HL7 Czech Imaging Report IG
0.1.0-ballot - ci-build Czechia flag

HL7 Czech Imaging Report IG, published by HL7 Czech Republic. This guide is not an authorized publication; it is the continuous build for version 0.1.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7-cz/img/ and changes regularly. See the Directory of published versions

Resource Profile: CZ_AdverseEventObligationsImg - Detailed Descriptions

Page standards status: Informative Maturity Level: 0

Definitions for the cz-adverseEvent-obl-img resource profile.

Guidance on how to interpret the contents of this table can be foundhere

0. AdverseEvent
Definition

Actual or potential/avoided event causing unintended physical injury resulting from or contributed to by medical care, a research study or other healthcare setting factors that requires additional monitoring, treatment, or hospitalization, or that results in death.

ShortMedical care, research study or other healthcare event causing physical injury
Control0..*
Is Modifierfalse
Summaryfalse
Alternate NamesAE
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. AdverseEvent.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. AdverseEvent.text
Definition

A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

ShortText summary of the resource, for human interpretation
Comments

Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

Control0..1
TypeNarrative
Is Modifierfalse
Obligations
    ObligationsActor
    SHALL:able-to-populateHdrCreator-L2
    SHALL:able-to-populateHdrCreator-L3
    SHALL:displayHdrConsumer-L2
    SHALL:displayHdrConsumer-L3
    Summaryfalse
    Alternate Namesnarrative, html, xhtml, display
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    6. AdverseEvent.modifierExtension
    Definition

    May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

    ShortExtensions that cannot be ignored
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
    Summaryfalse
    Requirements

    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

    Alternate Namesextensions, user content
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    8. AdverseEvent.actuality
    Definition

    Whether the event actually happened, or just had the potential to. Note that this is independent of whether anyone was affected or harmed or how severely.

    Shortactual | potential
    Control1..1
    BindingThe codes SHALL be taken from AdverseEventActualityhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
    (required to http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1)

    Overall nature of the adverse event, e.g. real or potential.

    Typecode
    Is Modifiertrue because This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen.
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    10. AdverseEvent.subject
    Definition

    This subject or group impacted by the event.

    ShortSubject impacted by event
    Comments

    If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject.

    Control1..1
    TypeReference(Patient, Group, Practitioner, RelatedPerson)
    Is Modifierfalse
    Summarytrue
    Requirements

    Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital.

    Alternate Namespatient
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    12. AdverseEvent.detected
    Definition

    Estimated or actual date the AdverseEvent began, in the opinion of the reporter.

    ShortWhen the event was detected
    Control0..1
    TypedateTime
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Obligations
      ObligationsActor
      SHOULD:able-to-populateHdrCreator-L2
      SHALL:able-to-populateHdrCreator-L3
      SHOULD:displayHdrConsumer-L2
      SHALL:displayHdrConsumer-L3
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      14. AdverseEvent.seriousness
      Definition

      Assessment whether this event was of real importance.

      ShortSeriousness of the event
      Control0..1
      BindingFor example codes, see AdverseEventSeriousnesshttp://hl7.org/fhir/ValueSet/adverse-event-seriousness|4.0.1
      (example to http://hl7.org/fhir/ValueSet/adverse-event-seriousness|4.0.1)

      Overall seriousness of this event for the patient.

      TypeCodeableConcept
      Is Modifierfalse
      Obligations
        ObligationsActor
        SHOULD:able-to-populateHdrCreator-L2
        SHALL:able-to-populateHdrCreator-L3
        SHOULD:displayHdrConsumer-L2
        SHALL:displayHdrConsumer-L3
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        16. AdverseEvent.suspectEntity
        Definition

        Describes the entity that is suspected to have caused the adverse event.

        ShortThe suspected agent causing the adverse event
        Control0..*
        TypeBackboneElement
        Is Modifierfalse
        Obligations
          ObligationsActor
          SHOULD:able-to-populateHdrCreator-L2
          SHALL:able-to-populateHdrCreator-L3
          SHOULD:displayHdrConsumer-L2
          SHALL:displayHdrConsumer-L3
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          18. AdverseEvent.suspectEntity.modifierExtension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

          ShortExtensions that cannot be ignored even if unrecognized
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
          Summarytrue
          Requirements

          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

          Alternate Namesextensions, user content, modifiers
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          20. AdverseEvent.suspectEntity.instance
          Definition

          Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.

          ShortRefers to the specific entity that caused the adverse event
          Control1..1
          TypeReference(Immunization, Procedure, Substance, Medication, MedicationAdministration, MedicationStatement, Device)
          Is Modifierfalse
          Summarytrue
          Alternate NamesSubstance or Medication or Device
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

          Guidance on how to interpret the contents of this table can be foundhere

          0. AdverseEvent
          2. AdverseEvent.text
          Obligations
            ObligationsActor
            SHALL:able-to-populateHdrCreator-L2
            SHALL:able-to-populateHdrCreator-L3
            SHALL:displayHdrConsumer-L2
            SHALL:displayHdrConsumer-L3
            4. AdverseEvent.detected
            Obligations
              ObligationsActor
              SHOULD:able-to-populateHdrCreator-L2
              SHALL:able-to-populateHdrCreator-L3
              SHOULD:displayHdrConsumer-L2
              SHALL:displayHdrConsumer-L3
              6. AdverseEvent.seriousness
              Obligations
                ObligationsActor
                SHOULD:able-to-populateHdrCreator-L2
                SHALL:able-to-populateHdrCreator-L3
                SHOULD:displayHdrConsumer-L2
                SHALL:displayHdrConsumer-L3
                8. AdverseEvent.suspectEntity
                Obligations
                  ObligationsActor
                  SHOULD:able-to-populateHdrCreator-L2
                  SHALL:able-to-populateHdrCreator-L3
                  SHOULD:displayHdrConsumer-L2
                  SHALL:displayHdrConsumer-L3

                  Guidance on how to interpret the contents of this table can be foundhere

                  0. AdverseEvent
                  Definition

                  Actual or potential/avoided event causing unintended physical injury resulting from or contributed to by medical care, a research study or other healthcare setting factors that requires additional monitoring, treatment, or hospitalization, or that results in death.

                  ShortMedical care, research study or other healthcare event causing physical injury
                  Control0..*
                  Is Modifierfalse
                  Summaryfalse
                  Alternate NamesAE
                  Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
                  dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
                  dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
                  dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
                  dom-6: A resource should have narrative for robust management (text.`div`.exists())
                  2. AdverseEvent.id
                  Definition

                  The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

                  ShortLogical id of this artifact
                  Comments

                  The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

                  Control0..1
                  Typeid
                  Is Modifierfalse
                  Summarytrue
                  4. AdverseEvent.meta
                  Definition

                  The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

                  ShortMetadata about the resource
                  Control0..1
                  TypeMeta
                  Is Modifierfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  6. AdverseEvent.implicitRules
                  Definition

                  A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

                  ShortA set of rules under which this content was created
                  Comments

                  Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

                  Control0..1
                  Typeuri
                  Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  8. AdverseEvent.language
                  Definition

                  The base language in which the resource is written.

                  ShortLanguage of the resource content
                  Comments

                  Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

                  Control0..1
                  BindingThe codes SHOULD be taken from CommonLanguages
                  (preferred to http://hl7.org/fhir/ValueSet/languages|4.0.1)

                  A human language.

                  Additional BindingsPurpose
                  AllLanguagesMax Binding
                  Typecode
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summaryfalse
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  10. AdverseEvent.text
                  Definition

                  A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

                  ShortText summary of the resource, for human interpretation
                  Comments

                  Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

                  Control0..1
                  TypeNarrative
                  Is Modifierfalse
                  Obligations
                    ObligationsActor
                    SHALL:able-to-populateHdrCreator-L2
                    SHALL:able-to-populateHdrCreator-L3
                    SHALL:displayHdrConsumer-L2
                    SHALL:displayHdrConsumer-L3
                    Summaryfalse
                    Alternate Namesnarrative, html, xhtml, display
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    12. AdverseEvent.contained
                    Definition

                    These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

                    ShortContained, inline Resources
                    Comments

                    This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

                    Control0..*
                    TypeResource
                    Is Modifierfalse
                    Summaryfalse
                    Alternate Namesinline resources, anonymous resources, contained resources
                    14. AdverseEvent.extension
                    Definition

                    May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                    ShortAdditional content defined by implementations
                    Comments

                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                    Control0..*
                    TypeExtension
                    Is Modifierfalse
                    Summaryfalse
                    Alternate Namesextensions, user content
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                    16. AdverseEvent.modifierExtension
                    Definition

                    May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                    ShortExtensions that cannot be ignored
                    Comments

                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                    Control0..*
                    TypeExtension
                    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
                    Summaryfalse
                    Requirements

                    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                    Alternate Namesextensions, user content
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                    18. AdverseEvent.identifier
                    Definition

                    Business identifiers assigned to this adverse event by the performer or other systems which remain constant as the resource is updated and propagates from server to server.

                    ShortBusiness identifier for the event
                    Comments

                    This is a business identifier, not a resource identifier (see discussion). It is best practice for the identifier to only appear on a single resource instance, however business practices may occasionally dictate that multiple resource instances with the same identifier can exist - possibly even with different resource types. For example, multiple Patient and a Person resource instance might share the same social insurance number.

                    NoteThis is a business identifier, not a resource identifier (see discussion)
                    Control0..1
                    TypeIdentifier
                    Is Modifierfalse
                    Summarytrue
                    Requirements

                    Allows identification of the adverse event as it is known by various participating systems and in a way that remains consistent across servers.

                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    20. AdverseEvent.actuality
                    Definition

                    Whether the event actually happened, or just had the potential to. Note that this is independent of whether anyone was affected or harmed or how severely.

                    Shortactual | potential
                    Control1..1
                    BindingThe codes SHALL be taken from AdverseEventActuality
                    (required to http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1)

                    Overall nature of the adverse event, e.g. real or potential.

                    Typecode
                    Is Modifiertrue because This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen.
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    22. AdverseEvent.category
                    Definition

                    The overall type of event, intended for search and filtering purposes.

                    Shortproduct-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
                    Control0..*
                    BindingUnless not suitable, these codes SHALL be taken from AdverseEventCategory
                    (extensible to http://hl7.org/fhir/ValueSet/adverse-event-category|4.0.1)

                    Overall categorization of the event, e.g. product-related or situational.

                    TypeCodeableConcept
                    Is Modifierfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    24. AdverseEvent.event
                    Definition

                    This element defines the specific type of event that occurred or that was prevented from occurring.

                    ShortType of the event itself in relation to the subject
                    Control0..1
                    BindingFor example codes, see SNOMEDCTClinicalFindings
                    (example to http://hl7.org/fhir/ValueSet/adverse-event-type|4.0.1)

                    Detailed type of event.

                    TypeCodeableConcept
                    Is Modifierfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    26. AdverseEvent.subject
                    Definition

                    This subject or group impacted by the event.

                    ShortSubject impacted by event
                    Comments

                    If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject.

                    Control1..1
                    TypeReference(Patient, Group, Practitioner, RelatedPerson)
                    Is Modifierfalse
                    Summarytrue
                    Requirements

                    Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital.

                    Alternate Namespatient
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    28. AdverseEvent.encounter
                    Definition

                    The Encounter during which AdverseEvent was created or to which the creation of this record is tightly associated.

                    ShortEncounter created as part of
                    Comments

                    This will typically be the encounter the event occurred within, but some activities may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter. For example, if a medication administration was considered an adverse event because it resulted in a rash, then the encounter when the medication administration was given is the context. If the patient reports the AdverseEvent during a second encounter, that second encounter is not the context.

                    Control0..1
                    TypeReference(Encounter)
                    Is Modifierfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    30. AdverseEvent.date
                    Definition

                    The date (and perhaps time) when the adverse event occurred.

                    ShortWhen the event occurred
                    Control0..1
                    TypedateTime
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    32. AdverseEvent.detected
                    Definition

                    Estimated or actual date the AdverseEvent began, in the opinion of the reporter.

                    ShortWhen the event was detected
                    Control0..1
                    TypedateTime
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Obligations
                      ObligationsActor
                      SHOULD:able-to-populateHdrCreator-L2
                      SHALL:able-to-populateHdrCreator-L3
                      SHOULD:displayHdrConsumer-L2
                      SHALL:displayHdrConsumer-L3
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      34. AdverseEvent.recordedDate
                      Definition

                      The date on which the existence of the AdverseEvent was first recorded.

                      ShortWhen the event was recorded
                      Comments

                      The recordedDate represents the date when this particular AdverseEvent record was created in the system, not the date of the most recent update. The date of the last record modification can be retrieved from the resource metadata.

                      Control0..1
                      TypedateTime
                      Is Modifierfalse
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      36. AdverseEvent.resultingCondition
                      Definition

                      Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical).

                      ShortEffect on the subject due to this event
                      Control0..*
                      TypeReference(Condition)
                      Is Modifierfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      38. AdverseEvent.location
                      Definition

                      The information about where the adverse event occurred.

                      ShortLocation where adverse event occurred
                      Control0..1
                      TypeReference(Location)
                      Is Modifierfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      40. AdverseEvent.seriousness
                      Definition

                      Assessment whether this event was of real importance.

                      ShortSeriousness of the event
                      Control0..1
                      BindingFor example codes, see AdverseEventSeriousness
                      (example to http://hl7.org/fhir/ValueSet/adverse-event-seriousness|4.0.1)

                      Overall seriousness of this event for the patient.

                      TypeCodeableConcept
                      Is Modifierfalse
                      Obligations
                        ObligationsActor
                        SHOULD:able-to-populateHdrCreator-L2
                        SHALL:able-to-populateHdrCreator-L3
                        SHOULD:displayHdrConsumer-L2
                        SHALL:displayHdrConsumer-L3
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        42. AdverseEvent.severity
                        Definition

                        Describes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.seriousness - a severe rash might not be serious, but a mild heart problem is.

                        Shortmild | moderate | severe
                        Control0..1
                        BindingThe codes SHALL be taken from AdverseEventSeverity
                        (required to http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1)

                        The severity of the adverse event itself, in direct relation to the subject.

                        TypeCodeableConcept
                        Is Modifierfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        44. AdverseEvent.outcome
                        Definition

                        Describes the type of outcome from the adverse event.

                        Shortresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
                        Control0..1
                        BindingThe codes SHALL be taken from AdverseEventOutcome
                        (required to http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1)

                        TODO (and should this be required?).

                        TypeCodeableConcept
                        Is Modifierfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        46. AdverseEvent.recorder
                        Definition

                        Information on who recorded the adverse event. May be the patient or a practitioner.

                        ShortWho recorded the adverse event
                        Control0..1
                        TypeReference(Patient, Practitioner, PractitionerRole, RelatedPerson)
                        Is Modifierfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        48. AdverseEvent.contributor
                        Definition

                        Parties that may or should contribute or have contributed information to the adverse event, which can consist of one or more activities. Such information includes information leading to the decision to perform the activity and how to perform the activity (e.g. consultant), information that the activity itself seeks to reveal (e.g. informant of clinical history), or information about what activity was performed (e.g. informant witness).

                        ShortWho was involved in the adverse event or the potential adverse event
                        Control0..*
                        TypeReference(Practitioner, PractitionerRole, Device)
                        Is Modifierfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        50. AdverseEvent.suspectEntity
                        Definition

                        Describes the entity that is suspected to have caused the adverse event.

                        ShortThe suspected agent causing the adverse event
                        Control0..*
                        TypeBackboneElement
                        Is Modifierfalse
                        Obligations
                          ObligationsActor
                          SHOULD:able-to-populateHdrCreator-L2
                          SHALL:able-to-populateHdrCreator-L3
                          SHOULD:displayHdrConsumer-L2
                          SHALL:displayHdrConsumer-L3
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          52. AdverseEvent.suspectEntity.id
                          Definition

                          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                          ShortUnique id for inter-element referencing
                          Control0..1
                          Typestring
                          Is Modifierfalse
                          XML FormatIn the XML format, this property is represented as an attribute.
                          Summaryfalse
                          54. AdverseEvent.suspectEntity.extension
                          Definition

                          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                          ShortAdditional content defined by implementations
                          Comments

                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                          Control0..*
                          TypeExtension
                          Is Modifierfalse
                          Summaryfalse
                          Alternate Namesextensions, user content
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          56. AdverseEvent.suspectEntity.modifierExtension
                          Definition

                          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                          ShortExtensions that cannot be ignored even if unrecognized
                          Comments

                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                          Control0..*
                          TypeExtension
                          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                          Summarytrue
                          Requirements

                          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                          Alternate Namesextensions, user content, modifiers
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          58. AdverseEvent.suspectEntity.instance
                          Definition

                          Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.

                          ShortRefers to the specific entity that caused the adverse event
                          Control1..1
                          TypeReference(Immunization, Procedure, Substance, Medication, MedicationAdministration, MedicationStatement, Device)
                          Is Modifierfalse
                          Summarytrue
                          Alternate NamesSubstance or Medication or Device
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          60. AdverseEvent.suspectEntity.causality
                          Definition

                          Information on the possible cause of the event.

                          ShortInformation on the possible cause of the event
                          Control0..*
                          TypeBackboneElement
                          Is Modifierfalse
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          62. AdverseEvent.suspectEntity.causality.id
                          Definition

                          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                          ShortUnique id for inter-element referencing
                          Control0..1
                          Typestring
                          Is Modifierfalse
                          XML FormatIn the XML format, this property is represented as an attribute.
                          Summaryfalse
                          64. AdverseEvent.suspectEntity.causality.extension
                          Definition

                          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                          ShortAdditional content defined by implementations
                          Comments

                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                          Control0..*
                          TypeExtension
                          Is Modifierfalse
                          Summaryfalse
                          Alternate Namesextensions, user content
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          66. AdverseEvent.suspectEntity.causality.modifierExtension
                          Definition

                          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                          ShortExtensions that cannot be ignored even if unrecognized
                          Comments

                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                          Control0..*
                          TypeExtension
                          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                          Summarytrue
                          Requirements

                          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                          Alternate Namesextensions, user content, modifiers
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          68. AdverseEvent.suspectEntity.causality.assessment
                          Definition

                          Assessment of if the entity caused the event.

                          ShortAssessment of if the entity caused the event
                          Control0..1
                          BindingFor example codes, see AdverseEventCausalityAssessment
                          (example to http://hl7.org/fhir/ValueSet/adverse-event-causality-assess|4.0.1)

                          Codes for the assessment of whether the entity caused the event.

                          TypeCodeableConcept
                          Is Modifierfalse
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          70. AdverseEvent.suspectEntity.causality.productRelatedness
                          Definition

                          AdverseEvent.suspectEntity.causalityProductRelatedness.

                          ShortAdverseEvent.suspectEntity.causalityProductRelatedness
                          Control0..1
                          Typestring
                          Is Modifierfalse
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          72. AdverseEvent.suspectEntity.causality.author
                          Definition

                          AdverseEvent.suspectEntity.causalityAuthor.

                          ShortAdverseEvent.suspectEntity.causalityAuthor
                          Control0..1
                          TypeReference(Practitioner, PractitionerRole)
                          Is Modifierfalse
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          74. AdverseEvent.suspectEntity.causality.method
                          Definition

                          ProbabilityScale | Bayesian | Checklist.

                          ShortProbabilityScale | Bayesian | Checklist
                          Control0..1
                          BindingFor example codes, see AdverseEventCausalityMethod
                          (example to http://hl7.org/fhir/ValueSet/adverse-event-causality-method|4.0.1)

                          TODO.

                          TypeCodeableConcept
                          Is Modifierfalse
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          76. AdverseEvent.subjectMedicalHistory
                          Definition

                          AdverseEvent.subjectMedicalHistory.

                          ShortAdverseEvent.subjectMedicalHistory
                          Control0..*
                          TypeReference(Condition, Observation, AllergyIntolerance, FamilyMemberHistory, Immunization, Procedure, Media, DocumentReference)
                          Is Modifierfalse
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          78. AdverseEvent.referenceDocument
                          Definition

                          AdverseEvent.referenceDocument.

                          ShortAdverseEvent.referenceDocument
                          Control0..*
                          TypeReference(DocumentReference)
                          Is Modifierfalse
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          80. AdverseEvent.study
                          Definition

                          AdverseEvent.study.

                          ShortAdverseEvent.study
                          Control0..*
                          TypeReference(ResearchStudy)
                          Is Modifierfalse
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))