SPL Mapping FHIR Implementation Guide
0.1.0 - Build CI
SPL Mapping FHIR Implementation Guide
0.1.0 - Build CI
SPL Mapping FHIR Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions
| Official URL: http://hl7.org/fhir/us/spl/StructureDefinition/DualSubmissionProvenance | Version: 0.1.0 | |||
| Standards status: Trial-use | Maturity Level: 1 | Computable Name: DualSubmissionProvenance | ||
A profile that links changes made to a FHIR system either via a converted SPL document or that are sent to a SPL system
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from Provenance
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  Provenance |
0..* | Provenance | Who, What, When for a set of resources | |
  target |
S | 1..* | Reference(SPLDocumentReference | ProductSubmissionDocument | RegistrantOrganization | LabelerOrganization | EstablishmentOrganization | GDUFAFacilityOrganization) | Target Reference(s) (usually version specific) |
 occurred[x] |
S | 1..1 | Period, dateTime | When the activity occurred |
| recorded |
S | 1..1 | instant | When the activity was recorded / updated |
| activity |
S | 1..1 | CodeableConcept | Activity that occurred |
 agent |
S | 1..1 | BackboneElement | Actor involved |
 type |
S | 1..1 | CodeableConcept | How the agent participated Required Pattern: At least the following |
  coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
 system |
1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/provenance-participant-type | |
 code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: assembler | |
| who |
S | 1..1 | Reference(Practitioner | PractitionerRole | RelatedPerson | Patient | Device | Organization) | Who participated |
| entity |
S | 1..* | BackboneElement | An entity used in this activity |
| role |
S | 1..1 | code | derivation | revision | quotation | source | removal Required Pattern: source |
| what |
1..1 | Reference(SPLDocumentReference | ProductSubmissionDocument | RegistrantOrganization | LabelerOrganization | EstablishmentOrganization | GDUFAFacilityOrganization) | Identity of entity | |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Provenance |
0..* | Provenance | Who, What, When for a set of resources | |
 implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
 modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored |
| target |
SΣ | 1..* | Reference(SPLDocumentReference | ProductSubmissionDocument | RegistrantOrganization | LabelerOrganization | EstablishmentOrganization | GDUFAFacilityOrganization) | Target Reference(s) (usually version specific) |
 occurred[x] |
S | 1..1 | When the activity occurred | |
 occurredPeriod |
Period | |||
| occurredDateTime |
dateTime | |||
| recorded |
SΣ | 1..1 | instant | When the activity was recorded / updated |
| activity |
S | 1..1 | CodeableConcept | Activity that occurred Binding: ProvenanceActivityType (extensible): The activity that took place. |
| agent |
S | 1..1 | BackboneElement | Actor involved |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
SΣ | 1..1 | CodeableConcept | How the agent participated Binding: ProvenanceParticipantType (extensible): The type of participation that a provenance agent played with respect to the activity. Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/provenance-participant-type | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: assembler | |
| who |
SΣ | 1..1 | Reference(Practitioner | PractitionerRole | RelatedPerson | Patient | Device | Organization) | Who participated |
| entity |
S | 1..* | BackboneElement | An entity used in this activity |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| role |
SΣ | 1..1 | code | derivation | revision | quotation | source | removal Binding: ProvenanceEntityRole (required): How an entity was used in an activity. Required Pattern: source |
| what |
Σ | 1..1 | Reference(SPLDocumentReference | ProductSubmissionDocument | RegistrantOrganization | LabelerOrganization | EstablishmentOrganization | GDUFAFacilityOrganization) | Identity of entity |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| Provenance.activity | extensible | ProvenanceActivityTypehttp://hl7.org/fhir/ValueSet/provenance-activity-typefrom the FHIR Standard | |
| Provenance.agent.type | extensible | Pattern: assemblerhttp://hl7.org/fhir/ValueSet/provenance-agent-typefrom the FHIR Standard | |
| Provenance.entity.role | required | Pattern: sourcehttp://hl7.org/fhir/ValueSet/provenance-entity-role|4.3.0from the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | Provenance | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Provenance | 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.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | Provenance | 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 | Provenance | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Provenance | 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() |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| Provenance |
0..* | Provenance | Who, What, When for a set of resources | |||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): IETF language tag
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained |
0..* | Resource | Contained, inline Resources dom-r4b: Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems | |||||
 extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| target |
SΣ | 1..* | Reference(SPLDocumentReference | ProductSubmissionDocument | RegistrantOrganization | LabelerOrganization | EstablishmentOrganization | GDUFAFacilityOrganization) | Target Reference(s) (usually version specific) | ||||
| occurred[x] |
S | 1..1 | When the activity occurred | |||||
| occurredPeriod |
Period | |||||||
| occurredDateTime |
dateTime | |||||||
| recorded |
SΣ | 1..1 | instant | When the activity was recorded / updated | ||||
| policy |
0..* | uri | Policy or plan the activity was defined by | |||||
| location |
0..1 | Reference(Location) | Where the activity occurred, if relevant | |||||
| reason |
0..* | CodeableConcept | Reason the activity is occurring Binding: PurposeOfUse (extensible): The reason the activity took place. | |||||
| activity |
S | 1..1 | CodeableConcept | Activity that occurred Binding: ProvenanceActivityType (extensible): The activity that took place. | ||||
| agent |
S | 1..1 | BackboneElement | Actor involved | ||||
| 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 | ||||
| type |
SΣ | 1..1 | CodeableConcept | How the agent participated Binding: ProvenanceParticipantType (extensible): The type of participation that a provenance agent played with respect to the activity. Required Pattern: At least the following | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/provenance-participant-type | |||||
| version |
0..1 | string | Version of the system - if relevant | |||||
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: assembler | |||||
| display |
0..1 | string | Representation defined by the system | |||||
| userSelected |
0..1 | boolean | If this coding was chosen directly by the user | |||||
| text |
0..1 | string | Plain text representation of the concept | |||||
| role |
0..* | CodeableConcept | What the agents role was Binding: SecurityRoleType (example): The role that a provenance agent played with respect to the activity. | |||||
| who |
SΣ | 1..1 | Reference(Practitioner | PractitionerRole | RelatedPerson | Patient | Device | Organization) | Who participated | ||||
| onBehalfOf |
0..1 | Reference(Practitioner | PractitionerRole | RelatedPerson | Patient | Device | Organization) | Who the agent is representing | |||||
| entity |
S | 1..* | BackboneElement | An entity used in this activity | ||||
| 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 | ||||
| role |
SΣ | 1..1 | code | derivation | revision | quotation | source | removal Binding: ProvenanceEntityRole (required): How an entity was used in an activity. Required Pattern: source | ||||
| what |
Σ | 1..1 | Reference(SPLDocumentReference | ProductSubmissionDocument | RegistrantOrganization | LabelerOrganization | EstablishmentOrganization | GDUFAFacilityOrganization) | Identity of entity | ||||
| agent |
0..* | See agent (Provenance) | Entity is attributed to this agent | |||||
| signature |
0..* | Signature | Signature on target | |||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | URI | |||
| Provenance.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard | ||||
| Provenance.reason | extensible | PurposeOfUsehttp://terminology.hl7.org/ValueSet/v3-PurposeOfUse | ||||
| Provenance.activity | extensible | ProvenanceActivityTypehttp://hl7.org/fhir/ValueSet/provenance-activity-typefrom the FHIR Standard | ||||
| Provenance.agent.type | extensible | Pattern: assemblerhttp://hl7.org/fhir/ValueSet/provenance-agent-typefrom the FHIR Standard | ||||
| Provenance.agent.role | example | SecurityRoleTypehttp://hl7.org/fhir/ValueSet/security-role-typefrom the FHIR Standard | ||||
| Provenance.entity.role | required | Pattern: sourcehttp://hl7.org/fhir/ValueSet/provenance-entity-role|4.3.0from the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | Provenance | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Provenance | 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.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | Provenance | 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 | Provenance | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Provenance | A resource should have narrative for robust management : text.`div`.exists() | |
| dom-r4b | warning | Provenance.contained | Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems : ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic) | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from Provenance
Summary
Mandatory: 4 elements
Must-Support: 9 elements
Structures
This structure refers to these other structures:
Maturity: 1
Differential View
This structure is derived from Provenance
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Provenance |
0..* | Provenance | Who, What, When for a set of resources | |
| target |
S | 1..* | Reference(SPLDocumentReference | ProductSubmissionDocument | RegistrantOrganization | LabelerOrganization | EstablishmentOrganization | GDUFAFacilityOrganization) | Target Reference(s) (usually version specific) |
| occurred[x] |
S | 1..1 | Period, dateTime | When the activity occurred |
| recorded |
S | 1..1 | instant | When the activity was recorded / updated |
| activity |
S | 1..1 | CodeableConcept | Activity that occurred |
| agent |
S | 1..1 | BackboneElement | Actor involved |
| type |
S | 1..1 | CodeableConcept | How the agent participated Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/provenance-participant-type | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: assembler | |
| who |
S | 1..1 | Reference(Practitioner | PractitionerRole | RelatedPerson | Patient | Device | Organization) | Who participated |
| entity |
S | 1..* | BackboneElement | An entity used in this activity |
| role |
S | 1..1 | code | derivation | revision | quotation | source | removal Required Pattern: source |
| what |
1..1 | Reference(SPLDocumentReference | ProductSubmissionDocument | RegistrantOrganization | LabelerOrganization | EstablishmentOrganization | GDUFAFacilityOrganization) | Identity of entity | |
| Documentation for this format | ||||
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Provenance |
0..* | Provenance | Who, What, When for a set of resources | |
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored |
| target |
SΣ | 1..* | Reference(SPLDocumentReference | ProductSubmissionDocument | RegistrantOrganization | LabelerOrganization | EstablishmentOrganization | GDUFAFacilityOrganization) | Target Reference(s) (usually version specific) |
| occurred[x] |
S | 1..1 | When the activity occurred | |
| occurredPeriod |
Period | |||
| occurredDateTime |
dateTime | |||
| recorded |
SΣ | 1..1 | instant | When the activity was recorded / updated |
| activity |
S | 1..1 | CodeableConcept | Activity that occurred Binding: ProvenanceActivityType (extensible): The activity that took place. |
| agent |
S | 1..1 | BackboneElement | Actor involved |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
SΣ | 1..1 | CodeableConcept | How the agent participated Binding: ProvenanceParticipantType (extensible): The type of participation that a provenance agent played with respect to the activity. Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/provenance-participant-type | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: assembler | |
| who |
SΣ | 1..1 | Reference(Practitioner | PractitionerRole | RelatedPerson | Patient | Device | Organization) | Who participated |
| entity |
S | 1..* | BackboneElement | An entity used in this activity |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| role |
SΣ | 1..1 | code | derivation | revision | quotation | source | removal Binding: ProvenanceEntityRole (required): How an entity was used in an activity. Required Pattern: source |
| what |
Σ | 1..1 | Reference(SPLDocumentReference | ProductSubmissionDocument | RegistrantOrganization | LabelerOrganization | EstablishmentOrganization | GDUFAFacilityOrganization) | Identity of entity |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| Provenance.activity | extensible | ProvenanceActivityTypehttp://hl7.org/fhir/ValueSet/provenance-activity-typefrom the FHIR Standard | |
| Provenance.agent.type | extensible | Pattern: assemblerhttp://hl7.org/fhir/ValueSet/provenance-agent-typefrom the FHIR Standard | |
| Provenance.entity.role | required | Pattern: sourcehttp://hl7.org/fhir/ValueSet/provenance-entity-role|4.3.0from the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | Provenance | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Provenance | 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.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | Provenance | 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 | Provenance | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Provenance | 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() |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| Provenance |
0..* | Provenance | Who, What, When for a set of resources | |||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): IETF language tag
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained |
0..* | Resource | Contained, inline Resources dom-r4b: Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| target |
SΣ | 1..* | Reference(SPLDocumentReference | ProductSubmissionDocument | RegistrantOrganization | LabelerOrganization | EstablishmentOrganization | GDUFAFacilityOrganization) | Target Reference(s) (usually version specific) | ||||
| occurred[x] |
S | 1..1 | When the activity occurred | |||||
| occurredPeriod |
Period | |||||||
| occurredDateTime |
dateTime | |||||||
| recorded |
SΣ | 1..1 | instant | When the activity was recorded / updated | ||||
| policy |
0..* | uri | Policy or plan the activity was defined by | |||||
| location |
0..1 | Reference(Location) | Where the activity occurred, if relevant | |||||
| reason |
0..* | CodeableConcept | Reason the activity is occurring Binding: PurposeOfUse (extensible): The reason the activity took place. | |||||
| activity |
S | 1..1 | CodeableConcept | Activity that occurred Binding: ProvenanceActivityType (extensible): The activity that took place. | ||||
| agent |
S | 1..1 | BackboneElement | Actor involved | ||||
| 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 | ||||
| type |
SΣ | 1..1 | CodeableConcept | How the agent participated Binding: ProvenanceParticipantType (extensible): The type of participation that a provenance agent played with respect to the activity. Required Pattern: At least the following | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/provenance-participant-type | |||||
| version |
0..1 | string | Version of the system - if relevant | |||||
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: assembler | |||||
| display |
0..1 | string | Representation defined by the system | |||||
| userSelected |
0..1 | boolean | If this coding was chosen directly by the user | |||||
| text |
0..1 | string | Plain text representation of the concept | |||||
| role |
0..* | CodeableConcept | What the agents role was Binding: SecurityRoleType (example): The role that a provenance agent played with respect to the activity. | |||||
| who |
SΣ | 1..1 | Reference(Practitioner | PractitionerRole | RelatedPerson | Patient | Device | Organization) | Who participated | ||||
| onBehalfOf |
0..1 | Reference(Practitioner | PractitionerRole | RelatedPerson | Patient | Device | Organization) | Who the agent is representing | |||||
| entity |
S | 1..* | BackboneElement | An entity used in this activity | ||||
| 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 | ||||
| role |
SΣ | 1..1 | code | derivation | revision | quotation | source | removal Binding: ProvenanceEntityRole (required): How an entity was used in an activity. Required Pattern: source | ||||
| what |
Σ | 1..1 | Reference(SPLDocumentReference | ProductSubmissionDocument | RegistrantOrganization | LabelerOrganization | EstablishmentOrganization | GDUFAFacilityOrganization) | Identity of entity | ||||
| agent |
0..* | See agent (Provenance) | Entity is attributed to this agent | |||||
| signature |
0..* | Signature | Signature on target | |||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | URI | |||
| Provenance.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard | ||||
| Provenance.reason | extensible | PurposeOfUsehttp://terminology.hl7.org/ValueSet/v3-PurposeOfUse | ||||
| Provenance.activity | extensible | ProvenanceActivityTypehttp://hl7.org/fhir/ValueSet/provenance-activity-typefrom the FHIR Standard | ||||
| Provenance.agent.type | extensible | Pattern: assemblerhttp://hl7.org/fhir/ValueSet/provenance-agent-typefrom the FHIR Standard | ||||
| Provenance.agent.role | example | SecurityRoleTypehttp://hl7.org/fhir/ValueSet/security-role-typefrom the FHIR Standard | ||||
| Provenance.entity.role | required | Pattern: sourcehttp://hl7.org/fhir/ValueSet/provenance-entity-role|4.3.0from the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | Provenance | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Provenance | 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.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | Provenance | 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 | Provenance | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Provenance | A resource should have narrative for robust management : text.`div`.exists() | |
| dom-r4b | warning | Provenance.contained | Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems : ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic) | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from Provenance
Summary
Mandatory: 4 elements
Must-Support: 9 elements
Structures
This structure refers to these other structures:
Maturity: 1
Other representations of profile: CSV, Excel, Schematron
IG © 2020+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.spl#0.1.0 based on FHIR 4.3.0. Generated 2024-05-02
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