US Core Implementation Guide (Release 1.0.1)
This page is part of the US Core (v1.0.1: STU1) based on FHIR R3. The current version which supercedes this version is 5.0.1. For a full list of available versions, see the Directory of published versions 
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<StructureDefinition xmlns="http://hl7.org/fhir"> <id value="us-core-device"/> <text> <status value="generated"/> <div xmlns="http://www.w3.org/1999/xhtml"><table border="0" cellpadding="0" cellspacing="0" style="border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;"><tr style="border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;"><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/STU3/formats.html#table" title="The logical name of the element">Name</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/STU3/formats.html#table" title="Information about the use of the element">Flags</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/STU3/formats.html#table" title="Minimum and Maximum # of times the the element can appear in the instance">Card.</a></th><th style="width: 100px" class="hierarchy"><a href="http://hl7.org/fhir/STU3/formats.html#table" title="Reference to the type of the element">Type</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/STU3/formats.html#table" title="Additional information about the element">Description & Constraints</a><span style="float: right"><a href="http://hl7.org/fhir/STU3/formats.html#table" title="Legend for this format"><img src="http://hl7.org/fhir/STU3/help16.png" alt="doco" style="background-color: inherit"/></a></span></th></tr><tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-us-core-device-definitions.html#Device" title="The US Core Implanted Device Profile is based upon the core FHIR Device Resource and created to meet the 2015 Edition Common Clinical Data Set 'Unique device identifier(s) for a patient’s implantable device(s)' requirements.">Device</a><a name="Device"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.4">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.4">*</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">US Core Implanted Device Profile</td></tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-us-core-device-definitions.html#Device.udi">udi</a><a name="Device.udi"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.4" href="http://hl7.org/fhir/STU3/datatypes.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-us-core-device-definitions.html#Device.udi.carrierHRF">carrierHRF</a><a name="Device.udi.carrierHRF"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.4">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.4">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.4" href="http://hl7.org/fhir/STU3/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-us-core-device-definitions.html#Device.udi.carrierAIDC">carrierAIDC</a><a name="Device.udi.carrierAIDC"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.4">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.4">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.4" href="http://hl7.org/fhir/STU3/datatypes.html#base64Binary">base64Binary</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-us-core-device-definitions.html#Device.type">type</a><a name="Device.type"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.4" href="http://hl7.org/fhir/STU3/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-weight:bold">Binding: </span><a href="http://hl7.org/fhir/STU3/valueset-device-kind.html">FHIR Device Types</a> (<a href="http://hl7.org/fhir/STU3/terminologies.html#extensible" title="To be conformant, the concept in this element SHALL be from the specified value set if any of the codes within the value set can apply to the concept being communicated. If the value set does not cover the concept (based on human review), alternate codings (or, data type allowing, text) may be included instead.">extensible</a>)</td></tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck00.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_reference.png" alt="." style="background-color: white; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> <a href="StructureDefinition-us-core-device-definitions.html#Device.patient">patient</a><a name="Device.patient"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/STU3/references.html">Reference</a>(<a href="StructureDefinition-us-core-patient.html">US Core Patient Profile</a>)</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr> <tr><td colspan="5" class="hierarchy"><br/><a href="http://hl7.org/fhir/STU3/formats.html#table" title="Legend for this format"><img src="http://hl7.org/fhir/STU3/help16.png" alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div> </text> <url value="http://hl7.org/fhir/us/core/StructureDefinition/us-core-device"/> <version value="1.0.1"/> <name value="US Core Device Profile"/> <status value="draft"/> <date value="2016-08-01T00:00:00+10:00"/> <publisher value="HL7 US Realm Steering Committee"/> <contact> <telecom> <system value="url"/> <value value="http://www.healthit.gov"/> </telecom> </contact> <jurisdiction> <coding> <system value="urn:iso:std:iso:3166"/> <code value="US"/> <display value="United States Minor Outlying Islands (the)"/> </coding> </jurisdiction> <fhirVersion value="3.0.1"/> <mapping> <identity value="argonaut-dq-dstu2"/> <uri value="http://unknown.org/Argonaut DQ DSTU2"/> <name value="Argonaut DQ DSTU2"/> </mapping> <mapping> <identity value="rim"/> <uri value="http://hl7.org/v3"/> <name value="RIM Mapping"/> </mapping> <mapping> <identity value="w5"/> <uri value="http://hl7.org/fhir/w5"/> <name value="W5 Mapping"/> </mapping> <mapping> <identity value="udi"/> <uri value="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm"/> <name value="UDI Mapping"/> </mapping> <kind value="resource"/> <abstract value="false"/> <type value="Device"/> <baseDefinition value="http://hl7.org/fhir/StructureDefinition/Device"/> <derivation value="constraint"/> <snapshot> <element id="Device"> <path value="Device"/> <short value="US Core Implanted Device Profile"/> <definition value="The US Core Implanted Device Profile is based upon the core FHIR Device Resource and created to meet the 2015 Edition Common Clinical Data Set 'Unique device identifier(s) for a patient’s implantable device(s)' requirements."/> <min value="0"/> <max value="*"/> <base> <path value="Device"/> <min value="0"/> <max value="*"/> </base> <constraint> <key value="dom-2"/> <severity value="error"/> <human value="If the resource is contained in another resource, it SHALL NOT contain nested Resources"/> <expression value="contained.contained.empty()"/> <xpath value="not(parent::f:contained and f:contained)"/> <source value="DomainResource"/> </constraint> <constraint> <key value="dom-1"/> <severity value="error"/> <human value="If the resource is contained in another resource, it SHALL NOT contain any narrative"/> <expression value="contained.text.empty()"/> <xpath value="not(parent::f:contained and f:text)"/> <source value="DomainResource"/> </constraint> <constraint> <key value="dom-4"/> <severity value="error"/> <human value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated"/> <expression value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"/> <xpath value="not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))"/> <source value="DomainResource"/> </constraint> <constraint> <key value="dom-3"/> <severity value="error"/> <human value="If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource"/> <expression value="contained.where(('#'+id in %resource.descendants().reference).not()).empty()"/> <xpath value="not(exists(for $id in f:contained/*/@id return $id[not(ancestor::f:contained/parent::*/descendant::f:reference/@value=concat('#', $id))]))"/> <source value="DomainResource"/> </constraint> <mustSupport value="false"/> <mapping> <identity value="rim"/> <map value="Entity. Role, or Act"/> </mapping> <mapping> <identity value="rim"/> <map value="Device"/> </mapping> <mapping> <identity value="w5"/> <map value="administrative.device"/> </mapping> <mapping> <identity value="argonaut-dq-dstu2"/> <map value="Device"/> </mapping> </element> <element id="Device.id"> <path value="Device.id"/> <short value="Logical id of this artifact"/> <definition value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes."/> <comment value="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 value="0"/> <max value="1"/> <base> <path value="Resource.id"/> <min value="0"/> <max value="1"/> </base> <type> <code value="id"/> </type> <isSummary value="true"/> </element> <element id="Device.meta"> <path value="Device.meta"/> <short value="Metadata about the resource"/> <definition value="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 value="0"/> <max value="1"/> <base> <path value="Resource.meta"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Meta"/> </type> <isSummary value="true"/> </element> <element id="Device.implicitRules"> <path value="Device.implicitRules"/> <short value="A set of rules under which this content was created"/> <definition value="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 value="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. This 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 value="0"/> <max value="1"/> <base> <path value="Resource.implicitRules"/> <min value="0"/> <max value="1"/> </base> <type> <code value="uri"/> </type> <isModifier value="true"/> <isSummary value="true"/> </element> <element id="Device.language"> <path value="Device.language"/> <short value="Language of the resource content"/> <definition value="The base language in which the resource is written."/> <comment value="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 value="0"/> <max value="1"/> <base> <path value="Resource.language"/> <min value="0"/> <max value="1"/> </base> <type> <code value="code"/> </type> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet"> <valueReference> <reference value="http://hl7.org/fhir/ValueSet/all-languages"/> </valueReference> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="Language"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding"> <valueBoolean value="true"/> </extension> <strength value="extensible"/> <description value="A human language."/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/languages"/> </valueSetReference> </binding> </element> <element id="Device.text"> <path value="Device.text"/> <short value="Text summary of the resource, for human interpretation"/> <definition value="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 value="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 value="narrative"/> <alias value="html"/> <alias value="xhtml"/> <alias value="display"/> <min value="0"/> <max value="1"/> <base> <path value="DomainResource.text"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Narrative"/> </type> <condition value="dom-1"/> <mapping> <identity value="rim"/> <map value="Act.text?"/> </mapping> </element> <element id="Device.contained"> <path value="Device.contained"/> <short value="Contained, inline Resources"/> <definition value="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 value="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 value="inline resources"/> <alias value="anonymous resources"/> <alias value="contained resources"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.contained"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Resource"/> </type> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="Device.extension"> <path value="Device.extension"/> <short value="Additional Content defined by implementations"/> <definition value="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 value="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 value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="Device.modifierExtension"> <path value="Device.modifierExtension"/> <short value="Extensions that cannot be ignored"/> <definition value="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 value="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 value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <isModifier value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="Device.identifier"> <path value="Device.identifier"/> <short value="Instance identifier"/> <definition value="Unique instance identifiers assigned to a device by manufacturers other organizations or owners."/> <comment value="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](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](device-mappings.html#udi) for a complete mapping of UDI parts to Device."/> <alias value="Serial Number"/> <min value="0"/> <max value="*"/> <base> <path value="Device.identifier"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Identifier"/> </type> <mapping> <identity value="udi"/> <map value="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."/> </mapping> <mapping> <identity value="rim"/> <map value=".id"/> </mapping> <mapping> <identity value="w5"/> <map value="id"/> </mapping> </element> <element id="Device.udi"> <path value="Device.udi"/> <short value="Unique Device Identifier (UDI) Barcode string"/> <definition value="[Unique device identifier (UDI)](device.html#5.11.3.2.2) assigned to device label or package."/> <comment value="UDI may identify an unique instance of a device, or it may only identify the type of the device. See [UDI mappings](device-mappings.html#udi) for a complete mapping of UDI parts to Device."/> <min value="1"/> <max value="1"/> <base> <path value="Device.udi"/> <min value="0"/> <max value="1"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() | (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="Element"/> </constraint> <mustSupport value="true"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value=".id and .code"/> </mapping> <mapping> <identity value="w5"/> <map value="id"/> </mapping> <mapping> <identity value="argonaut-dq-dstu2"/> <map value="Device.udi"/> </mapping> </element> <element id="Device.udi.id"> <path value="Device.udi.id"/> <representation value="xmlAttr"/> <short value="xml:id (or equivalent in JSON)"/> <definition value="unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Device.udi.extension"> <path value="Device.udi.extension"/> <short value="Additional Content defined by implementations"/> <definition value="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 value="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 value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Device.udi.modifierExtension"> <path value="Device.udi.modifierExtension"/> <short value="Extensions that cannot be ignored"/> <definition value="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 value="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 value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneElement.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <isModifier value="true"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="Device.udi.deviceIdentifier"> <path value="Device.udi.deviceIdentifier"/> <short value="Mandatory fixed portion of UDI"/> <definition value="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 value="DI"/> <min value="0"/> <max value="1"/> <base> <path value="Device.udi.deviceIdentifier"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <isSummary value="true"/> <mapping> <identity value="udi"/> <map value="The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device."/> </mapping> <mapping> <identity value="rim"/> <map value="Role.id.extension"/> </mapping> <mapping> <identity value="w5"/> <map value="what"/> </mapping> </element> <element id="Device.udi.name"> <path value="Device.udi.name"/> <short value="Device Name as appears on UDI label"/> <definition value="Name of device as used in labeling or catalog."/> <comment value="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 value="Brand Name"/> <min value="0"/> <max value="1"/> <base> <path value="Device.udi.name"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <isSummary value="true"/> <mapping> <identity value="udi"/> <map value="Propietary/Trade Name of the medical Device as used in the labeling or catalog"/> </mapping> <mapping> <identity value="rim"/> <map value=".displayName"/> </mapping> <mapping> <identity value="w5"/> <map value="what"/> </mapping> </element> <element id="Device.udi.jurisdiction"> <path value="Device.udi.jurisdiction"/> <short value="Regional UDI authority"/> <definition value="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 value="Allows a recipient of a UDI to know which database will contain the UDI-associated metadata."/> <min value="0"/> <max value="1"/> <base> <path value="Device.udi.jurisdiction"/> <min value="0"/> <max value="1"/> </base> <type> <code value="uri"/> </type> <mapping> <identity value="rim"/> <map value="Role.scoper"/> </mapping> </element> <element id="Device.udi.carrierHRF"> <path value="Device.udi.carrierHRF"/> <short value="UDI Human Readable Barcode String"/> <definition value="The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device."/> <comment value="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 value="Human Readable Form"/> <alias value="UDI"/> <alias value="Barcode String"/> <min value="0"/> <max value="1"/> <base> <path value="Device.udi.carrierHRF"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <mustSupport value="false"/> <isSummary value="true"/> <mapping> <identity value="udi"/> <map value="A unique device identifier (UDI) on a device label in plain text"/> </mapping> <mapping> <identity value="rim"/> <map value="Role.id.extension"/> </mapping> <mapping> <identity value="argonaut-dq-dstu2"/> <map value="Device.udi"/> </mapping> </element> <element id="Device.udi.carrierAIDC"> <path value="Device.udi.carrierAIDC"/> <short value="UDI Machine Readable Barcode String"/> <definition value="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 value="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 value="Automatic Identification and Data Capture"/> <alias value="UDI"/> <alias value="Barcode String"/> <min value="0"/> <max value="1"/> <base> <path value="Device.udi.carrierAIDC"/> <min value="0"/> <max value="1"/> </base> <type> <code value="base64Binary"/> </type> <mustSupport value="false"/> <isSummary value="true"/> <mapping> <identity value="udi"/> <map value="A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology."/> </mapping> <mapping> <identity value="rim"/> <map value="Role.id.extension"/> </mapping> <mapping> <identity value="argonaut-dq-dstu2"/> <map value="NA (not Supoorted)"/> </mapping> </element> <element id="Device.udi.issuer"> <path value="Device.udi.issuer"/> <short value="UDI Issuing Organization"/> <definition value="Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : 1) GS1: http://hl7.org/fhir/NamingSystem/gs1-di, 2) HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, 3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, 4) ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di."/> <alias value="Barcode System"/> <min value="0"/> <max value="1"/> <base> <path value="Device.udi.issuer"/> <min value="0"/> <max value="1"/> </base> <type> <code value="uri"/> </type> <mapping> <identity value="udi"/> <map value="All UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency. GS1 DIs: http://hl7.org/fhir/NamingSystem/gs1 HIBCC DIs: http://hl7.org/fhir/NamingSystem/hibcc ICCBBA DIs for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood ICCBA DIs for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other"/> </mapping> <mapping> <identity value="rim"/> <map value="Role.id.root"/> </mapping> </element> <element id="Device.udi.entryType"> <path value="Device.udi.entryType"/> <short value="barcode | rfid | manual +"/> <definition value="A coded entry to indicate how the data was entered."/> <requirements value="Supports a way to distinguish hand entered from machine read data."/> <min value="0"/> <max value="1"/> <base> <path value="Device.udi.entryType"/> <min value="0"/> <max value="1"/> </base> <type> <code value="code"/> </type> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="UDIEntryType"/> </extension> <strength value="required"/> <description value="Codes to identify how UDI data was entered"/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/udi-entry-type"/> </valueSetReference> </binding> <mapping> <identity value="rim"/> <map value="NA"/> </mapping> </element> <element id="Device.status"> <path value="Device.status"/> <short value="active | inactive | entered-in-error | unknown"/> <definition value="Status of the Device availability."/> <comment value="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 value="0"/> <max value="1"/> <base> <path value="Device.status"/> <min value="0"/> <max value="1"/> </base> <type> <code value="code"/> </type> <isModifier value="true"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="FHIRDeviceStatus"/> </extension> <strength value="required"/> <description value="The availability status of the device."/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/device-status"/> </valueSetReference> </binding> <mapping> <identity value="rim"/> <map value=".statusCode"/> </mapping> <mapping> <identity value="w5"/> <map value="status"/> </mapping> </element> <element id="Device.type"> <path value="Device.type"/> <short value="What kind of device this is"/> <definition value="Code or identifier to identify a kind of device."/> <min value="1"/> <max value="1"/> <base> <path value="Device.type"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <mustSupport value="true"/> <binding> <strength value="extensible"/> <description value="Codes to identify medical devices"/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/device-kind"/> </valueSetReference> </binding> <mapping> <identity value="udi"/> <map value="Type description using GMDN or other code system"/> </mapping> <mapping> <identity value="rim"/> <map value=".code"/> </mapping> <mapping> <identity value="w5"/> <map value="what"/> </mapping> <mapping> <identity value="argonaut-dq-dstu2"/> <map value="Device.type"/> </mapping> </element> <element id="Device.lotNumber"> <path value="Device.lotNumber"/> <short value="Lot number of manufacture"/> <definition value="Lot number assigned by the manufacturer."/> <min value="0"/> <max value="1"/> <base> <path value="Device.lotNumber"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <mapping> <identity value="udi"/> <map value="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."/> </mapping> <mapping> <identity value="rim"/> <map value=".lotNumberText"/> </mapping> <mapping> <identity value="w5"/> <map value="what"/> </mapping> </element> <element id="Device.manufacturer"> <path value="Device.manufacturer"/> <short value="Name of device manufacturer"/> <definition value="A name of the manufacturer."/> <min value="0"/> <max value="1"/> <base> <path value="Device.manufacturer"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <mapping> <identity value="udi"/> <map value="N/A"/> </mapping> <mapping> <identity value="rim"/> <map value=".playedRole[typeCode=MANU].scoper.name"/> </mapping> <mapping> <identity value="w5"/> <map value="what"/> </mapping> </element> <element id="Device.manufactureDate"> <path value="Device.manufactureDate"/> <short value="Date when the device was made"/> <definition value="The date and time when the device was manufactured."/> <min value="0"/> <max value="1"/> <base> <path value="Device.manufactureDate"/> <min value="0"/> <max value="1"/> </base> <type> <code value="dateTime"/> </type> <mapping> <identity value="udi"/> <map value="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”."/> </mapping> <mapping> <identity value="rim"/> <map value=".existenceTime.low"/> </mapping> <mapping> <identity value="w5"/> <map value="what"/> </mapping> </element> <element id="Device.expirationDate"> <path value="Device.expirationDate"/> <short value="Date and time of expiry of this device (if applicable)"/> <definition value="The date and time beyond which this device is no longer valid or should not be used (if applicable)."/> <min value="0"/> <max value="1"/> <base> <path value="Device.expirationDate"/> <min value="0"/> <max value="1"/> </base> <type> <code value="dateTime"/> </type> <mapping> <identity value="udi"/> <map value="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”."/> </mapping> <mapping> <identity value="rim"/> <map value=".expirationTime"/> </mapping> <mapping> <identity value="w5"/> <map value="what"/> </mapping> </element> <element id="Device.model"> <path value="Device.model"/> <short value="Model id assigned by the manufacturer"/> <definition value="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 value="0"/> <max value="1"/> <base> <path value="Device.model"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <mapping> <identity value="rim"/> <map value=".playedRole[typeCode=MANU].code"/> </mapping> <mapping> <identity value="w5"/> <map value="what"/> </mapping> </element> <element id="Device.version"> <path value="Device.version"/> <short value="Version number (i.e. software)"/> <definition value="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 value="0"/> <max value="1"/> <base> <path value="Device.version"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <mapping> <identity value="rim"/> <map value=".softwareName (included as part)"/> </mapping> <mapping> <identity value="w5"/> <map value="what"/> </mapping> </element> <element id="Device.patient"> <path value="Device.patient"/> <short value="Patient to whom Device is affixed"/> <definition value="Patient information, If the device is affixed to a person."/> <requirements value="If the device is implanted in a patient, then need to associate the device to the patient."/> <min value="1"/> <max value="1"/> <base> <path value="Device.patient"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/core/StructureDefinition/us-core-patient"/> </type> <mustSupport value="true"/> <mapping> <identity value="rim"/> <map value=".playedRole[typeCode=USED].scoper.playedRole[typeCode=PAT]"/> </mapping> <mapping> <identity value="w5"/> <map value="who.focus"/> </mapping> <mapping> <identity value="argonaut-dq-dstu2"/> <map value="Device.patient"/> </mapping> </element> <element id="Device.owner"> <path value="Device.owner"/> <short value="Organization responsible for device"/> <definition value="An organization that is responsible for the provision and ongoing maintenance of the device."/> <min value="0"/> <max value="1"/> <base> <path value="Device.owner"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization"/> </type> <mapping> <identity value="rim"/> <map value=".playedRole[typeCode=OWN].scoper"/> </mapping> <mapping> <identity value="w5"/> <map value="who.source"/> </mapping> </element> <element id="Device.contact"> <path value="Device.contact"/> <short value="Details for human/organization for support"/> <definition value="Contact details for an organization or a particular human that is responsible for the device."/> <comment value="used for troubleshooting etc."/> <min value="0"/> <max value="*"/> <base> <path value="Device.contact"/> <min value="0"/> <max value="*"/> </base> <type> <code value="ContactPoint"/> </type> <mapping> <identity value="rim"/> <map value=".scopedRole[typeCode=CON].player"/> </mapping> <mapping> <identity value="w5"/> <map value="who.source"/> </mapping> </element> <element id="Device.location"> <path value="Device.location"/> <short value="Where the resource is found"/> <definition value="The place where the device can be found."/> <requirements value="Device.location can be used to track device location."/> <min value="0"/> <max value="1"/> <base> <path value="Device.location"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Location"/> </type> <mapping> <identity value="rim"/> <map value=".playedRole[typeCode=LOCE].scoper"/> </mapping> <mapping> <identity value="w5"/> <map value="where"/> </mapping> </element> <element id="Device.url"> <path value="Device.url"/> <short value="Network address to contact device"/> <definition value="A network address on which the device may be contacted directly."/> <comment value="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 value="0"/> <max value="1"/> <base> <path value="Device.url"/> <min value="0"/> <max value="1"/> </base> <type> <code value="uri"/> </type> <mapping> <identity value="rim"/> <map value=".telecom"/> </mapping> <mapping> <identity value="w5"/> <map value="where"/> </mapping> </element> <element id="Device.note"> <path value="Device.note"/> <short value="Device notes and comments"/> <definition value="Descriptive information, usage information or implantation information that is not captured in an existing element."/> <min value="0"/> <max value="*"/> <base> <path value="Device.note"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Annotation"/> </type> <mapping> <identity value="rim"/> <map value=".text"/> </mapping> </element> <element id="Device.safety"> <path value="Device.safety"/> <short value="Safety Characteristics of Device"/> <definition value="Provides additional safety characteristics about a medical device. For example devices containing latex."/> <min value="0"/> <max value="*"/> <base> <path value="Device.safety"/> <min value="0"/> <max value="*"/> </base> <type> <code value="CodeableConcept"/> </type> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="DeviceSafety"/> </extension> <strength value="example"/> <description value="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 value="http://hl7.org/fhir/ValueSet/device-safety"/> </valueSetReference> </binding> <mapping> <identity value="rim"/> <map value="NA"/> </mapping> </element> </snapshot> <differential> <element id="Device"> <path value="Device"/> <short value="US Core Implanted Device Profile"/> <definition value="The US Core Implanted Device Profile is based upon the core FHIR Device Resource and created to meet the 2015 Edition Common Clinical Data Set 'Unique device identifier(s) for a patient’s implantable device(s)' requirements."/> <mustSupport value="false"/> <isModifier value="false"/> <mapping> <identity value="argonaut-dq-dstu2"/> <map value="Device"/> </mapping> </element> <element id="Device.udi"> <path value="Device.udi"/> <min value="1"/> <max value="1"/> <mustSupport value="true"/> <isModifier value="false"/> <mapping> <identity value="argonaut-dq-dstu2"/> <map value="Device.udi"/> </mapping> </element> <element id="Device.udi.carrierHRF"> <path value="Device.udi.carrierHRF"/> <alias value="UDI"/> <alias value="Barcode String"/> <min value="0"/> <max value="1"/> <type> <code value="string"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <mapping> <identity value="argonaut-dq-dstu2"/> <map value="Device.udi"/> </mapping> </element> <element id="Device.udi.carrierAIDC"> <path value="Device.udi.carrierAIDC"/> <alias value="UDI"/> <alias value="Barcode String"/> <min value="0"/> <max value="1"/> <type> <code value="base64Binary"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <mapping> <identity value="argonaut-dq-dstu2"/> <map value="NA (not Supoorted)"/> </mapping> </element> <element id="Device.type"> <path value="Device.type"/> <min value="1"/> <max value="1"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="true"/> <isModifier value="false"/> <binding> <strength value="extensible"/> <description value="Codes to identify medical devices"/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/device-kind"/> </valueSetReference> </binding> <mapping> <identity value="argonaut-dq-dstu2"/> <map value="Device.type"/> </mapping> </element> <element id="Device.patient"> <path value="Device.patient"/> <min value="1"/> <max value="1"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/us/core/StructureDefinition/us-core-patient"/> </type> <mustSupport value="true"/> <isModifier value="false"/> <mapping> <identity value="argonaut-dq-dstu2"/> <map value="Device.patient"/> </mapping> </element> </differential> </StructureDefinition>
US Core Version: 1.0.1 ®© FHIR Version: 3.0.1 (IG Publisher v3.0.1-11917) generated on Thu, Nov 2, 2017 22:55+1100. |
