| Left: | Composition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi) |
| Right: | Composition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi) |
| Error | StructureDefinition.version | Values for version differ: '1.0.0-ballot' vs '1.0.0' |
| Information | StructureDefinition.date | Values for date differ: '2022-12-04T18:49:33+00:00' vs '2023-07-26T13:32:34+00:00' |
| Warning | StructureDefinition.fhirVersion | Values for fhirVersion differ: '5.0.0-ballot' vs '5.0.0' |
| Warning | Composition.implicitRules | Elements differ in comments: 'Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.' vs 'Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.' |
| Warning | Composition.language | Elements differ in binding.description: 'IETF language tag' vs 'IETF language tag for a human language' |
| Warning | Composition.extension | Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' vs 'May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' |
| Warning | Composition.modifierExtension | Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).' vs 'May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).' |
| Warning | Composition.identifier.extension | Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' vs 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' |
| Warning | Composition.identifier.system | Elements differ in definition: 'Establishes the namespace for the value - that is, a absolute URL that describes a set values that are unique.' vs 'Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.' |
| Warning | Composition.identifier.value | Elements differ in comments: 'If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [Rendered Value extension]. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.' vs 'If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [http://hl7.org/fhir/StructureDefinition/rendered-value]). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.' |
| Warning | Composition.version | Elements differ in short: 'An explicitly assigned identifer of a variation of the content in the Composition' vs 'An explicitly assigned identifer of a variation of the content in the ePI' |
| Information | Composition.subject | Element minimum cardinalities differ: '1' vs '0' |
| Warning | Composition.attester.extension | Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' vs 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' |
| Warning | Composition.attester.modifierExtension | Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).' vs 'May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).' |
| Warning | Composition.relatesTo | Elements differ in comments: 'To reference (using relatesTo) a Bundle of type 'document' or another Composition where you only have the identifier, use a resourceReference with an identifier.\nHere is an example of using relatesTo to reference another Bundle of type 'document' or Composition where you only have the identifier: ``` <relatesTo > <type value='replaces' /> <resourceReference> <identifier> <system value='...' /> <value value='...' /> </identifier> </resourceReference> </relatesTo> ```' vs 'To reference (using relatesTo) a Bundle of type 'document' or another Composition where you only have the identifier, use a resourceReference with an identifier.\ When a Composition is an alternate representation of another type of document e.g. CDA, the other document could be referenced in a DocumentReference resource. Here is an example of using relatesTo to reference another Bundle of type 'document' or Composition where you only have the identifier: ``` 'relatesTo': [{ 'type': 'replaces', 'resourceReference': { 'identifier': { 'system': '...', 'value': '...' } } }] ```' |
| Warning | Composition.event.extension | Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' vs 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' |
| Warning | Composition.event.modifierExtension | Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).' vs 'May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).' |
| Warning | Composition.event.detail | Elements differ in short: 'The event(s) being documented' vs 'The event(s) being documented, as code(s), reference(s), or both' |
| Warning | Composition.event.detail | Elements differ in definition: 'The description and/or reference of the event(s) being documented. For example, this could be used to document such a colonoscopy or an appendectomy.' vs 'Represents the main clinical acts, such as a colonoscopy or an appendectomy, being documented. In some cases, the event is inherent in the typeCode, such as a 'History and Physical Report' in which case the procedure being documented is necessarily a 'History and Physical' act. The events may be included as a code or as a reference to an other resource.' |
| Warning | Composition.section.extension | Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' vs 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' |
| Warning | Composition.section.modifierExtension | Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).' vs 'May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).' |
| Warning | Composition.section.title | Elements differ in short: 'Label for section (e.g. for ToC)' vs 'Section heading defined by the market authorization holder' |
| Warning | Composition.section.title | Elements differ in definition: 'The label for this particular section. This will be part of the rendered content for the document, and is often used to build a table of contents.' vs 'This section heading is the counterpart to the coded section heading from the health authority's ePI template. For example, the health authority ePI template may have '1. What X is and what it is used for' as the coded section heading. The market authorization holder modifies this such that 'X' is replaced with the brand name of the drug.' |
| Information | Composition.section.title | Element minimum cardinalities differ: '0' vs '1' |
| Warning | Composition.section.code | Elements differ in short: 'unique identifier for this section.' vs 'Section heading defined by the health authority. Cannot be changed by the market authorization holder' |
| Warning | Composition.section.text | Elements differ in short: 'Narrative text for this section.' vs 'Narrative text for this section (e.g., paragraphs, bulleted lists, tables).' |
| Warning | Composition.section.orderedBy | Elements differ in short: 'Order of section entries.' vs 'Order of section entries' |
| Warning | Composition.section.section | Elements differ in short: 'Nested Sections (sub-section headings for level 2, 3, 4 or 5).' vs 'Nested sub-section headings for level 2, 3, 4 or 5.' |
| Warning | Composition.section.section | Elements differ in definition: 'Nested Sections (sub-section headings for level 2, 3, 4 or 5).' vs 'Nested Sections sub-section headings for level 2, 3, 4 or 5.' |
| Warning | Composition.section.section.extension | Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' vs 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' |
| Warning | Composition.section.section.modifierExtension | Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).' vs 'May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).' |
| Warning | Composition.section.section.title | Elements differ in short: 'Section heading' vs 'Section heading defined by the market authorization holder' |
| Information | Composition.section.section.title | Element minimum cardinalities differ: '0' vs '1' |
| Warning | Composition.section.section.code | Elements differ in short: 'unique identifier for this section.' vs 'Coded section heading defined by the health authority.' |
| Warning | Composition.section.section.orderedBy | Elements differ in short: 'Order of section entries.' vs 'Order of section entries' |
| Name | Value | Comments | |
|---|---|---|---|
 abstract | false | ||
| baseDefinition | http://hl7.org/fhir/StructureDefinition/Composition | ||
| copyright | |||
| date | 2022-12-04T18:49:33+00:00 | 2023-07-26T13:32:34+00:00 |
|
| description | The Composition captures the section headings, sub-section headings, and narrative text (For example, paragraphs, bulleted lists, tables) in an ePI. | ||
| experimental | |||
| fhirVersion | 5.0.0-ballot | 5.0.0 |
|
| jurisdiction | |||
 jurisdiction[0] | http://unstats.un.org/unsd/methods/m49/m49.htm#001 | ||
| kind | resource | ||
| name | CompositionUvEpi | ||
| publisher | HL7 International - Biomedical Research & Regulation Work Group |
| |
| purpose | This profile represents the constraints applied to the Composition resource used in an Electronic Product Information (ePI) document. | ||
| status | active | ||
| title | Composition (ePI) | ||
| type | Composition | ||
| url | http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi | ||
| version | 1.0.0-ballot | 1.0.0 |
|
| Name | L Flags | L Card. | L Type | L Description & Constraints | R Flags | R Card. | L Type | L Description & Constraints | Comments | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
 Composition | 0..* | Composition | A set of resources composed into a single coherent clinical statement with clinical attestation | 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 | Σ | 0..1 | id | Logical id of this artifact | |||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | Σ | 0..1 | Meta | Metadata about the resource | |||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| ||||
| language | 0..1 | code | Language of the resource content Binding: ?? (preferred): IETF language tag
| 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language |
| ||||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||||
| contained | 0..* | Resource | Contained, inline Resources | 0..* | Resource | Contained, inline Resources | |||||||
 extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations |
| ||||||
 modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| ||||
| url | Σ | 0..1 | uri | Canonical identifier for this Composition, represented as a URI (globally unique) | 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 | Σ | 1..* | Identifier | Unique identifier only for this version of the Composition | |||||
 id | 0..1 | id | Unique id for inter-element referencing | 0..1 | id | Unique id for inter-element referencing | |||||||
| Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | 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: ?? (required) | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: ?? (required): Identifies the purpose for this identifier, if known . | |||||
| type | Σ | 0..1 | CodeableConcept | Description of identifier Binding: ?? (extensible) | Σ | 0..1 | CodeableConcept | Description of identifier Binding: ?? (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 | Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient |
| ||||
| value | Σ | 1..1 | string | The value that is unique Example General: 123456 | 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 | 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) | 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 | 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: ?? (required): The workflow/clinical status of the composition. | ?!Σ | 1..1 | code | preliminary|final|amended|entered-in-error|deprecated Binding: ?? (required): The workflow/clinical status of the composition. | |||||
| type | Σ | 1..1 | CodeableConcept | Type of ePI document template Binding: ?? (extensible) | Σ | 1..1 | CodeableConcept | Type of ePI document template Binding: ?? (preferred): Type of a composition. | |||||
| category | Σ | 0..* | CodeableConcept | Categorization of ePI Binding: ?? (example): High-level kind of a clinical document at a macro level. | Σ | 0..* | CodeableConcept | Categorization of ePI Binding: ?? (example): High-level kind of a clinical document at a macro level. | |||||
| subject | Σ | 1..* | Reference(MedicinalProductDefinition (ePI)) | The authorized medicinal product(s) that this ePI's composition is about | 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 | 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. | 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 | Σ | 0..* | UsageContext | The context that the content is intended to support | |||||
| author | Σ | 1..* | Reference(Organization (ePI)) | The Organization responsible for the ePI | Σ | 1..* | Reference(Organization (ePI)) | The Organization responsible for the ePI | |||||
| name | Σ | 0..1 | string | Name for this Composition (computer friendly) | Σ | 0..1 | string | Name for this Composition (computer friendly) | |||||
| title | Σ | 1..1 | string | Title of the ePI Document | Σ | 1..1 | string | Title of the ePI Document | |||||
| note | 0..* | Annotation | For any additional notes | 0..* | Annotation | For any additional notes | |||||||
| attester | 0..* | BackboneElement | Attests to accuracy of composition | 0..* | BackboneElement | Attests to accuracy of composition | |||||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations |
| ||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ||||
| mode | 1..1 | CodeableConcept | personal | professional | legal | official Binding: ?? (preferred): The way in which a person authenticated a composition. | 1..1 | CodeableConcept | personal | professional | legal | official Binding: ?? (preferred): The way in which a person authenticated a composition. | |||||||
| time | 0..1 | dateTime | When the composition was attested | 0..1 | dateTime | When the composition was attested | |||||||
| party | 0..1 | Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization) | Who attested the composition | 0..1 | Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization) | Who attested the composition | |||||||
| custodian | Σ | 0..1 | Reference(Organization) | Organization which maintains the composition | Σ | 0..1 | Reference(Organization) | Organization which maintains the composition | |||||
| relatesTo | 0..* | RelatedArtifact | Cross-reference to anotherother ePI compositions or ePI document()s) | 0..* | RelatedArtifact | Cross-reference to anotherother ePI compositions or ePI document()s) |
| ||||||
| event | Σ | 0..* | BackboneElement | The clinical service(s) being documented | Σ | 0..* | BackboneElement | The clinical service(s) being documented | |||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations |
| ||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ||||
| code | Σ | 0..* | CodeableConcept | Code(s) that apply to the event being documented Binding: ?? (example): This list of codes represents the main clinical acts being documented. |
| ||||||||
| period | Σ | 0..1 | Period | The period covered by the documentation | Σ | 0..1 | Period | The period covered by the documentation | |||||
| detail | Σ | 0..* | Reference(Resource) | The event(s) being documented | Σ | 0..* | CodeableReference(Resource) | The event(s) being documented, as code(s), reference(s), or both Binding: ?? (example): This list of codes represents the main clinical acts being documented. |
| ||||
 section | C | 1..* | BackboneElement | Level 1 section heading for the whole ePI | C | 1..* | BackboneElement | Level 1 section heading for the whole ePI | |||||
 id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations |
| ||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| ||||
| title | 0..1 | string | Label for section (e.g. for ToC) | 1..1 | string | Section heading defined by the market authorization holder |
| ||||||
| code | 1..1 | CodeableConcept | unique identifier for this section. Binding: ?? (extensible) | 1..1 | CodeableConcept | Section heading defined by the health authority. Cannot be changed by the market authorization holder Binding: ?? (example) |
| ||||||
| author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | 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 | 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. | C | 0..1 | Narrative | Narrative text for this section (e.g., paragraphs, bulleted lists, tables). |
| ||||
| mode | 0..1 | code | working | snapshot | changes Binding: ?? (required): The processing mode that applies to this section. |
| |||||||||
| orderedBy | 0..1 | CodeableConcept | Order of section entries. Binding: ?? (preferred): What order applies to the items in the entry. | 0..1 | CodeableConcept | Order of section entries Binding: ?? (preferred): What order applies to the items in the entry. |
| ||||||
| entry | C | 0..* | Reference(Resource) | A reference to data that supports this section | C | 0..* | Reference(Resource) | A reference to data that supports this section | |||||
| emptyReason | C | 0..1 | CodeableConcept | Reason the section is empty. Binding: ?? (preferred): If a section is empty, why it is empty. | C | 0..1 | CodeableConcept | Reason the section is empty. Binding: ?? (preferred): If a section is empty, why it is empty. | |||||
| section | C | 0..* | BackboneElement | Nested Sections (sub-section headings for level 2, 3, 4 or 5). | 0..* | BackboneElement | Nested sub-section headings for level 2, 3, 4 or 5. |
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| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations |
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| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
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| title | 0..1 | string | Section heading | 1..1 | string | Section heading defined by the market authorization holder |
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| code | 1..1 | CodeableConcept | unique identifier for this section. Binding: ?? (extensible) | 1..1 | CodeableConcept | Coded section heading defined by the health authority. Binding: ?? (example) |
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| author | 0..* | Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) | Who and/or what authored the section | 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 | 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. | C | 0..1 | Narrative | Narrative text for this section. | |||||
| mode | 0..1 | code | working | snapshot | changes Binding: ?? (required): The processing mode that applies to this section. |
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| orderedBy | 0..1 | CodeableConcept | Order of section entries. Binding: ?? (preferred): What order applies to the items in the entry. | 0..1 | CodeableConcept | Order of section entries Binding: ?? (preferred): What order applies to the items in the entry. |
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| entry | C | 0..* | Reference(Resource) | A reference to data that supports this section | C | 0..* | Reference(Resource) | A reference to data that supports this section | |||||
| emptyReason | C | 0..1 | CodeableConcept | Reason the section is empty. Binding: ?? (preferred): If a section is empty, why it is empty. | C | 0..1 | CodeableConcept | Reason the section is empty. Binding: ?? (preferred): If a section is empty, why it is empty. | |||||
 section | C | 0..* | See section (Composition) | Nested Section | 0..* | See section (Composition) | Nested Section | ||||||
| Documentation for this format | |||||||||||||