EHDS Logical Information Models
0.1.0 - ci-build

EHDS Logical Information Models, published by Xt-EHR. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/Xt-EHR/xt-ehr-common/tree/stakeholder-consultation-D6-1 and changes regularly. See the Directory of published versions

## Logical Model: Device use model

Official URL: https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSDeviceUse | Version: 0.1.0
Draft as of 2025-07-08 | Computable Name: EHDSDeviceUse

EHDS refined base model for device use information

Medical devices and implants is suggested as a mandatory section of Patient Summary. Implementers should as a minimum be able to produce a list of devices and give an empty list reason if there are no devices. The only required element for each listed device, is specifying the device. The information elements for each device are listed in the EHDS-PS-Device model.
If the producing system have no record of devices to list (e.g. the patient has no devices, or the system have no device information), it must provide a reason for the empty list. This is similar to the other mandatory sections, and in accordance with the specification in ISO IPS.

Receiving systems must be able to handle the data and are encouraged to display the received information to the user but are not obliged to do so.

The information elements and value sets suggested is taken from eHN GL, MyHealth@EU and HL7 FHIR IPS.

Usages:

- Use this Logical Model: Patient summary model

### Views of Logical Model

Description of Differentials, Snapshots and how the different presentations work.

- Differential Table
- Snapshot Table

This structure is derived from EHDSDataSet

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
EHDSDeviceUse |  | 0..* | EHDSDataSet | Elements defined in Ancestors:header, presentedForm Device use model Instances of this logical model can be the target of a Reference
header |  |  |  |
status |  | 1..1 | CodeableConcept | Current status of the device usage. Binding Description: (preferred): HL7 device-statement-status
startDate |  | 0..1 | dateTime | Date when the device was implantable to the patient or the external device was first in use.
endDate |  | 0..1 | dateTime | Date when the device was explanted from the patient or the external device was no longer in use.
device[x] |  | 1..1 |  | The details of the device used.
deviceCodeableConcept |  |  | CodeableConcept |
deviceEHDSDevice |  |  | EHDSDevice |
bodySite |  | 0..1 | EHDSBodyStructure | Anatomical location of the device. May include laterality.
reason[x] |  | 0..* |  | Reason or justification for the use of the device.
reasonCodeableConcept |  |  | CodeableConcept |
reasonEHDSCondition |  |  | EHDSCondition |
reasonEHDSObservation |  |  | EHDSObservation |
reasonEHDSProcedure |  |  | EHDSProcedure |
source[x] |  | 0..1 |  | Who reported the device was being used by the patient.
sourceEHDSPatient |  |  | EHDSPatient |
sourceEHDSHealthProfessional |  |  | EHDSHealthProfessional |
sourceEHDSRelatedPerson |  |  | EHDSRelatedPerson |
note |  | 0..* | string | Note about the device statement that were not represented at all or sufficiently in one of the attributes provided in a class. These may include for example a comment, an instruction, or a note associated with the statement.
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet | URI
EHDSDeviceUse.header.status | preferred | ``

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
EHDSDeviceUse |  | 0..* | EHDSDataSet | Elements defined in Ancestors:header, presentedForm Device use model Instances of this logical model can be the target of a Reference
header |  | 1..1 | Base | Common header for all patient-related data
subject |  | 1..1 | EHDSPatient | Subject
identifier |  | 0..* | Identifier | Business identifier for the object
authorship |  | 1..* | Base | Authorship
author[x] |  | 1..1 |  | Author
authorEHDSHealthProfessional |  |  | EHDSHealthProfessional |
authorEHDSOrganisation |  |  | EHDSOrganisation |
authorEHDSDevice |  |  | EHDSDevice |
datetime |  | 1..1 | dateTime | Date and time of authoring/issuing
lastUpdate |  | 0..1 | dateTime | Date and time of the last update to the resource
status |  | 1..1 | CodeableConcept | Current status of the device usage. Binding Description: (preferred): HL7 device-statement-status
statusReason[x] |  | 0..1 |  | Reason for the current status of the resource.
statusReasonCodeableConcept |  |  | CodeableConcept |
statusReasonString |  |  | string |
language |  | 0..1 | CodeableConcept | Language Binding Description: (preferred): BCP 47
version |  | 0..1 | string | Version
presentedForm |  | 0..* | EHDSAttachment | A narrative easy-to-read representation of the full data set, e.g. PDF-version of a document
startDate |  | 0..1 | dateTime | Date when the device was implantable to the patient or the external device was first in use.
endDate |  | 0..1 | dateTime | Date when the device was explanted from the patient or the external device was no longer in use.
device[x] |  | 1..1 |  | The details of the device used.
deviceCodeableConcept |  |  | CodeableConcept |
deviceEHDSDevice |  |  | EHDSDevice |
bodySite |  | 0..1 | EHDSBodyStructure | Anatomical location of the device. May include laterality.
reason[x] |  | 0..* |  | Reason or justification for the use of the device.
reasonCodeableConcept |  |  | CodeableConcept |
reasonEHDSCondition |  |  | EHDSCondition |
reasonEHDSObservation |  |  | EHDSObservation |
reasonEHDSProcedure |  |  | EHDSProcedure |
source[x] |  | 0..1 |  | Who reported the device was being used by the patient.
sourceEHDSPatient |  |  | EHDSPatient |
sourceEHDSHealthProfessional |  |  | EHDSHealthProfessional |
sourceEHDSRelatedPerson |  |  | EHDSRelatedPerson |
note |  | 0..* | string | Note about the device statement that were not represented at all or sufficiently in one of the attributes provided in a class. These may include for example a comment, an instruction, or a note associated with the statement.
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet | URI
EHDSDeviceUse.header.status | preferred |
EHDSDeviceUse.header.language | preferred |

Other representations of model: CSV, Excel