Release 4B R5 Final QA

This page is part of the FHIR Specification (v4.3.0: R4B (v5.0.0-draft-final: Final QA Preview for R5 - STU see ballot notes ). The current version which supercedes this version is 5.0.0 . For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4 R3 R2

Security icon Work Group Maturity Level : 3   Trial Use Security Category : Not Classified Compartments : Device , Patient , Practitioner

Detailed Descriptions for the elements in the AuditEvent resource.

Summary false 0..1 Cardinality 0..* Terminology Binding Invariants Defined on this element sev-1 Rule Either a name or a query (NOT both) name.empty() or query.empty()
AuditEvent
Element Id AuditEvent
Definition

A record of an event made relevant for purposes of maintaining a security log. Typical uses include detection of intrusion attempts such as operations, privacy, security, maintenance, and monitoring for inappropriate usage. performance analysis.

Short Display Record of an event
Cardinality 0..*
Type DomainResource
Summary false
Comments

Based on IHE-ATNA.

AuditEvent.type AuditEvent.category
Element Id AuditEvent.type AuditEvent.category
Definition

Identifier for a family Classification of the type of event. For example, a menu item, program, rule, policy, function code, application name or URL. It identifies the performed function.

Short Display Type/identifier of event
Cardinality 1..1 0..*
Terminology Binding Audit Event ID ( Extensible Example )
Type Coding CodeableConcept
Requirements

This identifies the performed function. For "Execute" Event Action Code audit records, this identifies Codes that classify the application function performed. general type of event that happened.

Alternate Names type
Summary true
AuditEvent.subtype AuditEvent.code
Element Id AuditEvent.subtype AuditEvent.code
Definition

Identifier Describes what happened. The most specific code for the category of event.

Short Display Specific type of event
Cardinality 0..* 1..1
Terminology Binding Audit Event Sub-Type ( Extensible Example )
Type Coding CodeableConcept
Requirements

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

Alternate Names subtype
Summary true
AuditEvent.action
Element Id AuditEvent.action
Definition

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

Short Display Type of action performed during the event
Cardinality 0..1
Terminology Binding AuditEventAction Audit Event Action ( Required )
Type code
Requirements

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

Summary true
AuditEvent.period AuditEvent.severity
Element Id AuditEvent.period AuditEvent.severity
Definition

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

Short Display emergency | alert | critical | error | warning | notice | informational | debug
Cardinality 0..1
Terminology Binding Audit Event Severity ( Required )
Type code
Summary true
Comments

ATNA will map this to the SYSLOG PRI element.

AuditEvent.occurred[x]
Element Id AuditEvent.occurred[x]
Definition

The time or period during which the activity occurred.

Short Display When the activity occurred
Cardinality 0..1
Type Period | dateTime
[x] Note See Choice of Datatypes for further information about how to use [x]
Summary false
Comments

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

AuditEvent.recorded
Element Id AuditEvent.recorded
Definition

The time when the event was recorded.

Short Display Time when the event was recorded
Cardinality 1..1
Type instant
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.

Summary true
Comments

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

AuditEvent.outcome
Element Id AuditEvent.outcome
Definition

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

Short Display Whether the event succeeded or failed
Cardinality 0..1
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).

Summary true
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.

AuditEvent.outcome.code
Element Id AuditEvent.outcome.code
Definition

Indicates whether the event succeeded or failed.

Short Display Whether the event succeeded or failed
Cardinality 1..1
Terminology Binding AuditEventOutcome Audit Event Outcome ( Required Preferred )
Type code Coding
Requirements

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

Summary true
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.

AuditEvent.outcomeDesc AuditEvent.outcome.detail
Element Id AuditEvent.outcomeDesc AuditEvent.outcome.detail
Definition

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

Short Display Additional outcome detail
Cardinality 0..1 0..*
Terminology Binding Audit Event Outcome Detail ( Example )
Type string CodeableConcept
Summary true
Comments

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

AuditEvent.purposeOfEvent AuditEvent.authorization
Element Id AuditEvent.purposeOfEvent AuditEvent.authorization
Definition

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

Short Display Authorization related to the event
Cardinality 0..*
Terminology Binding PurposeOfUse icon ( Extensible Example )
Type CodeableConcept
Requirements

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

Alternate Names PurposeOfEvent
Summary true
Comments

Use AuditEvent.agent.purposeOfUse AuditEvent.agent.authorization when you know that it is specific to the agent, otherwise use AuditEvent.purposeOfEvent. 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.

AuditEvent.basedOn
Element Id AuditEvent.basedOn
Definition

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

Short Display Workflow authorization within which this event occurred
Cardinality 0..*
Type Reference ( CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest | Task )
Summary false
AuditEvent.patient
Element Id 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.

Short Display The patient is the subject of the data used/created/updated/deleted during the activity
Cardinality 0..1
Type Reference ( Patient )
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.

Summary false
AuditEvent.encounter
Element Id 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).

Short Display Encounter within which this event occurred or which the event is tightly associated
Cardinality 0..1
Type Reference ( Encounter )
Summary false
AuditEvent.agent
Element Id AuditEvent.agent
Definition

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

Short Display Actor involved in the event
Cardinality 1..*
Requirements

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

Alternate Names ActiveParticipant
Summary false true
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.

AuditEvent.agent.type
Element Id AuditEvent.agent.type
Definition

Specification The Functional Role of the participation type the user plays when performing the event.

Short Display How agent participated
Cardinality 0..1
Terminology Binding ParticipationRoleType Participation Role Type ( Extensible Preferred )
Type CodeableConcept
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.

Summary false
Comments

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

AuditEvent.agent.role
Element Id AuditEvent.agent.role
Definition

The structural roles of the agent indicating the agent's competency. The security role that enabling the user was acting under, that come from local codes defined by agent with respect to the access control security system (e.g. RBAC, ABAC) used activity.

Short Display Agent role in the local context. event
Cardinality 0..*
Terminology Binding SecurityRoleType Security Role Type ( Example )
Type CodeableConcept
Requirements

This value ties an audited event 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 a user's role(s). It is an optional value that the realization/performance of acts, where actions might be used concatenated to group events for analysis by user functional role categories. 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..

Summary false
Comments

Should be roles relevant to the event. Should not be an exhaustive list of roles. For example: Chief-of-Radiology, Nurse, Physician, Medical-Student, etc.

AuditEvent.agent.who
Element Id AuditEvent.agent.who
Definition

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

Short Display Identifier of who
Cardinality 0..1 1..1
Type Reference ( PractitionerRole | Practitioner | PractitionerRole | Organization | Device CareTeam | Patient | Device | RelatedPerson )
Requirements

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

Alternate Names userId
Summary true
Comments

Where a User ID is available it will go into who.identifier. AuditEvent.agent.altId Element Id AuditEvent.agent.altId Definition Alternative agent Identifier. For a human, this should be a user identifier text string from authentication system. This identifier would be one known to a common authentication system (e.g. single sign-on), if available. Cardinality 0..1 Type string Requirements In some situations, a human user may authenticate with one identity but, to access a specific application system, may use Where a synonymous identify. For example, some "single sign on" implementations will do this. The alternative identifier would then be the original identify used for authentication, and the User ID is the one known to and used by the application. Summary false AuditEvent.agent.name Element Id AuditEvent.agent.name Definition Human-meaningful name for the agent. Cardinality 0..1 Type string Requirements The User ID and Authorization User ID may be internal or otherwise obscure values. This field assists the auditor in identifying of the actual user. user (human readable) it will go into who.display.

AuditEvent.agent.requestor
Element Id AuditEvent.agent.requestor
Definition

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

Short Display Whether user is initiator
Cardinality 1..1 0..1
Type boolean
Meaning if Missing false
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.

Summary true
Comments

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

AuditEvent.agent.location
Element Id AuditEvent.agent.location
Definition

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

Short Display The agent location when the event occurred
Cardinality 0..1
Type Reference ( Location )
Summary false
AuditEvent.agent.policy
Element Id AuditEvent.agent.policy
Definition

The policy or plan Where the policy(ies) are known that authorized the activity being recorded. 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.

Short Display Policy that authorized the agent participation in the event
Cardinality 0..*
Type uri
Requirements

This value is used retrospectively to determine the authorization policies.

Summary false
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.

AuditEvent.agent.media AuditEvent.agent.network[x]
Element Id AuditEvent.agent.media AuditEvent.agent.network[x]
Definition

Type of media involved. Used when When the event is about exporting/importing onto media. Cardinality 0..1 Terminology Binding Media Type Code ( Extensible ) Type Coding Requirements Usually, this is used instead of specifying utilizes a network address. This field is not used for Media Id (i.e. there should be an agent describing the serial number of a CD). local system, and an agent describing remote system, with the network interface details.

Summary false AuditEvent.agent.network Element Id AuditEvent.agent.network Definition Short Display Logical This agent network location for application activity, if the activity has a network location.
Cardinality 0..1
Summary Type false Reference AuditEvent.agent.network.address Element Id AuditEvent.agent.network.address Definition An identifier for the network access point of the user device for the audit event. Cardinality ( Endpoint )| uri | string
Type [x] Note string See Choice of Datatypes for further information about how to use [x]
Requirements

This datum identifies the user's When a network access point, which may be distinct from protocol is used the server that performed endpoint is associated with the action. It agent most directly using the endpoint. This is an optional value usually the software agent that may be used has implemented the application level protocol. Preference is to group events recorded on separate servers for analysis define network in terms of a specific network access point's data access across Reference(Endpoint), or URI; use string only when address or hostname is all servers. 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).

Summary false
Comments

This could be a device id, IP address or some other identifier associated with a device. 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.

AuditEvent.agent.network.type AuditEvent.agent.authorization
Element Id AuditEvent.agent.network.type AuditEvent.agent.authorization
Definition

An identifier for the type of network access point The authorization (e.g., PurposeOfUse) that originated was used during the audit event. event being recorded.

Short Display Allowable authorization for this agent
Cardinality 0..1 0..*
Terminology Binding AuditEventAgentNetworkType PurposeOfUse icon ( Required Example )
Type code CodeableConcept
Requirements

This datum identifies the type of network access point identifier of the user device for the audit event. It is an optional value that may be used to group events recorded on separate servers for analysis of access according to a network access point's type. Summary false AuditEvent.agent.purposeOfUse Element Id AuditEvent.agent.purposeOfUse Definition The reason (purpose Record of use), specific any relevant security context, not restricted to this agent, that was used during the event being recorded. purposeOfUse valueSet. May include security compartments, refrain, obligation, or other security tags.

Alternate Names PurposeOfUse ( Extensible ) Type CodeableConcept
Summary false
Comments

Use AuditEvent.agent.purposeOfUse AuditEvent.agent.authorization when you know that is specific to the agent, otherwise use AuditEvent.purposeOfEvent. 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.

AuditEvent.source
Element Id AuditEvent.source
Definition

The system actor that is reporting the event.

Short Display Audit Event Reporter
Cardinality 1..1
Requirements

The event is reported by one source.

Summary false true
Comments

Since multi-tier, distributed, or composite applications make source identification ambiguous, this collection of fields Events are reported by the actor that detected them. This may repeat for each application or process actively involved in be one of the event. For example, multiple value-sets can identify participating web servers, application processes, and database server threads in an n-tier distributed application. Passive event participants (e.g. low-level network transports) need not actors, but may also be identified. 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.

AuditEvent.source.site
Element Id 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.

Short Display Logical source location within the enterprise
Cardinality 0..1
Type string Reference ( Location )
Requirements

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

Summary false
AuditEvent.source.observer
Element Id AuditEvent.source.observer
Definition

Identifier of the source where the event was detected.

Short Display The identity of source detecting the event
Cardinality 1..1
Type Reference ( PractitionerRole | Practitioner | PractitionerRole | Organization | Device CareTeam | Patient | Device | RelatedPerson )
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 Names SourceId
Summary true
AuditEvent.source.type
Element Id AuditEvent.source.type
Definition

Code specifying the type of source where event originated.

Short Display The type of source where event originated
Cardinality 0..*
Terminology Binding Audit Event Source Type ( Extensible Preferred )
Type Coding CodeableConcept
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.

Summary false
AuditEvent.entity
Element Id AuditEvent.entity
Definition

Specific instances of data or objects that have been accessed.

Short Display Data or objects used
Cardinality 0..*
Requirements

The event may have other entities involved.

Alternate Names ParticipantObject
Summary false true
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.

AuditEvent.entity.what
Element Id 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.

Cardinality 0..1 Type Reference ( Any ) Summary true AuditEvent.entity.type Element Id AuditEvent.entity.type Definition Short Display The type Specific instance of the object that was involved in this audit event. resource
Cardinality 0..1
Terminology Binding Type AuditEventEntityType Reference ( Extensible Any )
Type Coding Requirements To describe the object being acted upon. In addition to queries on the subject of the action in an auditable event, it is also important to be able to query on the object type for the action. Summary false true
Comments

This value Use .what.display when all you have is distinct from the user's role or any user relationship to the entity. a string (e.g. ParticipantObjectName).

AuditEvent.entity.role
Element Id AuditEvent.entity.role
Definition

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

Short Display What role the entity played
Cardinality 0..1
Terminology Binding AuditEventEntityRole Audit Event Entity Role ( Extensible Example )
Type Coding CodeableConcept
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.

Summary false
AuditEvent.entity.lifecycle AuditEvent.entity.securityLabel
Element Id AuditEvent.entity.lifecycle AuditEvent.entity.securityLabel
Definition

Identifier for the data life-cycle stage Security labels for the identified entity.

Cardinality 0..1 Terminology Binding ObjectLifecycleEvents ( Extensible ) Type Coding Requirements Institutional policies for privacy and security may optionally fall under different accountability rules based on data life cycle. This provides a differentiating value for those cases. Summary false Comments This can be used to provide an audit trail for data, over time, as it passes through the system. AuditEvent.entity.securityLabel Element Id AuditEvent.entity.securityLabel Definition Short Display Security labels for on the identified entity. entity
Cardinality 0..*
Terminology Binding SecurityLabels Example set of Security Labels ( Extensible Example )
Type Coding CodeableConcept
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.

Summary false
Comments

Copied from entity meta security tags.

AuditEvent.entity.name AuditEvent.entity.query
Element Id AuditEvent.entity.name AuditEvent.entity.query
Definition

A name of the entity in the audit event. Cardinality 0..1 Type string Requirements Use only where entity can't be identified with an identifier. Summary true Comments This field may be used in a query/report to identify audit events The query parameters for a specific person. For example, where multiple synonymous entity identifiers (patient number, medical record number, encounter number, etc.) have been used. Invariants Affect this element sev-1 Rule Either a name or a query (NOT both) name.empty() or query.empty() AuditEvent.entity.description Element Id AuditEvent.entity.description Definition Text that describes the entity in more detail. Cardinality 0..1 Type string Requirements Use only where entity can't be identified with an identifier. query-type entities.

Summary false AuditEvent.entity.query Element Id AuditEvent.entity.query Definition Short Display The query Query parameters for a query-type entities.
Cardinality 0..1
Type base64Binary
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.

Summary true
Comments

The meaning and secondary-encoding of the content of base64 encoded blob is specific to the AuditEvent.type, AuditEvent.subtype, AuditEvent.entity.type, 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.

Invariants Affect this element sev-1 Rule Either a name or a query (NOT both) name.empty() or query.empty()

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

AuditEvent.entity.detail
Element Id AuditEvent.entity.detail
Definition

Tagged value pairs for conveying additional information about the entity.

Short Display Additional Information about the entity
Cardinality 0..*
Requirements

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

Summary false
AuditEvent.entity.detail.type
Element Id AuditEvent.entity.detail.type
Definition

The type of extra detail provided in the value.

Short Display Name of the property
Cardinality 1..1
Terminology Binding Audit Event ID ( Example )
Type string CodeableConcept
Summary false
AuditEvent.entity.detail.value[x]
Element Id AuditEvent.entity.detail.value[x]
Definition

The value of the extra detail.

Short Display Property value
Cardinality 1..1
Type Quantity | CodeableConcept | string | boolean | integer | Range | Ratio | time | dateTime | Period | base64Binary
[x] Note See Choice of Data Types Datatypes for further information about how to use [x]
Requirements

Should not duplicate the entity value unless absolutely necessary.

Summary false
AuditEvent.entity.agent
Comments Element Id AuditEvent.entity.agent
Definition

The value can be string when known entity is attributed to be a string, else base64 encoding should be used an agent to protect binary or undefined content. The meaning and secondary-encoding of express the content of base64 encoded blob is specific to agent's responsibility for that entity in the AuditEvent.type, AuditEvent.subtype, AuditEvent.entity.type, and AuditEvent.entity.role. The base64 activity. This is most used to indicate when persistence media (the entity) are used by an agent. For example when importing data from a general-use device, the device would be described in an entity, and safe container for event specific the user importing data blobs regardless of from that media would be indicated as the encoding entity.agent.

Short Display Entity is attributed to this agent
Cardinality 0..*
Type See AuditEvent.agent
Summary false
Comments

A usecase where one AuditEvent.entity.agent is used by where the transaction being recorded. An AuditEvent consuming application must understand Entity that was used in the event it creation/updating of a target resource, is consuming and not in the formats used by context of the event. For example if auditing an Oracle network database access, same custodianship as the Oracle formats must 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 understood similar to where the Entity being referenced is managed outside FHIR, such as they will through HL7 V2, v3, or XDS. This might be simply encoded where the Entity being referenced is managed in another FHIR resource server. Thus it explains the base64binary blob. provenance of that Entity's use in the context of this AuditEvent activity.