 This IG
Composition.section.​section.section.orderedBy Base preferred List Order Codes 📍5.0.0 FHIR Std.
Composition.section.​section.section.emptyReason Base preferred List Empty Reasons 📍5.0.0 FHIR Std.
Composition.section.​section.section.section.​code Base example Document Section Codes 📍5.0.0 FHIR Std.
Composition.section.​section.section.section.​code.coding.code Base required Labelling Codes 📦1.0.0 This IG
Composition.section.​section.section.section.​orderedBy Base preferred List Order Codes 📍5.0.0 FHIR Std.
Composition.section.​section.section.section.​emptyReason Base preferred List Empty Reasons 📍5.0.0 FHIR Std.
Composition.section.​section.section.section.​section.code Base example Document Section Codes 📍5.0.0 FHIR Std.
Composition.section.​section.section.section.​section.code.coding.​code Base required Labelling Codes 📦1.0.0 This IG
Composition.section.​section.section.section.​section.orderedBy Base preferred List Order Codes 📍5.0.0 FHIR Std.
Composition.section.​section.section.section.​section.emptyReason Base preferred List Empty Reasons 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression

This structure is derived from Composition

Summary

Mandatory: 4 elements(15 nested mandatory elements)

 

Other representations of profile: CSV, Excel, Schematron