Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use
Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use
This page is part of the Electronic Medicinal Product Information (ePI) FHIR Implementation Guide (v1.0.0: STU1) based on FHIR v5.0.0. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions 
| Official URL: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi | Version: 1.0.0 | |||
| Standards status: Trial-use | Maturity Level: 2 | Computable Name: BundleUvEpi | ||
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.
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from Bundle
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  Bundle | C | 0..* | Bundle | Electronic Product Information Bundle Document bdl-epi-1: An ePI document must have no additional Composition (including Composition subclass) resources besides the first. |
  language | 1..1 | code | Language of the resource content | |
| 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 | 0..1 | CompositionUvEpi | A set of resources composed into a single coherent clinical statement with clinical attestation | |
| entry:organization | 0..* | BackboneElement | Organization | |
| resource | 0..1 | OrganizationUvEpi | A grouping of people or organizations with a common purpose | |
| entry:authorization | 0..* | BackboneElement | Regulated Authorization | |
| resource | 0..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 | 0..1 | MedicinalProductDefinitionUvEpi | Detailed definition of a medicinal product | |
| entry:packagedProduct | 0..* | BackboneElement | Packaged Product | |
| resource | 0..1 | PackagedProductDefinitionUvEpi | A medically related item or items, in a container or package | |
| entry:administrableProduct | 0..* | BackboneElement | Administrable Product | |
| resource | 0..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 | 0..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 | 0..1 | IngredientUvEpi | An ingredient of a manufactured item or pharmaceutical product | |
| entry:clinicalUse | 0..* | BackboneElement | Interactions, Warnings, Indications,Contraindications | |
| resource | 0..1 | ClinicalUseDefinition | A resource in the bundle | |
| entry:substanceDefinition | 0..* | BackboneElement | Substance Definition | |
| resource | 0..1 | SubstanceDefinitionUvEpi | The detailed description of a substance, typically at a level beyond what is used for prescribing | |
 entry:binary | 0..* | BackboneElement | Binary | |
 resource | 0..1 | Binary | A resource in the bundle | |
 signature | 0..1 | Signature | Digital Signature. | |
| Documentation for this format | ||||
| 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 |
|---|---|---|---|---|
| Bundle | C | 0..* | Bundle | Electronic Product Information Bundle Document bdl-epi-1: An ePI document must have no additional Composition (including Composition subclass) resources besides the first. |
 implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| language | 1..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language | |
 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 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 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | 0..1 | CompositionUvEpi | A set of resources composed into a single coherent clinical statement with clinical attestation | |
 request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
 modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
 response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status | Σ | 1..1 | string | Status response code (text optional) |
| entry:organization | ΣC | 0..* | BackboneElement | Organization 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | C | 0..1 | OrganizationUvEpi | A grouping of people or organizations with a common purpose |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status | Σ | 1..1 | string | Status response code (text optional) |
| entry:authorization | ΣC | 0..* | BackboneElement | Regulated Authorization 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | 0..1 | RegulatedAuthorizationUvEpi | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product | |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status | Σ | 1..1 | string | Status response code (text optional) |
| entry:medicinalProduct | ΣC | 0..* | BackboneElement | Medicinal Product 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | 0..1 | MedicinalProductDefinitionUvEpi | Detailed definition of a medicinal product | |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status | Σ | 1..1 | string | Status response code (text optional) |
| entry:packagedProduct | ΣC | 0..* | BackboneElement | Packaged Product 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | 0..1 | PackagedProductDefinitionUvEpi | A medically related item or items, in a container or package | |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status | Σ | 1..1 | string | Status response code (text optional) |
| entry:administrableProduct | ΣC | 0..* | BackboneElement | Administrable Product 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | C | 0..1 | AdministrableProductDefinitionUvEpi | A medicinal product in the final form, suitable for administration - after any mixing of multiple components |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status | Σ | 1..1 | string | Status response code (text optional) |
| entry:manufacturedItem | ΣC | 0..* | BackboneElement | Manufactured Item 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | 0..1 | ManufacturedItemDefinitionUvEpi | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product | |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status | Σ | 1..1 | string | Status response code (text optional) |
| entry:ingredient | ΣC | 0..* | BackboneElement | Ingredient 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | C | 0..1 | IngredientUvEpi | An ingredient of a manufactured item or pharmaceutical product |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status | Σ | 1..1 | string | Status response code (text optional) |
| entry:clinicalUse | ΣC | 0..* | BackboneElement | Interactions, Warnings, Indications,Contraindications 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | ΣC | 0..1 | ClinicalUseDefinition | A resource in the bundle |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status | Σ | 1..1 | string | Status response code (text optional) |
| entry:substanceDefinition | ΣC | 0..* | BackboneElement | Substance Definition 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | 0..1 | SubstanceDefinitionUvEpi | The detailed description of a substance, typically at a level beyond what is used for prescribing | |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status | Σ | 1..1 | string | Status response code (text optional) |
| entry:binary | ΣC | 0..* | BackboneElement | Binary 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | ΣC | 0..1 | Binary | A resource in the bundle |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status | Σ | 1..1 | string | Status response code (text optional) |
| signature | Σ | 0..1 | Signature | Digital Signature. |
| issues | ΣCTU | 0..1 | OperationOutcome | Issues with the Bundle |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code |
| Bundle.language | required | AllLanguages |
| Bundle.type | required | Fixed Value: document |
| Bundle.entry.request.method | required | HTTPVerb |
| Bundle.entry:composition.request.method | required | HTTPVerb |
| Bundle.entry:organization.request.method | required | HTTPVerb |
| Bundle.entry:authorization.request.method | required | HTTPVerb |
| Bundle.entry:medicinalProduct.request.method | required | HTTPVerb |
| Bundle.entry:packagedProduct.request.method | required | HTTPVerb |
| Bundle.entry:administrableProduct.request.method | required | HTTPVerb |
| Bundle.entry:manufacturedItem.request.method | required | HTTPVerb |
| Bundle.entry:ingredient.request.method | required | HTTPVerb |
| Bundle.entry:clinicalUse.request.method | required | HTTPVerb |
| Bundle.entry:substanceDefinition.request.method | required | HTTPVerb |
| Bundle.entry:binary.request.method | required | HTTPVerb |
| Id | Grade | Path(s) | Details | Requirements |
| apd-1 | error | Bundle.entry:administrableProduct.resource | RouteOfAdministration cannot be used when the 'formOf' product already uses MedicinalProductDefinition.route (and vice versa) : AdministrableProductDefinition.formOf.resolve().route.empty() | |
| 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() | |
| dom-2 | error | Bundle.entry:composition.resource, Bundle.entry:organization.resource, Bundle.entry:authorization.resource, Bundle.entry:medicinalProduct.resource, Bundle.entry:packagedProduct.resource, Bundle.entry:administrableProduct.resource, Bundle.entry:manufacturedItem.resource, Bundle.entry:ingredient.resource, Bundle.entry:substanceDefinition.resource | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Bundle.entry:composition.resource, Bundle.entry:organization.resource, Bundle.entry:authorization.resource, Bundle.entry:medicinalProduct.resource, Bundle.entry:packagedProduct.resource, Bundle.entry:administrableProduct.resource, Bundle.entry:manufacturedItem.resource, Bundle.entry:ingredient.resource, Bundle.entry:substanceDefinition.resource | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | Bundle.entry:composition.resource, Bundle.entry:organization.resource, Bundle.entry:authorization.resource, Bundle.entry:medicinalProduct.resource, Bundle.entry:packagedProduct.resource, Bundle.entry:administrableProduct.resource, Bundle.entry:manufacturedItem.resource, Bundle.entry:ingredient.resource, Bundle.entry:substanceDefinition.resource | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | Bundle.entry:composition.resource, Bundle.entry:organization.resource, Bundle.entry:authorization.resource, Bundle.entry:medicinalProduct.resource, Bundle.entry:packagedProduct.resource, Bundle.entry:administrableProduct.resource, Bundle.entry:manufacturedItem.resource, Bundle.entry:ingredient.resource, Bundle.entry:substanceDefinition.resource | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Bundle.entry:composition.resource, Bundle.entry:organization.resource, Bundle.entry:authorization.resource, Bundle.entry:medicinalProduct.resource, Bundle.entry:packagedProduct.resource, Bundle.entry:administrableProduct.resource, Bundle.entry:manufacturedItem.resource, Bundle.entry:ingredient.resource, Bundle.entry:substanceDefinition.resource | A resource should have narrative for robust management : text.`div`.exists() | |
| 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() | |
| ing-1 | error | Bundle.entry:ingredient.resource | If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource : Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2 | |
| org-1 | error | Bundle.entry:organization.resource | The organization SHALL at least have a name or an identifier, and possibly more than one : (identifier.count() + name.count()) > 0 |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Bundle | C | 0..* | Bundle | Electronic Product Information Bundle Document bdl-epi-1: An ePI document must have no additional Composition (including Composition subclass) resources besides the first. |
| 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 | 1..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language | |
| 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 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 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | 0..1 | CompositionUvEpi | A set of resources composed into a single coherent clinical statement with clinical attestation | |
| search | ΣC | 0..1 | BackboneElement | Search related information |
| 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 |
| mode | Σ | 0..1 | code | match | include - why this is in the result set Binding: SearchEntryMode (required): Why an 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. |
| score | Σ | 0..1 | decimal | Search ranking (between 0 and 1) |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| 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 |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| ifNoneMatch | Σ | 0..1 | string | For managing cache validation |
| ifModifiedSince | Σ | 0..1 | instant | For managing cache currency |
| ifMatch | Σ | 0..1 | string | For managing update contention |
| ifNoneExist | Σ | 0..1 | string | For conditional creates |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| 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 |
| status | Σ | 1..1 | string | Status response code (text optional) |
| location | Σ | 0..1 | uri | The location (if the operation returns a location) |
| etag | Σ | 0..1 | string | The Etag for the resource (if relevant) |
| lastModified | Σ | 0..1 | instant | Server's date time modified |
| outcome | Σ | 0..1 | Resource | OperationOutcome with hints and warnings (for batch/transaction) |
| entry:organization | ΣC | 0..* | BackboneElement | Organization 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | C | 0..1 | OrganizationUvEpi | A grouping of people or organizations with a common purpose |
| search | ΣC | 0..1 | BackboneElement | Search related information |
| 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 |
| mode | Σ | 0..1 | code | match | include - why this is in the result set Binding: SearchEntryMode (required): Why an 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. |
| score | Σ | 0..1 | decimal | Search ranking (between 0 and 1) |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| 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 |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| ifNoneMatch | Σ | 0..1 | string | For managing cache validation |
| ifModifiedSince | Σ | 0..1 | instant | For managing cache currency |
| ifMatch | Σ | 0..1 | string | For managing update contention |
| ifNoneExist | Σ | 0..1 | string | For conditional creates |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| 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 |
| status | Σ | 1..1 | string | Status response code (text optional) |
| location | Σ | 0..1 | uri | The location (if the operation returns a location) |
| etag | Σ | 0..1 | string | The Etag for the resource (if relevant) |
| lastModified | Σ | 0..1 | instant | Server's date time modified |
| outcome | Σ | 0..1 | Resource | OperationOutcome with hints and warnings (for batch/transaction) |
| entry:authorization | ΣC | 0..* | BackboneElement | Regulated Authorization 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | 0..1 | RegulatedAuthorizationUvEpi | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product | |
| search | ΣC | 0..1 | BackboneElement | Search related information |
| 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 |
| mode | Σ | 0..1 | code | match | include - why this is in the result set Binding: SearchEntryMode (required): Why an 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. |
| score | Σ | 0..1 | decimal | Search ranking (between 0 and 1) |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| 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 |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| ifNoneMatch | Σ | 0..1 | string | For managing cache validation |
| ifModifiedSince | Σ | 0..1 | instant | For managing cache currency |
| ifMatch | Σ | 0..1 | string | For managing update contention |
| ifNoneExist | Σ | 0..1 | string | For conditional creates |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| 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 |
| status | Σ | 1..1 | string | Status response code (text optional) |
| location | Σ | 0..1 | uri | The location (if the operation returns a location) |
| etag | Σ | 0..1 | string | The Etag for the resource (if relevant) |
| lastModified | Σ | 0..1 | instant | Server's date time modified |
| outcome | Σ | 0..1 | Resource | OperationOutcome with hints and warnings (for batch/transaction) |
| entry:medicinalProduct | ΣC | 0..* | BackboneElement | Medicinal Product 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | 0..1 | MedicinalProductDefinitionUvEpi | Detailed definition of a medicinal product | |
| search | ΣC | 0..1 | BackboneElement | Search related information |
| 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 |
| mode | Σ | 0..1 | code | match | include - why this is in the result set Binding: SearchEntryMode (required): Why an 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. |
| score | Σ | 0..1 | decimal | Search ranking (between 0 and 1) |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| 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 |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| ifNoneMatch | Σ | 0..1 | string | For managing cache validation |
| ifModifiedSince | Σ | 0..1 | instant | For managing cache currency |
| ifMatch | Σ | 0..1 | string | For managing update contention |
| ifNoneExist | Σ | 0..1 | string | For conditional creates |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| 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 |
| status | Σ | 1..1 | string | Status response code (text optional) |
| location | Σ | 0..1 | uri | The location (if the operation returns a location) |
| etag | Σ | 0..1 | string | The Etag for the resource (if relevant) |
| lastModified | Σ | 0..1 | instant | Server's date time modified |
| outcome | Σ | 0..1 | Resource | OperationOutcome with hints and warnings (for batch/transaction) |
| entry:packagedProduct | ΣC | 0..* | BackboneElement | Packaged Product 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | 0..1 | PackagedProductDefinitionUvEpi | A medically related item or items, in a container or package | |
| search | ΣC | 0..1 | BackboneElement | Search related information |
| 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 |
| mode | Σ | 0..1 | code | match | include - why this is in the result set Binding: SearchEntryMode (required): Why an 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. |
| score | Σ | 0..1 | decimal | Search ranking (between 0 and 1) |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| 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 |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| ifNoneMatch | Σ | 0..1 | string | For managing cache validation |
| ifModifiedSince | Σ | 0..1 | instant | For managing cache currency |
| ifMatch | Σ | 0..1 | string | For managing update contention |
| ifNoneExist | Σ | 0..1 | string | For conditional creates |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| 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 |
| status | Σ | 1..1 | string | Status response code (text optional) |
| location | Σ | 0..1 | uri | The location (if the operation returns a location) |
| etag | Σ | 0..1 | string | The Etag for the resource (if relevant) |
| lastModified | Σ | 0..1 | instant | Server's date time modified |
| outcome | Σ | 0..1 | Resource | OperationOutcome with hints and warnings (for batch/transaction) |
| entry:administrableProduct | ΣC | 0..* | BackboneElement | Administrable Product 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | C | 0..1 | AdministrableProductDefinitionUvEpi | A medicinal product in the final form, suitable for administration - after any mixing of multiple components |
| search | ΣC | 0..1 | BackboneElement | Search related information |
| 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 |
| mode | Σ | 0..1 | code | match | include - why this is in the result set Binding: SearchEntryMode (required): Why an 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. |
| score | Σ | 0..1 | decimal | Search ranking (between 0 and 1) |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| 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 |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| ifNoneMatch | Σ | 0..1 | string | For managing cache validation |
| ifModifiedSince | Σ | 0..1 | instant | For managing cache currency |
| ifMatch | Σ | 0..1 | string | For managing update contention |
| ifNoneExist | Σ | 0..1 | string | For conditional creates |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| 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 |
| status | Σ | 1..1 | string | Status response code (text optional) |
| location | Σ | 0..1 | uri | The location (if the operation returns a location) |
| etag | Σ | 0..1 | string | The Etag for the resource (if relevant) |
| lastModified | Σ | 0..1 | instant | Server's date time modified |
| outcome | Σ | 0..1 | Resource | OperationOutcome with hints and warnings (for batch/transaction) |
| entry:manufacturedItem | ΣC | 0..* | BackboneElement | Manufactured Item 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | 0..1 | ManufacturedItemDefinitionUvEpi | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product | |
| search | ΣC | 0..1 | BackboneElement | Search related information |
| 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 |
| mode | Σ | 0..1 | code | match | include - why this is in the result set Binding: SearchEntryMode (required): Why an 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. |
| score | Σ | 0..1 | decimal | Search ranking (between 0 and 1) |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| 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 |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| ifNoneMatch | Σ | 0..1 | string | For managing cache validation |
| ifModifiedSince | Σ | 0..1 | instant | For managing cache currency |
| ifMatch | Σ | 0..1 | string | For managing update contention |
| ifNoneExist | Σ | 0..1 | string | For conditional creates |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| 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 |
| status | Σ | 1..1 | string | Status response code (text optional) |
| location | Σ | 0..1 | uri | The location (if the operation returns a location) |
| etag | Σ | 0..1 | string | The Etag for the resource (if relevant) |
| lastModified | Σ | 0..1 | instant | Server's date time modified |
| outcome | Σ | 0..1 | Resource | OperationOutcome with hints and warnings (for batch/transaction) |
| entry:ingredient | ΣC | 0..* | BackboneElement | Ingredient 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | C | 0..1 | IngredientUvEpi | An ingredient of a manufactured item or pharmaceutical product |
| search | ΣC | 0..1 | BackboneElement | Search related information |
| 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 |
| mode | Σ | 0..1 | code | match | include - why this is in the result set Binding: SearchEntryMode (required): Why an 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. |
| score | Σ | 0..1 | decimal | Search ranking (between 0 and 1) |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| 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 |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| ifNoneMatch | Σ | 0..1 | string | For managing cache validation |
| ifModifiedSince | Σ | 0..1 | instant | For managing cache currency |
| ifMatch | Σ | 0..1 | string | For managing update contention |
| ifNoneExist | Σ | 0..1 | string | For conditional creates |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| 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 |
| status | Σ | 1..1 | string | Status response code (text optional) |
| location | Σ | 0..1 | uri | The location (if the operation returns a location) |
| etag | Σ | 0..1 | string | The Etag for the resource (if relevant) |
| lastModified | Σ | 0..1 | instant | Server's date time modified |
| outcome | Σ | 0..1 | Resource | OperationOutcome with hints and warnings (for batch/transaction) |
| entry:clinicalUse | ΣC | 0..* | BackboneElement | Interactions, Warnings, Indications,Contraindications 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | ΣC | 0..1 | ClinicalUseDefinition | A resource in the bundle |
| search | ΣC | 0..1 | BackboneElement | Search related information |
| 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 |
| mode | Σ | 0..1 | code | match | include - why this is in the result set Binding: SearchEntryMode (required): Why an 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. |
| score | Σ | 0..1 | decimal | Search ranking (between 0 and 1) |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| 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 |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| ifNoneMatch | Σ | 0..1 | string | For managing cache validation |
| ifModifiedSince | Σ | 0..1 | instant | For managing cache currency |
| ifMatch | Σ | 0..1 | string | For managing update contention |
| ifNoneExist | Σ | 0..1 | string | For conditional creates |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| 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 |
| status | Σ | 1..1 | string | Status response code (text optional) |
| location | Σ | 0..1 | uri | The location (if the operation returns a location) |
| etag | Σ | 0..1 | string | The Etag for the resource (if relevant) |
| lastModified | Σ | 0..1 | instant | Server's date time modified |
| outcome | Σ | 0..1 | Resource | OperationOutcome with hints and warnings (for batch/transaction) |
| entry:substanceDefinition | ΣC | 0..* | BackboneElement | Substance Definition 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | 0..1 | SubstanceDefinitionUvEpi | The detailed description of a substance, typically at a level beyond what is used for prescribing | |
| search | ΣC | 0..1 | BackboneElement | Search related information |
| 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 |
| mode | Σ | 0..1 | code | match | include - why this is in the result set Binding: SearchEntryMode (required): Why an 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. |
| score | Σ | 0..1 | decimal | Search ranking (between 0 and 1) |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| 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 |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| ifNoneMatch | Σ | 0..1 | string | For managing cache validation |
| ifModifiedSince | Σ | 0..1 | instant | For managing cache currency |
| ifMatch | Σ | 0..1 | string | For managing update contention |
| ifNoneExist | Σ | 0..1 | string | For conditional creates |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| 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 |
| status | Σ | 1..1 | string | Status response code (text optional) |
| location | Σ | 0..1 | uri | The location (if the operation returns a location) |
| etag | Σ | 0..1 | string | The Etag for the resource (if relevant) |
| lastModified | Σ | 0..1 | instant | Server's date time modified |
| outcome | Σ | 0..1 | Resource | OperationOutcome with hints and warnings (for batch/transaction) |
| entry:binary | ΣC | 0..* | BackboneElement | Binary 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | ΣC | 0..1 | Binary | A resource in the bundle |
| search | ΣC | 0..1 | BackboneElement | Search related information |
| 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 |
| mode | Σ | 0..1 | code | match | include - why this is in the result set Binding: SearchEntryMode (required): Why an 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. |
| score | Σ | 0..1 | decimal | Search ranking (between 0 and 1) |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| 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 |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| ifNoneMatch | Σ | 0..1 | string | For managing cache validation |
| ifModifiedSince | Σ | 0..1 | instant | For managing cache currency |
| ifMatch | Σ | 0..1 | string | For managing update contention |
| ifNoneExist | Σ | 0..1 | string | For conditional creates |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| 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 |
| status | Σ | 1..1 | string | Status response code (text optional) |
| location | Σ | 0..1 | uri | The location (if the operation returns a location) |
| etag | Σ | 0..1 | string | The Etag for the resource (if relevant) |
| lastModified | Σ | 0..1 | instant | Server's date time modified |
| outcome | Σ | 0..1 | Resource | OperationOutcome with hints and warnings (for batch/transaction) |
| signature | Σ | 0..1 | Signature | Digital Signature. |
| issues | ΣCTU | 0..1 | OperationOutcome | Issues with the Bundle |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code |
| Bundle.language | required | AllLanguages |
| Bundle.type | required | Fixed Value: document |
| Bundle.link.relation | required | LinkRelationTypes |
| Bundle.entry.search.mode | required | SearchEntryMode |
| Bundle.entry.request.method | required | HTTPVerb |
| Bundle.entry:composition.search.mode | required | SearchEntryMode |
| Bundle.entry:composition.request.method | required | HTTPVerb |
| Bundle.entry:organization.search.mode | required | SearchEntryMode |
| Bundle.entry:organization.request.method | required | HTTPVerb |
| Bundle.entry:authorization.search.mode | required | SearchEntryMode |
| Bundle.entry:authorization.request.method | required | HTTPVerb |
| Bundle.entry:medicinalProduct.search.mode | required | SearchEntryMode |
| Bundle.entry:medicinalProduct.request.method | required | HTTPVerb |
| Bundle.entry:packagedProduct.search.mode | required | SearchEntryMode |
| Bundle.entry:packagedProduct.request.method | required | HTTPVerb |
| Bundle.entry:administrableProduct.search.mode | required | SearchEntryMode |
| Bundle.entry:administrableProduct.request.method | required | HTTPVerb |
| Bundle.entry:manufacturedItem.search.mode | required | SearchEntryMode |
| Bundle.entry:manufacturedItem.request.method | required | HTTPVerb |
| Bundle.entry:ingredient.search.mode | required | SearchEntryMode |
| Bundle.entry:ingredient.request.method | required | HTTPVerb |
| Bundle.entry:clinicalUse.search.mode | required | SearchEntryMode |
| Bundle.entry:clinicalUse.request.method | required | HTTPVerb |
| Bundle.entry:substanceDefinition.search.mode | required | SearchEntryMode |
| Bundle.entry:substanceDefinition.request.method | required | HTTPVerb |
| Bundle.entry:binary.search.mode | required | SearchEntryMode |
| Bundle.entry:binary.request.method | required | HTTPVerb |
| Id | Grade | Path(s) | Details | Requirements |
| apd-1 | error | Bundle.entry:administrableProduct.resource | RouteOfAdministration cannot be used when the 'formOf' product already uses MedicinalProductDefinition.route (and vice versa) : AdministrableProductDefinition.formOf.resolve().route.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-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() | |
| dom-2 | error | Bundle.entry:composition.resource, Bundle.entry:organization.resource, Bundle.entry:authorization.resource, Bundle.entry:medicinalProduct.resource, Bundle.entry:packagedProduct.resource, Bundle.entry:administrableProduct.resource, Bundle.entry:manufacturedItem.resource, Bundle.entry:ingredient.resource, Bundle.entry:substanceDefinition.resource | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Bundle.entry:composition.resource, Bundle.entry:organization.resource, Bundle.entry:authorization.resource, Bundle.entry:medicinalProduct.resource, Bundle.entry:packagedProduct.resource, Bundle.entry:administrableProduct.resource, Bundle.entry:manufacturedItem.resource, Bundle.entry:ingredient.resource, Bundle.entry:substanceDefinition.resource | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | Bundle.entry:composition.resource, Bundle.entry:organization.resource, Bundle.entry:authorization.resource, Bundle.entry:medicinalProduct.resource, Bundle.entry:packagedProduct.resource, Bundle.entry:administrableProduct.resource, Bundle.entry:manufacturedItem.resource, Bundle.entry:ingredient.resource, Bundle.entry:substanceDefinition.resource | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | Bundle.entry:composition.resource, Bundle.entry:organization.resource, Bundle.entry:authorization.resource, Bundle.entry:medicinalProduct.resource, Bundle.entry:packagedProduct.resource, Bundle.entry:administrableProduct.resource, Bundle.entry:manufacturedItem.resource, Bundle.entry:ingredient.resource, Bundle.entry:substanceDefinition.resource | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Bundle.entry:composition.resource, Bundle.entry:organization.resource, Bundle.entry:authorization.resource, Bundle.entry:medicinalProduct.resource, Bundle.entry:packagedProduct.resource, Bundle.entry:administrableProduct.resource, Bundle.entry:manufacturedItem.resource, Bundle.entry:ingredient.resource, Bundle.entry:substanceDefinition.resource | A resource should have narrative for robust management : text.`div`.exists() | |
| 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() | |
| ing-1 | error | Bundle.entry:ingredient.resource | If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource : Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2 | |
| org-1 | error | Bundle.entry:organization.resource | The organization SHALL at least have a name or an identifier, and possibly more than one : (identifier.count() + name.count()) > 0 |
This structure is derived from Bundle
Summary
Mandatory: 7 elements
Fixed Value: 1 element
Prohibited: 3 elements
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
Maturity: 2
Differential View
This structure is derived from Bundle
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Bundle | C | 0..* | Bundle | Electronic Product Information Bundle Document bdl-epi-1: An ePI document must have no additional Composition (including Composition subclass) resources besides the first. |
| language | 1..1 | code | Language of the resource content | |
| 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 | 0..1 | CompositionUvEpi | A set of resources composed into a single coherent clinical statement with clinical attestation | |
| entry:organization | 0..* | BackboneElement | Organization | |
| resource | 0..1 | OrganizationUvEpi | A grouping of people or organizations with a common purpose | |
| entry:authorization | 0..* | BackboneElement | Regulated Authorization | |
| resource | 0..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 | 0..1 | MedicinalProductDefinitionUvEpi | Detailed definition of a medicinal product | |
| entry:packagedProduct | 0..* | BackboneElement | Packaged Product | |
| resource | 0..1 | PackagedProductDefinitionUvEpi | A medically related item or items, in a container or package | |
| entry:administrableProduct | 0..* | BackboneElement | Administrable Product | |
| resource | 0..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 | 0..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 | 0..1 | IngredientUvEpi | An ingredient of a manufactured item or pharmaceutical product | |
| entry:clinicalUse | 0..* | BackboneElement | Interactions, Warnings, Indications,Contraindications | |
| resource | 0..1 | ClinicalUseDefinition | A resource in the bundle | |
| entry:substanceDefinition | 0..* | BackboneElement | Substance Definition | |
| resource | 0..1 | SubstanceDefinitionUvEpi | The detailed description of a substance, typically at a level beyond what is used for prescribing | |
| entry:binary | 0..* | BackboneElement | Binary | |
| resource | 0..1 | Binary | A resource in the bundle | |
| signature | 0..1 | Signature | Digital Signature. | |
| Documentation for this format | ||||
| 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() |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Bundle | C | 0..* | Bundle | Electronic Product Information Bundle Document bdl-epi-1: An ePI document must have no additional Composition (including Composition subclass) resources besides the first. |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| language | 1..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language | |
| 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 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 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | 0..1 | CompositionUvEpi | A set of resources composed into a single coherent clinical statement with clinical attestation | |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status | Σ | 1..1 | string | Status response code (text optional) |
| entry:organization | ΣC | 0..* | BackboneElement | Organization 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | C | 0..1 | OrganizationUvEpi | A grouping of people or organizations with a common purpose |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status | Σ | 1..1 | string | Status response code (text optional) |
| entry:authorization | ΣC | 0..* | BackboneElement | Regulated Authorization 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | 0..1 | RegulatedAuthorizationUvEpi | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product | |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status | Σ | 1..1 | string | Status response code (text optional) |
| entry:medicinalProduct | ΣC | 0..* | BackboneElement | Medicinal Product 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | 0..1 | MedicinalProductDefinitionUvEpi | Detailed definition of a medicinal product | |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status | Σ | 1..1 | string | Status response code (text optional) |
| entry:packagedProduct | ΣC | 0..* | BackboneElement | Packaged Product 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | 0..1 | PackagedProductDefinitionUvEpi | A medically related item or items, in a container or package | |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status | Σ | 1..1 | string | Status response code (text optional) |
| entry:administrableProduct | ΣC | 0..* | BackboneElement | Administrable Product 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | C | 0..1 | AdministrableProductDefinitionUvEpi | A medicinal product in the final form, suitable for administration - after any mixing of multiple components |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status | Σ | 1..1 | string | Status response code (text optional) |
| entry:manufacturedItem | ΣC | 0..* | BackboneElement | Manufactured Item 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | 0..1 | ManufacturedItemDefinitionUvEpi | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product | |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status | Σ | 1..1 | string | Status response code (text optional) |
| entry:ingredient | ΣC | 0..* | BackboneElement | Ingredient 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | C | 0..1 | IngredientUvEpi | An ingredient of a manufactured item or pharmaceutical product |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status | Σ | 1..1 | string | Status response code (text optional) |
| entry:clinicalUse | ΣC | 0..* | BackboneElement | Interactions, Warnings, Indications,Contraindications 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | ΣC | 0..1 | ClinicalUseDefinition | A resource in the bundle |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status | Σ | 1..1 | string | Status response code (text optional) |
| entry:substanceDefinition | ΣC | 0..* | BackboneElement | Substance Definition 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | 0..1 | SubstanceDefinitionUvEpi | The detailed description of a substance, typically at a level beyond what is used for prescribing | |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status | Σ | 1..1 | string | Status response code (text optional) |
| entry:binary | ΣC | 0..* | BackboneElement | Binary 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | ΣC | 0..1 | Binary | A resource in the bundle |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status | Σ | 1..1 | string | Status response code (text optional) |
| signature | Σ | 0..1 | Signature | Digital Signature. |
| issues | ΣCTU | 0..1 | OperationOutcome | Issues with the Bundle |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code |
| Bundle.language | required | AllLanguages |
| Bundle.type | required | Fixed Value: document |
| Bundle.entry.request.method | required | HTTPVerb |
| Bundle.entry:composition.request.method | required | HTTPVerb |
| Bundle.entry:organization.request.method | required | HTTPVerb |
| Bundle.entry:authorization.request.method | required | HTTPVerb |
| Bundle.entry:medicinalProduct.request.method | required | HTTPVerb |
| Bundle.entry:packagedProduct.request.method | required | HTTPVerb |
| Bundle.entry:administrableProduct.request.method | required | HTTPVerb |
| Bundle.entry:manufacturedItem.request.method | required | HTTPVerb |
| Bundle.entry:ingredient.request.method | required | HTTPVerb |
| Bundle.entry:clinicalUse.request.method | required | HTTPVerb |
| Bundle.entry:substanceDefinition.request.method | required | HTTPVerb |
| Bundle.entry:binary.request.method | required | HTTPVerb |
| Id | Grade | Path(s) | Details | Requirements |
| apd-1 | error | Bundle.entry:administrableProduct.resource | RouteOfAdministration cannot be used when the 'formOf' product already uses MedicinalProductDefinition.route (and vice versa) : AdministrableProductDefinition.formOf.resolve().route.empty() | |
| 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() | |
| dom-2 | error | Bundle.entry:composition.resource, Bundle.entry:organization.resource, Bundle.entry:authorization.resource, Bundle.entry:medicinalProduct.resource, Bundle.entry:packagedProduct.resource, Bundle.entry:administrableProduct.resource, Bundle.entry:manufacturedItem.resource, Bundle.entry:ingredient.resource, Bundle.entry:substanceDefinition.resource | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Bundle.entry:composition.resource, Bundle.entry:organization.resource, Bundle.entry:authorization.resource, Bundle.entry:medicinalProduct.resource, Bundle.entry:packagedProduct.resource, Bundle.entry:administrableProduct.resource, Bundle.entry:manufacturedItem.resource, Bundle.entry:ingredient.resource, Bundle.entry:substanceDefinition.resource | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | Bundle.entry:composition.resource, Bundle.entry:organization.resource, Bundle.entry:authorization.resource, Bundle.entry:medicinalProduct.resource, Bundle.entry:packagedProduct.resource, Bundle.entry:administrableProduct.resource, Bundle.entry:manufacturedItem.resource, Bundle.entry:ingredient.resource, Bundle.entry:substanceDefinition.resource | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | Bundle.entry:composition.resource, Bundle.entry:organization.resource, Bundle.entry:authorization.resource, Bundle.entry:medicinalProduct.resource, Bundle.entry:packagedProduct.resource, Bundle.entry:administrableProduct.resource, Bundle.entry:manufacturedItem.resource, Bundle.entry:ingredient.resource, Bundle.entry:substanceDefinition.resource | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Bundle.entry:composition.resource, Bundle.entry:organization.resource, Bundle.entry:authorization.resource, Bundle.entry:medicinalProduct.resource, Bundle.entry:packagedProduct.resource, Bundle.entry:administrableProduct.resource, Bundle.entry:manufacturedItem.resource, Bundle.entry:ingredient.resource, Bundle.entry:substanceDefinition.resource | A resource should have narrative for robust management : text.`div`.exists() | |
| 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() | |
| ing-1 | error | Bundle.entry:ingredient.resource | If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource : Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2 | |
| org-1 | error | Bundle.entry:organization.resource | The organization SHALL at least have a name or an identifier, and possibly more than one : (identifier.count() + name.count()) > 0 |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Bundle | C | 0..* | Bundle | Electronic Product Information Bundle Document bdl-epi-1: An ePI document must have no additional Composition (including Composition subclass) resources besides the first. |
| 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 | 1..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language | |
| 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 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 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | 0..1 | CompositionUvEpi | A set of resources composed into a single coherent clinical statement with clinical attestation | |
| search | ΣC | 0..1 | BackboneElement | Search related information |
| 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 |
| mode | Σ | 0..1 | code | match | include - why this is in the result set Binding: SearchEntryMode (required): Why an 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. |
| score | Σ | 0..1 | decimal | Search ranking (between 0 and 1) |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| 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 |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| ifNoneMatch | Σ | 0..1 | string | For managing cache validation |
| ifModifiedSince | Σ | 0..1 | instant | For managing cache currency |
| ifMatch | Σ | 0..1 | string | For managing update contention |
| ifNoneExist | Σ | 0..1 | string | For conditional creates |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| 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 |
| status | Σ | 1..1 | string | Status response code (text optional) |
| location | Σ | 0..1 | uri | The location (if the operation returns a location) |
| etag | Σ | 0..1 | string | The Etag for the resource (if relevant) |
| lastModified | Σ | 0..1 | instant | Server's date time modified |
| outcome | Σ | 0..1 | Resource | OperationOutcome with hints and warnings (for batch/transaction) |
| entry:organization | ΣC | 0..* | BackboneElement | Organization 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | C | 0..1 | OrganizationUvEpi | A grouping of people or organizations with a common purpose |
| search | ΣC | 0..1 | BackboneElement | Search related information |
| 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 |
| mode | Σ | 0..1 | code | match | include - why this is in the result set Binding: SearchEntryMode (required): Why an 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. |
| score | Σ | 0..1 | decimal | Search ranking (between 0 and 1) |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| 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 |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| ifNoneMatch | Σ | 0..1 | string | For managing cache validation |
| ifModifiedSince | Σ | 0..1 | instant | For managing cache currency |
| ifMatch | Σ | 0..1 | string | For managing update contention |
| ifNoneExist | Σ | 0..1 | string | For conditional creates |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| 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 |
| status | Σ | 1..1 | string | Status response code (text optional) |
| location | Σ | 0..1 | uri | The location (if the operation returns a location) |
| etag | Σ | 0..1 | string | The Etag for the resource (if relevant) |
| lastModified | Σ | 0..1 | instant | Server's date time modified |
| outcome | Σ | 0..1 | Resource | OperationOutcome with hints and warnings (for batch/transaction) |
| entry:authorization | ΣC | 0..* | BackboneElement | Regulated Authorization 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | 0..1 | RegulatedAuthorizationUvEpi | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product | |
| search | ΣC | 0..1 | BackboneElement | Search related information |
| 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 |
| mode | Σ | 0..1 | code | match | include - why this is in the result set Binding: SearchEntryMode (required): Why an 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. |
| score | Σ | 0..1 | decimal | Search ranking (between 0 and 1) |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| 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 |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| ifNoneMatch | Σ | 0..1 | string | For managing cache validation |
| ifModifiedSince | Σ | 0..1 | instant | For managing cache currency |
| ifMatch | Σ | 0..1 | string | For managing update contention |
| ifNoneExist | Σ | 0..1 | string | For conditional creates |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| 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 |
| status | Σ | 1..1 | string | Status response code (text optional) |
| location | Σ | 0..1 | uri | The location (if the operation returns a location) |
| etag | Σ | 0..1 | string | The Etag for the resource (if relevant) |
| lastModified | Σ | 0..1 | instant | Server's date time modified |
| outcome | Σ | 0..1 | Resource | OperationOutcome with hints and warnings (for batch/transaction) |
| entry:medicinalProduct | ΣC | 0..* | BackboneElement | Medicinal Product 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | 0..1 | MedicinalProductDefinitionUvEpi | Detailed definition of a medicinal product | |
| search | ΣC | 0..1 | BackboneElement | Search related information |
| 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 |
| mode | Σ | 0..1 | code | match | include - why this is in the result set Binding: SearchEntryMode (required): Why an 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. |
| score | Σ | 0..1 | decimal | Search ranking (between 0 and 1) |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| 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 |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| ifNoneMatch | Σ | 0..1 | string | For managing cache validation |
| ifModifiedSince | Σ | 0..1 | instant | For managing cache currency |
| ifMatch | Σ | 0..1 | string | For managing update contention |
| ifNoneExist | Σ | 0..1 | string | For conditional creates |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| 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 |
| status | Σ | 1..1 | string | Status response code (text optional) |
| location | Σ | 0..1 | uri | The location (if the operation returns a location) |
| etag | Σ | 0..1 | string | The Etag for the resource (if relevant) |
| lastModified | Σ | 0..1 | instant | Server's date time modified |
| outcome | Σ | 0..1 | Resource | OperationOutcome with hints and warnings (for batch/transaction) |
| entry:packagedProduct | ΣC | 0..* | BackboneElement | Packaged Product 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | 0..1 | PackagedProductDefinitionUvEpi | A medically related item or items, in a container or package | |
| search | ΣC | 0..1 | BackboneElement | Search related information |
| 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 |
| mode | Σ | 0..1 | code | match | include - why this is in the result set Binding: SearchEntryMode (required): Why an 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. |
| score | Σ | 0..1 | decimal | Search ranking (between 0 and 1) |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| 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 |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| ifNoneMatch | Σ | 0..1 | string | For managing cache validation |
| ifModifiedSince | Σ | 0..1 | instant | For managing cache currency |
| ifMatch | Σ | 0..1 | string | For managing update contention |
| ifNoneExist | Σ | 0..1 | string | For conditional creates |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| 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 |
| status | Σ | 1..1 | string | Status response code (text optional) |
| location | Σ | 0..1 | uri | The location (if the operation returns a location) |
| etag | Σ | 0..1 | string | The Etag for the resource (if relevant) |
| lastModified | Σ | 0..1 | instant | Server's date time modified |
| outcome | Σ | 0..1 | Resource | OperationOutcome with hints and warnings (for batch/transaction) |
| entry:administrableProduct | ΣC | 0..* | BackboneElement | Administrable Product 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | C | 0..1 | AdministrableProductDefinitionUvEpi | A medicinal product in the final form, suitable for administration - after any mixing of multiple components |
| search | ΣC | 0..1 | BackboneElement | Search related information |
| 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 |
| mode | Σ | 0..1 | code | match | include - why this is in the result set Binding: SearchEntryMode (required): Why an 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. |
| score | Σ | 0..1 | decimal | Search ranking (between 0 and 1) |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| 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 |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| ifNoneMatch | Σ | 0..1 | string | For managing cache validation |
| ifModifiedSince | Σ | 0..1 | instant | For managing cache currency |
| ifMatch | Σ | 0..1 | string | For managing update contention |
| ifNoneExist | Σ | 0..1 | string | For conditional creates |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| 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 |
| status | Σ | 1..1 | string | Status response code (text optional) |
| location | Σ | 0..1 | uri | The location (if the operation returns a location) |
| etag | Σ | 0..1 | string | The Etag for the resource (if relevant) |
| lastModified | Σ | 0..1 | instant | Server's date time modified |
| outcome | Σ | 0..1 | Resource | OperationOutcome with hints and warnings (for batch/transaction) |
| entry:manufacturedItem | ΣC | 0..* | BackboneElement | Manufactured Item 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | 0..1 | ManufacturedItemDefinitionUvEpi | The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product | |
| search | ΣC | 0..1 | BackboneElement | Search related information |
| 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 |
| mode | Σ | 0..1 | code | match | include - why this is in the result set Binding: SearchEntryMode (required): Why an 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. |
| score | Σ | 0..1 | decimal | Search ranking (between 0 and 1) |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| 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 |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| ifNoneMatch | Σ | 0..1 | string | For managing cache validation |
| ifModifiedSince | Σ | 0..1 | instant | For managing cache currency |
| ifMatch | Σ | 0..1 | string | For managing update contention |
| ifNoneExist | Σ | 0..1 | string | For conditional creates |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| 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 |
| status | Σ | 1..1 | string | Status response code (text optional) |
| location | Σ | 0..1 | uri | The location (if the operation returns a location) |
| etag | Σ | 0..1 | string | The Etag for the resource (if relevant) |
| lastModified | Σ | 0..1 | instant | Server's date time modified |
| outcome | Σ | 0..1 | Resource | OperationOutcome with hints and warnings (for batch/transaction) |
| entry:ingredient | ΣC | 0..* | BackboneElement | Ingredient 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | C | 0..1 | IngredientUvEpi | An ingredient of a manufactured item or pharmaceutical product |
| search | ΣC | 0..1 | BackboneElement | Search related information |
| 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 |
| mode | Σ | 0..1 | code | match | include - why this is in the result set Binding: SearchEntryMode (required): Why an 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. |
| score | Σ | 0..1 | decimal | Search ranking (between 0 and 1) |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| 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 |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| ifNoneMatch | Σ | 0..1 | string | For managing cache validation |
| ifModifiedSince | Σ | 0..1 | instant | For managing cache currency |
| ifMatch | Σ | 0..1 | string | For managing update contention |
| ifNoneExist | Σ | 0..1 | string | For conditional creates |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| 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 |
| status | Σ | 1..1 | string | Status response code (text optional) |
| location | Σ | 0..1 | uri | The location (if the operation returns a location) |
| etag | Σ | 0..1 | string | The Etag for the resource (if relevant) |
| lastModified | Σ | 0..1 | instant | Server's date time modified |
| outcome | Σ | 0..1 | Resource | OperationOutcome with hints and warnings (for batch/transaction) |
| entry:clinicalUse | ΣC | 0..* | BackboneElement | Interactions, Warnings, Indications,Contraindications 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | ΣC | 0..1 | ClinicalUseDefinition | A resource in the bundle |
| search | ΣC | 0..1 | BackboneElement | Search related information |
| 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 |
| mode | Σ | 0..1 | code | match | include - why this is in the result set Binding: SearchEntryMode (required): Why an 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. |
| score | Σ | 0..1 | decimal | Search ranking (between 0 and 1) |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| 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 |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| ifNoneMatch | Σ | 0..1 | string | For managing cache validation |
| ifModifiedSince | Σ | 0..1 | instant | For managing cache currency |
| ifMatch | Σ | 0..1 | string | For managing update contention |
| ifNoneExist | Σ | 0..1 | string | For conditional creates |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| 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 |
| status | Σ | 1..1 | string | Status response code (text optional) |
| location | Σ | 0..1 | uri | The location (if the operation returns a location) |
| etag | Σ | 0..1 | string | The Etag for the resource (if relevant) |
| lastModified | Σ | 0..1 | instant | Server's date time modified |
| outcome | Σ | 0..1 | Resource | OperationOutcome with hints and warnings (for batch/transaction) |
| entry:substanceDefinition | ΣC | 0..* | BackboneElement | Substance Definition 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | 0..1 | SubstanceDefinitionUvEpi | The detailed description of a substance, typically at a level beyond what is used for prescribing | |
| search | ΣC | 0..1 | BackboneElement | Search related information |
| 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 |
| mode | Σ | 0..1 | code | match | include - why this is in the result set Binding: SearchEntryMode (required): Why an 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. |
| score | Σ | 0..1 | decimal | Search ranking (between 0 and 1) |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| 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 |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| ifNoneMatch | Σ | 0..1 | string | For managing cache validation |
| ifModifiedSince | Σ | 0..1 | instant | For managing cache currency |
| ifMatch | Σ | 0..1 | string | For managing update contention |
| ifNoneExist | Σ | 0..1 | string | For conditional creates |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| 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 |
| status | Σ | 1..1 | string | Status response code (text optional) |
| location | Σ | 0..1 | uri | The location (if the operation returns a location) |
| etag | Σ | 0..1 | string | The Etag for the resource (if relevant) |
| lastModified | Σ | 0..1 | instant | Server's date time modified |
| outcome | Σ | 0..1 | Resource | OperationOutcome with hints and warnings (for batch/transaction) |
| entry:binary | ΣC | 0..* | BackboneElement | Binary 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 | 0..1 | uri | URI for resource (e.g. the absolute URL server address, URI for UUID/OID, etc.) |
| resource | ΣC | 0..1 | Binary | A resource in the bundle |
| search | ΣC | 0..1 | BackboneElement | Search related information |
| 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 |
| mode | Σ | 0..1 | code | match | include - why this is in the result set Binding: SearchEntryMode (required): Why an 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. |
| score | Σ | 0..1 | decimal | Search ranking (between 0 and 1) |
| request | ΣC | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| 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 |
| method | ΣC | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| ifNoneMatch | Σ | 0..1 | string | For managing cache validation |
| ifModifiedSince | Σ | 0..1 | instant | For managing cache currency |
| ifMatch | Σ | 0..1 | string | For managing update contention |
| ifNoneExist | Σ | 0..1 | string | For conditional creates |
| response | ΣC | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| 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 |
| status | Σ | 1..1 | string | Status response code (text optional) |
| location | Σ | 0..1 | uri | The location (if the operation returns a location) |
| etag | Σ | 0..1 | string | The Etag for the resource (if relevant) |
| lastModified | Σ | 0..1 | instant | Server's date time modified |
| outcome | Σ | 0..1 | Resource | OperationOutcome with hints and warnings (for batch/transaction) |
| signature | Σ | 0..1 | Signature | Digital Signature. |
| issues | ΣCTU | 0..1 | OperationOutcome | Issues with the Bundle |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code |
| Bundle.language | required | AllLanguages |
| Bundle.type | required | Fixed Value: document |
| Bundle.link.relation | required | LinkRelationTypes |
| Bundle.entry.search.mode | required | SearchEntryMode |
| Bundle.entry.request.method | required | HTTPVerb |
| Bundle.entry:composition.search.mode | required | SearchEntryMode |
| Bundle.entry:composition.request.method | required | HTTPVerb |
| Bundle.entry:organization.search.mode | required | SearchEntryMode |
| Bundle.entry:organization.request.method | required | HTTPVerb |
| Bundle.entry:authorization.search.mode | required | SearchEntryMode |
| Bundle.entry:authorization.request.method | required | HTTPVerb |
| Bundle.entry:medicinalProduct.search.mode | required | SearchEntryMode |
| Bundle.entry:medicinalProduct.request.method | required | HTTPVerb |
| Bundle.entry:packagedProduct.search.mode | required | SearchEntryMode |
| Bundle.entry:packagedProduct.request.method | required | HTTPVerb |
| Bundle.entry:administrableProduct.search.mode | required | SearchEntryMode |
| Bundle.entry:administrableProduct.request.method | required | HTTPVerb |
| Bundle.entry:manufacturedItem.search.mode | required | SearchEntryMode |
| Bundle.entry:manufacturedItem.request.method | required | HTTPVerb |
| Bundle.entry:ingredient.search.mode | required | SearchEntryMode |
| Bundle.entry:ingredient.request.method | required | HTTPVerb |
| Bundle.entry:clinicalUse.search.mode | required | SearchEntryMode |
| Bundle.entry:clinicalUse.request.method | required | HTTPVerb |
| Bundle.entry:substanceDefinition.search.mode | required | SearchEntryMode |
| Bundle.entry:substanceDefinition.request.method | required | HTTPVerb |
| Bundle.entry:binary.search.mode | required | SearchEntryMode |
| Bundle.entry:binary.request.method | required | HTTPVerb |
| Id | Grade | Path(s) | Details | Requirements |
| apd-1 | error | Bundle.entry:administrableProduct.resource | RouteOfAdministration cannot be used when the 'formOf' product already uses MedicinalProductDefinition.route (and vice versa) : AdministrableProductDefinition.formOf.resolve().route.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-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() | |
| dom-2 | error | Bundle.entry:composition.resource, Bundle.entry:organization.resource, Bundle.entry:authorization.resource, Bundle.entry:medicinalProduct.resource, Bundle.entry:packagedProduct.resource, Bundle.entry:administrableProduct.resource, Bundle.entry:manufacturedItem.resource, Bundle.entry:ingredient.resource, Bundle.entry:substanceDefinition.resource | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Bundle.entry:composition.resource, Bundle.entry:organization.resource, Bundle.entry:authorization.resource, Bundle.entry:medicinalProduct.resource, Bundle.entry:packagedProduct.resource, Bundle.entry:administrableProduct.resource, Bundle.entry:manufacturedItem.resource, Bundle.entry:ingredient.resource, Bundle.entry:substanceDefinition.resource | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | Bundle.entry:composition.resource, Bundle.entry:organization.resource, Bundle.entry:authorization.resource, Bundle.entry:medicinalProduct.resource, Bundle.entry:packagedProduct.resource, Bundle.entry:administrableProduct.resource, Bundle.entry:manufacturedItem.resource, Bundle.entry:ingredient.resource, Bundle.entry:substanceDefinition.resource | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | Bundle.entry:composition.resource, Bundle.entry:organization.resource, Bundle.entry:authorization.resource, Bundle.entry:medicinalProduct.resource, Bundle.entry:packagedProduct.resource, Bundle.entry:administrableProduct.resource, Bundle.entry:manufacturedItem.resource, Bundle.entry:ingredient.resource, Bundle.entry:substanceDefinition.resource | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Bundle.entry:composition.resource, Bundle.entry:organization.resource, Bundle.entry:authorization.resource, Bundle.entry:medicinalProduct.resource, Bundle.entry:packagedProduct.resource, Bundle.entry:administrableProduct.resource, Bundle.entry:manufacturedItem.resource, Bundle.entry:ingredient.resource, Bundle.entry:substanceDefinition.resource | A resource should have narrative for robust management : text.`div`.exists() | |
| 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() | |
| ing-1 | error | Bundle.entry:ingredient.resource | If an ingredient is noted as an allergen (allergenicIndicator) then its substance should be a code. If the substance is a SubstanceDefinition, then the allegen information should be documented in that resource : Ingredient.where(allergenicIndicator=true).count() + Ingredient.substance.code.reference.count() < 2 | |
| org-1 | error | Bundle.entry:organization.resource | The organization SHALL at least have a name or an identifier, and possibly more than one : (identifier.count() + name.count()) > 0 |
This structure is derived from Bundle
Summary
Mandatory: 7 elements
Fixed Value: 1 element
Prohibited: 3 elements
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
Maturity: 2
Other representations of profile: CSV, Excel, Schematron
IG © 2022+ HL7 International - Biomedical Research & Regulation Work Group. Package hl7.fhir.uv.emedicinal-product-info#1.0.0 based on FHIR 5.0.0. Generated 2023-07-26
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