R6 Ballot (2nd Draft)

Publish-box (todo)

Security icon Work GroupMaturity Level: 4 Trial UseSecurity Category: Not Classified Compartments: Device, Patient, Practitioner

Detailed Descriptions for the elements in the AuditEvent resource.

AuditEvent
Element Id AuditEvent
Definition

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

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

Based on IHE-ATNA.

AuditEvent.type
Element Id 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.

Short Display High level categorization of audit event
Cardinality 1..1
Terminology Binding Audit Event ID (Example)
Type CodeableConcept
Alternate Names category; EventTypeCode
Summary true
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.

AuditEvent.subtype
Element Id AuditEvent.subtype
Definition

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

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

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

Alternate Names code; EventID
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 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.severity
Element Id 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 Audit Event Outcome (Preferred)
Type 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.outcome.detail
Element Id 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.

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

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

AuditEvent.authorization
Element Id AuditEvent.authorization
Definition

The 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 (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.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 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(Any)
Requirements

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

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. May also affect access control.

Summary true
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)
Requirements

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

Summary false
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).

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 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

The Functional Role of the user when performing the event.

Short Display How agent participated
Cardinality 0..1
Terminology Binding Participation Role Type (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 enabling the agent with respect to the activity.

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

Summary false
Comments

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 1..1
Type Reference(Practitioner | PractitionerRole | Organization | 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. Where a name of the 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 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

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.

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.network[x]
Element Id 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.

Short Display This agent network location for the activity
Cardinality 0..1
Type Reference(Endpoint)|uri|string
[x] Note See Choice of Datatypes 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 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).

Summary false
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 Id AuditEvent.agent.authorization
Definition

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

Short Display Allowable authorization for this agent
Cardinality 0..*
Terminology Binding PurposeOfUse icon (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 PurposeOfUse
Summary false
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 Id AuditEvent.source
Definition

The actor that is reporting the event.

Short Display Audit Event Reporter
Cardinality 1..1
Requirements

The event is reported by one source.

Summary true
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 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 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(Practitioner | PractitionerRole | Organization | 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 (Preferred)
Type 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 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.

Short Display Specific instance of resource
Cardinality 0..1
Type Reference(Any)
Summary true
Comments

Use .what.display when all you have is 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 Audit Event Entity Role (Example)
Type 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.securityLabel
Element Id AuditEvent.entity.securityLabel
Definition

Security labels for the identified entity.

Short Display Security labels on the entity
Cardinality 0..*
Terminology Binding Example set of Security Labels (Example)
Type 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.query
Element Id AuditEvent.entity.query
Definition

The query parameters for a query-type entities.

Short Display Query parameters
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, 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 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 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.

Short Display The name of the extra detail property
Cardinality 1..1
Terminology Binding Audit Event Entity Detail Type (Example)
Type 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 Datatypes for further information about how to use [x]
Requirements

Should not duplicate the entity value unless absolutely necessary.

Summary false
AuditEvent.entity.agent
Element Id 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.

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 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.