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## Unique Device Identifier (UDI): Rename US Core Implantable Device Profile

<!-- image of summary of changes-->



<!-- markdown table summary of proposal use adobe to convert to excel and then script to markdown or just copy/paste -->

DATA ELEMENT|APPLICABLE VOCABULARY STANDARD(S)<br/>Standards listed are required. If more than one is listed, at least one is required unless otherwise noted. Where an applicable vocabulary standard has not been identified, this field will remain empty.|US Core V8 Proposal
---|---|---
**Unique Device Identifier**<br/>Numeric or alphanumeric code that uniquely identifies a medical device.<br/><br/>Usage note: Contains a device identifier (DI) and may contain one or more production identifiers (PI).|FDA Unique Device Identification (UDI) System|**Rename** the [US Core Implantable Device Profile](#) to "US Core Device Profile" (see details below)

### Known issues

1. Renaming US Core Profile
- Pros:
- not "functionally" breaking change for implementers
- minimal disruption
- will conform to existing derived profiles
- Avoid duplicate Device profiles
- Extensive documentation and implementer notes applies equally to both implantables and non-implantable medical devices.
- Cons
- breaking change for validations and Ig authors deriving from this Profile. :broken_chain:
- **changes to scope may be confusing and lead to unmet expectations**.
- Options

1. Create a new US Core Device Profile
- based on the [Argonaut Device Profile](https://www.fhir.org/guides/argonaut/r2/StructureDefinition-argo-device.html)

1. Rename US Implantables to *US Core Medical Device Profile* and change `Device.patient` to min=0
- :thinking_face: What are medical devices? How would this profile be scoped?
- see the [`Device.type` binding](https://terminology.hl7.org/ValueSet-device-kind.html)
1. :+1: Rename US Implantables to *US Core Device Profile* and change `Device.patient` to min=0 **and** make udi elements "addl USCDI"
- Turns it into a generic Device profile that can reused across a broader set of use cases.
- :thinking_face: What are "medical devices"? How could this profile be scoped?

3. US Core Implantable Device Profile is compatible with the many (at least 12 that I know of) of [Device Profiles](https://fhir.org/guides/stats2/us-profile-res-device.html) out there ... (See [Analysis of Existing Device Profiles](#Analysis-of-Existing-Device-Profiles) below for details):
- Excluded software and communication (gateway) profiles.
- Based on this I do not think we need to add any new constraints on the current profile to be any more compatible

2. Other Considerations :

- Do we agree that searching by UDI not useful for patient facing apps? (US Core has no search API by UDI e.g., `GET [base]/Device?patient={Type/}[id]&udi-carrier=[HRFstring]`)
- (Note that this topic may more suitable for FHIR base and Orders and Observations?) The UDI may identify an instance of a device uniquely. Do FHIR implementers treat UDI it as a business identifier and commonly reference Device resources by it or the DI (e.g., linking a device to a claims). Guidance on this is lacking.

### Proposal

1. Rename the US Core Implantable Device Profile to "US Core Device Profile" (vs "US Core Medical Device Profile")
1. Change `Device.patient` to min=0
1. **Relax the UDI component constraints to "Add'l USCDI"**. (see figure above)
5. Update the existing documentation to reflect the change in scope from implantables to all devices.
6. Propose updates to provide scope and context and manage user expectations"
1. Update all reference from Device to US Core Device
1. Make US Core `Procedure.focaDevice` (`.usedReference??, .actor???`) and US Core Laboratory `Observation.device` *Add'l USCDI*
2. Add Guidance:
> - Certifying systems **SHALL** support references the US Core Device Profile using the :new: *Add'l USCDI* elements, `Procedure.focaDevice` (`.usedReference??, .actor???`) in the US Core Procedure Profile and `Observation.device` in the US Core Laboratory Observation Profile. All other references to the US Core Device Profile in US Core Profiles are optional.
6. Add guidance to avoid PHI in a re-used device:
> To minimize unintended references to patients when reusing medical devices (e.g., issuing a previously used monitoring device to a new patient), implementers **SHOULD** create a new US Core Device instance rather than updating an existing one.

### Decisions

Based on the Argonaut design calls ( see [Summary of Design Decisions](/u8iAyzZ0SGahQdbVzYpfoQ)) and subsequent Sept 2025 WGM discussion:
- [Sept 2025 WGM Slides](https://confluence.hl7.org/download/attachments/358885005/USCDI%20v6%20Design%20for%20US%20Core%20and%20C-CDA.pptx?version=1&modificationDate=1759008895006&api=v2)
- [WGM Minutes](https://confluence.hl7.org/spaces/CGP/pages/358284520/Cross+Group+Project+2025+September+-+Wed+Q3)

1. Rename Profile
1. Relax UDI constraints to Add'l USCDI
2. Update implementer guidance as proposed in the WGM notes
3. Update *optional* Target Profiles from Device to US Core Device

...

<!-- 1. Add search by UDI :thinking_face:
2. Documentation or conformance requirement on directly referencing Device resource by the UDI (logical identifier) :thinking_face: -->

### IG Updates

- [x] USCDI Mapping Table
- [x] Update US Core Profile
- [x] Update target references to it
- [x] Update Implementation Specific Guidance
- [x] New Example
- [ ] Update Capability Statement
- [x] Update Scopes
- [x] Update Provenance
- [X] Update Add'l USCDI table
- [ ] Update MS Reference table
- [ ] fix links

---
## Appendix

### Analysis of Existing Device Profiles

#### Most commonly profiled elements

(Generated by Grok, an xAI AI model, on August 07, 2025)

A checkmark (✅) indicates that the element is Must Support or has a minimum cardinality of 1 for the respective profile.

| Device Element | US Core Implantable Device Profile | Device (IPS) | PDex Device | Radiotherapy Seed Device | Radiotherapy Treatment Device | Device - At-Home In-Vitro Test | CRD Device | Count |
|----------------|------------------------------------|--------------|-------------|--------------------------|-------------------------------|--------------------------------|------------|-------|
| Derives from US Core | | | | ✅ | | | | 1 |
| Device.udiCarrier | ✅ (0..1) | | ✅ (0..*) | ✅ (0..1) | | ✅ (0..1) | ✅ (0..1) | 5 |
| Device.udiCarrier.deviceIdentifier | ✅ (1..1) | | ✅ (0..1) | ✅ (1..1) | | ✅ (1..1) | ✅ (0..1) | 5 |
| Device.udiCarrier.issuer | | | | | | ✅ (0..1) | | 1 |
| Device.udiCarrier.carrierHRF | ✅ (0..1) | | ✅ (0..1) | ✅ (0..1) | | | | 3 |
| Device.status | | | ✅ (0..1) | | | | | 1 |
| Device.distinctIdentifier | ✅ (0..1) | | ✅ (0..1) | ✅ (0..1) | | | | 3 |
| Device.manufacturer | | | ✅ (0..1) | | ✅ (1..1) | ✅ (0..1) | | 3 |
| Device.manufactureDate | ✅ (0..1) | | ✅ (0..1) | ✅ (0..1) | | ✅ (0..1) | | 4 |
| Device.expirationDate | ✅ (0..1) | | ✅ (0..1) | ✅ (0..1) | | ✅ (0..1) | | 4 |
| Device.lotNumber | ✅ (0..1) | | ✅ (0..1) | ✅ (0..1) | | ✅ (0..1) | | 4 |
| Device.serialNumber | ✅ (0..1) | | ✅ (0..1) | ✅ (0..1) | | ✅ (0..1) | | 4 |
| Device.deviceName | | | ✅ (0..*) | | ✅ (1..*) | ✅ (1..*) | | 3 |
| Device.deviceName.name | | ✅ (1..1) | ✅ (1..1) | ✅ (1..1) | ✅ (1..1) | ✅ (1..1) | ✅ (1..1) | 6 |
| Device.deviceName.type | | ✅ (1..1) | ✅ (1..1) | ✅ (1..1) | ✅ (1..1) | | ✅ (1..1) | 5 |
| Device.deviceName:manufacturer-name | | | | | ✅ (1..1) | | | 1 |
| Device.deviceName:manufacturer-name.name | | | | | ✅ (1..1) | | | 1 |
| Device.deviceName:manufacturer-name.type | | | | | ✅ (1..1) | | | 1 |
| Device.deviceName:modelName | | | | | | ✅ (1..1) | | 1 |
| Device.deviceName:modelName.name | | | | | | ✅ (1..1) | | 1 |
| Device.modelNumber | | | ✅ (0..1) | | | | | 1 |
| Device.type | ✅ (1..1) | ✅ (0..1) | ✅ (1..1) | ✅ (1..1) | | | | 4 |
| Device.specialization.systemType | | ✅ (1..1) | | ✅ (1..1) | | | ✅ (1..1) | 3 |
| Device.version.value | | ✅ (1..1) | | ✅ (1..1) | | ✅ (1..1) | ✅ (1..1) | 4 |
| Device.property | | | | | | | ✅ (0..*) | 1 |
| Device.property.type | | ✅ (1..1) | | ✅ (1..1) | | ✅ (1..1) | ✅ (1..1) | 4 |
| Device.patient | ✅ (1..1) | ✅ (1..1) | ✅ (1..1) | ✅ (1..1) | | | | 4 |
| Device.patient.reference | | ✅ (1..1) | | | | | | 1 |
| Device.extension:BillingOptions | | | | | | | ✅ (0..*) | 1