HL7中国FHIR Connectathon测试实施指南
2024.5.5 - release

本指南适用于HL7中国的FHIR Connectathon测试。

Resource Profile: CoreAuditEvent - 详细描述

Definitions for the profile-core-auditevent resource profile.

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|5.0.0)

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()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
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()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
18. AuditEvent.category
Definition

Classification of the type of event.

Short审计事件分类(粗粒度)
Control1..1
BindingThe codes SHALL be taken from AuditEventID
(required to http://hl7.org/fhir/ValueSet/audit-event-type)
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summarytrue
Requirements

Codes that classify the general type of event that happened.

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

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

Short审计事件类型(细粒度)
Control1..1
BindingThe codes SHALL be taken from AuditEventSubType
(required to http://hl7.org/fhir/ValueSet/audit-event-sub-type)
TypeCodeableConcept
Is Modifierfalse
Must Supportfalse
Summarytrue
Requirements

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

Alternate Namessubtype
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.

Short活动类型:创建、读取、更新、删除、执行
Control1..1
BindingThe codes SHALL be taken from AuditEventAction
(required to http://hl7.org/fhir/ValueSet/audit-event-action|5.0.0)

DICOM Audit Event Action

Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
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|5.0.0)

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.

Control1..1
TypedateTime
[x] NoteSee Choice of Data Types for 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()))
SlicingThis element introduces a set of slices on AuditEvent.occurred[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators:
  • type @ $this
  • 28. AuditEvent.occurred[x]:occurredDateTime
    Slice NameoccurredDateTime
    Definition

    The time or period during which the activity occurred.

    Short活动发生时间
    Comments

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

    Control1..1
    TypedateTime
    [x] NoteSee Choice of Data Types for 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()))
    30. AuditEvent.recorded
    Definition

    The time when the event was recorded.

    Short审计记录时间
    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 Supportfalse
    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()))
    32. AuditEvent.outcome
    Definition

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

    Short执行结果:成功、一般错误、严重错误、重大错误
    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
    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()))
    34. 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
    36. 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()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    38. 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()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    40. 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()))
    42. 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()))
    44. 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 Supportfalse
    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()))
    46. 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(CarePlan, DeviceRequest, ImmunizationRecommendation, MedicationRequest, NutritionOrder, ServiceRequest, Task)
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    48. 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
    Summaryfalse
    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.

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    50. 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
    Control0..1
    TypeReference(Encounter)
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    52. AuditEvent.agent
    Definition

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

    Short事件参与者
    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 Supportfalse
    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()))
    54. 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
    56. 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()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    58. 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()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    60. AuditEvent.agent.type
    Definition

    The Functional Role of the user when performing the event.

    Short事件参与者类型
    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()))
    62. 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()))
    64. AuditEvent.agent.who
    Definition

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

    Short参与者(可以是系统或者人员)
    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 Supportfalse
    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()))
    66. AuditEvent.agent.requestor
    Definition

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

    Short是否为事件的发起者
    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 Supportfalse
    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()))
    68. 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 Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    70. 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()))
    72. 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网络信息
    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.

    Control1..1
    TypeChoice of: Reference(Endpoint), uri, string
    [x] NoteSee Choice of Data Types for 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

    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()))
    74. 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 Supportfalse
    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()))
    76. AuditEvent.source
    Definition

    The actor that is reporting the event.

    Short审计源,记录了提交审计事件的系统
    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 Supportfalse
    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()))
    78. 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
    80. 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()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    82. 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()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    84. 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审计源所处位置
    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()))
    86. AuditEvent.source.observer
    Definition

    Identifier of the source where the event was detected.

    Short审计源系统标识
    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()))
    88. AuditEvent.source.type
    Definition

    Code specifying the type of source where event originated.

    Short审计源类型
    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()))
    90. 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 Supportfalse
    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()))
    92. 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
    94. 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()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    96. 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()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    98. 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 Supportfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    100. 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()))
    102. 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()))
    104. 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()))
    106. 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()))
    108. 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
    110. 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()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    112. 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()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    114. AuditEvent.entity.detail.type
    Definition

    The type of extra detail provided in the value.

    ShortName of the property
    Control1..1
    BindingFor example codes, see AuditEventID
    (example to http://hl7.org/fhir/ValueSet/audit-event-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()))
    116. 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] NoteSee Choice of Data Types for 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()))
    118. 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..*
    TypeSee ttp://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()))