FHIR Osiris Implementation Guide
2.1.0 - ci-build

FHIR Osiris Implementation Guide - Local Development build (v2.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: SequencingDevice - Detailed Descriptions

Draft as of 2024-03-21

Definitions for the sequencing-device resource profile.

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

0. Device
2. Device.identifier
Definition

Accession number of the molecular analysis method in the GEO (Gene Expression Omnibus) database

ShortGEO accession number
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
Must Supporttrue
4. Device.type
Definition

Name of the technology used to implement the analysis method.

ShortTechnology name
Control1..?
BindingUnless not suitable, these codes SHALL be taken from Platform Name
(extensible to https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/PlatformName)
Must Supporttrue
6. Device.version
NoteThis is a business versionId, not a resource version id (see discussion)
Control0..1
Must Supporttrue
8. Device.version.type
10. Device.version.type.coding
Definition

In the case of targeted sequencing, the name of the gene panel used.

ShortName of the gene panel
BindingThe codes SHALL be taken from Panel Name
(required to https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/PanelName)
12. Device.version.type.text
Pattern ValueName of the gene panel

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

0. Device
Definition

A type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device.

ShortItem used in healthcare
Control0..*
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.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-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 in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
2. Device.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.

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 it's narrative along with other profiles, value sets, etc.

Control0..1
This element is affected by the following invariants: ele-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 it's meaning or interpretation
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()))
4. Device.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 manageable, 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..*
This element is affected by the following invariants: ele-1
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Standards StatusNormative (from Trial Use)
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()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Device.modifierExtension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 6. Device.identifier
    Definition

    Accession number of the molecular analysis method in the GEO (Gene Expression Omnibus) database


    Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

    ShortGEO accession numberInstance identifier
    Comments

    The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used.

    NoteThis is a business identifier, not a resource identifier (see discussion)
    Control0..1*
    This element is affected by the following invariants: ele-1
    TypeIdentifier
    Must Supporttrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    8. Device.status
    Definition

    Status of the Device availability.

    Shortactive | inactive | entered-in-error | unknown
    Comments

    This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid.

    Control0..1
    This element is affected by the following invariants: ele-1
    BindingThe codes SHALL be taken from FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|4.0.1
    (required to http://hl7.org/fhir/ValueSet/device-status|4.0.1)

    The availability status of the device.

    Typecode
    Is Modifiertrue because This element is labelled 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
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    10. Device.type
    Definition

    Name of the technology used to implement the analysis method.


    The kind or type of device.

    ShortTechnology nameThe kind or type of device
    Comments

    Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

    Control10..1
    This element is affected by the following invariants: ele-1
    BindingUnless not suitable, these codes SHALL be taken from For example codes, see Platform Namehttp://hl7.org/fhir/ValueSet/device-type
    (extensible to https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/PlatformName)
    TypeCodeableConcept
    Must Supporttrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    12. Device.version
    Definition

    The actual design of the device or software version running on the device.

    ShortThe actual design of the device or software version running on the device
    NoteThis is a business versionId, not a resource version id (see discussion)
    Control0..1*
    This element is affected by the following invariants: ele-1
    TypeBackboneElement
    Must Supporttrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    14. Device.version.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 manageable, 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..*
    This element is affected by the following invariants: ele-1
    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()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    16. Device.version.type
    Definition

    The type of the device version.

    ShortThe type of the device version
    Comments

    Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

    Control0..1
    This element is affected by the following invariants: ele-1
    TypeCodeableConcept
    Alternate NamesΣ
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    18. Device.version.type.coding
    Definition

    In the case of targeted sequencing, the name of the gene panel used.


    A reference to a code defined by a terminology system.

    ShortName of the gene panelCode 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..*
    This element is affected by the following invariants: ele-1
    BindingThe codes SHALL be taken from For codes, see Panel Name
    (required to https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/PanelName)
    TypeCoding
    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()))
    20. Device.version.type.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
    This element is affected by the following invariants: ele-1
    Typestring
    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.

    Pattern ValueName of the gene panel
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    22. Device.version.value
    Definition

    The version text.

    ShortThe version text
    Comments

    Note that FHIR strings SHALL NOT exceed 1MB in size

    Control1..1
    This element is affected by the following invariants: ele-1
    Typestring
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    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 found here

    0. Device
    Definition

    A type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device.

    ShortItem used in healthcare
    Control0..*
    Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.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-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 in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
    dom-6: A resource should have narrative for robust management (text.`div`.exists())
    dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
    2. Device.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

    The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

    Control0..1
    Typeid
    Summarytrue
    4. Device.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
    This element is affected by the following invariants: ele-1
    TypeMeta
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    6. Device.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.

    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 it's narrative along with other profiles, value sets, etc.

    Control0..1
    This element is affected by the following invariants: ele-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 it's meaning or interpretation
    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()))
    8. Device.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
    This element is affected by the following invariants: ele-1
    BindingThe codes SHOULD be taken from CommonLanguages
    (preferred to http://hl7.org/fhir/ValueSet/languages)

    A human language.

    Additional BindingsPurpose
    AllLanguagesMax Binding
    Typecode
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    10. Device.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 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: ele-1
    TypeNarrative
    Alternate Namesnarrative, html, xhtml, display
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    12. Device.contained
    Definition

    These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

    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.

    Control0..*
    TypeResource
    Alternate Namesinline resources, anonymous resources, contained resources
    14. Device.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 manageable, 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..*
    This element is affected by the following invariants: ele-1
    TypeExtension
    Standards StatusNormative (from Trial Use)
    Alternate Namesextensions, user content
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    SlicingThis element introduces a set of slices on Device.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 16. Device.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 manageable, 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..*
      This element is affected by the following invariants: ele-1
      TypeExtension
      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
      Standards StatusNormative (from Trial Use)
      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()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      SlicingThis element introduces a set of slices on Device.modifierExtension. The slices are unordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 18. Device.identifier
        Definition

        Accession number of the molecular analysis method in the GEO (Gene Expression Omnibus) database

        ShortGEO accession number
        Comments

        The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used.

        NoteThis is a business identifier, not a resource identifier (see discussion)
        Control0..1
        This element is affected by the following invariants: ele-1
        TypeIdentifier
        Must Supporttrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        20. Device.definition
        Definition

        The reference to the definition for the device.

        ShortThe reference to the definition for the device
        Comments

        References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

        Control0..1
        This element is affected by the following invariants: ele-1
        TypeReference(DeviceDefinition)
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
        22. Device.udiCarrier
        Definition

        Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.

        ShortUnique Device Identifier (UDI) Barcode string
        Comments

        UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.

        Control0..*
        This element is affected by the following invariants: ele-1
        TypeBackboneElement
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        24. Device.udiCarrier.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
        Typestring
        XML FormatIn the XML format, this property is represented as an attribute.
        26. Device.udiCarrier.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 manageable, 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..*
        This element is affected by the following invariants: ele-1
        TypeExtension
        Standards StatusNormative (from Trial Use)
        Alternate Namesextensions, user content
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        SlicingThis element introduces a set of slices on Device.udiCarrier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 28. Device.udiCarrier.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 manageable, 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..*
          This element is affected by the following invariants: ele-1
          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()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          30. Device.udiCarrier.deviceIdentifier
          Definition

          The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.

          ShortMandatory fixed portion of UDI
          Comments

          Note that FHIR strings SHALL NOT exceed 1MB in size

          Control0..1
          This element is affected by the following invariants: ele-1
          Typestring
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Alternate NamesDI
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          32. Device.udiCarrier.issuer
          Definition

          Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include :

          1. GS1: http://hl7.org/fhir/NamingSystem/gs1-di,
          2. HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI,
          3. ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di,
          4. ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di.
          ShortUDI Issuing Organization
          Comments

          see http://en.wikipedia.org/wiki/Uniform_resource_identifier

          Control0..1
          This element is affected by the following invariants: ele-1
          Typeuri
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Alternate NamesBarcode System
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          34. Device.udiCarrier.jurisdiction
          Definition

          The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi.

          ShortRegional UDI authority
          Comments

          see http://en.wikipedia.org/wiki/Uniform_resource_identifier

          Control0..1
          This element is affected by the following invariants: ele-1
          Typeuri
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Requirements

          Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.

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

          The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - e.g., a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats SHALL be base64 encoded.

          ShortUDI Machine Readable Barcode String
          Comments

          The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

          Control0..1
          This element is affected by the following invariants: ele-1
          Typebase64Binary
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Alternate NamesAutomatic Identification and Data Capture
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          38. Device.udiCarrier.carrierHRF
          Definition

          The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.

          ShortUDI Human Readable Barcode String
          Comments

          If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

          Control0..1
          This element is affected by the following invariants: ele-1
          Typestring
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Alternate NamesHuman Readable Form
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          40. Device.udiCarrier.entryType
          Definition

          A coded entry to indicate how the data was entered.

          Shortbarcode | rfid | manual +
          Comments

          Note that FHIR strings SHALL NOT exceed 1MB in size

          Control0..1
          This element is affected by the following invariants: ele-1
          BindingThe codes SHALL be taken from UDIEntryType
          (required to http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1)

          Codes to identify how UDI data was entered.

          Typecode
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Requirements

          Supports a way to distinguish hand entered from machine read data.

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

          Status of the Device availability.

          Shortactive | inactive | entered-in-error | unknown
          Comments

          This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid.

          Control0..1
          This element is affected by the following invariants: ele-1
          BindingThe codes SHALL be taken from FHIRDeviceStatus
          (required to http://hl7.org/fhir/ValueSet/device-status|4.0.1)

          The availability status of the device.

          Typecode
          Is Modifiertrue because This element is labelled 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
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          44. Device.statusReason
          Definition

          Reason for the dtatus of the Device availability.

          Shortonline | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
          Comments

          Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

          Control0..*
          This element is affected by the following invariants: ele-1
          BindingUnless not suitable, these codes SHALL be taken from FHIRDeviceStatusReason
          (extensible to http://hl7.org/fhir/ValueSet/device-status-reason)

          The availability status reason of the device.

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

          The distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based product.

          ShortThe distinct identification string
          Comments

          For example, this applies to devices in the United States regulated under Code of Federal Regulation 21CFR§1271.290(c).

          Control0..1
          This element is affected by the following invariants: ele-1
          Typestring
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Alternate NamesDistinct Identification Code (DIC)
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          48. Device.manufacturer
          Definition

          A name of the manufacturer.

          ShortName of device manufacturer
          Comments

          Note that FHIR strings SHALL NOT exceed 1MB in size

          Control0..1
          This element is affected by the following invariants: ele-1
          Typestring
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          50. Device.manufactureDate
          Definition

          The date and time when the device was manufactured.

          ShortDate when the device was made
          Control0..1
          This element is affected by the following invariants: ele-1
          TypedateTime
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          52. Device.expirationDate
          Definition

          The date and time beyond which this device is no longer valid or should not be used (if applicable).

          ShortDate and time of expiry of this device (if applicable)
          Control0..1
          This element is affected by the following invariants: ele-1
          TypedateTime
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          54. Device.lotNumber
          Definition

          Lot number assigned by the manufacturer.

          ShortLot number of manufacture
          Comments

          Note that FHIR strings SHALL NOT exceed 1MB in size

          Control0..1
          This element is affected by the following invariants: ele-1
          Typestring
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          56. Device.serialNumber
          Definition

          The serial number assigned by the organization when the device was manufactured.

          ShortSerial number assigned by the manufacturer
          Comments

          Alphanumeric Maximum 20.

          Control0..1
          This element is affected by the following invariants: ele-1
          Typestring
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          58. Device.deviceName
          Definition

          This represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition.

          ShortThe name of the device as given by the manufacturer
          Control0..*
          This element is affected by the following invariants: ele-1
          TypeBackboneElement
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          60. Device.deviceName.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
          Typestring
          XML FormatIn the XML format, this property is represented as an attribute.
          62. Device.deviceName.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 manageable, 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..*
          This element is affected by the following invariants: ele-1
          TypeExtension
          Standards StatusNormative (from Trial Use)
          Alternate Namesextensions, user content
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          SlicingThis element introduces a set of slices on Device.deviceName.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 64. Device.deviceName.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 manageable, 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..*
            This element is affected by the following invariants: ele-1
            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()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            66. Device.deviceName.name
            Definition

            The name of the device.

            ShortThe name of the device
            Comments

            Note that FHIR strings SHALL NOT exceed 1MB in size

            Control1..1
            This element is affected by the following invariants: ele-1
            Typestring
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Alternate NamesΣ
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            68. Device.deviceName.type
            Definition

            The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName.

            Shortudi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
            Comments

            Note that FHIR strings SHALL NOT exceed 1MB in size

            Control1..1
            This element is affected by the following invariants: ele-1
            BindingThe codes SHALL be taken from DeviceNameType
            (required to http://hl7.org/fhir/ValueSet/device-nametype|4.0.1)

            The type of name the device is referred by.

            Typecode
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            70. Device.modelNumber
            Definition

            The model number for the device.

            ShortThe model number for the device
            Comments

            Note that FHIR strings SHALL NOT exceed 1MB in size

            Control0..1
            This element is affected by the following invariants: ele-1
            Typestring
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            72. Device.partNumber
            Definition

            The part number of the device.

            ShortThe part number of the device
            Comments

            Alphanumeric Maximum 20.

            Control0..1
            This element is affected by the following invariants: ele-1
            Typestring
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            74. Device.type
            Definition

            Name of the technology used to implement the analysis method.

            ShortTechnology name
            Comments

            Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

            Control1..1
            This element is affected by the following invariants: ele-1
            BindingUnless not suitable, these codes SHALL be taken from Platform Name
            (extensible to https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/PlatformName)
            TypeCodeableConcept
            Must Supporttrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            76. Device.specialization
            Definition

            The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication.

            ShortThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
            Control0..*
            This element is affected by the following invariants: ele-1
            TypeBackboneElement
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            78. Device.specialization.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
            Typestring
            XML FormatIn the XML format, this property is represented as an attribute.
            80. Device.specialization.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 manageable, 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..*
            This element is affected by the following invariants: ele-1
            TypeExtension
            Standards StatusNormative (from Trial Use)
            Alternate Namesextensions, user content
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            SlicingThis element introduces a set of slices on Device.specialization.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
            • value @ url
            • 82. Device.specialization.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 manageable, 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..*
              This element is affected by the following invariants: ele-1
              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()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              84. Device.specialization.systemType
              Definition

              The standard that is used to operate and communicate.

              ShortThe standard that is used to operate and communicate
              Comments

              Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

              Control1..1
              This element is affected by the following invariants: ele-1
              TypeCodeableConcept
              Alternate NamesΣ
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              86. Device.specialization.version
              Definition

              The version of the standard that is used to operate and communicate.

              ShortThe version of the standard that is used to operate and communicate
              Comments

              Note that FHIR strings SHALL NOT exceed 1MB in size

              NoteThis is a business versionId, not a resource version id (see discussion)
              Control0..1
              This element is affected by the following invariants: ele-1
              Typestring
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              88. Device.version
              Definition

              The actual design of the device or software version running on the device.

              ShortThe actual design of the device or software version running on the device
              NoteThis is a business versionId, not a resource version id (see discussion)
              Control0..1
              This element is affected by the following invariants: ele-1
              TypeBackboneElement
              Must Supporttrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              90. Device.version.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
              Typestring
              XML FormatIn the XML format, this property is represented as an attribute.
              92. Device.version.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 manageable, 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..*
              This element is affected by the following invariants: ele-1
              TypeExtension
              Standards StatusNormative (from Trial Use)
              Alternate Namesextensions, user content
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              SlicingThis element introduces a set of slices on Device.version.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 94. Device.version.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 manageable, 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..*
                This element is affected by the following invariants: ele-1
                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()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                96. Device.version.type
                Definition

                The type of the device version.

                ShortThe type of the device version
                Comments

                Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                Control0..1
                This element is affected by the following invariants: ele-1
                TypeCodeableConcept
                Alternate NamesΣ
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                98. Device.version.type.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
                Typestring
                XML FormatIn the XML format, this property is represented as an attribute.
                100. Device.version.type.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 manageable, 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..*
                This element is affected by the following invariants: ele-1
                TypeExtension
                Standards StatusNormative (from Trial Use)
                Alternate Namesextensions, user content
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                SlicingThis element introduces a set of slices on Device.version.type.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 102. Device.version.type.coding
                  Definition

                  In the case of targeted sequencing, the name of the gene panel used.

                  ShortName of the gene panel
                  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..*
                  This element is affected by the following invariants: ele-1
                  BindingThe codes SHALL be taken from Panel Name
                  (required to https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/PanelName)
                  TypeCoding
                  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()))
                  104. Device.version.type.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
                  This element is affected by the following invariants: ele-1
                  Typestring
                  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.

                  Pattern ValueName of the gene panel
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  106. Device.version.component
                  Definition

                  A single component of the device version.

                  ShortA single component of the device version
                  Control0..1
                  This element is affected by the following invariants: ele-1
                  TypeIdentifier
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  108. Device.version.value
                  Definition

                  The version text.

                  ShortThe version text
                  Comments

                  Note that FHIR strings SHALL NOT exceed 1MB in size

                  Control1..1
                  This element is affected by the following invariants: ele-1
                  Typestring
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  110. Device.property
                  Definition

                  The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties.

                  ShortThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
                  Control0..*
                  This element is affected by the following invariants: ele-1
                  TypeBackboneElement
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  112. Device.property.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
                  Typestring
                  XML FormatIn the XML format, this property is represented as an attribute.
                  114. Device.property.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 manageable, 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..*
                  This element is affected by the following invariants: ele-1
                  TypeExtension
                  Standards StatusNormative (from Trial Use)
                  Alternate Namesextensions, user content
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  SlicingThis element introduces a set of slices on Device.property.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
                  • value @ url
                  • 116. Device.property.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 manageable, 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..*
                    This element is affected by the following invariants: ele-1
                    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()))
                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                    118. Device.property.type
                    Definition

                    Code that specifies the property DeviceDefinitionPropetyCode (Extensible).

                    ShortCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
                    Comments

                    Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                    Control1..1
                    This element is affected by the following invariants: ele-1
                    TypeCodeableConcept
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    120. Device.property.valueQuantity
                    Definition

                    Property value as a quantity.

                    ShortProperty value as a quantity
                    Comments

                    The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator.

                    Control0..*
                    This element is affected by the following invariants: ele-1
                    TypeQuantity
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    qty-3: If a code for the unit is present, the system SHALL also be present (code.empty() or system.exists())
                    122. Device.property.valueCode
                    Definition

                    Property value as a code, e.g., NTP4 (synced to NTP).

                    ShortProperty value as a code, e.g., NTP4 (synced to NTP)
                    Comments

                    Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                    Control0..*
                    This element is affected by the following invariants: ele-1
                    TypeCodeableConcept
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    124. Device.patient
                    Definition

                    Patient information, If the device is affixed to a person.

                    ShortPatient to whom Device is affixed
                    Comments

                    References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

                    Control0..1
                    This element is affected by the following invariants: ele-1
                    TypeReference(Patient)
                    Requirements

                    If the device is implanted in a patient, then need to associate the device to the patient.

                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                    126. Device.owner
                    Definition

                    An organization that is responsible for the provision and ongoing maintenance of the device.

                    ShortOrganization responsible for device
                    Comments

                    References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

                    Control0..1
                    This element is affected by the following invariants: ele-1
                    TypeReference(Organization)
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                    128. Device.contact
                    Definition

                    Contact details for an organization or a particular human that is responsible for the device.

                    ShortDetails for human/organization for support
                    Comments

                    used for troubleshooting etc.

                    Control0..*
                    This element is affected by the following invariants: ele-1
                    TypeContactPoint
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    cpt-2: A system is required if a value is provided. (value.empty() or system.exists())
                    130. Device.location
                    Definition

                    The place where the device can be found.

                    ShortWhere the device is found
                    Comments

                    References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

                    Control0..1
                    This element is affected by the following invariants: ele-1
                    TypeReference(Location)
                    Requirements

                    Device.location can be used to track device location.

                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                    132. Device.url
                    Definition

                    A network address on which the device may be contacted directly.

                    ShortNetwork address to contact device
                    Comments

                    If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.

                    Control0..1
                    This element is affected by the following invariants: ele-1
                    Typeuri
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    134. Device.note
                    Definition

                    Descriptive information, usage information or implantation information that is not captured in an existing element.

                    ShortDevice notes and comments
                    Comments

                    For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).

                    Control0..*
                    This element is affected by the following invariants: ele-1
                    TypeAnnotation
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    136. Device.safety
                    Definition

                    Provides additional safety characteristics about a medical device. For example devices containing latex.

                    ShortSafety Characteristics of Device
                    Comments

                    Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                    Control0..*
                    This element is affected by the following invariants: ele-1
                    TypeCodeableConcept
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    138. Device.parent
                    Definition

                    The parent device.

                    ShortThe parent device
                    Comments

                    References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.

                    Control0..1
                    This element is affected by the following invariants: ele-1
                    TypeReference(Device)
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))