# US Core Device Profile - US Core Implementation Guide v9.0.0

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

## Resource Profile: US Core Device Profile 

| | | |
| :--- | :--- | :--- |
| *Official URL*:http://hl7.org/fhir/us/core/StructureDefinition/us-core-device | *Version*:9.0.0 | |
| * Standards status: *[Trial-use](http://hl7.org/fhir/R4/versions.html#std-process) | [Maturity Level](changes-between-versions.md#us-core-maturity-levels): 4 | *Computable Name*:USCoreDeviceProfile |
| *Other Identifiers:*OID:2.16.840.1.113883.4.642.40.2.42.69 | | |
| **Copyright/Legal**: Used by permission of HL7 International, all rights reserved Creative Commons License | | |

 
The US Core Device Profile inherits from the FHIR [Device](https://hl7.org/fhir/R4/device.html) resource; refer to it for scope and usage definitions. It sets minimum expectations for the Device resource to record, search, and fetch medical and non-medical devices (for example, software or crutches). This profile meets the requirements of the U.S. Core Data for Interoperability (USCDI) **Medical Device** Data Class, including FDA Unique Device Identification (UDI) information associated with a patient's medical device(s). It specifies which core elements, extensions, vocabularies, and value sets **SHALL** be present in the resource and constrains how the elements are used and provides the floor for standards development for specific use cases promotes interoperability and adoption. 

**Example Usage Scenarios:**

The following are example usage scenarios for this profile:

* Query for a Patient's Devices
* [Record or update](us-core-roadmap.md#future-candidate-requirements-under-consideration) a Patient Device

### Mandatory and Must Support Data Elements

The following data elements must always be present ([Mandatory](must-support.md) definition) or must be supported if the data is present in the sending system ([Must Support](must-support.md) definition). They are presented below in a simple human-readable explanation. Profile specific guidance and examples are provided as well. The [Formal Views](#profile) below provides the formal summary, definitions, and terminology requirements.

**Each Device Must Have:**

1. a code identifying the type of device

In addition, the following data elements must be supported if the data is present in the sending system ([Must Support](must-support.md) definition):

**Each Device Must Support:**

1. a patient1

**Additional USCDI Requirements:**

These [Additional USCDI Requirements](must-support.md#additional-uscdi-requirements) elements are not Mandatory or Must Support but are required for ONC Health IT certification testing and are included in the formal definition of the profile and the Condition examples.

1. UDI Unique Device Identifier (UDI) Barcode string.2
* Unique Device Identifier (UDI) numeric or alphanumeric code as the Human Readable Form (HRF) string representation of the barcode
* The Device Identifier (UDI-DI)

1. the manufacture date
1. the expiration date
1. the lot number
1. the serial number
1. the distinct identification number (e.g., Donation Identification Number(DIN))

1,2 see guidance below

### Profile Specific Implementation Guidance

This section provides detailed implementation guidance for the US Core Profile to support implementation and certification.

* Because this profile aligns with the USCDI Medical Devices Data Class, it supports the exchange of UDI information when available (for example, implantable devices or non-implantable medical devices, such as ventilators). However, systems are not expected to record any UDI data for every use case or device.
* *`Device.patient`'s minimum cardinality of zero supports use cases where devices may be tracked independently of a patient.

#### UDI Specific Implementation Guidance

* This profile follows the [HL7 Cross Paradigm Implementation Guide: UDI Pattern](https://www.hl7.org/implement/standards/product_brief.cfm?product_id=487) guidelines for exchanging information about the use and implantation of medical devices in patients. 
* 2A unique device identifier (UDI) is a unique numeric or alphanumeric code. There is a machine-readable version (AIDC - the Automatic Identification and Data Capture) and a human-readable version of the UDI (HRF - Human Readable Form string). This profile specifies that only the HRF must be supported. Considering the complexity of parsing AIDCs, there is **no expectation** at this time that one converts an AIDC to HRF upon receipt from a FHIR source that is not conformant to this profile or is using another interchange standard (e.g., C-CDA, HL7 v2, etc.). The UDI generally consists of a mandatory Device Identifier (DI) and a conditional Production identifier (PI) that identifies one or more of the five UDI-PI elements. The UDI and its components are mapped to the US Core Device Profile elements in the table below:
* Implementers **SHOULD** use the FDA Global UDI Database (GUDID) and associated APIs to parse and validate the UDI:[§](requirements.md#CONF-0341)
 
* Medical devices with UDI information **SHALL** represent the UDI code in `Device.udiCarrier.carrierHRF`.[§](requirements.md#CONF-0342) All five UDI-PI elements defined in the UDI code may not always be present in every UDI instance. However, those UDI-PI elements present **SHALL** be represented in the corresponding US Core Device Profile elements.[§](requirements.md#CONF-0343)


  UDI may not be present in all scenarios, such as historical medical devices, patient-reported implant information, payer-reported devices, or improperly documented implants. If UDI is not present and the manufacturer or model number information is available, they **SHOULD** be included to support historical reports of medical devices as follows:[§](requirements.md#CONF-0344),[§](requirements.md#CONF-0345)
* The [Quick Start](#search) section below describes searching for all devices. Records of implanted devices **MAY** be queried against UDI data, including:[§](requirements.md#CONF-0347),[§](requirements.md#CONF-0348),[§](requirements.md#CONF-0349),[§](requirements.md#CONF-0350)


  Implementers **MAY** also adopt custom SearchParameters for searching by:[§](requirements.md#CONF-0351),[§](requirements.md#CONF-0352),[§](requirements.md#CONF-0353),[§](requirements.md#CONF-0354),[§](requirements.md#CONF-0355)

**Usages:**

* Refer to this Profile: [US Core ADI DocumentReference Profile](StructureDefinition-us-core-adi-documentreference.md), [US Core CarePlan Profile](StructureDefinition-us-core-careplan.md), [US Core DiagnosticReport Profile for Laboratory Results Reporting](StructureDefinition-us-core-diagnosticreport-lab.md), [US Core DiagnosticReport Profile for Report and Note Exchange](StructureDefinition-us-core-diagnosticreport-note.md)... Show 11 more, [US Core DocumentReference Profile](StructureDefinition-us-core-documentreference.md), [US Core MedicationDispense Profile](StructureDefinition-us-core-medicationdispense.md), [US Core MedicationRequest Profile](StructureDefinition-us-core-medicationrequest.md), [US Core Observation Clinical Result Profile](StructureDefinition-us-core-observation-clinical-result.md), [US Core Observation Screening Assessment Profile](StructureDefinition-us-core-observation-screening-assessment.md), [US Core Procedure Profile](StructureDefinition-us-core-procedure.md), [US Core Provenance Profile](StructureDefinition-us-core-provenance.md), [US Core QuestionnaireResponse Profile](StructureDefinition-us-core-questionnaireresponse.md), [US Core ServiceRequest Profile](StructureDefinition-us-core-servicerequest.md), [US Core Simple Observation Profile](StructureDefinition-us-core-simple-observation.md) and [US Core Specimen Profile](StructureDefinition-us-core-specimen.md)
* Examples for this Profile: [Device/udi-2](Device-udi-2.md), [Device/udi-3](Device-udi-3.md), [Device/udi-4](Device-udi-4.md) and [Device/udi-5](Device-udi-5.md)
* CapabilityStatements using this Profile: [US Core Client CapabilityStatement](CapabilityStatement-us-core-client.md) and [US Core Server CapabilityStatement](CapabilityStatement-us-core-server.md)

You can also check for [usages in the FHIR IG Statistics](https://packages2.fhir.org/xig/hl7.fhir.us.core|current/StructureDefinition/us-core-device)

**Changes since version 8.0.1:**

* New Content

### 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-core-device.csv), [Excel](StructureDefinition-us-core-device.xlsx), [Schematron](StructureDefinition-us-core-device.sch) 

### Notes:

-------

**Quick Start**  

-------

Below is an overview of the required Server RESTful FHIR interactions for this profile - for example, search and read operations - when supporting the US Core interactions to access this profile's information (Profile Support + Interaction Support). Note that systems that support only US Core Profiles (Profile Only Support) are not required to support these interactions. See the [US Core Server CapabilityStatement](CapabilityStatement-us-core-server.md) for a complete list of supported RESTful interactions for this IG.

* See the [Scopes Format](scopes.md#scopes-format) section for a description of the SMART scopes syntax.
* See the [Search Syntax](general-guidance.md#search-syntax) section for a description of the US Core search syntax.
* See the [General Requirements](general-requirements.md) section for additional rules and expectations when a Server requires status parameters.
* See the [General Guidance](general-guidance.md) section for additional guidance on searching for multiple patients.

#### US Core Scopes

Servers providing access to medical device data **SHALL** support these [US Core SMART Scopes](scopes.md#smart-scopes):

* [resource level scopes](http://hl7.org/fhir/smart-app-launch/STU2.2/scopes-and-launch-context.html#scopes-for-requesting-clinical-data): `<patient|user|system>/Device.rs` [§](requirements.md#CONF-0137)

-------

#### Mandatory Search Parameters:

The following search parameters and search parameter combinations **SHALL** be supported:

1. **SHALL** support searching for all devices for a patient using the [patient](SearchParameter-us-core-device-patient.md) search parameter`GET [base]/Device?patient={Patient/}[id]`Example:
> 
1. GET [base]/Device?patient=Patient/1137192

**Implementation Notes**: Fetches a bundle of all US Core Device Profile resources for the specified patient ( see [how to search by reference](http://hl7.org/fhir/R4/search.html#reference)).

#### Optional Search Parameters:

The following search parameters and search parameter combinations **SHOULD** be supported

1. **SHOULD** support searching for a specific device type for a patient (for example, implantable devices) using the combination of the [patient](SearchParameter-us-core-device-patient.md) and [type](SearchParameter-us-core-device-type.md) search parameters`GET [base]/Device?patient={Patient/}[id]&type={system|}[search_code]`Example:
> 
1. GET [base]/Device?patient=Patient/1137192&type=http://snomed.info/sct|468063009

**Implementation Notes**: Fetches a bundle of all US Core Device Profile resources for the specified patient and type. ( see [how to search by reference](http://hl7.org/fhir/R4/search.html#reference) and [how to search by token](http://hl7.org/fhir/R4/search.html#token)).
1. **SHOULD** support searching for all devices with a given status for a patient (for example all active devices) using the combination of the [patient](SearchParameter-us-core-device-patient.md) and [status](SearchParameter-us-core-device-status.md) search parameters
* Including support **OR** search on `status` (e.g.`status={system|}[code],{system|}[code],...`)
`GET [base]/Device?patient={Patient/}[id]&status={system|}[search_code]{,{system|}[code],...}`Example:
> 
1. GET [base]/Device?patient=Patient/1137192&status=active

**Implementation Notes**: Fetches a bundle of all US Core Device Profile resources for the specified patient and status ( see [how to search by reference](http://hl7.org/fhir/R4/search.html#reference) and [how to search by token](http://hl7.org/fhir/R4/search.html#token)).



## Resource Content

```json
{
  "resourceType" : "StructureDefinition",
  "id" : "us-core-device",
  "extension" : [{
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
    "valueInteger" : 4
  },
  {
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
    "valueCode" : "cgp"
  },
  {
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
    "valueCode" : "trial-use",
    "_valueCode" : {
      "extension" : [{
        "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
        "valueCanonical" : "http://hl7.org/fhir/us/core/ImplementationGuide/hl7.fhir.us.core"
      }]
    }
  }],
  "url" : "http://hl7.org/fhir/us/core/StructureDefinition/us-core-device",
  "identifier" : [{
    "system" : "urn:ietf:rfc:3986",
    "value" : "urn:oid:2.16.840.1.113883.4.642.40.2.42.69"
  }],
  "version" : "9.0.0",
  "name" : "USCoreDeviceProfile",
  "title" : "US Core Device Profile",
  "status" : "active",
  "experimental" : false,
  "date" : "2023-10-17",
  "publisher" : "HL7 International / Cross-Group Projects",
  "contact" : [{
    "name" : "HL7 International / Cross-Group Projects",
    "telecom" : [{
      "system" : "url",
      "value" : "http://www.hl7.org/Special/committees/cgp"
    },
    {
      "system" : "email",
      "value" : "cgp@lists.HL7.org"
    }]
  }],
  "description" : "The US Core Device Profile inherits from the FHIR [Device](https://hl7.org/fhir/R4/device.html) resource; refer to it for scope and usage definitions. It sets minimum expectations for the Device resource to record, search, and fetch medical and non-medical devices (for example, software or crutches). This profile meets the requirements of the U.S. Core Data for Interoperability (USCDI) *Medical Device* Data Class, including FDA Unique Device Identification (UDI) information associated with a patient's medical device(s). It specifies which core elements, extensions, vocabularies, and value sets **SHALL** be present in the resource and constrains how the elements are used and provides the floor for standards development for specific use cases promotes interoperability and adoption.",
  "jurisdiction" : [{
    "coding" : [{
      "system" : "urn:iso:std:iso:3166",
      "code" : "US"
    }]
  }],
  "copyright" : "Used by permission of HL7 International, all rights reserved Creative Commons License",
  "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",
      "mustSupport" : false
    },
    {
      "id" : "Device.udiCarrier",
      "extension" : [{
        "url" : "http://hl7.org/fhir/us/core/StructureDefinition/uscdi-requirement",
        "valueBoolean" : true
      }],
      "path" : "Device.udiCarrier",
      "short" : "𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Unique Device Identifier (UDI) Barcode string",
      "comment" : "Some devices may not have UDI information (for example. historical data or patient reported data).",
      "max" : "1",
      "mustSupport" : false
    },
    {
      "id" : "Device.udiCarrier.deviceIdentifier",
      "path" : "Device.udiCarrier.deviceIdentifier",
      "min" : 1,
      "mustSupport" : true
    },
    {
      "id" : "Device.udiCarrier.carrierHRF",
      "path" : "Device.udiCarrier.carrierHRF",
      "alias" : ["UDI", "Barcode String"],
      "mustSupport" : true
    },
    {
      "id" : "Device.distinctIdentifier",
      "extension" : [{
        "url" : "http://hl7.org/fhir/us/core/StructureDefinition/uscdi-requirement",
        "valueBoolean" : true
      }],
      "path" : "Device.distinctIdentifier",
      "short" : "𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: The distinct identification string",
      "mustSupport" : false
    },
    {
      "id" : "Device.manufactureDate",
      "extension" : [{
        "url" : "http://hl7.org/fhir/us/core/StructureDefinition/uscdi-requirement",
        "valueBoolean" : true
      }],
      "path" : "Device.manufactureDate",
      "short" : "𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date when the device was made",
      "mustSupport" : false
    },
    {
      "id" : "Device.expirationDate",
      "extension" : [{
        "url" : "http://hl7.org/fhir/us/core/StructureDefinition/uscdi-requirement",
        "valueBoolean" : true
      }],
      "path" : "Device.expirationDate",
      "short" : "𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date and time of expiry of this device (if applicable)",
      "mustSupport" : false
    },
    {
      "id" : "Device.lotNumber",
      "extension" : [{
        "url" : "http://hl7.org/fhir/us/core/StructureDefinition/uscdi-requirement",
        "valueBoolean" : true
      }],
      "path" : "Device.lotNumber",
      "short" : "𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Lot number of manufacture",
      "mustSupport" : false
    },
    {
      "id" : "Device.serialNumber",
      "extension" : [{
        "url" : "http://hl7.org/fhir/us/core/StructureDefinition/uscdi-requirement",
        "valueBoolean" : true
      }],
      "path" : "Device.serialNumber",
      "short" : "𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Serial number assigned by the manufacturer",
      "mustSupport" : false
    },
    {
      "id" : "Device.type",
      "path" : "Device.type",
      "min" : 1,
      "mustSupport" : true,
      "binding" : {
        "strength" : "extensible",
        "description" : "Codes to identify medical devices",
        "valueSet" : "http://hl7.org/fhir/ValueSet/device-kind"
      }
    },
    {
      "id" : "Device.patient",
      "path" : "Device.patient",
      "short" : "Patient to whom Device is assigned",
      "definition" : "Patient information, if the device is assigned to a person.",
      "type" : [{
        "code" : "Reference",
        "targetProfile" : ["http://hl7.org/fhir/us/core/StructureDefinition/us-core-patient"]
      }],
      "mustSupport" : true
    }]
  }
}

```
