This page is part of the FHIR Specification (v1.0.0: DSTU 2 Ballot 3). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions
StructureDefinition for Profile of Device for decision support/quality metrics. Defines the core set of elements and extensions for quality rule and measure authors.
{ "resourceType": "StructureDefinition", "id": "qicore-device", "text": { "status": "generated", "div": "<div>!-- Snipped for Brevity --></div>" }, "url": "http://hl7.org/fhir/StructureDefinition/qicore-device", "name": "QICore-Device", "status": "draft", "publisher": "Health Level Seven International (Clinical Quality Information - QICore)", "contact": [ { "telecom": [ { "system": "other", "value": "http://hl7.org/special/committees/CQI" } ] } ], "date": "2015-03-11", "description": "Profile of Device for decision support/quality metrics. Defines the core set of elements and extensions for quality rule and measure authors.", "mapping": [ { "identity": "qdm", "uri": "http://www.healthit.gov/quality-data-model", "name": "Quality Data Model" } ], "kind": "resource", "constrainedType": "Device", "abstract": false, "base": "http://hl7.org/fhir/StructureDefinition/Device", "snapshot": { "element": [ { "path": "Device", "name": "QICore-Device", "short": "An instance of a manufactured thing that is used in the provision of healthcare", "definition": "This resource identifies an instance of a manufactured thing 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 includes 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 includes things such as a machine, a cellphone, a computer, an application, etc.", "min": 0, "max": "*", "base": { "path": "Device", "min": 0, "max": "*" }, "type": [ { "code": "Device" } ], "mapping": [ { "identity": "rim", "map": "Device" }, { "identity": "w5", "map": "administrative.device" }, { "identity": "qdm", "map": "Device, Applied or Order or Recommended" } ] }, { "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.", "comments": "The only time that a resource does not have an id is when it is being submitted to the server using a create operation. Bundles always have an id, though it is usually a generated UUID.", "min": 0, "max": "1", "base": { "path": "Device.id", "min": 0, "max": "1" }, "type": [ { "code": "id" } ], "isSummary": true }, { "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": "Device.meta", "min": 0, "max": "1" }, "type": [ { "code": "Meta" } ], "isSummary": true }, { "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.", "comments": "Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element as much as possible.", "min": 0, "max": "1", "base": { "path": "Device.implicitRules", "min": 0, "max": "1" }, "type": [ { "code": "uri" } ], "isModifier": true, "isSummary": true }, { "path": "Device.language", "short": "Language of the resource content", "definition": "The base language in which the resource is written.", "comments": "Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).", "min": 0, "max": "1", "base": { "path": "Device.language", "min": 0, "max": "1" }, "type": [ { "code": "code" } ], "binding": { "strength": "required", "description": "A human language", "valueSetUri": "http://tools.ietf.org/html/bcp47" } }, { "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.", "comments": "Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative.", "alias": [ "narrative", "html", "xhtml", "display" ], "min": 0, "max": "1", "base": { "path": "Device.text", "min": 0, "max": "1" }, "type": [ { "code": "Narrative" } ], "condition": [ "dom-1" ], "mapping": [ { "identity": "rim", "map": "Act.text?" } ] }, { "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.", "comments": "This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again.", "alias": [ "inline resources", "anonymous resources", "contained resources" ], "min": 0, "max": "*", "base": { "path": "Device.contained", "min": 0, "max": "*" }, "type": [ { "code": "Resource" } ], "mapping": [ { "identity": "rim", "map": "N/A" } ] }, { "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.", "comments": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Device.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "mapping": [ { "identity": "rim", "map": "N/A" } ] }, { "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.", "comments": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "Device.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "isModifier": true, "mapping": [ { "identity": "rim", "map": "N/A" } ] }, { "path": "Device.identifier", "short": "Instance id from manufacturer, owner, and others", "definition": "Unique instance identifiers assigned to a device by organizations like manufacturers or owners . If the identifier identifies the type of device, Device.type should be used.", "comments": "Often fixed to the device as a barcode and may include names given to the device in local usage. Note that some of the barcodes affixed to the device identify its type, not its instance. For the FDA Mandated Unique Device Identifier (UDI) use the Device.udi element.", "min": 0, "max": "*", "base": { "path": "Device.identifier", "min": 0, "max": "*" }, "type": [ { "code": "Identifier" } ], "mapping": [ { "identity": "rim", "map": ".id" }, { "identity": "w5", "map": "id" } ] }, { "path": "Device.type", "short": "What kind of device this is", "definition": "Code or identifier to identify a kind of device.", "comments": "For the FDA Mandated Unique Device Identifier (UDI) use the Device.udi element.", "min": 1, "max": "1", "base": { "path": "Device.type", "min": 1, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "mustSupport": true, "binding": { "strength": "preferred", "description": "Defines the nature of the device and the kind of functionality/services/behavior that may be expected from it", "valueSetUri": "https://www.gmdnagency.org/Info.aspx?pageid=1091" }, "mapping": [ { "identity": "rim", "map": ".code" }, { "identity": "w5", "map": "class" }, { "identity": "qdm", "map": "primary code" } ] }, { "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" } ] }, { "path": "Device.status", "short": "available | not-available | entered-in-error", "definition": "Status of the Device availability.", "min": 0, "max": "1", "base": { "path": "Device.status", "min": 0, "max": "1" }, "type": [ { "code": "code" } ], "mustSupport": true, "isModifier": true, "isSummary": true, "binding": { "strength": "required", "description": "The availability status of the device", "valueSetReference": { "reference": "http://hl7.org/fhir/ValueSet/devicestatus" } }, "mapping": [ { "identity": "rim", "map": ".statusCode" }, { "identity": "w5", "map": "status" } ] }, { "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": "rim", "map": ".playedRole[typeCode=MANU].scoper.name" } ] }, { "path": "Device.model", "short": "Model id assigned by the manufacturer", "definition": "The \"model\" - 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" } ] }, { "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)" } ] }, { "path": "Device.manufactureDate", "short": "Manufacture date", "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": "rim", "map": ".existenceTime.low" } ] }, { "path": "Device.expiry", "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.expiry", "min": 0, "max": "1" }, "type": [ { "code": "dateTime" } ], "mapping": [ { "identity": "rim", "map": ".expirationTime" }, { "identity": "w5", "map": "when.done" } ] }, { "path": "Device.udi", "short": "FDA Mandated Unique Device Identifier", "definition": "United States Food and Drug Administration mandated Unique Device Identifier (UDI). Use the human readable information (the content that the user sees, which is sometimes different to the exact syntax represented in the barcode) - see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm.", "comments": "The unique identifier may identify an instance of a device uniquely, or it may just identify the type of the device. A portion of the UDI - the DI part - can be extracted from the UDI when required, and used to look up information about the device through the GUDID.", "min": 0, "max": "1", "base": { "path": "Device.udi", "min": 0, "max": "1" }, "type": [ { "code": "string" } ], "mapping": [ { "identity": "rim", "map": ".id[where root is root for UDI]" }, { "identity": "w5", "map": "id" } ] }, { "path": "Device.lotNumber", "short": "Lot number of manufacture", "definition": "Lot number assigned by the manufacturer.", "comments": "Alphanumeric Maximum 20.", "min": 0, "max": "1", "base": { "path": "Device.lotNumber", "min": 0, "max": "1" }, "type": [ { "code": "string" } ], "mapping": [ { "identity": "rim", "map": ".lotNumberText" } ] }, { "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", "profile": [ "http://hl7.org/fhir/StructureDefinition/qicore-organization" ] } ], "mapping": [ { "identity": "rim", "map": ".playedRole[typeCode=OWN].scoper" } ] }, { "path": "Device.location", "short": "Where the resource is found", "definition": "The place where the device can be found.", "min": 0, "max": "1", "base": { "path": "Device.location", "min": 0, "max": "1" }, "type": [ { "code": "Reference", "profile": [ "http://hl7.org/fhir/StructureDefinition/qicore-location" ] } ], "mustSupport": true, "mapping": [ { "identity": "rim", "map": ".playedRole[typeCode=LOCE].scoper" }, { "identity": "w5", "map": "where" }, { "identity": "qdm", "map": "anatomical location site" } ] }, { "path": "Device.patient", "short": "If the resource is affixed to a person", "definition": "Patient information, if the resource is affixed to a person.", "min": 0, "max": "1", "base": { "path": "Device.patient", "min": 0, "max": "1" }, "type": [ { "code": "Reference", "profile": [ "http://hl7.org/fhir/StructureDefinition/qicore-patient" ] } ], "mustSupport": true, "mapping": [ { "identity": "rim", "map": ".playedRole[typeCode=USED].scoper.playedRole[typeCode=PAT]" }, { "identity": "w5", "map": "who.focus" } ] }, { "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.", "comments": "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" } ] }, { "path": "Device.url", "short": "Network address to contact device", "definition": "A network address on which the device may be contacted directly.", "comments": "If the device is running a FHIR server, the network address should be the root 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" } ] } ] }, "differential": { "element": [ { "path": "Device", "name": "QICore-Device", "min": 0, "max": "*", "type": [ { "code": "Device" } ], "mapping": [ { "identity": "qdm", "map": "Device, Applied or Order or Recommended" } ] }, { "path": "Device.type", "mustSupport": true, "mapping": [ { "identity": "qdm", "map": "primary code" } ] }, { "path": "Device.status", "mustSupport": true }, { "path": "Device.owner", "type": [ { "code": "Reference", "profile": [ "http://hl7.org/fhir/StructureDefinition/qicore-organization" ] } ] }, { "path": "Device.location", "type": [ { "code": "Reference", "profile": [ "http://hl7.org/fhir/StructureDefinition/qicore-location" ] } ], "mustSupport": true, "mapping": [ { "identity": "qdm", "map": "anatomical location site" } ] }, { "path": "Device.patient", "type": [ { "code": "Reference", "profile": [ "http://hl7.org/fhir/StructureDefinition/qicore-patient" ] } ], "mustSupport": true } ] } }