EHR and PHR System Functional Models - Record Lifecycle Events Implementation Guide
1.2.0 - Informative Release 2 International flag

EHR and PHR System Functional Models - Record Lifecycle Events Implementation Guide, published by HL7 International / Electronic Health Records. This guide is not an authorized publication; it is the continuous build for version 1.2.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ehrs-rle-ig/ and changes regularly. See the Directory of published versions

Resource Profile: EHRSFunctionalModelRecordLifecycleEventsAuditEvent - Detailed Descriptions

Page standards status: Informative Maturity Level: 1

Definitions for the ehrsrle-auditevent resource profile.

Guidance on how to interpret the contents of this table can be found here

0. AuditEvent
2. AuditEvent.type
Must Supporttrue
4. AuditEvent.subtype
BindingThe codes SHOULD be taken from ValueSet record-lifecycle-events
(preferred to http://hl7.org/fhir/uv/ehrs-rle/ValueSet/record-lifecycle-events)
Must Supporttrue
6. AuditEvent.action
Must Supporttrue
8. AuditEvent.recorded
Must Supporttrue
10. AuditEvent.authorization
Must Supporttrue
12. AuditEvent.agent
Must Supporttrue
14. AuditEvent.agent.who
Must Supporttrue
16. AuditEvent.agent.requestor
Must Supporttrue
18. AuditEvent.agent.location
Must Supporttrue
20. AuditEvent.agent.network[x]
[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
Must Supporttrue
22. AuditEvent.agent.authorization
Must Supporttrue
24. AuditEvent.source
Must Supporttrue
26. AuditEvent.entity
Must Supporttrue
28. AuditEvent.entity.what
Must Supporttrue

Guidance on how to interpret the contents of this table can be found here

0. AuditEvent
Definition

A record of an event relevant for purposes such as operations, privacy, security, maintenance, and performance analysis.

ShortRecord of an event
Comments

Based on IHE-ATNA.

Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: 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: 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: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. AuditEvent.implicitRules
Definition

A 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.

ShortA set of rules under which this content was created
Comments

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 its narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. AuditEvent.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

ShortContained, inline Resources
Comments

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.

Control0..*
This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
6. AuditEvent.modifierExtension
Definition

May 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 managable, 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).

ShortExtensions that cannot be ignored
Comments

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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Must Supportfalse
Summarytrue
Requirements

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.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. AuditEvent.type
Definition

Partitions the audit event into one or more categories that can be used to filter searching, to govern access control and/or to guide system behavior.

ShortHigh level categorization of audit event
Comments

Categorization might be done automatically (inferred by code) or manually by user assertion. The absence of a category may limit the ability to determine when the element should be handled, so strong consideration should be given to how systems will be able to determine category values for legacy data and how data that cannot be categorized will be handled. As well, some categories might not be mutually exclusive, so systems should prepare for multiple declared categories - even within a single category 'axis'. In general, there should not be a 'strong' binding ('required' or 'extensible') on the category element overall. Instead, the element can be sliced and bindings can be asserted that apply to particular repetitions.

Control1..1
BindingFor example codes, see AuditEventIDhttp://hl7.org/fhir/ValueSet/audit-event-type
(example to http://hl7.org/fhir/ValueSet/audit-event-type)

Type of event.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Alternate Namescategory, EventTypeCode
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. AuditEvent.subtype
Definition

Describes what happened. The most specific codes for the event.

ShortSpecific type of event
Control0..*
BindingThe codes SHOULD be taken from For example codes, see ValueSet record-lifecycle-eventshttp://hl7.org/fhir/ValueSet/audit-event-sub-type
(preferred to http://hl7.org/fhir/uv/ehrs-rle/ValueSet/record-lifecycle-events)
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

This field enables queries of messages by implementation-defined event categories.

Alternate Namescode, EventID
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. AuditEvent.action
Definition

Indicator for type of action performed during the event that generated the audit.

ShortType of action performed during the event
Control0..1
BindingThe codes SHALL be taken from AuditEventActionhttp://hl7.org/fhir/ValueSet/audit-event-action|6.0.0-ballot2
(required to http://hl7.org/fhir/ValueSet/audit-event-action|6.0.0-ballot2)

DICOM Audit Event Action

Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

This broadly indicates what kind of action was done on the AuditEvent.entity by the AuditEvent.agent.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. AuditEvent.recorded
Definition

The time when the event was recorded.

ShortTime when the event was recorded
Comments

In a distributed system, some sort of common time base (e.g. an NTP [RFC1305] server) is a good implementation tactic.

Control1..1
Typeinstant
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

This ties an event to a specific date and time. Security audits typically require a consistent time base (e.g. UTC), to eliminate time-zone issues arising from geographical distribution.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. AuditEvent.authorization
Definition

The authorization (e.g., PurposeOfUse) that was used during the event being recorded.

ShortAuthorization related to the event
Comments

Use AuditEvent.agent.authorization when you know that it is specific to the agent, otherwise use AuditEvent.authorization. For example, during a machine-to-machine transfer it might not be obvious to the audit system who caused the event, but it does know why.

Control0..*
BindingFor example codes, see PurposeOfUsehttp://terminology.hl7.org/ValueSet/v3-PurposeOfUse
(example to http://terminology.hl7.org/ValueSet/v3-PurposeOfUse)

The authorized purposeOfUse for the activity.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

Record of any relevant security context, not restricted to purposeOfUse valueSet. May include security compartments, refrain, obligation, or other security tags.

Alternate NamesPurposeOfEvent
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. AuditEvent.agent
Definition

An actor taking an active role in the event or activity that is logged.

ShortActor involved in the event
Comments

Several agents may be associated (i.e. have some responsibility for an activity) with an event or activity.

For example, an activity may be initiated by one user for other users or involve more than one user. However, only one user may be the initiator/requestor for the activity.

When a network are used in an event being recorded, there should be distinct agent elements for the known actors using the network. The agent with a network detail would be the responsible agent for use of that network.

Control1..*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

An agent can be a person, an organization, software, device, or other actors that may be ascribed responsibility.

Alternate NamesActiveParticipant
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. AuditEvent.agent.modifierExtension
Definition

May 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 managable, 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).

ShortExtensions that cannot be ignored even if unrecognized
Comments

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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

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.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. AuditEvent.agent.who
Definition

Reference to who this agent is that was involved in the event.

ShortIdentifier of who
Comments

Where a User ID is available it will go into who.identifier. Where a name of the user (human readable) it will go into who.display.

Control1..1
TypeReference(Practitioner, PractitionerRole, Organization, CareTeam, Patient, Device, RelatedPerson)
Is Modifierfalse
Must Supporttrue
Must Support TypesNo must-support rules about the choice of types/profiles
Summarytrue
Requirements

This field ties an audit event to a specific resource or identifier.

Alternate NamesuserId
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. AuditEvent.agent.requestor
Definition

Indicator that the user is or is not the requestor, or initiator, for the event being audited.

ShortWhether user is initiator
Comments

There can only be one initiator. If the initiator is not clear, then do not choose any one agent as the initiator.

Control0..1
Typeboolean
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

This value is used to distinguish between requestor-users and recipient-users. For example, one person may initiate a report-output to be sent to another user.

Meaning if Missingfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. AuditEvent.agent.location
Definition

Where the agent location is known, the agent location when the event occurred.

ShortThe agent location when the event occurred
Control0..1
TypeReference(Location)
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. AuditEvent.agent.network[x]
Definition

When the event utilizes a network there should be an agent describing the local system, and an agent describing remote system, with the network interface details.

ShortThis agent network location for the activity
Comments

When remote network endpoint is known, another agent representing the remote agent would indicate the remote network endpoint used. Convention is to indicate data flowing from Source to Destination. The convention for Search, given data flows both ways (query parameters vs results), is to have the Source as the initiator of the Search Transaction, and the Destination the responder to the Search transaction.

Control0..1
TypeChoice of: Reference(Endpoint), uri, string
[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Must Support TypesNo must-support rules about the choice of types/profiles
Summaryfalse
Requirements

When a network protocol is used the endpoint is associated with the agent most directly using the endpoint. This is usually the software agent that has implemented the application level protocol. Preference is to define network in terms of a Reference(Endpoint), or URI; use string only when address or hostname is all that is known. When encoding using string it is best to encode using the formal canonical host name, but if you can't, then you can encode numeric in Literal address form using square brackets '[]' as a v4 string (in dotted notation), or v6 string (in colon notation).

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
30. AuditEvent.agent.authorization
Definition

The authorization (e.g., PurposeOfUse) that was used during the event being recorded.

ShortAllowable authorization for this agent
Comments

Use AuditEvent.agent.authorization when you know that is specific to the agent, otherwise use AuditEvent.authorization. For example, during a machine-to-machine transfer it might not be obvious to the audit system who caused the event, but it does know why.

Control0..*
BindingFor example codes, see PurposeOfUsehttp://terminology.hl7.org/ValueSet/v3-PurposeOfUse
(example to http://terminology.hl7.org/ValueSet/v3-PurposeOfUse)

The reason the activity took place.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summaryfalse
Requirements

Record of any relevant security context, not restricted to purposeOfUse valueSet. May include security compartments, refrain, obligation, or other security tags.

Alternate NamesPurposeOfUse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
32. AuditEvent.source
Definition

The actor that is reporting the event.

ShortAudit Event Reporter
Comments

Events are reported by the actor that detected them. This may be one of the participating actors, but may also be different. The actor may be a human such as a medical-records clerk disclosing data manually, that clerk would be the source for the record of disclosure.

Control1..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

The event is reported by one source.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
34. AuditEvent.source.modifierExtension
Definition

May 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 managable, 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).

ShortExtensions that cannot be ignored even if unrecognized
Comments

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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

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.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. AuditEvent.source.observer
Definition

Identifier of the source where the event was detected.

ShortThe identity of source detecting the event
Control1..1
TypeReference(Practitioner, PractitionerRole, Organization, CareTeam, Patient, Device, RelatedPerson)
Is Modifierfalse
Must Supportfalse
Summarytrue
Requirements

This field ties the event to a specific source system. It may be used to group events for analysis according to where the event was detected.

Alternate NamesSourceId
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
38. AuditEvent.entity
Definition

Specific instances of data or objects that have been accessed.

ShortData or objects used
Comments

Required unless the values for event identification, agent identification, and audit source identification are sufficient to document the entire auditable event. Because events may have more than one entity, this group can be a repeating set of values.

Control0..*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

The event may have other entities involved.

Alternate NamesParticipantObject
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
40. AuditEvent.entity.modifierExtension
Definition

May 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 managable, 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).

ShortExtensions that cannot be ignored even if unrecognized
Comments

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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

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.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
42. AuditEvent.entity.what
Definition

Identifies a specific instance of the entity. The reference should be version specific. This is allowed to be a Parameters resource.

ShortSpecific instance of resource
Comments

Use .what.display when all you have is a string (e.g. ParticipantObjectName).

Control0..1
TypeReference(Resource)
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

Guidance on how to interpret the contents of this table can be found here

0. AuditEvent
Definition

A record of an event relevant for purposes such as operations, privacy, security, maintenance, and performance analysis.

ShortRecord of an event
Comments

Based on IHE-ATNA.

Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: 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: 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: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. AuditEvent.id
Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

ShortLogical id of this artifact
Comments

Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.

Control0..1
Typeid
Is Modifierfalse
Must Supportfalse
Summarytrue
4. AuditEvent.meta
Definition

The 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.

ShortMetadata about the resource
Control0..1
TypeMeta
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. AuditEvent.implicitRules
Definition

A 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.

ShortA set of rules under which this content was created
Comments

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 its narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. AuditEvent.language
Definition

The base language in which the resource is written.

ShortLanguage of the resource content
Comments

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).

Control0..1
BindingThe codes SHALL be taken from AllLanguages
(required to http://hl7.org/fhir/ValueSet/all-languages|6.0.0-ballot2)

IETF language tag for a human language

Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. AuditEvent.text
Definition

A 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.

ShortText summary of the resource, for human interpretation
Comments

Contained resources do not have a 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.

Control0..1
This element is affected by the following invariants: dom-6
TypeNarrative
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesnarrative, html, xhtml, display
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. AuditEvent.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

ShortContained, inline Resources
Comments

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.

Control0..*
This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
14. AuditEvent.extension
Definition

May 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 managable, 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.

ShortAdditional content defined by implementations
Comments

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.

Control0..*
TypeExtension
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. AuditEvent.modifierExtension
Definition

May 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 managable, 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).

ShortExtensions that cannot be ignored
Comments

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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Must Supportfalse
Summarytrue
Requirements

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.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. AuditEvent.type
Definition

Partitions the audit event into one or more categories that can be used to filter searching, to govern access control and/or to guide system behavior.

ShortHigh level categorization of audit event
Comments

Categorization might be done automatically (inferred by code) or manually by user assertion. The absence of a category may limit the ability to determine when the element should be handled, so strong consideration should be given to how systems will be able to determine category values for legacy data and how data that cannot be categorized will be handled. As well, some categories might not be mutually exclusive, so systems should prepare for multiple declared categories - even within a single category 'axis'. In general, there should not be a 'strong' binding ('required' or 'extensible') on the category element overall. Instead, the element can be sliced and bindings can be asserted that apply to particular repetitions.

Control1..1
BindingFor example codes, see AuditEventID
(example to http://hl7.org/fhir/ValueSet/audit-event-type)

Type of event.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Alternate Namescategory, EventTypeCode
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. AuditEvent.subtype
Definition

Describes what happened. The most specific codes for the event.

ShortSpecific type of event
Control0..*
BindingThe codes SHOULD be taken from ValueSet record-lifecycle-events
(preferred to http://hl7.org/fhir/uv/ehrs-rle/ValueSet/record-lifecycle-events)
TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

This field enables queries of messages by implementation-defined event categories.

Alternate Namescode, EventID
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. AuditEvent.action
Definition

Indicator for type of action performed during the event that generated the audit.

ShortType of action performed during the event
Control0..1
BindingThe codes SHALL be taken from AuditEventAction
(required to http://hl7.org/fhir/ValueSet/audit-event-action|6.0.0-ballot2)

DICOM Audit Event Action

Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

This broadly indicates what kind of action was done on the AuditEvent.entity by the AuditEvent.agent.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. AuditEvent.severity
Definition

Indicates and enables segmentation of various severity including debugging from critical.

Shortemergency | alert | critical | error | warning | notice | informational | debug
Comments

ATNA will map this to the SYSLOG PRI element.

Control0..1
BindingThe codes SHALL be taken from AuditEventSeverity
(required to http://hl7.org/fhir/ValueSet/audit-event-severity|6.0.0-ballot2)

This is in the SysLog header, PRI. http://tools.ietf.org/html/rfc5424#appendix-A.3

Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. AuditEvent.occurred[x]
Definition

The time or period during which the activity occurred.

ShortWhen the activity occurred
Comments

The time or period can be a little arbitrary; where possible, the time should correspond to human assessment of the activity time.

Control0..1
TypeChoice of: Period, dateTime
[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. AuditEvent.recorded
Definition

The time when the event was recorded.

ShortTime when the event was recorded
Comments

In a distributed system, some sort of common time base (e.g. an NTP [RFC1305] server) is a good implementation tactic.

Control1..1
Typeinstant
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

This ties an event to a specific date and time. Security audits typically require a consistent time base (e.g. UTC), to eliminate time-zone issues arising from geographical distribution.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
30. AuditEvent.outcome
Definition

Indicates whether the event succeeded or failed. A free text descripiton can be given in outcome.text.

ShortWhether the event succeeded or failed
Comments

In some cases a "success" may be partial, for example, an incomplete or interrupted transfer of a radiological study. For the purpose of establishing accountability, these distinctions are not relevant.

Control0..1
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summarytrue
Requirements

when a code is given there must be one code from the given codeSystem, and may be other equivilant codes from other codeSystems (for example http response codes such as 2xx, 4xx, or 5xx).

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
32. AuditEvent.outcome.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
34. AuditEvent.outcome.extension
Definition

May 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 managable, 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.

ShortAdditional content defined by implementations
Comments

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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. AuditEvent.outcome.modifierExtension
Definition

May 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 managable, 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).

ShortExtensions that cannot be ignored even if unrecognized
Comments

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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

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.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
38. AuditEvent.outcome.code
Definition

Indicates whether the event succeeded or failed.

ShortWhether the event succeeded or failed
Comments

In some cases a "success" may be partial, for example, an incomplete or interrupted transfer of a radiological study. For the purpose of establishing accountability, these distinctions are not relevant.

Control1..1
BindingThe codes SHOULD be taken from AuditEventOutcome
(preferred to http://hl7.org/fhir/ValueSet/audit-event-outcome)

DICOM Audit Event Outcome

TypeCoding
Is Modifierfalse
Must Supportfalse
Summarytrue
Requirements

when a code is given there must be one code from the given codeSystem.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
40. AuditEvent.outcome.detail
Definition

Additional details about the error. This may be a text description of the error or a system code that identifies the error.

ShortAdditional outcome detail
Comments

A human readable description of the error issue SHOULD be placed in details.text.

Control0..*
BindingFor example codes, see AuditEventOutcomeDetail
(example to http://hl7.org/fhir/ValueSet/audit-event-outcome-detail)

A code that provides details as the exact issue.

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
42. AuditEvent.authorization
Definition

The authorization (e.g., PurposeOfUse) that was used during the event being recorded.

ShortAuthorization related to the event
Comments

Use AuditEvent.agent.authorization when you know that it is specific to the agent, otherwise use AuditEvent.authorization. For example, during a machine-to-machine transfer it might not be obvious to the audit system who caused the event, but it does know why.

Control0..*
BindingFor example codes, see PurposeOfUse
(example to http://terminology.hl7.org/ValueSet/v3-PurposeOfUse)

The authorized purposeOfUse for the activity.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

Record of any relevant security context, not restricted to purposeOfUse valueSet. May include security compartments, refrain, obligation, or other security tags.

Alternate NamesPurposeOfEvent
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
44. AuditEvent.basedOn
Definition

Allows tracing of authorizatino for the events and tracking whether proposals/recommendations were acted upon.

ShortWorkflow authorization within which this event occurred
Control0..*
TypeReference(Resource)
Is Modifierfalse
Must Supportfalse
Summaryfalse
Requirements

Allows tracing of authorization for the audit event and tracking whether proposals/recommendations were acted upon.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
46. AuditEvent.patient
Definition

The patient element is available to enable deterministic tracking of activities that involve the patient as the subject of the data used in an activity.

ShortThe patient is the subject of the data used/created/updated/deleted during the activity
Control0..1
TypeReference(Patient)
Is Modifierfalse
Must Supportfalse
Summarytrue
Requirements

When the .patient is populated it shall be accurate to the subject of the used data. The .patient shall not be populated when the used data used/created/updated/deleted (.entity) by the activity does not involve a subject. Note that when the patient is an agent, they will be recorded as an agent. When the Patient resource is Created, Updated, or Deleted it will be recorded as an entity. May also affect access control.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
48. AuditEvent.encounter
Definition

This will typically be the encounter the event occurred, but some events may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission lab tests).

ShortEncounter within which this event occurred or which the event is tightly associated
Comments

This will typically be the encounter the audit event was created during, but some audit events may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission lab tests).

Control0..1
TypeReference(Encounter)
Is Modifierfalse
Must Supportfalse
Summaryfalse
Requirements

Links the audit event to the Encounter context. May also affect access control.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
50. AuditEvent.agent
Definition

An actor taking an active role in the event or activity that is logged.

ShortActor involved in the event
Comments

Several agents may be associated (i.e. have some responsibility for an activity) with an event or activity.

For example, an activity may be initiated by one user for other users or involve more than one user. However, only one user may be the initiator/requestor for the activity.

When a network are used in an event being recorded, there should be distinct agent elements for the known actors using the network. The agent with a network detail would be the responsible agent for use of that network.

Control1..*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

An agent can be a person, an organization, software, device, or other actors that may be ascribed responsibility.

Alternate NamesActiveParticipant
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
52. AuditEvent.agent.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
54. AuditEvent.agent.extension
Definition

May 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 managable, 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.

ShortAdditional content defined by implementations
Comments

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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
56. AuditEvent.agent.modifierExtension
Definition

May 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 managable, 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).

ShortExtensions that cannot be ignored even if unrecognized
Comments

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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

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.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
58. AuditEvent.agent.type
Definition

The Functional Role of the user when performing the event.

ShortHow agent participated
Comments

For example: assembler, author, prescriber, signer, investigator, etc.

Control0..1
BindingThe codes SHOULD be taken from ParticipationRoleType
(preferred to http://hl7.org/fhir/ValueSet/participation-role-type)

The Participation type of the agent to the event.

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summaryfalse
Requirements

Functional roles reflect functional aspects of relationships between entities. Functional roles are bound to the realization/performance of acts, where actions might be concatenated to an activity or even to a process. This element will hold the functional role that the agent played in the activity that is the focus of this Provenance. Where an agent played multiple functional roles, they will be listed as multiple .agent elements representing each functional participation. See ISO 21298:2018 - Health Informatics - Functional and structural roles, and ISO 22600-2:2014 - Health Informatics - Privilege Management and Access Control - Part 2: formal models.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
60. AuditEvent.agent.role
Definition

The structural roles of the agent indicating the agent's competency. The security role enabling the agent with respect to the activity.

ShortAgent role in the event
Comments

For example: Chief-of-Radiology, Nurse, Physician, Medical-Student, etc.

Control0..*
BindingFor example codes, see SecurityRoleType
(example to http://hl7.org/fhir/ValueSet/security-role-type)

What security role enabled the agent to participate in the event.

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summaryfalse
Requirements

Structural roles reflect the structural aspects of relationships between entities. Structural roles describe prerequisites, feasibilities, or competences for acts. Functional roles reflect functional aspects of relationships between entities. Functional roles are bound to the realization/performance of acts, where actions might be concatenated to an activity or even to a process. See ISO 21298:2018 - Health Informatics - Functional and structural roles, and ISO 22600-2:2014 - Health Informatics - Privilege Management and Access Control - Part 2: formal models..

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
62. AuditEvent.agent.who
Definition

Reference to who this agent is that was involved in the event.

ShortIdentifier of who
Comments

Where a User ID is available it will go into who.identifier. Where a name of the user (human readable) it will go into who.display.

Control1..1
TypeReference(Practitioner, PractitionerRole, Organization, CareTeam, Patient, Device, RelatedPerson)
Is Modifierfalse
Must Supporttrue
Must Support TypesNo must-support rules about the choice of types/profiles
Summarytrue
Requirements

This field ties an audit event to a specific resource or identifier.

Alternate NamesuserId
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
64. AuditEvent.agent.requestor
Definition

Indicator that the user is or is not the requestor, or initiator, for the event being audited.

ShortWhether user is initiator
Comments

There can only be one initiator. If the initiator is not clear, then do not choose any one agent as the initiator.

Control0..1
Typeboolean
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Requirements

This value is used to distinguish between requestor-users and recipient-users. For example, one person may initiate a report-output to be sent to another user.

Meaning if Missingfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
66. AuditEvent.agent.location
Definition

Where the agent location is known, the agent location when the event occurred.

ShortThe agent location when the event occurred
Control0..1
TypeReference(Location)
Is Modifierfalse
Must Supporttrue
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
68. AuditEvent.agent.policy
Definition

Where the policy(ies) are known that authorized the agent participation in the event. Typically, a single activity may have multiple applicable policies, such as patient consent, guarantor funding, etc. The policy would also indicate the security token used.

ShortPolicy that authorized the agent participation in the event
Comments

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.

Control0..*
Typeuri
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Requirements

This value is used retrospectively to determine the authorization policies.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
70. AuditEvent.agent.network[x]
Definition

When the event utilizes a network there should be an agent describing the local system, and an agent describing remote system, with the network interface details.

ShortThis agent network location for the activity
Comments

When remote network endpoint is known, another agent representing the remote agent would indicate the remote network endpoint used. Convention is to indicate data flowing from Source to Destination. The convention for Search, given data flows both ways (query parameters vs results), is to have the Source as the initiator of the Search Transaction, and the Destination the responder to the Search transaction.

Control0..1
TypeChoice of: Reference(Endpoint), uri, string
[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Must Support TypesNo must-support rules about the choice of types/profiles
Summaryfalse
Requirements

When a network protocol is used the endpoint is associated with the agent most directly using the endpoint. This is usually the software agent that has implemented the application level protocol. Preference is to define network in terms of a Reference(Endpoint), or URI; use string only when address or hostname is all that is known. When encoding using string it is best to encode using the formal canonical host name, but if you can't, then you can encode numeric in Literal address form using square brackets '[]' as a v4 string (in dotted notation), or v6 string (in colon notation).

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
72. AuditEvent.agent.authorization
Definition

The authorization (e.g., PurposeOfUse) that was used during the event being recorded.

ShortAllowable authorization for this agent
Comments

Use AuditEvent.agent.authorization when you know that is specific to the agent, otherwise use AuditEvent.authorization. For example, during a machine-to-machine transfer it might not be obvious to the audit system who caused the event, but it does know why.

Control0..*
BindingFor example codes, see PurposeOfUse
(example to http://terminology.hl7.org/ValueSet/v3-PurposeOfUse)

The reason the activity took place.

TypeCodeableConcept
Is Modifierfalse
Must Supporttrue
Summaryfalse
Requirements

Record of any relevant security context, not restricted to purposeOfUse valueSet. May include security compartments, refrain, obligation, or other security tags.

Alternate NamesPurposeOfUse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
74. AuditEvent.source
Definition

The actor that is reporting the event.

ShortAudit Event Reporter
Comments

Events are reported by the actor that detected them. This may be one of the participating actors, but may also be different. The actor may be a human such as a medical-records clerk disclosing data manually, that clerk would be the source for the record of disclosure.

Control1..1
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

The event is reported by one source.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
76. AuditEvent.source.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
78. AuditEvent.source.extension
Definition

May 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 managable, 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.

ShortAdditional content defined by implementations
Comments

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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
80. AuditEvent.source.modifierExtension
Definition

May 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 managable, 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).

ShortExtensions that cannot be ignored even if unrecognized
Comments

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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

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.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
82. AuditEvent.source.site
Definition

Logical source location within the healthcare enterprise network. For example, a hospital or other provider location within a multi-entity provider group.

ShortLogical source location within the enterprise
Control0..1
TypeReference(Location)
Is Modifierfalse
Must Supportfalse
Summaryfalse
Requirements

This value differentiates among the sites in a multi-site enterprise health information system.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
84. AuditEvent.source.observer
Definition

Identifier of the source where the event was detected.

ShortThe identity of source detecting the event
Control1..1
TypeReference(Practitioner, PractitionerRole, Organization, CareTeam, Patient, Device, RelatedPerson)
Is Modifierfalse
Must Supportfalse
Summarytrue
Requirements

This field ties the event to a specific source system. It may be used to group events for analysis according to where the event was detected.

Alternate NamesSourceId
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
86. AuditEvent.source.type
Definition

Code specifying the type of source where event originated.

ShortThe type of source where event originated
Control0..*
BindingThe codes SHOULD be taken from AuditEventSourceType
(preferred to http://hl7.org/fhir/ValueSet/security-source-type)

Code specifying the type of system that detected and recorded the event. Use of these codes is not required but is encouraged to maintain translation with DICOM AuditMessage schema.

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summaryfalse
Requirements

This field indicates which type of source is identified by the Audit Source ID. It is an optional value that may be used to group events for analysis according to the type of source where the event occurred.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
88. AuditEvent.entity
Definition

Specific instances of data or objects that have been accessed.

ShortData or objects used
Comments

Required unless the values for event identification, agent identification, and audit source identification are sufficient to document the entire auditable event. Because events may have more than one entity, this group can be a repeating set of values.

Control0..*
TypeBackboneElement
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

The event may have other entities involved.

Alternate NamesParticipantObject
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
90. AuditEvent.entity.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
92. AuditEvent.entity.extension
Definition

May 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 managable, 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.

ShortAdditional content defined by implementations
Comments

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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
94. AuditEvent.entity.modifierExtension
Definition

May 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 managable, 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).

ShortExtensions that cannot be ignored even if unrecognized
Comments

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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

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.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
96. AuditEvent.entity.what
Definition

Identifies a specific instance of the entity. The reference should be version specific. This is allowed to be a Parameters resource.

ShortSpecific instance of resource
Comments

Use .what.display when all you have is a string (e.g. ParticipantObjectName).

Control0..1
TypeReference(Resource)
Is Modifierfalse
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
98. AuditEvent.entity.role
Definition

Code representing the role the entity played in the event being audited.

ShortWhat role the entity played
Control0..1
BindingFor example codes, see AuditEventEntityRole
(example to http://hl7.org/fhir/ValueSet/object-role)

DICOM Audit Event Entity Role

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summaryfalse
Requirements

For some detailed audit analysis it may be necessary to indicate a more granular type of entity, based on the application role it serves.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
100. AuditEvent.entity.securityLabel
Definition

Security labels for the identified entity.

ShortSecurity labels on the entity
Comments

Copied from entity meta security tags.

Control0..*
BindingFor example codes, see SecurityLabelExamples
(example to http://hl7.org/fhir/ValueSet/security-label-examples)

Example Security Labels from the Healthcare Privacy and Security Classification System.

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summaryfalse
Requirements

This field identifies the security labels for a specific instance of an object, such as a patient, to detect/track privacy and security issues.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
102. AuditEvent.entity.query
Definition

The query parameters for a query-type entities.

ShortQuery parameters
Comments

The meaning and secondary-encoding of the content of base64 encoded blob is specific to the AuditEvent.type, AuditEvent.subtype, and AuditEvent.entity.role. The base64 is a general-use and safe container for event specific data blobs regardless of the encoding used by the transaction being recorded. An AuditEvent consuming application must understand the event it is consuming and the formats used by the event. For example, if auditing an Oracle network database access, the Oracle formats must be understood as they will be simply encoded in the base64binary blob.

The DICOM AuditMessage schema does not support both .name and .query being populated.

Control0..1
Typebase64Binary
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Requirements

For query events, it may be necessary to capture the actual query input to the query process in order to identify the specific event. Because of differences among query implementations and data encoding for them, this is a base 64 encoded data blob. It may be subsequently decoded or interpreted by downstream audit analysis processing.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
104. AuditEvent.entity.detail
Definition

Tagged value pairs for conveying additional information about the entity.

ShortAdditional Information about the entity
Control0..*
TypeBackboneElement
Is Modifierfalse
Must Supportfalse
Summaryfalse
Requirements

Implementation-defined data about specific details of the object accessed or used.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
106. AuditEvent.entity.detail.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
108. AuditEvent.entity.detail.extension
Definition

May 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 managable, 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.

ShortAdditional content defined by implementations
Comments

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.

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
110. AuditEvent.entity.detail.modifierExtension
Definition

May 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 managable, 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).

ShortExtensions that cannot be ignored even if unrecognized
Comments

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.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
Requirements

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.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
112. AuditEvent.entity.detail.type
Definition

The name of extra detail provided in the value. This element is the tag for the value. Where a simple string is used for the tag name, use the CodeableConcept.display element.

ShortThe name of the extra detail property
Control1..1
BindingFor example codes, see AuditEventEntityDetailType
(example to http://hl7.org/fhir/ValueSet/audit-entity-detail-type)

Additional detail about an entity used in an event.

TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
114. AuditEvent.entity.detail.value[x]
Definition

The value of the extra detail.

ShortProperty value
Control1..1
TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, time, dateTime, Period, base64Binary
[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Requirements

Should not duplicate the entity value unless absolutely necessary.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
116. AuditEvent.entity.agent
Definition

The entity is attributed to an agent to express the agent's responsibility for that entity in the activity. This is most used to indicate when persistence media (the entity) are used by an agent. For example when importing data from a device, the device would be described in an entity, and the user importing data from that media would be indicated as the entity.agent.

ShortEntity is attributed to this agent
Comments

A usecase where one AuditEvent.entity.agent is used where the Entity that was used in the creation/updating of a target resource, is not in the context of the same custodianship as the target resource, and thus the meaning of AuditEvent.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 AuditEvent activity.

Control0..*
TypeSeettp://hl7.org/fhir/StructureDefinition/AuditEvent#AuditEvent.agent
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))