HL7 Europe Base and Core FHIR IG
2.0.0-ballot - ballot 150

HL7 Europe Base and Core FHIR IG, published by HL7 Europe. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/base/ and changes regularly. See the Directory of published versions

Resource Profile: MedicalTestResultEuCore - Detailed Descriptions

Page standards status: Draft Maturity Level: 1

Definitions for the medicalTestResult-eu-core resource profile.

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

0. Observation
Definition

Measurements and simple assertions made about a patient, device or other subject.

ShortMeasurements and simple assertions
Comments

Used for simple observations such as device measurements, laboratory atomic results, vital signs, height, weight, smoking status, comments, etc. Other resources are used to provide context for observations such as laboratory reports, etc.

Control0..*
Is Modifierfalse
Summaryfalse
Alternate NamesVital Signs, Measurement, Results, Tests
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
2. Observation.implicitRules
Definition

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

ShortA set of rules under which this content was created
Comments

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

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

An Extension


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

ShortExtensionAdditional content defined by implementations
Comments

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

Control0..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Observation.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 6. Observation.extension:bodyStructure
    Slice NamebodyStructure
    Definition

    Indicates the body structure on the subject's body where the observation was made (i.e. the target site).

    ShortObserved body structure
    Control0..1
    This element is affected by the following invariants: ele-1
    TypeExtension(Cross-version Extension for R5.Observation.bodyStructure for use in FHIR R4) (Extension Type: Reference)
    Is Modifierfalse
    Summaryfalse
    Requirements

    EHDSObservation.anatomicLocation

    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    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. Observation.extension:triggeredBy
    Slice NametriggeredBy
    Definition

    Identifies the observation(s) that triggered the performance of this observation.

    ShortTriggering observation(s)
    Control0..*
    This element is affected by the following invariants: ele-1
    TypeExtension(Cross-version Extension for R5.Observation.triggeredBy for use in FHIR R4) (Extension Type: Choice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage, Meta)
    Is Modifierfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    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())
    10. Observation.extension:triggeredBy.extension
    Definition

    An Extension


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

    ShortExtensionAdditional 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.

    Control20..*
    TypeExtension
    Is Modifierfalse
    Summaryfalse
    Alternate Namesextensions, user content
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    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())
    SlicingThis element introduces a set of slices on Observation.extension.extension. The slices areUnordered and ClosedOpen, and can be differentiated using the following discriminators:
    • value @ url
    • 12. Observation.extension:triggeredBy.extension:observation
      Slice Nameobservation
      Definition

      An Extension

      ShortExtensionAdditional content defined by implementations
      Control10..1*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      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())
      14. Observation.extension:triggeredBy.extension:observation.extension
      Definition

      An Extension


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

      ShortExtensionAdditional content defined by implementations
      Comments

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

      Control0..0*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      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())
      SlicingThis element introduces a set of slices on Observation.extension.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 16. Observation.extension:triggeredBy.extension:observation.url
        Definition

        Source of the definition for the extension code - a logical name or a URL.

        Shortidentifies the meaning of the extension
        Comments

        The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

        Control1..1
        Typeuri
        Is Modifierfalse
        XML FormatIn the XML format, this property is represented as an attribute.
        Summaryfalse
        Fixed Valueobservation
        18. Observation.extension:triggeredBy.extension:observation.value[x]
        Definition

        Reference to the triggering observation.


        Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

        ShortTriggering observationValue of extension
        Control0..1
        TypeReference(MedicalTestResult (EU core)), date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Is Modifierfalse
        Summaryfalse
        Requirements

        EHDSObservation.triggeredBy[x]

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        20. Observation.extension:triggeredBy.extension:type
        Slice Nametype
        Definition

        The type of trigger. Reflex | Repeat | Re-run.

        Shortreflex | repeat | re-runAdditional content defined by implementations
        Control10..1*
        TypeExtension
        Is Modifierfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        22. Observation.extension:triggeredBy.extension:type.url
        Definition

        Source of the definition for the extension code - a logical name or a URL.

        Shortidentifies the meaning of the extension
        Comments

        The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

        Control1..1
        Typeuri
        Is Modifierfalse
        XML FormatIn the XML format, this property is represented as an attribute.
        Summaryfalse
        Fixed Valuetype
        24. Observation.extension:triggeredBy.extension:reason
        Slice Namereason
        Definition

        Provides the reason why this observation was performed as a result of the observation(s) referenced.

        ShortReason that the observation was triggeredAdditional content defined by implementations
        Control0..1*
        TypeExtension
        Is Modifierfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        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())
        26. Observation.extension:triggeredBy.extension:reason.url
        Definition

        Source of the definition for the extension code - a logical name or a URL.

        Shortidentifies the meaning of the extension
        Comments

        The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

        Control1..1
        Typeuri
        Is Modifierfalse
        XML FormatIn the XML format, this property is represented as an attribute.
        Summaryfalse
        Fixed Valuereason
        28. Observation.extension:triggeredBy.url
        Definition

        Source of the definition for the extension code - a logical name or a URL.

        Shortidentifies the meaning of the extension
        Comments

        The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

        Control1..1
        Typeuri
        Is Modifierfalse
        XML FormatIn the XML format, this property is represented as an attribute.
        Summaryfalse
        Fixed Valuehttp://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy
        30. Observation.extension:triggeredBy.value[x]
        Definition

        Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

        ShortValue of extension
        Control0..01
        TypeChoice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage, Meta
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        32. Observation.extension:value-r5
        Slice Namevalue-r5
        Definition

        Optional Extension Element - found in all resources.

        Shortonly for result of type Attachment
        Control0..1
        This element is affected by the following invariants: ele-1
        TypeExtension(http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value%5Bx%5D)
        Is Modifierfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        34. Observation.extension:value-r5.extension
        Definition

        An Extension


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

        ShortExtensionAdditional content defined by implementations
        Comments

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

        Control0..0*
        TypeExtension
        Is Modifierfalse
        Summaryfalse
        Alternate Namesextensions, user content
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        SlicingThis element introduces a set of slices on Observation.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 36. Observation.extension:value-r5.url
          Definition

          Source of the definition for the extension code - a logical name or a URL.

          Shortidentifies the meaning of the extension
          Comments

          The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

          Control1..1
          Typeuri
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          Fixed Valuehttp://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]
          38. Observation.extension:value-r5.value[x]
          Definition

          Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

          ShortValue of extension
          Control10..1
          TypeAttachment, date, Meta, Address, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Is Modifierfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          40. Observation.modifierExtension
          Definition

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

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

          ShortExtensions that cannot be ignored
          Comments

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

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

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

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

          A unique identifier assigned to this observation.

          ShortBusiness Identifier for observation
          NoteThis is a business identifier, not a resource identifier (see discussion)
          Control0..*
          TypeIdentifier
          Is Modifierfalse
          Summarytrue
          Requirements

          EHDSObservation.header.identifier


          Allows observations to be distinguished and referenced.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          44. Observation.basedOn
          Definition

          A plan, proposal or order that is fulfilled in whole or in part by this event. For example, a MedicationRequest may require a patient to have laboratory test performed before it is dispensed.

          ShortFulfills plan, proposal or order
          Control0..*
          TypeReference(CarePlan, DeviceRequest, ImmunizationRecommendation, MedicationRequest, NutritionOrder, ServiceRequest)
          Is Modifierfalse
          Summarytrue
          Requirements

          EHDSObservation.order


          Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon.

          Alternate NamesFulfills
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          46. Observation.status
          Definition

          The status of the result value.

          Shortregistered | preliminary | final | amended +
          Comments

          This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

          Control1..1
          BindingThe codes SHALL be taken from ObservationStatushttp://hl7.org/fhir/ValueSet/observation-status|4.0.1
          (required to http://hl7.org/fhir/ValueSet/observation-status|4.0.1)

          Codes providing the status of an observation.

          Typecode
          Is Modifiertrue 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 ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Requirements

          EHDSObservation.header.status


          Need to track the status of individual results. Some results are finalized before the whole report is finalized.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          48. Observation.category
          Definition

          A code that classifies the general type of observation being made.

          ShortClassification of type of observation
          Comments

          In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

          Control10..*
          BindingThe codes SHOULD be taken from ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-category|4.0.1
          (preferred to http://hl7.org/fhir/ValueSet/observation-category|4.0.1)

          Codes for high level observation categories.

          TypeCodeableConcept
          Is Modifierfalse
          Summaryfalse
          Requirements

          EHDSObservation has no requirement


          Used for filtering what observations are retrieved and displayed.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          SlicingThis element introduces a set of slices on Observation.category. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ $this
          • 50. Observation.category:laboratory
            Slice Namelaboratory
            Definition

            A code that classifies the general type of observation being made.

            ShortClassification of type of observation
            Comments

            In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

            Control0..1*
            BindingThe codes SHOULD be taken from ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-category|4.0.1
            (preferred to http://hl7.org/fhir/ValueSet/observation-category|4.0.1)

            Codes for high level observation categories.

            TypeCodeableConcept
            Is Modifierfalse
            Summaryfalse
            Requirements

            Used for filtering what observations are retrieved and displayed.

            Pattern Value{
              "coding" : [{
                "system" : "http://terminology.hl7.org/CodeSystem/observation-category",
                "code" : "laboratory"
              }]
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            52. Observation.category:vital-signs
            Slice Namevital-signs
            Definition

            A code that classifies the general type of observation being made.

            ShortClassification of type of observation
            Comments

            In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

            Control0..1*
            BindingThe codes SHOULD be taken from ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-category|4.0.1
            (preferred to http://hl7.org/fhir/ValueSet/observation-category|4.0.1)

            Codes for high level observation categories.

            TypeCodeableConcept
            Is Modifierfalse
            Summaryfalse
            Requirements

            Used for filtering what observations are retrieved and displayed.

            Pattern Value{
              "coding" : [{
                "system" : "http://terminology.hl7.org/CodeSystem/observation-category",
                "code" : "vital-signs"
              }]
            }
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            54. Observation.code
            Definition

            Describes what was observed. Sometimes this is called the observation "name".

            ShortType of observation (code / type)
            Comments

            All code-value and, if present, component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

            Control1..1
            BindingThe codes SHOULD be taken from For example codes, see Laboratory Codehttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
            (preferred to http://hl7.eu/fhir/base/ValueSet/lab-obsCode-eu-lab)
            TypeCodeableConcept
            Is Modifierfalse
            Summarytrue
            Requirements

            EHDSObservation.code


            Knowing what kind of observation is being made is essential to understanding the observation.

            Alternate NamesName
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            56. Observation.subject
            Definition

            The patient, or group of patients, location, or device this observation is about and into whose record the observation is placed. If the actual focus of the observation is different from the subject (or a sample of, part, or region of the subject), the focus element or the code itself specifies the actual focus of the observation.

            ShortWho and/or what the observation is about
            Comments

            One would expect this element to be a cardinality of 1..1. The only circumstance in which the subject can be missing is when the observation is made by a device that does not know the patient. In this case, the observation SHALL be matched to a patient through some context/channel matching technique, and at this point, the observation should be updated.

            Control10..1
            TypeReference(Patient (EU core), Patient, Group, Device, Location)
            Is Modifierfalse
            Summarytrue
            Requirements

            EHDSObservation.header.subject


            Observations have no value if you don't know who or what they're about.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            58. Observation.focus
            Definition

            The actual focus of an observation when it is not the patient of record representing something or someone associated with the patient such as a spouse, parent, fetus, or donor. For example, fetus observations in a mother's record. The focus of an observation could also be an existing condition, an intervention, the subject's diet, another observation of the subject, or a body structure such as tumor or implanted device. An example use case would be using the Observation resource to capture whether the mother is trained to change her child's tracheostomy tube. In this example, the child is the patient of record and the mother is the focus.

            ShortWhat the observation is about, when it is not about the subject of record
            Comments

            Typically, an observation is made about the subject - a patient, or group of patients, location, or device - and the distinction between the subject and what is directly measured for an observation is specified in the observation code itself ( e.g., "Blood Glucose") and does not need to be represented separately using this element. Use specimen if a reference to a specimen is required. If a code is required instead of a resource use either bodysite for bodysites or the standard extension focusCode.

            Control0..*
            TypeReference(Patient (EU core), RelatedPerson, Group, Device, Location (EU core), Resource)
            Is Modifierfalse
            Summarytrue
            Requirements

            EHDSObservation.directSubject[x]

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            60. Observation.effective[x]
            Definition

            The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the "physiologically relevant time". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself.

            ShortClinically relevant time/time-period for observation
            Comments

            At least a date should be present unless this observation is a historical report. For recording imprecise or "fuzzy" times (For example, a blood glucose measurement taken "after breakfast") use the Timing datatype which allow the measurement to be tied to regular life events.

            Control10..1
            TypeChoice of: dateTime, Period, Timing, instant
            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Requirements

            EHDSObservation.observationDate[x]


            Knowing when an observation was deemed true is important to its relevance as well as determining trends.

            Alternate NamesOccurrence
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            62. Observation.issued
            Definition

            The date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified.

            ShortDate/Time this version was made available
            Comments

            For Observations that don’t require review and verification, it may be the same as the lastUpdated time of the resource itself. For Observations that do require review and verification for certain updates, it might not be the same as the lastUpdated time of the resource itself due to a non-clinically significant update that doesn’t require the new version to be reviewed and verified again.

            Control0..1
            Typeinstant
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Requirements

            EHDSObservation.header.authorship.datetime

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            64. Observation.performer
            Definition

            Who was responsible for asserting the observed value as "true".

            ShortWho is responsible for the observation
            Control0..*
            TypeReference(Practitioner (EU core), PractitionerRole (EU core), Organization (EU core), Practitioner, PractitionerRole, Organization, CareTeam, Patient, RelatedPerson)
            Is Modifierfalse
            Summarytrue
            Requirements

            EHDSObservation.header.performer


            May give a degree of confidence in the observation and also indicates where follow-up questions should be directed.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            66. Observation.value[x]
            Definition

            The information determined as a result of making the observation, if the information has a simple value.

            ShortActual result
            Comments

            An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

            Control0..1
            This element is affected by the following invariants: obs-7
            TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Requirements

            EHDSObservation.result.value[x]


            An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            SlicingThis element introduces a set of slices on Observation.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • type @ $this
            • 68. Observation.value[x]:valueQuantity
              Slice NamevalueQuantity
              Definition

              The information determined as a result of making the observation, if the information has a simple value.

              ShortActual result
              Comments

              An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control0..1
              This element is affected by the following invariants: obs-7
              TypeQuantity, dateTime, boolean, string, SampledData, Period, Ratio, integer, time, Range, CodeableConcept
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Summarytrue
              Requirements

              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              70. Observation.value[x]:valueQuantity.extension:uncertainty
              Slice Nameuncertainty
              Definition

              The primary measure of variance/uncertainty of the value (the square root of the sum of the squares of the differences between all data points and the mean).

              ShortStandard Deviation (same units as the quantity)
              Comments

              standardDeviation has the same units as the quantity. It is used to normalize the data for computing the distribution function. Applications that cannot deal with probability distributions can still get an idea about the confidence level by looking at standardDeviation.

              Control0..1
              TypeExtension(Uncertainty) (Extension Type: decimal)
              Is Modifierfalse
              Summaryfalse
              Requirements

              EHDSObservation.result.uncertainty

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              72. Observation.value[x]:valueQuantity.comparator
              Definition

              How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

              Short< | <= | >= | > - how to understand the value
              Control0..1
              BindingThe codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1
              (required to http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1)

              How the Quantity should be understood and represented.

              Typecode
              Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

              Meaning if MissingIf there is no comparator, then there is no modification of the value
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              74. Observation.dataAbsentReason
              Definition

              Provides a reason why the expected value in the element Observation.value[x] is missing.

              ShortWhy the result is missing
              Comments

              Null or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "specimen unsatisfactory".

              The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Note that an observation may only be reported if there are values to report. For example differential cell counts values may be reported only when > 0. Because of these options, use-case agreements are required to interpret general observations for null or exceptional values.

              Control0..1
              This element is affected by the following invariants: obs-6
              BindingUnless not suitable, these codes SHALL be taken from DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason|4.0.1
              (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason|4.0.1)

              Codes specifying why the result (Observation.value[x]) is missing.

              TypeCodeableConcept
              Is Modifierfalse
              Summaryfalse
              Requirements

              EHDSObservation.dataAbsentReason


              For many results it is necessary to handle exceptional values in measurements.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              76. Observation.interpretation
              Definition

              A categorical assessment of an observation value. For example, high, low, normal.

              ShortHigh, low, normal, etc.
              Comments

              Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

              Control0..*
              BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretation|4.0.1
              (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation|4.0.1)

              Codes identifying interpretations of observations.

              TypeCodeableConcept
              Is Modifierfalse
              Summaryfalse
              Requirements

              EHDSObservation.interpretation


              For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

              Alternate NamesAbnormal Flag
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              78. Observation.note
              Definition

              Comments about the observation or the results.

              ShortComments about the observation
              Comments

              May include general statements about the observation, or statements about significant, unexpected or unreliable results values, or information about its source when relevant to its interpretation.

              Control0..*
              TypeAnnotation
              Is Modifierfalse
              Summaryfalse
              Requirements

              EHDSObservation.resultDescription


              Need to be able to provide free text additional information.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              80. Observation.bodySite
              Definition

              Indicates the site on the subject's body where the observation was made (i.e. the target site).

              ShortObserved body part
              Comments

              Only used if not implicit in code found in Observation.code. In many systems, this may be represented as a related observation instead of an inline component.

              If the use case requires BodySite to be handled as a separate resource (e.g. to identify and track separately) then use the standard extension bodySite.

              Control0..1
              BindingFor example codes, see SNOMEDCTBodyStructureshttp://hl7.org/fhir/ValueSet/body-site|4.0.1
              (example to http://hl7.org/fhir/ValueSet/body-site|4.0.1)

              Codes describing anatomical locations. May include laterality.

              TypeCodeableConcept
              Is Modifierfalse
              Summaryfalse
              Requirements

              EHDSObservation.anatomicLocation

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              82. Observation.method
              Definition

              Indicates the mechanism used to perform the observation.

              ShortHow it was done
              Comments

              Only used if not implicit in code for Observation.code.

              Control0..1
              BindingFor example codes, see ObservationMethodshttp://hl7.org/fhir/ValueSet/observation-methods|4.0.1
              (example to http://hl7.org/fhir/ValueSet/observation-methods|4.0.1)

              Methods for simple observations.

              TypeCodeableConcept
              Is Modifierfalse
              Summaryfalse
              Requirements

              EHDSObservation.method


              In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              84. Observation.device
              Definition

              The device used to generate the observation data.

              Short(Measurement) Device
              Comments

              Note that this is not meant to represent a device involved in the transmission of the result, e.g., a gateway. Such devices may be documented using the Provenance resource where relevant.

              Control0..1
              TypeReference(Device, DeviceMetric)
              Is Modifierfalse
              Summaryfalse
              Requirements

              Device information for laboratory observations

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              86. Observation.referenceRange
              Definition

              Guidance on how to interpret the value by comparison to a normal or recommended range. Multiple reference ranges are interpreted as an "OR". In other words, to represent two distinct target populations, two referenceRange elements would be used.

              ShortProvides guide for interpretation
              Comments

              Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

              Control0..*
              TypeBackboneElement
              Is Modifierfalse
              Summaryfalse
              Requirements

              EHDSObservation.referenceRange


              Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              obs-3: Must have at least a low or a high or text (low.exists() or high.exists() or text.exists())
              obs-3: Must have at least a low or a high or text (low.exists() or high.exists() or text.exists())
              88. Observation.referenceRange.modifierExtension
              Definition

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

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

              ShortExtensions that cannot be ignored even if unrecognized
              Comments

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

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

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

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

              This observation is a group observation (e.g. a battery, a panel of tests, a set of vital sign measurements) that includes the target as a member of the group.

              ShortRelated resource that belongs to the Observation group
              Comments

              When using this element, an observation will typically have either a value or a set of related resources, although both may be present in some cases. For a discussion on the ways Observations can assembled in groups together, see Notes below. Note that a system may calculate results from QuestionnaireResponse into a final score and represent the score as an Observation.


              When using this element, an observation will typically have either a value or a set of related resources, although both may be present in some cases. For a discussion on the ways Observations can assembled in groups together, see Notes below. Note that a system may calculate results from QuestionnaireResponse into a final score and represent the score as an Observation.

              Control0..*
              TypeReference(MedicalTestResult (EU core), Observation, QuestionnaireResponse, MolecularSequence)
              Is Modifierfalse
              Summarytrue
              Requirements

              EHDSObservation.hasMember[x]

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              92. Observation.derivedFrom
              Definition

              The target resource that represents a measurement from which this observation value is derived. For example, a calculated anion gap or a fetal measurement based on an ultrasound image.

              ShortRelated measurements the observation is made from
              Comments

              All the reference choices that are listed in this element can represent clinical observations and other measurements that may be the source for a derived value. The most common reference will be another Observation. For a discussion on the ways Observations can assembled in groups together, see Notes below.

              Control0..*
              TypeReference(MedicalTestResult (EU core), ImagingStudy, DocumentReference, ImagingStudy, Media, QuestionnaireResponse, Observation, MolecularSequence)
              Is Modifierfalse
              Summarytrue
              Requirements

              EHDSObservation.derivedFrom[x]

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              94. Observation.component
              Definition

              Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

              ShortComponent results
              Comments

              For a discussion on the ways Observations can be assembled in groups together see Notes below.

              Control0..*
              TypeBackboneElement
              Is Modifierfalse
              Summarytrue
              Requirements

              EHDSObservation.component


              Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              96. Observation.component.modifierExtension
              Definition

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

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

              ShortExtensions that cannot be ignored even if unrecognized
              Comments

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

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

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

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

              Describes what was observed. Sometimes this is called the observation "code".

              ShortType of component observation (code / type)
              Comments

              All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

              Control1..1
              BindingThe codes SHOULD be taken from For example codes, see Laboratory Codehttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
              (preferred to http://hl7.eu/fhir/base/ValueSet/lab-obsCode-eu-lab)
              TypeCodeableConcept
              Is Modifierfalse
              Summarytrue
              Requirements

              EHDSObservation.component.code


              Knowing what kind of observation is being made is essential to understanding the observation.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              100. Observation.component.value[x]
              Definition

              The information determined as a result of making the observation, if the information has a simple value.

              ShortActual component result
              Comments

              Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control0..1
              TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              EHDSObservation.component.result.value[x]


              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              SlicingThis element introduces a set of slices on Observation.component.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • type @ $this
              • 102. Observation.component.value[x]:valueQuantity
                Slice NamevalueQuantity
                Definition

                The information determined as a result of making the observation, if the information has a simple value.

                ShortActual component result
                Comments

                Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                Control0..1
                TypeQuantity, dateTime, boolean, string, SampledData, Period, Ratio, integer, time, Range, CodeableConcept
                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                Is Modifierfalse
                Summarytrue
                Requirements

                An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                104. Observation.component.value[x]:valueQuantity.extension:uncertainty
                Slice Nameuncertainty
                Definition

                The primary measure of variance/uncertainty of the value (the square root of the sum of the squares of the differences between all data points and the mean).

                ShortStandard Deviation (same units as the quantity)
                Comments

                standardDeviation has the same units as the quantity. It is used to normalize the data for computing the distribution function. Applications that cannot deal with probability distributions can still get an idea about the confidence level by looking at standardDeviation.

                Control0..1
                TypeExtension(Uncertainty) (Extension Type: decimal)
                Is Modifierfalse
                Summaryfalse
                Requirements

                EHDSObservation.component.result.uncertainty

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                106. Observation.component.value[x]:valueQuantity.comparator
                Definition

                How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

                Short< | <= | >= | > - how to understand the value
                Control0..1
                BindingThe codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1
                (required to http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1)

                How the Quantity should be understood and represented.

                Typecode
                Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Summarytrue
                Requirements

                Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

                Meaning if MissingIf there is no comparator, then there is no modification of the value
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                108. Observation.component.dataAbsentReason
                Definition

                Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                ShortWhy the component result is missing
                Comments

                "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                Control0..1
                This element is affected by the following invariants: obs-6
                BindingUnless not suitable, these codes SHALL be taken from DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason|4.0.1
                (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason|4.0.1)

                Codes specifying why the result (Observation.value[x]) is missing.

                TypeCodeableConcept
                Is Modifierfalse
                Summaryfalse
                Requirements

                EHDSObservation.component.dataAbsentReason


                For many results it is necessary to handle exceptional values in measurements.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                110. Observation.component.interpretation
                Definition

                A categorical assessment of an observation value. For example, high, low, normal.

                ShortHigh, low, normal, etc.
                Comments

                Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                Control0..*
                BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretation|4.0.1
                (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation|4.0.1)

                Codes identifying interpretations of observations.

                TypeCodeableConcept
                Is Modifierfalse
                Summaryfalse
                Requirements

                EHDSObservation.component.interpretation


                For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                Alternate NamesAbnormal Flag
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                112. Observation.component.referenceRange
                Definition

                Guidance on how to interpret the value by comparison to a normal or recommended range.

                ShortProvides guide for interpretation of component result
                Comments

                Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                Control0..*
                TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                Is Modifierfalse
                Summaryfalse
                Requirements

                EHDSObservation.component.referenceRange


                Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

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

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

                0. Observation
                2. Observation.extension
                SlicingThis element introduces a set of slices on Observation.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 4. Observation.extension:bodyStructure
                  Slice NamebodyStructure
                  Control0..1
                  TypeExtension(Cross-version Extension for R5.Observation.bodyStructure for use in FHIR R4) (Extension Type: Reference)
                  Requirements

                  EHDSObservation.anatomicLocation

                  6. Observation.extension:triggeredBy
                  Slice NametriggeredBy
                  Control0..*
                  TypeExtension(Cross-version Extension for R5.Observation.triggeredBy for use in FHIR R4) (Extension Type: Choice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage, Meta)
                  8. Observation.extension:triggeredBy.extension:observation
                  Slice Nameobservation
                  10. Observation.extension:triggeredBy.extension:observation.extension
                  Control0..0
                  12. Observation.extension:triggeredBy.extension:observation.value[x]
                  TypeReference(MedicalTestResult (EU core))
                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                  Requirements

                  EHDSObservation.triggeredBy[x]

                  14. Observation.extension:triggeredBy.value[x]
                  Control0..0
                  16. Observation.extension:value-r5
                  Slice Namevalue-r5
                  Shortonly for result of type Attachment
                  Control0..1
                  TypeExtension(http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value%5Bx%5D)
                  18. Observation.extension:value-r5.value[x]
                  TypeAttachment
                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                  20. Observation.identifier
                  NoteThis is a business identifier, not a resource identifier (see discussion)
                  Requirements

                  EHDSObservation.header.identifier

                  22. Observation.basedOn
                  Requirements

                  EHDSObservation.order

                  24. Observation.status
                  Requirements

                  EHDSObservation.header.status

                  26. Observation.category
                  Control1..?
                  Requirements

                  EHDSObservation has no requirement

                  SlicingThis element introduces a set of slices on Observation.category. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • value @ $this
                  • 28. Observation.category:laboratory
                    Slice Namelaboratory
                    Control0..1
                    Pattern Value{
                      "coding" : [{
                        "system" : "http://terminology.hl7.org/CodeSystem/observation-category",
                        "code" : "laboratory"
                      }]
                    }
                    30. Observation.category:vital-signs
                    Slice Namevital-signs
                    Control0..1
                    Pattern Value{
                      "coding" : [{
                        "system" : "http://terminology.hl7.org/CodeSystem/observation-category",
                        "code" : "vital-signs"
                      }]
                    }
                    32. Observation.code
                    BindingThe codes SHOULD be taken from Laboratory Code
                    (preferred to http://hl7.eu/fhir/base/ValueSet/lab-obsCode-eu-lab)
                    Requirements

                    EHDSObservation.code

                    34. Observation.subject
                    Control1..?
                    TypeReference(Patient (EU core))
                    Requirements

                    EHDSObservation.header.subject

                    36. Observation.focus
                    TypeReference(Patient (EU core), RelatedPerson, Group, Device, Location (EU core))
                    Requirements

                    EHDSObservation.directSubject[x]

                    38. Observation.effective[x]
                    Control1..?
                    TypeChoice of: dateTime, Period, Timing, instant
                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Requirements

                    EHDSObservation.observationDate[x]

                    40. Observation.issued
                    Requirements

                    EHDSObservation.header.authorship.datetime

                    42. Observation.performer
                    TypeReference(Practitioner (EU core), PractitionerRole (EU core), Organization (EU core))
                    Requirements

                    EHDSObservation.header.performer

                    44. Observation.value[x]
                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                    Requirements

                    EHDSObservation.result.value[x]

                    SlicingThis element introduces a set of slices on Observation.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                    • type @ $this
                    • 46. Observation.value[x]:valueQuantity
                      Slice NamevalueQuantity
                      Control0..1
                      TypeQuantity
                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                      48. Observation.value[x]:valueQuantity.extension:uncertainty
                      Slice Nameuncertainty
                      Control0..1
                      TypeExtension(Uncertainty) (Extension Type: decimal)
                      Requirements

                      EHDSObservation.result.uncertainty

                      50. Observation.dataAbsentReason
                      Requirements

                      EHDSObservation.dataAbsentReason

                      52. Observation.interpretation
                      Requirements

                      EHDSObservation.interpretation

                      54. Observation.note
                      Requirements

                      EHDSObservation.resultDescription

                      56. Observation.bodySite
                      Requirements

                      EHDSObservation.anatomicLocation

                      58. Observation.method
                      Requirements

                      EHDSObservation.method

                      60. Observation.device
                      Requirements

                      Device information for laboratory observations

                      62. Observation.referenceRange
                      Requirements

                      EHDSObservation.referenceRange

                      64. Observation.hasMember
                      TypeReference(MedicalTestResult (EU core))
                      Requirements

                      EHDSObservation.hasMember[x]

                      66. Observation.derivedFrom
                      TypeReference(MedicalTestResult (EU core), ImagingStudy)
                      Requirements

                      EHDSObservation.derivedFrom[x]

                      68. Observation.component
                      Requirements

                      EHDSObservation.component

                      70. Observation.component.code
                      BindingThe codes SHOULD be taken from Laboratory Code
                      (preferred to http://hl7.eu/fhir/base/ValueSet/lab-obsCode-eu-lab)
                      Requirements

                      EHDSObservation.component.code

                      72. Observation.component.value[x]
                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                      Requirements

                      EHDSObservation.component.result.value[x]

                      SlicingThis element introduces a set of slices on Observation.component.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                      • type @ $this
                      • 74. Observation.component.value[x]:valueQuantity
                        Slice NamevalueQuantity
                        Control0..1
                        TypeQuantity
                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                        76. Observation.component.value[x]:valueQuantity.extension:uncertainty
                        Slice Nameuncertainty
                        Control0..1
                        TypeExtension(Uncertainty) (Extension Type: decimal)
                        Requirements

                        EHDSObservation.component.result.uncertainty

                        78. Observation.component.dataAbsentReason
                        Requirements

                        EHDSObservation.component.dataAbsentReason

                        80. Observation.component.interpretation
                        Requirements

                        EHDSObservation.component.interpretation

                        82. Observation.component.referenceRange
                        Requirements

                        EHDSObservation.component.referenceRange

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

                        0. Observation
                        Definition

                        Measurements and simple assertions made about a patient, device or other subject.

                        ShortMeasurements and simple assertions
                        Comments

                        Used for simple observations such as device measurements, laboratory atomic results, vital signs, height, weight, smoking status, comments, etc. Other resources are used to provide context for observations such as laboratory reports, etc.

                        Control0..*
                        Is Modifierfalse
                        Summaryfalse
                        Alternate NamesVital Signs, Measurement, Results, Tests
                        Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
                        dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
                        dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
                        dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
                        dom-6: A resource should have narrative for robust management (text.`div`.exists())
                        obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
                        obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
                        2. Observation.id
                        Definition

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

                        ShortLogical id of this artifact
                        Comments

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

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

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

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

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

                        ShortA set of rules under which this content was created
                        Comments

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

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

                        The base language in which the resource is written.

                        ShortLanguage of the resource content
                        Comments

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

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

                        A human language.

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

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

                        ShortText summary of the resource, for human interpretation
                        Comments

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

                        Control0..1
                        TypeNarrative
                        Is Modifierfalse
                        Summaryfalse
                        Alternate Namesnarrative, html, xhtml, display
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        12. Observation.contained
                        Definition

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

                        ShortContained, inline Resources
                        Comments

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

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

                        An Extension

                        ShortExtension
                        Control0..*
                        TypeExtension
                        Is Modifierfalse
                        Summaryfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        SlicingThis element introduces a set of slices on Observation.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                        • value @ url
                        • 16. Observation.extension:bodyStructure
                          Slice NamebodyStructure
                          Definition

                          Indicates the body structure on the subject's body where the observation was made (i.e. the target site).

                          ShortObserved body structure
                          Control0..1
                          This element is affected by the following invariants: ele-1
                          TypeExtension(Cross-version Extension for R5.Observation.bodyStructure for use in FHIR R4) (Extension Type: Reference)
                          Is Modifierfalse
                          Summaryfalse
                          Requirements

                          EHDSObservation.anatomicLocation

                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          18. Observation.extension:triggeredBy
                          Slice NametriggeredBy
                          Definition

                          Identifies the observation(s) that triggered the performance of this observation.

                          ShortTriggering observation(s)
                          Control0..*
                          This element is affected by the following invariants: ele-1
                          TypeExtension(Cross-version Extension for R5.Observation.triggeredBy for use in FHIR R4) (Extension Type: Choice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage, Meta)
                          Is Modifierfalse
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          20. Observation.extension:triggeredBy.id
                          Definition

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

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

                          An Extension

                          ShortExtension
                          Control2..*
                          TypeExtension
                          Is Modifierfalse
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          SlicingThis element introduces a set of slices on Observation.extension.extension. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                          • value @ url
                          • 24. Observation.extension:triggeredBy.extension:observation
                            Slice Nameobservation
                            Definition

                            An Extension

                            ShortExtension
                            Control1..1
                            TypeExtension
                            Is Modifierfalse
                            Summaryfalse
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                            26. Observation.extension:triggeredBy.extension:observation.id
                            Definition

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

                            ShortUnique id for inter-element referencing
                            Control0..1
                            Typestring
                            Is Modifierfalse
                            XML FormatIn the XML format, this property is represented as an attribute.
                            Summaryfalse
                            28. Observation.extension:triggeredBy.extension:observation.extension
                            Definition

                            An Extension

                            ShortExtension
                            Control0..0
                            TypeExtension
                            Is Modifierfalse
                            Summaryfalse
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                            SlicingThis element introduces a set of slices on Observation.extension.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                            • value @ url
                            • 30. Observation.extension:triggeredBy.extension:observation.url
                              Definition

                              Source of the definition for the extension code - a logical name or a URL.

                              Shortidentifies the meaning of the extension
                              Comments

                              The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

                              Control1..1
                              Typeuri
                              Is Modifierfalse
                              XML FormatIn the XML format, this property is represented as an attribute.
                              Summaryfalse
                              Fixed Valueobservation
                              32. Observation.extension:triggeredBy.extension:observation.value[x]
                              Definition

                              Reference to the triggering observation.

                              ShortTriggering observation
                              Control0..1
                              TypeReference(MedicalTestResult (EU core))
                              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                              Is Modifierfalse
                              Summaryfalse
                              Requirements

                              EHDSObservation.triggeredBy[x]

                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              34. Observation.extension:triggeredBy.extension:type
                              Slice Nametype
                              Definition

                              The type of trigger. Reflex | Repeat | Re-run.

                              Shortreflex | repeat | re-run
                              Control1..1
                              TypeExtension
                              Is Modifierfalse
                              Summaryfalse
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                              36. Observation.extension:triggeredBy.extension:type.id
                              Definition

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

                              ShortUnique id for inter-element referencing
                              Control0..1
                              Typestring
                              Is Modifierfalse
                              XML FormatIn the XML format, this property is represented as an attribute.
                              Summaryfalse
                              38. Observation.extension:triggeredBy.extension:type.extension
                              Definition

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

                              ShortAdditional content defined by implementations
                              Comments

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

                              Control0..*
                              TypeExtension
                              Is Modifierfalse
                              Summaryfalse
                              Alternate Namesextensions, user content
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                              SlicingThis element introduces a set of slices on Observation.extension.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                              • value @ url
                              • 40. Observation.extension:triggeredBy.extension:type.url
                                Definition

                                Source of the definition for the extension code - a logical name or a URL.

                                Shortidentifies the meaning of the extension
                                Comments

                                The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

                                Control1..1
                                Typeuri
                                Is Modifierfalse
                                XML FormatIn the XML format, this property is represented as an attribute.
                                Summaryfalse
                                Fixed Valuetype
                                42. Observation.extension:triggeredBy.extension:type.value[x]
                                Definition

                                The type of trigger. Reflex | Repeat | Re-run.

                                Shortreflex | repeat | re-run
                                Control0..1
                                BindingThe codes SHALL be taken from R5_observation_triggeredbytype_for_R4 (0.0.1-snapshot-2)
                                (required to http://hl7.org/fhir/5.0/ValueSet/R5-observation-triggeredbytype-for-R4|0.0.1-snapshot-2)

                                The type of TriggeredBy Observation.

                                Typecode
                                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                Is Modifierfalse
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Summaryfalse
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                44. Observation.extension:triggeredBy.extension:reason
                                Slice Namereason
                                Definition

                                Provides the reason why this observation was performed as a result of the observation(s) referenced.

                                ShortReason that the observation was triggered
                                Control0..1
                                TypeExtension
                                Is Modifierfalse
                                Summaryfalse
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                46. Observation.extension:triggeredBy.extension:reason.id
                                Definition

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

                                ShortUnique id for inter-element referencing
                                Control0..1
                                Typestring
                                Is Modifierfalse
                                XML FormatIn the XML format, this property is represented as an attribute.
                                Summaryfalse
                                48. Observation.extension:triggeredBy.extension:reason.extension
                                Definition

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

                                ShortAdditional content defined by implementations
                                Comments

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

                                Control0..*
                                TypeExtension
                                Is Modifierfalse
                                Summaryfalse
                                Alternate Namesextensions, user content
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                SlicingThis element introduces a set of slices on Observation.extension.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                • value @ url
                                • 50. Observation.extension:triggeredBy.extension:reason.url
                                  Definition

                                  Source of the definition for the extension code - a logical name or a URL.

                                  Shortidentifies the meaning of the extension
                                  Comments

                                  The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

                                  Control1..1
                                  Typeuri
                                  Is Modifierfalse
                                  XML FormatIn the XML format, this property is represented as an attribute.
                                  Summaryfalse
                                  Fixed Valuereason
                                  52. Observation.extension:triggeredBy.extension:reason.value[x]
                                  Definition

                                  Provides the reason why this observation was performed as a result of the observation(s) referenced.

                                  ShortReason that the observation was triggered
                                  Control0..1
                                  Typestring
                                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Summaryfalse
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  54. Observation.extension:triggeredBy.url
                                  Definition

                                  Source of the definition for the extension code - a logical name or a URL.

                                  Shortidentifies the meaning of the extension
                                  Comments

                                  The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

                                  Control1..1
                                  Typeuri
                                  Is Modifierfalse
                                  XML FormatIn the XML format, this property is represented as an attribute.
                                  Summaryfalse
                                  Fixed Valuehttp://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy
                                  56. Observation.extension:triggeredBy.value[x]
                                  Definition

                                  Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

                                  ShortValue of extension
                                  Control0..0
                                  TypeChoice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage, Meta
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Summaryfalse
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  58. Observation.extension:value-r5
                                  Slice Namevalue-r5
                                  Definition

                                  Optional Extension Element - found in all resources.

                                  Shortonly for result of type Attachment
                                  Control0..1
                                  This element is affected by the following invariants: ele-1
                                  TypeExtension(http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value%5Bx%5D)
                                  Is Modifierfalse
                                  Summaryfalse
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                  60. Observation.extension:value-r5.id
                                  Definition

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

                                  ShortUnique id for inter-element referencing
                                  Control0..1
                                  Typestring
                                  Is Modifierfalse
                                  XML FormatIn the XML format, this property is represented as an attribute.
                                  Summaryfalse
                                  62. Observation.extension:value-r5.extension
                                  Definition

                                  An Extension

                                  ShortExtension
                                  Control0..0
                                  TypeExtension
                                  Is Modifierfalse
                                  Summaryfalse
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                  SlicingThis element introduces a set of slices on Observation.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                  • value @ url
                                  • 64. Observation.extension:value-r5.url
                                    Definition

                                    Source of the definition for the extension code - a logical name or a URL.

                                    Shortidentifies the meaning of the extension
                                    Comments

                                    The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

                                    Control1..1
                                    Typeuri
                                    Is Modifierfalse
                                    XML FormatIn the XML format, this property is represented as an attribute.
                                    Summaryfalse
                                    Fixed Valuehttp://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]
                                    66. Observation.extension:value-r5.value[x]
                                    Definition

                                    Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

                                    ShortValue of extension
                                    Control1..1
                                    TypeAttachment
                                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                    Is Modifierfalse
                                    Summaryfalse
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    68. Observation.modifierExtension
                                    Definition

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

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

                                    ShortExtensions that cannot be ignored
                                    Comments

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

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

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

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

                                    A unique identifier assigned to this observation.

                                    ShortBusiness Identifier for observation
                                    NoteThis is a business identifier, not a resource identifier (see discussion)
                                    Control0..*
                                    TypeIdentifier
                                    Is Modifierfalse
                                    Summarytrue
                                    Requirements

                                    EHDSObservation.header.identifier

                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    72. Observation.basedOn
                                    Definition

                                    A plan, proposal or order that is fulfilled in whole or in part by this event. For example, a MedicationRequest may require a patient to have laboratory test performed before it is dispensed.

                                    ShortFulfills plan, proposal or order
                                    Control0..*
                                    TypeReference(CarePlan, DeviceRequest, ImmunizationRecommendation, MedicationRequest, NutritionOrder, ServiceRequest)
                                    Is Modifierfalse
                                    Summarytrue
                                    Requirements

                                    EHDSObservation.order

                                    Alternate NamesFulfills
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    74. Observation.partOf
                                    Definition

                                    A larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure.

                                    ShortPart of referenced event
                                    Comments

                                    To link an Observation to an Encounter use encounter. See the Notes below for guidance on referencing another Observation.

                                    Control0..*
                                    TypeReference(MedicationAdministration, MedicationDispense, MedicationStatement, Procedure, Immunization, ImagingStudy)
                                    Is Modifierfalse
                                    Summarytrue
                                    Alternate NamesContainer
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    76. Observation.status
                                    Definition

                                    The status of the result value.

                                    Shortregistered | preliminary | final | amended +
                                    Comments

                                    This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

                                    Control1..1
                                    BindingThe codes SHALL be taken from ObservationStatus
                                    (required to http://hl7.org/fhir/ValueSet/observation-status|4.0.1)

                                    Codes providing the status of an observation.

                                    Typecode
                                    Is Modifiertrue 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 ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Summarytrue
                                    Requirements

                                    EHDSObservation.header.status

                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    78. Observation.category
                                    Definition

                                    A code that classifies the general type of observation being made.

                                    ShortClassification of type of observation
                                    Comments

                                    In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

                                    Control1..*
                                    BindingThe codes SHOULD be taken from ObservationCategoryCodes
                                    (preferred to http://hl7.org/fhir/ValueSet/observation-category|4.0.1)

                                    Codes for high level observation categories.

                                    TypeCodeableConcept
                                    Is Modifierfalse
                                    Summaryfalse
                                    Requirements

                                    EHDSObservation has no requirement

                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    SlicingThis element introduces a set of slices on Observation.category. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                    • value @ $this
                                    • 80. Observation.category:laboratory
                                      Slice Namelaboratory
                                      Definition

                                      A code that classifies the general type of observation being made.

                                      ShortClassification of type of observation
                                      Comments

                                      In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

                                      Control0..1
                                      BindingThe codes SHOULD be taken from ObservationCategoryCodes
                                      (preferred to http://hl7.org/fhir/ValueSet/observation-category|4.0.1)

                                      Codes for high level observation categories.

                                      TypeCodeableConcept
                                      Is Modifierfalse
                                      Summaryfalse
                                      Requirements

                                      Used for filtering what observations are retrieved and displayed.

                                      Pattern Value{
                                        "coding" : [{
                                          "system" : "http://terminology.hl7.org/CodeSystem/observation-category",
                                          "code" : "laboratory"
                                        }]
                                      }
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      82. Observation.category:vital-signs
                                      Slice Namevital-signs
                                      Definition

                                      A code that classifies the general type of observation being made.

                                      ShortClassification of type of observation
                                      Comments

                                      In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

                                      Control0..1
                                      BindingThe codes SHOULD be taken from ObservationCategoryCodes
                                      (preferred to http://hl7.org/fhir/ValueSet/observation-category|4.0.1)

                                      Codes for high level observation categories.

                                      TypeCodeableConcept
                                      Is Modifierfalse
                                      Summaryfalse
                                      Requirements

                                      Used for filtering what observations are retrieved and displayed.

                                      Pattern Value{
                                        "coding" : [{
                                          "system" : "http://terminology.hl7.org/CodeSystem/observation-category",
                                          "code" : "vital-signs"
                                        }]
                                      }
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      84. Observation.code
                                      Definition

                                      Describes what was observed. Sometimes this is called the observation "name".

                                      ShortType of observation (code / type)
                                      Comments

                                      All code-value and, if present, component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                      Control1..1
                                      BindingThe codes SHOULD be taken from Laboratory Code
                                      (preferred to http://hl7.eu/fhir/base/ValueSet/lab-obsCode-eu-lab)
                                      TypeCodeableConcept
                                      Is Modifierfalse
                                      Summarytrue
                                      Requirements

                                      EHDSObservation.code

                                      Alternate NamesName
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      86. Observation.subject
                                      Definition

                                      The patient, or group of patients, location, or device this observation is about and into whose record the observation is placed. If the actual focus of the observation is different from the subject (or a sample of, part, or region of the subject), the focus element or the code itself specifies the actual focus of the observation.

                                      ShortWho and/or what the observation is about
                                      Comments

                                      One would expect this element to be a cardinality of 1..1. The only circumstance in which the subject can be missing is when the observation is made by a device that does not know the patient. In this case, the observation SHALL be matched to a patient through some context/channel matching technique, and at this point, the observation should be updated.

                                      Control1..1
                                      TypeReference(Patient (EU core))
                                      Is Modifierfalse
                                      Summarytrue
                                      Requirements

                                      EHDSObservation.header.subject

                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      88. Observation.focus
                                      Definition

                                      The actual focus of an observation when it is not the patient of record representing something or someone associated with the patient such as a spouse, parent, fetus, or donor. For example, fetus observations in a mother's record. The focus of an observation could also be an existing condition, an intervention, the subject's diet, another observation of the subject, or a body structure such as tumor or implanted device. An example use case would be using the Observation resource to capture whether the mother is trained to change her child's tracheostomy tube. In this example, the child is the patient of record and the mother is the focus.

                                      ShortWhat the observation is about, when it is not about the subject of record
                                      Comments

                                      Typically, an observation is made about the subject - a patient, or group of patients, location, or device - and the distinction between the subject and what is directly measured for an observation is specified in the observation code itself ( e.g., "Blood Glucose") and does not need to be represented separately using this element. Use specimen if a reference to a specimen is required. If a code is required instead of a resource use either bodysite for bodysites or the standard extension focusCode.

                                      Control0..*
                                      TypeReference(Patient (EU core), RelatedPerson, Group, Device, Location (EU core))
                                      Is Modifierfalse
                                      Summarytrue
                                      Requirements

                                      EHDSObservation.directSubject[x]

                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      90. Observation.encounter
                                      Definition

                                      The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made.

                                      ShortHealthcare event during which this observation is made
                                      Comments

                                      This will typically be the encounter the event occurred within, but some events may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission laboratory tests).

                                      Control0..1
                                      TypeReference(Encounter)
                                      Is Modifierfalse
                                      Summarytrue
                                      Requirements

                                      For some observations it may be important to know the link between an observation and a particular encounter.

                                      Alternate NamesContext
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      92. Observation.effective[x]
                                      Definition

                                      The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the "physiologically relevant time". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself.

                                      ShortClinically relevant time/time-period for observation
                                      Comments

                                      At least a date should be present unless this observation is a historical report. For recording imprecise or "fuzzy" times (For example, a blood glucose measurement taken "after breakfast") use the Timing datatype which allow the measurement to be tied to regular life events.

                                      Control1..1
                                      TypeChoice of: dateTime, Period
                                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Summarytrue
                                      Requirements

                                      EHDSObservation.observationDate[x]

                                      Alternate NamesOccurrence
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      94. Observation.issued
                                      Definition

                                      The date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified.

                                      ShortDate/Time this version was made available
                                      Comments

                                      For Observations that don’t require review and verification, it may be the same as the lastUpdated time of the resource itself. For Observations that do require review and verification for certain updates, it might not be the same as the lastUpdated time of the resource itself due to a non-clinically significant update that doesn’t require the new version to be reviewed and verified again.

                                      Control0..1
                                      Typeinstant
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Summarytrue
                                      Requirements

                                      EHDSObservation.header.authorship.datetime

                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      96. Observation.performer
                                      Definition

                                      Who was responsible for asserting the observed value as "true".

                                      ShortWho is responsible for the observation
                                      Control0..*
                                      TypeReference(Practitioner (EU core), PractitionerRole (EU core), Organization (EU core))
                                      Is Modifierfalse
                                      Summarytrue
                                      Requirements

                                      EHDSObservation.header.performer

                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      98. Observation.value[x]
                                      Definition

                                      The information determined as a result of making the observation, if the information has a simple value.

                                      ShortActual result
                                      Comments

                                      An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                      Control0..1
                                      This element is affected by the following invariants: obs-7
                                      TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
                                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Summarytrue
                                      Requirements

                                      EHDSObservation.result.value[x]

                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      SlicingThis element introduces a set of slices on Observation.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                      • type @ $this
                                      • 100. Observation.value[x]:valueQuantity
                                        Slice NamevalueQuantity
                                        Definition

                                        The information determined as a result of making the observation, if the information has a simple value.

                                        ShortActual result
                                        Comments

                                        An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                        Control0..1
                                        This element is affected by the following invariants: obs-7
                                        TypeQuantity
                                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                        Is Modifierfalse
                                        Summarytrue
                                        Requirements

                                        An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        102. Observation.value[x]:valueQuantity.id
                                        Definition

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

                                        ShortUnique id for inter-element referencing
                                        Control0..1
                                        Typestring
                                        Is Modifierfalse
                                        XML FormatIn the XML format, this property is represented as an attribute.
                                        Summaryfalse
                                        104. Observation.value[x]:valueQuantity.extension
                                        Definition

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

                                        ShortAdditional content defined by implementations
                                        Comments

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

                                        Control0..*
                                        TypeExtension
                                        Is Modifierfalse
                                        Summaryfalse
                                        Alternate Namesextensions, user content
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                        SlicingThis element introduces a set of slices on Observation.value[x].extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                        • value @ url
                                        • 106. Observation.value[x]:valueQuantity.extension:uncertainty
                                          Slice Nameuncertainty
                                          Definition

                                          The primary measure of variance/uncertainty of the value (the square root of the sum of the squares of the differences between all data points and the mean).

                                          ShortStandard Deviation (same units as the quantity)
                                          Comments

                                          standardDeviation has the same units as the quantity. It is used to normalize the data for computing the distribution function. Applications that cannot deal with probability distributions can still get an idea about the confidence level by looking at standardDeviation.

                                          Control0..1
                                          TypeExtension(Uncertainty) (Extension Type: decimal)
                                          Is Modifierfalse
                                          Summaryfalse
                                          Requirements

                                          EHDSObservation.result.uncertainty

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                          108. Observation.value[x]:valueQuantity.value
                                          Definition

                                          The value of the measured amount. The value includes an implicit precision in the presentation of the value.

                                          ShortNumerical value (with implicit precision)
                                          Comments

                                          The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).

                                          Control0..1
                                          Typedecimal
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Summarytrue
                                          Requirements

                                          Precision is handled implicitly in almost all cases of measurement.

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          110. Observation.value[x]:valueQuantity.comparator
                                          Definition

                                          How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

                                          Short< | <= | >= | > - how to understand the value
                                          Control0..1
                                          BindingThe codes SHALL be taken from QuantityComparator
                                          (required to http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1)

                                          How the Quantity should be understood and represented.

                                          Typecode
                                          Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Summarytrue
                                          Requirements

                                          Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

                                          Meaning if MissingIf there is no comparator, then there is no modification of the value
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          112. Observation.value[x]:valueQuantity.unit
                                          Definition

                                          A human-readable form of the unit.

                                          ShortUnit representation
                                          Control0..1
                                          Typestring
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Summarytrue
                                          Requirements

                                          There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          114. Observation.value[x]:valueQuantity.system
                                          Definition

                                          The identification of the system that provides the coded form of the unit.

                                          ShortSystem that defines coded unit form
                                          Control0..1
                                          This element is affected by the following invariants: qty-3
                                          Typeuri
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Summarytrue
                                          Requirements

                                          Need to know the system that defines the coded form of the unit.

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          116. Observation.value[x]:valueQuantity.code
                                          Definition

                                          A computer processable form of the unit in some unit representation system.

                                          ShortCoded form of the unit
                                          Comments

                                          The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.

                                          Control0..1
                                          Typecode
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Summarytrue
                                          Requirements

                                          Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          118. Observation.dataAbsentReason
                                          Definition

                                          Provides a reason why the expected value in the element Observation.value[x] is missing.

                                          ShortWhy the result is missing
                                          Comments

                                          Null or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "specimen unsatisfactory".

                                          The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Note that an observation may only be reported if there are values to report. For example differential cell counts values may be reported only when > 0. Because of these options, use-case agreements are required to interpret general observations for null or exceptional values.

                                          Control0..1
                                          This element is affected by the following invariants: obs-6
                                          BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                          (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason|4.0.1)

                                          Codes specifying why the result (Observation.value[x]) is missing.

                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Summaryfalse
                                          Requirements

                                          EHDSObservation.dataAbsentReason

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          120. Observation.interpretation
                                          Definition

                                          A categorical assessment of an observation value. For example, high, low, normal.

                                          ShortHigh, low, normal, etc.
                                          Comments

                                          Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                          Control0..*
                                          BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                          (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation|4.0.1)

                                          Codes identifying interpretations of observations.

                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Summaryfalse
                                          Requirements

                                          EHDSObservation.interpretation

                                          Alternate NamesAbnormal Flag
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          122. Observation.note
                                          Definition

                                          Comments about the observation or the results.

                                          ShortComments about the observation
                                          Comments

                                          May include general statements about the observation, or statements about significant, unexpected or unreliable results values, or information about its source when relevant to its interpretation.

                                          Control0..*
                                          TypeAnnotation
                                          Is Modifierfalse
                                          Summaryfalse
                                          Requirements

                                          EHDSObservation.resultDescription

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          124. Observation.bodySite
                                          Definition

                                          Indicates the site on the subject's body where the observation was made (i.e. the target site).

                                          ShortObserved body part
                                          Comments

                                          Only used if not implicit in code found in Observation.code. In many systems, this may be represented as a related observation instead of an inline component.

                                          If the use case requires BodySite to be handled as a separate resource (e.g. to identify and track separately) then use the standard extension bodySite.

                                          Control0..1
                                          BindingFor example codes, see SNOMEDCTBodyStructures
                                          (example to http://hl7.org/fhir/ValueSet/body-site|4.0.1)

                                          Codes describing anatomical locations. May include laterality.

                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Summaryfalse
                                          Requirements

                                          EHDSObservation.anatomicLocation

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          126. Observation.method
                                          Definition

                                          Indicates the mechanism used to perform the observation.

                                          ShortHow it was done
                                          Comments

                                          Only used if not implicit in code for Observation.code.

                                          Control0..1
                                          BindingFor example codes, see ObservationMethods
                                          (example to http://hl7.org/fhir/ValueSet/observation-methods|4.0.1)

                                          Methods for simple observations.

                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Summaryfalse
                                          Requirements

                                          EHDSObservation.method

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          128. Observation.specimen
                                          Definition

                                          The specimen that was used when this observation was made.

                                          ShortSpecimen used for this observation
                                          Comments

                                          Should only be used if not implicit in code found in Observation.code. Observations are not made on specimens themselves; they are made on a subject, but in many cases by the means of a specimen. Note that although specimens are often involved, they are not always tracked and reported explicitly. Also note that observation resources may be used in contexts that track the specimen explicitly (e.g. Diagnostic Report).

                                          Control0..1
                                          TypeReference(Specimen)
                                          Is Modifierfalse
                                          Summaryfalse
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          130. Observation.device
                                          Definition

                                          The device used to generate the observation data.

                                          Short(Measurement) Device
                                          Comments

                                          Note that this is not meant to represent a device involved in the transmission of the result, e.g., a gateway. Such devices may be documented using the Provenance resource where relevant.

                                          Control0..1
                                          TypeReference(Device, DeviceMetric)
                                          Is Modifierfalse
                                          Summaryfalse
                                          Requirements

                                          Device information for laboratory observations

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          132. Observation.referenceRange
                                          Definition

                                          Guidance on how to interpret the value by comparison to a normal or recommended range. Multiple reference ranges are interpreted as an "OR". In other words, to represent two distinct target populations, two referenceRange elements would be used.

                                          ShortProvides guide for interpretation
                                          Comments

                                          Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                          Control0..*
                                          TypeBackboneElement
                                          Is Modifierfalse
                                          Summaryfalse
                                          Requirements

                                          EHDSObservation.referenceRange

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          obs-3: Must have at least a low or a high or text (low.exists() or high.exists() or text.exists())
                                          134. Observation.referenceRange.id
                                          Definition

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

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

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

                                          ShortAdditional content defined by implementations
                                          Comments

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

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

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

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

                                          ShortExtensions that cannot be ignored even if unrecognized
                                          Comments

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

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

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

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

                                          The value of the low bound of the reference range. The low bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the low bound is omitted, it is assumed to be meaningless (e.g. reference range is <=2.3).

                                          ShortLow Range, if relevant
                                          Control0..1
                                          This element is affected by the following invariants: obs-3
                                          TypeQuantity(SimpleQuantity)
                                          Is Modifierfalse
                                          Summaryfalse
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          142. Observation.referenceRange.high
                                          Definition

                                          The value of the high bound of the reference range. The high bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the high bound is omitted, it is assumed to be meaningless (e.g. reference range is >= 2.3).

                                          ShortHigh Range, if relevant
                                          Control0..1
                                          This element is affected by the following invariants: obs-3
                                          TypeQuantity(SimpleQuantity)
                                          Is Modifierfalse
                                          Summaryfalse
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          144. Observation.referenceRange.type
                                          Definition

                                          Codes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range.

                                          ShortReference range qualifier
                                          Comments

                                          This SHOULD be populated if there is more than one range. If this element is not present then the normal range is assumed.

                                          Control0..1
                                          BindingThe codes SHOULD be taken from ObservationReferenceRangeMeaningCodes
                                          (preferred to http://hl7.org/fhir/ValueSet/referencerange-meaning|4.0.1)

                                          Code for the meaning of a reference range.

                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Summaryfalse
                                          Requirements

                                          Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, etc., - for proper interpretation.

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          146. Observation.referenceRange.appliesTo
                                          Definition

                                          Codes to indicate the target population this reference range applies to. For example, a reference range may be based on the normal population or a particular sex or race. Multiple appliesTo are interpreted as an "AND" of the target populations. For example, to represent a target population of African American females, both a code of female and a code for African American would be used.

                                          ShortReference range population
                                          Comments

                                          This SHOULD be populated if there is more than one range. If this element is not present then the normal population is assumed.

                                          Control0..*
                                          BindingFor example codes, see ObservationReferenceRangeAppliesToCodes
                                          (example to http://hl7.org/fhir/ValueSet/referencerange-appliesto|4.0.1)

                                          Codes identifying the population the reference range applies to.

                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Summaryfalse
                                          Requirements

                                          Need to be able to identify the target population for proper interpretation.

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          148. Observation.referenceRange.age
                                          Definition

                                          The age at which this reference range is applicable. This is a neonatal age (e.g. number of weeks at term) if the meaning says so.

                                          ShortApplicable age range, if relevant
                                          Control0..1
                                          TypeRange
                                          Is Modifierfalse
                                          Summaryfalse
                                          Requirements

                                          Some analytes vary greatly over age.

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          150. Observation.referenceRange.text
                                          Definition

                                          Text based reference range in an observation which may be used when a quantitative range is not appropriate for an observation. An example would be a reference value of "Negative" or a list or table of "normals".

                                          ShortText based reference range in an observation
                                          Control0..1
                                          Typestring
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Summaryfalse
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          152. Observation.hasMember
                                          Definition

                                          This observation is a group observation (e.g. a battery, a panel of tests, a set of vital sign measurements) that includes the target as a member of the group.

                                          ShortRelated resource that belongs to the Observation group
                                          Comments

                                          When using this element, an observation will typically have either a value or a set of related resources, although both may be present in some cases. For a discussion on the ways Observations can assembled in groups together, see Notes below. Note that a system may calculate results from QuestionnaireResponse into a final score and represent the score as an Observation.

                                          Control0..*
                                          TypeReference(MedicalTestResult (EU core))
                                          Is Modifierfalse
                                          Summarytrue
                                          Requirements

                                          EHDSObservation.hasMember[x]

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          154. Observation.derivedFrom
                                          Definition

                                          The target resource that represents a measurement from which this observation value is derived. For example, a calculated anion gap or a fetal measurement based on an ultrasound image.

                                          ShortRelated measurements the observation is made from
                                          Comments

                                          All the reference choices that are listed in this element can represent clinical observations and other measurements that may be the source for a derived value. The most common reference will be another Observation. For a discussion on the ways Observations can assembled in groups together, see Notes below.

                                          Control0..*
                                          TypeReference(MedicalTestResult (EU core), ImagingStudy)
                                          Is Modifierfalse
                                          Summarytrue
                                          Requirements

                                          EHDSObservation.derivedFrom[x]

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          156. Observation.component
                                          Definition

                                          Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

                                          ShortComponent results
                                          Comments

                                          For a discussion on the ways Observations can be assembled in groups together see Notes below.

                                          Control0..*
                                          TypeBackboneElement
                                          Is Modifierfalse
                                          Summarytrue
                                          Requirements

                                          EHDSObservation.component

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          158. Observation.component.id
                                          Definition

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

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

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

                                          ShortAdditional content defined by implementations
                                          Comments

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

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

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

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

                                          ShortExtensions that cannot be ignored even if unrecognized
                                          Comments

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

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

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

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

                                          Describes what was observed. Sometimes this is called the observation "code".

                                          ShortType of component observation (code / type)
                                          Comments

                                          All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

                                          Control1..1
                                          BindingThe codes SHOULD be taken from Laboratory Code
                                          (preferred to http://hl7.eu/fhir/base/ValueSet/lab-obsCode-eu-lab)
                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Summarytrue
                                          Requirements

                                          EHDSObservation.component.code

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          166. Observation.component.value[x]
                                          Definition

                                          The information determined as a result of making the observation, if the information has a simple value.

                                          ShortActual component result
                                          Comments

                                          Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                          Control0..1
                                          TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
                                          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Summarytrue
                                          Requirements

                                          EHDSObservation.component.result.value[x]

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          SlicingThis element introduces a set of slices on Observation.component.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                          • type @ $this
                                          • 168. Observation.component.value[x]:valueQuantity
                                            Slice NamevalueQuantity
                                            Definition

                                            The information determined as a result of making the observation, if the information has a simple value.

                                            ShortActual component result
                                            Comments

                                            Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

                                            Control0..1
                                            TypeQuantity
                                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                            Is Modifierfalse
                                            Summarytrue
                                            Requirements

                                            An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            170. Observation.component.value[x]:valueQuantity.id
                                            Definition

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

                                            ShortUnique id for inter-element referencing
                                            Control0..1
                                            Typestring
                                            Is Modifierfalse
                                            XML FormatIn the XML format, this property is represented as an attribute.
                                            Summaryfalse
                                            172. Observation.component.value[x]:valueQuantity.extension
                                            Definition

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

                                            ShortAdditional content defined by implementations
                                            Comments

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

                                            Control0..*
                                            TypeExtension
                                            Is Modifierfalse
                                            Summaryfalse
                                            Alternate Namesextensions, user content
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                            SlicingThis element introduces a set of slices on Observation.component.value[x].extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                            • value @ url
                                            • 174. Observation.component.value[x]:valueQuantity.extension:uncertainty
                                              Slice Nameuncertainty
                                              Definition

                                              The primary measure of variance/uncertainty of the value (the square root of the sum of the squares of the differences between all data points and the mean).

                                              ShortStandard Deviation (same units as the quantity)
                                              Comments

                                              standardDeviation has the same units as the quantity. It is used to normalize the data for computing the distribution function. Applications that cannot deal with probability distributions can still get an idea about the confidence level by looking at standardDeviation.

                                              Control0..1
                                              TypeExtension(Uncertainty) (Extension Type: decimal)
                                              Is Modifierfalse
                                              Summaryfalse
                                              Requirements

                                              EHDSObservation.component.result.uncertainty

                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                              176. Observation.component.value[x]:valueQuantity.value
                                              Definition

                                              The value of the measured amount. The value includes an implicit precision in the presentation of the value.

                                              ShortNumerical value (with implicit precision)
                                              Comments

                                              The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).

                                              Control0..1
                                              Typedecimal
                                              Is Modifierfalse
                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                              Summarytrue
                                              Requirements

                                              Precision is handled implicitly in almost all cases of measurement.

                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              178. Observation.component.value[x]:valueQuantity.comparator
                                              Definition

                                              How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

                                              Short< | <= | >= | > - how to understand the value
                                              Control0..1
                                              BindingThe codes SHALL be taken from QuantityComparator
                                              (required to http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1)

                                              How the Quantity should be understood and represented.

                                              Typecode
                                              Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                              Summarytrue
                                              Requirements

                                              Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

                                              Meaning if MissingIf there is no comparator, then there is no modification of the value
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              180. Observation.component.value[x]:valueQuantity.unit
                                              Definition

                                              A human-readable form of the unit.

                                              ShortUnit representation
                                              Control0..1
                                              Typestring
                                              Is Modifierfalse
                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                              Summarytrue
                                              Requirements

                                              There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              182. Observation.component.value[x]:valueQuantity.system
                                              Definition

                                              The identification of the system that provides the coded form of the unit.

                                              ShortSystem that defines coded unit form
                                              Control0..1
                                              This element is affected by the following invariants: qty-3
                                              Typeuri
                                              Is Modifierfalse
                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                              Summarytrue
                                              Requirements

                                              Need to know the system that defines the coded form of the unit.

                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              184. Observation.component.value[x]:valueQuantity.code
                                              Definition

                                              A computer processable form of the unit in some unit representation system.

                                              ShortCoded form of the unit
                                              Comments

                                              The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.

                                              Control0..1
                                              Typecode
                                              Is Modifierfalse
                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                              Summarytrue
                                              Requirements

                                              Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.

                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              186. Observation.component.dataAbsentReason
                                              Definition

                                              Provides a reason why the expected value in the element Observation.component.value[x] is missing.

                                              ShortWhy the component result is missing
                                              Comments

                                              "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

                                              The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

                                              Control0..1
                                              This element is affected by the following invariants: obs-6
                                              BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                              (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason|4.0.1)

                                              Codes specifying why the result (Observation.value[x]) is missing.

                                              TypeCodeableConcept
                                              Is Modifierfalse
                                              Summaryfalse
                                              Requirements

                                              EHDSObservation.component.dataAbsentReason

                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              188. Observation.component.interpretation
                                              Definition

                                              A categorical assessment of an observation value. For example, high, low, normal.

                                              ShortHigh, low, normal, etc.
                                              Comments

                                              Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

                                              Control0..*
                                              BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                              (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation|4.0.1)

                                              Codes identifying interpretations of observations.

                                              TypeCodeableConcept
                                              Is Modifierfalse
                                              Summaryfalse
                                              Requirements

                                              EHDSObservation.component.interpretation

                                              Alternate NamesAbnormal Flag
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              190. Observation.component.referenceRange
                                              Definition

                                              Guidance on how to interpret the value by comparison to a normal or recommended range.

                                              ShortProvides guide for interpretation of component result
                                              Comments

                                              Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

                                              Control0..*
                                              TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
                                              Is Modifierfalse
                                              Summaryfalse
                                              Requirements

                                              EHDSObservation.component.referenceRange

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