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

European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide - Local Development build (v1.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: EUEpiComposition - Detailed Descriptions

Active as of 2025-04-02

Definitions for the EUEpiComposition resource profile.

Guidance on how to interpret the contents of this table can be found here

0. Composition
Definition

A set of healthcare-related information that is assembled together into a single logical package that provides a single coherent statement of meaning, establishes its own context and that has clinical attestation with regard to who is making the statement. A Composition defines the structure and narrative content necessary for a document. However, a Composition alone does not constitute a document. Rather, the Composition must be the first entry in a Bundle where Bundle.type=document, and any other resources referenced from Composition must be included as subsequent entries in the Bundle (for example Patient, Practitioner, Encounter, etc.).

ShortA set of resources composed into a single coherent clinical statement with clinical attestation
Comments

While the focus of this specification is on patient-specific clinical statements, this resource can also apply to other healthcare-related statements such as study protocol designs, healthcare invoices and other activities that are not necessarily patient-specific or clinical.

Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: 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: 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: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. Composition.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
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 its narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. Composition.language
Definition

The base language in which the resource is written.

ShortThe language of the EPI document narrative text.Language of the resource content
Comments

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

Control10..1
BindingThe codes SHALL be taken from AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0
(required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

IETF language tag for a human language

Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. Composition.text
Definition

A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

ShortText summary of the resource, for human interpretation.
Comments

Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

Control0..1
This element is affected by the following invariants: dom-6
TypeNarrative
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesnarrative, html, xhtml, display
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. Composition.contained
Definition

Images in ePI Composition documents included as contained binary resources.


These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

ShortImages in ePI Composition documents included as contained binary resources.Contained, inline Resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

Control0..*
This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
10. Composition.extension
Definition

The use of the imageReference extension avoids warning and error messages in common FHIR validators, as all contained resources must be referenced in the Composition resource.


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.

ShortThe use of the imageReference extension avoids warning and error messages in common FHIR validators.Additional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Composition.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 12. Composition.extension:imageReference
    Slice NameimageReference
    Definition

    Image reference extension used in Composition resource.

    ShortImage reference extension used in Composition resource.
    Control0..*
    TypeExtension(Image reference extension used in Composition resource.) (Extension Type: Reference)
    Is Modifierfalse
    Must Supportfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    14. Composition.modifierExtension
    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 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).

    ShortExtensions that cannot be ignored
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
    Must Supportfalse
    Summarytrue
    Requirements

    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

    Alternate Namesextensions, user content
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    16. Composition.identifier
    Definition

    Unlike the List identifier which persists, the Composition identifier does not persist across versions. Each new version of the Composition document receives a new identifier.


    A version-independent identifier for the Composition. This identifier stays constant as the composition is changed over time.

    ShortUnique identifier only for this version of the Composition.Version-independent identifier for the Composition
    Comments

    Similar to ClinicalDocument/setId in CDA. See discussion in resource definition for how these relate.

    NoteThis is a business identifier, not a resource identifier (see discussion)
    Control0..*
    TypeIdentifier
    Is Modifierfalse
    Must Supportfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    18. Composition.identifier.use
    Definition

    The purpose of this identifier.

    Shortusual | official | temp | secondary | old (If known)
    Comments

    Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

    Control0..1
    BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0
    (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

    Identifies the purpose for this identifier, if known .

    Typecode
    Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Requirements

    Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    20. Composition.identifier.system
    Definition

    Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

    ShortThe namespace for the identifier value
    Comments

    Identifier.system is always case sensitive.

    Control10..1
    Typeuri
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Requirements

    There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

    Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    22. Composition.identifier.value
    Definition

    The portion of the identifier typically relevant to the user and which is unique within the context of the system.

    ShortThe value that is unique
    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 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.

    Control10..1
    This element is affected by the following invariants: ident-1
    Typestring
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Example<br/><b>General</b>:123456
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    24. Composition.status
    Definition

    The workflow/clinical status of this composition. The status is a marker for the clinical standing of the document.

    ShortStatus of the composition document.registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown
    Comments

    If a composition is marked as withdrawn, the compositions/documents in the series, or data from the composition or document series, should never be displayed to a user without being clearly marked as untrustworthy. The flag "entered-in-error" is why this element is labeled as a modifier of other elements.

    Some reporting work flows require that the original narrative of a final document never be altered; instead, only new narrative can be added. The composition resource has no explicit status for explicitly noting whether this business rule is in effect. This would be handled by an extension if required.

    Control1..1
    BindingThe codes SHALL be taken from CompositionStatushttp://hl7.org/fhir/ValueSet/composition-status|5.0.0
    (required to http://hl7.org/fhir/ValueSet/composition-status|5.0.0)

    The workflow/clinical status of the composition.

    Typecode
    Is Modifiertrue because This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summarytrue
    Requirements

    Need to be able to mark interim, amended, or withdrawn compositions or documents.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    26. Composition.type
    Definition

    Specifies the type of EPI template. For example, Summary of Product Characteristics (SmPC), Annex II, Labelling and Product Leaflet, as defined in EMA QRD guides.


    Specifies the particular kind of composition (e.g. History and Physical, Discharge Summary, Progress Note). This usually equates to the purpose of making the composition.

    ShortType of EPI document template.Kind of composition (LOINC if possible)
    Comments

    For Composition type, LOINC is ubiquitous and strongly endorsed by HL7. Most implementation guides will require a specific LOINC code, or use LOINC as an extensible binding.

    Control1..1
    BindingThe codes SHOULD be taken from FHIRDocumentTypeCodeshttp://hl7.org/fhir/ValueSet/doc-typecodes
    (preferred to http://hl7.org/fhir/ValueSet/doc-typecodes)

    Type of a composition.

    TypeCodeableConcept
    Is Modifierfalse
    Must Supportfalse
    Summarytrue
    Requirements

    Key metadata element describing the composition, used in searching/filtering.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    28. Composition.subject
    Definition

    Who or what the composition is about. The composition can be about a person, (patient or healthcare practitioner), a device (e.g. a machine) or even a group of subjects (such as a document about a herd of livestock, or a set of patients that share a common exposure).

    ShortIn future implementations subject will contain references to relevant resources related with the composition.Who and/or what the composition is about
    Comments

    For clinical documents, this is usually the patient.

    Control0..*
    TypeReference(Resource)
    Is Modifierfalse
    Must Supportfalse
    Summarytrue
    Requirements

    Essential metadata for searching for the composition. Identifies who and/or what the composition/document is about.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    30. Composition.date
    Definition

    The composition editing time, when the composition was last logically changed by the author.

    ShortDate of last revision for this version of the authorized EPI document.Composition editing time
    Comments

    The Last Modified Date on the composition may be after the date of the document was attested without being changed. This means that the date on an amended document is the date of the amendment, not the date of original authorship.

    Control1..1
    TypedateTime
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summarytrue
    Requirements

    dateTime is used for tracking, organizing versions and searching. Note that this is the time of authoring this version of the Composition. When packaged in a document, Bundle.timestamp is the date of packaging.


    dateTime is used for tracking, organizing versions and searching. Note that this is the time of authoring this version of the Composition. When packaged in a document, Bundle.timestamp is the date of packaging.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    32. Composition.author
    Definition

    Identifies who is responsible for the information in the composition, not necessarily who typed it in.

    ShortThe organization responsible for the EPIWho and/or what authored the composition
    Control1..*
    TypeReference(Practitioner, PractitionerRole, Device, Patient, RelatedPerson, Organization)
    Is Modifierfalse
    Must Supportfalse
    Summarytrue
    Requirements

    Identifies who is responsible for the content.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    34. Composition.title
    Definition

    A brief summary name describing the EPI document. The title might include: Proprietary Name(s) (Non-proprietary Name(s)) Dose Form, Route of Administration.


    Official human-readable label for the composition.

    ShortTitle of the EPI documentHuman Readable name/title
    Comments

    For many compositions, the title is the same as the text or a display name of Composition.type (e.g. a "consultation" or "progress note"). Note that CDA does not make title mandatory, but there are no known cases where it is useful for title to be omitted, so it is mandatory here. Feedback on this requirement is welcome during the trial use period.

    Control1..1
    Typestring
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    36. Composition.section
    Definition

    This is the root or level 1 section heading in the EPI. All other section headings are sub-sections, or children, of this section heading


    The root of the sections that make up the composition.

    ShortLevel 1 section heading for the whole EPIComposition is broken into sections
    Control10..1*
    TypeBackboneElement
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantscmp-1: A section must contain at least one of text, entries, or sub-sections (text.exists() or entry.exists() or section.exists())
    cmp-2: A section can only have an emptyReason if it is empty (emptyReason.empty() or entry.empty())
    ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    38. Composition.section.modifierExtension
    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 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).

    ShortExtensions that cannot be ignored even if unrecognized
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
    Summarytrue
    Requirements

    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

    Alternate Namesextensions, user content, modifiers
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    40. Composition.section.title
    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.

    ShortLabel for section (e.g. for ToC)
    Comments

    The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.

    Control10..1
    Typestring
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summaryfalse
    Requirements

    Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.

    Alternate Namesheader, label, caption
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    42. Composition.section.code
    Definition

    A code identifying the kind of content contained within the section. This must be consistent with the section title.

    ShortClassification of section (recommended)
    Comments

    The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document.

    If the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.

    Control10..1
    BindingFor example codes, see DocumentSectionCodeshttp://hl7.org/fhir/ValueSet/doc-section-codes
    (example to http://hl7.org/fhir/ValueSet/doc-section-codes)

    Classification of a section of a composition/document.

    TypeCodeableConcept
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Requirements

    Provides computable standardized labels to topics within the document.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    44. Composition.section.entry
    Definition

    A reference to the actual resource from which the narrative in the section is derived.

    ShortA reference to data that supports this section
    Comments

    If there are no entries in the list, an emptyReason SHOULD be provided.

    Control0..*
    This element is affected by the following invariants: cmp-1, cmp-2
    TypeReference(Resource)
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    46. Composition.section.section
    Definition

    Nested Sections sub-section headings for level 2.


    A nested sub-section within this section.

    ShortNested sub-section headings for level 2Nested Section
    Comments

    Nested sections are primarily used to help human readers navigate to particular portions of the document.

    Control10..*
    TypeBackboneElement
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    48. Composition.section.section.modifierExtension
    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 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).

    ShortExtensions that cannot be ignored even if unrecognized
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
    Summarytrue
    Requirements

    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

    Alternate Namesextensions, user content, modifiers
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    50. Composition.section.section.title
    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.

    ShortLabel for section (e.g. for ToC)
    Comments

    The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.

    Control10..1
    Typestring
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summaryfalse
    Requirements

    Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.

    Alternate Namesheader, label, caption
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    52. Composition.section.section.code
    Definition

    A code identifying the kind of content contained within the section. This must be consistent with the section title.

    ShortClassification of section (recommended)
    Comments

    The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document.

    If the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.

    Control10..1
    BindingFor example codes, see DocumentSectionCodeshttp://hl7.org/fhir/ValueSet/doc-section-codes
    (example to http://hl7.org/fhir/ValueSet/doc-section-codes)

    Classification of a section of a composition/document.

    TypeCodeableConcept
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Requirements

    Provides computable standardized labels to topics within the document.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    54. Composition.section.section.entry
    Definition

    A reference to the actual resource from which the narrative in the section is derived.

    ShortA reference to data that supports this section
    Comments

    If there are no entries in the list, an emptyReason SHOULD be provided.

    Control0..*
    This element is affected by the following invariants: cmp-1, cmp-2
    TypeReference(Resource)
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    56. Composition.section.section.section
    Definition

    Nested Sections sub-section headings for level 3.


    A nested sub-section within this section.

    ShortNested sub-section headings for level 3.Nested Section
    Comments

    Nested sections are primarily used to help human readers navigate to particular portions of the document.

    Control0..*
    TypeBackboneElement
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    58. Composition.section.section.section.modifierExtension
    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 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).

    ShortExtensions that cannot be ignored even if unrecognized
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
    Summarytrue
    Requirements

    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

    Alternate Namesextensions, user content, modifiers
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    60. Composition.section.section.section.title
    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.

    ShortLabel for section (e.g. for ToC)
    Comments

    The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.

    Control10..1
    Typestring
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summaryfalse
    Requirements

    Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.

    Alternate Namesheader, label, caption
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    62. Composition.section.section.section.code
    Definition

    A code identifying the kind of content contained within the section. This must be consistent with the section title.

    ShortClassification of section (recommended)
    Comments

    The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document.

    If the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.

    Control10..1
    BindingFor example codes, see DocumentSectionCodeshttp://hl7.org/fhir/ValueSet/doc-section-codes
    (example to http://hl7.org/fhir/ValueSet/doc-section-codes)

    Classification of a section of a composition/document.

    TypeCodeableConcept
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Requirements

    Provides computable standardized labels to topics within the document.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    64. Composition.section.section.section.entry
    Definition

    A reference to the actual resource from which the narrative in the section is derived.

    ShortA reference to data that supports this section
    Comments

    If there are no entries in the list, an emptyReason SHOULD be provided.

    Control0..*
    This element is affected by the following invariants: cmp-1, cmp-2
    TypeReference(Resource)
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    66. Composition.section.section.section.section
    Definition

    Nested Sections sub-section headings for level 4.


    A nested sub-section within this section.

    ShortNested sub-section headings for level 4.Nested Section
    Comments

    Nested sections are primarily used to help human readers navigate to particular portions of the document.

    Control0..*
    TypeBackboneElement
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    68. Composition.section.section.section.section.modifierExtension
    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 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).

    ShortExtensions that cannot be ignored even if unrecognized
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
    Summarytrue
    Requirements

    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

    Alternate Namesextensions, user content, modifiers
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    70. Composition.section.section.section.section.title
    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.

    ShortLabel for section (e.g. for ToC)
    Comments

    The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.

    Control10..1
    Typestring
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summaryfalse
    Requirements

    Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.

    Alternate Namesheader, label, caption
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    72. Composition.section.section.section.section.code
    Definition

    A code identifying the kind of content contained within the section. This must be consistent with the section title.

    ShortClassification of section (recommended)
    Comments

    The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document.

    If the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.

    Control10..1
    BindingFor example codes, see DocumentSectionCodeshttp://hl7.org/fhir/ValueSet/doc-section-codes
    (example to http://hl7.org/fhir/ValueSet/doc-section-codes)

    Classification of a section of a composition/document.

    TypeCodeableConcept
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Requirements

    Provides computable standardized labels to topics within the document.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    74. Composition.section.section.section.section.entry
    Definition

    A reference to the actual resource from which the narrative in the section is derived.

    ShortA reference to data that supports this section
    Comments

    If there are no entries in the list, an emptyReason SHOULD be provided.

    Control0..*
    This element is affected by the following invariants: cmp-1, cmp-2
    TypeReference(Resource)
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    76. Composition.section.section.section.section.section
    Definition

    Nested Sections sub-section headings for level 5.


    A nested sub-section within this section.

    ShortNested sub-section headings for level 5.Nested Section
    Comments

    Nested sections are primarily used to help human readers navigate to particular portions of the document.

    Control0..*
    TypeBackboneElement
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    78. Composition.section.section.section.section.section.modifierExtension
    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 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).

    ShortExtensions that cannot be ignored even if unrecognized
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
    Summarytrue
    Requirements

    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

    Alternate Namesextensions, user content, modifiers
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    80. Composition.section.section.section.section.section.title
    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.

    ShortLabel for section (e.g. for ToC)
    Comments

    The title identifies the section for a human reader. The title must be consistent with the narrative of the resource that is the target of the section.content reference. Generally, sections SHOULD have titles, but in some documents, it is unnecessary or inappropriate. Typically, this is where a section has subsections that have their own adequately distinguishing title, or documents that only have a single section. Most Implementation Guides will make section title to be a required element.

    Control10..1
    Typestring
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summaryfalse
    Requirements

    Section headings are often standardized for different types of documents. They give guidance to humans on how the document is organized.

    Alternate Namesheader, label, caption
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    82. Composition.section.section.section.section.section.code
    Definition

    A code identifying the kind of content contained within the section. This must be consistent with the section title.

    ShortClassification of section (recommended)
    Comments

    The code identifies the section for an automated processor of the document. This is particularly relevant when using profiles to control the structure of the document.

    If the section has content (instead of sub-sections), the section.code does not change the meaning or interpretation of the resource that is the content of the section in the comments for the section.code.

    Control10..1
    BindingFor example codes, see DocumentSectionCodeshttp://hl7.org/fhir/ValueSet/doc-section-codes
    (example to http://hl7.org/fhir/ValueSet/doc-section-codes)

    Classification of a section of a composition/document.

    TypeCodeableConcept
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Requirements

    Provides computable standardized labels to topics within the document.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    84. Composition.section.section.section.section.section.text
    Definition

    A human-readable narrative that contains the attested content of the section, used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative.

    ShortText summary of the section, for human interpretation
    Comments

    Document profiles may define what content should be represented in the narrative to ensure clinical safety.

    Control10..1
    This element is affected by the following invariants: cmp-1
    TypeNarrative
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    86. Composition.section.section.section.section.section.entry
    Definition

    A reference to the actual resource from which the narrative in the section is derived.

    ShortA reference to data that supports this section
    Comments

    If there are no entries in the list, an emptyReason SHOULD be provided.

    Control0..*
    This element is affected by the following invariants: cmp-1, cmp-2
    TypeReference(Resource)
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))