R4 Ballot #2 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.5.0: R4 Ballot #2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4 R3 R2

10.1.11.3 StructureDefinition: DeviceMetricObservation

Orders and Observations Work Group Maturity Level: 1Trial Use Use Context: Any

The official URL for this profile is: 

http://hl7.org/fhir/StructureDefinition/devicemetricobservation

This profile describes the direct or derived, qualitative or quantitative physiological measurement, setting, or calculation data produced by a medical device or a device component.

This profile was published on Mon, Nov 17, 2014 00:00+1000 as a draft by Health Level Seven International (Health Care Devices).

10.1.11.3.1 Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots, and how the XML and JSON presentations work.

This structure is derived from Observation.

Summary

Mandatory: 5 elements
Must-Support: 12 elements
Prohibited: 4 elements

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation I0..*Measurements and simple assertions
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: Language (preferred)
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional Content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier SΣ0..*IdentifierBusiness Identifier for observation
... basedOn Σ0..*Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)Fulfills plan, proposal or order
... partOf Σ0..*Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)Part of referenced event
... status ?!SΣ1..1coderegistered | preliminary | final | amended +
Binding: ObservationStatus (required)
... category 0..*CodeableConceptClassification of type of observation
Binding: Observation Category Codes (preferred)
... code SΣ1..1CodeableConceptType of observation (code / type)
Binding: LOINC Codes (example)
... subject SΣ1..1Reference(Patient | Device)Who and/or what the observation is about
... focus Σ0..*Reference(Resource)What the observation is about, when it is not about the subject of record
... effectiveDateTime SΣ1..1dateTimeClinically relevant time/time-period for observation
... performer Σ0..*Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)Who is responsible for the observation
... value[x] SΣI0..1Quantity, CodeableConcept, string, Range, Ratio, SampledData, time, dateTime, PeriodActual result
... interpretation 0..1CodeableConceptHigh, low, normal, etc.
Binding: Observation Interpretation Codes (extensible)
... comment 0..1stringComments about the test result value
... bodySite S0..1CodeableConceptObserved body part
Binding: SNOMED CT Body Structures (example)
... method S0..1CodeableConceptHow it was done
Binding: Observation Methods (example)
... device S1..1Reference(DeviceMetric)(Measurement) Device
... referenceRange SI0..1BackboneElementProvides guide for interpretation
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... low I0..1SimpleQuantityLow Range, if relevant
.... high I0..1SimpleQuantityHigh Range, if relevant
.... type 0..1CodeableConceptReference range qualifier
Binding: Observation Reference Range Meaning Codes (preferred)
.... appliesTo 0..*CodeableConceptReference range population
Binding: Observation Reference Range Applies To Codes (example)
.... age 0..1RangeApplicable age range, if relevant
.... text 0..1stringText based reference range in an observation
... hasMember SΣ0..*Reference(Observation)Related resource that belongs to the Observation group
... derivedFrom SΣ0..*Reference(Observation)Related measurements the observation is made from
... component ΣI0..*BackboneElementComponent results
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... code Σ1..1CodeableConceptType of component observation (code / type)
Binding: LOINC Codes (example)
.... value[x] Σ0..1Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, PeriodActual component result
.... dataAbsentReason I0..1CodeableConceptWhy the component result is missing
Binding: DataAbsentReason (extensible)
.... interpretation 0..*CodeableConceptHigh, low, normal, etc.
Binding: Observation Interpretation Codes (extensible)
.... referenceRange 0..*Unknown reference to #Observation.referenceRange
Provides guide for interpretation of component result

doco Documentation for this format
<!-- Device Metric Observation Profile -->doco

<Observation xmlns="http://hl7.org/fhir"
>
  <!-- from Element: extension -->
 <id value="[id]"/><!-- 0..1 Logical id of this artifact -->
 <meta><!-- 0..1 Meta Metadata about the resource --></meta>
 <implicitRules value="[uri]"/><!-- 0..1 A set of rules under which this content was created -->
 <language value="[code]"/><!-- 0..1 Language of the resource content   -->
 <text><!-- 0..1 Narrative 
     Text summary of the resource, for human interpretation --></text>
 <contained><!-- 0..* Resource Contained, inline Resources --></contained>
 <modifierExtension><!-- 0..* Extension  Extensions that cannot be ignored  --></modifierExtension>
 <identifier><!-- 0..* Identifier 
     Business Identifier for observation --></identifier>
 <basedOn><!-- 0..* Reference(CarePlan) Fulfills plan, proposal or order --></basedOn>
 <partOf><!-- 0..* Reference(MedicationAdministration) Part of referenced event --></partOf>
 <status value="[code]"/><!-- 1..1 registered | preliminary | final | amended +   -->
 <category><!-- 0..* CodeableConcept Classification of  type of observation   --></category>
 <code><!-- 1..1 CodeableConcept Type of observation (code / type)   --></code>
 <subject><!-- 1..1 Reference(Patient) 
     Who and/or what the observation is about --></subject>
 <focus><!-- 0..* Reference(Resource) 
     What the observation is about, when it is not about the subject of record --></focus>
 <encounter><!-- 0..0 Reference(Encounter) 
     Healthcare event during which this observation is made --></encounter>
 <effectiveDateTime value="[dateTime]"/><!-- 1..1 Clinically relevant time/time-period for observation -->
 <issued value="[instant]"/><!-- 0..0 Date/Time this version was made available -->
 <performer><!-- 0..* Reference(Practitioner) 
     Who is responsible for the observation --></performer>
 <value[x]><!-- 0..1 Quantity|CodeableConcept|string|Range|Ratio|
   SampledData|time|dateTime|Period Actual result --></value[x]>
 <dataAbsentReason><!-- 0..0 CodeableConcept Why the result is missing   --></dataAbsentReason>
 <interpretation><!-- 0..1 CodeableConcept High, low, normal, etc.   --></interpretation>
 <comment value="[string]"/><!-- 0..1 Comments about the test result value -->
 <bodySite><!-- 0..1 CodeableConcept Observed body part   --></bodySite>
 <method><!-- 0..1 CodeableConcept How it was done   --></method>
 <specimen><!-- 0..0 Reference(Specimen) Specimen used for this observation --></specimen>
 <device><!-- 1..1 Reference(DeviceMetric) (Measurement) Device --></device>
 <referenceRange> ?? 0..1 BackboneElement  <!-- ?? 0..1 Provides guide for interpretation -->
  <modifierExtension><!-- 0..* Extension  Extensions that cannot be ignored if unrecognized  --></modifierExtension>
  <low><!-- 0..1 Quantity 
      Low Range, if relevant --></low>
  <high><!-- 0..1 Quantity 
      High Range, if relevant --></high>
  <type><!-- 0..1 CodeableConcept Reference range qualifier   --></type>
  <appliesTo><!-- 0..* CodeableConcept Reference range population   --></appliesTo>
  <age><!-- 0..1 Range 
      Applicable age range, if relevant --></age>
  <text value="[string]"/><!-- 0..1 Text based reference range in an observation -->
 </referenceRange>
 <hasMember><!-- 0..* Reference(Observation) 
     Related resource that belongs to the Observation group --></hasMember>
 <derivedFrom><!-- 0..* Reference(Observation) 
     Related measurements the observation is made from --></derivedFrom>
 <component> ?? 0..* BackboneElement  <!-- ?? 0..* Component results -->
  <modifierExtension><!-- 0..* Extension  Extensions that cannot be ignored if unrecognized  --></modifierExtension>
  <code><!-- 1..1 CodeableConcept Type of component observation (code / type)   --></code>
  <value[x]><!-- 0..1 Quantity|CodeableConcept|string|
    boolean|integer|Range|Ratio|SampledData|time|dateTime|Period 
      Actual component result --></value[x]>
  <dataAbsentReason><!-- 0..1 CodeableConcept Why the component result is missing   --></dataAbsentReason>
  <interpretation><!-- 0..* CodeableConcept High, low, normal, etc.   --></interpretation>
  <referenceRange><!-- See #Observation.referenceRange  Provides guide for interpretation of component result --></referenceRange>
 </component>
</Observation>

{ // Device Metric Observation Profile
  // from Element: extension
    "meta" : { Meta }, //Metadata about the resource
    "implicitRules" : "<uri>", //A set of rules under which this content was created
    "language" : "<code>", //Language of the resource content
    "text" : { Narrative }, //Text summary of the resource, for human interpretation
    "contained" : [{ Resource }], //Contained, inline Resources
    "modifierExtension" : [{ Extension }], //Extensions that cannot be ignored
    "identifier" : [{ Identifier }], //Business Identifier for observation
    "basedOn" : [{ Reference(CarePlan) }], //Fulfills plan, proposal or order
    "partOf" : [{ Reference(MedicationAdministration) }], //Part of referenced event
    "status" : "<code>", // R! registered | preliminary | final | amended +
    "category" : [{ CodeableConcept }], //Classification of  type of observation
    "code" : { CodeableConcept }, // R! Type of observation (code / type)
    "subject" : { Reference(Patient) }, // R! Who and/or what the observation is about
    "focus" : [{ Reference(Resource) }], //What the observation is about, when it is not about the subject of record
    "effectiveDateTime" : "<dateTime>", // R! Clinically relevant time/time-period for observation
    "performer" : [{ Reference(Practitioner) }], //Who is responsible for the observation
// value[x]: Actual result. One of these 9:
    "valueQuantity" : { Quantity }, //Actual result
    "valueCodeableConcept" : { CodeableConcept }, //Actual result
    "valueString" : "<string>", //Actual result
    "valueRange" : { Range }, //Actual result
    "valueRatio" : { Ratio }, //Actual result
    "valueSampledData" : { SampledData }, //Actual result
    "valueTime" : "<time>", //Actual result
    "valueDateTime" : "<dateTime>", //Actual result
    "valuePeriod" : { Period }, //Actual result
    "interpretation" : { CodeableConcept }, //High, low, normal, etc.
    "comment" : "<string>" //Comments about the test result value
    "bodySite" : { CodeableConcept }, //Observed body part
    "method" : { CodeableConcept }, //How it was done
    "device" : { Reference(DeviceMetric) }, // R! (Measurement) Device
    "referenceRange" : { BackboneElement }, // C?Provides guide for interpretation
    "hasMember" : [{ Reference(Observation) }], //Related resource that belongs to the Observation group
    "derivedFrom" : [{ Reference(Observation) }], //Related measurements the observation is made from
    "component" : [{ BackboneElement }], // C?Component results
  }

This structure is derived from Observation.

Summary

Mandatory: 5 elements
Must-Support: 12 elements
Prohibited: 4 elements

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation I0..*Measurements and simple assertions
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: Language (preferred)
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional Content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier SΣ0..*IdentifierBusiness Identifier for observation
... basedOn Σ0..*Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)Fulfills plan, proposal or order
... partOf Σ0..*Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)Part of referenced event
... status ?!SΣ1..1coderegistered | preliminary | final | amended +
Binding: ObservationStatus (required)
... category 0..*CodeableConceptClassification of type of observation
Binding: Observation Category Codes (preferred)
... code SΣ1..1CodeableConceptType of observation (code / type)
Binding: LOINC Codes (example)
... subject SΣ1..1Reference(Patient | Device)Who and/or what the observation is about
... focus Σ0..*Reference(Resource)What the observation is about, when it is not about the subject of record
... effectiveDateTime SΣ1..1dateTimeClinically relevant time/time-period for observation
... performer Σ0..*Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)Who is responsible for the observation
... value[x] SΣI0..1Quantity, CodeableConcept, string, Range, Ratio, SampledData, time, dateTime, PeriodActual result
... interpretation 0..1CodeableConceptHigh, low, normal, etc.
Binding: Observation Interpretation Codes (extensible)
... comment 0..1stringComments about the test result value
... bodySite S0..1CodeableConceptObserved body part
Binding: SNOMED CT Body Structures (example)
... method S0..1CodeableConceptHow it was done
Binding: Observation Methods (example)
... device S1..1Reference(DeviceMetric)(Measurement) Device
... referenceRange SI0..1BackboneElementProvides guide for interpretation
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... low I0..1SimpleQuantityLow Range, if relevant
.... high I0..1SimpleQuantityHigh Range, if relevant
.... type 0..1CodeableConceptReference range qualifier
Binding: Observation Reference Range Meaning Codes (preferred)
.... appliesTo 0..*CodeableConceptReference range population
Binding: Observation Reference Range Applies To Codes (example)
.... age 0..1RangeApplicable age range, if relevant
.... text 0..1stringText based reference range in an observation
... hasMember SΣ0..*Reference(Observation)Related resource that belongs to the Observation group
... derivedFrom SΣ0..*Reference(Observation)Related measurements the observation is made from
... component ΣI0..*BackboneElementComponent results
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... code Σ1..1CodeableConceptType of component observation (code / type)
Binding: LOINC Codes (example)
.... value[x] Σ0..1Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, PeriodActual component result
.... dataAbsentReason I0..1CodeableConceptWhy the component result is missing
Binding: DataAbsentReason (extensible)
.... interpretation 0..*CodeableConceptHigh, low, normal, etc.
Binding: Observation Interpretation Codes (extensible)
.... referenceRange 0..*Unknown reference to #Observation.referenceRange
Provides guide for interpretation of component result

doco Documentation for this format

XML Template

<!-- Device Metric Observation Profile -->doco

<Observation xmlns="http://hl7.org/fhir"
>
  <!-- from Element: extension -->
 <id value="[id]"/><!-- 0..1 Logical id of this artifact -->
 <meta><!-- 0..1 Meta Metadata about the resource --></meta>
 <implicitRules value="[uri]"/><!-- 0..1 A set of rules under which this content was created -->
 <language value="[code]"/><!-- 0..1 Language of the resource content   -->
 <text><!-- 0..1 Narrative 
     Text summary of the resource, for human interpretation --></text>
 <contained><!-- 0..* Resource Contained, inline Resources --></contained>
 <modifierExtension><!-- 0..* Extension  Extensions that cannot be ignored  --></modifierExtension>
 <identifier><!-- 0..* Identifier 
     Business Identifier for observation --></identifier>
 <basedOn><!-- 0..* Reference(CarePlan) Fulfills plan, proposal or order --></basedOn>
 <partOf><!-- 0..* Reference(MedicationAdministration) Part of referenced event --></partOf>
 <status value="[code]"/><!-- 1..1 registered | preliminary | final | amended +   -->
 <category><!-- 0..* CodeableConcept Classification of  type of observation   --></category>
 <code><!-- 1..1 CodeableConcept Type of observation (code / type)   --></code>
 <subject><!-- 1..1 Reference(Patient) 
     Who and/or what the observation is about --></subject>
 <focus><!-- 0..* Reference(Resource) 
     What the observation is about, when it is not about the subject of record --></focus>
 <encounter><!-- 0..0 Reference(Encounter) 
     Healthcare event during which this observation is made --></encounter>
 <effectiveDateTime value="[dateTime]"/><!-- 1..1 Clinically relevant time/time-period for observation -->
 <issued value="[instant]"/><!-- 0..0 Date/Time this version was made available -->
 <performer><!-- 0..* Reference(Practitioner) 
     Who is responsible for the observation --></performer>
 <value[x]><!-- 0..1 Quantity|CodeableConcept|string|Range|Ratio|
   SampledData|time|dateTime|Period Actual result --></value[x]>
 <dataAbsentReason><!-- 0..0 CodeableConcept Why the result is missing   --></dataAbsentReason>
 <interpretation><!-- 0..1 CodeableConcept High, low, normal, etc.   --></interpretation>
 <comment value="[string]"/><!-- 0..1 Comments about the test result value -->
 <bodySite><!-- 0..1 CodeableConcept Observed body part   --></bodySite>
 <method><!-- 0..1 CodeableConcept How it was done   --></method>
 <specimen><!-- 0..0 Reference(Specimen) Specimen used for this observation --></specimen>
 <device><!-- 1..1 Reference(DeviceMetric) (Measurement) Device --></device>
 <referenceRange> ?? 0..1 BackboneElement  <!-- ?? 0..1 Provides guide for interpretation -->
  <modifierExtension><!-- 0..* Extension  Extensions that cannot be ignored if unrecognized  --></modifierExtension>
  <low><!-- 0..1 Quantity 
      Low Range, if relevant --></low>
  <high><!-- 0..1 Quantity 
      High Range, if relevant --></high>
  <type><!-- 0..1 CodeableConcept Reference range qualifier   --></type>
  <appliesTo><!-- 0..* CodeableConcept Reference range population   --></appliesTo>
  <age><!-- 0..1 Range 
      Applicable age range, if relevant --></age>
  <text value="[string]"/><!-- 0..1 Text based reference range in an observation -->
 </referenceRange>
 <hasMember><!-- 0..* Reference(Observation) 
     Related resource that belongs to the Observation group --></hasMember>
 <derivedFrom><!-- 0..* Reference(Observation) 
     Related measurements the observation is made from --></derivedFrom>
 <component> ?? 0..* BackboneElement  <!-- ?? 0..* Component results -->
  <modifierExtension><!-- 0..* Extension  Extensions that cannot be ignored if unrecognized  --></modifierExtension>
  <code><!-- 1..1 CodeableConcept Type of component observation (code / type)   --></code>
  <value[x]><!-- 0..1 Quantity|CodeableConcept|string|
    boolean|integer|Range|Ratio|SampledData|time|dateTime|Period 
      Actual component result --></value[x]>
  <dataAbsentReason><!-- 0..1 CodeableConcept Why the component result is missing   --></dataAbsentReason>
  <interpretation><!-- 0..* CodeableConcept High, low, normal, etc.   --></interpretation>
  <referenceRange><!-- See #Observation.referenceRange  Provides guide for interpretation of component result --></referenceRange>
 </component>
</Observation>

JSON Template

{ // Device Metric Observation Profile
  // from Element: extension
    "meta" : { Meta }, //Metadata about the resource
    "implicitRules" : "<uri>", //A set of rules under which this content was created
    "language" : "<code>", //Language of the resource content
    "text" : { Narrative }, //Text summary of the resource, for human interpretation
    "contained" : [{ Resource }], //Contained, inline Resources
    "modifierExtension" : [{ Extension }], //Extensions that cannot be ignored
    "identifier" : [{ Identifier }], //Business Identifier for observation
    "basedOn" : [{ Reference(CarePlan) }], //Fulfills plan, proposal or order
    "partOf" : [{ Reference(MedicationAdministration) }], //Part of referenced event
    "status" : "<code>", // R! registered | preliminary | final | amended +
    "category" : [{ CodeableConcept }], //Classification of  type of observation
    "code" : { CodeableConcept }, // R! Type of observation (code / type)
    "subject" : { Reference(Patient) }, // R! Who and/or what the observation is about
    "focus" : [{ Reference(Resource) }], //What the observation is about, when it is not about the subject of record
    "effectiveDateTime" : "<dateTime>", // R! Clinically relevant time/time-period for observation
    "performer" : [{ Reference(Practitioner) }], //Who is responsible for the observation
// value[x]: Actual result. One of these 9:
    "valueQuantity" : { Quantity }, //Actual result
    "valueCodeableConcept" : { CodeableConcept }, //Actual result
    "valueString" : "<string>", //Actual result
    "valueRange" : { Range }, //Actual result
    "valueRatio" : { Ratio }, //Actual result
    "valueSampledData" : { SampledData }, //Actual result
    "valueTime" : "<time>", //Actual result
    "valueDateTime" : "<dateTime>", //Actual result
    "valuePeriod" : { Period }, //Actual result
    "interpretation" : { CodeableConcept }, //High, low, normal, etc.
    "comment" : "<string>" //Comments about the test result value
    "bodySite" : { CodeableConcept }, //Observed body part
    "method" : { CodeableConcept }, //How it was done
    "device" : { Reference(DeviceMetric) }, // R! (Measurement) Device
    "referenceRange" : { BackboneElement }, // C?Provides guide for interpretation
    "hasMember" : [{ Reference(Observation) }], //Related resource that belongs to the Observation group
    "derivedFrom" : [{ Reference(Observation) }], //Related measurements the observation is made from
    "component" : [{ BackboneElement }], // C?Component results
  }

 

Alternate definitions: Master Definition (XML, JSON), Schematron

10.1.11.3.2 Terminology Bindings

PathNameConformanceValueSet
Observation.languageLanguagepreferredLanguage
Observation.statusObservationStatusrequiredObservationStatus
Observation.categoryObservation Category CodespreferredObservation Category Codes
Observation.codeLOINC CodesexampleLOINC Codes
Observation.interpretationObservation Interpretation CodesextensibleObservation Interpretation Codes
Observation.bodySiteSNOMED CT Body StructuresexampleSNOMED CT Body Structures
Observation.methodObservation MethodsexampleObservation Methods
Observation.referenceRange.typeObservation Reference Range Meaning CodespreferredObservation Reference Range Meaning Codes
Observation.referenceRange.appliesToObservation Reference Range Applies To CodesexampleObservation Reference Range Applies To Codes
Observation.component.codeLOINC CodesexampleLOINC Codes
Observation.component.dataAbsentReasonDataAbsentReasonextensibleDataAbsentReason
Observation.component.interpretationObservation Interpretation CodesextensibleObservation Interpretation Codes
.