Generated Narrative: StructureDefinition ema-audit-event Name Flags Card. Type Description & Constraints AuditEvent 0..* AuditEventCl Event record kept for security purposes #xD; agent #xD; who 1..1 Reference(EMA Practitioner | EMA PractitionerRole | EMA Organization) Quien realizó la acción #xD; Documentation for this format
Evento de auditoría para trazabilidad de acciones en EMA Clinic, basado en AuditEventCl de CLCore.
A record of an event made for purposes of maintaining a security log. Typical uses include detection of intrusion attempts and monitoring for inappropriate usage.
If the resource is contained in another resource, it SHALL NOT contain nested Resources
not(parent::f:contained and f:contained)
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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))
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()
not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))
If a resource is contained in another resource, it SHALL NOT have a security label
When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time.
A resource should have narrative for robust management
The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
The only time that a resource does not have an id is when it is being submitted to the server using a create operation.
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.
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
A set of rules under which this content was created
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.
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 it's narrative along with other profiles, value sets, etc.
This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
The base language in which the resource is written.
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).
Text summary of the resource, for human interpretation
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.
Contained resources do not have 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.
These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.
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.
Additional content defined by implementations
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 manageable, 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.
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.
Must have either extensions or value[x], not both
exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
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 manageable, 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).
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](http://hl7.org/fhir/R4/extensibility.html#modifierExtension).
Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Identificador de una familia del evento. Por ejemplo, un elemento de menú, un programa, una regla, una política, un código de función, un nombre de aplicación o una URL. Identifica la función realizada.
This identifies the performed function. For "Execute" Event Action Code audit records, this identifies the application function performed.
Eventos de auditoría descritos en FHIR para DICOM
.code (type, subtype and action are pre-coordinated or sent as translations)
This field enables queries of messages by implementation-defined event categories.
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Extensions are always sliced by (at least) url
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 manageable, 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.
Sistema de ejemplo de códigos que describen con más detalle el evento
The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.
Need to be unambiguous about the source of the definition of the symbol.
fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.
Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.
fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).
Need to refer to a particular code in the system.
fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
A representation of the meaning of the code in the system, following the rules of the system.
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
C*E.2 - but note this is not well followed
fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
If this coding was chosen directly by the user
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.
This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.
fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
Create| Read/View/Print | Update | Delete | Execute
This broadly indicates what kind of action was done on the AuditEvent.entity by the AuditEvent.agent.
Códigos fijos extraídos de un set de DICOM por FHIR
The period during which the activity occurred.
The period can be a little arbitrary; where possible, the time should correspond to human assessment of the activity time.
In a distributed system, some sort of common time base (e.g. an NTP [RFC1305] server) is a good implementation tactic.
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.
Indicates whether the event succeeded or failed.
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.
A free text description of the outcome of the event.
The purposeOfUse (reason) that was used during the event being recorded.
Use AuditEvent.agent.purposeOfUse when you know that it is specific to the agent, otherwise use AuditEvent.purposeOfEvent. 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.
* .reasonCode [ControlActReason when Act.class = CACT Control Act] *.outboundRelationship[typeCode=RSON].target
Mínimo debe indicar quien requirió del recurso
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.
An agent can be a person, an organization, software, device, or other actors that may be ascribed responsibility.
Extensions that cannot be ignored even if unrecognized
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 manageable, 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).
Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Specification of the participation type the user plays when performing the event.
The Participation type of the agent to the event.
The security role that the user was acting under, that come from local codes defined by the access control security system (e.g. RBAC, ABAC) used in the local context.
Should be roles relevant to the event. Should not be an exhaustive list of roles.
This value ties an audited event to a user's role(s). It is an optional value that might be used to group events for analysis by user functional role categories.
What security role enabled the agent to participate in the event.
Referencia al recurso o Identificación de quien realizó la acción
Where a User ID is available it will go into who.identifier.
This field ties an audit event to a specific resource or identifier.
Alternative agent Identifier. For a human, this should be a user identifier text string from authentication system. This identifier would be one known to a common authentication system (e.g. single sign-on), if available.
In some situations, a human user may authenticate with one identity but, to access a specific application system, may use a synonymous identify. For example, some "single sign on" implementations will do this. The alternative identifier would then be the original identify used for authentication, and the User ID is the one known to and used by the application.
The User ID and Authorization User ID may be internal or otherwise obscure values. This field assists the auditor in identifying the actual user.
indicador de si Who es quien requirió la acción
There can only be one initiator. If the initiator is not clear, then do not choose any one agent as the initiator.
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.
If participation.typeCode was author, then true
* Role.Class =SDLOC *Role.Code = ServiceDeliveryLocationRoleType *Entity.Code = PlaceEntityType = df.Types of places for Entity.Class = PLC *EntityClass = PLC = df.A physical place or site with its containing structure. May be natural or man-made. The geographic position of a place might or might not be constant.
The policy or plan that authorized the activity being recorded. 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.
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.
This value is used retrospectively to determine the authorization policies.
Type of media involved. Used when the event is about exporting/importing onto media.
Usually, this is used instead of specifying a network address. This field is not used for Media Id (i.e. the serial number of a CD).
Used when the event is about exporting/importing onto media.
Ubicación de red lógica para la actividad de la aplicación, si la actividad tiene una ubicación de red.
Un identificador para el tipo de punto de acceso a la red que originó el evento de auditoría.
This could be a device id, IP address or some other identifier associated with a device.
This datum identifies the user's network access point, which may be distinct from the server that performed the action. It is an optional value that may be used to group events recorded on separate servers for analysis of a specific network access point's data access across all servers.
Un tipo de identificador para el tipo de punto de acceso a la red que originó el evento de auditoría.
This datum identifies the type of network access point identifier of the user device for the audit event. It is an optional value that may be used to group events recorded on separate servers for analysis of access according to a network access point's type.
Códigos extraídos de un set DICOM por FHIR
The reason (purpose of use), specific to this agent, that was used during the event being recorded.
Use AuditEvent.agent.purposeOfUse when you know that is specific to the agent, otherwise use AuditEvent.purposeOfEvent. 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.
*.reasonCode [ActHealthInformationPurposeOfUseReason codes/v:PurposeOfUse (2.16.840.1.113883.1.11.20448) * .outboundRelationship[typeCode=RSON or SUBJ].target
Since multi-tier, distributed, or composite applications make source identification ambiguous, this collection of fields may repeat for each application or process actively involved in the event. For example, multiple value-sets can identify participating web servers, application processes, and database server threads in an n-tier distributed application. Passive event participants (e.g. low-level network transports) need not be identified.
.participation[typeCode=INF].role[classCode=ASSIGN].player[classCode=DEV, determinerCode=INSTANCE]
Logical source location within the enterprise
Logical source location within the healthcare enterprise network. For example, a hospital or other provider location within a multi-entity provider group.
This value differentiates among the sites in a multi-site enterprise health information system.
Identificación del Observador donde se reportó el evento
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.
The type of source where event originated
Code specifying the type of source where event originated.
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.
Code specifying the type of system that detected and recorded the event.
Entidad que registra la ocurrencia del Evento
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.
The event may have other entities involved.
not(exists(f:name)) or not(exists(f:query))
.outboundRelationship[typeCode=SUBJ].target or .participation[typeCode=SBJ].role
Recurso o identificación de la entidad que registra la ocurrencia del evento
ParticipantObjectID and ParticipantObjectIDTypeCode
Provenance.target, Provenance.entity.what
The type of the object that was involved in this audit event.
This value is distinct from the user's role or any user relationship to the entity.
To describe the object being acted upon. In addition to queries on the subject of the action in an auditable event, it is also important to be able to query on the object type for the action.
Code for the entity type involved in the audit event.
Code representing the role the entity played in the event being audited.
For some detailed audit analysis it may be necessary to indicate a more granular type of entity, based on the application role it serves.
Code representing the role the entity played in the audit event.
role.code (not sure what this would mean for an Act)
Identifier for the data life-cycle stage for the entity.
This can be used to provide an audit trail for data, over time, as it passes through the system.
Institutional policies for privacy and security may optionally fall under different accountability rules based on data life cycle. This provides a differentiating value for those cases.
target of ObservationEvent[code="lifecycle"].value
Security labels for the identified entity.
This field identifies the security labels for a specific instance of an object, such as a patient, to detect/track privacy and security issues.
Security Labels from the Healthcare Privacy and Security Classification System.
A name of the entity in the audit event.
This field may be used in a query/report to identify audit events for a specific person. For example, where multiple synonymous entity identifiers (patient number, medical record number, encounter number, etc.) have been used.
Use only where entity can't be identified with an identifier.
Text that describes the entity in more detail.
The query parameters for a query-type entities.
The meaning and secondary-encoding of the content of base64 encoded blob is specific to the AuditEvent.type, AuditEvent.subtype, AuditEvent.entity.type, and AuditEvent.entity.role. The base64 is a general-use and safe container for event specific data blobs regardless of the encoding used by the transaction being recorded. An AuditEvent consuming application must understand the event it is consuming and the formats used by the event. For example, if auditing an Oracle network database access, the Oracle formats must be understood as they will be simply encoded in the base64binary blob.
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.
Tagged value pairs for conveying additional information about the entity.
Implementation-defined data about specific details of the object accessed or used.
.inboundRelationship[typeCode=SUBJ].target[classCode=OBS, moodCode=EVN]
The type of extra detail provided in the value.
The value can be string when known to be a string, else base64 encoding should be used to protect binary or undefined content. The meaning and secondary-encoding of the content of base64 encoded blob is specific to the AuditEvent.type, AuditEvent.subtype, AuditEvent.entity.type, and AuditEvent.entity.role. The base64 is a general-use and safe container for event specific data blobs regardless of the encoding used by the transaction being recorded. An AuditEvent consuming application must understand the event it is consuming and the formats used by the event. For example if auditing an Oracle network database access, the Oracle formats must be understood as they will be simply encoded in the base64binary blob.
Should not duplicate the entity value unless absolutely necessary.