PhdBaseObservation - Personal Health Device Implementation Guide v3.0.0-draft

Personal Health Device Implementation Guide, published by HL7 International / Devices. This guide is not an authorized publication; it is the continuous build for version 3.0.0-draft built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/phd/ and changes regularly. See the Directory of published versions

Resource Profile: PhdBaseObservation ( Abstract )

Official URL: http://hl7.org/fhir/uv/phd/StructureDefinition/PhdBaseObservation	Version: 3.0.0-draft	Highlight text changes?
Standards status: Trial-use	Maturity Level: 1	Computable Name: PhdBaseObservation
Other Identifiers: OID:2.16.840.1.113883.4.642.40.73.42.3

Common base profile with the elements that are common to the PHD IG Observation profiles.

The PHD Base Observation profile contains the elements that are common to all PHD Observation profiles describing measurements. These element are:

code: what the measurement is
subject: the patient this measurement refers to
effective[x]: the timestamp and perhaps duration of the measurement
device: reference to the PHD taking the measurement
derivedFrom / memberOf: references to related observations
components: contains any additional measurement descriptions (Supplemental Information)
category: a fixed value identifying observations generated by PHDs
measurementStatus: the status of the measurement
gatewayDevice extension: reference to the PHG responsible for generating the upload
coincidentTimestamp extension: reference to the coincidentTimestamp observation that relates PHD time and PHG time
performer: optional, when the patient is known to be the performer this may refer to the patient
identifier: the PHD conditional-create identifier for this measurement to avoid duplicate uploads

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description Differentials, Snapshots, and other representations.

Key Elements Table
Differential Table
Snapshot Table
Statistics/References
All

Name	Flags	Card.	Type	Description & Constraints Filter: Bindings Constraints Obligations
Observation	C	0..*	Observation	This is an abstract profile. Child profiles: PhdBitsEnumerationObservation, PhdCompoundNumericObservation, PhdCodedEnumerationObservation, PhdRtsaObservation, PhdNumericObservation, PhdStringObservation, PhdCompoundObservation Measurements and simple assertions Constraints: obs-6, obs-7, obs-10, obs-11, obs-12
id	Σ	0..1	id	Logical id of this artifact
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
extension:GatewayDevice		1..1	(Complex)	Device Gateway URL: http://hl7.org/fhir/StructureDefinition/device-gateway
extension		0..0		Extension Slice: Unordered, Open by value:url
url		1..1	uri	"http://hl7.org/fhir/StructureDefinition/device-gateway"
value[x]		0..1	CodeableReference(PhgDevice)	Reference to the PHG Device Binding: DeviceType (example)
extension:CoincidentTimeStamp		0..1	Reference(PhdCoincidentTimeStampObservation)	Coincident Timestamp Reference URL: http://hl7.org/fhir/uv/phd/StructureDefinition/CoincidentTimeStampReference
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored Slice: Unordered, Open by value:url
Slices for identifier	Σ	0..*	Identifier	Business Identifier for observation Slice: Unordered, Open by value:system
identifier:conditionalCreate	Σ	0..1	Identifier	Unique identifier of this measurement for a given patient and device
use	?!Σ	0..1	code	usual \| official \| temp \| secondary \| old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://hl7.org/fhir/uv/phd/StructureDefinition/PhdBaseObservation
value	ΣC	1..1	string	The value that is unique Example General: 123456
status	?!Σ	1..1	code	registered \| in-process \| specimen-in-process \| preliminary \| final \| amended \| corrected \| appended \| cancelled \| entered-in-error \| unknown \| cannot-be-obtained Binding: ObservationStatus (required): Codes providing the status of an observation.
Slices for category		1..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by value:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:PHD-Observation		1..1	CodeableConcept	PHD observation category Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/uv/phd/CodeSystem/PhdObservationCategories
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: phd
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
code	ΣC	1..1	CodeableConcept	Type of observation (code / type) Binding: MDC Non-Object codes (extensible): IEEE 11073-10101 Nomenclature codes for PHD measurements Constraints: mdc-1
subject	Σ	1..1	Reference(Patient \| PhdDevice)	Reference to the patient or the PhdDevice that is the subject of the observation
focus	?!Σ	0..*	Reference(Resource)	What the observation is about, when it is not about the subject of record
Slices for effective[x]	Σ	1..1		Clinically relevant time/time-period for observation Slice: Unordered, Closed by type:$this
effectiveDateTime			dateTime
effectivePeriod			Period
effective[x]:effectiveDateTime	Σ	0..1	dateTime	Clinically relevant time/time-period for observation
effective[x]:effectivePeriod	Σ	0..1	Period	Clinically relevant time/time-period for observation
start	ΣC	0..1	dateTime	Starting time with inclusive boundary
end	ΣC	0..1	dateTime	End time with inclusive boundary, if not ongoing
value[x]	ΣC	0..1		Actual result
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
valueAttachment			Attachment
dataAbsentReason	C	0..1	CodeableConcept	This element is populated when the Measurement Status indicates invalid, not available or measurement-ongoing. Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: DataAbsentReason (required)
interpretation		0..*	CodeableConcept	High, low, normal, etc Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
Slices for coding	Σ	1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by value:system
coding:MsmtStatusInterpretation	Σ	1..1	Coding	Measurement status interpretation when questionable, calibration-ongoing, validated, early-indication, threshold exceeded, alarm inhibited
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://hl7.org/fhir/uv/pocd/CodeSystem/measurement-status
code	ΣC	1..1	code	Symbol in syntax defined by the system
device		1..1	Reference(PhdDevice)	A reference to the device that generates the measurements or the device settings for the device
reference	ΣC	1..1	string	Reference to the device responsible for the measurement
hasMember	Σ	0..*	Reference(PhdBaseObservation)	Other PHD Observations that are part of this group observation.
derivedFrom	Σ	0..*	Reference(PhdBaseObservation)	A source the measurement data is derived from.
Slices for component	ΣC	0..*	BackboneElement	Component results Slice: Unordered, Open by value:code
component:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
code	ΣC	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCObsOrBoth (example): Codes identifying names of simple observations.
component:supplementalTypesComponent	ΣC	0..*	BackboneElement	Supplemental Type: A further description of the measurement type.
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
code	ΣC	1..1	CodeableConcept	Supplemental-Types code (68193) Binding: LOINCObsOrBoth (example): Codes identifying names of simple observations. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: urn:iso:std:iso:11073:10101
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 68193
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	ΣC	0..1	CodeableConcept	Actual component result
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.extension:GatewayDevice.value[x]	Base	example	Device Type	📦6.0.0-ballot5	FHIR Std.
Observation.identifier:conditionalCreate.use	Base	required	IdentifierUse	📍6.0.0-ballot5	FHIR Std.
Observation.status	Base	required	Observation Status	📍6.0.0-ballot5	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📍6.0.0-ballot5	FHIR Std.
Observation.category:PHD-Observation	Base	preferred	Observation Category Codes	📍6.0.0-ballot5	FHIR Std.
Observation.code	Base	extensible	MDC Non-Object codes	📦3.0.0-draft	This IG
Observation.dataAbsentReason	Base	extensible	Data Absent Reason	📍6.0.0-ballot5	FHIR Std.
Observation.dataAbsentReason.coding	Base	required	Data Absent Reason	📦6.0.0-ballot5	FHIR Std.
Observation.interpretation	Base	extensible	Observation Interpretation Codes	📍6.0.0-ballot5	FHIR Std.
Observation.component.code	Base	example	LOINC codes with Observation or Both	📍6.0.0-ballot5	FHIR Std.
Observation.component:supplementalTypesComponent.code	Base	example	LOINC codes with Observation or Both	📍6.0.0-ballot5	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.trace('id') in %resource.descendants().select(reference \| as(uri))) or descendants().where(reference='#' \| as(uri)='#').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())`
mdc-1	warning	Observation.code	A published MDC Code is preferred but private MDC codes are allowed as well.	`coding.exists() and coding.where(system = 'urn:iso:std:iso:11073:10101').exists()`
obs-6	error	Observation	Observation.dataAbsentReason SHALL only be present if Observation.value[x] is not present	`dataAbsentReason.empty() or value.empty()`
obs-7	error	Observation	If Observation.component.code is the same as Observation.code, then Observation.value SHALL NOT be present (the Observation.component.value[x] holds the value).	`value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()`
obs-10	error	Observation	Observation.component.dataAbsentReason SHALL only be present if Observation.component.value[x] is not present	`component.empty() or component.where(dataAbsentReason.exists()).all(value.empty())`
obs-11	error	Observation	if organizer exists and organizer = true, then value[x], dataAbsentReason and component SHALL NOT be present	`(organizer.exists() and organizer.allTrue()) implies (value.empty() and dataAbsentReason.empty() and component.empty())`
obs-12	warning	Observation	All observations SHOULD have a performer	`performer.exists()`

Name	Flags	Card.	Type	Description & Constraints Filter: Bindings Constraints Obligations
Observation		0..*	Observation	This is an abstract profile. Child profiles: PhdBitsEnumerationObservation, PhdCompoundNumericObservation, PhdCodedEnumerationObservation, PhdRtsaObservation, PhdNumericObservation, PhdStringObservation, PhdCompoundObservation Measurements and simple assertions
id		0..1	id	Logical id of this artifact
meta
Slices for security		0..*	Coding	Security Labels applied to this resource Slice: Unordered, Open by value:$this
security:PhdHtest		0..1	Coding	Security value set to HTEST when measurement status indicates demo or test data Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-ActReason
code		1..1	code	Symbol in syntax defined by the system Fixed Value: HTEST
extension		1..*	Extension	Extension
Slices for extension				Content/Rules for all slices
extension:GatewayDevice		1..1	(Complex)	Device Gateway URL: http://hl7.org/fhir/StructureDefinition/device-gateway
value[x]		0..1	CodeableReference(PhgDevice)	Reference to the PHG Device
extension:CoincidentTimeStamp		0..1	Reference(PhdCoincidentTimeStampObservation)	Coincident Timestamp Reference URL: http://hl7.org/fhir/uv/phd/StructureDefinition/CoincidentTimeStampReference
Slices for identifier		0..*	Identifier	Business Identifier for observation Slice: Unordered, Open by value:system
identifier:conditionalCreate		0..1	Identifier	Unique identifier of this measurement for a given patient and device
type		0..0		Description of identifier
system		1..1	uri	The namespace for the identifier value Required Pattern: http://hl7.org/fhir/uv/phd/StructureDefinition/PhdBaseObservation
value		1..1	string	The value that is unique
status		1..1	code	registered \| in-process \| specimen-in-process \| preliminary \| final \| amended \| corrected \| appended \| cancelled \| entered-in-error \| unknown \| cannot-be-obtained
Slices for category		1..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by value:$this
category:PHD-Observation		1..1	CodeableConcept	PHD observation category Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/uv/phd/CodeSystem/PhdObservationCategories
code		1..1	code	Symbol in syntax defined by the system Fixed Value: phd
code	C	1..1	CodeableConcept	Type of observation (code / type) Binding: MDC Non-Object codes (extensible): IEEE 11073-10101 Nomenclature codes for PHD measurements Constraints: mdc-1
coding
system		0..1	uri	Identity of the terminology system
code		0..1	code	Symbol in syntax defined by the system
subject		1..1	Reference(Patient \| PhdDevice)	Reference to the patient or the PhdDevice that is the subject of the observation
Slices for effective[x]		1..1		Clinically relevant time/time-period for observation Slice: Unordered, Open by type:$this
effectiveDateTime			dateTime
effectivePeriod			Period
effective[x]:effectiveDateTime		0..1	dateTime	Clinically relevant time/time-period for observation
effective[x]:effectivePeriod		0..1	Period	Clinically relevant time/time-period for observation
start		0..1	dateTime	Starting time with inclusive boundary
end		0..1	dateTime	End time with inclusive boundary, if not ongoing
value[x]		0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period, Attachment	Actual result
dataAbsentReason		0..1	CodeableConcept	This element is populated when the Measurement Status indicates invalid, not available or measurement-ongoing.
coding		0..*	Coding	Code defined by a terminology system Binding: DataAbsentReason (required)
interpretation		0..*	CodeableConcept	High, low, normal, etc
Slices for coding		1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by value:system
coding:MsmtStatusInterpretation		1..1	Coding	Measurement status interpretation when questionable, calibration-ongoing, validated, early-indication, threshold exceeded, alarm inhibited
system		1..1	uri	Identity of the terminology system Required Pattern: http://hl7.org/fhir/uv/pocd/CodeSystem/measurement-status
code		1..1	code	Symbol in syntax defined by the system
device		1..1	Reference(PhdDevice)	A reference to the device that generates the measurements or the device settings for the device
reference		1..1	string	Reference to the device responsible for the measurement
hasMember		0..*	Reference(PhdBaseObservation)	Other PHD Observations that are part of this group observation.
derivedFrom		0..*	Reference(PhdBaseObservation)	A source the measurement data is derived from.
Slices for component		0..*	BackboneElement	Component results Slice: Unordered, Open by value:code
component:supplementalTypesComponent		0..*	BackboneElement	Supplemental Type: A further description of the measurement type.
code		1..1	CodeableConcept	Supplemental-Types code (68193) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
system		1..1	uri	Identity of the terminology system Fixed Value: urn:iso:std:iso:11073:10101
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 68193
value[x]		0..1	CodeableConcept	Actual component result
coding
system		0..1	uri	Identity of the terminology system Required Pattern: urn:iso:std:iso:11073:10101
dataAbsentReason		0..0		Why the component result value is missing
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
Observation.code	Base	extensible	MDC Non-Object codes	📦3.0.0-draft	This IG
Observation.dataAbsentReason.coding	Base	required	Data Absent Reason	📦6.0.0-ballot5	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
mdc-1	warning	Observation.code	A published MDC Code is preferred but private MDC codes are allowed as well.	`coding.exists() and coding.where(system = 'urn:iso:std:iso:11073:10101').exists()`

Description & Constraints Filter: Filters

Observation

0..*

Observation

This is an abstract profile. Child profiles: PhdBitsEnumerationObservation, PhdCompoundNumericObservation, PhdCodedEnumerationObservation, PhdRtsaObservation, PhdNumericObservation, PhdStringObservation, PhdCompoundObservation
Measurements and simple assertions
Constraints: obs-6, obs-7, obs-10, obs-11, obs-12

0..1

Logical id of this artifact

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.meta.security	Base	extensible	All Security Labels	📍6.0.0-ballot5	FHIR Std.
Observation.meta.security:PhdHtest	Base	extensible	All Security Labels	📍6.0.0-ballot5	FHIR Std.
Observation.meta.tag	Base	example	Common Tags	📍6.0.0-ballot5	FHIR Std.
Observation.language	Base	required	All Languages	📍6.0.0-ballot5	FHIR Std.
Observation.extension:GatewayDevice.value[x]	Base	example	Device Type	📦6.0.0-ballot5	FHIR Std.
Observation.identifier:conditionalCreate.use	Base	required	IdentifierUse	📍6.0.0-ballot5	FHIR Std.
Observation.triggeredBy.type	Base	required	triggered Bytype	📍6.0.0-ballot5	FHIR Std.
Observation.status	Base	required	Observation Status	📍6.0.0-ballot5	FHIR Std.
Observation.statusReason	Base	example	Observation Status Reason	📍6.0.0-ballot5	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📍6.0.0-ballot5	FHIR Std.
Observation.category:PHD-Observation	Base	preferred	Observation Category Codes	📍6.0.0-ballot5	FHIR Std.
Observation.code	Base	extensible	MDC Non-Object codes	📦3.0.0-draft	This IG
Observation.dataAbsentReason	Base	extensible	Data Absent Reason	📍6.0.0-ballot5	FHIR Std.
Observation.dataAbsentReason.coding	Base	required	Data Absent Reason	📦6.0.0-ballot5	FHIR Std.
Observation.interpretation	Base	extensible	Observation Interpretation Codes	📍6.0.0-ballot5	FHIR Std.
Observation.context	Base	example	Observation Context Codes	📍6.0.0-ballot5	FHIR Std.
Observation.bodyStructure	Base	example	SNOMED CT Body Structures	📍6.0.0-ballot5	FHIR Std.
Observation.method	Base	example	Observation Methods	📍6.0.0-ballot5	FHIR Std.
Observation.device.type	Base	extensible	Resource Types	📍6.0.0-ballot5	FHIR Std.
Observation.supportingDevice	Base	example	Device Type	📍6.0.0-ballot5	FHIR Std.
Observation.referenceRange.normalValue	Base	example	Observation Reference Range Normal Value Codes	📍6.0.0-ballot5	FHIR Std.
Observation.referenceRange.type	Base	preferred	Observation Reference Range Meaning Codes	📍6.0.0-ballot5	FHIR Std.
Observation.referenceRange.appliesTo	Base	example	Observation Reference Range Applies To Codes	📍6.0.0-ballot5	FHIR Std.
Observation.component.code	Base	example	LOINC codes with Observation or Both	📍6.0.0-ballot5	FHIR Std.
Observation.component.dataAbsentReason	Base	extensible	Data Absent Reason	📍6.0.0-ballot5	FHIR Std.
Observation.component.interpretation	Base	extensible	Observation Interpretation Codes	📍6.0.0-ballot5	FHIR Std.
Observation.component:supplementalTypesComponent.code	Base	example	LOINC codes with Observation or Both	📍6.0.0-ballot5	FHIR Std.
Observation.component:supplementalTypesComponent.interpretation	Base	extensible	Observation Interpretation Codes	📍6.0.0-ballot5	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.trace('id') in %resource.descendants().select(reference \| as(uri))) or descendants().where(reference='#' \| as(uri)='#').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())`
mdc-1	warning	Observation.code	A published MDC Code is preferred but private MDC codes are allowed as well.	`coding.exists() and coding.where(system = 'urn:iso:std:iso:11073:10101').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	Observation.dataAbsentReason SHALL only be present if Observation.value[x] is not present	`dataAbsentReason.empty() or value.empty()`
obs-7	error	Observation	If Observation.component.code is the same as Observation.code, then Observation.value SHALL NOT be present (the Observation.component.value[x] holds the value).	`value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()`
obs-9	error	Observation.specimen	If Observation.specimen is a reference to Group, the group can only have specimens	`(reference.resolve().exists() and reference.resolve() is Group) implies reference.resolve().member.entity.resolve().all($this is Specimen)`
obs-10	error	Observation	Observation.component.dataAbsentReason SHALL only be present if Observation.component.value[x] is not present	`component.empty() or component.where(dataAbsentReason.exists()).all(value.empty())`
obs-11	error	Observation	if organizer exists and organizer = true, then value[x], dataAbsentReason and component SHALL NOT be present	`(organizer.exists() and organizer.allTrue()) implies (value.empty() and dataAbsentReason.empty() and component.empty())`
obs-12	warning	Observation	All observations SHOULD have a performer	`performer.exists()`
obs-13	error	Observation.referenceRange.low	If low.comparator exists, it must be '>=' or '>'.	`comparator.exists() implies (comparator = '>=' or comparator = '>')`
obs-14	error	Observation.referenceRange.high	If high.comparator exists, it must be '<=' or '<'.	`comparator.exists() implies (comparator = '<=' or comparator = '<')`

Summary

Mandatory: 8 elements(6 nested mandatory elements)
Prohibited: 2 elements

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

The element 1 is sliced based on the value of Observation.meta.security
The element 1 is sliced based on the value of Observation.identifier
The element 1 is sliced based on the value of Observation.category
The element 1 is sliced based on the value of Observation.effective[x]
The element 1 is sliced based on the value of Observation.interpretation.coding
The element 1 is sliced based on the value of Observation.component

Maturity: 1

Key Elements View

Name	Flags	Card.	Type	Description & Constraints Filter: Bindings Constraints Obligations
Observation	C	0..*	Observation	This is an abstract profile. Child profiles: PhdBitsEnumerationObservation, PhdCompoundNumericObservation, PhdCodedEnumerationObservation, PhdRtsaObservation, PhdNumericObservation, PhdStringObservation, PhdCompoundObservation Measurements and simple assertions Constraints: obs-6, obs-7, obs-10, obs-11, obs-12
id	Σ	0..1	id	Logical id of this artifact
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
extension:GatewayDevice		1..1	(Complex)	Device Gateway URL: http://hl7.org/fhir/StructureDefinition/device-gateway
extension		0..0		Extension Slice: Unordered, Open by value:url
url		1..1	uri	"http://hl7.org/fhir/StructureDefinition/device-gateway"
value[x]		0..1	CodeableReference(PhgDevice)	Reference to the PHG Device Binding: DeviceType (example)
extension:CoincidentTimeStamp		0..1	Reference(PhdCoincidentTimeStampObservation)	Coincident Timestamp Reference URL: http://hl7.org/fhir/uv/phd/StructureDefinition/CoincidentTimeStampReference
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored Slice: Unordered, Open by value:url
Slices for identifier	Σ	0..*	Identifier	Business Identifier for observation Slice: Unordered, Open by value:system
identifier:conditionalCreate	Σ	0..1	Identifier	Unique identifier of this measurement for a given patient and device
use	?!Σ	0..1	code	usual \| official \| temp \| secondary \| old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: http://hl7.org/fhir/uv/phd/StructureDefinition/PhdBaseObservation
value	ΣC	1..1	string	The value that is unique Example General: 123456
status	?!Σ	1..1	code	registered \| in-process \| specimen-in-process \| preliminary \| final \| amended \| corrected \| appended \| cancelled \| entered-in-error \| unknown \| cannot-be-obtained Binding: ObservationStatus (required): Codes providing the status of an observation.
Slices for category		1..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by value:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:PHD-Observation		1..1	CodeableConcept	PHD observation category Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/uv/phd/CodeSystem/PhdObservationCategories
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: phd
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
code	ΣC	1..1	CodeableConcept	Type of observation (code / type) Binding: MDC Non-Object codes (extensible): IEEE 11073-10101 Nomenclature codes for PHD measurements Constraints: mdc-1
subject	Σ	1..1	Reference(Patient \| PhdDevice)	Reference to the patient or the PhdDevice that is the subject of the observation
focus	?!Σ	0..*	Reference(Resource)	What the observation is about, when it is not about the subject of record
Slices for effective[x]	Σ	1..1		Clinically relevant time/time-period for observation Slice: Unordered, Closed by type:$this
effectiveDateTime			dateTime
effectivePeriod			Period
effective[x]:effectiveDateTime	Σ	0..1	dateTime	Clinically relevant time/time-period for observation
effective[x]:effectivePeriod	Σ	0..1	Period	Clinically relevant time/time-period for observation
start	ΣC	0..1	dateTime	Starting time with inclusive boundary
end	ΣC	0..1	dateTime	End time with inclusive boundary, if not ongoing
value[x]	ΣC	0..1		Actual result
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
valueAttachment			Attachment
dataAbsentReason	C	0..1	CodeableConcept	This element is populated when the Measurement Status indicates invalid, not available or measurement-ongoing. Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: DataAbsentReason (required)
interpretation		0..*	CodeableConcept	High, low, normal, etc Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
Slices for coding	Σ	1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by value:system
coding:MsmtStatusInterpretation	Σ	1..1	Coding	Measurement status interpretation when questionable, calibration-ongoing, validated, early-indication, threshold exceeded, alarm inhibited
system	Σ	1..1	uri	Identity of the terminology system Required Pattern: http://hl7.org/fhir/uv/pocd/CodeSystem/measurement-status
code	ΣC	1..1	code	Symbol in syntax defined by the system
device		1..1	Reference(PhdDevice)	A reference to the device that generates the measurements or the device settings for the device
reference	ΣC	1..1	string	Reference to the device responsible for the measurement
hasMember	Σ	0..*	Reference(PhdBaseObservation)	Other PHD Observations that are part of this group observation.
derivedFrom	Σ	0..*	Reference(PhdBaseObservation)	A source the measurement data is derived from.
Slices for component	ΣC	0..*	BackboneElement	Component results Slice: Unordered, Open by value:code
component:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
code	ΣC	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCObsOrBoth (example): Codes identifying names of simple observations.
component:supplementalTypesComponent	ΣC	0..*	BackboneElement	Supplemental Type: A further description of the measurement type.
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
code	ΣC	1..1	CodeableConcept	Supplemental-Types code (68193) Binding: LOINCObsOrBoth (example): Codes identifying names of simple observations. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: urn:iso:std:iso:11073:10101
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 68193
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	ΣC	0..1	CodeableConcept	Actual component result
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.extension:GatewayDevice.value[x]	Base	example	Device Type	📦6.0.0-ballot5	FHIR Std.
Observation.identifier:conditionalCreate.use	Base	required	IdentifierUse	📍6.0.0-ballot5	FHIR Std.
Observation.status	Base	required	Observation Status	📍6.0.0-ballot5	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📍6.0.0-ballot5	FHIR Std.
Observation.category:PHD-Observation	Base	preferred	Observation Category Codes	📍6.0.0-ballot5	FHIR Std.
Observation.code	Base	extensible	MDC Non-Object codes	📦3.0.0-draft	This IG
Observation.dataAbsentReason	Base	extensible	Data Absent Reason	📍6.0.0-ballot5	FHIR Std.
Observation.dataAbsentReason.coding	Base	required	Data Absent Reason	📦6.0.0-ballot5	FHIR Std.
Observation.interpretation	Base	extensible	Observation Interpretation Codes	📍6.0.0-ballot5	FHIR Std.
Observation.component.code	Base	example	LOINC codes with Observation or Both	📍6.0.0-ballot5	FHIR Std.
Observation.component:supplementalTypesComponent.code	Base	example	LOINC codes with Observation or Both	📍6.0.0-ballot5	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.trace('id') in %resource.descendants().select(reference \| as(uri))) or descendants().where(reference='#' \| as(uri)='#').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())`
mdc-1	warning	Observation.code	A published MDC Code is preferred but private MDC codes are allowed as well.	`coding.exists() and coding.where(system = 'urn:iso:std:iso:11073:10101').exists()`
obs-6	error	Observation	Observation.dataAbsentReason SHALL only be present if Observation.value[x] is not present	`dataAbsentReason.empty() or value.empty()`
obs-7	error	Observation	If Observation.component.code is the same as Observation.code, then Observation.value SHALL NOT be present (the Observation.component.value[x] holds the value).	`value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()`
obs-10	error	Observation	Observation.component.dataAbsentReason SHALL only be present if Observation.component.value[x] is not present	`component.empty() or component.where(dataAbsentReason.exists()).all(value.empty())`
obs-11	error	Observation	if organizer exists and organizer = true, then value[x], dataAbsentReason and component SHALL NOT be present	`(organizer.exists() and organizer.allTrue()) implies (value.empty() and dataAbsentReason.empty() and component.empty())`
obs-12	warning	Observation	All observations SHOULD have a performer	`performer.exists()`

Differential View

Name	Flags	Card.	Type	Description & Constraints Filter: Bindings Constraints Obligations
Observation		0..*	Observation	This is an abstract profile. Child profiles: PhdBitsEnumerationObservation, PhdCompoundNumericObservation, PhdCodedEnumerationObservation, PhdRtsaObservation, PhdNumericObservation, PhdStringObservation, PhdCompoundObservation Measurements and simple assertions
id		0..1	id	Logical id of this artifact
meta
Slices for security		0..*	Coding	Security Labels applied to this resource Slice: Unordered, Open by value:$this
security:PhdHtest		0..1	Coding	Security value set to HTEST when measurement status indicates demo or test data Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v3-ActReason
code		1..1	code	Symbol in syntax defined by the system Fixed Value: HTEST
extension		1..*	Extension	Extension
Slices for extension				Content/Rules for all slices
extension:GatewayDevice		1..1	(Complex)	Device Gateway URL: http://hl7.org/fhir/StructureDefinition/device-gateway
value[x]		0..1	CodeableReference(PhgDevice)	Reference to the PHG Device
extension:CoincidentTimeStamp		0..1	Reference(PhdCoincidentTimeStampObservation)	Coincident Timestamp Reference URL: http://hl7.org/fhir/uv/phd/StructureDefinition/CoincidentTimeStampReference
Slices for identifier		0..*	Identifier	Business Identifier for observation Slice: Unordered, Open by value:system
identifier:conditionalCreate		0..1	Identifier	Unique identifier of this measurement for a given patient and device
type		0..0		Description of identifier
system		1..1	uri	The namespace for the identifier value Required Pattern: http://hl7.org/fhir/uv/phd/StructureDefinition/PhdBaseObservation
value		1..1	string	The value that is unique
status		1..1	code	registered \| in-process \| specimen-in-process \| preliminary \| final \| amended \| corrected \| appended \| cancelled \| entered-in-error \| unknown \| cannot-be-obtained
Slices for category		1..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by value:$this
category:PHD-Observation		1..1	CodeableConcept	PHD observation category Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/uv/phd/CodeSystem/PhdObservationCategories
code		1..1	code	Symbol in syntax defined by the system Fixed Value: phd
code	C	1..1	CodeableConcept	Type of observation (code / type) Binding: MDC Non-Object codes (extensible): IEEE 11073-10101 Nomenclature codes for PHD measurements Constraints: mdc-1
coding
system		0..1	uri	Identity of the terminology system
code		0..1	code	Symbol in syntax defined by the system
subject		1..1	Reference(Patient \| PhdDevice)	Reference to the patient or the PhdDevice that is the subject of the observation
Slices for effective[x]		1..1		Clinically relevant time/time-period for observation Slice: Unordered, Open by type:$this
effectiveDateTime			dateTime
effectivePeriod			Period
effective[x]:effectiveDateTime		0..1	dateTime	Clinically relevant time/time-period for observation
effective[x]:effectivePeriod		0..1	Period	Clinically relevant time/time-period for observation
start		0..1	dateTime	Starting time with inclusive boundary
end		0..1	dateTime	End time with inclusive boundary, if not ongoing
value[x]		0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period, Attachment	Actual result
dataAbsentReason		0..1	CodeableConcept	This element is populated when the Measurement Status indicates invalid, not available or measurement-ongoing.
coding		0..*	Coding	Code defined by a terminology system Binding: DataAbsentReason (required)
interpretation		0..*	CodeableConcept	High, low, normal, etc
Slices for coding		1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by value:system
coding:MsmtStatusInterpretation		1..1	Coding	Measurement status interpretation when questionable, calibration-ongoing, validated, early-indication, threshold exceeded, alarm inhibited
system		1..1	uri	Identity of the terminology system Required Pattern: http://hl7.org/fhir/uv/pocd/CodeSystem/measurement-status
code		1..1	code	Symbol in syntax defined by the system
device		1..1	Reference(PhdDevice)	A reference to the device that generates the measurements or the device settings for the device
reference		1..1	string	Reference to the device responsible for the measurement
hasMember		0..*	Reference(PhdBaseObservation)	Other PHD Observations that are part of this group observation.
derivedFrom		0..*	Reference(PhdBaseObservation)	A source the measurement data is derived from.
Slices for component		0..*	BackboneElement	Component results Slice: Unordered, Open by value:code
component:supplementalTypesComponent		0..*	BackboneElement	Supplemental Type: A further description of the measurement type.
code		1..1	CodeableConcept	Supplemental-Types code (68193) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
system		1..1	uri	Identity of the terminology system Fixed Value: urn:iso:std:iso:11073:10101
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 68193
value[x]		0..1	CodeableConcept	Actual component result
coding
system		0..1	uri	Identity of the terminology system Required Pattern: urn:iso:std:iso:11073:10101
dataAbsentReason		0..0		Why the component result value is missing
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
Observation.code	Base	extensible	MDC Non-Object codes	📦3.0.0-draft	This IG
Observation.dataAbsentReason.coding	Base	required	Data Absent Reason	📦6.0.0-ballot5	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
mdc-1	warning	Observation.code	A published MDC Code is preferred but private MDC codes are allowed as well.	`coding.exists() and coding.where(system = 'urn:iso:std:iso:11073:10101').exists()`

Snapshot ViewView

Description & Constraints Filter: Filters

Observation

0..*

Observation

0..1

Logical id of this artifact

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.meta.security	Base	extensible	All Security Labels	📍6.0.0-ballot5	FHIR Std.
Observation.meta.security:PhdHtest	Base	extensible	All Security Labels	📍6.0.0-ballot5	FHIR Std.
Observation.meta.tag	Base	example	Common Tags	📍6.0.0-ballot5	FHIR Std.
Observation.language	Base	required	All Languages	📍6.0.0-ballot5	FHIR Std.
Observation.extension:GatewayDevice.value[x]	Base	example	Device Type	📦6.0.0-ballot5	FHIR Std.
Observation.identifier:conditionalCreate.use	Base	required	IdentifierUse	📍6.0.0-ballot5	FHIR Std.
Observation.triggeredBy.type	Base	required	triggered Bytype	📍6.0.0-ballot5	FHIR Std.
Observation.status	Base	required	Observation Status	📍6.0.0-ballot5	FHIR Std.
Observation.statusReason	Base	example	Observation Status Reason	📍6.0.0-ballot5	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📍6.0.0-ballot5	FHIR Std.
Observation.category:PHD-Observation	Base	preferred	Observation Category Codes	📍6.0.0-ballot5	FHIR Std.
Observation.code	Base	extensible	MDC Non-Object codes	📦3.0.0-draft	This IG
Observation.dataAbsentReason	Base	extensible	Data Absent Reason	📍6.0.0-ballot5	FHIR Std.
Observation.dataAbsentReason.coding	Base	required	Data Absent Reason	📦6.0.0-ballot5	FHIR Std.
Observation.interpretation	Base	extensible	Observation Interpretation Codes	📍6.0.0-ballot5	FHIR Std.
Observation.context	Base	example	Observation Context Codes	📍6.0.0-ballot5	FHIR Std.
Observation.bodyStructure	Base	example	SNOMED CT Body Structures	📍6.0.0-ballot5	FHIR Std.
Observation.method	Base	example	Observation Methods	📍6.0.0-ballot5	FHIR Std.
Observation.device.type	Base	extensible	Resource Types	📍6.0.0-ballot5	FHIR Std.
Observation.supportingDevice	Base	example	Device Type	📍6.0.0-ballot5	FHIR Std.
Observation.referenceRange.normalValue	Base	example	Observation Reference Range Normal Value Codes	📍6.0.0-ballot5	FHIR Std.
Observation.referenceRange.type	Base	preferred	Observation Reference Range Meaning Codes	📍6.0.0-ballot5	FHIR Std.
Observation.referenceRange.appliesTo	Base	example	Observation Reference Range Applies To Codes	📍6.0.0-ballot5	FHIR Std.
Observation.component.code	Base	example	LOINC codes with Observation or Both	📍6.0.0-ballot5	FHIR Std.
Observation.component.dataAbsentReason	Base	extensible	Data Absent Reason	📍6.0.0-ballot5	FHIR Std.
Observation.component.interpretation	Base	extensible	Observation Interpretation Codes	📍6.0.0-ballot5	FHIR Std.
Observation.component:supplementalTypesComponent.code	Base	example	LOINC codes with Observation or Both	📍6.0.0-ballot5	FHIR Std.
Observation.component:supplementalTypesComponent.interpretation	Base	extensible	Observation Interpretation Codes	📍6.0.0-ballot5	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.trace('id') in %resource.descendants().select(reference \| as(uri))) or descendants().where(reference='#' \| as(uri)='#').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())`
mdc-1	warning	Observation.code	A published MDC Code is preferred but private MDC codes are allowed as well.	`coding.exists() and coding.where(system = 'urn:iso:std:iso:11073:10101').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	Observation.dataAbsentReason SHALL only be present if Observation.value[x] is not present	`dataAbsentReason.empty() or value.empty()`
obs-7	error	Observation	If Observation.component.code is the same as Observation.code, then Observation.value SHALL NOT be present (the Observation.component.value[x] holds the value).	`value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()`
obs-9	error	Observation.specimen	If Observation.specimen is a reference to Group, the group can only have specimens	`(reference.resolve().exists() and reference.resolve() is Group) implies reference.resolve().member.entity.resolve().all($this is Specimen)`
obs-10	error	Observation	Observation.component.dataAbsentReason SHALL only be present if Observation.component.value[x] is not present	`component.empty() or component.where(dataAbsentReason.exists()).all(value.empty())`
obs-11	error	Observation	if organizer exists and organizer = true, then value[x], dataAbsentReason and component SHALL NOT be present	`(organizer.exists() and organizer.allTrue()) implies (value.empty() and dataAbsentReason.empty() and component.empty())`
obs-12	warning	Observation	All observations SHOULD have a performer	`performer.exists()`
obs-13	error	Observation.referenceRange.low	If low.comparator exists, it must be '>=' or '>'.	`comparator.exists() implies (comparator = '>=' or comparator = '>')`
obs-14	error	Observation.referenceRange.high	If high.comparator exists, it must be '<=' or '<'.	`comparator.exists() implies (comparator = '<=' or comparator = '<')`

Summary

Mandatory: 8 elements(6 nested mandatory elements)
Prohibited: 2 elements

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

The element 1 is sliced based on the value of Observation.meta.security
The element 1 is sliced based on the value of Observation.identifier
The element 1 is sliced based on the value of Observation.category
The element 1 is sliced based on the value of Observation.effective[x]
The element 1 is sliced based on the value of Observation.interpretation.coding
The element 1 is sliced based on the value of Observation.component

Maturity: 1

Other representations of profile: CSV, Excel, Schematron

Notes:

The following sections give more details on the data elements in a PHDBaseObservation resource.

Gateway Device extension

HL7 has defined an extension for the Observation resource to reference a gateway device. This extension is used to reference the Device resource representing the Personal Health Gateway (PHG) device.

Conditional-create Identifier - prevention of data duplication

The Conditional-create Identifier is defined to prevent data duplication. It can be used as the selection criterion in the conditional create when uploading observations.

Ideally the PHG will implement a duplication detection mechanism and filter out any observations that have already been uploaded. One possible mechanism is to record the latest timestamp of any observation received during a connection. Then for a given device and patient and upload destination, on a subsequent connection the PHG can filter out any observations with a timestamp earlier than the recorded latest timestamp of the previous connection. The latest timestamp is then updated given the information received during the current connection. This filter not only saves the server from handling the conditional update transaction but saves bandwidth and upload costs.

Additionally a globally unique identifier can be used in combination with a conditional create operation to prevent duplication of observations on the server when multiple PHGs can upload observations from the same PHD. The identifier is a concatenated string of elements that contain sufficient information to uniquely identify the observation. The identifier is the concatenation of the device identifier, patient identifier, the PHD timestamp of the observation, the observation type code, the measurement duration if present, and the list of Supplemental-Types codes if any. Each entry is separated by a dash (-). It is important to use the timestamp of the PHD and not the potentially modified timestamp placed in the Observation.effective[x] element. Two PHGs may have slightly different times which would allow an undesired duplicate observation to appear. Note that for this scheme to work PHDs should NOT change the timestamp of a generated observation.

Entry	value	Additional information
device	`PHD Device.identifier.value`	This value is a hexadecimal representation of the PHD system identifier (16 hexadecimal characters for the IEEE EUI-64 identifier, 12 for the EUI-48 transport address identifier) all capitals and without dashes
patient	`Patient.identifier.value`-`Patient.identifier.system` or provided logical id	The dashes are part of the identifier. When the service provider gives the PHG a pre-determined patient logical id the PHG creates no Patient resource and has no patient information. In that situation the provided logical id is used
type	`Observation.code.coding.code`	See MDC Nomenclature codes (decimal number)
timestamp	`Observation.effectiveDateTime` or `Observation.effectivePeriod.start`	The reported PHD timestamp. See Generating the PHD Reported Timestamp
duration	the length of `Observation.effectivePeriod`	See Generating the PHD Reported Timestamp
Supplemental Information	`Observation.component.valueCodeableConcept.coding.code`	A sequence of MDC codes (decimal number) separated by a dash from the "supplemental information" components.

The final identifier is made by concatenating the entries above as follows:

device-patient-type-timestamp-duration-Supplemental Information

All PHGs compliant to this IG should implement this identifier in the same manner. Compliance assures that even if the patient uploads the same observation to the same server from a different PHG, a duplicate of the observation will not be generated on the server. This is important since some PHDs do not provide a means of deleting stored and uploaded observations and will upload old observations again with each new addition of a observation as much as device storage allows.

An example of the this identifier from this example is given below:

{
  "resourceType" : "Observation",
  ...
  "identifier" : [
    {
      "system" : "http://hl7.org/fhir/uv/phd/StructureDefinition/PhdBaseObservation",
      "value" : "74E8FFFEFF051C00-sisansarahId-urn:oid:2.999.1.2.3.4.5.6.7.8.10-149530-20181113175903.00-150588"
    }
  ],
  ...
}

Obtaining the Type of observation

One obtains the IEEE 11073-10101 observation type for the code element in the same manner for all types of observations. See the section MDC Nomenclature codes for the details.

Subject

The subject element normally points to the PhdPatient resource using the logical id of the Patient resource, for example 'Patient/123546'. For device settings known to the PHG it should point to the PHD.

Performer

In situations where the gateway knows that the patient is the person performing the measurement, a Observation.performer element can also point to the PhdPatient resource. However, in most situations this is unknown and the performer is not filled in. And for coincident timestamp observations, the performer should not be provided. This profile puts no constraints on the performer element.

Timestamp: `effective[x]`

PHDs report timestamps in various methods and may not report timestamps at all. The PHG will include a timestamp in every observation that is uploaded using a conversion as needed based on the timestamp data received from the PHD. The timestamp types and corresponding PHG conversions are summarized below:

IEEE 11073-10206 timestamps represent a UTC time or a local time, that is synchronized with an external time source or not and can come with or without a TZ/DST offset or the timestamp represents a Tick Counter value. These timestamps can come from the current timeline of the PHD or not. In order to map a timestamp for the PHD's current timeline, the PHG needs the PHD's current time.

A timestamp comes from the current timeline of the PHD if the PHD's clock progressed naturally without discontinuities since the time reported in the timestamp. This information is included in the timestamp reported by an IEEE 11073-10206 compliant PHD, such as Bluetooth devices following the GHS specification. More information can be found in the IEEE 11073-10206 ACOM and Bluetooth GHS specifications.

Observations with a timestamp that is not from the current timeline of the PHD and that are not from a timeline synchronized with an external time source should be thrown away since there is no way to give them a correct timestamp.

The PHG can work with the assumption that the PHD and the PHG are always in the same time zone. This allows the PHG to set the offset of the timestamp to its offset.

For IEEE 11073-10206 timestamps the following table can be used:

Time type	Current	Synced	Offset	Recommended Mapping	Coincident Timestamp Observation required
UTC	Yes	Yes	Yes	Keep as is	No
UTC	Yes	Yes	No	Keep as is, but include PHG offset	No
UTC	Yes	No	Yes	Map to PHG timeline, including PHG offset	Yes
UTC	Yes	No	No	Map to PHG UTC timeline, include PHG offset	Yes
UTC	No	Yes	Yes	Keep as is	No
UTC	No	Yes	No	Keep as is, include PHG offset	No
UTC	No	No	Yes	Throw away	n.a.
UTC	No	No	No	Throw away	n.a.
Local	Yes	Yes	Yes	Map to UTC+offset	Yes
Local	Yes	Yes	No	Map to UTC+offset, including PHG offset	Yes
Local	Yes	No	Yes	Map to PHG timeline, including PHG offset	Yes
Local	Yes	No	No	Map to PHG timeline, including PHG offset	Yes
Local	No	Yes	Yes	Map to UTC+offset	No
Local	No	Yes	No	Map to UTC+offset, include PHG offset	No
Local	No	No	Yes	Throw away	n.a.
Local	No	No	No	Throw away	n.a.
Tick counter	Yes	n.a.	n.a.	Map to PHG timeline, including PHG offset	Yes
Tick counter	No	n.a.	n.a.	Throw away	n.a.

The PHG maps the 'converted' timestamp to either an Observation.effectiveDateTime element or an Observation.effectivePeriod element. The second situation occurs when the observation includes a Measurement-Duration (duration) attribute. Then the timestamp attribute gives the start of the period and the end of the period is obtained by adding the Measurement-Duration value to it. If no timestamp is provided, the PHG, using the time of reception of the observation as its timestamp must then do the reverse; the time of reception is the end time and the start time is given by subtracting the Measurement-Duration value from it. When the PHG modifies an Observation's timestamp as received from the PHD it shall also generate a Coincident Timestamp observation that records how the Observation.effective[x] element is generated.

extension: Coincident timestamp reference

This extension references Coincident Timestamp Observation resource that relates the PHD and PHG timelines. This occurs whenever the observation reported by the PHD has a timestamp. The Coincident Timestamp Observation reports how this Observation.effective[x] element is generated.

Device

The Observation.device element is a reference to the Device resource representing the PHD that generated the observation.

The derivedFrom element references Observation resources that are in some manner related to this Observation resource. In the PHD use case, this situation occurs whenever the observation reported by the PHD contains a derivedFrom attribute referencing a related Observation.

The hasMember element is used when the PHD Observation reports a group of related observations. In GHS an Observation can have an Is Member Of attribute that references a group observation. When uploading to a FHIR server the gateway should report the group observation with a hasMember reference to all member Observations.

In GHS the sensor related Observations are identified using a 32-bit Observation Id that is unique in the set of observations transferred during a connection.
Related observations are best uploaded in a single FHIR Bundle with logical ids assigned.

Source-Handle-Reference case (concept from IEEE 11073-20601 - deprecated)

A Source-Handle-Reference attribute points to a previously reported observation that is important to this observation. By previously it is meant that the observation is reported prior to the current observation but in the same connection. If multiple such observations have been received, the correct one is that which is most recently received. As an example, the cardiovascular specialization defines a session observation defining some type of exercise period, such as a run. All observations taken during that run have a source handle reference attribute pointing to the session observation. Since Source-Handle-Reference attributes use IEEE 11073-20601 Object handle values and not Logical resource ids to point to observations, the PHG will need to keep track of the Observation resources created during a connection to identify the correct Observation resource, and thus logical id, the Source-Handle-Reference attribute points to. Recent versions of the IEEE 11073-20601 standard also supports a Source-Handle-Reference-List containing a list of handles so there can be more than one entry generated due to these attributes. The references are placed in a derivedFrom element.

This mapping is quite often semantically incorrect. In FHIR the session observation resource should have "hasMember" references to all observations that are part of the session.

Supplemental Information - Components

component elements are used whenever the observation contains additional information attributes that further describe the observation. PHD observations can include Supplemental-Information that can be mapped to one or more FHIR Observation components.

The Supplemental Information attribute contains a list of one or more MDC codes that describe some property of the observation. There will be one component element for each entry in the list. For example, the code MDC_MODALITY_SPOT used in the pulse oximeter specialization indicates that the observation reported is a stable average. In contrast there is MDC_MODALITY_FAST and MDC_MODALITY_SLOW.

{
  "resourceType" : "Observation",
  ...
  "component" : [
    {
      "code" : {
        "coding" : [
          {
            "system" : "urn:iso:std:iso:11073:10101",
            "code" : "68193",
            "display" : "MDC_ATTR_SUPPLEMENTAL_TYPES"
          }
        ]
      },
      "valueCodeableConcept" : {
        "coding" : [
          {
            "system" : "urn:iso:std:iso:11073:10101",
            "code" : "150588",
            "display" : "MDC_MODALITY_SPOT"
          }
        ]
      }
    }
  ]
}

Should we move Supplemental Type information to an extension? In the PHD IG v1.0 an attempt was made to avoid extensions as much as possible. In this version we are using extensions for less often used attributes of the IEEE 11073-10206 model and in places were the conceptual models from PHD and FHIR model are too different to have a 1-1 mapping between parts of these models. The question is if this applies to Supplemental Type information as well. Should IEEE 11073-10206/20601 Supplemental Information be modeled as a FHIR `Observation.component` or as an extension in FHIR? Input is welcome.

Measurement Status

The Measurement Status attribute from IEEE 11073-10206 ACOM is used to report errors or other special conditions. The Bluetooth SIG GHS specification adds more possible conditions. It is possible to have multiple conditions simultaneously, but some combinations of conditions do not make sense and should not occur.

To report these conditions in FHIR requires the use of different elements:

The dataAbsentReason element is used to report the error or not-available condition.
The status element is used to report the entered-in-error condition.
The interpretation element is used to report the questionable, calibrating, early-estimate, manually-entered, threshold error, and thresholding disabled conditions.

The table below lists the error conditions and the FHIR data elements to which they are mapped. The code system from which the code is drawn is also shown using a codsystem#code notation.

IEEE 11073-10206 Measurement Status	FHIR Observation Resource Data Element	Further Remarks Options
Invalid	`dataAbsentReason` = DAR#error `status` = HL7Status#entered-in-error	A device or gateway could decide not to upload invalid observations and could report an error by other means.
Questionable	`interpretation` = PoCDStatus#questionable	-
Not-available	`dataAbsentReason` = DAR#not-performed	A device or gateway could decide not to upload observations with no value and could report an error by other means.
Calibrating	`interpretation` = PoCDStatus#calibration-ongoing	-
Test-data	`meta.security` = ActReason#HTEST	Test data should in most cases not be uploaded to a FHIR server, except for testing purposes.
Early-estimate	`interpretation` = PoCDStatus#early-indication `status` = HL7Status#preliminary	-
Manually-entered	-	Add a note to the Observation resource that it was manually entered.
Setting	-	For device settings, the Observation resource should reference the PHD Device as the subject and not the Patient.
Threshold error	`interpretation` = PoCDStatus#in-alarm	Applies to numeric data. Add a note to the Observation resource that it is outside its boundaries.
Thresholding disabled	`interpretation` = PoCDStatus#alarm-inhibited	Applies to numeric data. Add a note to the Observation resource that its boundaries are not checked.

DAR: Data Absent Reason CodeSystem HL7Status: Observation Status CodeSystem PoCDStatus: Measurement Status Codes CodeSystem ActReason: Act Reason CodeSystem

Resource Profile: PhdBaseObservation ( Abstract )

Formal Views of Profile Content

Terminology Bindings

Constraints

Terminology Bindings (Differential)

Constraints

Terminology Bindings

Constraints

Terminology Bindings

Constraints

Terminology Bindings (Differential)

Constraints

Terminology Bindings

Constraints

Notes:

Gateway Device extension

Conditional-create Identifier - prevention of data duplication

Obtaining the Type of observation

Subject

Performer

Timestamp: effective[x]

extension: Coincident timestamp reference

Device

derivedFrom and hasMember: related Observations

Source-Handle-Reference case (concept from IEEE 11073-20601 - deprecated)

Category

Supplemental Information - Components

Measurement Status

Timestamp: `effective[x]`