Womens Health Technology Coordinated Registry Network Implementation Guide For Comment Ballot

This page is part of the Womens Health Technology Coordinated Registry Network FHIR IG (v0.1.0: STU 1 Draft) based on FHIR v3.5.0. . For a full list of available versions, see the Directory of published versions

StructureDefinition-devicedefinition-crn

source file: source/pages/_includes/devicedefinition-crn-intro.md

Scope and Usage

The profile is to be used for the WTH CRN project to capture the specific device information used to treat women with various health conditions.

Mandatory Data Elements and Terminology

The following data-elements are mandatory (i.e data MUST be present). blah blah blah

must have:

  1. deviceName
  2. manufacturer

Additional Profile specific implementation guidance:

Examples

  • Examples to be added after finalization of data elements.

Formal Views of Profile Content

Description of Profiles, Differentials, and Snapshots.

The official URL for this profile is: http://hl7.org/fhir/us/womens-health-registries/StructureDefinition/devicedefinition-crn

Published on Wed Feb 15 00:00:00 AEST 2017 as a active by .

This profile builds on DeviceDefinition


Summary

Mandatory: 4 elements (3 nested mandatory elements)
Must-Support: 9 elements

NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition I0..*An instance of a medical-related component of a medical device
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: Common Languages (preferred)
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional Content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier 0..*IdentifierInstance identifier
... udiDeviceIdentifier SI0..1BackboneElementUnique Device Identifier (UDI) Barcode string
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... deviceIdentifier S1..1stringThe identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier
.... issuer S1..1uriThe organization that assigns the identifier algorithm
.... jurisdiction S1..1uriThe jurisdiction to which the deviceIdentifier applies
... manufacturer[x] S1..1string, Reference(Organization)Name of device manufacturer
... deviceName SI1..1BackboneElementA name given to the device to identify it
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... name S1..1stringThe name of the device
.... type S1..1codeudi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Binding: DeviceNameType (required)
... modelNumber S0..1stringThe model number for the device
... type 0..1CodeableConceptWhat kind of device or device system this is
Binding: FHIRDeviceTypes (example)
... specialization I0..*BackboneElementThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... systemType 1..1stringThe standard that is used to operate and communicate
.... version 0..1stringThe version of the standard that is used to operate and communicate
... version 0..*stringThe actual design of the device or software version running on the device
... safety Σ0..*CodeableConceptSafety characteristics of the device
... shelfLifeStorage 0..*ProductShelfLifeShelf Life and storage information
... physicalCharacteristics 0..1ProdCharacteristicDimensions, color etc.
... languageCode 0..*CodeableConceptLanguage code for the human-readable text strings produced by the device (all supported)
... capability I0..*BackboneElementDevice capabilities
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... type 1..1CodeableConceptType of capability
.... description 0..*CodeableConceptDescription of capability
... property I0..*BackboneElementThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... type 1..1CodeableConceptCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuanity 0..*QuantityProperty value as a quantity
.... valueCode 0..*CodeableConceptProperty value as a code, e.g., NTP4 (synced to NTP)
... owner 0..1Reference(Organization)Organization responsible for device
... contact 0..*ContactPointDetails for human/organization for support
... url 0..1uriNetwork address to contact device
... onlineInformation 0..1uriAccess to on-line information
... note 0..*AnnotationDevice notes and comments
... quantity 0..1QuantityThe quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product)
... parentDevice Σ0..1Reference(DeviceDefinition)The parent device it can be part of
... material I0..*BackboneElementA substance used to create the material(s) of which the device is made
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... substance 1..1CodeableConceptThe substance
.... alternate 0..1booleanIndicates an alternative material of the device
.... allergenicIndicator 0..1booleanWhether the substance is a known or suspected allergen

doco Documentation for this format

       // 
 {
   "resourceType" : "DeviceDefinition",
    "id" : "<id>", // Logical id of this artifact
    "meta" : {Meta}, // Metadata about the resource
    "implicitRules" : "<uri>", // A set of rules under which this content was created
    "language" : "<code>", // Language of the resource content
    "text" : {Narrative}, // Text summary of the resource, for human interpretation
    "contained" : [{Resource}], // Contained, inline Resources
    "extension": [
    ],
    "identifier" : [{Identifier}], // Instance identifier
    "udiDeviceIdentifier" : [{ // C? Only One!  Unique Device Identifier (UDI) Barcode string
      "extension": [
      ],
      "deviceIdentifier" : "<string>", // R! The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier
      "issuer" : "<uri>", // R! The organization that assigns the identifier algorithm
      "jurisdiction" : "<uri>", // R! The jurisdiction to which the deviceIdentifier applies
    }],
// manufacturer[x]: Name of device manufacturer. One of these 2:
    "manufacturerString" : "<string>", // R! Name of device manufacturer
    "manufacturerReference" : {Reference(Organization)}, // R! Name of device manufacturer
    "deviceName" : [{ // C? R! Only One!  A name given to the device to identify it
      "extension": [
      ],
      "name" : "<string>", // R! The name of the device
      "type" : "<code>", // R! udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
    }],
    "modelNumber" : "<string>", // The model number for the device
    "type" : {CodeableConcept}, // What kind of device or device system this is
    "specialization" : [{ // C? The capabilities supported on a  device, the standards to which the device conforms for a particular purpose, and used for the communication
      "extension": [
      ],
      "systemType" : "<string>", // R! The standard that is used to operate and communicate
      "version" : "<string>", // The version of the standard that is used to operate and communicate
    }],
    "version" : ["<string>"], // The actual design of the device or software version running on the device
    "safety" : [{CodeableConcept}], // Safety characteristics of the device
    "shelfLifeStorage" : [{ProductShelfLife}], // Shelf Life and storage information
    "physicalCharacteristics" : {ProdCharacteristic}, // Dimensions, color etc.
    "languageCode" : [{CodeableConcept}], // Language code for the human-readable text strings produced by the device (all supported)
    "capability" : [{ // C? Device capabilities
      "extension": [
      ],
      "type" : {CodeableConcept}, // R! Type of capability
      "description" : [{CodeableConcept}], // Description of capability
    }],
    "property" : [{ // C? The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
      "extension": [
      ],
      "type" : {CodeableConcept}, // R! Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
      "valueQuanity" : [{Quantity}], // Property value as a quantity
      "valueCode" : [{CodeableConcept}], // Property value as a code, e.g., NTP4 (synced to NTP)
    }],
    "owner" : {Reference(Organization)}, // Organization responsible for device
    "contact" : [{ContactPoint}], // Details for human/organization for support
    "url" : "<uri>", // Network address to contact device
    "onlineInformation" : "<uri>", // Access to on-line information
    "note" : [{Annotation}], // Device notes and comments
    "quantity" : {Quantity}, // The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product)
    "parentDevice" : {Reference(DeviceDefinition)}, // The parent device it can be part of
    "material" : [{ // C? A substance used to create the material(s) of which the device is made
      "extension": [
      ],
      "substance" : {CodeableConcept}, // R! The substance
      "alternate" : <boolean>, // Indicates an alternative material of the device
      "allergenicIndicator" : <boolean>, // Whether the substance is a known or suspected allergen
    }]
  }

     

Summary

Mandatory: 4 elements (3 nested mandatory elements)
Must-Support: 9 elements

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition I0..*An instance of a medical-related component of a medical device
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: Common Languages (preferred)
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional Content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier 0..*IdentifierInstance identifier
... udiDeviceIdentifier SI0..1BackboneElementUnique Device Identifier (UDI) Barcode string
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... deviceIdentifier S1..1stringThe identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier
.... issuer S1..1uriThe organization that assigns the identifier algorithm
.... jurisdiction S1..1uriThe jurisdiction to which the deviceIdentifier applies
... manufacturer[x] S1..1string, Reference(Organization)Name of device manufacturer
... deviceName SI1..1BackboneElementA name given to the device to identify it
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... name S1..1stringThe name of the device
.... type S1..1codeudi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Binding: DeviceNameType (required)
... modelNumber S0..1stringThe model number for the device
... type 0..1CodeableConceptWhat kind of device or device system this is
Binding: FHIRDeviceTypes (example)
... specialization I0..*BackboneElementThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... systemType 1..1stringThe standard that is used to operate and communicate
.... version 0..1stringThe version of the standard that is used to operate and communicate
... version 0..*stringThe actual design of the device or software version running on the device
... safety Σ0..*CodeableConceptSafety characteristics of the device
... shelfLifeStorage 0..*ProductShelfLifeShelf Life and storage information
... physicalCharacteristics 0..1ProdCharacteristicDimensions, color etc.
... languageCode 0..*CodeableConceptLanguage code for the human-readable text strings produced by the device (all supported)
... capability I0..*BackboneElementDevice capabilities
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... type 1..1CodeableConceptType of capability
.... description 0..*CodeableConceptDescription of capability
... property I0..*BackboneElementThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... type 1..1CodeableConceptCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuanity 0..*QuantityProperty value as a quantity
.... valueCode 0..*CodeableConceptProperty value as a code, e.g., NTP4 (synced to NTP)
... owner 0..1Reference(Organization)Organization responsible for device
... contact 0..*ContactPointDetails for human/organization for support
... url 0..1uriNetwork address to contact device
... onlineInformation 0..1uriAccess to on-line information
... note 0..*AnnotationDevice notes and comments
... quantity 0..1QuantityThe quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product)
... parentDevice Σ0..1Reference(DeviceDefinition)The parent device it can be part of
... material I0..*BackboneElementA substance used to create the material(s) of which the device is made
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... substance 1..1CodeableConceptThe substance
.... alternate 0..1booleanIndicates an alternative material of the device
.... allergenicIndicator 0..1booleanWhether the substance is a known or suspected allergen

doco Documentation for this format

JSON Template


          // 
 {
   "resourceType" : "DeviceDefinition",
    "id" : "<id>", // Logical id of this artifact
    "meta" : {Meta}, // Metadata about the resource
    "implicitRules" : "<uri>", // A set of rules under which this content was created
    "language" : "<code>", // Language of the resource content
    "text" : {Narrative}, // Text summary of the resource, for human interpretation
    "contained" : [{Resource}], // Contained, inline Resources
    "extension": [
    ],
    "identifier" : [{Identifier}], // Instance identifier
    "udiDeviceIdentifier" : [{ // C? Only One!  Unique Device Identifier (UDI) Barcode string
      "extension": [
      ],
      "deviceIdentifier" : "<string>", // R! The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier
      "issuer" : "<uri>", // R! The organization that assigns the identifier algorithm
      "jurisdiction" : "<uri>", // R! The jurisdiction to which the deviceIdentifier applies
    }],
// manufacturer[x]: Name of device manufacturer. One of these 2:
    "manufacturerString" : "<string>", // R! Name of device manufacturer
    "manufacturerReference" : {Reference(Organization)}, // R! Name of device manufacturer
    "deviceName" : [{ // C? R! Only One!  A name given to the device to identify it
      "extension": [
      ],
      "name" : "<string>", // R! The name of the device
      "type" : "<code>", // R! udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
    }],
    "modelNumber" : "<string>", // The model number for the device
    "type" : {CodeableConcept}, // What kind of device or device system this is
    "specialization" : [{ // C? The capabilities supported on a  device, the standards to which the device conforms for a particular purpose, and used for the communication
      "extension": [
      ],
      "systemType" : "<string>", // R! The standard that is used to operate and communicate
      "version" : "<string>", // The version of the standard that is used to operate and communicate
    }],
    "version" : ["<string>"], // The actual design of the device or software version running on the device
    "safety" : [{CodeableConcept}], // Safety characteristics of the device
    "shelfLifeStorage" : [{ProductShelfLife}], // Shelf Life and storage information
    "physicalCharacteristics" : {ProdCharacteristic}, // Dimensions, color etc.
    "languageCode" : [{CodeableConcept}], // Language code for the human-readable text strings produced by the device (all supported)
    "capability" : [{ // C? Device capabilities
      "extension": [
      ],
      "type" : {CodeableConcept}, // R! Type of capability
      "description" : [{CodeableConcept}], // Description of capability
    }],
    "property" : [{ // C? The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
      "extension": [
      ],
      "type" : {CodeableConcept}, // R! Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
      "valueQuanity" : [{Quantity}], // Property value as a quantity
      "valueCode" : [{CodeableConcept}], // Property value as a code, e.g., NTP4 (synced to NTP)
    }],
    "owner" : {Reference(Organization)}, // Organization responsible for device
    "contact" : [{ContactPoint}], // Details for human/organization for support
    "url" : "<uri>", // Network address to contact device
    "onlineInformation" : "<uri>", // Access to on-line information
    "note" : [{Annotation}], // Device notes and comments
    "quantity" : {Quantity}, // The quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product)
    "parentDevice" : {Reference(DeviceDefinition)}, // The parent device it can be part of
    "material" : [{ // C? A substance used to create the material(s) of which the device is made
      "extension": [
      ],
      "substance" : {CodeableConcept}, // R! The substance
      "alternate" : <boolean>, // Indicates an alternative material of the device
      "allergenicIndicator" : <boolean>, // Whether the substance is a known or suspected allergen
    }]
  }

        

Downloads: StructureDefinition: (XML, JSON), Schema: XML Schematron


Quick Start

Below is an overview of the required set of RESTful FHIR interactions - for example, search and read operations - for this profile. See the Conformance requirements for a complete list of supported RESTful interactions for this IG.

Search Requirements

There are no specific search requirements by the WHT CRN IG beyond what is required by the base resource.