Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use
Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use
This page is part of the Electronic Medicinal Product Information (ePI) FHIR Implementation Guide (v1.0.0: STU1) based on FHIR v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions 
| Official URL: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi | Version: 1.0.0 | |||
| Standards status: Trial-use | Maturity Level: 2 | Computable Name: CompositionUvEpi | ||
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:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from Composition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  Composition | 0..* | Composition | A set of resources composed into a single coherent clinical statement with clinical attestation | |
  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 | 1..1 | string | Section heading defined by the market authorization holder | |
| code | 1..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 | 1..1 | string | Section heading defined by the market authorization holder | |
| code | 1..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 | ||||
| Path | Conformance | ValueSet |
| Composition.section.code | example | VsSectionCode |
| Composition.section.section.code | example | VsSectionCode |
| 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 |
| 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 |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| title | 1..1 | string | Section heading defined by the market authorization holder | |
| code | 1..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 | 1..1 | string | Section heading defined by the market authorization holder | |
| code | 1..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 | ||||
| Path | Conformance | ValueSet |
| Composition.identifier.use | required | IdentifierUse |
| Composition.status | required | CompositionStatus |
| Composition.type | preferred | FHIRDocumentTypeCodes |
| Composition.category | example | ReferencedItemCategoryValueSet |
| Composition.section.code | example | VsSectionCode |
| Composition.section.emptyReason | preferred | ListEmptyReasons |
| Composition.section.section.code | example | VsSectionCode |
| Composition.section.section.emptyReason | preferred | ListEmptyReasons |
| 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 | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language | |
| 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 |
| 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 | Section heading defined by the market authorization holder | |
| code | 1..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 | 1..1 | string | Section heading defined by the market authorization holder | |
| code | 1..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 | ||||
| Path | Conformance | ValueSet |
| Composition.language | required | AllLanguages |
| Composition.identifier.use | required | IdentifierUse |
| Composition.identifier.type | extensible | IdentifierTypeCodes |
| Composition.status | required | CompositionStatus |
| Composition.type | preferred | FHIRDocumentTypeCodes |
| Composition.category | example | ReferencedItemCategoryValueSet |
| Composition.attester.mode | preferred | CompositionAttestationMode |
| Composition.event.detail | example | ActCode |
| Composition.section.code | example | VsSectionCode |
| Composition.section.orderedBy | preferred | ListOrderCodes |
| Composition.section.emptyReason | preferred | ListEmptyReasons |
| Composition.section.section.code | example | VsSectionCode |
| Composition.section.section.orderedBy | preferred | ListOrderCodes |
| Composition.section.section.emptyReason | preferred | ListEmptyReasons |
| 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() | |
| 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: 6 elements (2 nested mandatory elements)
Structures
This structure refers to these other structures:
Maturity: 2
Differential View
This structure is derived from Composition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Composition | 0..* | Composition | A set of resources composed into a single coherent clinical statement with clinical attestation | |
| 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 | 1..1 | string | Section heading defined by the market authorization holder | |
| code | 1..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 | 1..1 | string | Section heading defined by the market authorization holder | |
| code | 1..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 | ||||
| Path | Conformance | ValueSet |
| Composition.section.code | example | VsSectionCode |
| Composition.section.section.code | example | VsSectionCode |
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 |
| 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 |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| title | 1..1 | string | Section heading defined by the market authorization holder | |
| code | 1..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 | 1..1 | string | Section heading defined by the market authorization holder | |
| code | 1..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 | ||||
| Path | Conformance | ValueSet |
| Composition.identifier.use | required | IdentifierUse |
| Composition.status | required | CompositionStatus |
| Composition.type | preferred | FHIRDocumentTypeCodes |
| Composition.category | example | ReferencedItemCategoryValueSet |
| Composition.section.code | example | VsSectionCode |
| Composition.section.emptyReason | preferred | ListEmptyReasons |
| Composition.section.section.code | example | VsSectionCode |
| Composition.section.section.emptyReason | preferred | ListEmptyReasons |
| 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 | 0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language | |
| 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 |
| 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 | Section heading defined by the market authorization holder | |
| code | 1..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 | 1..1 | string | Section heading defined by the market authorization holder | |
| code | 1..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 | ||||
| Path | Conformance | ValueSet |
| Composition.language | required | AllLanguages |
| Composition.identifier.use | required | IdentifierUse |
| Composition.identifier.type | extensible | IdentifierTypeCodes |
| Composition.status | required | CompositionStatus |
| Composition.type | preferred | FHIRDocumentTypeCodes |
| Composition.category | example | ReferencedItemCategoryValueSet |
| Composition.attester.mode | preferred | CompositionAttestationMode |
| Composition.event.detail | example | ActCode |
| Composition.section.code | example | VsSectionCode |
| Composition.section.orderedBy | preferred | ListOrderCodes |
| Composition.section.emptyReason | preferred | ListEmptyReasons |
| Composition.section.section.code | example | VsSectionCode |
| Composition.section.section.orderedBy | preferred | ListOrderCodes |
| Composition.section.section.emptyReason | preferred | ListEmptyReasons |
| 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() | |
| 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: 6 elements (2 nested mandatory elements)
Structures
This structure refers to these other structures:
Maturity: 2
Other representations of profile: CSV, Excel, Schematron
IG © 2022+ HL7 International - Biomedical Research & Regulation Work Group. Package hl7.fhir.uv.emedicinal-product-info#1.0.0 based on FHIR 5.0.0. Generated 2023-07-26
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