Electronic Medicinal Product Information (ePI) FHIR Implementation Guide, published by HL7 International - Biomedical Research & Regulation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions

• Content
• Detailed Descriptions
• Mappings
• Examples
• XML
• JSON
• TTL

Resource Profile: Composition (ePI)

The Composition captures the section headings, sub-section headings, and narrative text (For example, paragraphs, bulleted lists, tables) in an ePI.

This profile represents the constraints applied to the Composition resource used in an Electronic Product Information (ePI) document.

Usage:

• Use this Resource Profile: Bundle - ePI
• Examples for this Resource Profile: Composition/5467a2fd-2463-4ec7-a6bb-b7322000f867 and Composition/fe63fd6a-afe8-4b61-a203-0cf4a69ffb60

Formal Views of Profile Content

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

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from Composition

Name	Flags	Card.	Type	Description & Constraints
Composition			Composition
language		1..1	code	The language of the ePI's narrative text
identifier		1..*	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
version		0..1	string	An explicitly assigned identifer of a variation of the content in the ePI
status		1..1	code	preliminary|final|amended|entered-in-error|deprecated
type		1..1	CodeableConcept	Type of ePI document template
category		0..*	CodeableConcept	Categorization of ePI
subject		0..*	Reference(MedicinalProductDefinition (ePI))	The authorized medicinal product(s) that this ePI's composition is about
date		1..1	dateTime	Date of last revision for this version of the authorized ePI.
author		1..*	Reference(Organization (ePI))	The Organization responsible for the ePI
title		1..1	string	Title of the ePI Document
relatesTo		0..*	RelatedArtifact	Cross-reference to anotherother ePI compositions or ePI document()s)
section		1..*	BackboneElement	Level 1 section heading for the whole ePI
title		0..1	string	Section heading defined by the market authorization holder
code		0..1	CodeableConcept	Section heading defined by the health authority. Cannot be changed by the market authorization holder Binding: Section Codes (example)
text		0..1	Narrative	Narrative text for this section (e.g., paragraphs, bulleted lists, tables).
emptyReason		0..1	CodeableConcept	Reason the section is empty.
section		0..*	BackboneElement	Nested sub-section headings for level 2, 3, 4 or 5.
title		0..1	string	Section heading defined by the market authorization holder
code		0..1	CodeableConcept	Coded section heading defined by the health authority. Binding: Section Codes (example)
text		0..1	Narrative	Narrative text for this section.
emptyReason		0..1	CodeableConcept	Reason the section is empty.
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Composition.section.code	example	VsSectionCode http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/sectionCode from this IG
Composition.section.section.code	example	VsSectionCode http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/sectionCode from this IG

Name	Flags	Card.	Type	Description & Constraints
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's narrative text Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	1..*	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
version	Σ	0..1	string	An explicitly assigned identifer of a variation of the content in the ePI
status	?!Σ	1..1	code	preliminary|final|amended|entered-in-error|deprecated 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.
category	Σ	0..*	CodeableConcept	Categorization of ePI Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
subject	Σ	0..*	Reference(MedicinalProductDefinition (ePI))	The authorized medicinal product(s) that this ePI's composition is about
date	Σ	1..1	dateTime	Date of last revision for this version of the authorized ePI.
author	Σ	1..*	Reference(Organization (ePI))	The Organization responsible for the ePI
title	Σ	1..1	string	Title of the ePI Document
relatesTo		0..*	RelatedArtifact	Cross-reference to anotherother ePI compositions or ePI document()s)
section	C	1..*	BackboneElement	Level 1 section heading for the whole ePI cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Section heading defined by the market authorization holder
code		0..1	CodeableConcept	Section heading defined by the health authority. Cannot be changed by the market authorization holder Binding: Section Codes (example)
text	C	0..1	Narrative	Narrative text for this section (e.g., paragraphs, bulleted lists, tables).
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Reason 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 2, 3, 4 or 5.
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Section heading defined by the market authorization holder
code		0..1	CodeableConcept	Coded section heading defined by the health authority. Binding: Section Codes (example)
text	C	0..1	Narrative	Narrative text for this section.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Reason the section is empty. Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Composition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
Composition.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
Composition.status	required	CompositionStatus http://hl7.org/fhir/ValueSet/composition-status|5.0.0 from the FHIR Standard
Composition.type	preferred	FHIRDocumentTypeCodes http://hl7.org/fhir/ValueSet/doc-typecodes from the FHIR Standard
Composition.category	example	ReferencedItemCategoryValueSet http://hl7.org/fhir/ValueSet/referenced-item-category from the FHIR Standard
Composition.section.code	example	VsSectionCode http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/sectionCode from this IG
Composition.section.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section.section.code	example	VsSectionCode http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/sectionCode from this IG
Composition.section.section.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard

Constraints

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

Name	Flags	Card.	Type	Description & Constraints
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's narrative text Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
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	1..*	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 ePI
status	?!Σ	1..1	code	preliminary|final|amended|entered-in-error|deprecated 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.
category	Σ	0..*	CodeableConcept	Categorization of ePI Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
subject	Σ	0..*	Reference(MedicinalProductDefinition (ePI))	The authorized medicinal product(s) that this ePI's composition is about
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.
useContext	Σ	0..*	UsageContext	The context that the content is intended to support
author	Σ	1..*	Reference(Organization (ePI))	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	Cross-reference to anotherother ePI compositions or ePI document()s)
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..*	BackboneElement	Level 1 section heading for the whole ePI cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty
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	Section heading defined by the market authorization holder
code		0..1	CodeableConcept	Section heading defined by the health authority. Cannot be changed by the market authorization holder Binding: Section Codes (example)
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	Narrative text for this section (e.g., paragraphs, bulleted lists, tables).
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	Reason 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 2, 3, 4 or 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	Section heading defined by the market authorization holder
code		0..1	CodeableConcept	Coded section heading defined by the health authority. Binding: Section Codes (example)
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	Narrative text for this section.
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	Reason the section is empty. Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Composition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
Composition.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
Composition.identifier.type	extensible	IdentifierTypeCodes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
Composition.status	required	CompositionStatus http://hl7.org/fhir/ValueSet/composition-status|5.0.0 from the FHIR Standard
Composition.type	preferred	FHIRDocumentTypeCodes http://hl7.org/fhir/ValueSet/doc-typecodes from the FHIR Standard
Composition.category	example	ReferencedItemCategoryValueSet http://hl7.org/fhir/ValueSet/referenced-item-category from the FHIR Standard
Composition.attester.mode	preferred	CompositionAttestationMode http://hl7.org/fhir/ValueSet/composition-attestation-mode from the FHIR Standard
Composition.event.detail	example	ActCode http://terminology.hl7.org/ValueSet/v3-ActCode
Composition.section.code	example	VsSectionCode http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/sectionCode from this IG
Composition.section.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section.section.code	example	VsSectionCode http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/sectionCode from this IG
Composition.section.section.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section.section.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard

Constraints

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

This structure is derived from Composition

Summary

Mandatory: 5 elements

Structures

This structure refers to these other structures:

• MedicinalProductDefinition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi)
• Organization (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi)

Maturity: 2

Differential View

This structure is derived from Composition

Name	Flags	Card.	Type	Description & Constraints
Composition			Composition
language		1..1	code	The language of the ePI's narrative text
identifier		1..*	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
version		0..1	string	An explicitly assigned identifer of a variation of the content in the ePI
status		1..1	code	preliminary|final|amended|entered-in-error|deprecated
type		1..1	CodeableConcept	Type of ePI document template
category		0..*	CodeableConcept	Categorization of ePI
subject		0..*	Reference(MedicinalProductDefinition (ePI))	The authorized medicinal product(s) that this ePI's composition is about
date		1..1	dateTime	Date of last revision for this version of the authorized ePI.
author		1..*	Reference(Organization (ePI))	The Organization responsible for the ePI
title		1..1	string	Title of the ePI Document
relatesTo		0..*	RelatedArtifact	Cross-reference to anotherother ePI compositions or ePI document()s)
section		1..*	BackboneElement	Level 1 section heading for the whole ePI
title		0..1	string	Section heading defined by the market authorization holder
code		0..1	CodeableConcept	Section heading defined by the health authority. Cannot be changed by the market authorization holder Binding: Section Codes (example)
text		0..1	Narrative	Narrative text for this section (e.g., paragraphs, bulleted lists, tables).
emptyReason		0..1	CodeableConcept	Reason the section is empty.
section		0..*	BackboneElement	Nested sub-section headings for level 2, 3, 4 or 5.
title		0..1	string	Section heading defined by the market authorization holder
code		0..1	CodeableConcept	Coded section heading defined by the health authority. Binding: Section Codes (example)
text		0..1	Narrative	Narrative text for this section.
emptyReason		0..1	CodeableConcept	Reason the section is empty.
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Composition.section.code	example	VsSectionCode http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/sectionCode from this IG
Composition.section.section.code	example	VsSectionCode http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/sectionCode from this IG

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
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's narrative text Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	1..*	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
version	Σ	0..1	string	An explicitly assigned identifer of a variation of the content in the ePI
status	?!Σ	1..1	code	preliminary|final|amended|entered-in-error|deprecated 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.
category	Σ	0..*	CodeableConcept	Categorization of ePI Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
subject	Σ	0..*	Reference(MedicinalProductDefinition (ePI))	The authorized medicinal product(s) that this ePI's composition is about
date	Σ	1..1	dateTime	Date of last revision for this version of the authorized ePI.
author	Σ	1..*	Reference(Organization (ePI))	The Organization responsible for the ePI
title	Σ	1..1	string	Title of the ePI Document
relatesTo		0..*	RelatedArtifact	Cross-reference to anotherother ePI compositions or ePI document()s)
section	C	1..*	BackboneElement	Level 1 section heading for the whole ePI cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Section heading defined by the market authorization holder
code		0..1	CodeableConcept	Section heading defined by the health authority. Cannot be changed by the market authorization holder Binding: Section Codes (example)
text	C	0..1	Narrative	Narrative text for this section (e.g., paragraphs, bulleted lists, tables).
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Reason 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 2, 3, 4 or 5.
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title		0..1	string	Section heading defined by the market authorization holder
code		0..1	CodeableConcept	Coded section heading defined by the health authority. Binding: Section Codes (example)
text	C	0..1	Narrative	Narrative text for this section.
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Reason the section is empty. Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Composition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
Composition.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
Composition.status	required	CompositionStatus http://hl7.org/fhir/ValueSet/composition-status|5.0.0 from the FHIR Standard
Composition.type	preferred	FHIRDocumentTypeCodes http://hl7.org/fhir/ValueSet/doc-typecodes from the FHIR Standard
Composition.category	example	ReferencedItemCategoryValueSet http://hl7.org/fhir/ValueSet/referenced-item-category from the FHIR Standard
Composition.section.code	example	VsSectionCode http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/sectionCode from this IG
Composition.section.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section.section.code	example	VsSectionCode http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/sectionCode from this IG
Composition.section.section.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard

Constraints

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

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
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's narrative text Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
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	1..*	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 ePI
status	?!Σ	1..1	code	preliminary|final|amended|entered-in-error|deprecated 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.
category	Σ	0..*	CodeableConcept	Categorization of ePI Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
subject	Σ	0..*	Reference(MedicinalProductDefinition (ePI))	The authorized medicinal product(s) that this ePI's composition is about
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.
useContext	Σ	0..*	UsageContext	The context that the content is intended to support
author	Σ	1..*	Reference(Organization (ePI))	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	Cross-reference to anotherother ePI compositions or ePI document()s)
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..*	BackboneElement	Level 1 section heading for the whole ePI cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty
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	Section heading defined by the market authorization holder
code		0..1	CodeableConcept	Section heading defined by the health authority. Cannot be changed by the market authorization holder Binding: Section Codes (example)
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	Narrative text for this section (e.g., paragraphs, bulleted lists, tables).
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	Reason 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 2, 3, 4 or 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	Section heading defined by the market authorization holder
code		0..1	CodeableConcept	Coded section heading defined by the health authority. Binding: Section Codes (example)
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	Narrative text for this section.
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	Reason the section is empty. Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Composition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
Composition.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|5.0.0 from the FHIR Standard
Composition.identifier.type	extensible	IdentifierTypeCodes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
Composition.status	required	CompositionStatus http://hl7.org/fhir/ValueSet/composition-status|5.0.0 from the FHIR Standard
Composition.type	preferred	FHIRDocumentTypeCodes http://hl7.org/fhir/ValueSet/doc-typecodes from the FHIR Standard
Composition.category	example	ReferencedItemCategoryValueSet http://hl7.org/fhir/ValueSet/referenced-item-category from the FHIR Standard
Composition.attester.mode	preferred	CompositionAttestationMode http://hl7.org/fhir/ValueSet/composition-attestation-mode from the FHIR Standard
Composition.event.detail	example	ActCode http://terminology.hl7.org/ValueSet/v3-ActCode
Composition.section.code	example	VsSectionCode http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/sectionCode from this IG
Composition.section.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard
Composition.section.section.code	example	VsSectionCode http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/sectionCode from this IG
Composition.section.section.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section.section.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard

Constraints

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

This structure is derived from Composition

Summary

Mandatory: 5 elements

Structures

This structure refers to these other structures:

• MedicinalProductDefinition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi)
• Organization (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi)

Maturity: 2

Other representations of profile: CSV, Excel, Schematron