# US Quality Core Device - US Quality Core Implementation Guide v0.1.0

* [**Table of Contents**](toc.md)
* [**Artifacts Summary**](artifacts.md)
* **US Quality Core Device**

## Resource Profile: US Quality Core Device 

| | |
| :--- | :--- |
| *Official URL*:http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-device | *Version*:0.1.0 |
| Active as of 2026-03-31 | *Computable Name*:USQualityCoreDevice |

 
Profile of Device for decision support/quality metrics. Defines the core set of elements and extensions for quality rule and measure authors. 

**Usage**
FHIR defines the [Device Resource](http://hl7.org/fhir/R4/device.html) as 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. FHIR and US Core further differentiate devices into two “classes”: 
* Devices that interact with the human body but do not stay in it are referred to as non-implantable medical devices.
* Implantable devices are those which stay in the human body with a medical objective for an extended period of time, or even a lifetime.
 [Definition reference: Imam W. How to use ISO 13485:2016 to manage implantable devices, ISO 13485 Blog. July 4, 2016. Available at: [https://advisera.com/13485academy/blog/2017/07/04/how-to-use-iso-134852016-to-manage-implantable-medical-devices/](https://advisera.com/13485academy/blog/2017/07/04/how-to-use-iso-134852016-to-manage-implantable-medical-devices/). Accessed 28 January 2020.] 
 

The FHIR Device Resource addresses both implantable and non-implantable devices. US Core only references Implantable Device. US Quality Core uses Implantable Device from US Core. Separately, builds directly from FHIR to address non-implantable devices with US Quality Core profiles as the device resource.

Therefore, when creating an expression for an eCQM or a CDS artifact, assure you are using the appropriate Device or Implantable Device resource.

  See the [patterns](patterns.md) page for implementation and usage patterns.  

### Examples

 

| |
| :--- |
| [General Device Example](Device-example.md) |

 

**Usages:**

* Refer to this Profile: [US Quality Core AdverseEvent](StructureDefinition-us-quality-core-adverseevent.md), [US Quality Core Communication](StructureDefinition-us-quality-core-communication.md), [US Quality Core CommunicationRequest](StructureDefinition-us-quality-core-communicationrequest.md), [US Quality Core DeviceUseStatement](StructureDefinition-us-quality-core-deviceusestatement.md)... Show 5 more, [US Quality Core ImagingStudy](StructureDefinition-us-quality-core-imagingstudy.md), [US Quality Core NonPatient Observation](StructureDefinition-us-quality-core-nonpatient-observation.md), [US Quality Core QuestionnaireResponse](StructureDefinition-us-quality-core-questionnaireresponse.md), [US Quality Core Service Not Requested](StructureDefinition-us-quality-core-servicenotrequested.md) and [US Quality Core ServiceRequest](StructureDefinition-us-quality-core-servicerequest.md)
* Examples for this Profile: [Device/example](Device-example.md)

You can also check for [usages in the FHIR IG Statistics](https://packages2.fhir.org/xig/fhir.astp.us-quality-core|current/StructureDefinition/us-quality-core-device)

### Formal Views of Profile Content

 [Description of Profiles, Differentials, Snapshots and how the different presentations work](http://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#structure-definitions). 

 

Other representations of profile: [CSV](StructureDefinition-us-quality-core-device.csv), [Excel](StructureDefinition-us-quality-core-device.xlsx), [Schematron](StructureDefinition-us-quality-core-device.sch) 



## Resource Content

```json
{
  "resourceType" : "StructureDefinition",
  "id" : "us-quality-core-device",
  "url" : "http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-device",
  "version" : "0.1.0",
  "name" : "USQualityCoreDevice",
  "title" : "US Quality Core Device",
  "status" : "active",
  "experimental" : false,
  "date" : "2026-03-31",
  "publisher" : "ASTP",
  "contact" : [{
    "telecom" : [{
      "system" : "url",
      "value" : "https://www.healthit.gov/"
    }]
  }],
  "description" : "Profile of Device for decision support/quality metrics. Defines the core set of elements and extensions for quality rule and measure authors.",
  "jurisdiction" : [{
    "coding" : [{
      "system" : "urn:iso:std:iso:3166",
      "code" : "US",
      "display" : "United States of America"
    }],
    "text" : "USA"
  }],
  "fhirVersion" : "4.0.1",
  "mapping" : [{
    "identity" : "rim",
    "uri" : "http://hl7.org/v3",
    "name" : "RIM Mapping"
  },
  {
    "identity" : "w5",
    "uri" : "http://hl7.org/fhir/fivews",
    "name" : "FiveWs Pattern Mapping"
  },
  {
    "identity" : "udi",
    "uri" : "http://fda.gov/UDI",
    "name" : "UDI Mapping"
  }],
  "kind" : "resource",
  "abstract" : false,
  "type" : "Device",
  "baseDefinition" : "http://hl7.org/fhir/StructureDefinition/Device",
  "derivation" : "constraint",
  "differential" : {
    "element" : [{
      "id" : "Device",
      "path" : "Device"
    },
    {
      "id" : "Device.udiCarrier",
      "path" : "Device.udiCarrier",
      "short" : "Unique Device Identifier (UDI) Barcode string"
    },
    {
      "id" : "Device.udiCarrier.deviceIdentifier",
      "path" : "Device.udiCarrier.deviceIdentifier",
      "short" : "Mandatory fixed portion of UDI"
    },
    {
      "id" : "Device.type",
      "path" : "Device.type",
      "short" : "The kind or type of device"
    },
    {
      "id" : "Device.patient",
      "path" : "Device.patient",
      "short" : "Patient to whom Device is affixed",
      "min" : 1,
      "max" : "1",
      "type" : [{
        "code" : "Reference",
        "targetProfile" : ["http://fhir.org/guides/astp/us-quality-core/StructureDefinition/us-quality-core-patient"]
      }]
    }]
  }
}

```
