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

Resource Profile: 02 EU EPI Composition (General)

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

This profile represents the constraints applied to the Composition resource used in ePI, as defined by the EU ePI Common Standard. The Composition captures the section headings, sub-section headings, and narrative text (For example, paragraphs, bulleted lists, tables) in an ePI document.

This profile represents the constraints applied to the Composition resource used in Electronic Product Information (EPI) Bundle resources.

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
... language 1..1 code The language of the EPI document narrative text.
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
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:PmsId 0..* Identifier PMS ID
URL: http://ema.europa.eu/fhir/StructureDefinition/ext-epi-pmsid
.... extension:Gtin 0..* Identifier GTIN
URL: http://ema.europa.eu/fhir/StructureDefinition/ext-epi-gtin
.... extension:QrdTemplateVersion 1..1 string QRD template version
URL: http://ema.europa.eu/fhir/StructureDefinition/ext-epi-qrdtemplate-version
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Unique identifier only for this version of the Composition.
.... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
.... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
.... value ΣC 1..1 string The value that is unique
Example General: 123456
... status ?!Σ 1..1 code Status of the composition document.
Binding: CompositionStatus (required): The workflow/clinical status of the composition.
... type Σ 1..1 CodeableConcept Type of EPI document template.
Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
... subject Σ 0..* Reference(Resource) In future implementations subject will contain references to relevant resources related with the composition.
... date Σ 1..1 dateTime Date of last revision for this version of the authorized EPI document.
... author Σ 1..* Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) The organization responsible for the EPI
... title Σ 1..1 string Title of the EPI document
... 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
.... title 1..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.
.... 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
..... title 1..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.
..... 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
...... title 1..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.
...... 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
....... title 1..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.
....... 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
........ title 1..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.
........ text C 1..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
........ 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.identifier.​use Base required IdentifierUse 📍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.
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
... language 1..1 code The language of the EPI document narrative text.
... text 0..1 Narrative Text summary of the resource, for human interpretation.
... contained 0..* Resource Images in ePI Composition documents included as contained binary resources.
.... extension:PmsId 0..* Identifier PMS ID
URL: http://ema.europa.eu/fhir/StructureDefinition/ext-epi-pmsid
.... extension:Gtin 0..* Identifier GTIN
URL: http://ema.europa.eu/fhir/StructureDefinition/ext-epi-gtin
.... extension:QrdTemplateVersion 1..1 string QRD template version
URL: http://ema.europa.eu/fhir/StructureDefinition/ext-epi-qrdtemplate-version
... identifier 0..* Identifier Unique identifier only for this version of the Composition.
.... system 1..1 uri The namespace for the identifier value
.... value 1..1 string The value that is unique
... status 1..1 code Status of the composition document.
... type 1..1 CodeableConcept Type of EPI document template.
.... coding
..... code 0..1 code Symbol in syntax defined by the system
Binding: Document Type (required)
... subject 0..* Reference(Resource) In future implementations subject will contain references to relevant resources related with the composition.
... date 1..1 dateTime Date of last revision for this version of the authorized EPI document.
... author 1..* Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) The organization responsible for the EPI
... title 1..1 string Title of the EPI document
... section 1..1 BackboneElement Level 1 section heading for the whole EPI
.... title 1..1 string Label for section (e.g. for ToC)
.... code 1..1 CodeableConcept Classification of section (recommended)
.... section 1..* BackboneElement Nested sub-section headings for level 2
..... title 1..1 string Label for section (e.g. for ToC)
..... code 1..1 CodeableConcept Classification of section (recommended)
..... section 0..* BackboneElement Nested sub-section headings for level 3.
...... title 1..1 string Label for section (e.g. for ToC)
...... code 1..1 CodeableConcept Classification of section (recommended)
...... section 0..* BackboneElement Nested sub-section headings for level 4.
....... title 1..1 string Label for section (e.g. for ToC)
....... code 1..1 CodeableConcept Classification of section (recommended)
....... section 0..* BackboneElement Nested sub-section headings for level 5.
........ title 1..1 string Label for section (e.g. for ToC)
........ code 1..1 CodeableConcept Classification of section (recommended)
........ text 1..1 Narrative Text summary of the section, for human interpretation

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Composition.type.coding.​code Base required Document Type 📦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 1..1 code The language of the EPI document narrative text.
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 Images in ePI Composition documents included as contained binary resources.
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:PmsId 0..* Identifier PMS ID
URL: http://ema.europa.eu/fhir/StructureDefinition/ext-epi-pmsid
.... extension:Gtin 0..* Identifier GTIN
URL: http://ema.europa.eu/fhir/StructureDefinition/ext-epi-gtin
.... extension:QrdTemplateVersion 1..1 string QRD template version
URL: http://ema.europa.eu/fhir/StructureDefinition/ext-epi-qrdtemplate-version
... 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 Unique identifier only for this version of the 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
.... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
.... type Σ 0..1 CodeableConcept Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
.... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
.... value ΣC 1..1 string The value that is unique
Example General: 123456
.... period Σ 0..1 Period Time period when id is/was valid for use
.... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
... version Σ 0..1 string An explicitly assigned identifer of a variation of the content in the Composition
... status ?!Σ 1..1 code Status of the composition document.
Binding: CompositionStatus (required): The workflow/clinical status of the composition.
... type Σ 1..1 CodeableConcept Type of EPI document template.
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 0..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 0..1 code Symbol in syntax defined by the system
Binding: Document Type (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
... 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) In future implementations subject will contain references to relevant resources related with the composition.
... encounter Σ 0..1 Reference(Encounter) Context of the Composition
... date Σ 1..1 dateTime Date of last revision for this version of the authorized EPI document.
... useContext Σ 0..* UsageContext The context that the content is intended to support
... author Σ 1..* Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) The organization responsible for the EPI
... name Σ 0..1 string Name for this Composition (computer friendly)
... title Σ 1..1 string Title of the EPI document
... 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 1..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.
.... 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 1..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.
..... 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 1..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.
...... 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 1..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.
....... 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 1..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.
........ 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 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.identifier.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
Composition.identifier.​type Base extensible Identifier Type Codes 📍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.type.coding.​code Base required Document Type 📦1.0.0 This IG
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.​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.
Composition.section.​section.section.code Base example Document Section Codes 📍5.0.0 FHIR Std.
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.​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.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

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
... language 1..1 code The language of the EPI document narrative text.
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
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:PmsId 0..* Identifier PMS ID
URL: http://ema.europa.eu/fhir/StructureDefinition/ext-epi-pmsid
.... extension:Gtin 0..* Identifier GTIN
URL: http://ema.europa.eu/fhir/StructureDefinition/ext-epi-gtin
.... extension:QrdTemplateVersion 1..1 string QRD template version
URL: http://ema.europa.eu/fhir/StructureDefinition/ext-epi-qrdtemplate-version
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Unique identifier only for this version of the Composition.
.... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
.... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
.... value ΣC 1..1 string The value that is unique
Example General: 123456
... status ?!Σ 1..1 code Status of the composition document.
Binding: CompositionStatus (required): The workflow/clinical status of the composition.
... type Σ 1..1 CodeableConcept Type of EPI document template.
Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
... subject Σ 0..* Reference(Resource) In future implementations subject will contain references to relevant resources related with the composition.
... date Σ 1..1 dateTime Date of last revision for this version of the authorized EPI document.
... author Σ 1..* Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) The organization responsible for the EPI
... title Σ 1..1 string Title of the EPI document
... 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
.... title 1..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.
.... 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
..... title 1..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.
..... 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
...... title 1..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.
...... 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
....... title 1..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.
....... 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
........ title 1..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.
........ text C 1..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
........ 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.identifier.​use Base required IdentifierUse 📍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.
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
... language 1..1 code The language of the EPI document narrative text.
... text 0..1 Narrative Text summary of the resource, for human interpretation.
... contained 0..* Resource Images in ePI Composition documents included as contained binary resources.
.... extension:PmsId 0..* Identifier PMS ID
URL: http://ema.europa.eu/fhir/StructureDefinition/ext-epi-pmsid
.... extension:Gtin 0..* Identifier GTIN
URL: http://ema.europa.eu/fhir/StructureDefinition/ext-epi-gtin
.... extension:QrdTemplateVersion 1..1 string QRD template version
URL: http://ema.europa.eu/fhir/StructureDefinition/ext-epi-qrdtemplate-version
... identifier 0..* Identifier Unique identifier only for this version of the Composition.
.... system 1..1 uri The namespace for the identifier value
.... value 1..1 string The value that is unique
... status 1..1 code Status of the composition document.
... type 1..1 CodeableConcept Type of EPI document template.
.... coding
..... code 0..1 code Symbol in syntax defined by the system
Binding: Document Type (required)
... subject 0..* Reference(Resource) In future implementations subject will contain references to relevant resources related with the composition.
... date 1..1 dateTime Date of last revision for this version of the authorized EPI document.
... author 1..* Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) The organization responsible for the EPI
... title 1..1 string Title of the EPI document
... section 1..1 BackboneElement Level 1 section heading for the whole EPI
.... title 1..1 string Label for section (e.g. for ToC)
.... code 1..1 CodeableConcept Classification of section (recommended)
.... section 1..* BackboneElement Nested sub-section headings for level 2
..... title 1..1 string Label for section (e.g. for ToC)
..... code 1..1 CodeableConcept Classification of section (recommended)
..... section 0..* BackboneElement Nested sub-section headings for level 3.
...... title 1..1 string Label for section (e.g. for ToC)
...... code 1..1 CodeableConcept Classification of section (recommended)
...... section 0..* BackboneElement Nested sub-section headings for level 4.
....... title 1..1 string Label for section (e.g. for ToC)
....... code 1..1 CodeableConcept Classification of section (recommended)
....... section 0..* BackboneElement Nested sub-section headings for level 5.
........ title 1..1 string Label for section (e.g. for ToC)
........ code 1..1 CodeableConcept Classification of section (recommended)
........ text 1..1 Narrative Text summary of the section, for human interpretation

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Composition.type.coding.​code Base required Document Type 📦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 1..1 code The language of the EPI document narrative text.
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 Images in ePI Composition documents included as contained binary resources.
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:PmsId 0..* Identifier PMS ID
URL: http://ema.europa.eu/fhir/StructureDefinition/ext-epi-pmsid
.... extension:Gtin 0..* Identifier GTIN
URL: http://ema.europa.eu/fhir/StructureDefinition/ext-epi-gtin
.... extension:QrdTemplateVersion 1..1 string QRD template version
URL: http://ema.europa.eu/fhir/StructureDefinition/ext-epi-qrdtemplate-version
... 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 Unique identifier only for this version of the 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
.... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
.... type Σ 0..1 CodeableConcept Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
.... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
.... value ΣC 1..1 string The value that is unique
Example General: 123456
.... period Σ 0..1 Period Time period when id is/was valid for use
.... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
... version Σ 0..1 string An explicitly assigned identifer of a variation of the content in the Composition
... status ?!Σ 1..1 code Status of the composition document.
Binding: CompositionStatus (required): The workflow/clinical status of the composition.
... type Σ 1..1 CodeableConcept Type of EPI document template.
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 0..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 0..1 code Symbol in syntax defined by the system
Binding: Document Type (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
... 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) In future implementations subject will contain references to relevant resources related with the composition.
... encounter Σ 0..1 Reference(Encounter) Context of the Composition
... date Σ 1..1 dateTime Date of last revision for this version of the authorized EPI document.
... useContext Σ 0..* UsageContext The context that the content is intended to support
... author Σ 1..* Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) The organization responsible for the EPI
... name Σ 0..1 string Name for this Composition (computer friendly)
... title Σ 1..1 string Title of the EPI document
... 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 1..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.
.... 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 1..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.
..... 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 1..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.
...... 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 1..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.
....... 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 1..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.
........ 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 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.identifier.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
Composition.identifier.​type Base extensible Identifier Type Codes 📍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.type.coding.​code Base required Document Type 📦1.0.0 This IG
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.​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.
Composition.section.​section.section.code Base example Document Section Codes 📍5.0.0 FHIR Std.
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.​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.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

 

Other representations of profile: CSV, Excel, Schematron