Global Core Electronic Medicinal Product Information (ePI), published by HL7 International - Biomedical Research & Regulation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions

• Content
• Detailed Descriptions
• Mappings
• Examples
• XML
• JSON
• TTL

Resource Profile: Bundle - ePI

Medicinal product information is a pivotal source of regulated and scientifically validated information that assists healthcare professionals in prescribing and dispensing the medicine and informs consumers about its safe and effective use. This profile represents the constraints applied to the Bundle resource used in the Electronic Product Information (ePI) FHIR Implementation Guide.

This profile represents the constraints applied to the Bundle resource used to create an Electronic Product Information (ePI) document.

Usages:

• Examples for this Profile: Bundle/bundlepackageleaflet75type1, Bundle/bundlepackageleaflet75type2 and Bundle/bundlepackageleaflet75type3
• CapabilityStatements using this Profile: Simple Vulcan ePI Server Capability Statement

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

• Key Elements Table
• Differential Table
• Snapshot Table
• Statistics/References
• All

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Bundle	C	0..*	Bundle	Electronic Product Information Bundle Document Constraints: bdl-1, bdl-2, bdl-7, bdl-9, bdl-10, bdl-11, bdl-12, bdl-13, bdl-14, bdl-15, bdl-16, bdl-17, bdl-18, bdl-3a, bdl-3b, bdl-3c, bdl-3d, bdl-epi-1
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
identifier	ΣC	1..1	Identifier	Persistent identifier for the bundle
type	ΣC	1..1	code	document | message | transaction | transaction-response | batch | batch-response | history | searchset | collection | subscription-notification Binding: BundleType (required): Indicates the purpose of a bundle - how it is intended to be used. Fixed Value: document
timestamp	ΣC	1..1	instant	Persistent original date of approval
Slices for entry	ΣC	1..*	BackboneElement	Entry resource in the ePI bundle Slice: Unordered, Open by type:$this.resource Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
entry:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	ΣC	1..1	Resource	A resource in the bundle
entry:composition	ΣC	1..1	BackboneElement	ePI Composition Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	CompositionUvEpi	A set of resources composed into a single coherent clinical statement with clinical attestation
entry:organization	ΣC	0..*	BackboneElement	Organization Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	OrganizationUvEpi	A grouping of people or organizations with a common purpose
entry:authorization	ΣC	0..*	BackboneElement	Regulated Authorization Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	RegulatedAuthorizationUvEpi	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
entry:medicinalProduct	ΣC	0..*	BackboneElement	Medicinal Product Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	MedicinalProductDefinitionUvEpi	Detailed definition of a medicinal product
entry:packagedProduct	ΣC	0..*	BackboneElement	Packaged Product Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	PackagedProductDefinitionUvEpi	A medically related item or items, in a container or package
entry:administrableProduct	ΣC	0..*	BackboneElement	Administrable Product Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	AdministrableProductDefinitionUvEpi	A medicinal product in the final form, suitable for administration - after any mixing of multiple components
entry:manufacturedItem	ΣC	0..*	BackboneElement	Manufactured Item Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	ManufacturedItemDefinitionUvEpi	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
entry:ingredient	ΣC	0..*	BackboneElement	Ingredient Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	IngredientUvEpi	An ingredient of a manufactured item or pharmaceutical product
entry:clinicalUse	ΣC	0..*	BackboneElement	Interactions, Warnings, Indications,Contraindications Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	ΣC	1..1	ClinicalUseDefinition	A resource in the bundle
entry:substanceDefinition	ΣC	0..*	BackboneElement	Substance Definition Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	SubstanceDefinitionUvEpi	The detailed description of a substance, typically at a level beyond what is used for prescribing
entry:binary	ΣC	0..*	BackboneElement	Binary Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	ΣC	1..1	Binary	A resource in the bundle
signature	Σ	0..1	Signature	Digital Signature.
issues	ΣC	0..1	OperationOutcome	Issues with the Bundle
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Bundle.type	required	Fixed Value: document http://hl7.org/fhir/ValueSet/bundle-type|5.0.0 From the FHIR Standard
Bundle.entry.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:composition.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:organization.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:authorization.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:medicinalProduct.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:packagedProduct.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:administrableProduct.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:manufacturedItem.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:ingredient.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:clinicalUse.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:substanceDefinition.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:binary.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
bdl-1	error	Bundle	total only when a search or history : total.empty() or (type = 'searchset') or (type = 'history')
bdl-2	error	Bundle	entry.search only when a search : (type = 'searchset') or entry.search.empty()
bdl-5	error	Bundle.entry, Bundle.entry:composition, Bundle.entry:organization, Bundle.entry:authorization, Bundle.entry:medicinalProduct, Bundle.entry:packagedProduct, Bundle.entry:administrableProduct, Bundle.entry:manufacturedItem, Bundle.entry:ingredient, Bundle.entry:clinicalUse, Bundle.entry:substanceDefinition, Bundle.entry:binary	must be a resource unless there's a request or response : resource.exists() or request.exists() or response.exists()
bdl-7	error	Bundle	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-8	error	Bundle.entry, Bundle.entry:composition, Bundle.entry:organization, Bundle.entry:authorization, Bundle.entry:medicinalProduct, Bundle.entry:packagedProduct, Bundle.entry:administrableProduct, Bundle.entry:manufacturedItem, Bundle.entry:ingredient, Bundle.entry:clinicalUse, Bundle.entry:substanceDefinition, Bundle.entry:binary	fullUrl cannot be a version specific reference : fullUrl.exists() implies fullUrl.contains('/_history/').not()
bdl-9	error	Bundle	A document must have an identifier with a system and a value : type = 'document' implies (identifier.system.exists() and identifier.value.exists())
bdl-10	error	Bundle	A document must have a date : type = 'document' implies (timestamp.hasValue())
bdl-11	error	Bundle	A document must have a Composition as the first resource : type = 'document' implies entry.first().resource.is(Composition)
bdl-12	error	Bundle	A message must have a MessageHeader as the first resource : type = 'message' implies entry.first().resource.is(MessageHeader)
bdl-13	error	Bundle	A subscription-notification must have a SubscriptionStatus as the first resource : type = 'subscription-notification' implies entry.first().resource.is(SubscriptionStatus)
bdl-14	error	Bundle	entry.request.method PATCH not allowed for history : type = 'history' implies entry.request.method != 'PATCH'
bdl-15	error	Bundle	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	error	Bundle	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	error	Bundle	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	error	Bundle	Self link is required for searchsets. : type = 'searchset' implies link.where(relation = 'self' and url.exists()).exists()
bdl-3a	error	Bundle	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	error	Bundle	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	error	Bundle	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	error	Bundle	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())
bdl-epi-1	error	Bundle	An ePI document must have no additional Composition (including Composition subclass) resources besides the first. : entry.tail().where(resource is Composition).empty()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from Bundle

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Bundle	C	0..*	Bundle	Electronic Product Information Bundle Document Constraints: bdl-epi-1
identifier		1..1	Identifier	Persistent identifier for the bundle
type		1..1	code	document | message | transaction | transaction-response | batch | batch-response | history | searchset | collection | subscription-notification Fixed Value: document
timestamp		1..1	instant	Persistent original date of approval
Slices for entry		1..*	BackboneElement	Entry resource in the ePI bundle Slice: Unordered, Open by type:$this.resource
entry:All Slices				Content/Rules for all slices
fullUrl		1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	Resource	A resource in the bundle
search		0..0
request		0..0
response		0..0
entry:composition		1..1	BackboneElement	ePI Composition
resource		1..1	CompositionUvEpi	A set of resources composed into a single coherent clinical statement with clinical attestation
entry:organization		0..*	BackboneElement	Organization
resource		1..1	OrganizationUvEpi	A grouping of people or organizations with a common purpose
entry:authorization		0..*	BackboneElement	Regulated Authorization
resource		1..1	RegulatedAuthorizationUvEpi	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
entry:medicinalProduct		0..*	BackboneElement	Medicinal Product
resource		1..1	MedicinalProductDefinitionUvEpi	Detailed definition of a medicinal product
entry:packagedProduct		0..*	BackboneElement	Packaged Product
resource		1..1	PackagedProductDefinitionUvEpi	A medically related item or items, in a container or package
entry:administrableProduct		0..*	BackboneElement	Administrable Product
resource		1..1	AdministrableProductDefinitionUvEpi	A medicinal product in the final form, suitable for administration - after any mixing of multiple components
entry:manufacturedItem		0..*	BackboneElement	Manufactured Item
resource		1..1	ManufacturedItemDefinitionUvEpi	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
entry:ingredient		0..*	BackboneElement	Ingredient
resource		1..1	IngredientUvEpi	An ingredient of a manufactured item or pharmaceutical product
entry:clinicalUse		0..*	BackboneElement	Interactions, Warnings, Indications,Contraindications
resource		1..1	ClinicalUseDefinition	A resource in the bundle
entry:substanceDefinition		0..*	BackboneElement	Substance Definition
resource		1..1	SubstanceDefinitionUvEpi	The detailed description of a substance, typically at a level beyond what is used for prescribing
entry:binary		0..*	BackboneElement	Binary
resource		1..1	Binary	A resource in the bundle
signature		0..1	Signature	Digital Signature.
Documentation for this format

Constraints

Id	Grade	Path(s)	Details	Requirements
bdl-epi-1	error	Bundle	An ePI document must have no additional Composition (including Composition subclass) resources besides the first. : entry.tail().where(resource is Composition).empty()

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Bundle	C	0..*	Bundle	Electronic Product Information Bundle Document Constraints: bdl-1, bdl-2, bdl-7, bdl-9, bdl-10, bdl-11, bdl-12, bdl-13, bdl-14, bdl-15, bdl-16, bdl-17, bdl-18, bdl-3a, bdl-3b, bdl-3c, bdl-3d, bdl-epi-1
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter
identifier	ΣC	1..1	Identifier	Persistent identifier for the bundle
type	ΣC	1..1	code	document | message | transaction | transaction-response | batch | batch-response | history | searchset | collection | subscription-notification Binding: BundleType (required): Indicates the purpose of a bundle - how it is intended to be used. Fixed Value: document
timestamp	ΣC	1..1	instant	Persistent original date of approval
total	ΣC	0..1	unsignedInt	If search, the total number of matches
link	ΣC	0..*	BackboneElement	Links related to this Bundle
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
relation	ΣC	1..1	code	See http://www.iana.org/assignments/link-relations/link-relations.xhtml#link-relations-1 Binding: LinkRelationTypes (required)
url	ΣC	1..1	uri	Reference details for the link
Slices for entry	ΣC	1..*	BackboneElement	Entry resource in the ePI bundle Slice: Unordered, Open by type:$this.resource Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
entry:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	ΣC	1..1	Resource	A resource in the bundle
entry:composition	ΣC	1..1	BackboneElement	ePI Composition Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	CompositionUvEpi	A set of resources composed into a single coherent clinical statement with clinical attestation
entry:organization	ΣC	0..*	BackboneElement	Organization Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	OrganizationUvEpi	A grouping of people or organizations with a common purpose
entry:authorization	ΣC	0..*	BackboneElement	Regulated Authorization Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	RegulatedAuthorizationUvEpi	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
entry:medicinalProduct	ΣC	0..*	BackboneElement	Medicinal Product Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	MedicinalProductDefinitionUvEpi	Detailed definition of a medicinal product
entry:packagedProduct	ΣC	0..*	BackboneElement	Packaged Product Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	PackagedProductDefinitionUvEpi	A medically related item or items, in a container or package
entry:administrableProduct	ΣC	0..*	BackboneElement	Administrable Product Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	AdministrableProductDefinitionUvEpi	A medicinal product in the final form, suitable for administration - after any mixing of multiple components
entry:manufacturedItem	ΣC	0..*	BackboneElement	Manufactured Item Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	ManufacturedItemDefinitionUvEpi	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
entry:ingredient	ΣC	0..*	BackboneElement	Ingredient Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	IngredientUvEpi	An ingredient of a manufactured item or pharmaceutical product
entry:clinicalUse	ΣC	0..*	BackboneElement	Interactions, Warnings, Indications,Contraindications Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	ΣC	1..1	ClinicalUseDefinition	A resource in the bundle
entry:substanceDefinition	ΣC	0..*	BackboneElement	Substance Definition Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	SubstanceDefinitionUvEpi	The detailed description of a substance, typically at a level beyond what is used for prescribing
entry:binary	ΣC	0..*	BackboneElement	Binary Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	ΣC	1..1	Binary	A resource in the bundle
signature	Σ	0..1	Signature	Digital Signature.
issues	ΣC	0..1	OperationOutcome	Issues with the Bundle
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Bundle.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 From the FHIR Standard
Bundle.type	required	Fixed Value: document http://hl7.org/fhir/ValueSet/bundle-type|5.0.0 From the FHIR Standard
Bundle.link.relation	required	LinkRelationTypes http://hl7.org/fhir/ValueSet/iana-link-relations|5.0.0 From the FHIR Standard
Bundle.entry.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:composition.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:composition.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:organization.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:organization.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:authorization.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:authorization.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:medicinalProduct.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:medicinalProduct.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:packagedProduct.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:packagedProduct.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:administrableProduct.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:administrableProduct.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:manufacturedItem.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:manufacturedItem.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:ingredient.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:ingredient.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:clinicalUse.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:clinicalUse.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:substanceDefinition.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:substanceDefinition.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:binary.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:binary.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
bdl-1	error	Bundle	total only when a search or history : total.empty() or (type = 'searchset') or (type = 'history')
bdl-2	error	Bundle	entry.search only when a search : (type = 'searchset') or entry.search.empty()
bdl-5	error	Bundle.entry, Bundle.entry:composition, Bundle.entry:organization, Bundle.entry:authorization, Bundle.entry:medicinalProduct, Bundle.entry:packagedProduct, Bundle.entry:administrableProduct, Bundle.entry:manufacturedItem, Bundle.entry:ingredient, Bundle.entry:clinicalUse, Bundle.entry:substanceDefinition, Bundle.entry:binary	must be a resource unless there's a request or response : resource.exists() or request.exists() or response.exists()
bdl-7	error	Bundle	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-8	error	Bundle.entry, Bundle.entry:composition, Bundle.entry:organization, Bundle.entry:authorization, Bundle.entry:medicinalProduct, Bundle.entry:packagedProduct, Bundle.entry:administrableProduct, Bundle.entry:manufacturedItem, Bundle.entry:ingredient, Bundle.entry:clinicalUse, Bundle.entry:substanceDefinition, Bundle.entry:binary	fullUrl cannot be a version specific reference : fullUrl.exists() implies fullUrl.contains('/_history/').not()
bdl-9	error	Bundle	A document must have an identifier with a system and a value : type = 'document' implies (identifier.system.exists() and identifier.value.exists())
bdl-10	error	Bundle	A document must have a date : type = 'document' implies (timestamp.hasValue())
bdl-11	error	Bundle	A document must have a Composition as the first resource : type = 'document' implies entry.first().resource.is(Composition)
bdl-12	error	Bundle	A message must have a MessageHeader as the first resource : type = 'message' implies entry.first().resource.is(MessageHeader)
bdl-13	error	Bundle	A subscription-notification must have a SubscriptionStatus as the first resource : type = 'subscription-notification' implies entry.first().resource.is(SubscriptionStatus)
bdl-14	error	Bundle	entry.request.method PATCH not allowed for history : type = 'history' implies entry.request.method != 'PATCH'
bdl-15	error	Bundle	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	error	Bundle	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	error	Bundle	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	error	Bundle	Self link is required for searchsets. : type = 'searchset' implies link.where(relation = 'self' and url.exists()).exists()
bdl-3a	error	Bundle	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	error	Bundle	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	error	Bundle	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	error	Bundle	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())
bdl-epi-1	error	Bundle	An ePI document must have no additional Composition (including Composition subclass) resources besides the first. : entry.tail().where(resource is Composition).empty()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from Bundle

Summary

Mandatory: 5 elements(1 nested mandatory element)
Fixed: 1 element
Prohibited: 3 elements

Structures

This structure refers to these other structures:

• Composition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi)
• Organization (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi)
• RegulatedAuthorization (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi)
• MedicinalProductDefinition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi)
• PackagedProductDefinition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi)
• AdministrableProductDefinition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/AdministrableProductDefinition-uv-epi)
• ManufacturedItemDefinition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi)
• Ingredient (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi)
• SubstanceDefinition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of Bundle.entry

Maturity: 2

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Bundle	C	0..*	Bundle	Electronic Product Information Bundle Document Constraints: bdl-1, bdl-2, bdl-7, bdl-9, bdl-10, bdl-11, bdl-12, bdl-13, bdl-14, bdl-15, bdl-16, bdl-17, bdl-18, bdl-3a, bdl-3b, bdl-3c, bdl-3d, bdl-epi-1
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
identifier	ΣC	1..1	Identifier	Persistent identifier for the bundle
type	ΣC	1..1	code	document | message | transaction | transaction-response | batch | batch-response | history | searchset | collection | subscription-notification Binding: BundleType (required): Indicates the purpose of a bundle - how it is intended to be used. Fixed Value: document
timestamp	ΣC	1..1	instant	Persistent original date of approval
Slices for entry	ΣC	1..*	BackboneElement	Entry resource in the ePI bundle Slice: Unordered, Open by type:$this.resource Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
entry:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	ΣC	1..1	Resource	A resource in the bundle
entry:composition	ΣC	1..1	BackboneElement	ePI Composition Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	CompositionUvEpi	A set of resources composed into a single coherent clinical statement with clinical attestation
entry:organization	ΣC	0..*	BackboneElement	Organization Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	OrganizationUvEpi	A grouping of people or organizations with a common purpose
entry:authorization	ΣC	0..*	BackboneElement	Regulated Authorization Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	RegulatedAuthorizationUvEpi	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
entry:medicinalProduct	ΣC	0..*	BackboneElement	Medicinal Product Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	MedicinalProductDefinitionUvEpi	Detailed definition of a medicinal product
entry:packagedProduct	ΣC	0..*	BackboneElement	Packaged Product Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	PackagedProductDefinitionUvEpi	A medically related item or items, in a container or package
entry:administrableProduct	ΣC	0..*	BackboneElement	Administrable Product Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	AdministrableProductDefinitionUvEpi	A medicinal product in the final form, suitable for administration - after any mixing of multiple components
entry:manufacturedItem	ΣC	0..*	BackboneElement	Manufactured Item Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	ManufacturedItemDefinitionUvEpi	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
entry:ingredient	ΣC	0..*	BackboneElement	Ingredient Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	IngredientUvEpi	An ingredient of a manufactured item or pharmaceutical product
entry:clinicalUse	ΣC	0..*	BackboneElement	Interactions, Warnings, Indications,Contraindications Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	ΣC	1..1	ClinicalUseDefinition	A resource in the bundle
entry:substanceDefinition	ΣC	0..*	BackboneElement	Substance Definition Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	SubstanceDefinitionUvEpi	The detailed description of a substance, typically at a level beyond what is used for prescribing
entry:binary	ΣC	0..*	BackboneElement	Binary Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	ΣC	1..1	Binary	A resource in the bundle
signature	Σ	0..1	Signature	Digital Signature.
issues	ΣC	0..1	OperationOutcome	Issues with the Bundle
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Bundle.type	required	Fixed Value: document http://hl7.org/fhir/ValueSet/bundle-type|5.0.0 From the FHIR Standard
Bundle.entry.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:composition.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:organization.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:authorization.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:medicinalProduct.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:packagedProduct.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:administrableProduct.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:manufacturedItem.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:ingredient.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:clinicalUse.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:substanceDefinition.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:binary.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
bdl-1	error	Bundle	total only when a search or history : total.empty() or (type = 'searchset') or (type = 'history')
bdl-2	error	Bundle	entry.search only when a search : (type = 'searchset') or entry.search.empty()
bdl-5	error	Bundle.entry, Bundle.entry:composition, Bundle.entry:organization, Bundle.entry:authorization, Bundle.entry:medicinalProduct, Bundle.entry:packagedProduct, Bundle.entry:administrableProduct, Bundle.entry:manufacturedItem, Bundle.entry:ingredient, Bundle.entry:clinicalUse, Bundle.entry:substanceDefinition, Bundle.entry:binary	must be a resource unless there's a request or response : resource.exists() or request.exists() or response.exists()
bdl-7	error	Bundle	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-8	error	Bundle.entry, Bundle.entry:composition, Bundle.entry:organization, Bundle.entry:authorization, Bundle.entry:medicinalProduct, Bundle.entry:packagedProduct, Bundle.entry:administrableProduct, Bundle.entry:manufacturedItem, Bundle.entry:ingredient, Bundle.entry:clinicalUse, Bundle.entry:substanceDefinition, Bundle.entry:binary	fullUrl cannot be a version specific reference : fullUrl.exists() implies fullUrl.contains('/_history/').not()
bdl-9	error	Bundle	A document must have an identifier with a system and a value : type = 'document' implies (identifier.system.exists() and identifier.value.exists())
bdl-10	error	Bundle	A document must have a date : type = 'document' implies (timestamp.hasValue())
bdl-11	error	Bundle	A document must have a Composition as the first resource : type = 'document' implies entry.first().resource.is(Composition)
bdl-12	error	Bundle	A message must have a MessageHeader as the first resource : type = 'message' implies entry.first().resource.is(MessageHeader)
bdl-13	error	Bundle	A subscription-notification must have a SubscriptionStatus as the first resource : type = 'subscription-notification' implies entry.first().resource.is(SubscriptionStatus)
bdl-14	error	Bundle	entry.request.method PATCH not allowed for history : type = 'history' implies entry.request.method != 'PATCH'
bdl-15	error	Bundle	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	error	Bundle	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	error	Bundle	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	error	Bundle	Self link is required for searchsets. : type = 'searchset' implies link.where(relation = 'self' and url.exists()).exists()
bdl-3a	error	Bundle	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	error	Bundle	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	error	Bundle	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	error	Bundle	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())
bdl-epi-1	error	Bundle	An ePI document must have no additional Composition (including Composition subclass) resources besides the first. : entry.tail().where(resource is Composition).empty()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Differential View

This structure is derived from Bundle

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Bundle	C	0..*	Bundle	Electronic Product Information Bundle Document Constraints: bdl-epi-1
identifier		1..1	Identifier	Persistent identifier for the bundle
type		1..1	code	document | message | transaction | transaction-response | batch | batch-response | history | searchset | collection | subscription-notification Fixed Value: document
timestamp		1..1	instant	Persistent original date of approval
Slices for entry		1..*	BackboneElement	Entry resource in the ePI bundle Slice: Unordered, Open by type:$this.resource
entry:All Slices				Content/Rules for all slices
fullUrl		1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	Resource	A resource in the bundle
search		0..0
request		0..0
response		0..0
entry:composition		1..1	BackboneElement	ePI Composition
resource		1..1	CompositionUvEpi	A set of resources composed into a single coherent clinical statement with clinical attestation
entry:organization		0..*	BackboneElement	Organization
resource		1..1	OrganizationUvEpi	A grouping of people or organizations with a common purpose
entry:authorization		0..*	BackboneElement	Regulated Authorization
resource		1..1	RegulatedAuthorizationUvEpi	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
entry:medicinalProduct		0..*	BackboneElement	Medicinal Product
resource		1..1	MedicinalProductDefinitionUvEpi	Detailed definition of a medicinal product
entry:packagedProduct		0..*	BackboneElement	Packaged Product
resource		1..1	PackagedProductDefinitionUvEpi	A medically related item or items, in a container or package
entry:administrableProduct		0..*	BackboneElement	Administrable Product
resource		1..1	AdministrableProductDefinitionUvEpi	A medicinal product in the final form, suitable for administration - after any mixing of multiple components
entry:manufacturedItem		0..*	BackboneElement	Manufactured Item
resource		1..1	ManufacturedItemDefinitionUvEpi	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
entry:ingredient		0..*	BackboneElement	Ingredient
resource		1..1	IngredientUvEpi	An ingredient of a manufactured item or pharmaceutical product
entry:clinicalUse		0..*	BackboneElement	Interactions, Warnings, Indications,Contraindications
resource		1..1	ClinicalUseDefinition	A resource in the bundle
entry:substanceDefinition		0..*	BackboneElement	Substance Definition
resource		1..1	SubstanceDefinitionUvEpi	The detailed description of a substance, typically at a level beyond what is used for prescribing
entry:binary		0..*	BackboneElement	Binary
resource		1..1	Binary	A resource in the bundle
signature		0..1	Signature	Digital Signature.
Documentation for this format

Constraints

Id	Grade	Path(s)	Details	Requirements
bdl-epi-1	error	Bundle	An ePI document must have no additional Composition (including Composition subclass) resources besides the first. : entry.tail().where(resource is Composition).empty()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Bundle	C	0..*	Bundle	Electronic Product Information Bundle Document Constraints: bdl-1, bdl-2, bdl-7, bdl-9, bdl-10, bdl-11, bdl-12, bdl-13, bdl-14, bdl-15, bdl-16, bdl-17, bdl-18, bdl-3a, bdl-3b, bdl-3c, bdl-3d, bdl-epi-1
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter
identifier	ΣC	1..1	Identifier	Persistent identifier for the bundle
type	ΣC	1..1	code	document | message | transaction | transaction-response | batch | batch-response | history | searchset | collection | subscription-notification Binding: BundleType (required): Indicates the purpose of a bundle - how it is intended to be used. Fixed Value: document
timestamp	ΣC	1..1	instant	Persistent original date of approval
total	ΣC	0..1	unsignedInt	If search, the total number of matches
link	ΣC	0..*	BackboneElement	Links related to this Bundle
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
relation	ΣC	1..1	code	See http://www.iana.org/assignments/link-relations/link-relations.xhtml#link-relations-1 Binding: LinkRelationTypes (required)
url	ΣC	1..1	uri	Reference details for the link
Slices for entry	ΣC	1..*	BackboneElement	Entry resource in the ePI bundle Slice: Unordered, Open by type:$this.resource Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
entry:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	ΣC	1..1	Resource	A resource in the bundle
entry:composition	ΣC	1..1	BackboneElement	ePI Composition Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	CompositionUvEpi	A set of resources composed into a single coherent clinical statement with clinical attestation
entry:organization	ΣC	0..*	BackboneElement	Organization Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	OrganizationUvEpi	A grouping of people or organizations with a common purpose
entry:authorization	ΣC	0..*	BackboneElement	Regulated Authorization Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	RegulatedAuthorizationUvEpi	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
entry:medicinalProduct	ΣC	0..*	BackboneElement	Medicinal Product Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	MedicinalProductDefinitionUvEpi	Detailed definition of a medicinal product
entry:packagedProduct	ΣC	0..*	BackboneElement	Packaged Product Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	PackagedProductDefinitionUvEpi	A medically related item or items, in a container or package
entry:administrableProduct	ΣC	0..*	BackboneElement	Administrable Product Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	AdministrableProductDefinitionUvEpi	A medicinal product in the final form, suitable for administration - after any mixing of multiple components
entry:manufacturedItem	ΣC	0..*	BackboneElement	Manufactured Item Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	ManufacturedItemDefinitionUvEpi	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product
entry:ingredient	ΣC	0..*	BackboneElement	Ingredient Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	IngredientUvEpi	An ingredient of a manufactured item or pharmaceutical product
entry:clinicalUse	ΣC	0..*	BackboneElement	Interactions, Warnings, Indications,Contraindications Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	ΣC	1..1	ClinicalUseDefinition	A resource in the bundle
entry:substanceDefinition	ΣC	0..*	BackboneElement	Substance Definition Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource		1..1	SubstanceDefinitionUvEpi	The detailed description of a substance, typically at a level beyond what is used for prescribing
entry:binary	ΣC	0..*	BackboneElement	Binary Constraints: bdl-5, bdl-8 This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
link	Σ	0..*	See link (Bundle)	Links related to this entry
fullUrl	ΣC	1..1	uri	URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.)
resource	ΣC	1..1	Binary	A resource in the bundle
signature	Σ	0..1	Signature	Digital Signature.
issues	ΣC	0..1	OperationOutcome	Issues with the Bundle
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Bundle.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 From the FHIR Standard
Bundle.type	required	Fixed Value: document http://hl7.org/fhir/ValueSet/bundle-type|5.0.0 From the FHIR Standard
Bundle.link.relation	required	LinkRelationTypes http://hl7.org/fhir/ValueSet/iana-link-relations|5.0.0 From the FHIR Standard
Bundle.entry.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:composition.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:composition.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:organization.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:organization.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:authorization.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:authorization.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:medicinalProduct.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:medicinalProduct.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:packagedProduct.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:packagedProduct.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:administrableProduct.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:administrableProduct.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:manufacturedItem.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:manufacturedItem.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:ingredient.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:ingredient.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:clinicalUse.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:clinicalUse.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:substanceDefinition.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:substanceDefinition.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard
Bundle.entry:binary.search.mode	required	SearchEntryMode http://hl7.org/fhir/ValueSet/search-entry-mode|5.0.0 From the FHIR Standard
Bundle.entry:binary.request.method	required	HTTPVerb http://hl7.org/fhir/ValueSet/http-verb|5.0.0 From the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
bdl-1	error	Bundle	total only when a search or history : total.empty() or (type = 'searchset') or (type = 'history')
bdl-2	error	Bundle	entry.search only when a search : (type = 'searchset') or entry.search.empty()
bdl-5	error	Bundle.entry, Bundle.entry:composition, Bundle.entry:organization, Bundle.entry:authorization, Bundle.entry:medicinalProduct, Bundle.entry:packagedProduct, Bundle.entry:administrableProduct, Bundle.entry:manufacturedItem, Bundle.entry:ingredient, Bundle.entry:clinicalUse, Bundle.entry:substanceDefinition, Bundle.entry:binary	must be a resource unless there's a request or response : resource.exists() or request.exists() or response.exists()
bdl-7	error	Bundle	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-8	error	Bundle.entry, Bundle.entry:composition, Bundle.entry:organization, Bundle.entry:authorization, Bundle.entry:medicinalProduct, Bundle.entry:packagedProduct, Bundle.entry:administrableProduct, Bundle.entry:manufacturedItem, Bundle.entry:ingredient, Bundle.entry:clinicalUse, Bundle.entry:substanceDefinition, Bundle.entry:binary	fullUrl cannot be a version specific reference : fullUrl.exists() implies fullUrl.contains('/_history/').not()
bdl-9	error	Bundle	A document must have an identifier with a system and a value : type = 'document' implies (identifier.system.exists() and identifier.value.exists())
bdl-10	error	Bundle	A document must have a date : type = 'document' implies (timestamp.hasValue())
bdl-11	error	Bundle	A document must have a Composition as the first resource : type = 'document' implies entry.first().resource.is(Composition)
bdl-12	error	Bundle	A message must have a MessageHeader as the first resource : type = 'message' implies entry.first().resource.is(MessageHeader)
bdl-13	error	Bundle	A subscription-notification must have a SubscriptionStatus as the first resource : type = 'subscription-notification' implies entry.first().resource.is(SubscriptionStatus)
bdl-14	error	Bundle	entry.request.method PATCH not allowed for history : type = 'history' implies entry.request.method != 'PATCH'
bdl-15	error	Bundle	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	error	Bundle	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	error	Bundle	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	error	Bundle	Self link is required for searchsets. : type = 'searchset' implies link.where(relation = 'self' and url.exists()).exists()
bdl-3a	error	Bundle	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	error	Bundle	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	error	Bundle	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	error	Bundle	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())
bdl-epi-1	error	Bundle	An ePI document must have no additional Composition (including Composition subclass) resources besides the first. : entry.tail().where(resource is Composition).empty()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from Bundle

Summary

Mandatory: 5 elements(1 nested mandatory element)
Fixed: 1 element
Prohibited: 3 elements

Structures

This structure refers to these other structures:

• Composition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi)
• Organization (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi)
• RegulatedAuthorization (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi)
• MedicinalProductDefinition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi)
• PackagedProductDefinition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi)
• AdministrableProductDefinition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/AdministrableProductDefinition-uv-epi)
• ManufacturedItemDefinition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi)
• Ingredient (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi)
• SubstanceDefinition (ePI) (http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of Bundle.entry

Maturity: 2