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eHealth Network guidelines
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| Sammanfattningsvis attribut som behövs: | |
| EHDSDeviceUse.identifier | Användare, förskrivare? |
| EHDSDeviceUse.status | På marknaden, tillbakadragen? |
| EHDSDeviceUse.implantDate | Användningsdatum |
| EHDSDeviceUse.device | Produktbeskrivning? Trade Item description? |
| EHDSDeviceUse.subject | Patienten |
| EHDSDeviceUse.bodySite | Kroppsdel, sida? |
| EHDSDevice.identifier | UDI-DI |
| EHDSDevice.manufacturer | Tillverkare, leverantör |
| EHDSDevice.expiryDate | Utgångsdatum |
| EHDSDevice.lotNumber | UDI-PI |
| EHDSDevice.serialNumber | UDI-PI |
| EHDSDevice.name | Varumärke |
| EHDSDevice.modelNumber | Modellnamn? EMDN nummer(klassifikation)? |
| EHDSDevice.type | Produkttyp, enl klassificeringssystem? Functional name? |
Device use
Exporterat från logisk modell "Device use model" (under arbete)
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| ID | Path | Min | Max | Type(s) | Short | Definition | Binding Strength | Binding Description | Läkemedelsverket | Region Västerbotten | Inera | E-hälso-myndigheten |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| EHDSDeviceUse | EHDSDeviceUse | 0 | * | Device use model | C.25 - EHDS refined base model for Device Use | |||||||
| EHDSDeviceUse.identifier | EHDSDeviceUse.identifier | 0 | * | Identifier | C.25.1 - Identifier | An identifier for this statement. | Betyder detta vem som använder? | |||||
| EHDSDeviceUse.status | EHDSDeviceUse.status | 0 | 1 | CodeableConcept | C.25.2 - Status | Current status of the Device Usage. | preferred | HL7 device-statement-status | Är detta om produkt är i bruk? | |||
| EHDSDeviceUse.implantDate | EHDSDeviceUse.implantDate | 0 | 1 | dateTime | C.25.3 - Implant date | Date when procedure was performed. | Obligatoriskt | |||||
| 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 when the device is planned to be explanted. | Villkorat obligatoriskt | |||||
| EHDSDeviceUse.device | EHDSDeviceUse.device | 1 | 1 | Reference (https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSDevice) | C.25.5 - Device | The details of the device used. | Obligatoriskt. Vilka detaljer menas? Produktbeskrivning? Annat (modell, längd, storlek, hö/vä, ref nr, mm?) | |||||
| EHDSDeviceUse.subject | EHDSDeviceUse.subject | 1 | 1 | Reference (https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/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. | Obligatoriskt | |||||
| EHDSDeviceUse.note | EHDSDeviceUse.note | 0 | * | Narrative | 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(https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSPatient|https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSHealthProfessional|https://www.xt-ehr.eu/specifications/fhir/StructureDefinition/EHDSRelatedPerson) | C.25.10 - Source | Who reported the device was being used by the patient. | Samma som C.25.1 - Identifier? |
Device
Exporterat från logisk modell "Device model" (under arbete)
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| ID | Path | Min | Max | Type(s) | Short | Definition | Binding Strength | Binding Description | Läkemedelsverket | Region Västerbotten | Inera | E-hälso-myndigheten |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| EHDSDevice | EHDSDevice | 0 | * | Device model | C.12 - EHDS refined base model for Device information | Vad menas här? | ||||||
| EHDSDevice.identifier | EHDSDevice.identifier | 1 | * | Identifier | C.12.1 - Identifier | 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? | ||||
| EHDSDevice.manufacturer | EHDSDevice.manufacturer | 0 | 1 | string | C.12.2 - Manufacturer | Name of device manufacturer | Actor ID/SRN + "Organisation name" från Eudamed | Obligatoriskt | ||||
| EHDSDevice.manufactureDate | EHDSDevice.manufactureDate | 0 | 1 | dateTime | C.12.3 - Manufacture date | The date and time when the device was manufactured | Villkorat obligatoriskt. Kan vara (del av) UDI-PI | |||||
| 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). | Obligatoriskt | |||||
| EHDSDevice.lotNumber | EHDSDevice.lotNumber | 0 | 1 | string | C.12.5 - Lot number | Lot number of manufacture | Obligatoriskt (UDI-PI) | |||||
| EHDSDevice.serialNumber | EHDSDevice.serialNumber | 0 | 1 | string | C.12.6 - Serial number | Serial number assigned by the manufacturer | Villkorat obligatoriskt (UDI-PI) | |||||
| 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 | Obligatoriskt | |||||
| EHDSDevice.modelNumber | EHDSDevice.modelNumber | 0 | 1 | string | C.12.8 - Model number | 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 | C.12.9 - Version | The actual design of the device or software version running on the device | Villkorat obligatoriskt? | |||||
| EHDSDevice.type | EHDSDevice.type | 0 | * | CodeableConcept | C.12.10 - Type | Device type | preferred | SNOMED CT, EMDN | Obligatoriskt. Typ av produkt? Ex Höftprotes, Pacemaker mm? | |||
| EHDSDevice.note | EHDSDevice.note | 0 | * | Narrative | C.12.11 - Note | Device notes and comments |