HL7 Czech Imaging Report IG
0.1.0-ballot - ci-build CZ

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: Adverse Event: Obligations - Detailed Descriptions

Draft as of 2026-05-26

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

- Key Elements Table
- Differential Table
- Snapshot Table

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.
Short | Medical care, research study or other healthcare event causing physical injury
Control | 0..*
Is Modifier | false
Summary | false
Alternate Names | AE
Invariants | 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().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.
Short | A 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.
Control | 0..1
Type | uri
Is Modifier | true 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 Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Invariants | ele-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.
Short | Text 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.
Control | 0..1
Type | Narrative
Is Modifier | false
Obligations |
Obligations | Actor
SHALL:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHALL:display | Consumer_L2
SHALL:display | Consumer_L3
Summary | false
Alternate Names | narrative, html, xhtml, display
Invariants | ele-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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summary | false
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 Names | extensions, user content
Invariants | 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. 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.
Short | actual | potential
Control | 1..1
Binding | The codes SHALL be taken from AdverseEventActuality http://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.
Type | code
Is Modifier | true because This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen.
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Invariants | ele-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.
Short | Subject impacted by event
Comments | If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject.
Control | 1..1
Type | Reference(Patient, Group, Practitioner, RelatedPerson)
Is Modifier | false
Summary | true
Requirements | Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital.
Alternate Names | patient
Invariants | ele-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.
Short | When the event was detected
Control | 0..1
Type | dateTime
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
Summary | true
Invariants | ele-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.
Short | Seriousness of the event
Control | 0..1
Binding | For example codes, see AdverseEventSeriousness http://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.
Type | CodeableConcept
Is Modifier | false
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
Summary | true
Invariants | ele-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.
Short | The suspected agent causing the adverse event
Control | 0..*
Type | BackboneElement
Is Modifier | false
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
Summary | true
Invariants | ele-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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
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 Names | extensions, user content, modifiers
Invariants | 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())
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.
Short | Refers to the specific entity that caused the adverse event
Control | 1..1
Type | Reference(Immunization, Procedure, Substance, Medication, MedicationAdministration, MedicationStatement, Device)
Is Modifier | false
Summary | true
Alternate Names | Substance or Medication or Device
Invariants | ele-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 |
Obligations | Actor
SHALL:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHALL:display | Consumer_L2
SHALL:display | Consumer_L3
4. AdverseEvent.detected
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
6. AdverseEvent.seriousness
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
8. AdverseEvent.suspectEntity
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_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.
Short | Medical care, research study or other healthcare event causing physical injury
Control | 0..*
Is Modifier | false
Summary | false
Alternate Names | AE
Invariants | 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().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.
Short | Logical 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.
Control | 0..1
Type | id
Is Modifier | false
Summary | true
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.
Short | Metadata about the resource
Control | 0..1
Type | Meta
Is Modifier | false
Summary | true
Invariants | ele-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.
Short | A 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.
Control | 0..1
Type | uri
Is Modifier | true 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 Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Invariants | ele-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.
Short | Language 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).
Control | 0..1
Binding | The codes SHOULD be taken from CommonLanguages (preferred to `http://hl7.org/fhir/ValueSet/languages|4.0.1` ) A human language.
Additional Bindings | Purpose
AllLanguages | Max Binding
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Invariants | ele-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.
Short | Text 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.
Control | 0..1
Type | Narrative
Is Modifier | false
Obligations |
Obligations | Actor
SHALL:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHALL:display | Consumer_L2
SHALL:display | Consumer_L3
Summary | false
Alternate Names | narrative, html, xhtml, display
Invariants | ele-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.
Short | Contained, 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.
Control | 0..*
Type | Resource
Is Modifier | false
Summary | false
Alternate Names | inline 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.
Short | Additional 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | 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. 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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summary | false
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 Names | extensions, user content
Invariants | 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. 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.
Short | Business 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.
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..1
Type | Identifier
Is Modifier | false
Summary | true
Requirements | Allows identification of the adverse event as it is known by various participating systems and in a way that remains consistent across servers.
Invariants | ele-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.
Short | actual | potential
Control | 1..1
Binding | The 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.
Type | code
Is Modifier | true because This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen.
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Invariants | ele-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.
Short | product-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
Control | 0..*
Binding | Unless 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.
Type | CodeableConcept
Is Modifier | false
Summary | true
Invariants | ele-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.
Short | Type of the event itself in relation to the subject
Control | 0..1
Binding | For example codes, see SNOMEDCTClinicalFindings (example to `http://hl7.org/fhir/ValueSet/adverse-event-type|4.0.1` ) Detailed type of event.
Type | CodeableConcept
Is Modifier | false
Summary | true
Invariants | ele-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.
Short | Subject impacted by event
Comments | If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject.
Control | 1..1
Type | Reference(Patient, Group, Practitioner, RelatedPerson)
Is Modifier | false
Summary | true
Requirements | Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital.
Alternate Names | patient
Invariants | ele-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.
Short | Encounter 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.
Control | 0..1
Type | Reference(Encounter)
Is Modifier | false
Summary | true
Invariants | ele-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.
Short | When the event occurred
Control | 0..1
Type | dateTime
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Invariants | ele-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.
Short | When the event was detected
Control | 0..1
Type | dateTime
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
Summary | true
Invariants | ele-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.
Short | When 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.
Control | 0..1
Type | dateTime
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Invariants | ele-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).
Short | Effect on the subject due to this event
Control | 0..*
Type | Reference(Condition)
Is Modifier | false
Summary | true
Invariants | ele-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.
Short | Location where adverse event occurred
Control | 0..1
Type | Reference(Location)
Is Modifier | false
Summary | true
Invariants | ele-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.
Short | Seriousness of the event
Control | 0..1
Binding | For 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.
Type | CodeableConcept
Is Modifier | false
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
Summary | true
Invariants | ele-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.
Short | mild | moderate | severe
Control | 0..1
Binding | The 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.
Type | CodeableConcept
Is Modifier | false
Summary | true
Invariants | ele-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.
Short | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Control | 0..1
Binding | The 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?).
Type | CodeableConcept
Is Modifier | false
Summary | true
Invariants | ele-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.
Short | Who recorded the adverse event
Control | 0..1
Type | Reference(Patient, Practitioner, PractitionerRole, RelatedPerson)
Is Modifier | false
Summary | true
Invariants | ele-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).
Short | Who was involved in the adverse event or the potential adverse event
Control | 0..*
Type | Reference(Practitioner, PractitionerRole, Device)
Is Modifier | false
Summary | true
Invariants | ele-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.
Short | The suspected agent causing the adverse event
Control | 0..*
Type | BackboneElement
Is Modifier | false
Obligations |
Obligations | Actor
SHOULD:able-to-populate | Creator_L2
SHALL:able-to-populate | Creator_L3
SHOULD:display | Consumer_L2
SHALL:display | Consumer_L3
Summary | true
Invariants | ele-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.
Short | Unique id for inter-element referencing
Control | 0..1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
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.
Short | Additional 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | 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. 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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
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 Names | extensions, user content, modifiers
Invariants | 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. 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.
Short | Refers to the specific entity that caused the adverse event
Control | 1..1
Type | Reference(Immunization, Procedure, Substance, Medication, MedicationAdministration, MedicationStatement, Device)
Is Modifier | false
Summary | true
Alternate Names | Substance or Medication or Device
Invariants | ele-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.
Short | Information on the possible cause of the event
Control | 0..*
Type | BackboneElement
Is Modifier | false
Summary | true
Invariants | ele-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.
Short | Unique id for inter-element referencing
Control | 0..1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
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.
Short | Additional 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | 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()`)
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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
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 Names | extensions, user content, modifiers
Invariants | 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()`)
68. AdverseEvent.suspectEntity.causality.assessment
Definition | Assessment of if the entity caused the event.
Short | Assessment of if the entity caused the event
Control | 0..1
Binding | For 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.
Type | CodeableConcept
Is Modifier | false
Summary | true
Invariants | ele-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.
Short | AdverseEvent.suspectEntity.causalityProductRelatedness
Control | 0..1
Type | string
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | true
Invariants | ele-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.
Short | AdverseEvent.suspectEntity.causalityAuthor
Control | 0..1
Type | Reference(Practitioner, PractitionerRole)
Is Modifier | false
Summary | true
Invariants | ele-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.
Short | ProbabilityScale | Bayesian | Checklist
Control | 0..1
Binding | For example codes, see AdverseEventCausalityMethod (example to `http://hl7.org/fhir/ValueSet/adverse-event-causality-method|4.0.1` ) TODO.
Type | CodeableConcept
Is Modifier | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
76. AdverseEvent.subjectMedicalHistory
Definition | AdverseEvent.subjectMedicalHistory.
Short | AdverseEvent.subjectMedicalHistory
Control | 0..*
Type | Reference(Condition, Observation, AllergyIntolerance, FamilyMemberHistory, Immunization, Procedure, Media, DocumentReference)
Is Modifier | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
78. AdverseEvent.referenceDocument
Definition | AdverseEvent.referenceDocument.
Short | AdverseEvent.referenceDocument
Control | 0..*
Type | Reference(DocumentReference)
Is Modifier | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
80. AdverseEvent.study
Definition | AdverseEvent.study.
Short | AdverseEvent.study
Control | 0..*
Type | Reference(ResearchStudy)
Is Modifier | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)