HL7 Portugal FHIR Implementation Guide para alergias e reacções adversas ao medicamento
1.0.0-ballot - CI Build
HL7 Portugal FHIR Implementation Guide para alergias e reacções adversas ao medicamento, published by HL7 Portugal. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-pt/adr-ig/ and changes regularly. See the Directory of published versions
Active as of 2024-12-09 |
Definitions for the ReacaoAdversa resource profile.
Guidance on how to interpret the contents of this table can be found here
0. AdverseEvent | |
2. AdverseEvent.identifier | |
Short | Identificação da reacção |
Note | This is a business identifier, not a resource identifier (see discussion) |
Must Support | true |
4. AdverseEvent.code | |
Short | Código da Reacção que aconteceu |
Control | 1..? |
Binding | The codes SHOULD be taken from MedDRA ValueSet (preferred to https://hl7.pt/fhir/ADR/ValueSet/meddra-vs ) |
Must Support | true |
6. AdverseEvent.subject | |
Short | Doente sobre o qual existiu uma potencial reacção |
Must Support | true |
8. AdverseEvent.occurrence[x] | |
Short | Data inicio e duração reacção |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Must Support | true |
10. AdverseEvent.seriousness | |
Binding | The codes SHALL be taken from Gravidade RAM ValueSet (required to https://hl7.pt/fhir/ADR/ValueSet/adr-gravidade-vs ) |
Must Support | true |
12. AdverseEvent.outcome | |
Binding | The codes SHALL be taken from Evolução de uma RAM ValueSet (required to https://hl7.pt/fhir/ADR/ValueSet/adr-evolucao-vs ) |
Must Support | true |
14. AdverseEvent.recorder | |
Short | Notificador |
Must Support | true |
16. AdverseEvent.suspectEntity | |
Control | 1..1 |
Must Support | true |
18. AdverseEvent.suspectEntity.instance[x] | |
Short | Medicamento suspeito da reaação adversa |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Must Support | true |
20. AdverseEvent.suspectEntity.causality | |
22. AdverseEvent.suspectEntity.causality.assessmentMethod | |
Short | Método de imputação de causalidade |
Must Support | true |
24. AdverseEvent.suspectEntity.causality.entityRelatedness | |
Short | Grau de causalidade |
Binding | The codes SHALL be taken from Causalidade ValueSet (required to https://hl7.pt/fhir/ADR/ValueSet/adr-causalidade-vs ) |
Must Support | true |
26. AdverseEvent.preventiveAction | |
Short | Medida Tomada |
Must Support | true |
28. AdverseEvent.mitigatingAction | |
Short | Medida Tomada |
Must Support | true |
Guidance on how to interpret the contents of this table can be found here
0. AdverseEvent | |
Definition | An event (i.e. any change to current patient status) that may be related to unintended effects on a patient or research participant. The unintended effects may require additional monitoring, treatment, hospitalization, or may result in death. The AdverseEvent resource also extends to potential or avoided events that could have had such effects. There are two major domains where the AdverseEvent resource is expected to be used. One is in clinical care reported adverse events and the other is in reporting adverse events in clinical research trial management. Adverse events can be reported by healthcare providers, patients, caregivers or by medical products manufacturers. Given the differences between these two concepts, we recommend consulting the domain specific implementation guides when implementing the AdverseEvent Resource. The implementation guides include specific extensions, value sets and constraints. |
Short | An event that may be related to unintended effects on a patient or research participant |
Control | 0..* |
Is Modifier | false |
Must Support | 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()) dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()) dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty()) dom-6: A resource should have narrative for robust management (text.`div`.exists()) |
2. 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 its 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 its meaning or interpretation |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
4. AdverseEvent.contained | |
Definition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning. |
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..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5 |
Type | Resource |
Is Modifier | false |
Must Support | false |
Summary | false |
Alternate Names | inline resources, anonymous resources, contained resources |
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 managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
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 |
Must Support | false |
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 |
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.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 | Identificação da reacçãoBusiness 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..* |
Type | Identifier |
Is Modifier | false |
Must Support | true |
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())) |
10. AdverseEvent.status | |
Definition | The current state of the adverse event or potential adverse event. |
Short | in-progress | completed | entered-in-error | unknown |
Comments | This is not the reporting of the event to any regulatory or quality organization. This is not the outcome of the patient's condition. |
Control | 1..1 |
Binding | The codes SHALL be taken from AdverseEventStatushttp://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0 (required to http://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0 )Codes identifying the lifecycle stage of an event. |
Type | code |
Is Modifier | true because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
12. AdverseEvent.actuality | |
Definition | Whether the event actually happened or was a near miss. Note that this is independent of whether anyone was affected or harmed or how severely. |
Short | actual | potential |
Comments | AllergyIntolerance should be used for the initial capture or recording of the individual's propensity to an adverse reaction to a substance. If an AllergyIntolerance does not exist, then an adverse reaction should be recorded as an AllergyIntolerance. If an AllergyIntolerance does exist and the substance was given, then an adverse reaction should be recorded as an AdverseEvent due to the aberrant workflow. |
Control | 1..1 |
Binding | The codes SHALL be taken from AdverseEventActualityhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0 (required to http://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0 )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 |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
14. AdverseEvent.code | |
Definition | Specific event that occurred or that was averted, such as patient fall, wrong organ removed, or wrong blood transfused. |
Short | Código da Reacção que aconteceuEvent or incident that occurred or was averted |
Control | 10..1 |
Binding | The codes SHOULD be taken from For example codes, see MedDRA ValueSethttp://hl7.org/fhir/ValueSet/adverse-event-type (preferred to https://hl7.pt/fhir/ADR/ValueSet/meddra-vs ) |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
16. AdverseEvent.subject | |
Definition | This subject or group impacted by the event. |
Short | Doente sobre o qual existiu uma potencial reacçãoSubject impacted by event |
Comments | If AdverseEvent.resultingEffect differs among members of the group, then use Patient as the subject. |
Control | 1..1 |
Type | Reference(Patient, Group, Practitioner, RelatedPerson, ResearchSubject) |
Is Modifier | false |
Must Support | true |
Must Support Types | No must-support rules about the choice of types/profiles |
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())) |
18. AdverseEvent.occurrence[x] | |
Definition | The date (and perhaps time) when the adverse event occurred. |
Short | Data inicio e duração reacçãoWhen the event occurred |
Control | 0..1 |
Type | Choice of: dateTime, Period, Timing |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Must Support Types | No must-support rules about the choice of types/profiles |
Summary | true |
Alternate Names | timing |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
20. AdverseEvent.seriousness | |
Definition | Assessment whether this event, or averted event, was of clinical importance. |
Short | Seriousness or gravity of the event |
Comments | Using an example, a rash can have an AdverseEvent.resultingEffect.severity = severe, yet an AdverseEvent.seriousness = non-serious. Alternatively, a medication given with the wrong dose (chemotherapy given with too low of a dose) can have an AdverseEvent.resultingEffect.severity = mild, yet an adverseEvent.seriousness = serious. Another example would be a beta blocker clinical trial where patients with asthma should be excluded, yet a patient with asthma was included and had an asthmatic episode where AdverseEvent.resultingEffect.severity = mild, yet an adverseEvent.seriousness = serious. |
Control | 0..1 |
Binding | The codes SHALL be taken from For example codes, see Gravidade RAM ValueSethttp://hl7.org/fhir/ValueSet/adverse-event-seriousness (required to https://hl7.pt/fhir/ADR/ValueSet/adr-gravidade-vs ) |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
22. AdverseEvent.outcome | |
Definition | Describes the type of outcome from the adverse event, such as resolved, recovering, ongoing, resolved-with-sequelae, or fatal. |
Short | Type of outcome from the adverse event |
Control | 0..* |
Binding | The codes SHALL be taken from For example codes, see Evolução de uma RAM ValueSethttp://hl7.org/fhir/ValueSet/adverse-event-outcome (required to https://hl7.pt/fhir/ADR/ValueSet/adr-evolucao-vs ) |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
24. AdverseEvent.recorder | |
Definition | Information on who recorded the adverse event. May be the patient or a practitioner. |
Short | NotificadorWho recorded the adverse event |
Control | 0..1 |
Type | Reference(Patient, Practitioner, PractitionerRole, RelatedPerson, ResearchSubject) |
Is Modifier | false |
Must Support | true |
Must Support Types | No must-support rules about the choice of types/profiles |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
26. AdverseEvent.suspectEntity | |
Definition | Describes the entity that is suspected to have caused the adverse event. |
Short | The suspected agent causing the adverse event |
Control | 10..1* |
Type | BackboneElement |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
28. 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 managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
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()) |
30. AdverseEvent.suspectEntity.instance[x] | |
Definition | Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device. |
Short | Medicamento suspeito da reaação adversaRefers to the specific entity that caused the adverse event |
Control | 1..1 |
Type | Choice of: CodeableConcept, Reference(Immunization, Procedure, Substance, Medication, MedicationAdministration, MedicationStatement, Device, BiologicallyDerivedProduct, ResearchStudy) |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Must Support | true |
Must Support Types | No must-support rules about the choice of types/profiles |
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())) |
32. AdverseEvent.suspectEntity.causality | |
Definition | Information on the possible cause of the event. |
Short | Information on the possible cause of the event |
Control | 0..1 |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
34. 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 managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
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()) |
36. AdverseEvent.suspectEntity.causality.assessmentMethod | |
Definition | The method of evaluating the relatedness of the suspected entity to the event. |
Short | Método de imputação de causalidadeMethod of evaluating the relatedness of the suspected entity to the event |
Control | 0..1 |
Binding | For example codes, see AdverseEventCausalityMethodhttp://hl7.org/fhir/ValueSet/adverse-event-causality-method (example to http://hl7.org/fhir/ValueSet/adverse-event-causality-method )TODO. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
38. AdverseEvent.suspectEntity.causality.entityRelatedness | |
Definition | The result of the assessment regarding the relatedness of the suspected entity to the event. |
Short | Grau de causalidadeResult of the assessment regarding the relatedness of the suspected entity to the event |
Control | 0..1 |
Binding | The codes SHALL be taken from For example codes, see Causalidade ValueSethttp://hl7.org/fhir/ValueSet/adverse-event-causality-assess (required to https://hl7.pt/fhir/ADR/ValueSet/adr-causalidade-vs ) |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
40. AdverseEvent.preventiveAction | |
Definition | Preventive actions that contributed to avoiding the adverse event. |
Short | Medida TomadaPreventive actions that contributed to avoiding the adverse event |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
42. AdverseEvent.preventiveAction.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
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()) |
44. AdverseEvent.preventiveAction.item[x] | |
Definition | The action that contributed to avoiding the adverse event. |
Short | Action that contributed to avoiding the adverse event |
Control | 1..1 |
Binding | For example codes, see AdverseEventPreventiveActionhttp://hl7.org/fhir/ValueSet/adverse-event-preventive-action (example to http://hl7.org/fhir/ValueSet/adverse-event-preventive-action )Codes describing the preventive actions that contributed to avoiding the adverse event. |
Type | Choice of: Reference(Immunization, Procedure, DocumentReference, MedicationAdministration, MedicationRequest), CodeableConcept |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
46. AdverseEvent.mitigatingAction | |
Definition | The ameliorating action taken after the adverse event occured in order to reduce the extent of harm. |
Short | Medida TomadaAmeliorating actions taken after the adverse event occured in order to reduce the extent of harm |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
48. AdverseEvent.mitigatingAction.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
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()) |
50. AdverseEvent.mitigatingAction.item[x] | |
Definition | The ameliorating action taken after the adverse event occured in order to reduce the extent of harm. |
Short | Ameliorating action taken after the adverse event occured in order to reduce the extent of harm |
Control | 1..1 |
Binding | For example codes, see AdverseEventMitigatingActionhttp://hl7.org/fhir/ValueSet/adverse-event-mitigating-action (example to http://hl7.org/fhir/ValueSet/adverse-event-mitigating-action )Codes describing the ameliorating actions taken after the adverse event occured in order to reduce the extent of harm. |
Type | Choice of: Reference(Procedure, DocumentReference, MedicationAdministration, MedicationRequest), CodeableConcept |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Must Support | false |
Summary | true |
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 found here
0. AdverseEvent | |
Definition | An event (i.e. any change to current patient status) that may be related to unintended effects on a patient or research participant. The unintended effects may require additional monitoring, treatment, hospitalization, or may result in death. The AdverseEvent resource also extends to potential or avoided events that could have had such effects. There are two major domains where the AdverseEvent resource is expected to be used. One is in clinical care reported adverse events and the other is in reporting adverse events in clinical research trial management. Adverse events can be reported by healthcare providers, patients, caregivers or by medical products manufacturers. Given the differences between these two concepts, we recommend consulting the domain specific implementation guides when implementing the AdverseEvent Resource. The implementation guides include specific extensions, value sets and constraints. |
Short | An event that may be related to unintended effects on a patient or research participant |
Control | 0..* |
Is Modifier | false |
Must Support | 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() )dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated ( contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() )dom-5: If a resource is contained in another resource, it SHALL NOT have a security label ( contained.meta.security.empty() )dom-6: A resource should have narrative for robust management ( text.`div`.exists() ) |
2. 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 | Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case. |
Control | 0..1 |
Type | id |
Is Modifier | false |
Must Support | 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 |
Must Support | 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 its 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 its meaning or interpretation |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
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 SHALL be taken from AllLanguages (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0 )IETF language tag for a human language |
Type | code |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
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 a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later. |
Control | 0..1 This element is affected by the following invariants: dom-6 |
Type | Narrative |
Is Modifier | false |
Must Support | false |
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, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning. |
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..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5 |
Type | Resource |
Is Modifier | false |
Must Support | 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 managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
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 |
Must Support | 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 managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
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 |
Must Support | false |
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 |
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 | Identificação da reacção |
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..* |
Type | Identifier |
Is Modifier | false |
Must Support | true |
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.status | |
Definition | The current state of the adverse event or potential adverse event. |
Short | in-progress | completed | entered-in-error | unknown |
Comments | This is not the reporting of the event to any regulatory or quality organization. This is not the outcome of the patient's condition. |
Control | 1..1 |
Binding | The codes SHALL be taken from AdverseEventStatus (required to http://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0 )Codes identifying the lifecycle stage of an event. |
Type | code |
Is Modifier | true because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
22. AdverseEvent.actuality | |
Definition | Whether the event actually happened or was a near miss. Note that this is independent of whether anyone was affected or harmed or how severely. |
Short | actual | potential |
Comments | AllergyIntolerance should be used for the initial capture or recording of the individual's propensity to an adverse reaction to a substance. If an AllergyIntolerance does not exist, then an adverse reaction should be recorded as an AllergyIntolerance. If an AllergyIntolerance does exist and the substance was given, then an adverse reaction should be recorded as an AdverseEvent due to the aberrant workflow. |
Control | 1..1 |
Binding | The codes SHALL be taken from AdverseEventActuality (required to http://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0 )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 |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
24. AdverseEvent.category | |
Definition | The overall type of event, intended for search and filtering purposes. |
Short | wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site |
Control | 0..* |
Binding | For example codes, see AdverseEventCategory (example to http://hl7.org/fhir/ValueSet/adverse-event-category )Overall categorization of the event, e.g. product-related or situational. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
26. AdverseEvent.code | |
Definition | Specific event that occurred or that was averted, such as patient fall, wrong organ removed, or wrong blood transfused. |
Short | Código da Reacção que aconteceu |
Control | 1..1 |
Binding | The codes SHOULD be taken from MedDRA ValueSet (preferred to https://hl7.pt/fhir/ADR/ValueSet/meddra-vs ) |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
28. AdverseEvent.subject | |
Definition | This subject or group impacted by the event. |
Short | Doente sobre o qual existiu uma potencial reacção |
Comments | If AdverseEvent.resultingEffect differs among members of the group, then use Patient as the subject. |
Control | 1..1 |
Type | Reference(Patient, Group, Practitioner, RelatedPerson, ResearchSubject) |
Is Modifier | false |
Must Support | true |
Must Support Types | No must-support rules about the choice of types/profiles |
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()) ) |
30. AdverseEvent.encounter | |
Definition | The Encounter associated with the start of the AdverseEvent. |
Short | The Encounter associated with the start of the AdverseEvent |
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 associated encounter. If the patient reports the AdverseEvent during a second encounter, that second encounter is not the associated encounter. |
Control | 0..1 |
Type | Reference(Encounter) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
32. AdverseEvent.occurrence[x] | |
Definition | The date (and perhaps time) when the adverse event occurred. |
Short | Data inicio e duração reacção |
Control | 0..1 |
Type | Choice of: dateTime, Period, Timing |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | true |
Must Support Types | No must-support rules about the choice of types/profiles |
Summary | true |
Alternate Names | timing |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
34. 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 |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
36. 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 |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
38. AdverseEvent.resultingEffect | |
Definition | Information about the condition that occurred as a result of the adverse event, such as hives due to the exposure to a substance (for example, a drug or a chemical) or a broken leg as a result of the fall. |
Short | Effect on the subject due to this event |
Control | 0..* |
Type | Reference(Condition, Observation) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
40. 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 |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
42. AdverseEvent.seriousness | |
Definition | Assessment whether this event, or averted event, was of clinical importance. |
Short | Seriousness or gravity of the event |
Comments | Using an example, a rash can have an AdverseEvent.resultingEffect.severity = severe, yet an AdverseEvent.seriousness = non-serious. Alternatively, a medication given with the wrong dose (chemotherapy given with too low of a dose) can have an AdverseEvent.resultingEffect.severity = mild, yet an adverseEvent.seriousness = serious. Another example would be a beta blocker clinical trial where patients with asthma should be excluded, yet a patient with asthma was included and had an asthmatic episode where AdverseEvent.resultingEffect.severity = mild, yet an adverseEvent.seriousness = serious. |
Control | 0..1 |
Binding | The codes SHALL be taken from Gravidade RAM ValueSet (required to https://hl7.pt/fhir/ADR/ValueSet/adr-gravidade-vs ) |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
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, such as resolved, recovering, ongoing, resolved-with-sequelae, or fatal. |
Short | Type of outcome from the adverse event |
Control | 0..* |
Binding | The codes SHALL be taken from Evolução de uma RAM ValueSet (required to https://hl7.pt/fhir/ADR/ValueSet/adr-evolucao-vs ) |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
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 | Notificador |
Control | 0..1 |
Type | Reference(Patient, Practitioner, PractitionerRole, RelatedPerson, ResearchSubject) |
Is Modifier | false |
Must Support | true |
Must Support Types | No must-support rules about the choice of types/profiles |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
48. AdverseEvent.participant | |
Definition | Indicates who or what participated in the adverse event and how they were involved. |
Short | Who was involved in the adverse event or the potential adverse event and what they did |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
50. AdverseEvent.participant.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 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
52. AdverseEvent.participant.extension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
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() ) |
54. AdverseEvent.participant.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
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() ) |
56. AdverseEvent.participant.function | |
Definition | Distinguishes the type of involvement of the actor in the adverse event, such as contributor or informant. |
Short | Type of involvement |
Control | 0..1 |
Binding | For example codes, see AdverseEventParticipantFunction (example to http://hl7.org/fhir/ValueSet/adverse-event-participant-function )Codes describing the type of involvement of the actor in the adverse event. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
58. AdverseEvent.participant.actor | |
Definition | Indicates who or what participated in the event. |
Short | Who was involved in the adverse event or the potential adverse event |
Comments | For example, the physician prescribing a drug, a nurse administering the drug, a device that administered the drug, a witness to the event, or an informant of clinical history. |
Control | 1..1 |
Type | Reference(Practitioner, PractitionerRole, Organization, CareTeam, Patient, Device, RelatedPerson, ResearchSubject) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
60. AdverseEvent.study | |
Definition | The research study that the subject is enrolled in. |
Short | Research study that the subject is enrolled in |
Control | 0..* |
Type | Reference(ResearchStudy) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
62. AdverseEvent.expectedInResearchStudy | |
Definition | Considered likely or probable or anticipated in the research study. Whether the reported event matches any of the outcomes for the patient that are considered by the study as known or likely. |
Short | Considered likely or probable or anticipated in the research study |
Control | 0..1 |
Type | boolean |
Is Modifier | false |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Must Support | false |
Summary | false |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
64. AdverseEvent.suspectEntity | |
Definition | Describes the entity that is suspected to have caused the adverse event. |
Short | The suspected agent causing the adverse event |
Control | 1..1 |
Type | BackboneElement |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
66. 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 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
68. 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 managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
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() ) |
70. 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 managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
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() ) |
72. AdverseEvent.suspectEntity.instance[x] | |
Definition | Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device. |
Short | Medicamento suspeito da reaação adversa |
Control | 1..1 |
Type | Choice of: CodeableConcept, Reference(Immunization, Procedure, Substance, Medication, MedicationAdministration, MedicationStatement, Device, BiologicallyDerivedProduct, ResearchStudy) |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Must Support | true |
Must Support Types | No must-support rules about the choice of types/profiles |
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()) ) |
74. AdverseEvent.suspectEntity.causality | |
Definition | Information on the possible cause of the event. |
Short | Information on the possible cause of the event |
Control | 0..1 |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
76. 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 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
78. 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 managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
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() ) |
80. 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 managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
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() ) |
82. AdverseEvent.suspectEntity.causality.assessmentMethod | |
Definition | The method of evaluating the relatedness of the suspected entity to the event. |
Short | Método de imputação de causalidade |
Control | 0..1 |
Binding | For example codes, see AdverseEventCausalityMethod (example to http://hl7.org/fhir/ValueSet/adverse-event-causality-method )TODO. |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
84. AdverseEvent.suspectEntity.causality.entityRelatedness | |
Definition | The result of the assessment regarding the relatedness of the suspected entity to the event. |
Short | Grau de causalidade |
Control | 0..1 |
Binding | The codes SHALL be taken from Causalidade ValueSet (required to https://hl7.pt/fhir/ADR/ValueSet/adr-causalidade-vs ) |
Type | CodeableConcept |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
86. AdverseEvent.suspectEntity.causality.author | |
Definition | The author of the information on the possible cause of the event. |
Short | Author of the information on the possible cause of the event |
Control | 0..1 |
Type | Reference(Practitioner, PractitionerRole, Patient, RelatedPerson, ResearchSubject) |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
88. AdverseEvent.contributingFactor | |
Definition | The contributing factors suspected to have increased the probability or severity of the adverse event. |
Short | Contributing factors suspected to have increased the probability or severity of the adverse event |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
90. AdverseEvent.contributingFactor.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 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
92. AdverseEvent.contributingFactor.extension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
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() ) |
94. AdverseEvent.contributingFactor.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
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() ) |
96. AdverseEvent.contributingFactor.item[x] | |
Definition | The item that is suspected to have increased the probability or severity of the adverse event. |
Short | Item suspected to have increased the probability or severity of the adverse event |
Control | 1..1 |
Binding | For example codes, see AdverseEventContributingFactor (example to http://hl7.org/fhir/ValueSet/adverse-event-contributing-factor )Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event. |
Type | Choice of: Reference(Condition, Observation, AllergyIntolerance, FamilyMemberHistory, Immunization, Procedure, Device, DeviceUsage, DocumentReference, MedicationAdministration, MedicationStatement), CodeableConcept |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
98. AdverseEvent.preventiveAction | |
Definition | Preventive actions that contributed to avoiding the adverse event. |
Short | Medida Tomada |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
100. AdverseEvent.preventiveAction.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 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
102. AdverseEvent.preventiveAction.extension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
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() ) |
104. AdverseEvent.preventiveAction.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
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() ) |
106. AdverseEvent.preventiveAction.item[x] | |
Definition | The action that contributed to avoiding the adverse event. |
Short | Action that contributed to avoiding the adverse event |
Control | 1..1 |
Binding | For example codes, see AdverseEventPreventiveAction (example to http://hl7.org/fhir/ValueSet/adverse-event-preventive-action )Codes describing the preventive actions that contributed to avoiding the adverse event. |
Type | Choice of: Reference(Immunization, Procedure, DocumentReference, MedicationAdministration, MedicationRequest), CodeableConcept |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
108. AdverseEvent.mitigatingAction | |
Definition | The ameliorating action taken after the adverse event occured in order to reduce the extent of harm. |
Short | Medida Tomada |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | true |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
110. AdverseEvent.mitigatingAction.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 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
112. AdverseEvent.mitigatingAction.extension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
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() ) |
114. AdverseEvent.mitigatingAction.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
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() ) |
116. AdverseEvent.mitigatingAction.item[x] | |
Definition | The ameliorating action taken after the adverse event occured in order to reduce the extent of harm. |
Short | Ameliorating action taken after the adverse event occured in order to reduce the extent of harm |
Control | 1..1 |
Binding | For example codes, see AdverseEventMitigatingAction (example to http://hl7.org/fhir/ValueSet/adverse-event-mitigating-action )Codes describing the ameliorating actions taken after the adverse event occured in order to reduce the extent of harm. |
Type | Choice of: Reference(Procedure, DocumentReference, MedicationAdministration, MedicationRequest), CodeableConcept |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
118. AdverseEvent.supportingInfo | |
Definition | Supporting information relevant to the event. |
Short | Supporting information relevant to the event |
Control | 0..* |
Type | BackboneElement |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
120. AdverseEvent.supportingInfo.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 This element is affected by the following invariants: ele-1 |
Type | string |
Is Modifier | false |
XML Format | In the XML format, this property is represented as an attribute. |
Summary | false |
122. AdverseEvent.supportingInfo.extension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
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() ) |
124. AdverseEvent.supportingInfo.modifierExtension | |
Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
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() ) |
126. AdverseEvent.supportingInfo.item[x] | |
Definition | Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a pencillin administration and the patient had a previously documented penicillin allergy. In a clinical trials context, an example is a bunion or rash that was present prior to the study. Additionally, the supporting item can be a document that is relevant to this instance of the adverse event that is not part of the subject's medical history. For example, a clinical note, staff list, or material safety data sheet (MSDS). Supporting information is not a contributing factor, preventive action, or mitigating action. |
Short | Subject medical history or document relevant to this adverse event |
Control | 1..1 |
Binding | For example codes, see AdverseEventSupportingInforation (example to http://hl7.org/fhir/ValueSet/adverse-event-supporting-info )Codes describing the supporting information relevant to the event. |
Type | Choice of: Reference(Condition, Observation, AllergyIntolerance, FamilyMemberHistory, Immunization, Procedure, DocumentReference, MedicationAdministration, MedicationStatement, QuestionnaireResponse), CodeableConcept |
[x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |
128. AdverseEvent.note | |
Definition | Comments made about the adverse event by the performer, subject or other participants. |
Short | Comment on adverse event |
Control | 0..* |
Type | Annotation |
Is Modifier | false |
Must Support | false |
Summary | true |
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()) ) |