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Exporterat från logisk modell "Device use model" (under arbete). Uppdaterad enligt remissversionen av modellen 2025-08-26:
Device use model - EHDS Logical Information Models v0.1.0
| ID | Path | Min | Max | Type(s) | Short | Definition | Binding Strength | Binding Description | Läkemedelsverket | Region Västerbotten | Region Östergötland | Inera | E-hälso-myndigheten |
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| EHDSDeviceUse | EHDSDeviceUse | 0 | * |
| Device use model |
C.25 - | EHDS refined base model for Device Use |
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| jag förstår inte hur strukturen är uppbyggd och vad som avses med device use model |
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| EHDSDeviceUse.header | EHDSDeviceUse.header | 1 | 1 | Base | Common header for all patient-related data | Common header for all patient-related data |
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| ?? |
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| EHDSDeviceUse.header.subject | EHDSDeviceUse.header.subject | 1 | 1 | https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSPatient | Subject | Patient/subject information |
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| Obligatoriskt |
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| EHDSDeviceUse.header.identifier | EHDSDeviceUse.header.identifier | 0 | * | Identifier |
C.25.1 - Identifier | An identifier for this statement. | Betyder detta vem som använder? | Hur relaterar den här till C.25.10? | EHDSDeviceUse.status | EHDSDeviceUse.status | 0 | 1 | CodeableConcept | C.25.2 - Status | Current status of the Device Usage. | | Business identifier for the object | Business identifier for the object |
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| Vad menas, är det patient eller produkt? |
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| EHDSDeviceUse.header.authorship | EHDSDeviceUse.header.authorship | 1 | * | Base | Authorship | Resource authoring details |
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| ?? |
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| EHDSDeviceUse.header.authorship.author[x] | EHDSDeviceUse.header.authorship.author[x] | 1 | 1 | https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSHealthProfessional
https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSOrganisationhttps://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSDevice | Author | Author(s) by whom the resource was/were authored. Multiple authors could be provided. |
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| ?? Vad menas, är det förskrivare, ansvarig person, vad? |
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| EHDSDeviceUse.header.authorship.datetime | EHDSDeviceUse.header.authorship.datetime | 1 | 1 | dateTime | Date and time of authoring/issuing | Date and time of the issuing the document/resource by its author. |
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| ?? Handlar detta om när dokumentationen blir gjord? |
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| EHDSDeviceUse.header.lastUpdate | EHDSDeviceUse.header.lastUpdate | 0 | 1 | dateTime | Date and time of the last update to the resource | Date and time of the last update to the document/information |
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| ?? Är det när dokumentationen av produkten utfördes? |
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| EHDSDeviceUse.header.status | EHDSDeviceUse.header.status | 1 | 1 | CodeableConcept | Current status of the device usage. | Status of the resource | preferred | HL7 device-statement-status |
| Är detta om produkt är i bruk? Annika: Ja, det verkar så. Verkar vara exempelvis: - The device is still being used.
- The device is no longer being used.
- The device was not used.
| är det om den är implanterad men inte aktiverad tex, eller gäller det regulatorisk status? |
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| EHDSDeviceUse.header.statusReason[x] | EHDSDeviceUse.header.statusReason[x] | 0 | 1 | CodeableConcept
string | Reason for the current status of the resource. | Reason for the current status of the resource. |
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| ?? Vad menas? Om produkten är i bruk, tillbakadragen etc? |
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| EHDSDeviceUse.header.language | EHDSDeviceUse |
.implantDateEHDSDeviceUse.implantDate | 0 | 1 | dateTime | C.25.3 - Implant date | | .header.language | 0 | 1 | CodeableConcept | Language | Language in which the resource is written. Language is expressed by the IETF language tag. | preferred | BCP 47 |
| ?? Vad menas? Vilket språk produktbeskrivning, mm eller dokumentationen är på? |
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| EHDSDeviceUse.header.version | EHDSDeviceUse.header.version | 0 | 1 | string | Version | Business version of the resource. |
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| Vilken version av produkt eller? |
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| EHDSDeviceUse.presentedForm | EHDSDeviceUse.presentedForm | 0 | * | https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSAttachment | A narrative easy-to-read representation of the full data set, e.g. PDF-version of a document | A narrative easy-to-read representation of the full data set, e.g. PDF-version of a document |
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| ?? Vad för dokument? Bruksanvisning, Produktbeskrivning, eller vad? Var hämtas det ifrån? |
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| EHDSDeviceUse.startDate | EHDSDeviceUse.startDate | 0 | 1 | dateTime | Date when the device was implantable to the patient or the external device was first in use. | Date when the device was implantable to the patient or the external device was first in use |
Date when procedure was performed| . |
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| Obligatoriskt | Skulle det kunna röra sig om andra produkter än om just implantat? |
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| EHDSDeviceUse.endDate | EHDSDeviceUse.endDate | 0 | 1 | dateTime |
C.25.4 - End date | Date when the device was explanted from the patient or the external device was no longer in use |
; likewise is planned to be explanted| was explanted from the patient or the external device was no longer in use. |
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| Villkorat obligatoriskt |
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| EHDSDeviceUse.device[x] | EHDSDeviceUse.device[x] | 1 | 1 |
Reference() | The details of the device used. |
C.25.5 - Device | The details of the device used. |
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| Obligatoriskt. |
Vilka Vilka detaljer menas? Produktbeskrivning? Annat (modell, längd, storlek, hö/vä, ref nr, mm?) Annika: Refererar till EHDSDevice | är det en hänvisning till informationsmodellen för "device"? Annika: Ja |
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| EHDSDeviceUse. |
subjectsubject1Reference
(EHDSPatient)C.25.6 - Subject | The patient using the device. | Obligatoriskt | EHDSDeviceUse.bodySite | EHDSDeviceUse.bodySite | 0 | 1 | CodeableConcept | C.25.7 - Body site | Anatomical location of the device. May include laterality. |
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| Obligatoriskt | Vilka attribut kan matas in? text? specificerade kroppsdelar? |
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| EHDSDeviceUse. |
notenoteNarrative | C.25.8 - Note | Details 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. | Vad menas? | EHDSDeviceUse.recorded | EHDSDeviceUse.recorded | 0 | 1 | dateTime | C.25.9 - Recorded | Date and time at which the statement was made/recorded. | Samma som C.25.3 - Implant date? | EHDSDeviceUse.source | EHDSDeviceUse.source | 0 | 1 | Reference(|EHDSHealthProfessional|https) | Who reported the device was being used by the patient. |
C.25.10 - Source | Who reported the device was being used by the patient. |
Samma som C.25.1 - Identifier
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| ? Hör det ihop med device eller device use? Vem menas, sjukvården eller patienten själv? |
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| EHDSDeviceUse.note | EHDSDeviceUse.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. | 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. |
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| Vad menas? Ska ex varningar, försiktighetsåtgärder in här? Ska det skrivas i fritext eller hämtas någonstans ifrån? |
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Device
Exporterat från logisk modell "Device model" (under arbete). Uppdaterad enligt remissversionen av modellen 2025-08-26:
Device model - EHDS Logical Information Models v0.1.0
| ID | Path | Min | Max | Type(s) | Short | Definition | Binding Strength | Binding Description | Läkemedelsverket | Region Västerbotten | Region Östergötland | Inera | E-hälso-myndigheten |
|---|
| EHDSDevice | EHDSDevice | 0 | * |
| Device model |
C.12 - | EHDS refined base model for Device information |
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| Vad menas här? |
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| EHDSDevice.identifier | EHDSDevice.identifier | 1 | * | Identifier |
C.12.1 - Identifier| Identifier of the device which is unique within in a defined scope. Multiple identifiers can be used. | An identifier of the device which is unique within in a defined scope. Multiple identifiers can be used. |
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| UDI/DI:s från Eudamed | Obligatoriskt om det menas UDI-DI? Hämtas direkt från produkten |
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| EHDSDevice.manufacturer | EHDSDevice.manufacturer | 0 | 1 | string |
C.12.2 - Manufacturer| Name of device manufacturer | Name of device manufacturer |
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| Actor ID/SRN + "Organisation name" från Eudamed | Obligatoriskt |
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| EHDSDevice.manufactureDate | EHDSDevice.manufactureDate | 0 | 1 | dateTime |
C.12.3 - Manufacture date| The date and time when the device was manufactured | The date and time when the device was manufactured |
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| Villkorat obligatoriskt. Kan vara (del av) UDI-PI |
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| EHDSDevice.expiryDate | EHDSDevice.expiryDate | 0 | 1 | dateTime |
C.12.4 - Expiry date| The date and time beyond which this device is no longer valid or should not be used (if applicable). | The date and time beyond which this device is no longer valid or should not be used (if applicable). |
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| EHDSDevice.lotNumber | EHDSDevice.lotNumber | 0 | 1 | string |
C.12.5 - | Lot number of manufacture | Lot number of manufacture |
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| Obligatoriskt (UDI-PI) | skulle säga att detta är villkorat obligatoriskt med till att gälla förbrukningsartiklar alternativt sterila produkter. |
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| EHDSDevice.serialNumber | EHDSDevice.serialNumber | 0 | 1 | string |
C.12.6 - | Serial number assigned by the manufacturer | Serial number assigned by the manufacturer |
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| Villkorat obligatoriskt (UDI-PI) |
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| EHDSDevice.name | EHDSDevice.name | 0 | * | string |
C.12.7 - Name| The name and name type of the device as known to the manufacturer and/or patient | The name and name type of the device as known to the manufacturer and/or patient |
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| Obligatoriskt |
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| EHDSDevice.modelNumber | EHDSDevice.modelNumber | 0 | 1 | string |
C.12.8 - Model number| The manufacturer's model number for the device | The manufacturer's model number for the device |
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| Obligatoriskt. Men vad menas med modell nummer? Version? Bara heta modell? |
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| EHDSDevice.version | EHDSDevice.version | 0 | 1 | string |
C.12.9 - Version| The actual design of the device or software version running on the device | The actual design of the device or software version running on the device |
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| Villkorat obligatoriskt? |
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| EHDSDevice.type | EHDSDevice.type | 0 | * | CodeableConcept |
C.12.10 - Type| Device type | Device type | preferred | SNOMED CT, EMDN |
| Obligatoriskt. Typ av produkt? Ex Höftprotes, Pacemaker mm? | Finns det något generiskt kodsystem för olika typer av MTP?? Vilka värden skulle detta fält kunna erhålla |
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| EHDSDevice.note | EHDSDevice.note | 0 | * |
Narrative | C.12.11 - Note| string | Device notes and comments | Device notes and comments |
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