Implementation Guide
Health Device Data Transfer
Version 0.1.0 - ballot

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

Resource Profile: Observation – Continuous Glucose Measurement

Official URL: https://gematik.de/fhir/hddt/StructureDefinition/hddt-continuous-glucose-measurement Version: 0.1.0
Draft as of 2025-10-27 Computable Name: HddtContinuousGlucoseMeasurement

Copyright/Legal: Copyright (c) 2025 gematik GmbH

Profile for capturing continuous glucose measurements from real-time monitoring devices (esp. rtCGM).

This profile defines the exchange of raw measurement data for the Mandatory Interoperable Value (MIV) "Continuous Glucose Measurement" which is technically defined by the ValueSet hddt-miv-continuous-glucose-measurement. This MIV is e.g. implemented by real-time Continuous Glocose Monitoring devices (rtCGM) and Automated Insulin Delivery systems (AID) that control an insulin pump from rtCGM data. Future non-invasive measuring methods will expectedly be linked with this MIV and therefore use this profile for sharing data with DiGA, too.

Obligations and Conventions:

Devices for continuously measuring glucose values may produce data with a sample rate of more than 1000 values per day (e.g. current rtCGM provide measures for glucose in interstitial fluid with up to one value per minute). For sharing such data efficently, this profile makes use of the FHIR sampledData data type. Sampled data is portioned into chunks of a fixed size (for an exception see below), with the chunk size being set by the resource server (e.g. such that 24 h of measurements fit into a single chunk). If a DiGA requests data for a period where the end time is earlier that the expected end time of the current chunk, the resource server only fills up the chunk up to the requested end time and sets the Observation.status to incomplete while Observation.effectivePeriod captures the full period of the chunk (see section "Retrieving Data" in the HDDT specification for details on chunks and missing data).

Each Continuous Glucose Measurement MUST either hold a reference to a Sensor Type And Calibration Status DeviceMetric resource or to a Personal Health Device Device resource (eXclusive OR). A reference to Sensor Type And Calibration Status MUST be provided from the Observation resource if the sensor for continuous measuring needs to be calibrated (either automatically or by the user) or if the sensor may change its calibration status over time. A change in DeviceMetric.calibration.state or a change of Device.status to inactive finalizes the current chunk and therefore is the only reason why a chunk may be smaller than the defined fixed size.

Constraints applied:

  • code is constrained to the ValueSet that represents the MIV Continuous Glucose Measurement
  • effective[x] is restricted to effectivePeriod and constrained as mandatory. Both a starting time and an end tme MUST be given.
  • value[x] is restricted to valueSampledData. The elements valueSampledData.origin.unit, valueSampledData.origin.system, and valueSampledData.origin.code are mandatory. valueSampledData.origin.system is restricted to UCUM. Observation.valueSampledData MAY only be omitted in case of an error that accured with the measurement. In this case, Observation.dataAbsentReason MUST be provided.
  • device is set to be mandatory in order to provide the DiGA with information about the sensor’s calibration status and with information about the static and dynamic attributes of the Personal Health Device.

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 Chunk of continuous glucose measurements
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 Status of the continuous glucose measurements chunk
Binding: ObservationStatus (required): Codes providing the status of an observation.
... effective[x] Σ 1..1 Period Time interval of CGM measurements chunk
.... start ΣC 1..1 dateTime Starting time with inclusive boundary
.... end ΣC 1..1 dateTime End time with inclusive boundary, if not ongoing
... value[x] SΣC 0..1 SampledData Series of glucose measurements
.... origin Σ 1..1 SimpleQuantity(4.0.1) Zero value and units
..... unit Σ 0..1 string Unit of continuous glucose measurement
..... system ΣC 1..1 uri System that defines coded unit form
Fixed Value: http://unitsofmeasure.org
..... code Σ 1..1 code UCUM code for unit of measurements
Binding: UCUMCodes (required): Defines the measurement unit for continuous glucose values using UCUM codes.
.... period Σ 1..1 decimal Number of milliseconds between samples
.... dimensions Σ 1..1 positiveInt Number of sample points at each time point
.... data 1..1 string Decimal values with spaces, or "E" | "U" | "L"
... dataAbsentReason C 0..1 CodeableConcept Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
... device 1..1 Reference(Device – Personal Health Device | DeviceMetric – Sensor Type and Calibration Status) Reference to personal health device or its sensor type and calibration status

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 ValueSet – Continuous Glucose Measurement from LOINC 📦0.1.0 This IG
Observation.value[x].​origin.code Base required UCUM Codes 📦4.0.1 FHIR Std.
Observation.dataAbsentReason Base extensible DataAbsentReason 📍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 Chunk of continuous glucose measurements
... status 1..1 code Status of the continuous glucose measurements chunk
... code 1..1 CodeableConcept Type of continuous glucose measurement
Binding: ValueSet – Continuous Glucose Measurement from LOINC (required): Specifies the type of continuous glucose measurement using codes from the ValueSet for CGM measurements.
... effective[x] 1..1 Period Time interval of CGM measurements chunk
.... start 1..1 dateTime Starting time with inclusive boundary
.... end 1..1 dateTime End time with inclusive boundary, if not ongoing
.... origin
..... unit 0..1 string Unit of continuous glucose measurement
..... system 1..1 uri System that defines coded unit form
Fixed Value: http://unitsofmeasure.org
..... code 1..1 code UCUM code for unit of measurements
Binding: UCUMCodes (required): Defines the measurement unit for continuous glucose values using UCUM codes.
.... data 1..1 string Decimal values with spaces, or "E" | "U" | "L"
... dataAbsentReason 0..1 CodeableConcept Why the result is missing
... device 1..1 Reference(Device – Personal Health Device | DeviceMetric – Sensor Type and Calibration Status) Reference to personal health device or its sensor type and calibration status

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Observation.code Base required ValueSet – Continuous Glucose Measurement from LOINC 📦0.1.0 This IG
Observation.value[x].​origin.code Base required UCUM Codes 📦4.0.1 FHIR Std.
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* Observation Chunk of continuous glucose measurements
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 Status of the continuous glucose measurements chunk
Binding: ObservationStatus (required): Codes providing the status of an observation.
... category 0..* CodeableConcept Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
... code Σ 1..1 CodeableConcept Type of continuous glucose measurement
Binding: ValueSet – Continuous Glucose Measurement from LOINC (required): Specifies the type of continuous glucose measurement using codes from the ValueSet for CGM measurements.
... 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 Period Time interval of CGM measurements chunk
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... start ΣC 1..1 dateTime Starting time with inclusive boundary
.... end ΣC 1..1 dateTime End time with inclusive boundary, if not ongoing
... 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 SampledData Series of glucose measurements
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... origin Σ 1..1 SimpleQuantity(4.0.1) Zero value and units
..... 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 0..1 decimal Numerical value (with implicit precision)
..... unit Σ 0..1 string Unit of continuous glucose measurement
..... system ΣC 1..1 uri System that defines coded unit form
Fixed Value: http://unitsofmeasure.org
..... code Σ 1..1 code UCUM code for unit of measurements
Binding: UCUMCodes (required): Defines the measurement unit for continuous glucose values using UCUM codes.
.... period Σ 1..1 decimal Number of milliseconds between samples
.... factor Σ 0..1 decimal Multiply data by this before adding to origin
.... lowerLimit Σ 0..1 decimal Lower limit of detection
.... upperLimit Σ 0..1 decimal Upper limit of detection
.... dimensions Σ 1..1 positiveInt Number of sample points at each time point
.... data 1..1 string Decimal values with spaces, or "E" | "U" | "L"
... 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 or its sensor type and calibration status
... 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
... derivedFrom Σ 0..* Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) Related measurements the observation is made from
... 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 ValueSet – Continuous Glucose Measurement from LOINC 📦0.1.0 This IG
Observation.value[x].​origin.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()

This structure is derived from Observation

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* Observation Chunk of continuous glucose measurements
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 Status of the continuous glucose measurements chunk
Binding: ObservationStatus (required): Codes providing the status of an observation.
... effective[x] Σ 1..1 Period Time interval of CGM measurements chunk
.... start ΣC 1..1 dateTime Starting time with inclusive boundary
.... end ΣC 1..1 dateTime End time with inclusive boundary, if not ongoing
... value[x] SΣC 0..1 SampledData Series of glucose measurements
.... origin Σ 1..1 SimpleQuantity(4.0.1) Zero value and units
..... unit Σ 0..1 string Unit of continuous glucose measurement
..... system ΣC 1..1 uri System that defines coded unit form
Fixed Value: http://unitsofmeasure.org
..... code Σ 1..1 code UCUM code for unit of measurements
Binding: UCUMCodes (required): Defines the measurement unit for continuous glucose values using UCUM codes.
.... period Σ 1..1 decimal Number of milliseconds between samples
.... dimensions Σ 1..1 positiveInt Number of sample points at each time point
.... data 1..1 string Decimal values with spaces, or "E" | "U" | "L"
... dataAbsentReason C 0..1 CodeableConcept Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
... device 1..1 Reference(Device – Personal Health Device | DeviceMetric – Sensor Type and Calibration Status) Reference to personal health device or its sensor type and calibration status

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 ValueSet – Continuous Glucose Measurement from LOINC 📦0.1.0 This IG
Observation.value[x].​origin.code Base required UCUM Codes 📦4.0.1 FHIR Std.
Observation.dataAbsentReason Base extensible DataAbsentReason 📍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 Chunk of continuous glucose measurements
... status 1..1 code Status of the continuous glucose measurements chunk
... code 1..1 CodeableConcept Type of continuous glucose measurement
Binding: ValueSet – Continuous Glucose Measurement from LOINC (required): Specifies the type of continuous glucose measurement using codes from the ValueSet for CGM measurements.
... effective[x] 1..1 Period Time interval of CGM measurements chunk
.... start 1..1 dateTime Starting time with inclusive boundary
.... end 1..1 dateTime End time with inclusive boundary, if not ongoing
.... origin
..... unit 0..1 string Unit of continuous glucose measurement
..... system 1..1 uri System that defines coded unit form
Fixed Value: http://unitsofmeasure.org
..... code 1..1 code UCUM code for unit of measurements
Binding: UCUMCodes (required): Defines the measurement unit for continuous glucose values using UCUM codes.
.... data 1..1 string Decimal values with spaces, or "E" | "U" | "L"
... dataAbsentReason 0..1 CodeableConcept Why the result is missing
... device 1..1 Reference(Device – Personal Health Device | DeviceMetric – Sensor Type and Calibration Status) Reference to personal health device or its sensor type and calibration status

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Observation.code Base required ValueSet – Continuous Glucose Measurement from LOINC 📦0.1.0 This IG
Observation.value[x].​origin.code Base required UCUM Codes 📦4.0.1 FHIR Std.

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* Observation Chunk of continuous glucose measurements
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 Status of the continuous glucose measurements chunk
Binding: ObservationStatus (required): Codes providing the status of an observation.
... category 0..* CodeableConcept Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
... code Σ 1..1 CodeableConcept Type of continuous glucose measurement
Binding: ValueSet – Continuous Glucose Measurement from LOINC (required): Specifies the type of continuous glucose measurement using codes from the ValueSet for CGM measurements.
... 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 Period Time interval of CGM measurements chunk
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... start ΣC 1..1 dateTime Starting time with inclusive boundary
.... end ΣC 1..1 dateTime End time with inclusive boundary, if not ongoing
... 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 SampledData Series of glucose measurements
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... origin Σ 1..1 SimpleQuantity(4.0.1) Zero value and units
..... 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 0..1 decimal Numerical value (with implicit precision)
..... unit Σ 0..1 string Unit of continuous glucose measurement
..... system ΣC 1..1 uri System that defines coded unit form
Fixed Value: http://unitsofmeasure.org
..... code Σ 1..1 code UCUM code for unit of measurements
Binding: UCUMCodes (required): Defines the measurement unit for continuous glucose values using UCUM codes.
.... period Σ 1..1 decimal Number of milliseconds between samples
.... factor Σ 0..1 decimal Multiply data by this before adding to origin
.... lowerLimit Σ 0..1 decimal Lower limit of detection
.... upperLimit Σ 0..1 decimal Upper limit of detection
.... dimensions Σ 1..1 positiveInt Number of sample points at each time point
.... data 1..1 string Decimal values with spaces, or "E" | "U" | "L"
... 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 or its sensor type and calibration status
... 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
... derivedFrom Σ 0..* Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) Related measurements the observation is made from
... 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 ValueSet – Continuous Glucose Measurement from LOINC 📦0.1.0 This IG
Observation.value[x].​origin.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()

This structure is derived from Observation

 

Other representations of profile: CSV, Excel, Schematron