Release 5 Draft Ballot

This is the Continuous Integration Build of FHIR (will be incorrect/inconsistent at times).
See the Directory of published versions

Security Work GroupMaturity Level: 3 Trial UseSecurity Category: Not Classified Compartments: Device, Patient, Practitioner

Detailed Descriptions for the elements in the AuditEvent resource.

AuditEvent
Element IdAuditEvent
Definition

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

Cardinality0..*
TypeDomainResource
Summaryfalse
Comments

Based on IHE-ATNA.

AuditEvent.category
Element IdAuditEvent.category
Definition

Classification of the type of event.

Cardinality0..*
Terminology BindingAudit Event ID (Example)
TypeCodeableConcept
Requirements

Codes that classify the general type of event that happened.

Alternate Namestype
Summarytrue
AuditEvent.code
Element IdAuditEvent.code
Definition

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

Cardinality1..1
Terminology BindingAudit Event Sub-Type (Example)
TypeCodeableConcept
Requirements

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

Alternate Namessubtype
Summarytrue
AuditEvent.action
Element IdAuditEvent.action
Definition

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

Cardinality0..1
Terminology BindingAuditEventAction (Required)
Typecode
Requirements

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

Summarytrue
AuditEvent.severity
Element IdAuditEvent.severity
Definition

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

Cardinality0..1
Terminology BindingAuditEventSeverity (Required)
Typecode
Summarytrue
Comments

ATNA will map this to the SYSLOG PRI element.

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

The time or period during which the activity occurred.

Cardinality0..1
TypePeriod|dateTime
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summaryfalse
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 IdAuditEvent.recorded
Definition

The time when the event was recorded.

Cardinality1..1
Typeinstant
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.

Summarytrue
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 IdAuditEvent.outcome
Definition

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

Cardinality0..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).

Summarytrue
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 IdAuditEvent.outcome.code
Definition

Indicates whether the event succeeded or failed.

Cardinality1..1
Terminology BindingAuditEventOutcome (Preferred)
TypeCoding
Requirements

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

Summarytrue
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.detail
Element IdAuditEvent.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.

Cardinality0..*
Terminology BindingAuditEventOutcomeDetail (Example)
TypeCodeableConcept
Summarytrue
Comments

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

AuditEvent.authorization
Element IdAuditEvent.authorization
Definition

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

Cardinality0..*
Terminology BindingPurposeOfUse (Example)
TypeCodeableConcept
Requirements

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

Alternate NamesPurposeOfEvent
Summarytrue
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.

AuditEvent.basedOn
Element IdAuditEvent.basedOn
Definition

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

Cardinality0..*
TypeReference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest | Task)
PatternsReference(CarePlan,DeviceRequest,ImmunizationRecommendation,MedicationRequest,NutritionOrder,ServiceRequest,Task): No common pattern
Summaryfalse
AuditEvent.encounter
Element IdAuditEvent.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).

Cardinality0..1
TypeReference(Encounter)
Summaryfalse
AuditEvent.agent
Element IdAuditEvent.agent
Definition

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

Cardinality1..*
Requirements

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

Alternate NamesActiveParticipant
Summaryfalse
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 IdAuditEvent.agent.type
Definition

The Functional Role of the user when performing the event.

Cardinality0..1
Terminology BindingParticipationRoleType (Example)
TypeCodeableConcept
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.

Summaryfalse
Comments

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

AuditEvent.agent.role
Element IdAuditEvent.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.

Cardinality0..*
Terminology BindingSecurityRoleType (Example)
TypeCodeableConcept
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..

Summaryfalse
Comments

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

AuditEvent.agent.who
Element IdAuditEvent.agent.who
Definition

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

Cardinality1..1
TypeReference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson)
PatternsReference(Practitioner,PractitionerRole,Organization,CareTeam,Patient,Device,RelatedPerson): Common patterns = Participant
Requirements

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

Alternate NamesuserId
Summarytrue
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.

AuditEvent.agent.requestor
Element IdAuditEvent.agent.requestor
Definition

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

Cardinality0..1
Typeboolean
Meaning if Missingfalse
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.

Summarytrue
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 IdAuditEvent.agent.location
Definition

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

Cardinality0..1
TypeReference(Location)
Summaryfalse
AuditEvent.agent.policy
Element IdAuditEvent.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.

Cardinality0..*
Typeuri
Requirements

This value is used retrospectively to determine the authorization policies.

Summaryfalse
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.network[x]
Element IdAuditEvent.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.

Cardinality0..1
TypeReference(Endpoint)|uri|string
[x] NoteSee Choice of Data Types for further information about how to use [x]
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 terns of a Reference(Endpoint), or URI; use address only when address or hostname is known.

Summaryfalse
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.

AuditEvent.agent.authorization
Element IdAuditEvent.agent.authorization
Definition

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

Cardinality0..*
Terminology BindingPurposeOfUse (Example)
TypeCodeableConcept
Requirements

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

Alternate NamesPurposeOfUse
Summaryfalse
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.

AuditEvent.source
Element IdAuditEvent.source
Definition

The actor that is reporting the event.

Cardinality1..1
Requirements

The event is reported by one source.

Summaryfalse
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.

AuditEvent.source.site
Element IdAuditEvent.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.

Cardinality0..1
TypeReference(Location)
Requirements

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

Summaryfalse
AuditEvent.source.observer
Element IdAuditEvent.source.observer
Definition

Identifier of the source where the event was detected.

Cardinality1..1
TypeReference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson)
PatternsReference(Practitioner,PractitionerRole,Organization,CareTeam,Patient,Device,RelatedPerson): Common patterns = Participant
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
Summarytrue
AuditEvent.source.type
Element IdAuditEvent.source.type
Definition

Code specifying the type of source where event originated.

Cardinality0..*
Terminology BindingAudit Event Source Type (Preferred)
TypeCodeableConcept
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.

Summaryfalse
AuditEvent.entity
Element IdAuditEvent.entity
Definition

Specific instances of data or objects that have been accessed.

Cardinality0..*
Requirements

The event may have other entities involved.

Alternate NamesParticipantObject
Summaryfalse
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 IdAuditEvent.entity.what
Definition

Identifies a specific instance of the entity. The reference should be version specific.

Cardinality0..1
TypeReference(Any)
Summarytrue
Comments

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

AuditEvent.entity.role
Element IdAuditEvent.entity.role
Definition

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

Cardinality0..1
Terminology BindingAuditEventEntityRole (Extensible)
TypeCodeableConcept
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.

Summaryfalse
AuditEvent.entity.securityLabel
Element IdAuditEvent.entity.securityLabel
Definition

Security labels for the identified entity.

Cardinality0..*
Terminology BindingSecurityLabels (Extensible)
TypeCodeableConcept
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.

Summaryfalse
Comments

Copied from entity meta security tags.

AuditEvent.entity.query
Element IdAuditEvent.entity.query
Definition

The query parameters for a query-type entities.

Cardinality0..1
Typebase64Binary
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.

Summarytrue
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.

AuditEvent.entity.detail
Element IdAuditEvent.entity.detail
Definition

Tagged value pairs for conveying additional information about the entity.

Cardinality0..*
Requirements

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

Summaryfalse
AuditEvent.entity.detail.type
Element IdAuditEvent.entity.detail.type
Definition

The type of extra detail provided in the value.

Cardinality1..1
Terminology BindingAudit Event ID (Example)
TypeCodeableConcept
Summaryfalse
AuditEvent.entity.detail.value[x]
Element IdAuditEvent.entity.detail.value[x]
Definition

The value of the extra detail.

Cardinality1..1
TypeQuantity|CodeableConcept|string|boolean|integer|Range|Ratio|time|dateTime|Period|base64Binary
[x] NoteSee Choice of Data Types for further information about how to use [x]
Requirements

Should not duplicate the entity value unless absolutely necessary.

Summaryfalse
AuditEvent.entity.agent
Element IdAuditEvent.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.

Cardinality0..*
TypeSee AuditEvent.agent
Summaryfalse
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.