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| ID | Path | Min | Max | Type(s) | Short | Definition | Binding Strength | Binding Description | Läkemedelsverket | Region Västerbotten | Region Östergötland | Inera | E-hälso-myndigheten |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| EHDSDeviceUse | EHDSDeviceUse | 0 | * | Device use model | EHDS refined base model for Device Use | jag förstår inte hur strukturen är uppbyggd och vad som avses med device use model | |||||||
| EHDSDeviceUse.header | EHDSDeviceUse.header | 1 | 1 | Base | Common header for all patient-related data | Common header for all patient-related data | ?? | ||||||
| EHDSDeviceUse.header.subject | EHDSDeviceUse.header.subject | 1 | 1 | https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSPatient | Subject | Patient/subject information | Obligatoriskt | ||||||
| EHDSDeviceUse.header.identifier | EHDSDeviceUse.header.identifier | 0 | * | Identifier | Business identifier for the object | Business identifier for the object | Vad menas, är det patient eller produkt? | ||||||
| EHDSDeviceUse.header.authorship | EHDSDeviceUse.header.authorship | 1 | * | Base | Authorship | Resource authoring details | ?? | ||||||
| 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. | ?? Vad menas, är det förskrivare, ansvarig person, vad? | ||||||
| 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. | ?? Handlar detta om när dokumentationen blir gjord? | ||||||
| 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 | ?? Är det när dokumentationen av produkten utfördes? | ||||||
| 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:
| är det om den är implanterad men inte aktiverad tex, eller gäller det regulatorisk status? | |||
| 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. | ?? Vad menas? Om produkten är i bruk, tillbakadragen etc? | ||||||
| EHDSDeviceUse.header.language | EHDSDeviceUse.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? | ||||
| EHDSDeviceUse.header.version | EHDSDeviceUse.header.version | 0 | 1 | string | Version | Business version of the resource. | Vilken version av produkt eller? | ||||||
| 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 documentversion of a document | ?? Vad för dokument? Bruksanvisning, Produktbeskrivning, eller vad? Var hämtas det ifrån? | ||||||
| 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. | Obligatoriskt | Skulle det kunna röra sig om andra produkter än om just implantat? | |||||
| EHDSDeviceUse.endDate | EHDSDeviceUse.endDate | 0 | 1 | dateTime | Date when the device was explanted from the patient or the external device was no longer in use. | Date when the device was explanted from the patient or the external device was no longer in use. | Villkorat obligatoriskt | ||||||
| EHDSDeviceUse.device[x] | EHDSDeviceUse.device[x] | 1 | 1 | CodeableConcept https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSDevice | The details of the device used. | The details of the device used. | Obligatoriskt. 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 | |||||
| EHDSDeviceUse.bodySite | EHDSDeviceUse.bodySite | 0 | 1 | https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSBodyStructure | Anatomical location of the device. May include laterality. | Anatomical location of the device. May include laterality. | Obligatoriskt | Vilka attribut kan matas in? text? specificerade kroppsdelar? | |||||
| EHDSDeviceUse.reason[x] | EHDSDeviceUse.reason[x] | 0 | * | CodeableConcept https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSConditionhttps://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSObservationhttps://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSProcedure | Reason or justification for the use of the device. | Reason or justification for the use of the device. | ? Diagnos, Orsak? | ||||||
| EHDSDeviceUse.source[x] | EHDSDeviceUse.source[x] | 0 | 1 | https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSPatient https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSHealthProfessionalhttps://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSRelatedPerson | Who reported the device was being used by the patient. | Who reported the device was being used by the patient. | ? Hör det ihop med device eller device use? Vem menas, sjukvården eller patienten själv? | ||||||
| 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. | Vad menas? Ska ex varningar, försiktighetsåtgärder in här? Ska det skrivas i fritext eller hämtas någonstans ifrån? |
Device
Exporterat från logisk modell "Device model". Uppdaterad enligt remissversionen av modellen 2025-08-26:
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| 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 | EHDS refined base model for Device information | Vad menas här? | |||||||
| EHDSDevice.identifier | EHDSDevice.identifier | 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. | UDI/DI:s från Eudamed | Obligatoriskt om det menas UDI-DI? Hämtas direkt från produkten | |||||
| EHDSDevice.manufacturer | EHDSDevice.manufacturer | 0 | 1 | string | Name of device manufacturer | Name of device manufacturer | Actor ID/SRN + "Organisation name" från Eudamed | Obligatoriskt | |||||
| EHDSDevice.manufactureDate | EHDSDevice.manufactureDate | 0 | 1 | dateTime | The date and time when the device was manufactured | The date and time when the device was manufactured | Villkorat obligatoriskt. Kan vara (del av) UDI-PI | ||||||
| EHDSDevice.expiryDate | EHDSDevice.expiryDate | 0 | 1 | dateTime | 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). | Obligatoriskt | ||||||
| EHDSDevice.lotNumber | EHDSDevice.lotNumber | 0 | 1 | string | Lot number of manufacture | Lot number of manufacture | Obligatoriskt (UDI-PI) | skulle säga att detta är villkorat obligatoriskt med till att gälla förbrukningsartiklar alternativt sterila produkter. | |||||
| EHDSDevice.serialNumber | EHDSDevice.serialNumber | 0 | 1 | string | Serial number assigned by the manufacturer | Serial number assigned by the manufacturer | Villkorat obligatoriskt (UDI-PI) | ||||||
| EHDSDevice.name | EHDSDevice.name | 0 | * | string | 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 | Obligatoriskt | ||||||
| EHDSDevice.modelNumber | EHDSDevice.modelNumber | 0 | 1 | string | The manufacturer's model number for the device | The manufacturer's model number for the device | Obligatoriskt. Men vad menas med modell nummer? Version? Bara heta modell? | ||||||
| EHDSDevice.version | EHDSDevice.version | 0 | 1 | string | 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 | Villkorat obligatoriskt? | ||||||
| EHDSDevice.type | EHDSDevice.type | 0 | * | CodeableConcept | 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 | |||
| EHDSDevice.note | EHDSDevice.note | 0 | * | string | Device notes and comments | Device notes and comments |
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