Guía de Implementación Core de Costa Rica
0.1.0 - ci-build
Guía de Implementación Core de Costa Rica - Versión en desarrollo (v0.1.0): borrador de trabajo de la Iniciativa HL7® Costa Rica, que puede cambiar sin aviso.
| Estado de las normas de la página: Draft |
Definiciones del cr-auditevent perfil de los recursos.
Las indicaciones para interpretar el contenido de esta tabla estánaquí
| 0. AuditEvent | |
| Definición | Registro de un acceso u operación sobre datos en el HIE: quién lo hizo, desde qué sistema, con qué propósito, sobre qué datos de qué paciente y con qué resultado, incluidos los intentos fallidos. A record of an event relevant for purposes such as operations, privacy, security, maintenance, and performance analysis. |
| Resumen | Evento de auditoría: quién accedió a qué y con qué resultadoRecord of an event |
| Comentarios | Based on IHE-ATNA. |
| Control | 0..* |
| Es modificador | false |
| Must Support | false |
| Resumen | false |
| Invariantes | dom-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()) cr-auditoria-rest: Un evento rest lleva el código de la interacción REST. ( category.coding.where(code = 'rest').exists() implies code.coding.where(system = 'http://hl7.org/fhir/restful-interaction').exists())cr-auditoria-accion: La acción es coherente con la interacción: las lecturas, búsquedas e historias son R; create es C; update y patch son U; delete es D; las demás son E. ( code.coding.where(system = 'http://hl7.org/fhir/restful-interaction').all(iif(code in ('read' | 'vread' | 'search' | 'search-type' | 'search-system' | 'history' | 'history-instance' | 'history-type' | 'history-system'), %resource.action = 'R', iif(code = 'create', %resource.action = 'C', iif(code in ('update' | 'patch'), %resource.action = 'U', iif(code = 'delete', %resource.action = 'D', %resource.action = 'E'))))))cr-auditoria-detalle: Un resultado que no es success lleva su detalle. ( outcome.code.code != 'success' implies outcome.detail.exists())cr-auditoria-proposito: Un evento con datos de un paciente indica el propósito de uso. ( patient.exists() implies authorization.exists())cr-auditoria-agentes: El evento lleva un agente cliente y un agente servidor (DICOM 110152 y 110153). ( agent.where(type.coding.where(system = 'http://dicom.nema.org/resources/ontology/DCM' and code = '110152').exists()).exists() and agent.where(type.coding.where(system = 'http://dicom.nema.org/resources/ontology/DCM' and code = '110153').exists()).exists())cr-auditoria-red: El cliente y el servidor indican su red (dirección IP, subsistema X-Road o URL). ( agent.where(type.coding.where(code = '110153' or code = '110152').exists()).all(network.exists()))cr-auditoria-solicitante: Hay un solo solicitante (requestor = true): el usuario o, si no hay usuario, el cliente. ( agent.where(requestor = true).count() = 1)cr-auditoria-paciente: El paciente del evento va también como entidad con role 1 (Patient), como en IHE BALP. ( patient.exists() implies entity.where(role.coding.where(system = 'http://terminology.hl7.org/CodeSystem/object-role' and code = '1').exists()).exists())cr-auditoria-entidades: Cada entidad indica el recurso (what), salvo la consulta (role 24), que indica la consulta (query). ( entity.all(iif(role.coding.where(code = '24').exists(), query.exists(), what.exists())))cr-auditoria-fechas: La fecha del evento no es posterior a la fecha de registro. ( occurred.ofType(dateTime).empty() or occurred.ofType(dateTime) <= recorded) |
| 2. AuditEvent.implicitRules | |
| Definición | 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. |
| Resumen | A set of rules under which this content was created |
| Comentarios | 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. |
| Control | 0..1 |
| Tipo | uri |
| Es modificador | true porque This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation |
| Valor primitivo | Este elemento primitivo puede estar presente, ausente o reemplazado por una extensión |
| Must Support | false |
| Resumen | true |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 4. AuditEvent.contained | |
| Definición | 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. |
| Resumen | Contained, inline Resources |
| Comentarios | 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. |
| Control | 0..* Este elemento está afectado por las siguientes invariantes: dom-2, dom-4, dom-3, dom-5 |
| Tipo | Resource |
| Es modificador | false |
| Must Support | false |
| Resumen | false |
| Nombres alternativos | inline resources, anonymous resources, contained resources |
| 6. AuditEvent.modifierExtension | |
| Definición | 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). |
| Resumen | Extensions that cannot be ignored |
| Comentarios | 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. |
| Control | 0..* |
| Tipo | Extension |
| Es modificador | true porque Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them |
| Must Support | false |
| Resumen | true |
| Requisitos | 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. |
| Nombres alternativos | extensions, user content |
| Invariantes | ele-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()) |
| 8. AuditEvent.category | |
| Definición | Classification of the type of event. |
| Resumen | Categoría: rest | 110114 (autenticación) | 110113 (alerta de seguridad)Type/identifier of event |
| Control | 10..1* |
| Vinculación | Los códigos DEBEN tomarse de Para códigos de ejemplo, vea Categoría del evento de auditoríahttp://hl7.org/fhir/ValueSet/audit-event-type|5.0.0 (required to https://hl7.or.cr/fhir/terminology/ValueSet/cr-categoria-auditoria) |
| Tipo | CodeableConcept |
| Es modificador | false |
| Must Support | true |
| Resumen | true |
| Requisitos | Codes that classify the general type of event that happened. |
| Nombres alternativos | type |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 10. AuditEvent.code | |
| Definición | Describes what happened. The most specific code for the event. |
| Resumen | Qué se hizo: la interacción REST (read, search, create...) o el evento de DICOMSpecific type of event |
| Control | 1..1 |
| Vinculación | Para códigos de ejemplo, vea AuditEventSubTypehttp://hl7.org/fhir/ValueSet/audit-event-sub-type|5.0.0 (example to http://hl7.org/fhir/ValueSet/audit-event-sub-type|5.0.0)Specific type of event. |
| Tipo | CodeableConcept |
| Es modificador | false |
| Must Support | true |
| Resumen | true |
| Requisitos | This field enables queries of messages by implementation-defined event categories. |
| Nombres alternativos | subtype |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 12. AuditEvent.action | |
| Definición | Indicator for type of action performed during the event that generated the audit. |
| Resumen | C | R | U | D | E, coherente con el códigoType of action performed during the event |
| Control | 10..1 |
| Vinculación | Los códigos DEBEN tomarse de AuditEventActionhttp://hl7.org/fhir/ValueSet/audit-event-action|5.0.0 (required to http://hl7.org/fhir/ValueSet/audit-event-action|5.0.0)DICOM Audit Event Action |
| Tipo | code |
| Es modificador | false |
| Valor primitivo | Este elemento primitivo puede estar presente, ausente o reemplazado por una extensión |
| Must Support | true |
| Resumen | true |
| Requisitos | This broadly indicates what kind of action was done on the AuditEvent.entity by the AuditEvent.agent. |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 14. AuditEvent.occurred[x] | |
| Definición | The time or period during which the activity occurred. |
| Resumen | Cuándo ocurrió el evento (no posterior al registro)When the activity occurred |
| Comentarios | The time or period can be a little arbitrary; where possible, the time should correspond to human assessment of the activity time. |
| Control | 0..1 |
| Tipo | dateTime, Period |
| Nota sobre [x] | VeaElección de tipos de datospara más información sobre cómo usar [x] |
| Es modificador | false |
| Valor primitivo | Este elemento primitivo puede estar presente, ausente o reemplazado por una extensión |
| Must Support | true |
| Resumen | false |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) cr-documento-fecha-hora: La fecha lleva fecha y hora, no solo la fecha. ( toString().contains('T')) |
| 16. AuditEvent.recorded | |
| Definición | The time when the event was recorded. |
| Resumen | Cuándo se registró el eventoTime when the event was recorded |
| Comentarios | In a distributed system, some sort of common time base (e.g. an NTP [RFC1305] server) is a good implementation tactic. |
| Control | 1..1 |
| Tipo | instant |
| Es modificador | false |
| Valor primitivo | Este elemento primitivo puede estar presente, ausente o reemplazado por una extensión |
| Must Support | true |
| Resumen | true |
| Requisitos | 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. |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 18. AuditEvent.outcome | |
| Definición | Indicates whether the event succeeded or failed. A free text descripiton can be given in outcome.text. |
| Resumen | Resultado del evento, también en los fallosWhether the event succeeded or failed |
| Comentarios | 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. |
| Control | 10..1 |
| Tipo | BackboneElement |
| Es modificador | false |
| Must Support | true |
| Resumen | true |
| Requisitos | 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). |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 20. AuditEvent.outcome.modifierExtension | |
| Definición | 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). |
| Resumen | Extensions that cannot be ignored even if unrecognized |
| Comentarios | 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. |
| Control | 0..* |
| Tipo | Extension |
| Es modificador | true porque Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Resumen | true |
| Requisitos | 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. |
| Nombres alternativos | extensions, user content, modifiers |
| Invariantes | ele-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()) |
| 22. AuditEvent.outcome.code | |
| Definición | Indicates whether the event succeeded or failed. |
| Resumen | success | warning | error | fatalWhether the event succeeded or failed |
| Comentarios | 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. |
| Control | 1..1 |
| Vinculación | Los códigos DEBEN tomarse de Los códigos DEBERÍAN tomarse de AuditEventOutcomehttp://hl7.org/fhir/ValueSet/audit-event-outcome|5.0.0 (required to http://hl7.org/fhir/ValueSet/audit-event-outcome) |
| Tipo | Coding |
| Es modificador | false |
| Must Support | true |
| Resumen | true |
| Requisitos | when a code is given there must be one code from the given codeSystem. |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 24. AuditEvent.outcome.detail | |
| Definición | Additional details about the error. This may be a text description of the error or a system code that identifies the error. |
| Resumen | Detalle (código HTTP y texto), sin datos clínicosAdditional outcome detail |
| Comentarios | A human readable description of the error issue SHOULD be placed in details.text. |
| Control | 0..* |
| Vinculación | Para códigos de ejemplo, vea AuditEventOutcomeDetailhttp://hl7.org/fhir/ValueSet/audit-event-outcome-detail|5.0.0 (example to http://hl7.org/fhir/ValueSet/audit-event-outcome-detail|5.0.0)A code that provides details as the exact issue. |
| Tipo | CodeableConcept |
| Es modificador | false |
| Must Support | true |
| Resumen | true |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 26. AuditEvent.authorization | |
| Definición | The authorization (e.g., PurposeOfUse) that was used during the event being recorded. |
| Resumen | Propósito de uso: TREAT | ETREAT | COC | PATRQT | PUBHLTH | HRESCH | HOPERAT | HSYSADMIN | HLEGALAuthorization related to the event |
| Comentarios | 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. |
| Control | 0..1* |
| Vinculación | Los códigos DEBEN tomarse de Para códigos de ejemplo, vea Propósito de usohttp://terminology.hl7.org/ValueSet/v3-PurposeOfUse (required to https://hl7.or.cr/fhir/terminology/ValueSet/cr-proposito-uso) |
| Tipo | CodeableConcept |
| Es modificador | false |
| Must Support | true |
| Resumen | true |
| Requisitos | Record of any relevant security context, not restricted to purposeOfUse valueSet. May include security compartments, refrain, obligation, or other security tags. |
| Nombres alternativos | PurposeOfEvent |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 28. AuditEvent.patient | |
| Definición | 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. |
| Resumen | Paciente de los datos (un evento por paciente)The patient is the subject of the data used/created/updated/deleted during the activity |
| Control | 0..1 |
| Tipo | Reference(Paciente, Patient) |
| Es modificador | false |
| Must Support | true |
| Resumen | false |
| Requisitos | 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. |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 30. AuditEvent.agent | |
| Definición | Quiénes intervienen: siempre el sistema cliente y el sistema servidor (DICOM 110152 destino y 110153 origen, según hacia dónde van los datos: en una lectura el cliente es el destino) y, si la operación la hace una persona, el usuario (IRCP). An actor taking an active role in the event or activity that is logged. |
| Resumen | El cliente, el servidor y, si la hace una persona, el usuarioActor involved in the event |
| Comentarios | 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. |
| Control | 21..* |
| Tipo | BackboneElement |
| Es modificador | false |
| Must Support | true |
| Resumen | true |
| Requisitos | An agent can be a person, an organization, software, device, or other actors that may be ascribed responsibility. |
| Nombres alternativos | ActiveParticipant |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 32. AuditEvent.agent.modifierExtension | |
| Definición | 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). |
| Resumen | Extensions that cannot be ignored even if unrecognized |
| Comentarios | 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. |
| Control | 0..* |
| Tipo | Extension |
| Es modificador | true porque Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Resumen | true |
| Requisitos | 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. |
| Nombres alternativos | extensions, user content, modifiers |
| Invariantes | ele-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()) |
| 34. AuditEvent.agent.type | |
| Definición | The Functional Role of the user when performing the event. |
| Resumen | 110152 (destino) | 110153 (origen) | IRCP (usuario)How agent participated |
| Comentarios | For example: assembler, author, prescriber, signer, investigator, etc. |
| Control | 10..1 |
| Vinculación | Los códigos DEBEN tomarse de Los códigos DEBERÍAN tomarse de Tipo de agente de auditoríahttp://hl7.org/fhir/ValueSet/participation-role-type|5.0.0 (required to https://hl7.or.cr/fhir/terminology/ValueSet/cr-tipo-agente-auditoria) |
| Tipo | CodeableConcept |
| Es modificador | false |
| Must Support | true |
| Resumen | false |
| Requisitos | 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. |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 36. AuditEvent.agent.who | |
| Definición | Reference to who this agent is that was involved in the event. |
| Resumen | El sistema registrado en el HIE, o la persona usuariaIdentifier of who |
| Comentarios | 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. |
| Control | 1..1 |
| Tipo | Reference(Sistema de información, Rol del profesional, Profesional de salud, Paciente, Practitioner, PractitionerRole, Organization, CareTeam, Patient, Device, RelatedPerson) |
| Es modificador | false |
| Must Support | true |
| Must Support Types | No must-support rules about the choice of types/profiles |
| Resumen | true |
| Requisitos | This field ties an audit event to a specific resource or identifier. |
| Nombres alternativos | userId |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 38. AuditEvent.agent.requestor | |
| Definición | Indicator that the user is or is not the requestor, or initiator, for the event being audited. |
| Resumen | true para el usuario o, si no hay usuario, para el clienteWhether user is initiator |
| Comentarios | There can only be one initiator. If the initiator is not clear, then do not choose any one agent as the initiator. |
| Control | 0..1 |
| Tipo | boolean |
| Es modificador | false |
| Valor primitivo | Este elemento primitivo puede estar presente, ausente o reemplazado por una extensión |
| Must Support | true |
| Resumen | true |
| Requisitos | 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 Missing | false |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 40. AuditEvent.agent.policy | |
| Definición | 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. |
| Resumen | Identificador del token (jti) del usuarioPolicy that authorized the agent participation in the event |
| Comentarios | 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. |
| Control | 0..1* |
| Tipo | uri |
| Es modificador | false |
| Valor primitivo | Este elemento primitivo puede estar presente, ausente o reemplazado por una extensión |
| Must Support | true |
| Resumen | false |
| Requisitos | This value is used retrospectively to determine the authorization policies. |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 42. AuditEvent.agent.network[x] | |
| Definición | 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. |
| Resumen | Red: la IP o el subsistema X-Road del cliente, la URL del servidorThis agent network location for the activity |
| Comentarios | 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. |
| Control | 0..1 |
| Tipo | Elección de: Reference(Endpoint), uri, string |
| Nota sobre [x] | VeaElección de tipos de datospara más información sobre cómo usar [x] |
| Es modificador | false |
| Valor primitivo | Este elemento primitivo puede estar presente, ausente o reemplazado por una extensión |
| Must Support | true |
| Must Support Types | No must-support rules about the choice of types/profiles |
| Resumen | false |
| Requisitos | 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). |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 44. AuditEvent.source | |
| Definición | The actor that is reporting the event. |
| Resumen | Quién registró el eventoAudit Event Reporter |
| Comentarios | 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. |
| Control | 1..1 |
| Tipo | BackboneElement |
| Es modificador | false |
| Must Support | true |
| Resumen | true |
| Requisitos | The event is reported by one source. |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 46. AuditEvent.source.modifierExtension | |
| Definición | 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). |
| Resumen | Extensions that cannot be ignored even if unrecognized |
| Comentarios | 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. |
| Control | 0..* |
| Tipo | Extension |
| Es modificador | true porque Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Resumen | true |
| Requisitos | 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. |
| Nombres alternativos | extensions, user content, modifiers |
| Invariantes | ele-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()) |
| 48. AuditEvent.source.observer | |
| Definición | Identifier of the source where the event was detected. |
| Resumen | El sistema que registró el eventoThe identity of source detecting the event |
| Control | 1..1 |
| Tipo | Reference(Sistema de información, Practitioner, PractitionerRole, Organization, CareTeam, Patient, Device, RelatedPerson) |
| Es modificador | false |
| Must Support | false |
| Resumen | true |
| Requisitos | 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. |
| Nombres alternativos | SourceId |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 50. AuditEvent.source.type | |
| Definición | Code specifying the type of source where event originated. |
| Resumen | Tipo de la fuente (4: servidor de aplicaciones)The type of source where event originated |
| Control | 10..1* |
| Vinculación | Los códigos DEBEN tomarse de Los códigos DEBERÍAN tomarse de AuditEventSourceTypehttp://hl7.org/fhir/ValueSet/security-source-type|5.0.0 (required to http://hl7.org/fhir/ValueSet/security-source-type) |
| Tipo | CodeableConcept |
| Es modificador | false |
| Must Support | true |
| Resumen | false |
| Requisitos | 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. |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 52. AuditEvent.entity | |
| Definición | Specific instances of data or objects that have been accessed. |
| Resumen | El paciente, los datos, la consulta y la transacciónData or objects used |
| Comentarios | 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. |
| Control | 0..* |
| Tipo | BackboneElement |
| Es modificador | false |
| Must Support | true |
| Resumen | true |
| Requisitos | The event may have other entities involved. |
| Nombres alternativos | ParticipantObject |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 54. AuditEvent.entity.modifierExtension | |
| Definición | 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). |
| Resumen | Extensions that cannot be ignored even if unrecognized |
| Comentarios | 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. |
| Control | 0..* |
| Tipo | Extension |
| Es modificador | true porque Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Resumen | true |
| Requisitos | 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. |
| Nombres alternativos | extensions, user content, modifiers |
| Invariantes | ele-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()) |
| 56. AuditEvent.entity.what | |
| Definición | Identifies a specific instance of the entity. The reference should be version specific. This is allowed to be a Parameters resource. |
| Resumen | El recurso (la versión concreta si se conoce) o el identificador de la transacciónSpecific instance of resource |
| Comentarios | Use .what.display when all you have is a string (e.g. ParticipantObjectName). |
| Control | 0..1 |
| Tipo | Reference(Resource) |
| Es modificador | false |
| Must Support | true |
| Resumen | true |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 58. AuditEvent.entity.role | |
| Definición | Code representing the role the entity played in the event being audited. |
| Resumen | 1 (paciente) | 4 (datos) | 24 (consulta); sin role, la transacciónWhat role the entity played |
| Control | 0..1 |
| Vinculación | Los códigos DEBEN tomarse de Para códigos de ejemplo, vea AuditEventEntityRolehttp://hl7.org/fhir/ValueSet/object-role|5.0.0 (required to http://hl7.org/fhir/ValueSet/object-role) |
| Tipo | CodeableConcept |
| Es modificador | false |
| Must Support | true |
| Resumen | false |
| Requisitos | For some detailed audit analysis it may be necessary to indicate a more granular type of entity, based on the application role it serves. |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 60. AuditEvent.entity.securityLabel | |
| Definición | Security labels for the identified entity. |
| Resumen | Las etiquetas de seguridad del recursoSecurity labels on the entity |
| Comentarios | Copied from entity meta security tags. |
| Control | 0..* |
| Vinculación | Para códigos de ejemplo, vea SecurityLabelExampleshttp://hl7.org/fhir/ValueSet/security-label-examples|5.0.0 (example to http://hl7.org/fhir/ValueSet/security-label-examples|5.0.0)Example Security Labels from the Healthcare Privacy and Security Classification System. |
| Tipo | CodeableConcept |
| Es modificador | false |
| Must Support | true |
| Resumen | false |
| Requisitos | This field identifies the security labels for a specific instance of an object, such as a patient, to detect/track privacy and security issues. |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 62. AuditEvent.entity.query | |
| Definición | The query parameters for a query-type entities. |
| Resumen | La consulta, en base64 (solo en la entidad consulta)Query parameters |
| Comentarios | 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. |
| Control | 0..1 |
| Tipo | base64Binary |
| Es modificador | false |
| Valor primitivo | Este elemento primitivo puede estar presente, ausente o reemplazado por una extensión |
| Must Support | true |
| Resumen | true |
| Requisitos | 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. |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
Las indicaciones para interpretar el contenido de esta tabla estánaquí
| 0. AuditEvent | |
| Definición | Registro de un acceso u operación sobre datos en el HIE: quién lo hizo, desde qué sistema, con qué propósito, sobre qué datos de qué paciente y con qué resultado, incluidos los intentos fallidos. |
| Resumen | Evento de auditoría: quién accedió a qué y con qué resultado |
| Invariantes | cr-auditoria-rest: Un evento rest lleva el código de la interacción REST. (category.coding.where(code = 'rest').exists() implies code.coding.where(system = 'http://hl7.org/fhir/restful-interaction').exists())cr-auditoria-accion: La acción es coherente con la interacción: las lecturas, búsquedas e historias son R; create es C; update y patch son U; delete es D; las demás son E. ( code.coding.where(system = 'http://hl7.org/fhir/restful-interaction').all(iif(code in ('read' | 'vread' | 'search' | 'search-type' | 'search-system' | 'history' | 'history-instance' | 'history-type' | 'history-system'), %resource.action = 'R', iif(code = 'create', %resource.action = 'C', iif(code in ('update' | 'patch'), %resource.action = 'U', iif(code = 'delete', %resource.action = 'D', %resource.action = 'E'))))))cr-auditoria-detalle: Un resultado que no es success lleva su detalle. ( outcome.code.code != 'success' implies outcome.detail.exists())cr-auditoria-proposito: Un evento con datos de un paciente indica el propósito de uso. ( patient.exists() implies authorization.exists())cr-auditoria-agentes: El evento lleva un agente cliente y un agente servidor (DICOM 110152 y 110153). ( agent.where(type.coding.where(system = 'http://dicom.nema.org/resources/ontology/DCM' and code = '110152').exists()).exists() and agent.where(type.coding.where(system = 'http://dicom.nema.org/resources/ontology/DCM' and code = '110153').exists()).exists())cr-auditoria-red: El cliente y el servidor indican su red (dirección IP, subsistema X-Road o URL). ( agent.where(type.coding.where(code = '110153' or code = '110152').exists()).all(network.exists()))cr-auditoria-solicitante: Hay un solo solicitante (requestor = true): el usuario o, si no hay usuario, el cliente. ( agent.where(requestor = true).count() = 1)cr-auditoria-paciente: El paciente del evento va también como entidad con role 1 (Patient), como en IHE BALP. ( patient.exists() implies entity.where(role.coding.where(system = 'http://terminology.hl7.org/CodeSystem/object-role' and code = '1').exists()).exists())cr-auditoria-entidades: Cada entidad indica el recurso (what), salvo la consulta (role 24), que indica la consulta (query). ( entity.all(iif(role.coding.where(code = '24').exists(), query.exists(), what.exists())))cr-auditoria-fechas: La fecha del evento no es posterior a la fecha de registro. ( occurred.ofType(dateTime).empty() or occurred.ofType(dateTime) <= recorded) |
| 2. AuditEvent.category | |
| Resumen | Categoría: rest | 110114 (autenticación) | 110113 (alerta de seguridad) |
| Control | 1..1 |
| Vinculación | Los códigos DEBEN tomarse de Categoría del evento de auditoría (required to https://hl7.or.cr/fhir/terminology/ValueSet/cr-categoria-auditoria) |
| Must Support | true |
| 4. AuditEvent.code | |
| Resumen | Qué se hizo: la interacción REST (read, search, create...) o el evento de DICOM |
| Must Support | true |
| 6. AuditEvent.action | |
| Resumen | C | R | U | D | E, coherente con el código |
| Control | 1..? |
| Must Support | true |
| 8. AuditEvent.occurred[x] | |
| Resumen | Cuándo ocurrió el evento (no posterior al registro) |
| Tipo | dateTime, Period |
| Nota sobre [x] | VeaElección de tipos de datospara más información sobre cómo usar [x] |
| Valor primitivo | Este elemento primitivo puede estar presente, ausente o reemplazado por una extensión |
| Must Support | true |
| Invariantes | cr-documento-fecha-hora: La fecha lleva fecha y hora, no solo la fecha. (toString().contains('T')) |
| 10. AuditEvent.recorded | |
| Resumen | Cuándo se registró el evento |
| Must Support | true |
| 12. AuditEvent.outcome | |
| Resumen | Resultado del evento, también en los fallos |
| Control | 1..? |
| Must Support | true |
| 14. AuditEvent.outcome.code | |
| Resumen | success | warning | error | fatal |
| Vinculación | Los códigos DEBEN tomarse de AuditEventOutcome (required to http://hl7.org/fhir/ValueSet/audit-event-outcome) |
| Must Support | true |
| 16. AuditEvent.outcome.detail | |
| Resumen | Detalle (código HTTP y texto), sin datos clínicos |
| Must Support | true |
| 18. AuditEvent.authorization | |
| Resumen | Propósito de uso: TREAT | ETREAT | COC | PATRQT | PUBHLTH | HRESCH | HOPERAT | HSYSADMIN | HLEGAL |
| Control | 0..1 |
| Vinculación | Los códigos DEBEN tomarse de Propósito de uso (required to https://hl7.or.cr/fhir/terminology/ValueSet/cr-proposito-uso) |
| Must Support | true |
| 20. AuditEvent.patient | |
| Resumen | Paciente de los datos (un evento por paciente) |
| Tipo | Reference(Paciente) |
| Must Support | true |
| 22. AuditEvent.agent | |
| Definición | Quiénes intervienen: siempre el sistema cliente y el sistema servidor (DICOM 110152 destino y 110153 origen, según hacia dónde van los datos: en una lectura el cliente es el destino) y, si la operación la hace una persona, el usuario (IRCP). |
| Resumen | El cliente, el servidor y, si la hace una persona, el usuario |
| Control | 2..? |
| Must Support | true |
| 24. AuditEvent.agent.type | |
| Resumen | 110152 (destino) | 110153 (origen) | IRCP (usuario) |
| Control | 1..? |
| Vinculación | Los códigos DEBEN tomarse de Tipo de agente de auditoría (required to https://hl7.or.cr/fhir/terminology/ValueSet/cr-tipo-agente-auditoria) |
| Must Support | true |
| 26. AuditEvent.agent.who | |
| Resumen | El sistema registrado en el HIE, o la persona usuaria |
| Tipo | Reference(Sistema de información, Rol del profesional, Profesional de salud, Paciente) |
| Must Support | true |
| Must Support Types | No must-support rules about the choice of types/profiles |
| 28. AuditEvent.agent.requestor | |
| Resumen | true para el usuario o, si no hay usuario, para el cliente |
| Must Support | true |
| 30. AuditEvent.agent.policy | |
| Resumen | Identificador del token (jti) del usuario |
| Control | 0..1 |
| Must Support | true |
| 32. AuditEvent.agent.network[x] | |
| Resumen | Red: la IP o el subsistema X-Road del cliente, la URL del servidor |
| Nota sobre [x] | VeaElección de tipos de datospara más información sobre cómo usar [x] |
| Must Support | true |
| 34. AuditEvent.source | |
| Resumen | Quién registró el evento |
| Must Support | true |
| 36. AuditEvent.source.observer | |
| Resumen | El sistema que registró el evento |
| Tipo | Reference(Sistema de información) |
| 38. AuditEvent.source.type | |
| Resumen | Tipo de la fuente (4: servidor de aplicaciones) |
| Control | 1..1 |
| Vinculación | Los códigos DEBEN tomarse de AuditEventSourceType (required to http://hl7.org/fhir/ValueSet/security-source-type) |
| Must Support | true |
| 40. AuditEvent.entity | |
| Resumen | El paciente, los datos, la consulta y la transacción |
| Must Support | true |
| 42. AuditEvent.entity.what | |
| Resumen | El recurso (la versión concreta si se conoce) o el identificador de la transacción |
| Must Support | true |
| 44. AuditEvent.entity.role | |
| Resumen | 1 (paciente) | 4 (datos) | 24 (consulta); sin role, la transacción |
| Vinculación | Los códigos DEBEN tomarse de AuditEventEntityRole (required to http://hl7.org/fhir/ValueSet/object-role) |
| Must Support | true |
| 46. AuditEvent.entity.securityLabel | |
| Resumen | Las etiquetas de seguridad del recurso |
| Must Support | true |
| 48. AuditEvent.entity.query | |
| Resumen | La consulta, en base64 (solo en la entidad consulta) |
| Must Support | true |
Las indicaciones para interpretar el contenido de esta tabla estánaquí
| 0. AuditEvent | |
| Definición | Registro de un acceso u operación sobre datos en el HIE: quién lo hizo, desde qué sistema, con qué propósito, sobre qué datos de qué paciente y con qué resultado, incluidos los intentos fallidos. |
| Resumen | Evento de auditoría: quién accedió a qué y con qué resultado |
| Comentarios | Based on IHE-ATNA. |
| Control | 0..* |
| Es modificador | false |
| Must Support | false |
| Resumen | false |
| Invariantes | dom-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())cr-auditoria-rest: Un evento rest lleva el código de la interacción REST. ( category.coding.where(code = 'rest').exists() implies code.coding.where(system = 'http://hl7.org/fhir/restful-interaction').exists())cr-auditoria-accion: La acción es coherente con la interacción: las lecturas, búsquedas e historias son R; create es C; update y patch son U; delete es D; las demás son E. ( code.coding.where(system = 'http://hl7.org/fhir/restful-interaction').all(iif(code in ('read' | 'vread' | 'search' | 'search-type' | 'search-system' | 'history' | 'history-instance' | 'history-type' | 'history-system'), %resource.action = 'R', iif(code = 'create', %resource.action = 'C', iif(code in ('update' | 'patch'), %resource.action = 'U', iif(code = 'delete', %resource.action = 'D', %resource.action = 'E'))))))cr-auditoria-detalle: Un resultado que no es success lleva su detalle. ( outcome.code.code != 'success' implies outcome.detail.exists())cr-auditoria-proposito: Un evento con datos de un paciente indica el propósito de uso. ( patient.exists() implies authorization.exists())cr-auditoria-agentes: El evento lleva un agente cliente y un agente servidor (DICOM 110152 y 110153). ( agent.where(type.coding.where(system = 'http://dicom.nema.org/resources/ontology/DCM' and code = '110152').exists()).exists() and agent.where(type.coding.where(system = 'http://dicom.nema.org/resources/ontology/DCM' and code = '110153').exists()).exists())cr-auditoria-red: El cliente y el servidor indican su red (dirección IP, subsistema X-Road o URL). ( agent.where(type.coding.where(code = '110153' or code = '110152').exists()).all(network.exists()))cr-auditoria-solicitante: Hay un solo solicitante (requestor = true): el usuario o, si no hay usuario, el cliente. ( agent.where(requestor = true).count() = 1)cr-auditoria-paciente: El paciente del evento va también como entidad con role 1 (Patient), como en IHE BALP. ( patient.exists() implies entity.where(role.coding.where(system = 'http://terminology.hl7.org/CodeSystem/object-role' and code = '1').exists()).exists())cr-auditoria-entidades: Cada entidad indica el recurso (what), salvo la consulta (role 24), que indica la consulta (query). ( entity.all(iif(role.coding.where(code = '24').exists(), query.exists(), what.exists())))cr-auditoria-fechas: La fecha del evento no es posterior a la fecha de registro. ( occurred.ofType(dateTime).empty() or occurred.ofType(dateTime) <= recorded) |
| 2. AuditEvent.id | |
| Definición | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. |
| Resumen | Logical id of this artifact |
| Comentarios | 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. |
| Control | 0..1 |
| Tipo | id |
| Es modificador | false |
| Must Support | false |
| Resumen | true |
| 4. AuditEvent.meta | |
| Definición | 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. |
| Resumen | Metadata about the resource |
| Control | 0..1 |
| Tipo | Meta |
| Es modificador | false |
| Must Support | false |
| Resumen | true |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 6. AuditEvent.implicitRules | |
| Definición | 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. |
| Resumen | A set of rules under which this content was created |
| Comentarios | 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. |
| Control | 0..1 |
| Tipo | uri |
| Es modificador | true porque This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation |
| Valor primitivo | Este elemento primitivo puede estar presente, ausente o reemplazado por una extensión |
| Must Support | false |
| Resumen | true |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 8. AuditEvent.language | |
| Definición | The base language in which the resource is written. |
| Resumen | Language of the resource content |
| Comentarios | 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). |
| Control | 0..1 |
| Vinculación | Los códigos DEBEN tomarse de AllLanguages (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)IETF language tag for a human language |
| Tipo | code |
| Es modificador | false |
| Valor primitivo | Este elemento primitivo puede estar presente, ausente o reemplazado por una extensión |
| Must Support | false |
| Resumen | false |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 10. AuditEvent.text | |
| Definición | 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. |
| Resumen | Text summary of the resource, for human interpretation |
| Comentarios | 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. |
| Control | 0..1 Este elemento está afectado por las siguientes invariantes: dom-6 |
| Tipo | Narrative |
| Es modificador | false |
| Must Support | false |
| Resumen | false |
| Nombres alternativos | narrative, html, xhtml, display |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 12. AuditEvent.contained | |
| Definición | 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. |
| Resumen | Contained, inline Resources |
| Comentarios | 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. |
| Control | 0..* Este elemento está afectado por las siguientes invariantes: dom-2, dom-4, dom-3, dom-5 |
| Tipo | Resource |
| Es modificador | false |
| Must Support | false |
| Resumen | false |
| Nombres alternativos | inline resources, anonymous resources, contained resources |
| 14. AuditEvent.extension | |
| Definición | 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. |
| Resumen | Additional content defined by implementations |
| Comentarios | 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. |
| Control | 0..* |
| Tipo | Extension |
| Es modificador | false |
| Must Support | false |
| Resumen | false |
| Nombres alternativos | extensions, user content |
| Invariantes | ele-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 | |
| Definición | 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). |
| Resumen | Extensions that cannot be ignored |
| Comentarios | 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. |
| Control | 0..* |
| Tipo | Extension |
| Es modificador | true porque Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them |
| Must Support | false |
| Resumen | true |
| Requisitos | 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. |
| Nombres alternativos | extensions, user content |
| Invariantes | ele-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 | |
| Definición | Classification of the type of event. |
| Resumen | Categoría: rest | 110114 (autenticación) | 110113 (alerta de seguridad) |
| Control | 1..1 |
| Vinculación | Los códigos DEBEN tomarse de Categoría del evento de auditoría (required to https://hl7.or.cr/fhir/terminology/ValueSet/cr-categoria-auditoria) |
| Tipo | CodeableConcept |
| Es modificador | false |
| Must Support | true |
| Resumen | true |
| Requisitos | Codes that classify the general type of event that happened. |
| Nombres alternativos | type |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 20. AuditEvent.code | |
| Definición | Describes what happened. The most specific code for the event. |
| Resumen | Qué se hizo: la interacción REST (read, search, create...) o el evento de DICOM |
| Control | 1..1 |
| Vinculación | Para códigos de ejemplo, vea AuditEventSubType (example to http://hl7.org/fhir/ValueSet/audit-event-sub-type|5.0.0)Specific type of event. |
| Tipo | CodeableConcept |
| Es modificador | false |
| Must Support | true |
| Resumen | true |
| Requisitos | This field enables queries of messages by implementation-defined event categories. |
| Nombres alternativos | subtype |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 22. AuditEvent.action | |
| Definición | Indicator for type of action performed during the event that generated the audit. |
| Resumen | C | R | U | D | E, coherente con el código |
| Control | 1..1 |
| Vinculación | Los códigos DEBEN tomarse de AuditEventAction (required to http://hl7.org/fhir/ValueSet/audit-event-action|5.0.0)DICOM Audit Event Action |
| Tipo | code |
| Es modificador | false |
| Valor primitivo | Este elemento primitivo puede estar presente, ausente o reemplazado por una extensión |
| Must Support | true |
| Resumen | true |
| Requisitos | This broadly indicates what kind of action was done on the AuditEvent.entity by the AuditEvent.agent. |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 24. AuditEvent.severity | |
| Definición | Indicates and enables segmentation of various severity including debugging from critical. |
| Resumen | emergency | alert | critical | error | warning | notice | informational | debug |
| Comentarios | ATNA will map this to the SYSLOG PRI element. |
| Control | 0..1 |
| Vinculación | Los códigos DEBEN tomarse de 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 |
| Tipo | code |
| Es modificador | false |
| Valor primitivo | Este elemento primitivo puede estar presente, ausente o reemplazado por una extensión |
| Must Support | false |
| Resumen | true |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 26. AuditEvent.occurred[x] | |
| Definición | The time or period during which the activity occurred. |
| Resumen | Cuándo ocurrió el evento (no posterior al registro) |
| Comentarios | The time or period can be a little arbitrary; where possible, the time should correspond to human assessment of the activity time. |
| Control | 0..1 |
| Tipo | dateTime |
| Nota sobre [x] | VeaElección de tipos de datospara más información sobre cómo usar [x] |
| Es modificador | false |
| Valor primitivo | Este elemento primitivo puede estar presente, ausente o reemplazado por una extensión |
| Must Support | true |
| Resumen | false |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))cr-documento-fecha-hora: La fecha lleva fecha y hora, no solo la fecha. ( toString().contains('T')) |
| 28. AuditEvent.recorded | |
| Definición | The time when the event was recorded. |
| Resumen | Cuándo se registró el evento |
| Comentarios | In a distributed system, some sort of common time base (e.g. an NTP [RFC1305] server) is a good implementation tactic. |
| Control | 1..1 |
| Tipo | instant |
| Es modificador | false |
| Valor primitivo | Este elemento primitivo puede estar presente, ausente o reemplazado por una extensión |
| Must Support | true |
| Resumen | true |
| Requisitos | 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. |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 30. AuditEvent.outcome | |
| Definición | Indicates whether the event succeeded or failed. A free text descripiton can be given in outcome.text. |
| Resumen | Resultado del evento, también en los fallos |
| Comentarios | 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. |
| Control | 1..1 |
| Tipo | BackboneElement |
| Es modificador | false |
| Must Support | true |
| Resumen | true |
| Requisitos | 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). |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 32. AuditEvent.outcome.id | |
| Definición | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Resumen | Unique id for inter-element referencing |
| Control | 0..1 Este elemento está afectado por las siguientes invariantes: ele-1 |
| Tipo | string |
| Es modificador | false |
| Formato XML | En el formato XML, esta propiedad se representa como un atributo. |
| Resumen | false |
| 34. AuditEvent.outcome.extension | |
| Definición | 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. |
| Resumen | Additional content defined by implementations |
| Comentarios | 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. |
| Control | 0..* |
| Tipo | Extension |
| Es modificador | false |
| Resumen | false |
| Nombres alternativos | extensions, user content |
| Invariantes | ele-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()) |
| 36. AuditEvent.outcome.modifierExtension | |
| Definición | 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). |
| Resumen | Extensions that cannot be ignored even if unrecognized |
| Comentarios | 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. |
| Control | 0..* |
| Tipo | Extension |
| Es modificador | true porque Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Resumen | true |
| Requisitos | 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. |
| Nombres alternativos | extensions, user content, modifiers |
| Invariantes | ele-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.code | |
| Definición | Indicates whether the event succeeded or failed. |
| Resumen | success | warning | error | fatal |
| Comentarios | 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. |
| Control | 1..1 |
| Vinculación | Los códigos DEBEN tomarse de AuditEventOutcome (required to http://hl7.org/fhir/ValueSet/audit-event-outcome) |
| Tipo | Coding |
| Es modificador | false |
| Must Support | true |
| Resumen | true |
| Requisitos | when a code is given there must be one code from the given codeSystem. |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 40. AuditEvent.outcome.detail | |
| Definición | Additional details about the error. This may be a text description of the error or a system code that identifies the error. |
| Resumen | Detalle (código HTTP y texto), sin datos clínicos |
| Comentarios | A human readable description of the error issue SHOULD be placed in details.text. |
| Control | 0..* |
| Vinculación | Para códigos de ejemplo, vea AuditEventOutcomeDetail (example to http://hl7.org/fhir/ValueSet/audit-event-outcome-detail|5.0.0)A code that provides details as the exact issue. |
| Tipo | CodeableConcept |
| Es modificador | false |
| Must Support | true |
| Resumen | true |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 42. AuditEvent.authorization | |
| Definición | The authorization (e.g., PurposeOfUse) that was used during the event being recorded. |
| Resumen | Propósito de uso: TREAT | ETREAT | COC | PATRQT | PUBHLTH | HRESCH | HOPERAT | HSYSADMIN | HLEGAL |
| Comentarios | 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. |
| Control | 0..1 |
| Vinculación | Los códigos DEBEN tomarse de Propósito de uso (required to https://hl7.or.cr/fhir/terminology/ValueSet/cr-proposito-uso) |
| Tipo | CodeableConcept |
| Es modificador | false |
| Must Support | true |
| Resumen | true |
| Requisitos | Record of any relevant security context, not restricted to purposeOfUse valueSet. May include security compartments, refrain, obligation, or other security tags. |
| Nombres alternativos | PurposeOfEvent |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 44. AuditEvent.basedOn | |
| Definición | Allows tracing of authorizatino for the events and tracking whether proposals/recommendations were acted upon. |
| Resumen | Workflow authorization within which this event occurred |
| Control | 0..* |
| Tipo | Reference(CarePlan, DeviceRequest, ImmunizationRecommendation, MedicationRequest, NutritionOrder, ServiceRequest, Task) |
| Es modificador | false |
| Must Support | false |
| Resumen | false |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 46. AuditEvent.patient | |
| Definición | 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. |
| Resumen | Paciente de los datos (un evento por paciente) |
| Control | 0..1 |
| Tipo | Reference(Paciente) |
| Es modificador | false |
| Must Support | true |
| Resumen | false |
| Requisitos | 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. |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 48. AuditEvent.encounter | |
| Definición | 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). |
| Resumen | Encounter within which this event occurred or which the event is tightly associated |
| Control | 0..1 |
| Tipo | Reference(Encounter) |
| Es modificador | false |
| Must Support | false |
| Resumen | false |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 50. AuditEvent.agent | |
| Definición | Quiénes intervienen: siempre el sistema cliente y el sistema servidor (DICOM 110152 destino y 110153 origen, según hacia dónde van los datos: en una lectura el cliente es el destino) y, si la operación la hace una persona, el usuario (IRCP). |
| Resumen | El cliente, el servidor y, si la hace una persona, el usuario |
| Comentarios | 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. |
| Control | 2..* |
| Tipo | BackboneElement |
| Es modificador | false |
| Must Support | true |
| Resumen | true |
| Requisitos | An agent can be a person, an organization, software, device, or other actors that may be ascribed responsibility. |
| Nombres alternativos | ActiveParticipant |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 52. AuditEvent.agent.id | |
| Definición | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Resumen | Unique id for inter-element referencing |
| Control | 0..1 Este elemento está afectado por las siguientes invariantes: ele-1 |
| Tipo | string |
| Es modificador | false |
| Formato XML | En el formato XML, esta propiedad se representa como un atributo. |
| Resumen | false |
| 54. AuditEvent.agent.extension | |
| Definición | 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. |
| Resumen | Additional content defined by implementations |
| Comentarios | 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. |
| Control | 0..* |
| Tipo | Extension |
| Es modificador | false |
| Resumen | false |
| Nombres alternativos | extensions, user content |
| Invariantes | ele-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()) |
| 56. AuditEvent.agent.modifierExtension | |
| Definición | 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). |
| Resumen | Extensions that cannot be ignored even if unrecognized |
| Comentarios | 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. |
| Control | 0..* |
| Tipo | Extension |
| Es modificador | true porque Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Resumen | true |
| Requisitos | 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. |
| Nombres alternativos | extensions, user content, modifiers |
| Invariantes | ele-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.type | |
| Definición | The Functional Role of the user when performing the event. |
| Resumen | 110152 (destino) | 110153 (origen) | IRCP (usuario) |
| Comentarios | For example: assembler, author, prescriber, signer, investigator, etc. |
| Control | 1..1 |
| Vinculación | Los códigos DEBEN tomarse de Tipo de agente de auditoría (required to https://hl7.or.cr/fhir/terminology/ValueSet/cr-tipo-agente-auditoria) |
| Tipo | CodeableConcept |
| Es modificador | false |
| Must Support | true |
| Resumen | false |
| Requisitos | 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. |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 60. AuditEvent.agent.role | |
| Definición | The structural roles of the agent indicating the agent's competency. The security role enabling the agent with respect to the activity. |
| Resumen | Agent role in the event |
| Comentarios | For example: Chief-of-Radiology, Nurse, Physician, Medical-Student, etc. |
| Control | 0..* |
| Vinculación | Para códigos de ejemplo, vea SecurityRoleType (example to http://hl7.org/fhir/ValueSet/security-role-type|5.0.0)What security role enabled the agent to participate in the event. |
| Tipo | CodeableConcept |
| Es modificador | false |
| Must Support | false |
| Resumen | false |
| Requisitos | 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.. |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 62. AuditEvent.agent.who | |
| Definición | Reference to who this agent is that was involved in the event. |
| Resumen | El sistema registrado en el HIE, o la persona usuaria |
| Comentarios | 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. |
| Control | 1..1 |
| Tipo | Reference(Sistema de información, Rol del profesional, Profesional de salud, Paciente) |
| Es modificador | false |
| Must Support | true |
| Must Support Types | No must-support rules about the choice of types/profiles |
| Resumen | true |
| Requisitos | This field ties an audit event to a specific resource or identifier. |
| Nombres alternativos | userId |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 64. AuditEvent.agent.requestor | |
| Definición | Indicator that the user is or is not the requestor, or initiator, for the event being audited. |
| Resumen | true para el usuario o, si no hay usuario, para el cliente |
| Comentarios | There can only be one initiator. If the initiator is not clear, then do not choose any one agent as the initiator. |
| Control | 0..1 |
| Tipo | boolean |
| Es modificador | false |
| Valor primitivo | Este elemento primitivo puede estar presente, ausente o reemplazado por una extensión |
| Must Support | true |
| Resumen | true |
| Requisitos | 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 Missing | false |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 66. AuditEvent.agent.location | |
| Definición | Where the agent location is known, the agent location when the event occurred. |
| Resumen | The agent location when the event occurred |
| Control | 0..1 |
| Tipo | Reference(Location) |
| Es modificador | false |
| Must Support | false |
| Resumen | false |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 68. AuditEvent.agent.policy | |
| Definición | 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. |
| Resumen | Identificador del token (jti) del usuario |
| Comentarios | 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. |
| Control | 0..1 |
| Tipo | uri |
| Es modificador | false |
| Valor primitivo | Este elemento primitivo puede estar presente, ausente o reemplazado por una extensión |
| Must Support | true |
| Resumen | false |
| Requisitos | This value is used retrospectively to determine the authorization policies. |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 70. AuditEvent.agent.network[x] | |
| Definición | 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. |
| Resumen | Red: la IP o el subsistema X-Road del cliente, la URL del servidor |
| Comentarios | 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. |
| Control | 0..1 |
| Tipo | Elección de: Reference(Endpoint), uri, string |
| Nota sobre [x] | VeaElección de tipos de datospara más información sobre cómo usar [x] |
| Es modificador | false |
| Valor primitivo | Este elemento primitivo puede estar presente, ausente o reemplazado por una extensión |
| Must Support | true |
| Must Support Types | No must-support rules about the choice of types/profiles |
| Resumen | false |
| Requisitos | 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). |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 72. AuditEvent.agent.authorization | |
| Definición | The authorization (e.g., PurposeOfUse) that was used during the event being recorded. |
| Resumen | Allowable authorization for this agent |
| Comentarios | 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. |
| Control | 0..* |
| Vinculación | Para códigos de ejemplo, vea PurposeOfUse (example to http://terminology.hl7.org/ValueSet/v3-PurposeOfUse)The reason the activity took place. |
| Tipo | CodeableConcept |
| Es modificador | false |
| Must Support | false |
| Resumen | false |
| Requisitos | Record of any relevant security context, not restricted to purposeOfUse valueSet. May include security compartments, refrain, obligation, or other security tags. |
| Nombres alternativos | PurposeOfUse |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 74. AuditEvent.source | |
| Definición | The actor that is reporting the event. |
| Resumen | Quién registró el evento |
| Comentarios | 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. |
| Control | 1..1 |
| Tipo | BackboneElement |
| Es modificador | false |
| Must Support | true |
| Resumen | true |
| Requisitos | The event is reported by one source. |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 76. AuditEvent.source.id | |
| Definición | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Resumen | Unique id for inter-element referencing |
| Control | 0..1 Este elemento está afectado por las siguientes invariantes: ele-1 |
| Tipo | string |
| Es modificador | false |
| Formato XML | En el formato XML, esta propiedad se representa como un atributo. |
| Resumen | false |
| 78. AuditEvent.source.extension | |
| Definición | 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. |
| Resumen | Additional content defined by implementations |
| Comentarios | 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. |
| Control | 0..* |
| Tipo | Extension |
| Es modificador | false |
| Resumen | false |
| Nombres alternativos | extensions, user content |
| Invariantes | ele-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()) |
| 80. AuditEvent.source.modifierExtension | |
| Definición | 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). |
| Resumen | Extensions that cannot be ignored even if unrecognized |
| Comentarios | 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. |
| Control | 0..* |
| Tipo | Extension |
| Es modificador | true porque Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Resumen | true |
| Requisitos | 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. |
| Nombres alternativos | extensions, user content, modifiers |
| Invariantes | ele-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.site | |
| Definición | Logical source location within the healthcare enterprise network. For example, a hospital or other provider location within a multi-entity provider group. |
| Resumen | Logical source location within the enterprise |
| Control | 0..1 |
| Tipo | Reference(Location) |
| Es modificador | false |
| Must Support | false |
| Resumen | false |
| Requisitos | This value differentiates among the sites in a multi-site enterprise health information system. |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 84. AuditEvent.source.observer | |
| Definición | Identifier of the source where the event was detected. |
| Resumen | El sistema que registró el evento |
| Control | 1..1 |
| Tipo | Reference(Sistema de información) |
| Es modificador | false |
| Must Support | false |
| Resumen | true |
| Requisitos | 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. |
| Nombres alternativos | SourceId |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 86. AuditEvent.source.type | |
| Definición | Code specifying the type of source where event originated. |
| Resumen | Tipo de la fuente (4: servidor de aplicaciones) |
| Control | 1..1 |
| Vinculación | Los códigos DEBEN tomarse de AuditEventSourceType (required to http://hl7.org/fhir/ValueSet/security-source-type) |
| Tipo | CodeableConcept |
| Es modificador | false |
| Must Support | true |
| Resumen | false |
| Requisitos | 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. |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 88. AuditEvent.entity | |
| Definición | Specific instances of data or objects that have been accessed. |
| Resumen | El paciente, los datos, la consulta y la transacción |
| Comentarios | 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. |
| Control | 0..* |
| Tipo | BackboneElement |
| Es modificador | false |
| Must Support | true |
| Resumen | true |
| Requisitos | The event may have other entities involved. |
| Nombres alternativos | ParticipantObject |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 90. AuditEvent.entity.id | |
| Definición | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Resumen | Unique id for inter-element referencing |
| Control | 0..1 Este elemento está afectado por las siguientes invariantes: ele-1 |
| Tipo | string |
| Es modificador | false |
| Formato XML | En el formato XML, esta propiedad se representa como un atributo. |
| Resumen | false |
| 92. AuditEvent.entity.extension | |
| Definición | 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. |
| Resumen | Additional content defined by implementations |
| Comentarios | 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. |
| Control | 0..* |
| Tipo | Extension |
| Es modificador | false |
| Resumen | false |
| Nombres alternativos | extensions, user content |
| Invariantes | ele-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()) |
| 94. AuditEvent.entity.modifierExtension | |
| Definición | 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). |
| Resumen | Extensions that cannot be ignored even if unrecognized |
| Comentarios | 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. |
| Control | 0..* |
| Tipo | Extension |
| Es modificador | true porque Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Resumen | true |
| Requisitos | 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. |
| Nombres alternativos | extensions, user content, modifiers |
| Invariantes | ele-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.what | |
| Definición | Identifies a specific instance of the entity. The reference should be version specific. This is allowed to be a Parameters resource. |
| Resumen | El recurso (la versión concreta si se conoce) o el identificador de la transacción |
| Comentarios | Use .what.display when all you have is a string (e.g. ParticipantObjectName). |
| Control | 0..1 |
| Tipo | Reference(Resource) |
| Es modificador | false |
| Must Support | true |
| Resumen | true |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 98. AuditEvent.entity.role | |
| Definición | Code representing the role the entity played in the event being audited. |
| Resumen | 1 (paciente) | 4 (datos) | 24 (consulta); sin role, la transacción |
| Control | 0..1 |
| Vinculación | Los códigos DEBEN tomarse de AuditEventEntityRole (required to http://hl7.org/fhir/ValueSet/object-role) |
| Tipo | CodeableConcept |
| Es modificador | false |
| Must Support | true |
| Resumen | false |
| Requisitos | For some detailed audit analysis it may be necessary to indicate a more granular type of entity, based on the application role it serves. |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 100. AuditEvent.entity.securityLabel | |
| Definición | Security labels for the identified entity. |
| Resumen | Las etiquetas de seguridad del recurso |
| Comentarios | Copied from entity meta security tags. |
| Control | 0..* |
| Vinculación | Para códigos de ejemplo, vea SecurityLabelExamples (example to http://hl7.org/fhir/ValueSet/security-label-examples|5.0.0)Example Security Labels from the Healthcare Privacy and Security Classification System. |
| Tipo | CodeableConcept |
| Es modificador | false |
| Must Support | true |
| Resumen | false |
| Requisitos | This field identifies the security labels for a specific instance of an object, such as a patient, to detect/track privacy and security issues. |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 102. AuditEvent.entity.query | |
| Definición | The query parameters for a query-type entities. |
| Resumen | La consulta, en base64 (solo en la entidad consulta) |
| Comentarios | 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. |
| Control | 0..1 |
| Tipo | base64Binary |
| Es modificador | false |
| Valor primitivo | Este elemento primitivo puede estar presente, ausente o reemplazado por una extensión |
| Must Support | true |
| Resumen | true |
| Requisitos | 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. |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 104. AuditEvent.entity.detail | |
| Definición | Tagged value pairs for conveying additional information about the entity. |
| Resumen | Additional Information about the entity |
| Control | 0..* |
| Tipo | BackboneElement |
| Es modificador | false |
| Must Support | false |
| Resumen | false |
| Requisitos | Implementation-defined data about specific details of the object accessed or used. |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 106. AuditEvent.entity.detail.id | |
| Definición | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Resumen | Unique id for inter-element referencing |
| Control | 0..1 Este elemento está afectado por las siguientes invariantes: ele-1 |
| Tipo | string |
| Es modificador | false |
| Formato XML | En el formato XML, esta propiedad se representa como un atributo. |
| Resumen | false |
| 108. AuditEvent.entity.detail.extension | |
| Definición | 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. |
| Resumen | Additional content defined by implementations |
| Comentarios | 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. |
| Control | 0..* |
| Tipo | Extension |
| Es modificador | false |
| Resumen | false |
| Nombres alternativos | extensions, user content |
| Invariantes | ele-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()) |
| 110. AuditEvent.entity.detail.modifierExtension | |
| Definición | 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). |
| Resumen | Extensions that cannot be ignored even if unrecognized |
| Comentarios | 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. |
| Control | 0..* |
| Tipo | Extension |
| Es modificador | true porque Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Resumen | true |
| Requisitos | 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. |
| Nombres alternativos | extensions, user content, modifiers |
| Invariantes | ele-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.type | |
| Definición | The type of extra detail provided in the value. |
| Resumen | Name of the property |
| Control | 1..1 |
| Vinculación | Para códigos de ejemplo, vea AuditEventID (example to http://hl7.org/fhir/ValueSet/audit-event-type|5.0.0)Additional detail about an entity used in an event. |
| Tipo | CodeableConcept |
| Es modificador | false |
| Must Support | false |
| Resumen | false |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 114. AuditEvent.entity.detail.value[x] | |
| Definición | The value of the extra detail. |
| Resumen | Property value |
| Control | 1..1 |
| Tipo | Elección de: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, time, dateTime, Period, base64Binary |
| Nota sobre [x] | VeaElección de tipos de datospara más información sobre cómo usar [x] |
| Es modificador | false |
| Valor primitivo | Este elemento primitivo puede estar presente, ausente o reemplazado por una extensión |
| Must Support | false |
| Resumen | false |
| Requisitos | Should not duplicate the entity value unless absolutely necessary. |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 116. AuditEvent.entity.agent | |
| Definición | 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. |
| Resumen | Entity is attributed to this agent |
| Comentarios | 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. |
| Control | 0..* |
| Tipo | Veattp://hl7.org/fhir/StructureDefinition/AuditEvent#AuditEvent.agent |
| Es modificador | false |
| Must Support | false |
| Resumen | false |
| Invariantes | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |