API for the Exchange of Medicinal Product Information (APIX), published by Gravitate Health Project. 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/cander2/apix-ig/ and changes regularly. See the Directory of published versions

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• Detailed Descriptions
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Resource Profile: APIX Provenance Profile

Profile for tracking origin and history of regulatory submission data.

Usages:

• This Profile is not used by any profiles in this Implementation Guide

Formal Views of Profile Content

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

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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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
contained		0..*	Resource	Contained, inline Resources
Slices for extension				Content/Rules for all slices
extension:regulatoryContext		0..1	CodeableConcept	Extension URL: http://example.com/fhir/StructureDefinition/RegulatoryContext Binding: http://example.com/fhir/CodeSystem/apix-regulatory-context (required)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
target	Σ	1..*	Reference(DocumentReference | Task)	Target Reference(s) (usually version specific)
recorded	Σ	1..1	instant	When the activity was recorded / updated
activity		1..1	CodeableConcept	Activity that occurred Binding: APIX Provenance Activity Value Set (required)
agent	ΣC	1..*	BackboneElement	Actor involved Constraints: prov-1, prov-2, prov-3
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
who	ΣC	1..1	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson)	The agent that participated in the event
onBehalfOf	C	0..1	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient)	The agent that delegated
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Provenance.activity	required	ApixProvenanceActivityValueSet http://example.com/fhir/ValueSet/apix-provenance-activity From this IG

Constraints

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 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	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()
prov-1	error	Provenance.agent	Who and onBehalfOf cannot be the same : who.resolve().exists() and onBehalfOf.resolve().exists() implies who.resolve() != onBehalfOf.resolve()
prov-2	error	Provenance.agent	If who is a PractitionerRole, onBehalfOf can't reference the same Practitioner : who.resolve().ofType(PractitionerRole).practitioner.resolve().exists() and onBehalfOf.resolve().ofType(Practitioner).exists() implies who.resolve().practitioner.resolve() != onBehalfOf.resolve()
prov-3	error	Provenance.agent	If who is an organization, onBehalfOf can't be a PractitionerRole within that organization : who.resolve().ofType(Organization).exists() and onBehalfOf.resolve().ofType(PractitionerRole).organization.resolve().exists() implies who.resolve() != onBehalfOf.resolve().organization.resolve()

This structure is derived from Provenance

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Provenance		0..*	Provenance	Who, What, When for a set of resources
Slices for extension				Content/Rules for all slices
extension:regulatoryContext		0..1	CodeableConcept	Extension URL: http://example.com/fhir/StructureDefinition/RegulatoryContext Binding: http://example.com/fhir/CodeSystem/apix-regulatory-context (required)
target		1..*	Reference(DocumentReference | Task)	Target Reference(s) (usually version specific)
recorded		1..1	instant	When the activity was recorded / updated
activity		1..1	CodeableConcept	Activity that occurred Binding: APIX Provenance Activity Value Set (required)
agent		1..*	BackboneElement	Actor involved
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Provenance.activity	required	ApixProvenanceActivityValueSet http://example.com/fhir/ValueSet/apix-provenance-activity From this IG

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter
text		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:regulatoryContext		0..1	CodeableConcept	Extension URL: http://example.com/fhir/StructureDefinition/RegulatoryContext Binding: http://example.com/fhir/CodeSystem/apix-regulatory-context (required)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
target	Σ	1..*	Reference(DocumentReference | Task)	Target Reference(s) (usually version specific)
occurred[x]		0..1		When the activity occurred
occurredPeriod			Period
occurredDateTime			dateTime
recorded	Σ	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
authorization		0..*	CodeableReference()	Authorization (purposeOfUse) related to the event Binding: PurposeOfUse (example): The authorized purposeOfUse for the activity.
activity		1..1	CodeableConcept	Activity that occurred Binding: APIX Provenance Activity Value Set (required)
basedOn		0..*	Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest | Task)	Workflow authorization within which this event occurred
patient		0..1	Reference(Patient)	The patient is the subject of the data created/updated (.target) by the activity
encounter		0..1	Reference(Encounter)	Encounter within which this event occurred or which the event is tightly associated
agent	ΣC	1..*	BackboneElement	Actor involved Constraints: prov-1, prov-2, prov-3
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	Σ	0..1	CodeableConcept	How the agent participated Binding: ParticipationRoleType (example): The type of participation that a provenance agent played with respect to the activity.
role		0..*	CodeableConcept	What the agents role was Binding: SecurityRoleType (example): The role that a provenance agent played with respect to the activity.
who	ΣC	1..1	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson)	The agent that participated in the event
onBehalfOf	C	0..1	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient)	The agent that delegated
entity	Σ	0..*	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	Σ	1..1	code	revision | quotation | source | instantiates | removal Binding: ProvenanceEntityRole (required): How an entity was used in an activity.
what	Σ	1..1	Reference(Resource)	Identity of entity
agent		0..*	See agent (Provenance)	Entity is attributed to this agent
signature		0..*	Signature	Signature on target
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Provenance.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 From the FHIR Standard
Provenance.authorization	example	PurposeOfUse http://terminology.hl7.org/ValueSet/v3-PurposeOfUse
Provenance.activity	required	ApixProvenanceActivityValueSet http://example.com/fhir/ValueSet/apix-provenance-activity From this IG
Provenance.agent.type	example	ParticipationRoleType http://hl7.org/fhir/ValueSet/participation-role-type From the FHIR Standard
Provenance.agent.role	example	SecurityRoleType http://hl7.org/fhir/ValueSet/security-role-type From the FHIR Standard
Provenance.entity.role	required	ProvenanceEntityRole http://hl7.org/fhir/ValueSet/provenance-entity-role|5.0.0 From the FHIR Standard

Constraints

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 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	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()
prov-1	error	Provenance.agent	Who and onBehalfOf cannot be the same : who.resolve().exists() and onBehalfOf.resolve().exists() implies who.resolve() != onBehalfOf.resolve()
prov-2	error	Provenance.agent	If who is a PractitionerRole, onBehalfOf can't reference the same Practitioner : who.resolve().ofType(PractitionerRole).practitioner.resolve().exists() and onBehalfOf.resolve().ofType(Practitioner).exists() implies who.resolve().practitioner.resolve() != onBehalfOf.resolve()
prov-3	error	Provenance.agent	If who is an organization, onBehalfOf can't be a PractitionerRole within that organization : who.resolve().ofType(Organization).exists() and onBehalfOf.resolve().ofType(PractitionerRole).organization.resolve().exists() implies who.resolve() != onBehalfOf.resolve().organization.resolve()

This structure is derived from Provenance

Summary

Mandatory: 4 elements

Extensions

This structure refers to these extensions:

• http://example.com/fhir/StructureDefinition/RegulatoryContext

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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
contained		0..*	Resource	Contained, inline Resources
Slices for extension				Content/Rules for all slices
extension:regulatoryContext		0..1	CodeableConcept	Extension URL: http://example.com/fhir/StructureDefinition/RegulatoryContext Binding: http://example.com/fhir/CodeSystem/apix-regulatory-context (required)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
target	Σ	1..*	Reference(DocumentReference | Task)	Target Reference(s) (usually version specific)
recorded	Σ	1..1	instant	When the activity was recorded / updated
activity		1..1	CodeableConcept	Activity that occurred Binding: APIX Provenance Activity Value Set (required)
agent	ΣC	1..*	BackboneElement	Actor involved Constraints: prov-1, prov-2, prov-3
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
who	ΣC	1..1	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson)	The agent that participated in the event
onBehalfOf	C	0..1	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient)	The agent that delegated
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Provenance.activity	required	ApixProvenanceActivityValueSet http://example.com/fhir/ValueSet/apix-provenance-activity From this IG

Constraints

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 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	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()
prov-1	error	Provenance.agent	Who and onBehalfOf cannot be the same : who.resolve().exists() and onBehalfOf.resolve().exists() implies who.resolve() != onBehalfOf.resolve()
prov-2	error	Provenance.agent	If who is a PractitionerRole, onBehalfOf can't reference the same Practitioner : who.resolve().ofType(PractitionerRole).practitioner.resolve().exists() and onBehalfOf.resolve().ofType(Practitioner).exists() implies who.resolve().practitioner.resolve() != onBehalfOf.resolve()
prov-3	error	Provenance.agent	If who is an organization, onBehalfOf can't be a PractitionerRole within that organization : who.resolve().ofType(Organization).exists() and onBehalfOf.resolve().ofType(PractitionerRole).organization.resolve().exists() implies who.resolve() != onBehalfOf.resolve().organization.resolve()

Differential View

This structure is derived from Provenance

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Provenance		0..*	Provenance	Who, What, When for a set of resources
Slices for extension				Content/Rules for all slices
extension:regulatoryContext		0..1	CodeableConcept	Extension URL: http://example.com/fhir/StructureDefinition/RegulatoryContext Binding: http://example.com/fhir/CodeSystem/apix-regulatory-context (required)
target		1..*	Reference(DocumentReference | Task)	Target Reference(s) (usually version specific)
recorded		1..1	instant	When the activity was recorded / updated
activity		1..1	CodeableConcept	Activity that occurred Binding: APIX Provenance Activity Value Set (required)
agent		1..*	BackboneElement	Actor involved
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Provenance.activity	required	ApixProvenanceActivityValueSet http://example.com/fhir/ValueSet/apix-provenance-activity From this IG

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter
text		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:regulatoryContext		0..1	CodeableConcept	Extension URL: http://example.com/fhir/StructureDefinition/RegulatoryContext Binding: http://example.com/fhir/CodeSystem/apix-regulatory-context (required)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
target	Σ	1..*	Reference(DocumentReference | Task)	Target Reference(s) (usually version specific)
occurred[x]		0..1		When the activity occurred
occurredPeriod			Period
occurredDateTime			dateTime
recorded	Σ	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
authorization		0..*	CodeableReference()	Authorization (purposeOfUse) related to the event Binding: PurposeOfUse (example): The authorized purposeOfUse for the activity.
activity		1..1	CodeableConcept	Activity that occurred Binding: APIX Provenance Activity Value Set (required)
basedOn		0..*	Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest | Task)	Workflow authorization within which this event occurred
patient		0..1	Reference(Patient)	The patient is the subject of the data created/updated (.target) by the activity
encounter		0..1	Reference(Encounter)	Encounter within which this event occurred or which the event is tightly associated
agent	ΣC	1..*	BackboneElement	Actor involved Constraints: prov-1, prov-2, prov-3
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	Σ	0..1	CodeableConcept	How the agent participated Binding: ParticipationRoleType (example): The type of participation that a provenance agent played with respect to the activity.
role		0..*	CodeableConcept	What the agents role was Binding: SecurityRoleType (example): The role that a provenance agent played with respect to the activity.
who	ΣC	1..1	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson)	The agent that participated in the event
onBehalfOf	C	0..1	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient)	The agent that delegated
entity	Σ	0..*	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	Σ	1..1	code	revision | quotation | source | instantiates | removal Binding: ProvenanceEntityRole (required): How an entity was used in an activity.
what	Σ	1..1	Reference(Resource)	Identity of entity
agent		0..*	See agent (Provenance)	Entity is attributed to this agent
signature		0..*	Signature	Signature on target
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Provenance.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 From the FHIR Standard
Provenance.authorization	example	PurposeOfUse http://terminology.hl7.org/ValueSet/v3-PurposeOfUse
Provenance.activity	required	ApixProvenanceActivityValueSet http://example.com/fhir/ValueSet/apix-provenance-activity From this IG
Provenance.agent.type	example	ParticipationRoleType http://hl7.org/fhir/ValueSet/participation-role-type From the FHIR Standard
Provenance.agent.role	example	SecurityRoleType http://hl7.org/fhir/ValueSet/security-role-type From the FHIR Standard
Provenance.entity.role	required	ProvenanceEntityRole http://hl7.org/fhir/ValueSet/provenance-entity-role|5.0.0 From the FHIR Standard

Constraints

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 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	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()
prov-1	error	Provenance.agent	Who and onBehalfOf cannot be the same : who.resolve().exists() and onBehalfOf.resolve().exists() implies who.resolve() != onBehalfOf.resolve()
prov-2	error	Provenance.agent	If who is a PractitionerRole, onBehalfOf can't reference the same Practitioner : who.resolve().ofType(PractitionerRole).practitioner.resolve().exists() and onBehalfOf.resolve().ofType(Practitioner).exists() implies who.resolve().practitioner.resolve() != onBehalfOf.resolve()
prov-3	error	Provenance.agent	If who is an organization, onBehalfOf can't be a PractitionerRole within that organization : who.resolve().ofType(Organization).exists() and onBehalfOf.resolve().ofType(PractitionerRole).organization.resolve().exists() implies who.resolve() != onBehalfOf.resolve().organization.resolve()

This structure is derived from Provenance

Summary

Mandatory: 4 elements

Extensions

This structure refers to these extensions:

• http://example.com/fhir/StructureDefinition/RegulatoryContext

Other representations of profile: CSV, Excel, Schematron