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JSON Format: StructureDefinition-Device-uv-ips

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{
  "resourceType" : "StructureDefinition",
  "id" : "Device-uv-ips",
  "meta" : {
    "lastUpdated" : "2018-02-14T11:49:41.487+01:00"
  },
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">This profile represents the constraints applied to the Device resource by the International Patient Summary (IPS) FHIR Implementation Guide, based on FHIR R4. A device used by or implanted on the patient is described in the patient summary as an instance of a Device resource constrained by this profile.</div>"
  },
  "url" : "http://hl7.eu/fhir/trillium2/StructureDefinition/Device-uv-ips",
  "version" : "0.1.0",
  "name" : "Device_uv_ips",
  "title" : "Device (Trillium II)",
  "status" : "draft",
  "date" : "2018-02-14T00:00:00+01:00",
  "publisher" : "Trillium II Project",
  "description" : "This profile represents the constraints applied to the Device resource by the International Patient Summary (IPS) FHIR Implementation Guide, based on FHIR R4. A device used by or implanted on the patient is described in the patient summary as an instance of a Device resource constrained by this profile.",
  "jurisdiction" : [
    {
      "coding" : [
        {
          "system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
          "code" : "001",
          "display" : "World"
        }
      ]
    }
  ],
  "purpose" : "This profile constrains the representation of a medical device used by or impanted on the patient, in the context of the international patient summary as specified by the IPS project of HL7 International.",
  "fhirVersion" : "3.0.1",
  "mapping" : [
    {
      "identity" : "rim",
      "uri" : "http://hl7.org/v3",
      "name" : "RIM Mapping"
    },
    {
      "identity" : "w5",
      "uri" : "http://hl7.org/fhir/w5",
      "name" : "W5 Mapping"
    },
    {
      "identity" : "udi",
      "uri" : "http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm",
      "name" : "UDI Mapping"
    }
  ],
  "kind" : "resource",
  "abstract" : false,
  "type" : "Device",
  "baseDefinition" : "http://hl7.org/fhir/StructureDefinition/Device",
  "derivation" : "constraint",
  "snapshot" : {
    "element" : [
      {
        "id" : "Device",
        "path" : "Device",
        "short" : "Item used in healthcare",
        "definition" : "This resource identifies an instance or 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.  Medical devices include durable (reusable) medical equipment, implantable devices, as well as disposable equipment used for diagnostic, treatment, and research for healthcare and public health.  Non-medical devices may include items such as a machine, cellphone, computer, application, etc.",
        "comment" : "This profile applies the rules defined by HL7 International for representing the UDI in the FHIR standard, by the document \"Medical Devices and Unique Device Identification (UDI) Pattern, Release 1\"",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Device",
          "min" : 0,
          "max" : "*"
        },
        "constraint" : [
          {
            "key" : "dom-2",
            "severity" : "error",
            "human" : "If the resource is contained in another resource, it SHALL NOT contain nested Resources",
            "expression" : "contained.contained.empty()",
            "xpath" : "not(parent::f:contained and f:contained)",
            "source" : "DomainResource"
          },
          {
            "key" : "dom-1",
            "severity" : "error",
            "human" : "If the resource is contained in another resource, it SHALL NOT contain any narrative",
            "expression" : "contained.text.empty()",
            "xpath" : "not(parent::f:contained and f:text)",
            "source" : "DomainResource"
          },
          {
            "key" : "dom-4",
            "severity" : "error",
            "human" : "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
            "expression" : "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()",
            "xpath" : "not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))",
            "source" : "DomainResource"
          },
          {
            "key" : "dom-3",
            "severity" : "error",
            "human" : "If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource",
            "expression" : "contained.where(('#'+id in %resource.descendants().reference).not()).empty()",
            "xpath" : "not(exists(for $id in f:contained/*/@id return $id[not(ancestor::f:contained/parent::*/descendant::f:reference/@value=concat('#', $id))]))",
            "source" : "DomainResource"
          }
        ],
        "mustSupport" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "Entity. Role, or Act"
          },
          {
            "identity" : "rim",
            "map" : "Device"
          },
          {
            "identity" : "w5",
            "map" : "administrative.device"
          }
        ]
      },
      {
        "id" : "Device.id",
        "path" : "Device.id",
        "short" : "Logical id of this artifact",
        "definition" : "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
        "comment" : "The only time that a resource does not have an id is when it is being submitted to the server using a create operation.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Resource.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "id"
          }
        ],
        "mustSupport" : true,
        "isSummary" : true
      },
      {
        "id" : "Device.meta",
        "path" : "Device.meta",
        "short" : "Metadata about the resource",
        "definition" : "The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content may not always be associated with version changes to the resource.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Resource.meta",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Meta"
          }
        ],
        "mustSupport" : true,
        "isSummary" : true
      },
      {
        "id" : "Device.implicitRules",
        "path" : "Device.implicitRules",
        "short" : "A set of rules under which this content was created",
        "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.",
        "comment" : "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. \n\nThis element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Resource.implicitRules",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "uri"
          }
        ],
        "isModifier" : true,
        "isSummary" : true
      },
      {
        "id" : "Device.language",
        "path" : "Device.language",
        "short" : "Language of the resource content",
        "definition" : "The base language in which the resource is written.",
        "comment" : "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).",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Resource.language",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "code"
          }
        ],
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet",
              "valueReference" : {
                "reference" : "http://hl7.org/fhir/ValueSet/all-languages"
              }
            },
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "Language"
            },
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
              "valueBoolean" : true
            }
          ],
          "strength" : "extensible",
          "description" : "A human language.",
          "valueSetReference" : {
            "reference" : "http://hl7.org/fhir/ValueSet/languages"
          }
        }
      },
      {
        "id" : "Device.text",
        "path" : "Device.text",
        "short" : "Text summary of the resource, for human interpretation",
        "definition" : "A human-readable narrative that contains a summary of the resource, and may 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.",
        "comment" : "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 in formation is added later.",
        "alias" : [
          "narrative",
          "html",
          "xhtml",
          "display"
        ],
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "DomainResource.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Narrative"
          }
        ],
        "condition" : [
          "dom-1"
        ],
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "Act.text?"
          }
        ]
      },
      {
        "id" : "Device.contained",
        "path" : "Device.contained",
        "short" : "Contained, inline Resources",
        "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.",
        "comment" : "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.",
        "alias" : [
          "inline resources",
          "anonymous resources",
          "contained resources"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "DomainResource.contained",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Resource"
          }
        ],
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Device.extension",
        "path" : "Device.extension",
        "short" : "Additional Content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the resource. In order 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.",
        "comment" : "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.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "DomainResource.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Device.modifierExtension",
        "path" : "Device.modifierExtension",
        "short" : "Extensions that cannot be ignored",
        "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. Usually modifier elements provide negation or qualification. In order 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.",
        "comment" : "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.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "DomainResource.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "isModifier" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Device.identifier",
        "path" : "Device.identifier",
        "short" : "Instance identifier",
        "definition" : "Unique instance identifiers assigned to a device by manufacturers other organizations or owners.",
        "comment" : "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.  For [UDI](http://hl7.org/fhir/STU3/device.html#5.11.3.2.2),  this element corresponds to the variable portion of the UDI that identifies the serial number of a specific device. See [UDI mappings](http://hl7.org/fhir/STU3/device-mappings.html#udi) for a complete mapping of UDI parts to Device.",
        "alias" : [
          "Serial Number"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Device.identifier",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Identifier"
          }
        ],
        "mustSupport" : true,
        "mapping" : [
          {
            "identity" : "udi",
            "map" : "The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI.   The identifier.type code should be set to “SNO”(Serial Number) and the system left empty."
          },
          {
            "identity" : "rim",
            "map" : ".id"
          },
          {
            "identity" : "w5",
            "map" : "id"
          }
        ]
      },
      {
        "id" : "Device.udi",
        "path" : "Device.udi",
        "short" : "Unique Device Identifier (UDI) Barcode string",
        "definition" : "[Unique device identifier (UDI)](http://hl7.org/fhir/STU3/device.html#5.11.3.2.2) assigned to device label or package.",
        "comment" : "UDI may identify an unique instance of a device, or it may only identify the type of the device.  See [UDI mappings](http://hl7.org/fhir/STU3/device-mappings.html#udi) for a complete mapping of UDI parts to Device.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Device.udi",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "BackboneElement"
          }
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() | (children().count() > id.count())",
            "xpath" : "@value|f:*|h:div",
            "source" : "Element"
          }
        ],
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : ".id and .code"
          },
          {
            "identity" : "w5",
            "map" : "id"
          }
        ]
      },
      {
        "id" : "Device.udi.id",
        "path" : "Device.udi.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "xml:id (or equivalent in JSON)",
        "definition" : "unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Device.udi.extension",
        "path" : "Device.udi.extension",
        "short" : "Additional Content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. In order 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.",
        "comment" : "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.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Device.udi.modifierExtension",
        "path" : "Device.udi.modifierExtension",
        "short" : "Extensions that cannot be ignored",
        "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 that contains it. Usually modifier elements provide negation or qualification. In order 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.",
        "comment" : "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.",
        "alias" : [
          "extensions",
          "user content",
          "modifiers"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "BackboneElement.modifierExtension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "isModifier" : true,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Device.udi.deviceIdentifier",
        "path" : "Device.udi.deviceIdentifier",
        "short" : "Mandatory fixed portion of UDI",
        "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.",
        "alias" : [
          "DI"
        ],
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Device.udi.deviceIdentifier",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "udi",
            "map" : "The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device."
          },
          {
            "identity" : "rim",
            "map" : "Role.id.extension"
          },
          {
            "identity" : "w5",
            "map" : "what"
          }
        ]
      },
      {
        "id" : "Device.udi.name",
        "path" : "Device.udi.name",
        "short" : "Device Name as appears on UDI label",
        "definition" : "Name of device as used in labeling or catalog.",
        "comment" : "Use the `Device.type`  for a generic type or kind of device name.  Note the [GUDID](http://www.fda.gov/medicaldevices/deviceregulationandguidance/uniquedeviceidentification/globaludidatabasegudid/default.htm) lists the name as the 'Brand Name'.",
        "alias" : [
          "Brand Name"
        ],
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Device.udi.name",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "udi",
            "map" : "Propietary/Trade Name of the medical Device as used in the labeling or catalog"
          },
          {
            "identity" : "rim",
            "map" : ".displayName"
          },
          {
            "identity" : "w5",
            "map" : "what"
          }
        ]
      },
      {
        "id" : "Device.udi.jurisdiction",
        "path" : "Device.udi.jurisdiction",
        "short" : "Regional UDI authority",
        "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.",
        "requirements" : "Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Device.udi.jurisdiction",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "uri"
          }
        ],
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "Role.scoper"
          }
        ]
      },
      {
        "id" : "Device.udi.carrierHRF",
        "path" : "Device.udi.carrierHRF",
        "short" : "UDI Human Readable Barcode String",
        "definition" : "The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.",
        "comment" : "If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.",
        "alias" : [
          "Human Readable Form"
        ],
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Device.udi.carrierHRF",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "udi",
            "map" : "A unique device identifier (UDI) on a device label in plain text"
          },
          {
            "identity" : "rim",
            "map" : "Role.id.extension"
          }
        ]
      },
      {
        "id" : "Device.udi.carrierAIDC",
        "path" : "Device.udi.carrierAIDC",
        "short" : "UDI Machine Readable Barcode String",
        "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.",
        "comment" : "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.",
        "alias" : [
          "Automatic Identification and Data Capture"
        ],
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Device.udi.carrierAIDC",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "base64Binary"
          }
        ],
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "udi",
            "map" : "A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology."
          },
          {
            "identity" : "rim",
            "map" : "Role.id.extension"
          }
        ]
      },
      {
        "id" : "Device.udi.issuer",
        "path" : "Device.udi.issuer",
        "short" : "UDI Issuing Organization",
        "definition" : "Organization that is charged with issuing UDIs for devices.  For example, the US FDA issuers include :\n1) GS1: \nhttp://hl7.org/fhir/NamingSystem/gs1-di, \n2) HIBCC:\nhttp://hl7.org/fhir/NamingSystem/hibcc-dI, \n3) ICCBBA for blood containers:\nhttp://hl7.org/fhir/NamingSystem/iccbba-blood-di, \n4) ICCBA for other devices:\nhttp://hl7.org/fhir/NamingSystem/iccbba-other-di.",
        "alias" : [
          "Barcode System"
        ],
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Device.udi.issuer",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "uri"
          }
        ],
        "mapping" : [
          {
            "identity" : "udi",
            "map" : "All UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency.\nGS1 DIs: \n http://hl7.org/fhir/NamingSystem/gs1\nHIBCC DIs:\n http://hl7.org/fhir/NamingSystem/hibcc\nICCBBA DIs for blood containers:\n http://hl7.org/fhir/NamingSystem/iccbba-blood\nICCBA DIs for other devices:\n http://hl7.org/fhir/NamingSystem/iccbba-other"
          },
          {
            "identity" : "rim",
            "map" : "Role.id.root"
          }
        ]
      },
      {
        "id" : "Device.udi.entryType",
        "path" : "Device.udi.entryType",
        "short" : "barcode | rfid | manual +",
        "definition" : "A coded entry to indicate how the data was entered.",
        "requirements" : "Supports a way to distinguish hand entered from machine read data.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Device.udi.entryType",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "code"
          }
        ],
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "UDIEntryType"
            }
          ],
          "strength" : "required",
          "description" : "Codes to identify how UDI data was entered",
          "valueSetReference" : {
            "reference" : "http://hl7.org/fhir/ValueSet/udi-entry-type"
          }
        },
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "NA"
          }
        ]
      },
      {
        "id" : "Device.status",
        "path" : "Device.status",
        "short" : "active | inactive | entered-in-error | unknown",
        "definition" : "Status of the Device availability.",
        "comment" : "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.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Device.status",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "code"
          }
        ],
        "isModifier" : true,
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "FHIRDeviceStatus"
            }
          ],
          "strength" : "required",
          "description" : "The availability status of the device.",
          "valueSetReference" : {
            "reference" : "http://hl7.org/fhir/ValueSet/device-status"
          }
        },
        "mapping" : [
          {
            "identity" : "rim",
            "map" : ".statusCode"
          },
          {
            "identity" : "w5",
            "map" : "status"
          }
        ]
      },
      {
        "id" : "Device.type",
        "path" : "Device.type",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "coding.system"
            }
          ],
          "description" : "Discriminated by code system",
          "rules" : "open"
        },
        "short" : "Type of device.\r\nPreferably valued by using SNOMED CT.\r\nThe absence of information, or of devices relevant for purpose of this IPS, shall be explicitly stated by using the codes included in the absent-or-unknown-devices-uv-ips value set.",
        "definition" : "A concept that may be defined by a formal reference to a terminology or ontology or may be provided by text.",
        "comment" : "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.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Device.type",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept",
            "profile" : "http://hl7.org/fhir/uv/ips/StructureDefinition/CodeableConcept-uv-ips"
          }
        ],
        "mustSupport" : true,
        "binding" : {
          "strength" : "preferred",
          "description" : "The type of device",
          "valueSetReference" : {
            "reference" : "http://hl7.org/fhir/uv/ips/ValueSet/medical-devices-uv-ips"
          }
        },
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          },
          {
            "identity" : "v2",
            "map" : "CE/CNE/CWE"
          },
          {
            "identity" : "rim",
            "map" : "CD"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept rdfs:subClassOf dt:CD"
          }
        ]
      },
      {
        "id" : "Device.type:absentOrUnknownDevice",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
            "valueCode" : "normative"
          },
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
            "valueCode" : "4.0.0"
          }
        ],
        "path" : "Device.type",
        "sliceName" : "absentOrUnknownDevice",
        "short" : "Concept - reference to a terminology or just  text",
        "definition" : "Slice to be valued in case of no information or known absence of relevant devices for the purpose of this IPS",
        "comment" : "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.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Device.type",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "CodeableConcept",
            "profile" : "http://hl7.org/fhir/uv/ips/StructureDefinition/CodeableConcept-uv-ips"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "xpath" : "@value|f:*|h:div",
            "source" : "Element"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "absentOrUnknownDevice"
            }
          ],
          "strength" : "required",
          "description" : "Absent problem or unknown device",
          "valueSetReference" : {
            "reference" : "http://hl7.org/fhir/uv/ips/ValueSet/absent-or-unknown-devices-uv-ips"
          }
        },
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          },
          {
            "identity" : "v2",
            "map" : "CE/CNE/CWE"
          },
          {
            "identity" : "rim",
            "map" : "CD"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept rdfs:subClassOf dt:CD"
          }
        ]
      },
      {
        "id" : "Device.type:absentOrUnknownDevice.id",
        "path" : "Device.type.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Device.type:absentOrUnknownDevice.extension",
        "path" : "Device.type.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "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.",
        "comment" : "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.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Device.type:absentOrUnknownDevice.coding",
        "path" : "Device.type.coding",
        "short" : "Code defined by a terminology system",
        "definition" : "A reference to a code defined by a terminology system.",
        "comment" : "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.",
        "requirements" : "Allows for alternative encodings within a code system, and translations to other code systems.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.coding",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Coding",
            "profile" : "http://hl7.org/fhir/uv/ips/StructureDefinition/Coding-uv-ips"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1-8, C*E.10-22"
          },
          {
            "identity" : "rim",
            "map" : "union(., ./translation)"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
          }
        ]
      },
      {
        "id" : "Device.type:absentOrUnknownDevice.coding.id",
        "path" : "Device.type.coding.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Unique id for inter-element referencing",
        "definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Device.type:absentOrUnknownDevice.coding.extension",
        "path" : "Device.type.coding.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional content defined by implementations",
        "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.",
        "comment" : "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.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Device.type:absentOrUnknownDevice.coding.system",
        "path" : "Device.type.coding.system",
        "short" : "Identity of the terminology system",
        "definition" : "The identification of the code system that defines the meaning of the symbol in the code.",
        "comment" : "The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...).  OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.",
        "requirements" : "Need to be unambiguous about the source of the definition of the symbol.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Coding.system",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "uri"
          }
        ],
        "fixedUri" : "http://hl7.org/fhir/uv/ips/CodeSystem/absent-unknown-uv-ips",
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.3"
          },
          {
            "identity" : "rim",
            "map" : "./codeSystem"
          },
          {
            "identity" : "orim",
            "map" : "fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem"
          }
        ]
      },
      {
        "id" : "Device.type:absentOrUnknownDevice.coding.version",
        "path" : "Device.type.coding.version",
        "short" : "Version of the system - if relevant",
        "definition" : "The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.",
        "comment" : "Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Coding.version",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.7"
          },
          {
            "identity" : "rim",
            "map" : "./codeSystemVersion"
          },
          {
            "identity" : "orim",
            "map" : "fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion"
          }
        ]
      },
      {
        "id" : "Device.type:absentOrUnknownDevice.coding.code",
        "path" : "Device.type.coding.code",
        "short" : "Symbol in syntax defined by the system",
        "definition" : "A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).",
        "requirements" : "Need to refer to a particular code in the system.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Coding.code",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "code"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.1"
          },
          {
            "identity" : "rim",
            "map" : "./code"
          },
          {
            "identity" : "orim",
            "map" : "fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code"
          }
        ]
      },
      {
        "id" : "Device.type:absentOrUnknownDevice.coding.display",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "Device.type.coding.display",
        "short" : "Representation defined by the system",
        "definition" : "A representation of the meaning of the code in the system, following the rules of the system.",
        "requirements" : "Need to be able to carry a human-readable meaning of the code for readers that do not know  the system.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Coding.display",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.2 - but note this is not well followed"
          },
          {
            "identity" : "rim",
            "map" : "CV.displayName"
          },
          {
            "identity" : "orim",
            "map" : "fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName"
          }
        ]
      },
      {
        "id" : "Device.type:absentOrUnknownDevice.coding.display.id",
        "path" : "Device.type.coding.display.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "xml:id (or equivalent in JSON)",
        "definition" : "unique id for the element within a resource (for internal references)",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Device.type:absentOrUnknownDevice.coding.display.extension",
        "path" : "Device.type.coding.display.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "rules" : "open"
        },
        "short" : "Extension",
        "definition" : "An Extension",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Device.type:absentOrUnknownDevice.coding.display.extension:translation",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
            "valueCode" : "normative"
          },
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-normative-version",
            "valueCode" : "4.0.0"
          }
        ],
        "path" : "Device.type.coding.display.extension",
        "sliceName" : "translation",
        "short" : "Language Translation (Localization)",
        "definition" : "Language translation from base language of resource to another language.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension",
            "profile" : "http://hl7.org/fhir/StructureDefinition/translation"
          }
        ],
        "condition" : [
          "ele-1"
        ],
        "constraint" : [
          {
            "key" : "ele-1",
            "severity" : "error",
            "human" : "All FHIR elements must have a @value or children",
            "expression" : "hasValue() or (children().count() > id.count())",
            "xpath" : "@value|f:*|h:div",
            "source" : "Element"
          },
          {
            "key" : "ext-1",
            "severity" : "error",
            "human" : "Must have either extensions or value[x], not both",
            "expression" : "extension.exists() != value.exists()",
            "xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
            "source" : "Extension"
          }
        ],
        "mustSupport" : true,
        "isModifier" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "ST.translation"
          }
        ]
      },
      {
        "id" : "Device.type:absentOrUnknownDevice.coding.display.value",
        "path" : "Device.type.coding.display.value",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "Primitive value for string",
        "definition" : "The actual value",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "string.value",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/regex",
                "valueString" : "[ \\r\\n\\t\\S]+"
              }
            ],
            "_code" : {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-json-type",
                  "valueString" : "string"
                },
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-xml-type",
                  "valueString" : "xsd:string"
                },
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-rdf-type",
                  "valueString" : "xsd:string"
                }
              ]
            }
          }
        ],
        "maxLength" : 1048576,
        "isModifier" : false,
        "isSummary" : false
      },
      {
        "id" : "Device.type:absentOrUnknownDevice.coding.userSelected",
        "path" : "Device.type.coding.userSelected",
        "short" : "If this coding was chosen directly by the user",
        "definition" : "Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).",
        "comment" : "Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.",
        "requirements" : "This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Coding.userSelected",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "boolean"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "Sometimes implied by being first"
          },
          {
            "identity" : "rim",
            "map" : "CD.codingRationale"
          },
          {
            "identity" : "orim",
            "map" : "fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map;   fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\\#true a [     fhir:source \"true\";     fhir:target dt:CDCoding.codingRationale\\#O   ]"
          }
        ]
      },
      {
        "id" : "Device.type:absentOrUnknownDevice.text",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "Device.type.text",
        "short" : "Plain text representation of the concept",
        "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.",
        "comment" : "Very often the text is the same as a displayName of one of the codings.",
        "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.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "CodeableConcept.text",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "v2",
            "map" : "C*E.9. But note many systems use C*E.2 for this"
          },
          {
            "identity" : "rim",
            "map" : "./originalText[mediaType/code=\"text/plain\"]/data"
          },
          {
            "identity" : "orim",
            "map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
          }
        ]
      },
      {
        "id" : "Device.lotNumber",
        "path" : "Device.lotNumber",
        "short" : "Lot number of manufacture",
        "definition" : "Lot number assigned by the manufacturer.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Device.lotNumber",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "mapping" : [
          {
            "identity" : "udi",
            "map" : "The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI."
          },
          {
            "identity" : "rim",
            "map" : ".lotNumberText"
          },
          {
            "identity" : "w5",
            "map" : "what"
          }
        ]
      },
      {
        "id" : "Device.manufacturer",
        "path" : "Device.manufacturer",
        "short" : "Name of device manufacturer",
        "definition" : "A name of the manufacturer.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Device.manufacturer",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "mapping" : [
          {
            "identity" : "udi",
            "map" : "N/A"
          },
          {
            "identity" : "rim",
            "map" : ".playedRole[typeCode=MANU].scoper.name"
          },
          {
            "identity" : "w5",
            "map" : "what"
          }
        ]
      },
      {
        "id" : "Device.manufactureDate",
        "path" : "Device.manufactureDate",
        "short" : "Date when the device was made",
        "definition" : "The date and time when the device was manufactured.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Device.manufactureDate",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "dateTime"
          }
        ],
        "mapping" : [
          {
            "identity" : "udi",
            "map" : "The date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.  For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS].  If hour is present, the minutes and seconds should both be set to “00”."
          },
          {
            "identity" : "rim",
            "map" : ".existenceTime.low"
          },
          {
            "identity" : "w5",
            "map" : "what"
          }
        ]
      },
      {
        "id" : "Device.expirationDate",
        "path" : "Device.expirationDate",
        "short" : "Date and time of expiry of this device (if applicable)",
        "definition" : "The date and time beyond which this device is no longer valid or should not be used (if applicable).",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Device.expirationDate",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "dateTime"
          }
        ],
        "mapping" : [
          {
            "identity" : "udi",
            "map" : "the expiration date of a specific device -  which is a component of the production identifier (PI), a conditional, variable portion of a UDI.  For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS].  If hour is present, the minutes and seconds should both be set to “00”."
          },
          {
            "identity" : "rim",
            "map" : ".expirationTime"
          },
          {
            "identity" : "w5",
            "map" : "what"
          }
        ]
      },
      {
        "id" : "Device.model",
        "path" : "Device.model",
        "short" : "Model id assigned by the manufacturer",
        "definition" : "The \"model\" is an identifier assigned by the manufacturer to identify the product by its type. This number is shared by the all devices sold as the same type.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Device.model",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "mapping" : [
          {
            "identity" : "rim",
            "map" : ".playedRole[typeCode=MANU].code"
          },
          {
            "identity" : "w5",
            "map" : "what"
          }
        ]
      },
      {
        "id" : "Device.version",
        "path" : "Device.version",
        "short" : "Version number (i.e. software)",
        "definition" : "The version of the device, if the device has multiple releases under the same model, or if the device is software or carries firmware.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Device.version",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "mapping" : [
          {
            "identity" : "rim",
            "map" : ".softwareName (included as part)"
          },
          {
            "identity" : "w5",
            "map" : "what"
          }
        ]
      },
      {
        "id" : "Device.patient",
        "path" : "Device.patient",
        "short" : "Patient to whom Device is affixed",
        "definition" : "Patient information, If the device is affixed to a person.",
        "requirements" : "If the device is implanted in a patient, then need to associate the device to the patient.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Device.patient",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : "http://hl7.eu/fhir/trillium2/StructureDefinition/Patient-uv-ips"
          }
        ],
        "mustSupport" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : ".playedRole[typeCode=USED].scoper.playedRole[typeCode=PAT]"
          },
          {
            "identity" : "w5",
            "map" : "who.focus"
          }
        ]
      },
      {
        "id" : "Device.patient.id",
        "path" : "Device.patient.id",
        "representation" : [
          "xmlAttr"
        ],
        "short" : "xml:id (or equivalent in JSON)",
        "definition" : "unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Element.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Device.patient.extension",
        "path" : "Device.patient.extension",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "url"
            }
          ],
          "description" : "Extensions are always sliced by (at least) url",
          "rules" : "open"
        },
        "short" : "Additional Content defined by implementations",
        "definition" : "May be used to represent additional information that is not part of the basic definition of the element. In order 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.",
        "comment" : "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.",
        "alias" : [
          "extensions",
          "user content"
        ],
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Element.extension",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Extension"
          }
        ],
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "n/a"
          }
        ]
      },
      {
        "id" : "Device.patient.reference",
        "path" : "Device.patient.reference",
        "short" : "Literal reference, Relative, internal or absolute URL",
        "definition" : "A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.",
        "comment" : "Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries.   Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure \"/[type]/[id]\" then it should be assumed that the reference is to a FHIR RESTful server.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "Reference.reference",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "condition" : [
          "ref-1"
        ],
        "mustSupport" : true,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Device.patient.identifier",
        "path" : "Device.patient.identifier",
        "short" : "Logical reference, when literal reference is not known",
        "definition" : "An identifier for the other resource. This is used when there is no way to reference the other resource directly, either because the entity is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.",
        "comment" : "When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. \n\nWhen both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference\n\nApplications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Reference.identifier",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Identifier"
          }
        ],
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : ".identifier"
          }
        ]
      },
      {
        "id" : "Device.patient.display",
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean" : true
          }
        ],
        "path" : "Device.patient.display",
        "short" : "Text alternative for the resource",
        "definition" : "Plain text narrative that identifies the resource in addition to the resource reference.",
        "comment" : "This is generally not the same as the Resource.text of the referenced resource.  The purpose is to identify what's being referenced, not to fully describe it.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Reference.display",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "N/A"
          }
        ]
      },
      {
        "id" : "Device.owner",
        "path" : "Device.owner",
        "short" : "Organization responsible for device",
        "definition" : "An organization that is responsible for the provision and ongoing maintenance of the device.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Device.owner",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : "http://hl7.org/fhir/StructureDefinition/Organization"
          }
        ],
        "mapping" : [
          {
            "identity" : "rim",
            "map" : ".playedRole[typeCode=OWN].scoper"
          },
          {
            "identity" : "w5",
            "map" : "who.source"
          }
        ]
      },
      {
        "id" : "Device.contact",
        "path" : "Device.contact",
        "short" : "Details for human/organization for support",
        "definition" : "Contact details for an organization or a particular human that is responsible for the device.",
        "comment" : "used for troubleshooting etc.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Device.contact",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "ContactPoint"
          }
        ],
        "mapping" : [
          {
            "identity" : "rim",
            "map" : ".scopedRole[typeCode=CON].player"
          },
          {
            "identity" : "w5",
            "map" : "who.source"
          }
        ]
      },
      {
        "id" : "Device.location",
        "path" : "Device.location",
        "short" : "Where the resource is found",
        "definition" : "The place where the device can be found.",
        "requirements" : "Device.location can be used to track device location.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Device.location",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : "http://hl7.org/fhir/StructureDefinition/Location"
          }
        ],
        "mapping" : [
          {
            "identity" : "rim",
            "map" : ".playedRole[typeCode=LOCE].scoper"
          },
          {
            "identity" : "w5",
            "map" : "where"
          }
        ]
      },
      {
        "id" : "Device.url",
        "path" : "Device.url",
        "short" : "Network address to contact device",
        "definition" : "A network address on which the device may be contacted directly.",
        "comment" : "If the device is running a FHIR server, the network address should  be the Base URL from which a conformance statement may be retrieved.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Device.url",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "uri"
          }
        ],
        "mapping" : [
          {
            "identity" : "rim",
            "map" : ".telecom"
          },
          {
            "identity" : "w5",
            "map" : "where"
          }
        ]
      },
      {
        "id" : "Device.note",
        "path" : "Device.note",
        "short" : "Device notes and comments",
        "definition" : "Descriptive information, usage information or implantation information that is not captured in an existing element.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Device.note",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "Annotation"
          }
        ],
        "mapping" : [
          {
            "identity" : "rim",
            "map" : ".text"
          }
        ]
      },
      {
        "id" : "Device.safety",
        "path" : "Device.safety",
        "short" : "Safety Characteristics of Device",
        "definition" : "Provides additional safety characteristics about a medical device.  For example devices containing latex.",
        "min" : 0,
        "max" : "*",
        "base" : {
          "path" : "Device.safety",
          "min" : 0,
          "max" : "*"
        },
        "type" : [
          {
            "code" : "CodeableConcept"
          }
        ],
        "isSummary" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "DeviceSafety"
            }
          ],
          "strength" : "example",
          "description" : "Codes used to identify medical devices safety characterics. These codes are derived in part from the [United States Food and Drug Administration recommendations](http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm107708.pdf) and are provided here as a suggestive example.",
          "valueSetReference" : {
            "reference" : "http://hl7.org/fhir/ValueSet/device-safety"
          }
        },
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "NA"
          }
        ]
      }
    ]
  },
  "differential" : {
    "element" : [
      {
        "id" : "Device",
        "path" : "Device",
        "comment" : "This profile applies the rules defined by HL7 International for representing the UDI in the FHIR standard, by the document \"Medical Devices and Unique Device Identification (UDI) Pattern, Release 1\"",
        "mustSupport" : true
      },
      {
        "id" : "Device.id",
        "path" : "Device.id",
        "mustSupport" : true
      },
      {
        "id" : "Device.meta",
        "path" : "Device.meta",
        "mustSupport" : true
      },
      {
        "id" : "Device.identifier",
        "path" : "Device.identifier",
        "mustSupport" : true
      },
      {
        "id" : "Device.type",
        "path" : "Device.type",
        "slicing" : {
          "discriminator" : [
            {
              "type" : "value",
              "path" : "coding.system"
            }
          ],
          "description" : "Discriminated by code system",
          "rules" : "open"
        },
        "short" : "Type of device.\r\nPreferably valued by using SNOMED CT.\r\nThe absence of information, or of devices relevant for purpose of this IPS, shall be explicitly stated by using the codes included in the absent-or-unknown-devices-uv-ips value set.",
        "min" : 0,
        "max" : "1",
        "type" : [
          {
            "code" : "CodeableConcept",
            "profile" : "http://hl7.org/fhir/uv/ips/StructureDefinition/CodeableConcept-uv-ips"
          }
        ],
        "mustSupport" : true,
        "binding" : {
          "strength" : "preferred",
          "description" : "The type of device",
          "valueSetReference" : {
            "reference" : "http://hl7.org/fhir/uv/ips/ValueSet/medical-devices-uv-ips"
          }
        }
      },
      {
        "id" : "Device.type:absentOrUnknownDevice",
        "path" : "Device.type",
        "sliceName" : "absentOrUnknownDevice",
        "definition" : "Slice to be valued in case of no information or known absence of relevant devices for the purpose of this IPS",
        "max" : "1",
        "type" : [
          {
            "code" : "CodeableConcept",
            "profile" : "http://hl7.org/fhir/uv/ips/StructureDefinition/CodeableConcept-uv-ips"
          }
        ],
        "mustSupport" : true,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "absentOrUnknownDevice"
            }
          ],
          "strength" : "required",
          "description" : "Absent problem or unknown device",
          "valueSetReference" : {
            "reference" : "http://hl7.org/fhir/uv/ips/ValueSet/absent-or-unknown-devices-uv-ips"
          }
        }
      },
      {
        "id" : "Device.type:absentOrUnknownDevice.coding",
        "path" : "Device.type.coding",
        "min" : 1,
        "max" : "1",
        "mustSupport" : true
      },
      {
        "id" : "Device.type:absentOrUnknownDevice.coding.system",
        "path" : "Device.type.coding.system",
        "min" : 1,
        "max" : "1",
        "fixedUri" : "http://hl7.org/fhir/uv/ips/CodeSystem/absent-unknown-uv-ips",
        "mustSupport" : true
      },
      {
        "id" : "Device.patient",
        "path" : "Device.patient",
        "min" : 1,
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : "http://hl7.eu/fhir/trillium2/StructureDefinition/Patient-uv-ips"
          }
        ],
        "mustSupport" : true
      },
      {
        "id" : "Device.patient.reference",
        "path" : "Device.patient.reference",
        "min" : 1,
        "mustSupport" : true
      }
    ]
  }
}