Personal Health Device Implementation Guide
3.0.0-draft - STU 3 - R6 Global (Whole world)

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: PhdCoincidentTimeStampObservation - Detailed Descriptions

Page standards status: Trial-use Maturity Level: 1

Definitions for the PhdCoincidentTimeStampObservation resource profile

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

0. Observation
Definition

The PhdCoincidentTimeStampObservation reports the current time of the PHD sensor at the current time of the PHG.


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

ShortMeasurements and simple assertions
Comments

Used to record the correction the PHG applied to the PHD measurement timestamps (if any) and to be able to recover the original timestamps reported by the PHD should that be needed.


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

Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate NamesVital Sign, Measurement, Result, Test Performed, Observable
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
obs-6: Observation.dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
obs-7: 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: 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: 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: All observations SHOULD have a performer (performer.exists())
2. Observation.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. For DomainResources, if more than one implicitRules policy applies, additional policies may be conveyed using the additionalImplicitRules extension.

ShortA set of rules under which this content was created
Comments

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

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

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

ShortContained, inline Resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels. Contained resources may be a resource type defined in the FHIR specification, or an additional resource.

Control0..*
This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
6. Observation.modifierExtension
Definition

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

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

ShortExtensions that cannot be ignored
Comments

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

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

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

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on Observation.modifierExtension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 8. Observation.status
    Definition

    The status of the result value. Always 'final'


    The status of the result value.

    Shortregistered | in-process | specimen-in-process | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | unknown | cannot-be-obtained
    Comments

    The value shall be set to 'final'


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

    Control1..1
    BindingThe codes SHALL be taken from ObservationStatushttp://hl7.org/fhir/ValueSet/observation-status|6.0.0-ballot5
    (required to http://hl7.org/fhir/ValueSet/observation-status|6.0.0-ballot5)

    Codes providing the status of an observation.

    Typecode
    Is Modifiertrue because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supportfalse
    Summarytrue
    Requirements

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

    Pattern Valuefinal
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    10. Observation.code
    Definition

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

    ShortType of observation (code / type)
    Comments

    All code-value and, if present, component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation. All codings in Observation.code are expected to be sufficiently precise to allow a user with the code and value to be able to understand the value - though not all codes will necessarily convey the same level of detail. Codings in Observation.category SHOULD be concepts that are too broad to be able to understand the meaning of the Observation.value without also having an Observation.code.

    See Interoperability Issues using code value pairs in FHIR for additional information.

    Control1..1
    This element is affected by the following invariants: obs-7
    BindingFor example codes, see LOINCObsOrBothhttp://hl7.org/fhir/ValueSet/observation-codes-observationorboth|6.0.0-ballot5
    (example to http://hl7.org/fhir/ValueSet/observation-codes-observationorboth|6.0.0-ballot5)

    Codes identifying names of simple observations.

    TypeCodeableConcept
    Is Modifierfalse
    Must Supportfalse
    Summarytrue
    Requirements

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

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

    A reference to a code defined by a terminology system.

    ShortCode defined by a terminology system
    Comments

    Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

    Control10..*
    TypeCoding
    Is Modifierfalse
    Summarytrue
    Requirements

    Allows for alternative encodings within a code system, and translations to other code systems.

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

      A reference to a code defined by a terminology system.

      ShortThe type of time clock used by the PHDCode defined by a terminology system
      Comments

      Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

      Control10..1*
      BindingThe codes SHALL be taken from For codes, see MDC Clock Types
      (required to http://hl7.org/fhir/uv/phd/ValueSet/MDCClockTypes)

      MDC codes for PHD clock types

      TypeCoding
      Is Modifierfalse
      Summarytrue
      Requirements

      Allows for alternative encodings within a code system, and translations to other code systems.

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

      Reference to the PHD device for which the coincident timestamp measurement is reported. This element will point to a Device resource following the Phd Device Profile.


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

      ShortReference to the PHD device for which the coincident timestamp measurement is reportedWho and/or what the observation is about
      Comments

      One would expect this element to be a cardinality of 1..1. The only circumstance in which the subject can be missing is when the observation is made by a device that does not know the patient. In this case, the observation SHALL be matched to a patient through some context/channel matching technique, and at this point, the observation should be updated. The subject of an Observation may in some cases be a procedure. This supports the regulatory inspection use case where observations are captured during inspections of a procedure that is being performed (independent of any particular patient or whether patient related at all).

      Control10..1
      TypeReference(PhdDevice, Patient, Group, Device, Location, Organization, Procedure, Practitioner, Medication, Substance, BiologicallyDerivedProduct, NutritionProduct)
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Requirements

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

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

      A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

      ShortLiteral reference, Relative, internal or absolute URL
      Comments

      Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

      Control10..1
      This element is affected by the following invariants: ref-2, ref-1
      Typestring
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      20. Observation.focus
      Definition

      This element is not used in PHD as the coincident timestamp is not associated with a focus.


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

      a caregiver (RelatedPerson) has back strain and is unable to provide ADL support to a patient (Subject).

      ShortNo focus in PHD. The coincident timestamp is not associated with a focus.What the observation is about, when it is not about the subject of record
      Comments

      Examples demonstrating the use of subject and focus in an Observation:

      • A parent is trained to change their child's tracheostomy tube. The child is the subject, and the parent is the focus.

      • A fetal heart rate recorded in a mother's record. The mother is the subject, and the fetus is the focus.

      • Features of a body structure, such as a tumor. The patient is the subject, and the specific body structure is the focus.

      • Metrics captured from a medical device. The patient-attached device is the subject, the specific device metric is the focus, and the observing device itself is referenced in .device.

      Control0..0*
      TypeReference(Resource)
      Is Modifiertrue because This element is labeled as a modifier because it changes who is the target of the observation. See the use cases in the definition.
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      22. Observation.effective[x]
      Definition

      The time of the PHG at the time the current time of the PHD is ascertained.


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

      ShortThe current time of the PHG at the current time of the PHD. Absent if PHD is better synchronizedClinically relevant time/time-period for observation
      Comments

      This element is absent if the PHD has superior time synchronization relative to the PHG. When this element is absent it indicates that the PHG reported the measurement timestamps of the PHD without modification.


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

      Control0..1
      TypeChoice of: dateTime, Period, Timing, instant
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summarytrue
      Requirements

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

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

      The current time of the PHD. It will be either a valueDateTime if a wallclock time or a valueQuantity if a relative time or a dataAbsentReason if there is a time fault. The relative time is expressed in microseconds


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

      ShortThe current time of the PHD as a wallclock time (dateTime), relative time (Quantity), or if a time fault a dataAbsentReasonActual result
      Comments
      • An observation may have:
        1. a single value here
        2. both a value and a set of related or component values
        3. only a set of related or component values.
      • If a value is present, the datatype for this element should be determined by the code.
      • CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the code defines a coded value.
      • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
      • For additional guidance, see the Notes section below.
      • See Interoperability Issues using code value pairs in FHIR for additional information.
      Control0..1
      This element is affected by the following invariants: obs-7, obs-6, obs-11
      TypeChoice of: Quantity, dateTime, boolean, string, SampledData, Period, Ratio, Attachment, integer, time, Range, CodeableConcept
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summarytrue
      Requirements

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

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

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

      ShortWhy the result value is missing
      Comments

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

      The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed.

      Control0..1
      This element is affected by the following invariants: obs-6, obs-11
      BindingUnless not suitable, these codes SHALL be taken from DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason|6.0.0-ballot5
      (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason|6.0.0-ballot5)

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

      TypeCodeableConcept
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Requirements

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

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

      A reference to a code defined by a terminology system.

      ShortCode defined by a terminology system
      Comments

      Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

      Control0..*
      TypeCoding
      Is Modifierfalse
      Summarytrue
      Requirements

      Allows for alternative encodings within a code system, and translations to other code systems.

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

        This element is populated when the PHD has a time fault and the current time of the PHD cannot be obtained.


        A reference to a code defined by a terminology system.

        ShortTime Fault: The PHD has a time faultCode defined by a terminology system
        Comments

        Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

        Control0..1*
        TypeCoding
        Is Modifierfalse
        Summarytrue
        Requirements

        Allows for alternative encodings within a code system, and translations to other code systems.

        Pattern Value{
          "system" : "http://terminology.hl7.org/CodeSystem/data-absent-reason",
          "code" : "unknown"
        }
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        32. Observation.specimen
        Definition

        This element is not used in PHD as the coincident timestamp is not associated with a specimen.


        The specimen that was used when this observation was made.

        ShortNo specimen in PHD. The coincident timestamp is not associated with a specimen.Specimen used for this observation
        Comments

        SHOULD be used when the observation is performed on a specimen. The type of specimen SHOULD be consistent with anything implied in the Observation.code value.

        Control0..01
        TypeReference(Specimen, Group)
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        obs-9: 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))
        34. Observation.device
        Definition

        A reference to the device that generates the measurements or the device settings for the device.

        ShortA reference to the device that generates the measurements or the device settings for the device
        Comments

        This field will reference the PHG Device.


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

        Control10..1
        TypeReference(PhgDevice, Device, DeviceMetric)
        Is Modifierfalse
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        36. Observation.device.reference
        Definition

        Reference to the PHG device responsible for the coincident timestamp measurement. This element will point to a Device resource following the Phg Device Profile.


        A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

        ShortReference to the PHG device responsible for the coincident timestamp measurementLiteral reference, Relative, internal or absolute URL
        Comments

        Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

        Control10..1
        This element is affected by the following invariants: ref-2, ref-1
        Typestring
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        38. Observation.hasMember
        Definition

        This element is not used in PHD as the coincident timestamp is not part of a group observation.


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

        ShortNo reference to a group observation in PHD. The coincident timestamp is not part of a group observation.Related resource that belongs to the Observation group
        Comments

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

        Control0..0*
        TypeReference(Observation, QuestionnaireResponse)
        Is Modifierfalse
        Must Supportfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        40. Observation.derivedFrom
        Definition

        This element is not used in PHD as the coincident timestamp is not derived from another observation.


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

        ShortNo reference to a source observation in PHD. The coincident timestamp is not derived from another observation.Related resource from which the observation is made
        Comments

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

        Control0..0*
        TypeReference(DocumentReference, ImagingStudy, ImagingSelection, QuestionnaireResponse, Observation)
        Is Modifierfalse
        Must Supportfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        42. Observation.component
        Definition

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

        ShortComponent results
        Comments

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

        Control0..*
        This element is affected by the following invariants: obs-7, obs-11, obs-10
        TypeBackboneElement
        Is Modifierfalse
        Must Supportfalse
        Summarytrue
        Requirements

        Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, reference range, dataAbsentReason, and interpretation can differ between the components and are not inherited; these should be provided if appropriate.

        Invariantsele-1: All FHIR elements must have a @value or children or both (hasValue() or (children().count() > id.count()))
        SlicingThis element introduces a set of slices on Observation.component. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ code
        • 44. Observation.component.modifierExtension
          Definition

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

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

          ShortExtensions that cannot be ignored even if unrecognized
          Comments

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

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

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

          Alternate Namesextensions, user content, modifiers
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          SlicingThis element introduces a set of slices on Observation.component.modifierExtension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 46. Observation.component.code
            Definition

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

            ShortType of component observation (code / type)
            Comments

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

            Control1..1
            This element is affected by the following invariants: obs-7
            BindingFor example codes, see LOINCObsOrBothhttp://hl7.org/fhir/ValueSet/observation-codes-observationorboth|6.0.0-ballot5
            (example to http://hl7.org/fhir/ValueSet/observation-codes-observationorboth|6.0.0-ballot5)

            Codes identifying names of simple observations.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Requirements

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

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

            The method used to synchronize the clock of the PHD. This element is populated if the PHD supports clock synchronization.


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

            ShortClock Synchronization Method: The method used to synchronize the clock.Component results
            Comments

            Clock synchronization methods may include NTP, PTP, or other mechanisms.


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

            Control0..1*
            This element is affected by the following invariants: obs-7, obs-11, obs-10
            TypeBackboneElement
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Requirements

            Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, reference range, dataAbsentReason, and interpretation can differ between the components and are not inherited; these should be provided if appropriate.

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

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

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

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

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

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

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

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            SlicingThis element introduces a set of slices on Observation.component.modifierExtension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • value @ url
            • 52. Observation.component:clockSyncMethod.code
              Definition

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

              ShortType of component observation (code / type)
              Comments

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

              Control1..1
              This element is affected by the following invariants: obs-7
              BindingFor example codes, see LOINCObsOrBothhttp://hl7.org/fhir/ValueSet/observation-codes-observationorboth|6.0.0-ballot5
              (example to http://hl7.org/fhir/ValueSet/observation-codes-observationorboth|6.0.0-ballot5)

              Codes identifying names of simple observations.

              TypeCodeableConcept
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Requirements

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

              Pattern Value{
                "coding" : [{
                  "system" : "urn:iso:std:iso:11073:10101",
                  "code" : "68220"
                }]
              }
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              54. Observation.component:clockSyncMethod.value[x]
              Definition

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

              ShortActual component result
              Comments

              Used when observation has a set of component observations:

              • An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived).
              • If a value is present, the datatype for this element should be determined by the code.
              • CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the code defines a coded value.
              • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
              • If a value is present, the datatype for this element should be determined by the code.
              • CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the code defines a coded value.
              • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
              • For additional guidance, see the Notes section below.
              Control0..1
              This element is affected by the following invariants: obs-10
              TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period, Attachment
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supportfalse
              Summarytrue
              Requirements

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

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

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

                ShortThe clock synchronization method last used by the PHD/PHG to synchronize the clock of the PHDActual component result
                Comments

                Used when observation has a set of component observations:

                • An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived).
                • If a value is present, the datatype for this element should be determined by the code.
                • CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the code defines a coded value.
                • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
                • If a value is present, the datatype for this element should be determined by the code.
                • CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the code defines a coded value.
                • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
                • For additional guidance, see the Notes section below.
                Control0..1
                This element is affected by the following invariants: obs-10
                BindingUnless not suitable, these codes SHALL be taken from For codes, see MDC Time Synchronization Methods
                (extensible to http://hl7.org/fhir/uv/phd/ValueSet/MDCTimeSyncMethods)
                TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, Attachment, integer, time, Range
                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Requirements

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

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

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

                ShortWhy the component result value is missing
                Comments

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

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

                Control0..01
                This element is affected by the following invariants: obs-10
                BindingUnless not suitable, these codes SHALL be taken from DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason|6.0.0-ballot5
                (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason|6.0.0-ballot5)

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

                TypeCodeableConcept
                Is Modifierfalse
                Must Supportfalse
                Summaryfalse
                Requirements

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

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

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

                0. Observation
                Definition

                The PhdCoincidentTimeStampObservation reports the current time of the PHD sensor at the current time of the PHG.

                Comments

                Used to record the correction the PHG applied to the PHD measurement timestamps (if any) and to be able to recover the original timestamps reported by the PHD should that be needed.

                2. Observation.status
                Definition

                The status of the result value. Always 'final'

                Comments

                The value shall be set to 'final'

                Pattern Valuefinal
                4. Observation.code
                6. Observation.code.coding
                Control1..?
                SlicingThis element introduces a set of slices on Observation.code.coding. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • value @ $this
                • 8. Observation.code.coding:MDCType
                  Slice NameMDCType
                  ShortThe type of time clock used by the PHD
                  Control1..1
                  BindingThe codes SHALL be taken from MDC Clock Types
                  (required to http://hl7.org/fhir/uv/phd/ValueSet/MDCClockTypes)

                  MDC codes for PHD clock types

                  10. Observation.subject
                  Definition

                  Reference to the PHD device for which the coincident timestamp measurement is reported. This element will point to a Device resource following the Phd Device Profile.

                  ShortReference to the PHD device for which the coincident timestamp measurement is reported
                  Control1..?
                  TypeReference(PhdDevice)
                  12. Observation.subject.reference
                  Control1..?
                  14. Observation.focus
                  Definition

                  This element is not used in PHD as the coincident timestamp is not associated with a focus.

                  ShortNo focus in PHD. The coincident timestamp is not associated with a focus.
                  Control0..0
                  16. Observation.effective[x]
                  Definition

                  The time of the PHG at the time the current time of the PHD is ascertained.

                  ShortThe current time of the PHG at the current time of the PHD. Absent if PHD is better synchronized
                  Comments

                  This element is absent if the PHD has superior time synchronization relative to the PHG. When this element is absent it indicates that the PHG reported the measurement timestamps of the PHD without modification.

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

                  The current time of the PHD. It will be either a valueDateTime if a wallclock time or a valueQuantity if a relative time or a dataAbsentReason if there is a time fault. The relative time is expressed in microseconds

                  ShortThe current time of the PHD as a wallclock time (dateTime), relative time (Quantity), or if a time fault a dataAbsentReason
                  TypeChoice of: Quantity, dateTime, boolean, string, SampledData, Period, Ratio, Attachment, integer, time, Range, CodeableConcept
                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  20. Observation.dataAbsentReason
                  22. Observation.dataAbsentReason.coding
                  SlicingThis element introduces a set of slices on Observation.dataAbsentReason.coding. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • value @ $this
                  • 24. Observation.dataAbsentReason.coding:TimeFault
                    Slice NameTimeFault
                    Definition

                    This element is populated when the PHD has a time fault and the current time of the PHD cannot be obtained.

                    ShortTime Fault: The PHD has a time fault
                    Control0..1
                    Pattern Value{
                      "system" : "http://terminology.hl7.org/CodeSystem/data-absent-reason",
                      "code" : "unknown"
                    }
                    26. Observation.specimen
                    Definition

                    This element is not used in PHD as the coincident timestamp is not associated with a specimen.

                    ShortNo specimen in PHD. The coincident timestamp is not associated with a specimen.
                    Control0..0
                    28. Observation.device
                    Comments

                    This field will reference the PHG Device.

                    Control1..?
                    TypeReference(PhgDevice)
                    30. Observation.device.reference
                    Definition

                    Reference to the PHG device responsible for the coincident timestamp measurement. This element will point to a Device resource following the Phg Device Profile.

                    ShortReference to the PHG device responsible for the coincident timestamp measurement
                    Control1..?
                    32. Observation.hasMember
                    Definition

                    This element is not used in PHD as the coincident timestamp is not part of a group observation.

                    ShortNo reference to a group observation in PHD. The coincident timestamp is not part of a group observation.
                    Control0..0
                    34. Observation.derivedFrom
                    Definition

                    This element is not used in PHD as the coincident timestamp is not derived from another observation.

                    ShortNo reference to a source observation in PHD. The coincident timestamp is not derived from another observation.
                    Control0..0
                    36. Observation.component
                    SlicingThis element introduces a set of slices on Observation.component. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                    • value @ code
                    • 38. Observation.component:clockSyncMethod
                      Slice NameclockSyncMethod
                      Definition

                      The method used to synchronize the clock of the PHD. This element is populated if the PHD supports clock synchronization.

                      ShortClock Synchronization Method: The method used to synchronize the clock.
                      Comments

                      Clock synchronization methods may include NTP, PTP, or other mechanisms.

                      Control0..1
                      40. Observation.component:clockSyncMethod.code
                      Pattern Value{
                        "coding" : [{
                          "system" : "urn:iso:std:iso:11073:10101",
                          "code" : "68220"
                        }]
                      }
                      42. Observation.component:clockSyncMethod.value[x]
                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                      SlicingThis element introduces a set of slices on Observation.component.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                      • type @ $this
                      • 44. Observation.component:clockSyncMethod.value[x]:valueCodeableConcept
                        Slice NamevalueCodeableConcept
                        ShortThe clock synchronization method last used by the PHD/PHG to synchronize the clock of the PHD
                        Control0..1
                        BindingUnless not suitable, these codes SHALL be taken from MDC Time Synchronization Methods
                        (extensible to http://hl7.org/fhir/uv/phd/ValueSet/MDCTimeSyncMethods)
                        TypeCodeableConcept
                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                        46. Observation.component:clockSyncMethod.dataAbsentReason
                        Control0..0

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

                        0. Observation
                        Definition

                        The PhdCoincidentTimeStampObservation reports the current time of the PHD sensor at the current time of the PHG.

                        ShortMeasurements and simple assertions
                        Comments

                        Used to record the correction the PHG applied to the PHD measurement timestamps (if any) and to be able to recover the original timestamps reported by the PHD should that be needed.

                        Control0..*
                        Is Modifierfalse
                        Must Supportfalse
                        Summaryfalse
                        Alternate NamesVital Sign, Measurement, Result, Test Performed, Observable
                        Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
                        dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty())
                        dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
                        dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
                        dom-6: A resource should have narrative for robust management (text.`div`.exists())
                        obs-6: Observation.dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
                        obs-7: 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: 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: 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: All observations SHOULD have a performer (performer.exists())
                        2. Observation.id
                        Definition

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

                        ShortLogical id of this artifact
                        Comments

                        Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resource id depends on the given use case.

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

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

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

                        A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. For DomainResources, if more than one implicitRules policy applies, additional policies may be conveyed using the additionalImplicitRules extension.

                        ShortA set of rules under which this content was created
                        Comments

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

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

                        The base language in which the resource is written.

                        ShortLanguage of the resource content
                        Comments

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

                        Control0..1
                        BindingThe codes SHALL be taken from AllLanguages
                        (required to http://hl7.org/fhir/ValueSet/all-languages|6.0.0-ballot5)

                        IETF language tag for a human language

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

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

                        ShortText summary of the resource, for human interpretation
                        Comments

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

                        Control0..1
                        This element is affected by the following invariants: dom-6
                        TypeNarrative
                        Is Modifierfalse
                        Must Supportfalse
                        Summaryfalse
                        Alternate Namesnarrative, html, xhtml, display
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        12. Observation.contained
                        Definition

                        These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

                        ShortContained, inline Resources
                        Comments

                        This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels. Contained resources may be a resource type defined in the FHIR specification, or an additional resource.

                        Control0..*
                        This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
                        TypeResource
                        Is Modifierfalse
                        Must Supportfalse
                        Summaryfalse
                        Alternate Namesinline resources, anonymous resources, contained resources
                        14. Observation.extension
                        Definition

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

                        ShortAdditional content defined by implementations
                        Comments

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

                        Control0..*
                        TypeExtension
                        Is Modifierfalse
                        Must Supportfalse
                        Summaryfalse
                        Alternate Namesextensions, user content
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        SlicingThis element introduces a set of slices on Observation.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                        • value @ url
                        • 16. Observation.modifierExtension
                          Definition

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

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

                          ShortExtensions that cannot be ignored
                          Comments

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

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

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

                          Alternate Namesextensions, user content
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          SlicingThis element introduces a set of slices on Observation.modifierExtension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                          • value @ url
                          • 18. Observation.identifier
                            Definition

                            A unique identifier assigned to this observation.

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

                            Allows observations to be distinguished and referenced.

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

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

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

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

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

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

                            ShortTriggering observation(s)
                            Control0..*
                            TypeBackboneElement
                            Is Modifierfalse
                            Must Supportfalse
                            Summaryfalse
                            Invariantsele-1: All FHIR elements must have a @value or children or both (hasValue() or (children().count() > id.count()))
                            24. Observation.triggeredBy.id
                            Definition

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

                            ShortUnique id for inter-element referencing
                            Control0..1
                            This element is affected by the following invariants: ele-1
                            Typestring
                            Is Modifierfalse
                            XML FormatIn the XML format, this property is represented as an attribute.
                            Summaryfalse
                            26. Observation.triggeredBy.extension
                            Definition

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

                            ShortAdditional content defined by implementations
                            Comments

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

                            Control0..*
                            TypeExtension
                            Is Modifierfalse
                            Summaryfalse
                            Alternate Namesextensions, user content
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            SlicingThis element introduces a set of slices on Observation.triggeredBy.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                            • value @ url
                            • 28. Observation.triggeredBy.modifierExtension
                              Definition

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

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

                              ShortExtensions that cannot be ignored even if unrecognized
                              Comments

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

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

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

                              Alternate Namesextensions, user content, modifiers
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              SlicingThis element introduces a set of slices on Observation.triggeredBy.modifierExtension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                              • value @ url
                              • 30. Observation.triggeredBy.observation
                                Definition

                                Reference to the triggering observation.

                                ShortTriggering observation
                                Control1..1
                                TypeReference(Observation)
                                Is Modifierfalse
                                Must Supportfalse
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                32. Observation.triggeredBy.type
                                Definition

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

                                Shortreflex | repeat | re-run
                                Control1..1
                                BindingThe codes SHALL be taken from TriggeredBytype
                                (required to http://hl7.org/fhir/ValueSet/observation-triggeredbytype|6.0.0-ballot5)

                                The type of TriggeredBy Observation.

                                Typecode
                                Is Modifierfalse
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Must Supportfalse
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                34. Observation.triggeredBy.reason
                                Definition

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

                                ShortReason that the observation was triggered
                                Control0..1
                                Typestring
                                Is Modifierfalse
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Must Supportfalse
                                Summaryfalse
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                36. Observation.partOf
                                Definition

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

                                ShortPart of referenced event
                                Comments

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

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

                                The status of the result value. Always 'final'

                                Shortregistered | in-process | specimen-in-process | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | unknown | cannot-be-obtained
                                Comments

                                The value shall be set to 'final'

                                Control1..1
                                BindingThe codes SHALL be taken from ObservationStatus
                                (required to http://hl7.org/fhir/ValueSet/observation-status|6.0.0-ballot5)

                                Codes providing the status of an observation.

                                Typecode
                                Is Modifiertrue because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Must Supportfalse
                                Summarytrue
                                Requirements

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

                                Pattern Valuefinal
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                40. Observation.statusReason
                                Definition

                                Captures the reason for the current state of the Observation.

                                ShortReason for current status
                                Comments

                                This is generally only used for "exception" statuses such as "not-done", "suspended" or "cancelled".

                                Control0..1
                                BindingFor example codes, see ObservationStatusReason
                                (example to http://hl7.org/fhir/ValueSet/observation-status-reason|6.0.0-ballot5)

                                Codes identifying the reason for the current state of an observation.

                                TypeCodeableConcept
                                Is Modifierfalse
                                Must Supportfalse
                                Summaryfalse
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                42. Observation.category
                                Definition

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

                                ShortClassification of type of observation
                                Comments

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

                                Control0..*
                                BindingThe codes SHOULD be taken from ObservationCategoryCodes
                                (preferred to http://hl7.org/fhir/ValueSet/observation-category|6.0.0-ballot5)

                                Codes for high level observation categories.

                                TypeCodeableConcept
                                Is Modifierfalse
                                Must Supportfalse
                                Summaryfalse
                                Requirements

                                Used for filtering what observations are retrieved and displayed.

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

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

                                ShortType of observation (code / type)
                                Comments

                                All code-value and, if present, component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation. All codings in Observation.code are expected to be sufficiently precise to allow a user with the code and value to be able to understand the value - though not all codes will necessarily convey the same level of detail. Codings in Observation.category SHOULD be concepts that are too broad to be able to understand the meaning of the Observation.value without also having an Observation.code.

                                See Interoperability Issues using code value pairs in FHIR for additional information.

                                Control1..1
                                This element is affected by the following invariants: obs-7
                                BindingFor example codes, see LOINCObsOrBoth
                                (example to http://hl7.org/fhir/ValueSet/observation-codes-observationorboth|6.0.0-ballot5)

                                Codes identifying names of simple observations.

                                TypeCodeableConcept
                                Is Modifierfalse
                                Must Supportfalse
                                Summarytrue
                                Requirements

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

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

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

                                ShortUnique id for inter-element referencing
                                Control0..1
                                This element is affected by the following invariants: ele-1
                                Typestring
                                Is Modifierfalse
                                XML FormatIn the XML format, this property is represented as an attribute.
                                Summaryfalse
                                48. Observation.code.extension
                                Definition

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

                                ShortAdditional content defined by implementations
                                Comments

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

                                Control0..*
                                TypeExtension
                                Is Modifierfalse
                                Summaryfalse
                                Alternate Namesextensions, user content
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                SlicingThis element introduces a set of slices on Observation.code.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                • value @ url
                                • 50. Observation.code.coding
                                  Definition

                                  A reference to a code defined by a terminology system.

                                  ShortCode defined by a terminology system
                                  Comments

                                  Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                  Control1..*
                                  TypeCoding
                                  Is Modifierfalse
                                  Summarytrue
                                  Requirements

                                  Allows for alternative encodings within a code system, and translations to other code systems.

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

                                    A reference to a code defined by a terminology system.

                                    ShortThe type of time clock used by the PHD
                                    Comments

                                    Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                    Control1..1
                                    BindingThe codes SHALL be taken from MDC Clock Types
                                    (required to http://hl7.org/fhir/uv/phd/ValueSet/MDCClockTypes)

                                    MDC codes for PHD clock types

                                    TypeCoding
                                    Is Modifierfalse
                                    Summarytrue
                                    Requirements

                                    Allows for alternative encodings within a code system, and translations to other code systems.

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

                                    A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                    ShortPlain text representation of the concept
                                    Comments

                                    Very often the text is the same as a displayName of one of the codings.

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

                                    The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

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

                                    Reference to the PHD device for which the coincident timestamp measurement is reported. This element will point to a Device resource following the Phd Device Profile.

                                    ShortReference to the PHD device for which the coincident timestamp measurement is reported
                                    Comments

                                    One would expect this element to be a cardinality of 1..1. The only circumstance in which the subject can be missing is when the observation is made by a device that does not know the patient. In this case, the observation SHALL be matched to a patient through some context/channel matching technique, and at this point, the observation should be updated. The subject of an Observation may in some cases be a procedure. This supports the regulatory inspection use case where observations are captured during inspections of a procedure that is being performed (independent of any particular patient or whether patient related at all).

                                    Control1..1
                                    TypeReference(PhdDevice)
                                    Is Modifierfalse
                                    Must Supportfalse
                                    Summarytrue
                                    Requirements

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

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

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

                                    ShortUnique id for inter-element referencing
                                    Control0..1
                                    This element is affected by the following invariants: ele-1
                                    Typestring
                                    Is Modifierfalse
                                    XML FormatIn the XML format, this property is represented as an attribute.
                                    Summaryfalse
                                    60. Observation.subject.extension
                                    Definition

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

                                    ShortAdditional content defined by implementations
                                    Comments

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

                                    Control0..*
                                    TypeExtension
                                    Is Modifierfalse
                                    Summaryfalse
                                    Alternate Namesextensions, user content
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    SlicingThis element introduces a set of slices on Observation.subject.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                    • value @ url
                                    • 62. Observation.subject.reference
                                      Definition

                                      A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

                                      ShortLiteral reference, Relative, internal or absolute URL
                                      Comments

                                      Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

                                      Control1..1
                                      This element is affected by the following invariants: ref-2, ref-1
                                      Typestring
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      64. Observation.subject.type
                                      Definition

                                      The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

                                      The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).

                                      ShortType the reference refers to (e.g. "Patient") - must be a resource in resources
                                      Comments

                                      This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a known RESTful URL) or by resolving the target of the reference.

                                      Control0..1
                                      BindingUnless not suitable, these codes SHALL be taken from ResourceType
                                      (extensible to http://hl7.org/fhir/ValueSet/resource-types|6.0.0-ballot5)

                                      Aa resource (or, for logical models, the URI of the logical model).

                                      Typeuri
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      66. Observation.subject.identifier
                                      Definition

                                      An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

                                      ShortLogical reference, when literal reference is not known
                                      Comments

                                      When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

                                      When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

                                      Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

                                      Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

                                      This element only allows for a single identifier. In the case where additional identifiers are required, use the additional identifier extension.

                                      NoteThis is a business identifier, not a resource identifier (see discussion)
                                      Control0..1
                                      This element is affected by the following invariants: ref-2
                                      TypeIdentifier
                                      Is Modifierfalse
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      68. Observation.subject.display
                                      Definition

                                      Plain text narrative that identifies the resource in addition to the resource reference.

                                      ShortText alternative for the resource
                                      Comments

                                      This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

                                      Control0..1
                                      This element is affected by the following invariants: ref-2
                                      Typestring
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      70. Observation.focus
                                      Definition

                                      This element is not used in PHD as the coincident timestamp is not associated with a focus.

                                      ShortNo focus in PHD. The coincident timestamp is not associated with a focus.
                                      Comments

                                      Examples demonstrating the use of subject and focus in an Observation:

                                      • A parent is trained to change their child's tracheostomy tube. The child is the subject, and the parent is the focus.

                                      • A fetal heart rate recorded in a mother's record. The mother is the subject, and the fetus is the focus.

                                      • Features of a body structure, such as a tumor. The patient is the subject, and the specific body structure is the focus.

                                      • Metrics captured from a medical device. The patient-attached device is the subject, the specific device metric is the focus, and the observing device itself is referenced in .device.

                                      Control0..0
                                      TypeReference(Resource)
                                      Is Modifiertrue because This element is labeled as a modifier because it changes who is the target of the observation. See the use cases in the definition.
                                      Must Supportfalse
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      72. Observation.organizer
                                      Definition

                                      This observation serves as an organizer or grouper for a set of (one or more) sub-observations.

                                      ShortThis observation organizes/groups a set of sub-observations
                                      Comments

                                      An observation that is an organizer/grouper does not have a value (or dataAbsentReason) of its own - all values are included in the sub-observations. The sub-observations are linked using hasMember element references (in some instances there may be no hasMember references, as it is possible that the organizer/grouper observation may be created first, and the sub-observations are not created until a later time). An organizer/grouper observation also does not contain any components.

                                      Control0..1
                                      This element is affected by the following invariants: obs-11
                                      Typeboolean
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Must Supportfalse
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      74. Observation.encounter
                                      Definition

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

                                      ShortHealthcare event during which this observation is made. If you need to place the observation within one or more episodes of care, use the workflow-episodeOfCare extension
                                      Comments

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

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

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

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

                                      The time of the PHG at the time the current time of the PHD is ascertained.

                                      ShortThe current time of the PHG at the current time of the PHD. Absent if PHD is better synchronized
                                      Comments

                                      This element is absent if the PHD has superior time synchronization relative to the PHG. When this element is absent it indicates that the PHG reported the measurement timestamps of the PHD without modification.

                                      Control0..1
                                      TypeChoice of: dateTime, Period, Timing, instant
                                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Must Supportfalse
                                      Summarytrue
                                      Requirements

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

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

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

                                      ShortDate/Time this version was made available
                                      Comments

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

                                      Control0..1
                                      Typeinstant
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Must Supportfalse
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      80. Observation.performer
                                      Definition

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

                                      ShortWho is responsible for the observation
                                      Comments

                                      Group is only allowed in the circumstance where the group represents a family or a household, and should not represent groups of Practitioners where other more specific resources can be used instead.

                                      Control0..*
                                      TypeReference(Practitioner, PractitionerRole, Organization, CareTeam, Patient, RelatedPerson, HealthcareService, Group)
                                      Is Modifierfalse
                                      Must Supportfalse
                                      Summarytrue
                                      Requirements

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

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

                                      The current time of the PHD. It will be either a valueDateTime if a wallclock time or a valueQuantity if a relative time or a dataAbsentReason if there is a time fault. The relative time is expressed in microseconds

                                      ShortThe current time of the PHD as a wallclock time (dateTime), relative time (Quantity), or if a time fault a dataAbsentReason
                                      Comments
                                      • An observation may have:
                                        1. a single value here
                                        2. both a value and a set of related or component values
                                        3. only a set of related or component values.
                                      • If a value is present, the datatype for this element should be determined by the code.
                                      • CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the code defines a coded value.
                                      • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
                                      • For additional guidance, see the Notes section below.
                                      • See Interoperability Issues using code value pairs in FHIR for additional information.
                                      Control0..1
                                      This element is affected by the following invariants: obs-7, obs-6, obs-11
                                      TypeChoice of: Quantity, dateTime
                                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Must Supportfalse
                                      Summarytrue
                                      Requirements

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

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

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

                                      ShortWhy the result value is missing
                                      Comments

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

                                      The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed.

                                      Control0..1
                                      This element is affected by the following invariants: obs-6, obs-11
                                      BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                      (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason|6.0.0-ballot5)

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

                                      TypeCodeableConcept
                                      Is Modifierfalse
                                      Must Supportfalse
                                      Summaryfalse
                                      Requirements

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

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

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

                                      ShortUnique id for inter-element referencing
                                      Control0..1
                                      This element is affected by the following invariants: ele-1
                                      Typestring
                                      Is Modifierfalse
                                      XML FormatIn the XML format, this property is represented as an attribute.
                                      Summaryfalse
                                      88. Observation.dataAbsentReason.extension
                                      Definition

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

                                      ShortAdditional content defined by implementations
                                      Comments

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

                                      Control0..*
                                      TypeExtension
                                      Is Modifierfalse
                                      Summaryfalse
                                      Alternate Namesextensions, user content
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      SlicingThis element introduces a set of slices on Observation.dataAbsentReason.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                      • value @ url
                                      • 90. Observation.dataAbsentReason.coding
                                        Definition

                                        A reference to a code defined by a terminology system.

                                        ShortCode defined by a terminology system
                                        Comments

                                        Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                        Control0..*
                                        TypeCoding
                                        Is Modifierfalse
                                        Summarytrue
                                        Requirements

                                        Allows for alternative encodings within a code system, and translations to other code systems.

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

                                          This element is populated when the PHD has a time fault and the current time of the PHD cannot be obtained.

                                          ShortTime Fault: The PHD has a time fault
                                          Comments

                                          Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                          Control0..1
                                          TypeCoding
                                          Is Modifierfalse
                                          Summarytrue
                                          Requirements

                                          Allows for alternative encodings within a code system, and translations to other code systems.

                                          Pattern Value{
                                            "system" : "http://terminology.hl7.org/CodeSystem/data-absent-reason",
                                            "code" : "unknown"
                                          }
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          94. Observation.dataAbsentReason.text
                                          Definition

                                          A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                          ShortPlain text representation of the concept
                                          Comments

                                          Very often the text is the same as a displayName of one of the codings.

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

                                          The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

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

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

                                          ShortHigh, low, normal, etc
                                          Comments

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

                                          Control0..*
                                          BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                          (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation|6.0.0-ballot5)

                                          Codes identifying interpretations of observations.

                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summaryfalse
                                          Requirements

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

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

                                          Contextual information that is relevant to understanding the observation value or interpretation. The referenced information may be concurrent or precede the observation.

                                          ShortContext for understanding the observation
                                          Comments

                                          This element provides essential contextual information that affects how the observation should be interpreted. For example, knowing that a patient is diabetic, fasting, or paraplegic may be critical to properly understanding lab results or other observations. Similarly, information about the timing, view, or imaging mode may be relevant to understanding an imaging measurement. This element is intended for interpretive context and not for conveying order, request, or fulfillment workflow information.

                                          Control0..*
                                          BindingFor example codes, see ObservationContextCodes
                                          (example to http://hl7.org/fhir/ValueSet/observation-context|6.0.0-ballot5)

                                          Codes identifying contextual factors that affect interpretation of observations.

                                          TypeCodeableReference(Resource)
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summaryfalse
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          100. Observation.note
                                          Definition

                                          Comments about the observation or the results.

                                          ShortComments about the observation
                                          Comments

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

                                          Control0..*
                                          TypeAnnotation
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summaryfalse
                                          Requirements

                                          Need to be able to provide free text additional information.

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

                                          DEPRECATED: This element is deprecated. Use bodyStructure instead. Indicates the site on the subject's body where the observation was made (i.e. the target site).

                                          ShortDEPRECATED: Observed body part
                                          Comments

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

                                          Control0..1
                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summaryfalse
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          104. Observation.bodyStructure
                                          Definition

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

                                          ShortObserved body structure
                                          Comments

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

                                          Control0..*
                                          BindingFor example codes, see SNOMEDCTBodyStructures
                                          (example to http://hl7.org/fhir/ValueSet/body-site|6.0.0-ballot5)

                                          SNOMED CT Body Structures

                                          TypeCodeableReference(BodyStructure)
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summaryfalse
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          106. Observation.method
                                          Definition

                                          Indicates the mechanism used to perform the observation.

                                          ShortHow it was done
                                          Comments

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

                                          Control0..1
                                          BindingFor example codes, see ObservationMethods
                                          (example to http://hl7.org/fhir/ValueSet/observation-methods|6.0.0-ballot5)

                                          Methods for simple observations.

                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summaryfalse
                                          Requirements

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

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

                                          This element is not used in PHD as the coincident timestamp is not associated with a specimen.

                                          ShortNo specimen in PHD. The coincident timestamp is not associated with a specimen.
                                          Comments

                                          SHOULD be used when the observation is performed on a specimen. The type of specimen SHOULD be consistent with anything implied in the Observation.code value.

                                          Control0..0
                                          TypeReference(Specimen, Group)
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summaryfalse
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          obs-9: 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))
                                          110. Observation.device
                                          Definition

                                          A reference to the device that generates the measurements or the device settings for the device.

                                          ShortA reference to the device that generates the measurements or the device settings for the device
                                          Comments

                                          This field will reference the PHG Device.

                                          Control1..1
                                          TypeReference(PhgDevice)
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summaryfalse
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          112. Observation.device.id
                                          Definition

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

                                          ShortUnique id for inter-element referencing
                                          Control0..1
                                          This element is affected by the following invariants: ele-1
                                          Typestring
                                          Is Modifierfalse
                                          XML FormatIn the XML format, this property is represented as an attribute.
                                          Summaryfalse
                                          114. Observation.device.extension
                                          Definition

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

                                          ShortAdditional content defined by implementations
                                          Comments

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

                                          Control0..*
                                          TypeExtension
                                          Is Modifierfalse
                                          Summaryfalse
                                          Alternate Namesextensions, user content
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          SlicingThis element introduces a set of slices on Observation.device.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                          • value @ url
                                          • 116. Observation.device.reference
                                            Definition

                                            Reference to the PHG device responsible for the coincident timestamp measurement. This element will point to a Device resource following the Phg Device Profile.

                                            ShortReference to the PHG device responsible for the coincident timestamp measurement
                                            Comments

                                            Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

                                            Control1..1
                                            This element is affected by the following invariants: ref-2, ref-1
                                            Typestring
                                            Is Modifierfalse
                                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            118. Observation.device.type
                                            Definition

                                            The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

                                            The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).

                                            ShortType the reference refers to (e.g. "Patient") - must be a resource in resources
                                            Comments

                                            This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a known RESTful URL) or by resolving the target of the reference.

                                            Control0..1
                                            BindingUnless not suitable, these codes SHALL be taken from ResourceType
                                            (extensible to http://hl7.org/fhir/ValueSet/resource-types|6.0.0-ballot5)

                                            Aa resource (or, for logical models, the URI of the logical model).

                                            Typeuri
                                            Is Modifierfalse
                                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            120. Observation.device.identifier
                                            Definition

                                            An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

                                            ShortLogical reference, when literal reference is not known
                                            Comments

                                            When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

                                            When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

                                            Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

                                            Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

                                            This element only allows for a single identifier. In the case where additional identifiers are required, use the additional identifier extension.

                                            NoteThis is a business identifier, not a resource identifier (see discussion)
                                            Control0..1
                                            This element is affected by the following invariants: ref-2
                                            TypeIdentifier
                                            Is Modifierfalse
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            122. Observation.device.display
                                            Definition

                                            Plain text narrative that identifies the resource in addition to the resource reference.

                                            ShortText alternative for the resource
                                            Comments

                                            This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

                                            Control0..1
                                            This element is affected by the following invariants: ref-2
                                            Typestring
                                            Is Modifierfalse
                                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            124. Observation.supportingDevice
                                            Definition

                                            A reference to additional devices, kits, or reagents (e.g., Test Kit, Calibration Kit, QC materials) used to support the generation of the measurement.

                                            ShortDevice supporting generation of the measurement
                                            Control0..*
                                            BindingFor example codes, see DeviceType
                                            (example to http://hl7.org/fhir/ValueSet/device-type|6.0.0-ballot5)

                                            Type of device supporting the generation of the measurement.

                                            TypeCodeableReference(Device)
                                            Is Modifierfalse
                                            Must Supportfalse
                                            Summaryfalse
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            126. Observation.referenceRange
                                            Definition

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

                                            ShortProvides guide for interpretation
                                            Comments

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

                                            Control0..*
                                            TypeBackboneElement
                                            Is Modifierfalse
                                            Must Supportfalse
                                            Summaryfalse
                                            Requirements

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

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

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

                                            ShortUnique id for inter-element referencing
                                            Control0..1
                                            This element is affected by the following invariants: ele-1
                                            Typestring
                                            Is Modifierfalse
                                            XML FormatIn the XML format, this property is represented as an attribute.
                                            Summaryfalse
                                            130. Observation.referenceRange.extension
                                            Definition

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

                                            ShortAdditional content defined by implementations
                                            Comments

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

                                            Control0..*
                                            TypeExtension
                                            Is Modifierfalse
                                            Summaryfalse
                                            Alternate Namesextensions, user content
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            SlicingThis element introduces a set of slices on Observation.referenceRange.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                            • value @ url
                                            • 132. Observation.referenceRange.modifierExtension
                                              Definition

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

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

                                              ShortExtensions that cannot be ignored even if unrecognized
                                              Comments

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

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

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

                                              Alternate Namesextensions, user content, modifiers
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              SlicingThis element introduces a set of slices on Observation.referenceRange.modifierExtension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                              • value @ url
                                              • 134. Observation.referenceRange.low
                                                Definition

                                                The value of the low bound of the reference range.

                                                ShortLow Range, if relevant
                                                Comments

                                                When low.comparator is not populated (the low.comparator element was not available prior to FHIR R6), the low bound of the reference range endpoint is inclusive of the value (e.g., reference range is '>=5' - '<=9'). Alternatively, this can be specified explicitly by populating low.comparator = '>='. When the low bound of the reference range endpoint is intended to be exclusive of the value (e.g., reference range is '>5' - '<9'), this is specified with low.comparator = '>'. If the low bound is omitted, it is assumed to be meaningless (e.g., reference range is '<=2.3').

                                                Control0..1
                                                This element is affected by the following invariants: obs-3
                                                TypeQuantity
                                                Is Modifierfalse
                                                Must Supportfalse
                                                Summaryfalse
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                obs-13: If low.comparator exists, it must be '>=' or '>'. (comparator.exists() implies (comparator = '>=' or comparator = '>'))
                                                136. Observation.referenceRange.high
                                                Definition

                                                The value of the high bound of the reference range.

                                                ShortHigh Range, if relevant
                                                Comments

                                                When high.comparator is not populated (the high.comparator element was not available prior to FHIR R6), the high bound of the reference range endpoint is inclusive of the value (e.g., reference range is '>=5' - '<=9'). Alternatively, this can be specified explicitly by populating high.comparator = '<='. When the high bound of the reference range endpoint is intended to be exclusive of the value (e.g., reference range is '>5' - '<9'), this is specified with high.comparator = '<'. If the high bound is omitted, it is assumed to be meaningless (e.g., reference range is '>=2.3').

                                                Control0..1
                                                This element is affected by the following invariants: obs-3
                                                TypeQuantity
                                                Is Modifierfalse
                                                Must Supportfalse
                                                Summaryfalse
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                obs-14: If high.comparator exists, it must be '<=' or '<'. (comparator.exists() implies (comparator = '<=' or comparator = '<'))
                                                138. Observation.referenceRange.normalValue
                                                Definition

                                                The value of the normal value of the reference range.

                                                ShortNormal value, if relevant
                                                Control0..1
                                                BindingFor example codes, see ObservationReferenceRangeNormalValueCodes
                                                (example to http://hl7.org/fhir/ValueSet/observation-referencerange-normalvalue|6.0.0-ballot5)

                                                Codes identifying the normal value of the observation.

                                                TypeCodeableConcept
                                                Is Modifierfalse
                                                Must Supportfalse
                                                Summaryfalse
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                140. Observation.referenceRange.type
                                                Definition

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

                                                ShortReference range qualifier
                                                Comments

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

                                                Control0..1
                                                BindingThe codes SHOULD be taken from ObservationReferenceRangeMeaningCodes
                                                (preferred to http://hl7.org/fhir/ValueSet/referencerange-meaning|6.0.0-ballot5)

                                                Code for the meaning of a reference range.

                                                TypeCodeableConcept
                                                Is Modifierfalse
                                                Must Supportfalse
                                                Summaryfalse
                                                Requirements

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

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

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

                                                ShortReference range population
                                                Comments

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

                                                Control0..*
                                                BindingFor example codes, see ObservationReferenceRangeAppliesToCodes
                                                (example to http://hl7.org/fhir/ValueSet/referencerange-appliesto|6.0.0-ballot5)

                                                Codes identifying the population the reference range applies to.

                                                TypeCodeableConcept
                                                Is Modifierfalse
                                                Must Supportfalse
                                                Summaryfalse
                                                Requirements

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

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

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

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

                                                Some analytes vary greatly over age.

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

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

                                                ShortText based reference range in an observation
                                                Control0..1
                                                This element is affected by the following invariants: obs-3
                                                Typemarkdown
                                                Is Modifierfalse
                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                Must Supportfalse
                                                Summaryfalse
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                148. Observation.hasMember
                                                Definition

                                                This element is not used in PHD as the coincident timestamp is not part of a group observation.

                                                ShortNo reference to a group observation in PHD. The coincident timestamp is not part of a group observation.
                                                Comments

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

                                                Control0..0
                                                TypeReference(Observation, QuestionnaireResponse)
                                                Is Modifierfalse
                                                Must Supportfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                150. Observation.derivedFrom
                                                Definition

                                                This element is not used in PHD as the coincident timestamp is not derived from another observation.

                                                ShortNo reference to a source observation in PHD. The coincident timestamp is not derived from another observation.
                                                Comments

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

                                                Control0..0
                                                TypeReference(DocumentReference, ImagingStudy, ImagingSelection, QuestionnaireResponse, Observation)
                                                Is Modifierfalse
                                                Must Supportfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                152. Observation.component
                                                Definition

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

                                                ShortComponent results
                                                Comments

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

                                                Control0..*
                                                This element is affected by the following invariants: obs-7, obs-11, obs-10
                                                TypeBackboneElement
                                                Is Modifierfalse
                                                Must Supportfalse
                                                Summarytrue
                                                Requirements

                                                Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, reference range, dataAbsentReason, and interpretation can differ between the components and are not inherited; these should be provided if appropriate.

                                                Invariantsele-1: All FHIR elements must have a @value or children or both (hasValue() or (children().count() > id.count()))
                                                SlicingThis element introduces a set of slices on Observation.component. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                • value @ code
                                                • 154. Observation.component.id
                                                  Definition

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

                                                  ShortUnique id for inter-element referencing
                                                  Control0..1
                                                  This element is affected by the following invariants: ele-1
                                                  Typestring
                                                  Is Modifierfalse
                                                  XML FormatIn the XML format, this property is represented as an attribute.
                                                  Summaryfalse
                                                  156. Observation.component.extension
                                                  Definition

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

                                                  ShortAdditional content defined by implementations
                                                  Comments

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

                                                  Control0..*
                                                  TypeExtension
                                                  Is Modifierfalse
                                                  Summaryfalse
                                                  Alternate Namesextensions, user content
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  SlicingThis element introduces a set of slices on Observation.component.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                  • value @ url
                                                  • 158. Observation.component.modifierExtension
                                                    Definition

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

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

                                                    ShortExtensions that cannot be ignored even if unrecognized
                                                    Comments

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

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

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

                                                    Alternate Namesextensions, user content, modifiers
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    SlicingThis element introduces a set of slices on Observation.component.modifierExtension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                    • value @ url
                                                    • 160. Observation.component.code
                                                      Definition

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

                                                      ShortType of component observation (code / type)
                                                      Comments

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

                                                      Control1..1
                                                      This element is affected by the following invariants: obs-7
                                                      BindingFor example codes, see LOINCObsOrBoth
                                                      (example to http://hl7.org/fhir/ValueSet/observation-codes-observationorboth|6.0.0-ballot5)

                                                      Codes identifying names of simple observations.

                                                      TypeCodeableConcept
                                                      Is Modifierfalse
                                                      Must Supportfalse
                                                      Summarytrue
                                                      Requirements

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

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

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

                                                      ShortActual component result
                                                      Comments

                                                      Used when observation has a set of component observations:

                                                      • An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived).
                                                      • If a value is present, the datatype for this element should be determined by the code.
                                                      • CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the code defines a coded value.
                                                      • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
                                                      • If a value is present, the datatype for this element should be determined by the code.
                                                      • CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the code defines a coded value.
                                                      • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
                                                      • For additional guidance, see the Notes section below.
                                                      Control0..1
                                                      This element is affected by the following invariants: obs-10
                                                      TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period, Attachment
                                                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                      Is Modifierfalse
                                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                      Must Supportfalse
                                                      Summarytrue
                                                      Requirements

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

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

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

                                                      ShortWhy the component result value is missing
                                                      Comments

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

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

                                                      Control0..1
                                                      This element is affected by the following invariants: obs-10
                                                      BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                      (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason|6.0.0-ballot5)

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

                                                      TypeCodeableConcept
                                                      Is Modifierfalse
                                                      Must Supportfalse
                                                      Summaryfalse
                                                      Requirements

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

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

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

                                                      ShortHigh, low, normal, etc
                                                      Comments

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

                                                      Control0..*
                                                      BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                      (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation|6.0.0-ballot5)

                                                      Codes identifying interpretations of observations.

                                                      TypeCodeableConcept
                                                      Is Modifierfalse
                                                      Must Supportfalse
                                                      Summaryfalse
                                                      Requirements

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

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

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

                                                      ShortProvides guide for interpretation of component result value
                                                      Comments

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

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

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

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

                                                      The method used to synchronize the clock of the PHD. This element is populated if the PHD supports clock synchronization.

                                                      ShortClock Synchronization Method: The method used to synchronize the clock.
                                                      Comments

                                                      Clock synchronization methods may include NTP, PTP, or other mechanisms.

                                                      Control0..1
                                                      This element is affected by the following invariants: obs-7, obs-11, obs-10
                                                      TypeBackboneElement
                                                      Is Modifierfalse
                                                      Must Supportfalse
                                                      Summarytrue
                                                      Requirements

                                                      Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, reference range, dataAbsentReason, and interpretation can differ between the components and are not inherited; these should be provided if appropriate.

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

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

                                                      ShortUnique id for inter-element referencing
                                                      Control0..1
                                                      This element is affected by the following invariants: ele-1
                                                      Typestring
                                                      Is Modifierfalse
                                                      XML FormatIn the XML format, this property is represented as an attribute.
                                                      Summaryfalse
                                                      174. Observation.component:clockSyncMethod.extension
                                                      Definition

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

                                                      ShortAdditional content defined by implementations
                                                      Comments

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

                                                      Control0..*
                                                      TypeExtension
                                                      Is Modifierfalse
                                                      Summaryfalse
                                                      Alternate Namesextensions, user content
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      SlicingThis element introduces a set of slices on Observation.component.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                      • value @ url
                                                      • 176. Observation.component:clockSyncMethod.modifierExtension
                                                        Definition

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

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

                                                        ShortExtensions that cannot be ignored even if unrecognized
                                                        Comments

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

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

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

                                                        Alternate Namesextensions, user content, modifiers
                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        SlicingThis element introduces a set of slices on Observation.component.modifierExtension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                        • value @ url
                                                        • 178. Observation.component:clockSyncMethod.code
                                                          Definition

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

                                                          ShortType of component observation (code / type)
                                                          Comments

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

                                                          Control1..1
                                                          This element is affected by the following invariants: obs-7
                                                          BindingFor example codes, see LOINCObsOrBoth
                                                          (example to http://hl7.org/fhir/ValueSet/observation-codes-observationorboth|6.0.0-ballot5)

                                                          Codes identifying names of simple observations.

                                                          TypeCodeableConcept
                                                          Is Modifierfalse
                                                          Must Supportfalse
                                                          Summarytrue
                                                          Requirements

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

                                                          Pattern Value{
                                                            "coding" : [{
                                                              "system" : "urn:iso:std:iso:11073:10101",
                                                              "code" : "68220"
                                                            }]
                                                          }
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          180. Observation.component:clockSyncMethod.value[x]
                                                          Definition

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

                                                          ShortActual component result
                                                          Comments

                                                          Used when observation has a set of component observations:

                                                          • An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived).
                                                          • If a value is present, the datatype for this element should be determined by the code.
                                                          • CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the code defines a coded value.
                                                          • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
                                                          • If a value is present, the datatype for this element should be determined by the code.
                                                          • CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the code defines a coded value.
                                                          • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
                                                          • For additional guidance, see the Notes section below.
                                                          Control0..1
                                                          This element is affected by the following invariants: obs-10
                                                          TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period, Attachment
                                                          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                          Is Modifierfalse
                                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                          Must Supportfalse
                                                          Summarytrue
                                                          Requirements

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

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

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

                                                            ShortThe clock synchronization method last used by the PHD/PHG to synchronize the clock of the PHD
                                                            Comments

                                                            Used when observation has a set of component observations:

                                                            • An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived).
                                                            • If a value is present, the datatype for this element should be determined by the code.
                                                            • CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the code defines a coded value.
                                                            • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
                                                            • If a value is present, the datatype for this element should be determined by the code.
                                                            • CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the code defines a coded value.
                                                            • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
                                                            • For additional guidance, see the Notes section below.
                                                            Control0..1
                                                            This element is affected by the following invariants: obs-10
                                                            BindingUnless not suitable, these codes SHALL be taken from MDC Time Synchronization Methods
                                                            (extensible to http://hl7.org/fhir/uv/phd/ValueSet/MDCTimeSyncMethods)
                                                            TypeCodeableConcept
                                                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                            Is Modifierfalse
                                                            Must Supportfalse
                                                            Summarytrue
                                                            Requirements

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

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

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

                                                            ShortWhy the component result value is missing
                                                            Comments

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

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

                                                            Control0..0
                                                            This element is affected by the following invariants: obs-10
                                                            BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
                                                            (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason|6.0.0-ballot5)

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

                                                            TypeCodeableConcept
                                                            Is Modifierfalse
                                                            Must Supportfalse
                                                            Summaryfalse
                                                            Requirements

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

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

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

                                                            ShortHigh, low, normal, etc
                                                            Comments

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

                                                            Control0..*
                                                            BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
                                                            (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation|6.0.0-ballot5)

                                                            Codes identifying interpretations of observations.

                                                            TypeCodeableConcept
                                                            Is Modifierfalse
                                                            Must Supportfalse
                                                            Summaryfalse
                                                            Requirements

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

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

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

                                                            ShortProvides guide for interpretation of component result value
                                                            Comments

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

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

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

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