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Patient Summary Guideline
| Data | Element | Description | Preferred Code Systems | Kommentar | Arbetsgruppens analys och tolkning | Frågeställning |
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| * ** A.2 Patient summary body data elements |
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| A.2.3.2 | Medical devices and implants |
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| A.2.3.2.1 | Device and implant description | Describes the patient's implanted and external medical devices and equipment upon which their health status depends. Includes devices such as cardiac pacemakers, implantable fibrillator, prosthesis, ferromagnetic bone implants, etc. of which the HP needs to be aware. | SNOMED CT GPS* EMDN | Snomed CT ger bara en beskrivning av att det finns ett implantat och vilken typ av implantat. Ingenting om identiteten på implantat eller beskrivningar av ett visst implantat. EMDN- Är en nomenklatur för beskrivning av produkter i en hierarki, indelat i kategori, grupp och typ. Beskriver enbart vilken sorts produkt det är. | Information om den medicintekniska produkten: - Namn på produkt
- Namn på tillverkare
- Tillverkningsdatum
- Utgångsdatum
- Modellnummer
- Version
- Produkttyp (kod enligt Snomed CT eller EMDN)
- Notering (fritext)
Information kopplat till patientens användning av produkten: |
Patient- Status (kod, om produkten fortfarande används eller inte)
- Kroppsdel, sida av kroppen (kod)
- Datum då informationen registrerades
- Vem som registrerade informationen
- Notering (fritext)
| Vi behöver dessutom artikelbeskrivning: "An understandable and useable description of a trade item using brand, function, size and other descriptors." I UDI databasen är 11.B. Reference, Article or Catalogue number obligatoriskt. Vill vi att det ska finnas med också?
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| A.2.3.2.2 | Device ID | Normalised identifier of the device instance such as UDI according to REGULATION (EU) 2017/745 |
| UDI = UDI-DI + UDI-PI | - Identifierare (UDI-DI)
- Batchnummer
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och serienummer - (del av UDI-PI)
- Serienummer (del av UDI-PI)
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| A.2.3.2.3 | Implant date | Date when procedure was performed | ISO 8601 |
| Startdatum/Datum för ibruktagande |
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| A.2.3.2.4 | 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 | ISO 8601 |
| Slutdatum |
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* In a foreseeable future, the suggested preferred vocabularies might be superseded or
complemented, as mentioned in Guidelines Article 11(2).
** The Preferred code system(s) has been selected based on adequacy to convey the
information using the methodology of the Subgroup on Semantics. When more alternative
international code systems are available, all are listed when it is assumed to be unlikely that
agreement can be reached short term. Mapping between code systems could be proposed for
specific use cases.
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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 | | 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 |
Current status of the Device Usage. | 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. |
implantDateEHDSDeviceUse.implantDate | 0 | 1 | dateTime | C.25.3 - Implant date | | 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? |
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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 |
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| 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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| 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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Frågor vi vill ha svar på
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