Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
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Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.20 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc/ and changes regularly. See the Directory of published versions

Resource Profile: EctdComposition32S10 - Detailed Descriptions

Draft as of 2024-03-04

Definitions for the ectd-composition-32s10 resource profile.

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

0. Composition
2. Composition.meta
4. Composition.meta.profile
Control1..1
Must Supporttrue
6. Composition.identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
Must Supporttrue
8. Composition.status
Pattern Valuefinal
10. Composition.type
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types",
    "code" : "32S10",
    "display" : "Substance General Information"
  }]
}
12. Composition.author
Control0..1
TypeReference(Sponsor Organization)
Must Supporttrue
14. Composition.title
Must Supporttrue
16. Composition.section
Definition

Substance General Information the 3.2.S.1 eCTD heading.

Control1..1
Must Supporttrue
18. Composition.section.title
Control1..?
Must Supporttrue
20. Composition.section.code
Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types",
    "code" : "32S10",
    "display" : "Substance General Information"
  }]
}
22. Composition.section.entry
Control1..1
TypeReference(Substance General Information)
Must Supporttrue

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.meta
Definition

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

ShortMetadata about the resource
Control0..1
TypeMeta
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. Composition.meta.profile
Definition

A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

ShortProfiles this resource claims to conform to
Comments

It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

Control10..1*
Typecanonical(StructureDefinition)
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. 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()))
8. Composition.contained
Definition

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.

ShortContained, 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.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())
12. Composition.identifier
Definition

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

ShortVersion-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..1*
TypeIdentifier
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. Composition.status
Definition

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

Shortregistered | 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
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.

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

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.

ShortKind 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
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summarytrue
Requirements

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

Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types",
    "code" : "32S10",
    "display" : "Substance General Information"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. Composition.date
Definition

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

ShortComposition 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.

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

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

ShortWho and/or what authored the composition
Control1..1*
TypeReference(Sponsor Organization, Practitioner, PractitionerRole, Device, Patient, RelatedPerson, Organization)
Is Modifierfalse
Must Supporttrue
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()))
22. Composition.title
Definition

Official human-readable label for the composition.

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

Substance General Information the 3.2.S.1 eCTD heading.


The root of the sections that make up the composition.

ShortComposition is broken into sections
Control10..1*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
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()))
26. 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())
28. 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 Supporttrue
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()))
30. 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.

Control0..1
BindingFor example codes, see DocumentSectionCodeshttp://hl7.org/fhir/ValueSet/doc-section-codes
(example to http://hl7.org/fhir/ValueSet/doc-section-codes
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summaryfalse
Requirements

Provides computable standardized labels to topics within the document.

Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types",
    "code" : "32S10",
    "display" : "Substance General Information"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
32. 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.

Control10..1*
This element is affected by the following invariants: cmp-1, cmp-2
TypeReference(Substance General Information, Resource)
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

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.id
Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

ShortLogical id of this artifact
Comments

Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.

Control0..1
Typeid
Is Modifierfalse
Must Supportfalse
Summarytrue
4. Composition.meta
Definition

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

ShortMetadata about the resource
Control0..1
TypeMeta
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. Composition.meta.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typeid
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
8. Composition.meta.extension
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 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.

ShortAdditional 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
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.meta.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
10. Composition.meta.versionId
Definition

The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.

ShortVersion specific identifier
Comments

The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.

Control0..1
Typeid
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. Composition.meta.lastUpdated
Definition

When the resource last changed - e.g. when the version changed.

ShortWhen the resource version last changed
Comments

This element is generally omitted in instances submitted in a PUT or POST. Instead, it is populated in the response instance and when retrieving information using a GET. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.

Control0..1
Typeinstant
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. Composition.meta.source
Definition

A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.

ShortIdentifies where the resource comes from
Comments

The exact use of the source (and the possible implied Provenance.entity.role and agent.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. The source may correspond to Provenance.entity.what[x] or Provenance.agent.who[x], though it may be a more general or abstract reference.

This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.

Control0..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. Composition.meta.profile
Definition

A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

ShortProfiles this resource claims to conform to
Comments

It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

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

Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.

ShortSecurity Labels applied to this resource
Comments

The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.

Control0..*
BindingUnless not suitable, these codes SHALL be taken from AllSecurityLabels
(extensible to http://hl7.org/fhir/ValueSet/security-labels
TypeCoding
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. Composition.meta.tag
Definition

Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.

ShortTags applied to this resource
Comments

The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.

Control0..*
BindingFor example codes, see CommonTags
(example to http://hl7.org/fhir/ValueSet/common-tags
TypeCoding
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. 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()))
24. Composition.language
Definition

The base language in which the resource is written.

ShortLanguage 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).

Control0..1
BindingThe codes SHALL be taken from AllLanguages
(required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0
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()))
26. 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()))
28. Composition.contained
Definition

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.

ShortContained, 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
30. Composition.extension
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 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.

ShortAdditional 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())
32. 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())
34. Composition.url
Definition

An absolute URI that is used to identify this Composition when it is referenced in a specification, model, design or an instance; also called its canonical identifier. This SHOULD be globally unique and SHOULD be a literal address at which an authoritative instance of this Composition is (or will be) published. This URL can be the target of a canonical reference. It SHALL remain the same when the Composition is stored on different servers.

ShortCanonical identifier for this Composition, represented as a URI (globally unique)
Comments

Can be a urn:uuid: or a urn:oid: but real http: addresses are preferred. Multiple instances may share the same URL if they have a distinct version.

Control0..1
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Requirements

Allows the Composition to be referenced by a single globally unique identifier.

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

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

ShortVersion-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..1
TypeIdentifier
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
38. Composition.version
Definition

An explicitly assigned identifer of a variation of the content in the Composition.

ShortAn explicitly assigned identifer of a variation of the content in the Composition
Comments

While each resource, including the composition itself, has its own version identifier, this is a formal identifier for the logical version of the Composition as a whole. It would remain constant if the resources were moved to a new server, and all got new individual resource versions, for example.

NoteThis is a business versionId, not a resource version id (see discussion)
Control0..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()))
40. Composition.status
Definition

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

Shortregistered | 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 CompositionStatus
(required to http://hl7.org/fhir/ValueSet/composition-status|5.0.0
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.

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

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.

ShortKind 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 FHIRDocumentTypeCodes
(preferred to http://hl7.org/fhir/ValueSet/doc-typecodes
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summarytrue
Requirements

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

Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types",
    "code" : "32S10",
    "display" : "Substance General Information"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
44. Composition.category
Definition

A categorization for the type of the composition - helps for indexing and searching. This may be implied by or derived from the code specified in the Composition Type.

ShortCategorization of Composition
Control0..*
BindingFor example codes, see ReferencedItemCategoryValueSet
(example to http://hl7.org/fhir/ValueSet/referenced-item-category
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summarytrue
Requirements

Helps humans to assess whether the composition is of interest when viewing an index of compositions or documents.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
46. 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).

ShortWho 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()))
48. Composition.encounter
Definition

Describes the clinical encounter or type of care this documentation is associated with.

ShortContext of the Composition
Control0..1
TypeReference(Encounter)
Is Modifierfalse
Must Supportfalse
Summarytrue
Requirements

Provides context for the composition and supports searching.

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

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

ShortComposition 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.

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

The content was developed with a focus and intent of supporting the contexts that are listed. These contexts may be general categories (gender, age, ...) or may be references to specific programs (insurance plans, studies, ...) and may be used to assist with indexing and searching for appropriate Composition instances.

ShortThe context that the content is intended to support
Comments

When multiple useContexts are specified, there is no expectation that all or any of the contexts apply.

Control0..*
TypeUsageContext
Is Modifierfalse
Must Supportfalse
Summarytrue
Requirements

Assist in searching for appropriate content.

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

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

ShortWho and/or what authored the composition
Control1..1
TypeReference(Sponsor Organization)
Is Modifierfalse
Must Supporttrue
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()))
56. Composition.name
Definition

A natural language name identifying the {{title}}. This name should be usable as an identifier for the module by machine processing applications such as code generation.

ShortName for this Composition (computer friendly)
Comments

The name is not expected to be globally unique. The name should be a simple alphanumeric type name to ensure that it is machine-processing friendly.

Control0..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Requirements

Support human navigation and code generation.

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

Official human-readable label for the composition.

ShortHuman 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 Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
60. Composition.note
Definition

For any additional notes.

ShortFor any additional notes
Comments

A comment, general note or annotation not coded elsewhere.

Control0..*
TypeAnnotation
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
62. Composition.attester
Definition

A participant who has attested to the accuracy of the composition/document.

ShortAttests to accuracy of composition
Comments

Only list each attester once.

Control0..*
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summaryfalse
Requirements

Identifies responsibility for the accuracy of the composition content.

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

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
66. Composition.attester.extension
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 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.

ShortAdditional 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
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())
68. Composition.attester.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.attester.mode
Definition

The type of attestation the authenticator offers.

Shortpersonal | professional | legal | official
Control1..1
BindingThe codes SHOULD be taken from CompositionAttestationMode
(preferred to http://hl7.org/fhir/ValueSet/composition-attestation-mode
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summaryfalse
Requirements

Indicates the level of authority of the attestation.

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

When the composition was attested by the party.

ShortWhen the composition was attested
Control0..1
TypedateTime
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Requirements

Identifies when the information in the composition was deemed accurate. (Things may have changed since then.).

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

Who attested the composition in the specified way.

ShortWho attested the composition
Control0..1
TypeReference(Patient, RelatedPerson, Practitioner, PractitionerRole, Organization)
Is Modifierfalse
Must Supportfalse
Summaryfalse
Requirements

Identifies who has taken on the responsibility for accuracy of the composition content.

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

Identifies the organization or group who is responsible for ongoing maintenance of and access to the composition/document information.

ShortOrganization which maintains the composition
Comments

This is useful when documents are derived from a composition - provides guidance for how to get the latest version of the document. This is optional because this is sometimes not known by the authoring system, and can be inferred by context. However, it is important that this information be known when working with a derived document, so providing a custodian is encouraged.

Control0..1
TypeReference(Organization)
Is Modifierfalse
Must Supportfalse
Summarytrue
Requirements

Identifies where to go to find the current version, where to report issues, etc.

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

Relationships that this composition has with other compositions or documents that already exist.

ShortRelationships to other compositions/documents
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.
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": "..."
    }
  } 
}]
Control0..*
TypeRelatedArtifact
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
80. Composition.event
Definition

The clinical service, such as a colonoscopy or an appendectomy, being documented.

ShortThe clinical service(s) being documented
Comments

The event needs to be consistent with the type element, though can provide further information if desired.

Control0..*
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summarytrue
Requirements

Provides context for the composition and creates a linkage between a resource describing an event and the composition created describing the event.

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

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
84. Composition.event.extension
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 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.

ShortAdditional 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
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())
86. Composition.event.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())
88. Composition.event.period
Definition

The period of time covered by the documentation. There is no assertion that the documentation is a complete representation for this period, only that it documents events during this time.

ShortThe period covered by the documentation
Control0..1
TypePeriod
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
90. Composition.event.detail
Definition

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.

ShortThe event(s) being documented, as code(s), reference(s), or both
Comments

An event can further specialize the act inherent in the typeCode, such as where it is simply "Procedure Report" and the procedure was a "colonoscopy". If one or more events are included, they SHALL NOT conflict with the values inherent in the classCode, practiceSettingCode or typeCode, as such a conflict would create an ambiguous situation. This short list of codes is provided to be used as key words for certain types of queries.

Control0..*
BindingFor example codes, see v3 Code System ActCode
(example to http://terminology.hl7.org/ValueSet/v3-ActCode
TypeCodeableReference(Resource)
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
92. Composition.section
Definition

Substance General Information the 3.2.S.1 eCTD heading.

ShortComposition is broken into sections
Control1..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
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()))
94. Composition.section.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
96. Composition.section.extension
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 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.

ShortAdditional 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
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())
98. 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())
100. 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.

Control1..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
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()))
102. 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.

Control0..1
BindingFor example codes, see DocumentSectionCodes
(example to http://hl7.org/fhir/ValueSet/doc-section-codes
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summaryfalse
Requirements

Provides computable standardized labels to topics within the document.

Pattern Value{
  "coding" : [{
    "system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types",
    "code" : "32S10",
    "display" : "Substance General Information"
  }]
}
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
104. Composition.section.author
Definition

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

ShortWho and/or what authored the section
Control0..*
TypeReference(Practitioner, PractitionerRole, Device, Patient, RelatedPerson, Organization)
Is Modifierfalse
Must Supportfalse
Summaryfalse
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()))
106. Composition.section.focus
Definition

The actual focus of the section when it is not the subject of the composition, but instead represents something or someone associated with the subject such as (for a patient subject) a spouse, parent, fetus, or donor. If not focus is specified, the focus is assumed to be focus of the parent section, or, for a section in the Composition itself, the subject of the composition. Sections with a focus SHALL only include resources where the logical subject (patient, subject, focus, etc.) matches the section focus, or the resources have no logical subject (few resources).

ShortWho/what the section is about, when it is not about the subject of composition
Comments

Typically, sections in a doument are about the subject of the document, whether that is a patient, or group of patients, location, or device, or whatever. For some kind of documents, some sections actually contain data about related entities. Typical examples are a section in a newborn discharge summary concerning the mother, or family history documents, with a section about each family member, though there are many other examples.

Control0..1
TypeReference(Resource)
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
108. Composition.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.

Control0..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()))
110. Composition.section.orderedBy
Definition

Specifies the order applied to the items in the section entries.

ShortOrder of section entries
Comments

Applications SHOULD render ordered lists in the order provided, but MAY allow users to re-order based on their own preferences as well. If there is no order specified, the order is unknown, though there may still be some order.

Control0..1
BindingThe codes SHOULD be taken from ListOrderCodes
(preferred to http://hl7.org/fhir/ValueSet/list-order
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summaryfalse
Requirements

Important for presentation and rendering. Lists may be sorted to place more important information first or to group related entries.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
112. 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.

Control1..1
This element is affected by the following invariants: cmp-1, cmp-2
TypeReference(Substance General Information)
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
114. Composition.section.emptyReason
Definition

If the section is empty, why the list is empty. An empty section typically has some text explaining the empty reason.

ShortWhy the section is empty
Comments

The various reasons for an empty section make a significant interpretation to its interpretation. Note that this code is for use when the entire section content has been suppressed, and not for when individual items are omitted - implementers may consider using a text note or a flag on an entry in these cases.

Control0..1
This element is affected by the following invariants: cmp-2
BindingThe codes SHOULD be taken from ListEmptyReasons
(preferred to http://hl7.org/fhir/ValueSet/list-empty-reason
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summaryfalse
Requirements

Allows capturing things like "none exist" or "not asked" which can be important for most lists.

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

A nested sub-section within this section.

ShortNested Section
Comments

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

Control0..*
TypeSee ttp://hl7.org/fhir/StructureDefinition/Composition#Composition.section
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))