Notice
- Important: This guidance is under active development by NHS England and content may be added or updated on a regular basis.
- This Implementation Guide is currently in Draft and SHOULD NOT be used for development or active implementation without express direction from the NHS England Genomics Unit.
StructureDefinition Provenance
The Genomics Provenance SHOULD be provided alongside updates to controlled documents such as ServiceRequests and DiagnosticReports by integrated systems on any update operation to ensure auditability for any changes to resources.
It is not expected that updates which do not affect the clinical content of the document will need associated Provenance resources, e.g. addition of local identifiers (though for the purporses of the Genomic Order Management Alpha, all updates to ServiceRequest and DiagnosticReport resources will be expected to have accompanying Provenance resources). On material changes to controlled resources, ServiceRequest and DiagnosticReport, users SHOULD use the transaction endpoint on the server to bundle the updated resource and Provenance event into a single transaction.
The HL7 FHIR specification also provides the capability to attach a Provenance resource using a custom header parameter. Using this mechanism would allow clients to submit requests to the resource specific PUT enpoints for ServiceRequests and DiagnosticReports, while still aloowing changes to be captured within a Provenance resource using a single interaction. This mechanism will not be supported within the Genomic Order Management Alpha but will be investigated by the NHS England Genomics Unit for implementation in future phases.
| Profile url | FHIR Module | Normative Status |
|---|---|---|
| http://hl7.org/fhir/StructureDefinition/Provenance | HL7 International | trial-use |
| Provenance | I | DomainResource | Element idProvenance Who, What, When for a set of resources Alternate namesHistory, Event, Activity DefinitionProvenance of a resource is a record that describes entities and processes involved in producing and delivering or otherwise influencing that resource. Provenance provides a critical foundation for assessing authenticity, enabling trust, and allowing reproducibility. Provenance assertions are a form of contextual metadata and can themselves become important records with their own provenance. Provenance statement indicates clinical significance in terms of confidence in authenticity, reliability, and trustworthiness, integrity, and stage in lifecycle (e.g. Document Completion - has the artifact been legally authenticated), all of which may impact security, privacy, and trust policies. Some parties may be duplicated between the target resource and its provenance. For instance, the prescriber is usually (but not always) the author of the prescription resource. This resource is defined with close consideration for W3C Provenance.
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| id | Σ | 0..1 | string | There are no (further) constraints on this element Element idProvenance.id Logical id of this artifact DefinitionThe logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. The only time that a resource does not have an id is when it is being submitted to the server using a create operation. |
| meta | Σ | 0..1 | Meta | There are no (further) constraints on this element Element idProvenance.meta Metadata about the resource DefinitionThe metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
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| implicitRules | Σ ?! | 0..1 | uri | There are no (further) constraints on this element Element idProvenance.implicitRules A set of rules under which this content was created DefinitionA reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.
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| language | 0..1 | codeBinding | There are no (further) constraints on this element Element idProvenance.language Language of the resource content DefinitionThe base language in which the resource is written. Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). A human language.
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| text | 0..1 | Narrative | There are no (further) constraints on this element Element idProvenance.text Text summary of the resource, for human interpretation Alternate namesnarrative, html, xhtml, display DefinitionA human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety. Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
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| contained | 0..* | Resource | There are no (further) constraints on this element Element idProvenance.contained Contained, inline Resources Alternate namesinline resources, anonymous resources, contained resources DefinitionThese resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.
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| extension | I | 0..* | Extension | There are no (further) constraints on this element Element idProvenance.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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| modifierExtension | ?! I | 0..* | Extension | There are no (further) constraints on this element Element idProvenance.modifierExtension Extensions that cannot be ignored Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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| target | Σ I | 1..* | Reference(Resource) | Element idProvenance.target Target Reference(s) (usually version specific) DefinitionThe Reference(s) that were generated or updated by the activity described in this resource. A provenance can point to more than one target if multiple resources were created/updated by the same activity. Target references are usually version specific, but might not be, if a version has not been assigned or if the provenance information is part of the set of resources being maintained (i.e. a document). When using the RESTful API, the identity of the resource might not be known (especially not the version specific one); the client may either submit the resource first, and then the provenance, or it may submit both using a single transaction. See the notes on transaction for further discussion.
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| occurred[x] | 0..1 | Element idProvenance.occurred[x] When the activity occurred DefinitionThe period during which the activity occurred. The period can be a little arbitrary; where possible, the time should correspond to human assessment of the activity time.
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| occurredPeriod | Period | Data type | ||
| occurredDateTime | dateTime | Data type | ||
| recorded | Σ | 1..1 | instant | Element idProvenance.recorded When the activity was recorded / updated DefinitionThe instant of time at which the activity was recorded. This can be a little different from the time stamp on the resource if there is a delay between recording the event and updating the provenance and target resource.
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| policy | 0..* | uri | Element idProvenance.policy Policy or plan the activity was defined by DefinitionPolicy or plan the activity was defined by. Typically, a single activity may have multiple applicable policy documents, such as patient consent, guarantor funding, etc. For example: Where an OAuth token authorizes, the unique identifier from the OAuth token is placed into the policy element Where a policy engine (e.g. XACML) holds policy logic, the unique policy identifier is placed into the policy element.
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| location | I | 0..1 | Reference(Location) | Element idProvenance.location Where the activity occurred, if relevant DefinitionWhere the activity occurred, if relevant. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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| reason | 0..* | CodeableConceptBinding | Element idProvenance.reason Reason the activity is occurring DefinitionThe reason that the activity was taking place. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. The reason the activity took place.
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| activity | 0..1 | CodeableConceptBinding | Element idProvenance.activity Activity that occurred DefinitionAn activity is something that occurs over a period of time and acts upon or with entities; it may include consuming, processing, transforming, modifying, relocating, using, or generating entities. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. The activity that took place.
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| agent | 1..* | BackboneElement | Element idProvenance.agent Actor involved DefinitionAn actor taking a role in an activity for which it can be assigned some degree of responsibility for the activity taking place. An agent can be a person, an organization, software, device, or other entities that may be ascribed responsibility. Several agents may be associated (i.e. has some responsibility for an activity) with an activity and vice-versa.
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| id | 0..1 | string | There are no (further) constraints on this element Element idProvenance.agent.id Unique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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| extension | I | 0..* | Extension | There are no (further) constraints on this element Element idProvenance.agent.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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| modifierExtension | Σ ?! I | 0..* | Extension | There are no (further) constraints on this element Element idProvenance.agent.modifierExtension Extensions that cannot be ignored even if unrecognized Alternate namesextensions, user content, modifiers DefinitionMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
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| type | Σ | 0..1 | CodeableConceptBinding | Element idProvenance.agent.type How the agent participated DefinitionThe participation the agent had with respect to the activity. For example: author, performer, enterer, attester, etc. The type of participation that a provenance agent played with respect to the activity.
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| role | 0..* | CodeableConcept | Element idProvenance.agent.role What the agents role was DefinitionThe function of the agent with respect to the activity. The security role enabling the agent with respect to the activity. For example: doctor, nurse, clerk, etc. The role that a provenance agent played with respect to the activity.
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| who | Σ I | 1..1 | Reference(Practitioner | PractitionerRole | RelatedPerson | Patient | Device | Organization) | Element idProvenance.agent.who Who participated DefinitionThe individual, device or organization that participated in the event. whoIdentity should be used when the agent is not a Resource type. Reference(Practitioner | PractitionerRole | RelatedPerson | Patient | Device | Organization) Constraints
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| onBehalfOf | I | 0..1 | Reference(Practitioner | PractitionerRole | RelatedPerson | Patient | Device | Organization) | Element idProvenance.agent.onBehalfOf Who the agent is representing DefinitionThe individual, device, or organization for whom the change was made. onBehalfOfIdentity should be used when the agent is not a Resource type. Reference(Practitioner | PractitionerRole | RelatedPerson | Patient | Device | Organization) Constraints
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| entity | 0..* | BackboneElement | Element idProvenance.entity An entity used in this activity DefinitionAn entity used in this activity.
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| id | 0..1 | string | There are no (further) constraints on this element Element idProvenance.entity.id Unique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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| extension | I | 0..* | Extension | There are no (further) constraints on this element Element idProvenance.entity.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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| modifierExtension | Σ ?! I | 0..* | Extension | There are no (further) constraints on this element Element idProvenance.entity.modifierExtension Extensions that cannot be ignored even if unrecognized Alternate namesextensions, user content, modifiers DefinitionMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
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| role | Σ | 1..1 | codeBinding | Element idProvenance.entity.role derivation | revision | quotation | source | removal DefinitionHow the entity was used during the activity. Note that FHIR strings SHALL NOT exceed 1MB in size How an entity was used in an activity.
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| what | Σ I | 1..1 | Reference(Resource) | Element idProvenance.entity.what Identity of entity DefinitionIdentity of the Entity used. May be a logical or physical uri and maybe absolute or relative. whatIdentity should be used for entities that are not a Resource type.
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| agent | 0..* | see (agent) | There are no (further) constraints on this element Element idProvenance.entity.agent Entity is attributed to this agent DefinitionThe entity is attributed to an agent to express the agent's responsibility for that entity, possibly along with other agents. This description can be understood as shorthand for saying that the agent was responsible for the activity which generated the entity. A usecase where one Provenance.entity.agent is used where the Entity that was used in the creation/updating of the Target, is not in the context of the same custodianship as the Target, and thus the meaning of Provenance.entity.agent is to say that the entity referenced is managed elsewhere and that this Agent provided access to it. This would be similar to where the Entity being referenced is managed outside FHIR, such as through HL7 v2, v3, or XDS. This might be where the Entity being referenced is managed in another FHIR resource server. Thus it explains the Provenance of that Entity's use in the context of this Provenance activity.
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| signature | 0..* | Signature | Element idProvenance.signature Signature on target DefinitionA digital signature on the target Reference(s). The signer should match a Provenance.agent. The purpose of the signature is indicated. The elements of the Signature Resource are for ease of access of these elements. For digital signatures (Xml DigSig, JWS), the non-repudiation proof comes from the Signature validation, which includes validation of the referenced objects (e.g. Resources) (a.k.a., Content) in the XML-Signature Detached form.
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- Provenance-NonWGSTestOrderFormCancellation-Example
- Provenance-NonWGSTestOrderFormUpdated-SolidTumor-Example
- Provenance-NonWGSTestOrderForm-FetalScenario-Example
- Provenance-ServiceRequestUpdate-Example
- Provenance-WGSTestOrderForm-DirectToLab-Example
- Provenance-WGSTestOrderForm-TrioTestingProbandFather-Example
Additional Guidance
target
SHALL be provided. This SHOULD be a reference to the resource on the central GMS system that was updated."target": [ { "reference": "ServiceRequest/ServiceRequest-SavedTestOrderUpdated-Example" } ],
recorded
SHALL be provided, the date/time when the update took place."recorded": "2023-08-10T11:10:00Z",
reason
The reason why the update took place. If the codes provided by HL7 are not granular enough, or additional notes need to be recorded detailing the reasoning behind a change, this SHOULD be added as text to 'reason.text'."reason": [ { "coding": [ { "system": "http://terminology.hl7.org/CodeSystem/v3-ActReason", "code": "TREAT", "display": "treatment" } ], "text": "Test inappropriate for patient" } ],
agent
SHOULD be provided where actions are user initiated. The user which performed the change, as identified through CIS2 authentication token."agent": [ { "type": { "coding": [ { "system": "http://terminology.hl7.org/CodeSystem/provenance-participant-type", "code": "author", "display": "Author" } ] }, "who": { "reference": "PractitionerRole/PractitionerRole-TestClinicalScientist-Example", "identifier": { "system": "https://fhir.nhs.uk/Id/sds-user-id", "value": "9999999997" } } } ],
signature
Signed, encrypted copy of the document, for validation that the document has not been tampered with (the requirement to include this field has not yet been validated)."signature": [ { "type": [ { "system": "urn:iso-astm:E1762-95:2013", "code": "1.2.840.10065.1.12.1.15", "display": "Addendum Signature" } ], "when": "2023-08-10T11:10:00Z", "who": { "reference": "PractitionerRole/PractitionerRole-TestClinicalScientist-Example", "identifier": { "system": "https://fhir.nhs.uk/Id/sds-user-id", "value": "9999999997" } }, "data": "DQo8U2lnbm...F0dXJlPg0K" } ]