Health Device Data Transfer
Version 1.0.0-rc2 - release

Specification of health data transfer from devices to DiGA (§ 374a SGB V)

Resource Profile: Observation – Complete Lung Function Testing

Official URL: https://gematik.de/fhir/hddt/StructureDefinition/hddt-lung-function-testing-complete Version: 1.0.0-rc2
Active as of 2026-03-04 Computable Name: HddtLungFunctionTestingComplete

Copyright/Legal: Copyright (c) 2026 gematik GmbH

Profile for capturing the relative lung function testings (i.e. an individual measurement divided by the corresponding reference value) as FHIR Observation resources.

This profile defines the exchange of a single relative value for the Mandatory Interoperable Value (MIV) "Lung Function Testing" which is technically defined by the ValueSet hddt-miv-lung-function-testing. This MIV is e.g. implemented by peak flow meter that can connect to a Personal Health Gateway (e.g. a mobile app for tracking lung function values) through wireless or wired communication.

Obligations and Conventions:

Each Lung Function Testing MAY either hold a reference to a Sensor Type And Calibration Status DeviceMetric resource or to a Personal Health Device Device resource (eXclusive OR). Typically the reference will be to a Device resource, but the option to reference a DeviceMetric resource is provided for compatibility with the overarching HDDT specification.

Each instance of this Observation MUST reference the Observations holding the corresponding raw measurement and reference value via the derivedFrom element.

Constraints applied:

  • status is restricted to final
  • code is constrained to a subset of the MIV Lung Function Relative Values ValueSet, defined by the HddtLungFunctionRelativeValues ValueSet.
  • effective[x] is restricted to effectiveDateTime and constrained as mandatory.
  • value[x] is restricted to valueQuantity. The elements valueQuantity.value, valueQuantity.system, and valueQuantity.code are constrained in a way that a value MUST be provided and that UCUM MUST be used for encoding the unit of measurement. Observation.valueQuantity MAY only be omitted in case of an error that accured with the measurement. In this case, Observation.dataAbsentReason MUST be provided.
  • derivedFrom is constrained to require exactly two references: one to the raw lung function testing Observation and one to the lung function reference value Observation.

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

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

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* Observation Measurements and simple assertions
Constraints: obs-6, obs-7
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... status ?!Σ 1..1 code Measurement status
Binding: ObservationStatus (required): Codes providing the status of an observation.
Fixed Value: final
... effective[x] Σ 1..1 dateTime Time of measurement
... value[x] SΣC 0..1 Quantity Calculated lung function value as percentage of reference value
.... value Σ 1..1 decimal Numerical value (with implicit precision)
.... comparator ?!Σ 0..1 code < | <= | >= | > - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.
.... system ΣC 1..1 uri System that defines coded unit form
Fixed Value: http://unitsofmeasure.org
.... code Σ 1..1 code Coded form of the unit
Binding: UCUMCodes (required): Defines the unit of measurement using codes from the UCUM units ValueSet. The UCUM code MUST be compliant with the unit that is linked with the LOINC code given as Observation.code.
... device 1..1 Reference(Device – Personal Health Device | DeviceMetric – Sensor Type and Calibration Status) Reference to personal health device
... Slices for derivedFrom Σ 2..2 Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) Related measurements the observation is made from
Slice: Unordered, Closed by profile:resolve()
.... derivedFrom:measurement Σ 1..1 Reference(Observation – Lung Function Testing) Reference to raw lung function testing
.... derivedFrom:referenceValue Σ 1..1 Reference(Observation – Lung Function Reference Value) Reference to lung function reference value

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Observation.status Base required ObservationStatus 📍4.0.1 FHIR Std.
Observation.code Base required Lung Function Relative Values from LOINC 📦1.0.0-rc2 This IG
Observation.value[x].​comparator Base required QuantityComparator 📍4.0.1 FHIR Std.
Observation.value[x].​code Base required UCUM Codes 📦4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Observation If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Observation 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 error Observation 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 error Observation If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Observation A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
obs-6 error Observation dataAbsentReason SHALL only be present if Observation.value[x] is not present dataAbsentReason.empty() or value.empty()
obs-7 error Observation 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()

This structure is derived from Observation

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation 0..* Observation Measurements and simple assertions
... status 1..1 code Measurement status
Fixed Value: final
... code 1..1 CodeableConcept Percentage measurement type for lung function
Binding: Lung Function Relative Values from LOINC (required): Specifies the type of measurement using codes from the ValueSet for lung function testing as percentage of the reference value. Constrained via invariant to either PEF or FEV1.
... effective[x] 1..1 dateTime Time of measurement
.... value 1..1 decimal Numerical value (with implicit precision)
.... system 1..1 uri System that defines coded unit form
Fixed Value: http://unitsofmeasure.org
.... code 1..1 code Coded form of the unit
Binding: UCUMCodes (required): Defines the unit of measurement using codes from the UCUM units ValueSet. The UCUM code MUST be compliant with the unit that is linked with the LOINC code given as Observation.code.
... device 1..1 Reference(Device – Personal Health Device | DeviceMetric – Sensor Type and Calibration Status) Reference to personal health device
... Slices for derivedFrom 2..2 Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) Related measurements the observation is made from
Slice: Unordered, Closed by profile:resolve()
.... derivedFrom:measurement 1..1 Reference(Observation – Lung Function Testing) Reference to raw lung function testing
.... derivedFrom:referenceValue 1..1 Reference(Observation – Lung Function Reference Value) Reference to lung function reference value

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Observation.code Base required Lung Function Relative Values from LOINC 📦1.0.0-rc2 This IG
Observation.value[x].​code Base required UCUM Codes 📦4.0.1 FHIR Std.
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* Observation Measurements and simple assertions
Constraints: obs-6, obs-7
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business Identifier for observation
... basedOn Σ 0..* Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) Fulfills plan, proposal or order
... partOf Σ 0..* Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) Part of referenced event
... status ?!Σ 1..1 code Measurement status
Binding: ObservationStatus (required): Codes providing the status of an observation.
Fixed Value: final
... category 0..* CodeableConcept Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
... code Σ 1..1 CodeableConcept Percentage measurement type for lung function
Binding: Lung Function Relative Values from LOINC (required): Specifies the type of measurement using codes from the ValueSet for lung function testing as percentage of the reference value. Constrained via invariant to either PEF or FEV1.
... subject Σ 0..1 Reference(Patient | Group | Device | Location) Who and/or what the observation is about
... focus Σ 0..* Reference(Resource) What the observation is about, when it is not about the subject of record
... encounter Σ 0..1 Reference(Encounter) Healthcare event during which this observation is made
... effective[x] Σ 1..1 dateTime Time of measurement
... issued Σ 0..1 instant Date/Time this version was made available
... performer Σ 0..* Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) Who is responsible for the observation
... value[x] SΣC 0..1 Quantity Calculated lung function value as percentage of reference value
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... value Σ 1..1 decimal Numerical value (with implicit precision)
.... comparator ?!Σ 0..1 code < | <= | >= | > - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.
.... unit Σ 0..1 string Unit representation
.... system ΣC 1..1 uri System that defines coded unit form
Fixed Value: http://unitsofmeasure.org
.... code Σ 1..1 code Coded form of the unit
Binding: UCUMCodes (required): Defines the unit of measurement using codes from the UCUM units ValueSet. The UCUM code MUST be compliant with the unit that is linked with the LOINC code given as Observation.code.
... dataAbsentReason C 0..1 CodeableConcept Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
... interpretation 0..* CodeableConcept High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
... note 0..* Annotation Comments about the observation
... bodySite 0..1 CodeableConcept Observed body part
Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
... method 0..1 CodeableConcept How it was done
Binding: ObservationMethods (example): Methods for simple observations.
... specimen 0..1 Reference(Specimen) Specimen used for this observation
... device 1..1 Reference(Device – Personal Health Device | DeviceMetric – Sensor Type and Calibration Status) Reference to personal health device
... referenceRange C 0..* BackboneElement Provides guide for interpretation
Constraints: obs-3
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... low C 0..1 SimpleQuantity(4.0.1) Low Range, if relevant
.... high C 0..1 SimpleQuantity(4.0.1) High Range, if relevant
.... type 0..1 CodeableConcept Reference range qualifier
Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
.... appliesTo 0..* CodeableConcept Reference range population
Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
.... age 0..1 Range Applicable age range, if relevant
.... text 0..1 string Text based reference range in an observation
... hasMember Σ 0..* Reference(Observation | QuestionnaireResponse | MolecularSequence) Related resource that belongs to the Observation group
... Slices for derivedFrom Σ 2..2 Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) Related measurements the observation is made from
Slice: Unordered, Closed by profile:resolve()
.... derivedFrom:measurement Σ 1..1 Reference(Observation – Lung Function Testing) Reference to raw lung function testing
.... derivedFrom:referenceValue Σ 1..1 Reference(Observation – Lung Function Reference Value) Reference to lung function reference value
... component Σ 0..* BackboneElement Component results
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.
.... value[x] Σ 0..1 Actual component result
..... valueQuantity Quantity
..... valueCodeableConcept CodeableConcept
..... valueString string
..... valueBoolean boolean
..... valueInteger integer
..... valueRange Range
..... valueRatio Ratio
..... valueSampledData SampledData
..... valueTime time
..... valueDateTime dateTime
..... valuePeriod Period
.... dataAbsentReason C 0..1 CodeableConcept Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
.... interpretation 0..* CodeableConcept High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
.... referenceRange 0..* See referenceRange (Observation) Provides guide for interpretation of component result

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Observation.language Base preferred Common Languages 📍4.0.1 FHIR Std.
Observation.status Base required ObservationStatus 📍4.0.1 FHIR Std.
Observation.category Base preferred Observation Category Codes 📍4.0.1 FHIR Std.
Observation.code Base required Lung Function Relative Values from LOINC 📦1.0.0-rc2 This IG
Observation.value[x].​comparator Base required QuantityComparator 📍4.0.1 FHIR Std.
Observation.value[x].​code Base required UCUM Codes 📦4.0.1 FHIR Std.
Observation.dataAbsentReason Base extensible DataAbsentReason 📍4.0.1 FHIR Std.
Observation.interpretation Base extensible Observation Interpretation Codes 📍4.0.1 FHIR Std.
Observation.bodySite Base example SNOMED CT Body Structures 📍4.0.1 FHIR Std.
Observation.method Base example Observation Methods 📍4.0.1 FHIR Std.
Observation.referenceRange.​type Base preferred Observation Reference Range Meaning Codes 📍4.0.1 FHIR Std.
Observation.referenceRange.​appliesTo Base example Observation Reference Range Applies To Codes 📍4.0.1 FHIR Std.
Observation.component.​code Base example LOINC Codes 📍4.0.1 FHIR Std.
Observation.component.​dataAbsentReason Base extensible DataAbsentReason 📍4.0.1 FHIR Std.
Observation.component.​interpretation Base extensible Observation Interpretation Codes 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Observation If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Observation 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 error Observation 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 error Observation If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Observation A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
obs-3 error Observation.referenceRange Must have at least a low or a high or text low.exists() or high.exists() or text.exists()
obs-6 error Observation dataAbsentReason SHALL only be present if Observation.value[x] is not present dataAbsentReason.empty() or value.empty()
obs-7 error Observation 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()

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* Observation Measurements and simple assertions
Constraints: obs-6, obs-7
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... status ?!Σ 1..1 code Measurement status
Binding: ObservationStatus (required): Codes providing the status of an observation.
Fixed Value: final
... effective[x] Σ 1..1 dateTime Time of measurement
... value[x] SΣC 0..1 Quantity Calculated lung function value as percentage of reference value
.... value Σ 1..1 decimal Numerical value (with implicit precision)
.... comparator ?!Σ 0..1 code < | <= | >= | > - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.
.... system ΣC 1..1 uri System that defines coded unit form
Fixed Value: http://unitsofmeasure.org
.... code Σ 1..1 code Coded form of the unit
Binding: UCUMCodes (required): Defines the unit of measurement using codes from the UCUM units ValueSet. The UCUM code MUST be compliant with the unit that is linked with the LOINC code given as Observation.code.
... device 1..1 Reference(Device – Personal Health Device | DeviceMetric – Sensor Type and Calibration Status) Reference to personal health device
... Slices for derivedFrom Σ 2..2 Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) Related measurements the observation is made from
Slice: Unordered, Closed by profile:resolve()
.... derivedFrom:measurement Σ 1..1 Reference(Observation – Lung Function Testing) Reference to raw lung function testing
.... derivedFrom:referenceValue Σ 1..1 Reference(Observation – Lung Function Reference Value) Reference to lung function reference value

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Observation.status Base required ObservationStatus 📍4.0.1 FHIR Std.
Observation.code Base required Lung Function Relative Values from LOINC 📦1.0.0-rc2 This IG
Observation.value[x].​comparator Base required QuantityComparator 📍4.0.1 FHIR Std.
Observation.value[x].​code Base required UCUM Codes 📦4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Observation If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Observation 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 error Observation 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 error Observation If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Observation A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
obs-6 error Observation dataAbsentReason SHALL only be present if Observation.value[x] is not present dataAbsentReason.empty() or value.empty()
obs-7 error Observation 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()

Differential View

This structure is derived from Observation

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation 0..* Observation Measurements and simple assertions
... status 1..1 code Measurement status
Fixed Value: final
... code 1..1 CodeableConcept Percentage measurement type for lung function
Binding: Lung Function Relative Values from LOINC (required): Specifies the type of measurement using codes from the ValueSet for lung function testing as percentage of the reference value. Constrained via invariant to either PEF or FEV1.
... effective[x] 1..1 dateTime Time of measurement
.... value 1..1 decimal Numerical value (with implicit precision)
.... system 1..1 uri System that defines coded unit form
Fixed Value: http://unitsofmeasure.org
.... code 1..1 code Coded form of the unit
Binding: UCUMCodes (required): Defines the unit of measurement using codes from the UCUM units ValueSet. The UCUM code MUST be compliant with the unit that is linked with the LOINC code given as Observation.code.
... device 1..1 Reference(Device – Personal Health Device | DeviceMetric – Sensor Type and Calibration Status) Reference to personal health device
... Slices for derivedFrom 2..2 Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) Related measurements the observation is made from
Slice: Unordered, Closed by profile:resolve()
.... derivedFrom:measurement 1..1 Reference(Observation – Lung Function Testing) Reference to raw lung function testing
.... derivedFrom:referenceValue 1..1 Reference(Observation – Lung Function Reference Value) Reference to lung function reference value

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Observation.code Base required Lung Function Relative Values from LOINC 📦1.0.0-rc2 This IG
Observation.value[x].​code Base required UCUM Codes 📦4.0.1 FHIR Std.

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* Observation Measurements and simple assertions
Constraints: obs-6, obs-7
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business Identifier for observation
... basedOn Σ 0..* Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) Fulfills plan, proposal or order
... partOf Σ 0..* Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) Part of referenced event
... status ?!Σ 1..1 code Measurement status
Binding: ObservationStatus (required): Codes providing the status of an observation.
Fixed Value: final
... category 0..* CodeableConcept Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
... code Σ 1..1 CodeableConcept Percentage measurement type for lung function
Binding: Lung Function Relative Values from LOINC (required): Specifies the type of measurement using codes from the ValueSet for lung function testing as percentage of the reference value. Constrained via invariant to either PEF or FEV1.
... subject Σ 0..1 Reference(Patient | Group | Device | Location) Who and/or what the observation is about
... focus Σ 0..* Reference(Resource) What the observation is about, when it is not about the subject of record
... encounter Σ 0..1 Reference(Encounter) Healthcare event during which this observation is made
... effective[x] Σ 1..1 dateTime Time of measurement
... issued Σ 0..1 instant Date/Time this version was made available
... performer Σ 0..* Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) Who is responsible for the observation
... value[x] SΣC 0..1 Quantity Calculated lung function value as percentage of reference value
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... value Σ 1..1 decimal Numerical value (with implicit precision)
.... comparator ?!Σ 0..1 code < | <= | >= | > - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.
.... unit Σ 0..1 string Unit representation
.... system ΣC 1..1 uri System that defines coded unit form
Fixed Value: http://unitsofmeasure.org
.... code Σ 1..1 code Coded form of the unit
Binding: UCUMCodes (required): Defines the unit of measurement using codes from the UCUM units ValueSet. The UCUM code MUST be compliant with the unit that is linked with the LOINC code given as Observation.code.
... dataAbsentReason C 0..1 CodeableConcept Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
... interpretation 0..* CodeableConcept High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
... note 0..* Annotation Comments about the observation
... bodySite 0..1 CodeableConcept Observed body part
Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
... method 0..1 CodeableConcept How it was done
Binding: ObservationMethods (example): Methods for simple observations.
... specimen 0..1 Reference(Specimen) Specimen used for this observation
... device 1..1 Reference(Device – Personal Health Device | DeviceMetric – Sensor Type and Calibration Status) Reference to personal health device
... referenceRange C 0..* BackboneElement Provides guide for interpretation
Constraints: obs-3
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... low C 0..1 SimpleQuantity(4.0.1) Low Range, if relevant
.... high C 0..1 SimpleQuantity(4.0.1) High Range, if relevant
.... type 0..1 CodeableConcept Reference range qualifier
Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
.... appliesTo 0..* CodeableConcept Reference range population
Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
.... age 0..1 Range Applicable age range, if relevant
.... text 0..1 string Text based reference range in an observation
... hasMember Σ 0..* Reference(Observation | QuestionnaireResponse | MolecularSequence) Related resource that belongs to the Observation group
... Slices for derivedFrom Σ 2..2 Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) Related measurements the observation is made from
Slice: Unordered, Closed by profile:resolve()
.... derivedFrom:measurement Σ 1..1 Reference(Observation – Lung Function Testing) Reference to raw lung function testing
.... derivedFrom:referenceValue Σ 1..1 Reference(Observation – Lung Function Reference Value) Reference to lung function reference value
... component Σ 0..* BackboneElement Component results
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code Σ 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.
.... value[x] Σ 0..1 Actual component result
..... valueQuantity Quantity
..... valueCodeableConcept CodeableConcept
..... valueString string
..... valueBoolean boolean
..... valueInteger integer
..... valueRange Range
..... valueRatio Ratio
..... valueSampledData SampledData
..... valueTime time
..... valueDateTime dateTime
..... valuePeriod Period
.... dataAbsentReason C 0..1 CodeableConcept Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
.... interpretation 0..* CodeableConcept High, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
.... referenceRange 0..* See referenceRange (Observation) Provides guide for interpretation of component result

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Observation.language Base preferred Common Languages 📍4.0.1 FHIR Std.
Observation.status Base required ObservationStatus 📍4.0.1 FHIR Std.
Observation.category Base preferred Observation Category Codes 📍4.0.1 FHIR Std.
Observation.code Base required Lung Function Relative Values from LOINC 📦1.0.0-rc2 This IG
Observation.value[x].​comparator Base required QuantityComparator 📍4.0.1 FHIR Std.
Observation.value[x].​code Base required UCUM Codes 📦4.0.1 FHIR Std.
Observation.dataAbsentReason Base extensible DataAbsentReason 📍4.0.1 FHIR Std.
Observation.interpretation Base extensible Observation Interpretation Codes 📍4.0.1 FHIR Std.
Observation.bodySite Base example SNOMED CT Body Structures 📍4.0.1 FHIR Std.
Observation.method Base example Observation Methods 📍4.0.1 FHIR Std.
Observation.referenceRange.​type Base preferred Observation Reference Range Meaning Codes 📍4.0.1 FHIR Std.
Observation.referenceRange.​appliesTo Base example Observation Reference Range Applies To Codes 📍4.0.1 FHIR Std.
Observation.component.​code Base example LOINC Codes 📍4.0.1 FHIR Std.
Observation.component.​dataAbsentReason Base extensible DataAbsentReason 📍4.0.1 FHIR Std.
Observation.component.​interpretation Base extensible Observation Interpretation Codes 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Observation If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Observation 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 error Observation 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 error Observation If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Observation A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
obs-3 error Observation.referenceRange Must have at least a low or a high or text low.exists() or high.exists() or text.exists()
obs-6 error Observation dataAbsentReason SHALL only be present if Observation.value[x] is not present dataAbsentReason.empty() or value.empty()
obs-7 error Observation 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()

 

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