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.).

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.

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.

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.

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.

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.

An Extension

Reference to the Marketing Authorisation Holder organization. When Author and MAH are the same entity, both Composition.author and this extension reference the same Organization resource.

Optional image of the product or administration device (e.g., package, inhaler, pen, injection device) as base64-encoded data. Displayed as a header above the root chapter with no direct reference to content sections.

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).

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.

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.

Fixed to 'final'. Only finalized ePIL documents are accepted for submission (eAAPI) and delivered to consumers (eCAPI). Document workflow states such as drafts or discarded versions are not represented in the FHIR resource — these are managed by the platform, not the IG.

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.

The workflow/clinical status of the composition.

Need to be able to mark interim, amended, or withdrawn compositions or documents.

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.

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.

Type of a composition.

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

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).

For clinical documents, this is usually the patient.

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

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

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.

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.

Reference to the organization that created and submitted the ePIL document. This may be the MAH itself or a subcompany acting on behalf of the MAH.

Identifies who is responsible for the content.

Free-text title of the ePIL combining the invented name with all strengths and pharmaceutical forms (e.g., 'Tripapolon 100mg, 300mg, 500mg Tabletten'). This structured title is displayed in ePIL listings and should include all marketed strengths and dosage forms covered by this document.

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.

References to related versions of this Product Information Leaflet or other related documents.

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": "..."
    }
  } 
}]

Reference to the previous version that this document replaces. Used for change tracking in conjunction with section-level change extensions.

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": "..."
    }
  } 
}]

The type of relationship to the related artifact.

The presence of both sides of a relationship type (e.g. successor and predecessor) is required to support use cases where one side of a relationship is not represented in FHIR. However, this feature SHALL NOT be used to create bi-directional resource links in FHIR instances. Specifically, following the methodology of "new points to old" and "many points to one", when using related artifact elements to describe and reference FHIR resources, the type element SHALL be drawn from the fhir-related-artifact-type ValueSet.

The type of relationship to the related artifact.

The month when the previous version was published in YYYY-MM format (e.g., '2025-12').

Level 1 section heading for the whole EPI

An Extension

When present and set to true, indicates this section has been modified compared to the previous version referenced in relatesTo.

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).

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.

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.

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

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

Nested Sections sub-section headings for level 2.

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

An Extension

When present and set to true, indicates this level 2 subsection has been modified compared to the previous version.

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).

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.

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.

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

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.

Classification of a section of a composition/document.

Provides computable standardized labels to topics within the document.

A reference to a code defined by a terminology system.

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

Allows for alternative encodings within a code system, and translations to other code systems.

The identification of the code system that defines the meaning of the symbol in the code.

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.

Need to be unambiguous about the source of the definition of the symbol.

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

Need to refer to a particular code in the system.

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

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

The root of the sections that make up the composition.

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).

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.

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.

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

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.

Classification of a section of a composition/document.

Provides computable standardized labels to topics within the document.

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

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

Nested Sections sub-section headings for level 2.

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

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).

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.

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.

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

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.

Classification of a section of a composition/document.

Provides computable standardized labels to topics within the document.

A reference to a code defined by a terminology system.

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

Allows for alternative encodings within a code system, and translations to other code systems.

The identification of the code system that defines the meaning of the symbol in the code.

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.

Need to be unambiguous about the source of the definition of the symbol.

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

Need to refer to a particular code in the system.

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

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

The root of the sections that make up the composition.

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).

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.

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.

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.

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.

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

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

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.

Classification of a section of a composition/document.

Provides computable standardized labels to topics within the document.

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

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

Nested Sections sub-section headings for level 2.

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

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).

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.

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.

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

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

A nested sub-section within this section.

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

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).

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.

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.

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.

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.

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

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

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.

Classification of a section of a composition/document.

Provides computable standardized labels to topics within the document.

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

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

A nested sub-section within this section.

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

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).

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.

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.

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.

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.

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

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

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.

Classification of a section of a composition/document.

Provides computable standardized labels to topics within the document.

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

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

Nested Sections sub-section headings for level 3.

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

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).

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.

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.

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

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

A nested sub-section within this section.

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

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).

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.

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.

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.

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.

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

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

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.

Classification of a section of a composition/document.

Provides computable standardized labels to topics within the document.

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

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

A nested sub-section within this section.

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

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).

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.

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.

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.

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.

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

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

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.

Classification of a section of a composition/document.

Provides computable standardized labels to topics within the document.

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

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

Nested Sections sub-section headings for level 3.

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

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).

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.

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.

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

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

A nested sub-section within this section.

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

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).

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.

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.

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.

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.

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

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

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.

Classification of a section of a composition/document.

Provides computable standardized labels to topics within the document.

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

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

References to related versions of this Product Information Leaflet or other related documents.

Reference to the previous version that this document replaces. Used for change tracking in conjunction with section-level change extensions.

The month when the previous version was published in YYYY-MM format (e.g., '2025-12').

When present and set to true, indicates this section has been modified compared to the previous version referenced in relatesTo.

When present and set to true, indicates this level 2 subsection has been modified compared to the previous version.

When present and set to true, indicates this level 3 subsection has been modified compared to the previous version.

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.).

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.

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

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.

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.

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.

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.

The base language in which the resource is written.

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).

IETF language tag for a human language

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.

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.

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.

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.

An Extension

Reference to the Marketing Authorisation Holder organization. When Author and MAH are the same entity, both Composition.author and this extension reference the same Organization resource.

Optional image of the product or administration device (e.g., package, inhaler, pen, injection device) as base64-encoded data. Displayed as a header above the root chapter with no direct reference to content sections.

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).

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.

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.

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.

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.

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

A UUID uniquely identifying this specific version of the Product Information Leaflet (PIL).

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

Semantic version identifier for this ePIL document following semver format (e.g., '1.0.0', '2.1.3'). This is distinct from the unique identifier and allows tracking of document revisions using MAJOR.MINOR.PATCH versioning.

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.

Fixed to 'final'. Only finalized ePIL documents are accepted for submission (eAAPI) and delivered to consumers (eCAPI). Document workflow states such as drafts or discarded versions are not represented in the FHIR resource — these are managed by the platform, not the IG.

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.

The workflow/clinical status of the composition.

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

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.

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.

Type of a composition.

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

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

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.

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.

A reference to a code defined by a terminology system.

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

Allows for alternative encodings within a code system, and translations to other code systems.

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

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.

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.

The identification of the code system that defines the meaning of the symbol in the code.

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.

Need to be unambiguous about the source of the definition of the symbol.

The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

Need to refer to a particular code in the system.

A representation of the meaning of the code in the system, following the rules of the system.

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

Very often the text is the same as a displayName of one of the codings.

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

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.

High-level kind of a clinical document at a macro level.

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

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).

For clinical documents, this is usually the patient.

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

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

Provides context for the composition and supports searching.

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

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.

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.

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.

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

Assist in searching for appropriate content.

Reference to the organization that created and submitted the ePIL document. This may be the MAH itself or a subcompany acting on behalf of the MAH.

Identifies who is responsible for the content.

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.

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.

Support human navigation and code generation.

Free-text title of the ePIL combining the invented name with all strengths and pharmaceutical forms (e.g., 'Tripapolon 100mg, 300mg, 500mg Tabletten'). This structured title is displayed in ePIL listings and should include all marketed strengths and dosage forms covered by this document.

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.

For any additional notes.

A comment, general note or annotation not coded elsewhere.

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

Only list each attester once.

Identifies responsibility for the accuracy of the composition content.

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

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.

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.

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).

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.

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.

The type of attestation the authenticator offers.

The way in which a person authenticated a composition.

Indicates the level of authority of the attestation.

When the composition was attested by the party.

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

Who attested the composition in the specified way.

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

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

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.

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

References to related versions of this Product Information Leaflet or other related documents.

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": "..."
    }
  } 
}]

Reference to the previous version that this document replaces. Used for change tracking in conjunction with section-level change extensions.

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": "..."
    }
  } 
}]

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

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.

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.

The type of relationship to the related artifact.

The presence of both sides of a relationship type (e.g. successor and predecessor) is required to support use cases where one side of a relationship is not represented in FHIR. However, this feature SHALL NOT be used to create bi-directional resource links in FHIR instances. Specifically, following the methodology of "new points to old" and "many points to one", when using related artifact elements to describe and reference FHIR resources, the type element SHALL be drawn from the fhir-related-artifact-type ValueSet.

The type of relationship to the related artifact.

Provides additional classifiers of the related artifact.

Additional classifiers for the related artifact.

A short label that can be used to reference the citation from elsewhere in the containing artifact, such as a footnote index.

A brief description of the document or knowledge resource being referenced, suitable for display to a consumer.

A bibliographic citation for the related artifact. This text SHOULD be formatted according to an accepted citation format.

Additional structured information about citations should be captured as extensions.

The document being referenced, represented as an attachment. This is exclusive with the resource element.