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: CMCeCTDDocument32S23 - Detailed Descriptions

Draft as of 2024-03-04

Definitions for the cmc-ectd-document-32s23 resource profile.

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

0. Bundle
ShortCMC eCTD 32S23 Bundle
Invariantscmc-identifer: A document must have an identifier with a system and a value (type = 'document' implies (identifier.exists(system.exists() and value.exists())))
cmc-32S23: The composition must be EctdComposition32S23 (entry.select(resource as Composition).where(type.exists(coding.exists(code='32S23'))).exists())
2. Bundle.meta
4. Bundle.meta.profile
Control1..1
Must Supporttrue
6. Bundle.identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Control1..?
Must Supporttrue
8. Bundle.identifier.extension
Control1..?
10. Bundle.identifier.extension:version
Slice Nameversion
Control1..1
TypeExtension(Profile IG Version) (Extension Type: string)
Must Supporttrue
12. Bundle.type
Shortdocument
Must Supporttrue
Pattern Valuedocument
14. Bundle.timestamp
Control1..?
Must Supporttrue
16. Bundle.entry
Control1..?
Must Supporttrue
18. Bundle.entry.fullUrl
Control1..?
Must Supporttrue
20. Bundle.entry.resource
Control1..?
Must Supporttrue

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

0. Bundle
Definition

A container for a collection of resources.

ShortCMC eCTD 32S23 BundleContains a collection of resources
Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsbdl-1: total only when a search or history (total.empty() or (type = 'searchset') or (type = 'history'))
bdl-2: entry.search only when a search ((type = 'searchset') or entry.search.empty())
bdl-7: FullUrl must be unique in a bundle, or else entries with the same fullUrl must have different meta.versionId (except in history bundles) ((type = 'history') or entry.where(fullUrl.exists()).select(fullUrl&iif(resource.meta.versionId.exists(), resource.meta.versionId, '')).isDistinct())
bdl-9: A document must have an identifier with a system and a value (type = 'document' implies (identifier.system.exists() and identifier.value.exists()))
bdl-10: A document must have a date (type = 'document' implies (timestamp.hasValue()))
bdl-11: A document must have a Composition as the first resource (type = 'document' implies entry.first().resource.is(Composition))
bdl-12: A message must have a MessageHeader as the first resource (type = 'message' implies entry.first().resource.is(MessageHeader))
bdl-13: A subscription-notification must have a SubscriptionStatus as the first resource (type = 'subscription-notification' implies entry.first().resource.is(SubscriptionStatus))
bdl-14: entry.request.method PATCH not allowed for history (type = 'history' implies entry.request.method != 'PATCH')
bdl-15: Bundle resources where type is not transaction, transaction-response, batch, or batch-response or when the request is a POST SHALL have Bundle.entry.fullUrl populated (type='transaction' or type='transaction-response' or type='batch' or type='batch-response' or entry.all(fullUrl.exists() or request.method='POST'))
bdl-16: Issue.severity for all issues within the OperationOutcome must be either 'information' or 'warning'. (issues.exists() implies (issues.issue.severity = 'information' or issues.issue.severity = 'warning'))
bdl-17: Use and meaning of issues for documents has not been validated because the content will not be rendered in the document. (type = 'document' implies issues.empty())
bdl-18: Self link is required for searchsets. (type = 'searchset' implies link.where(relation = 'self' and url.exists()).exists())
bdl-3a: For collections of type document, message, searchset or collection, all entries must contain resources, and not have request or response elements (type in ('document' | 'message' | 'searchset' | 'collection') implies entry.all(resource.exists() and request.empty() and response.empty()))
bdl-3b: For collections of type history, all entries must contain request or response elements, and resources if the method is POST, PUT or PATCH (type = 'history' implies entry.all(request.exists() and response.exists() and ((request.method in ('POST' | 'PATCH' | 'PUT')) = resource.exists())))
bdl-3c: For collections of type transaction or batch, all entries must contain request elements, and resources if the method is POST, PUT or PATCH (type in ('transaction' | 'batch') implies entry.all(request.method.exists() and ((request.method in ('POST' | 'PATCH' | 'PUT')) = resource.exists())))
bdl-3d: For collections of type transaction-response or batch-response, all entries must contain response elements (type in ('transaction-response' | 'batch-response') implies entry.all(response.exists()))
cmc-identifer: A document must have an identifier with a system and a value (type = 'document' implies (identifier.exists(system.exists() and value.exists())))
cmc-32S23: The composition must be EctdComposition32S23 (entry.select(resource as Composition).where(type.exists(coding.exists(code='32S23'))).exists())
2. Bundle.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. Bundle.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. Bundle.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. Bundle.identifier
Definition

A persistent identifier for the bundle that won't change as a bundle is copied from server to server.

ShortPersistent identifier for the bundle
Comments

Persistent identity generally only matters for batches of type Document, Message, and Collection. It would not normally be populated for search and history results and servers ignore Bundle.identifier when processing batches and transactions. For Documents the .identifier SHALL be populated such that the .identifier is globally unique.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control10..1
This element is affected by the following invariants: bdl-9
TypeIdentifier
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. Bundle.identifier.extension
Definition

An Extension


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.

ShortExtensionAdditional 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.

Control10..*
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 Bundle.identifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
12. Bundle.identifier.extension:version
Slice Nameversion
Definition

The Implementation Guide version number of the bundle profile to which the instance conforms. Additionally, all the profiles of the resources in the bundle must conform to this version.

ShortIG Version
Control1..1
TypeExtension(Profile IG Version) (Extension Type: string)
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
14. Bundle.identifier.use
Definition

The purpose of this identifier.

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

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

Control0..1
BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0
(required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

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

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

Indicates the purpose of this bundle - how it is intended to be used.

Shortdocumentdocument | message | transaction | transaction-response | batch | batch-response | history | searchset | collection | subscription-notification
Comments

It's possible to use a bundle for other purposes (e.g. a document can be accepted as a transaction). This is primarily defined so that there can be specific rules for some of the bundle types.

Control1..1
This element is affected by the following invariants: bdl-1, bdl-2, bdl-3a, bdl-3b, bdl-3c, bdl-3d, bdl-7, bdl-9, bdl-10, bdl-11, bdl-12, bdl-13, bdl-14, bdl-15, bdl-17, bdl-18
BindingThe codes SHALL be taken from BundleTypehttp://hl7.org/fhir/ValueSet/bundle-type|5.0.0
(required to http://hl7.org/fhir/ValueSet/bundle-type|5.0.0
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Pattern Valuedocument
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. Bundle.timestamp
Definition

The date/time that the bundle was assembled - i.e. when the resources were placed in the bundle.

ShortWhen the bundle was assembled
Comments

For many bundles, the timestamp is equal to .meta.lastUpdated, because they are not stored (e.g. search results). When a bundle is placed in a persistent store, .meta.lastUpdated will be usually be changed by the server. When the bundle is a message, a middleware agent altering the message (even if not stored) SHOULD update .meta.lastUpdated. .timestamp is used to track the original time of the Bundle, and SHOULD be populated.

Usage:

  • document : the date the document was created. Note: the composition may predate the document, or be associated with multiple documents. The date of the composition - the authoring time - may be earlier than the document assembly time
  • message : the date that the content of the message was assembled. This date is not changed by middleware engines unless they add additional data that changes the meaning of the time of the message
  • history : the date that the history was assembled. This time would be used as the _since time to ask for subsequent updates
  • searchset : the time that the search set was assembled. Note that different pages MAY have different timestamps but need not. Having different timestamps does not imply that subsequent pages will represent or include changes made since the initial query
  • transaction | transaction-response | batch | batch-response | collection : no particular assigned meaning

The timestamp value should be greater than the lastUpdated and other timestamps in the resources in the bundle, and it should be equal or earlier than the .meta.lastUpdated on the Bundle itself.

Control10..1
This element is affected by the following invariants: bdl-10
Typeinstant
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()))
20. Bundle.entry
Definition

An entry in a bundle resource - will either contain a resource or information about a resource (transactions and history only).

ShortEntry in the bundle - will have a resource or information
Control10..*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsbdl-5: must be a resource unless there's a request or response (resource.exists() or request.exists() or response.exists())
bdl-8: fullUrl cannot be a version specific reference (fullUrl.exists() implies fullUrl.contains('/_history/').not())
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. Bundle.entry.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())
24. Bundle.entry.fullUrl
Definition

The Absolute URL for the resource. Except for transactions and batches, each entry in a Bundle must have a fullUrl. The fullUrl SHALL NOT disagree with the id in the resource - i.e. if the fullUrl is not a urn:uuid, the URL shall be version-independent URL consistent with the Resource.id. The fullUrl is a version independent reference to the resource. Even when not required, fullUrl MAY be set to a urn:uuid to allow referencing entries in a transaction. The fullUrl can be an arbitrary URI and is not limited to urn:uuid, urn:oid, http, and https. The fullUrl element SHALL have a value except when:

  • invoking a create
  • invoking or responding to an operation where the body is not a single identified resource
  • invoking or returning the results of a search or history operation.
ShortURI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
Comments

fullUrl might not be unique in the context of a resource. Note that since FHIR resources do not need to be served through the FHIR API, the fullURL might be a URN or an absolute URL that does not end with the logical id of the resource (Resource.id). However, but if the fullUrl does look like a RESTful server URL (e.g. meets the regex, then the 'id' portion of the fullUrl SHALL end with the Resource.id.

Note that the fullUrl is not the same as the canonical URL - it's an absolute url for an endpoint serving the resource (these will happen to have the same value on the canonical server for the resource with the canonical URL).

Control10..1
This element is affected by the following invariants: bdl-7, bdl-15, bdl-8
Typeuri
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()))
26. Bundle.entry.resource
Definition

The Resource for the entry. The purpose/meaning of the resource is determined by the Bundle.type. This is allowed to be a Parameters resource if and only if it is referenced by something else within the Bundle that provides context/meaning.

ShortA resource in the bundle
Control10..1
This element is affected by the following invariants: bdl-3a, bdl-3b, bdl-3c, bdl-7, bdl-11, bdl-12, bdl-13, bdl-5
TypeResource
Is Modifierfalse
Must Supporttrue
Summarytrue
28. Bundle.entry.request
Definition

Additional information about how this entry should be processed as part of a transaction or batch. For history, it shows how the entry was processed to create the version contained in the entry.

ShortAdditional execution information (transaction/batch/history)
Control0..1
This element is affected by the following invariants: bdl-3a, bdl-3b, bdl-5
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
30. Bundle.entry.request.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())
32. Bundle.entry.request.method
Definition

In a transaction or batch, this is the HTTP action to be executed for this entry. In a history bundle, this indicates the HTTP action that occurred.

ShortGET | HEAD | POST | PUT | DELETE | PATCH
Control1..1
This element is affected by the following invariants: bdl-3b, bdl-3c, bdl-14, bdl-15
BindingThe codes SHALL be taken from HTTPVerbhttp://hl7.org/fhir/ValueSet/http-verb|5.0.0
(required to http://hl7.org/fhir/ValueSet/http-verb|5.0.0
Typecode
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()))
34. Bundle.entry.request.url
Definition

The URL for this entry, relative to the root (the address to which the request is posted).

ShortURL for HTTP equivalent of this entry
Comments

E.g. for a Patient Create, the method would be "POST" and the URL would be "Patient". For a Patient Update, the method would be PUT and the URL would be "Patient/[id]".

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

Indicates the results of processing the corresponding 'request' entry in the batch or transaction being responded to or what the results of an operation where when returning history.

ShortResults of execution (transaction/batch/history)
Control0..1
This element is affected by the following invariants: bdl-3a, bdl-3b, bdl-3d, bdl-5
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
38. Bundle.entry.response.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

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

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

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

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

The status code returned by processing this entry. The status SHALL start with a 3 digit HTTP code (e.g. 404) and may contain the standard HTTP description associated with the status code.

ShortStatus response code (text optional)
Control1..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
42. Bundle.issues
Definition

Captures issues and warnings that relate to the construction of the Bundle and the content within it.

ShortIssues with the Bundle
Comments

Usage notes: These issues and warnings must apply to the Bundle as a whole, not to individual entries.Messages relating to the processing of individual entries (e.g. in a batch or transaction) SHALL be reported in the entry.response.outcome for that entry. If there are errors that arise in the creation of the Bundle, then that should be handled by an OperationOutcome being returned instead of the Bundle.

Control0..1
This element is affected by the following invariants: bdl-16, bdl-17
TypeResource(OperationOutcome)
Is Modifierfalse
Must Supportfalse
Summarytrue

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

0. Bundle
Definition

A container for a collection of resources.

ShortCMC eCTD 32S23 Bundle
Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsbdl-1: total only when a search or history (total.empty() or (type = 'searchset') or (type = 'history'))
bdl-2: entry.search only when a search ((type = 'searchset') or entry.search.empty())
bdl-7: FullUrl must be unique in a bundle, or else entries with the same fullUrl must have different meta.versionId (except in history bundles) ((type = 'history') or entry.where(fullUrl.exists()).select(fullUrl&iif(resource.meta.versionId.exists(), resource.meta.versionId, '')).isDistinct())
bdl-9: A document must have an identifier with a system and a value (type = 'document' implies (identifier.system.exists() and identifier.value.exists()))
bdl-10: A document must have a date (type = 'document' implies (timestamp.hasValue()))
bdl-11: A document must have a Composition as the first resource (type = 'document' implies entry.first().resource.is(Composition))
bdl-12: A message must have a MessageHeader as the first resource (type = 'message' implies entry.first().resource.is(MessageHeader))
bdl-13: A subscription-notification must have a SubscriptionStatus as the first resource (type = 'subscription-notification' implies entry.first().resource.is(SubscriptionStatus))
bdl-14: entry.request.method PATCH not allowed for history (type = 'history' implies entry.request.method != 'PATCH')
bdl-15: Bundle resources where type is not transaction, transaction-response, batch, or batch-response or when the request is a POST SHALL have Bundle.entry.fullUrl populated (type='transaction' or type='transaction-response' or type='batch' or type='batch-response' or entry.all(fullUrl.exists() or request.method='POST'))
bdl-16: Issue.severity for all issues within the OperationOutcome must be either 'information' or 'warning'. (issues.exists() implies (issues.issue.severity = 'information' or issues.issue.severity = 'warning'))
bdl-17: Use and meaning of issues for documents has not been validated because the content will not be rendered in the document. (type = 'document' implies issues.empty())
bdl-18: Self link is required for searchsets. (type = 'searchset' implies link.where(relation = 'self' and url.exists()).exists())
bdl-3a: For collections of type document, message, searchset or collection, all entries must contain resources, and not have request or response elements (type in ('document' | 'message' | 'searchset' | 'collection') implies entry.all(resource.exists() and request.empty() and response.empty()))
bdl-3b: For collections of type history, all entries must contain request or response elements, and resources if the method is POST, PUT or PATCH (type = 'history' implies entry.all(request.exists() and response.exists() and ((request.method in ('POST' | 'PATCH' | 'PUT')) = resource.exists())))
bdl-3c: For collections of type transaction or batch, all entries must contain request elements, and resources if the method is POST, PUT or PATCH (type in ('transaction' | 'batch') implies entry.all(request.method.exists() and ((request.method in ('POST' | 'PATCH' | 'PUT')) = resource.exists())))
bdl-3d: For collections of type transaction-response or batch-response, all entries must contain response elements (type in ('transaction-response' | 'batch-response') implies entry.all(response.exists()))
cmc-identifer: A document must have an identifier with a system and a value (type = 'document' implies (identifier.exists(system.exists() and value.exists())))
cmc-32S23: The composition must be EctdComposition32S23 (entry.select(resource as Composition).where(type.exists(coding.exists(code='32S23'))).exists())
2. Bundle.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. Bundle.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. Bundle.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. Bundle.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 Bundle.meta.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
10. Bundle.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. Bundle.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. Bundle.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. Bundle.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. Bundle.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. Bundle.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. Bundle.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. Bundle.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. Bundle.identifier
Definition

A persistent identifier for the bundle that won't change as a bundle is copied from server to server.

ShortPersistent identifier for the bundle
Comments

Persistent identity generally only matters for batches of type Document, Message, and Collection. It would not normally be populated for search and history results and servers ignore Bundle.identifier when processing batches and transactions. For Documents the .identifier SHALL be populated such that the .identifier is globally unique.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control1..1
This element is affected by the following invariants: bdl-9
TypeIdentifier
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. Bundle.identifier.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
30. Bundle.identifier.extension
Definition

An Extension

ShortExtension
Control1..*
TypeExtension
Is Modifierfalse
Summaryfalse
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 Bundle.identifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
32. Bundle.identifier.extension:version
Slice Nameversion
Definition

The Implementation Guide version number of the bundle profile to which the instance conforms. Additionally, all the profiles of the resources in the bundle must conform to this version.

ShortIG Version
Control1..1
TypeExtension(Profile IG Version) (Extension Type: string)
Is Modifierfalse
Must Supporttrue
Summaryfalse
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. Bundle.identifier.use
Definition

The purpose of this identifier.

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

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

Control0..1
BindingThe codes SHALL be taken from IdentifierUse
(required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

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

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

A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

ShortDescription of identifier
Comments

This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

Control0..1
BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodes
(extensible to http://hl7.org/fhir/ValueSet/identifier-type
TypeCodeableConcept
Is Modifierfalse
Summarytrue
Requirements

Allows users to make use of identifiers when the identifier system is not known.

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

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

ShortThe namespace for the identifier value
Comments

Identifier.system is always case sensitive.

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

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

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

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

ShortThe value that is unique
Comments

If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

Control0..1
This element is affected by the following invariants: ident-1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Example<br/><b>General</b>:123456
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
42. Bundle.identifier.period
Definition

Time period during which identifier is/was valid for use.

ShortTime period when id is/was valid for use
Control0..1
TypePeriod
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
44. Bundle.identifier.assigner
Definition

Organization that issued/manages the identifier.

ShortOrganization that issued id (may be just text)
Comments

The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

Control0..1
TypeReference(Organization)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
46. Bundle.type
Definition

Indicates the purpose of this bundle - how it is intended to be used.

Shortdocument
Comments

It's possible to use a bundle for other purposes (e.g. a document can be accepted as a transaction). This is primarily defined so that there can be specific rules for some of the bundle types.

Control1..1
This element is affected by the following invariants: bdl-1, bdl-2, bdl-3a, bdl-3b, bdl-3c, bdl-3d, bdl-7, bdl-9, bdl-10, bdl-11, bdl-12, bdl-13, bdl-14, bdl-15, bdl-17, bdl-18
BindingThe codes SHALL be taken from BundleType
(required to http://hl7.org/fhir/ValueSet/bundle-type|5.0.0
Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Pattern Valuedocument
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
48. Bundle.timestamp
Definition

The date/time that the bundle was assembled - i.e. when the resources were placed in the bundle.

ShortWhen the bundle was assembled
Comments

For many bundles, the timestamp is equal to .meta.lastUpdated, because they are not stored (e.g. search results). When a bundle is placed in a persistent store, .meta.lastUpdated will be usually be changed by the server. When the bundle is a message, a middleware agent altering the message (even if not stored) SHOULD update .meta.lastUpdated. .timestamp is used to track the original time of the Bundle, and SHOULD be populated.

Usage:

  • document : the date the document was created. Note: the composition may predate the document, or be associated with multiple documents. The date of the composition - the authoring time - may be earlier than the document assembly time
  • message : the date that the content of the message was assembled. This date is not changed by middleware engines unless they add additional data that changes the meaning of the time of the message
  • history : the date that the history was assembled. This time would be used as the _since time to ask for subsequent updates
  • searchset : the time that the search set was assembled. Note that different pages MAY have different timestamps but need not. Having different timestamps does not imply that subsequent pages will represent or include changes made since the initial query
  • transaction | transaction-response | batch | batch-response | collection : no particular assigned meaning

The timestamp value should be greater than the lastUpdated and other timestamps in the resources in the bundle, and it should be equal or earlier than the .meta.lastUpdated on the Bundle itself.

Control1..1
This element is affected by the following invariants: bdl-10
Typeinstant
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()))
50. Bundle.total
Definition

If a set of search matches, this is the (potentially estimated) total number of entries of type 'match' across all pages in the search. It does not include search.mode = 'include' or 'outcome' entries and it does not provide a count of the number of entries in the Bundle.

ShortIf search, the total number of matches
Comments

Only used if the bundle is a search result set. The total does not include resources such as OperationOutcome and included resources, only the total number of matching resources.

Control0..1
This element is affected by the following invariants: bdl-1
TypeunsignedInt
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()))
52. Bundle.link
Definition

A series of links that provide context to this bundle.

ShortLinks related to this Bundle
Comments

Both Bundle.link and Bundle.entry.link are defined to support providing additional context when Bundles are used (e.g. HATEOAS).

Bundle.entry.link corresponds to links found in the HTTP header if the resource in the entry was read directly.

This specification defines some specific uses of Bundle.link for searching and paging, but no specific uses for Bundle.entry.link, and no defined function in a transaction - the meaning is implementation specific. The behavior of navigation link types (next/prev/first/last) are well defined for searchset and history Bundles but are not currently defined for other types. Implementers who choose to use such link relationships for other bundle types will need to negotiate behavior with their interoperability partners.

Control0..*
This element is affected by the following invariants: bdl-18
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
54. Bundle.link.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
56. Bundle.link.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())
58. Bundle.link.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

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

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

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

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

A name which details the functional use for this link - see http://www.iana.org/assignments/link-relations/link-relations.xhtml#link-relations-1.

ShortSee http://www.iana.org/assignments/link-relations/link-relations.xhtml#link-relations-1
Control1..1
This element is affected by the following invariants: bdl-18
BindingThe codes SHALL be taken from LinkRelationTypes
(required to http://hl7.org/fhir/ValueSet/iana-link-relations|5.0.0
Typecode
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()))
62. Bundle.link.url
Definition

The reference details for the link.

ShortReference details for the link
Control1..1
This element is affected by the following invariants: bdl-18
Typeuri
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()))
64. Bundle.entry
Definition

An entry in a bundle resource - will either contain a resource or information about a resource (transactions and history only).

ShortEntry in the bundle - will have a resource or information
Control1..*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsbdl-5: must be a resource unless there's a request or response (resource.exists() or request.exists() or response.exists())
bdl-8: fullUrl cannot be a version specific reference (fullUrl.exists() implies fullUrl.contains('/_history/').not())
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
66. Bundle.entry.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
68. Bundle.entry.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())
70. Bundle.entry.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())
72. Bundle.entry.link
Definition

A series of links that provide context to this entry.

ShortLinks related to this entry
Control0..*
TypeSee ttp://hl7.org/fhir/StructureDefinition/Bundle#Bundle.link
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
74. Bundle.entry.fullUrl
Definition

The Absolute URL for the resource. Except for transactions and batches, each entry in a Bundle must have a fullUrl. The fullUrl SHALL NOT disagree with the id in the resource - i.e. if the fullUrl is not a urn:uuid, the URL shall be version-independent URL consistent with the Resource.id. The fullUrl is a version independent reference to the resource. Even when not required, fullUrl MAY be set to a urn:uuid to allow referencing entries in a transaction. The fullUrl can be an arbitrary URI and is not limited to urn:uuid, urn:oid, http, and https. The fullUrl element SHALL have a value except when:

  • invoking a create
  • invoking or responding to an operation where the body is not a single identified resource
  • invoking or returning the results of a search or history operation.
ShortURI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
Comments

fullUrl might not be unique in the context of a resource. Note that since FHIR resources do not need to be served through the FHIR API, the fullURL might be a URN or an absolute URL that does not end with the logical id of the resource (Resource.id). However, but if the fullUrl does look like a RESTful server URL (e.g. meets the regex, then the 'id' portion of the fullUrl SHALL end with the Resource.id.

Note that the fullUrl is not the same as the canonical URL - it's an absolute url for an endpoint serving the resource (these will happen to have the same value on the canonical server for the resource with the canonical URL).

Control1..1
This element is affected by the following invariants: bdl-7, bdl-15, bdl-8
Typeuri
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()))
76. Bundle.entry.resource
Definition

The Resource for the entry. The purpose/meaning of the resource is determined by the Bundle.type. This is allowed to be a Parameters resource if and only if it is referenced by something else within the Bundle that provides context/meaning.

ShortA resource in the bundle
Control1..1
This element is affected by the following invariants: bdl-3a, bdl-3b, bdl-3c, bdl-7, bdl-11, bdl-12, bdl-13, bdl-5
TypeResource
Is Modifierfalse
Must Supporttrue
Summarytrue
78. Bundle.entry.search
Definition

Information about the search process that lead to the creation of this entry.

ShortSearch related information
Control0..1
This element is affected by the following invariants: bdl-2
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
80. Bundle.entry.search.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
82. Bundle.entry.search.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())
84. Bundle.entry.search.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())
86. Bundle.entry.search.mode
Definition

Why this entry is in the result set - whether it's included as a match or because of an _include requirement, or to convey information or warning information about the search process.

Shortmatch | include - why this is in the result set
Comments

There is only one mode. In some corner cases, a resource may be included because it is both a match and an include. In these circumstances, 'match' takes precedence.

Control0..1
BindingThe codes SHALL be taken from SearchEntryMode
(required to http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0
Typecode
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()))
88. Bundle.entry.search.score
Definition

When searching, the server's search ranking score for the entry.

ShortSearch ranking (between 0 and 1)
Comments

Servers are not required to return a ranking score. 1 is most relevant, and 0 is least relevant. Often, search results are sorted by score, but the client may specify a different sort order.

See Patient Match for the EMPI search which relates to this element.

Control0..1
Typedecimal
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()))
90. Bundle.entry.request
Definition

Additional information about how this entry should be processed as part of a transaction or batch. For history, it shows how the entry was processed to create the version contained in the entry.

ShortAdditional execution information (transaction/batch/history)
Control0..1
This element is affected by the following invariants: bdl-3a, bdl-3b, bdl-5
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
92. Bundle.entry.request.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
94. Bundle.entry.request.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())
96. Bundle.entry.request.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())
98. Bundle.entry.request.method
Definition

In a transaction or batch, this is the HTTP action to be executed for this entry. In a history bundle, this indicates the HTTP action that occurred.

ShortGET | HEAD | POST | PUT | DELETE | PATCH
Control1..1
This element is affected by the following invariants: bdl-3b, bdl-3c, bdl-14, bdl-15
BindingThe codes SHALL be taken from HTTPVerb
(required to http://hl7.org/fhir/ValueSet/http-verb|5.0.0
Typecode
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()))
100. Bundle.entry.request.url
Definition

The URL for this entry, relative to the root (the address to which the request is posted).

ShortURL for HTTP equivalent of this entry
Comments

E.g. for a Patient Create, the method would be "POST" and the URL would be "Patient". For a Patient Update, the method would be PUT and the URL would be "Patient/[id]".

Control1..1
Typeuri
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()))
102. Bundle.entry.request.ifNoneMatch
Definition

If the ETag values match, return a 304 Not Modified status. See the API documentation for "Conditional Read".

ShortFor managing cache validation
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()))
104. Bundle.entry.request.ifModifiedSince
Definition

Only perform the operation if the last updated date matches. See the API documentation for "Conditional Read".

ShortFor managing cache currency
Control0..1
Typeinstant
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()))
106. Bundle.entry.request.ifMatch
Definition

Only perform the operation if the Etag value matches. For more information, see the API section "Managing Resource Contention".

ShortFor managing update contention
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()))
108. Bundle.entry.request.ifNoneExist
Definition

Instruct the server not to perform the create if a specified resource already exists. For further information, see the API documentation for "Conditional Create". This is just the query portion of the URL - what follows the "?" (not including the "?").

ShortFor conditional creates
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()))
110. Bundle.entry.response
Definition

Indicates the results of processing the corresponding 'request' entry in the batch or transaction being responded to or what the results of an operation where when returning history.

ShortResults of execution (transaction/batch/history)
Control0..1
This element is affected by the following invariants: bdl-3a, bdl-3b, bdl-3d, bdl-5
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
112. Bundle.entry.response.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
114. Bundle.entry.response.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())
116. Bundle.entry.response.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())
118. Bundle.entry.response.status
Definition

The status code returned by processing this entry. The status SHALL start with a 3 digit HTTP code (e.g. 404) and may contain the standard HTTP description associated with the status code.

ShortStatus response code (text optional)
Control1..1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
120. Bundle.entry.response.location
Definition

The location header created by processing this operation, populated if the operation returns a location.

ShortThe location (if the operation returns a location)
Control0..1
Typeuri
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()))
122. Bundle.entry.response.etag
Definition

The Etag for the resource, if the operation for the entry produced a versioned resource (see Resource Metadata and Versioning and Managing Resource Contention).

ShortThe Etag for the resource (if relevant)
Comments

Etags match the Resource.meta.versionId. The ETag has to match the version id in the header if a resource is included.

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()))
124. Bundle.entry.response.lastModified
Definition

The date/time that the resource was modified on the server.

ShortServer's date time modified
Comments

This has to match the same time in the meta header (meta.lastUpdated) if a resource is included.

Control0..1
Typeinstant
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()))
126. Bundle.entry.response.outcome
Definition

An OperationOutcome containing hints and warnings produced as part of processing this entry in a batch or transaction.

ShortOperationOutcome with hints and warnings (for batch/transaction)
Comments

For a POST/PUT operation, this is the equivalent outcome that would be returned for prefer = operationoutcome - except that the resource is always returned whether or not the outcome is returned.

This outcome is not used for error responses in batch/transaction, only for hints and warnings. In a batch operation, the error will be in Bundle.entry.response, and for transaction, there will be a single OperationOutcome instead of a bundle in the case of an error.

Control0..1
TypeResource
Is Modifierfalse
Must Supportfalse
Summarytrue
128. Bundle.signature
Definition

Digital Signature - base64 encoded. XML-DSig or a JWS.

ShortDigital Signature
Comments

The signature could be created by the "author" of the bundle or by the originating device. Requirements around inclusion of a signature, verification of signatures and treatment of signed/non-signed bundles is implementation-environment specific.

Control0..1
TypeSignature
Is Modifierfalse
Must Supportfalse
Summarytrue
Requirements

A Signature holds an electronic representation of a signature and its supporting context in a FHIR accessible form. The signature may either be a cryptographic type (XML DigSig or a JWS), which is able to provide non-repudiation proof, or it may be a graphical image that represents a signature or a signature process. This element allows capturing signatures on documents, messages, transactions or even search responses, to support content-authentication, non-repudiation or other business cases. This is primarily relevant where the bundle may travel through multiple hops or via other mechanisms where HTTPS non-repudiation is insufficient.

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

Captures issues and warnings that relate to the construction of the Bundle and the content within it.

ShortIssues with the Bundle
Comments

Usage notes: These issues and warnings must apply to the Bundle as a whole, not to individual entries.Messages relating to the processing of individual entries (e.g. in a batch or transaction) SHALL be reported in the entry.response.outcome for that entry. If there are errors that arise in the creation of the Bundle, then that should be handled by an OperationOutcome being returned instead of the Bundle.

Control0..1
This element is affected by the following invariants: bdl-16, bdl-17
TypeResource(OperationOutcome)
Is Modifierfalse
Must Supportfalse
Summarytrue