HL7 Vietnam VN Core FHIR Implementation Guide

Bộ Hướng dẫn Triển khai Core FHIR cho Việt Nam
0.5.0 - Draft for Community Review Viet Nam cờ

Bộ Hướng dẫn Triển khai Core FHIR cho Việt Nam - Draft for Community Review (v0.5.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Hồ sơ tài nguyên: Thiết bị cấy ghép VN Core — VN Core Implantable Device Profile

URL chính thức: http://fhir.hl7.org.vn/core/StructureDefinition/vn-core-implantable-device Phiên bản: 0.5.0
Computable Name: VNCoreImplantableDevice

Bản quyền/Pháp lý: Căn cứ thiết kế: FHIR R4 Device, US Core Implantable Device pattern, TT 04/2017/TT-BYT, TT 24/2025/TT-BYT, VBHN 14/VBHN-BYT, QĐ 3176/QĐ-BYT, NĐ 98/2021/NĐ-CP đã được sửa đổi, bổ sung bởi NĐ 07/2023/NĐ-CP (03/03/2023) và NĐ 04/2025/NĐ-CP (hiệu lực 01/01/2025), TT 05/2022/TT-BYT đã được sửa đổi, bổ sung bởi TT 59/2025/TT-BYT, TCVN 13995:2024 và TCVN 13996:2024. QĐ 3107/QĐ-BYT (2024) và QĐ 847/QĐ-BYT (2025) là nguồn terminology/provenance ứng viên, chưa là required binding.

Profile Device chuyên cho thiết bị cấy ghép gắn với người bệnh tại Việt Nam. Kế thừa VNCoreDevice nhưng siết các điểm tối thiểu theo thông lệ US Core Implantable Device: patient-bound, type bắt buộc, status bắt buộc, UDI/lifecycle/safety là Must Support. UDI carrier là best practice quốc tế của HL7/FHIR và TCVN về UDI; pháp luật Việt Nam hiện chưa được model như yêu cầu UDI bắt buộc cho mọi thiết bị, nên profile chỉ cảnh báo khi UDI carrier thiếu nội dung HRF/AIDC. QĐ 847/QĐ-BYT (2025) và QĐ 3107/QĐ-BYT (2024) là nguồn terminology/provenance ứng viên cho danh pháp thiết bị (package hl7.fhir.vn.device), không phải required binding trong profile này. Căn cứ pháp lý cập nhật: NĐ 98/2021/NĐ-CP đã được sửa đổi, bổ sung bởi NĐ 07/2023/NĐ-CP và NĐ 04/2025/NĐ-CP; TT 05/2022/TT-BYT đã được sửa đổi, bổ sung bởi TT 59/2025/TT-BYT.

Usages:

You can also check for usages in the FHIR IG Statistics

Các dạng xem hình thức của nội dung hồ sơ

Mô tả profile, differential, snapshot và các biểu diễn liên quan.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device C 0..* VNCoreDevice Item used in healthcare
Constraints: vn-implant-udi-carrier-content, vn-implant-regnum-class-cd
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... Slices for extension Content/Rules for all slices
.... extension:deviceGroup 0..1 CodeableConcept Nhóm TBYT BHYT N01-N09
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-group
Binding: Nhóm thiết bị y tế theo danh mục BHYT — VN Device Group VS (extensible)
.... extension:riskClass S 0..1 CodeableConcept Phân loại rủi ro A/B/C/D — Must Support cho thiết bị cấy ghép
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-risk-class
Binding: Phân loại rủi ro thiết bị y tế — VN Device Risk Class VS (required)
.... extension:registrationNumber S 0..1 Identifier Số lưu hành TBYT — Must Support cho thiết bị cấy ghép C/D
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-registration-number
.... extension:isIVD 0..1 boolean Cờ IVD (chẩn đoán in vitro)
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-ivd
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
.... identifier:medicalDeviceItemCode S 0..1 Identifier Mã vật tư/thiết bị y tế (MA_VAT_TU)
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... system Σ 1..1 uri The namespace for the identifier value
Fixed Value: http://fhir.hl7.org.vn/core/sid/medical-device-item-code
..... value SΣ 1..1 string Giá trị MA_VAT_TU
Example General: 123456
.... identifier:serialNumber S 0..1 Identifier Số serial dạng Identifier
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: SNO
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... system Σ 1..1 uri The namespace for the identifier value
Fixed Value: http://fhir.hl7.org.vn/core/sid/device-serial-number
..... value SΣ 1..1 string Số serial
Example General: 123456
... udiCarrier SΣ 0..* BackboneElement UDI carrier của thiết bị cấy ghép khi có
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... deviceIdentifier SΣ 0..1 string UDI Device Identifier
.... carrierAIDC SΣ 0..1 base64Binary UDI automatic identification and data capture
.... carrierHRF SΣ 0..1 string UDI human-readable form
... status ?!SΣ 1..1 code Trạng thái thiết bị cấy ghép
Binding: FHIRDeviceStatus (required): The availability status of the device.
... distinctIdentifier S 0..1 string Định danh phân biệt thiết bị cấy ghép
... manufacturer S 0..1 string Hãng sản xuất
... manufactureDate S 0..1 dateTime Ngày sản xuất
... expirationDate S 0..1 dateTime Hạn sử dụng
... lotNumber S 0..1 string Số lô
... serialNumber S 0..1 string Số serial
... modelNumber S 0..1 string Model / quy cách
... type S 1..1 CodeableConcept Loại thiết bị cấy ghép
Binding: DeviceType (example): Codes to identify medical devices.
... patient S 1..1 Reference(Bệnh nhân VN Core — VN Core Patient Profile) Bệnh nhân đang/đã được cấy ghép thiết bị
... safety SΣ 0..* CodeableConcept Thông tin an toàn của thiết bị cấy ghép

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Device.identifier:medicalDeviceItemCode.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
Device.identifier:serialNumber.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
Device.identifier:serialNumber.​type Base extensible IdentifierType 📍4.0.1 FHIR Std.
Device.status Base required FHIRDeviceStatus 📍4.0.1 FHIR Std.
Device.type Base example Device Type 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Device If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Device If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error Device If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error Device If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Device A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
vn-implant-regnum-class-cd warning Device Thiết bị cấy ghép loại C hoặc D theo NĐ 98/2021/NĐ-CP Điều 4 (đã được sửa đổi, bổ sung bởi NĐ 07/2023/NĐ-CP và NĐ 04/2025/NĐ-CP) phải có số lưu hành TBYT do Bộ Y tế cấp. Cảnh báo nếu thiếu. extension('http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-risk-class').value.coding.where(code = 'C' or code = 'D').empty() or extension('http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-registration-number').exists()
vn-implant-udi-carrier-content warning Device Nếu ghi nhận UDI carrier cho thiết bị cấy ghép, nên có ít nhất HRF hoặc AIDC để hỗ trợ truy xuất và quét mã. udiCarrier.empty() or udiCarrier.all(carrierHRF.exists() or carrierAIDC.exists())

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device C 0..* VNCoreDevice Item used in healthcare
Constraints: vn-implant-udi-carrier-content, vn-implant-regnum-class-cd
... Slices for extension Content/Rules for all slices
.... extension:riskClass S 0..1 VNCoreExtDeviceRiskClass Phân loại rủi ro A/B/C/D — Must Support cho thiết bị cấy ghép
.... extension:registrationNumber S 0..1 VNCoreExtDeviceRegistrationNumber Số lưu hành TBYT — Must Support cho thiết bị cấy ghép C/D
... udiCarrier 0..* BackboneElement UDI carrier của thiết bị cấy ghép khi có
.... carrierAIDC S 0..1 base64Binary UDI automatic identification and data capture
... status 1..1 code Trạng thái thiết bị cấy ghép
... type 1..1 CodeableConcept Loại thiết bị cấy ghép
... patient 1..1 Reference(Bệnh nhân VN Core — VN Core Patient Profile) Bệnh nhân đang/đã được cấy ghép thiết bị
... safety S 0..* CodeableConcept Thông tin an toàn của thiết bị cấy ghép

doco Documentation for this format

Constraints

Id Grade Path(s) Description Expression
vn-implant-regnum-class-cd warning Device Thiết bị cấy ghép loại C hoặc D theo NĐ 98/2021/NĐ-CP Điều 4 (đã được sửa đổi, bổ sung bởi NĐ 07/2023/NĐ-CP và NĐ 04/2025/NĐ-CP) phải có số lưu hành TBYT do Bộ Y tế cấp. Cảnh báo nếu thiếu. extension('http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-risk-class').value.coding.where(code = 'C' or code = 'D').empty() or extension('http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-registration-number').exists()
vn-implant-udi-carrier-content warning Device Nếu ghi nhận UDI carrier cho thiết bị cấy ghép, nên có ít nhất HRF hoặc AIDC để hỗ trợ truy xuất và quét mã. udiCarrier.empty() or udiCarrier.all(carrierHRF.exists() or carrierAIDC.exists())
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device C 0..* VNCoreDevice Item used in healthcare
Constraints: vn-implant-udi-carrier-content, vn-implant-regnum-class-cd
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:deviceGroup 0..1 CodeableConcept Nhóm TBYT BHYT N01-N09
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-group
Binding: Nhóm thiết bị y tế theo danh mục BHYT — VN Device Group VS (extensible)
.... extension:riskClass S 0..1 CodeableConcept Phân loại rủi ro A/B/C/D — Must Support cho thiết bị cấy ghép
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-risk-class
Binding: Phân loại rủi ro thiết bị y tế — VN Device Risk Class VS (required)
.... extension:registrationNumber S 0..1 Identifier Số lưu hành TBYT — Must Support cho thiết bị cấy ghép C/D
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-registration-number
.... extension:isIVD 0..1 boolean Cờ IVD (chẩn đoán in vitro)
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-ivd
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... Slices for identifier S 0..* Identifier Định danh TBYT (mã vật tư/thiết bị, serial number)
Slice: Unordered, Open by value:system
.... identifier:medicalDeviceItemCode S 0..1 Identifier Mã vật tư/thiết bị y tế (MA_VAT_TU)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 0..* Coding Code defined by a terminology system
...... text Σ 0..1 string Plain text representation of the concept
Required Pattern: Mã vật tư/thiết bị y tế
..... system Σ 1..1 uri The namespace for the identifier value
Fixed Value: http://fhir.hl7.org.vn/core/sid/medical-device-item-code
..... value SΣ 1..1 string Giá trị MA_VAT_TU
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
.... identifier:serialNumber S 0..1 Identifier Số serial dạng Identifier
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: SNO
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... system Σ 1..1 uri The namespace for the identifier value
Fixed Value: http://fhir.hl7.org.vn/core/sid/device-serial-number
..... value SΣ 1..1 string Số serial
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
... definition 0..1 Reference(DeviceDefinition) The reference to the definition for the device
... udiCarrier SΣ 0..* BackboneElement UDI carrier của thiết bị cấy ghép khi có
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... deviceIdentifier SΣ 0..1 string UDI Device Identifier
.... issuer 0..1 uri UDI Issuing Organization
.... jurisdiction 0..1 uri Regional UDI authority
.... carrierAIDC SΣ 0..1 base64Binary UDI automatic identification and data capture
.... carrierHRF SΣ 0..1 string UDI human-readable form
.... entryType 0..1 code barcode | rfid | manual +
Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
... status ?!SΣ 1..1 code Trạng thái thiết bị cấy ghép
Binding: FHIRDeviceStatus (required): The availability status of the device.
... statusReason 0..* CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.
... distinctIdentifier S 0..1 string Định danh phân biệt thiết bị cấy ghép
... manufacturer S 0..1 string Hãng sản xuất
... manufactureDate S 0..1 dateTime Ngày sản xuất
... expirationDate S 0..1 dateTime Hạn sử dụng
... lotNumber S 0..1 string Số lô
... serialNumber S 0..1 string Số serial
... deviceName 0..* BackboneElement The name of the device as given by the manufacturer
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name 1..1 string The name of the device
.... type 1..1 code udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Binding: DeviceNameType (required): The type of name the device is referred by.
... modelNumber S 0..1 string Model / quy cách
... partNumber 0..1 string The part number of the device
... type S 1..1 CodeableConcept Loại thiết bị cấy ghép
Binding: DeviceType (example): Codes to identify medical devices.
... specialization 0..* BackboneElement The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... systemType 1..1 CodeableConcept The standard that is used to operate and communicate
.... version 0..1 string The version of the standard that is used to operate and communicate
... version 0..* BackboneElement The actual design of the device or software version running on the device
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 0..1 CodeableConcept The type of the device version
.... component 0..1 Identifier A single component of the device version
.... value 1..1 string The version text
... property 0..* BackboneElement The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 1..1 CodeableConcept Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuantity 0..* Quantity Property value as a quantity
.... valueCode 0..* CodeableConcept Property value as a code, e.g., NTP4 (synced to NTP)
... patient S 1..1 Reference(Bệnh nhân VN Core — VN Core Patient Profile) Bệnh nhân đang/đã được cấy ghép thiết bị
... owner 0..1 Reference(Organization) Organization responsible for device
... contact 0..* ContactPoint Details for human/organization for support
... location 0..1 Reference(Location) Where the device is found
... url 0..1 uri Network address to contact device
... note 0..* Annotation Ghi chú (tên VTYT, quy cách...)
... safety SΣ 0..* CodeableConcept Thông tin an toàn của thiết bị cấy ghép
... parent 0..1 Reference(Device) The parent device

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Device.language Base preferred Common Languages 📍4.0.1 FHIR Std.
Device.identifier:medicalDeviceItemCode.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
Device.identifier:medicalDeviceItemCode.​type Base extensible IdentifierType 📍4.0.1 FHIR Std.
Device.identifier:serialNumber.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
Device.identifier:serialNumber.​type Base extensible IdentifierType 📍4.0.1 FHIR Std.
Device.udiCarrier.entryType Base required UDIEntryType 📍4.0.1 FHIR Std.
Device.status Base required FHIRDeviceStatus 📍4.0.1 FHIR Std.
Device.statusReason Base extensible FHIRDeviceStatusReason 📍4.0.1 FHIR Std.
Device.deviceName.type Base required DeviceNameType 📍4.0.1 FHIR Std.
Device.type Base example Device Type 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Device If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Device If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error Device If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error Device If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Device A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
vn-implant-regnum-class-cd warning Device Thiết bị cấy ghép loại C hoặc D theo NĐ 98/2021/NĐ-CP Điều 4 (đã được sửa đổi, bổ sung bởi NĐ 07/2023/NĐ-CP và NĐ 04/2025/NĐ-CP) phải có số lưu hành TBYT do Bộ Y tế cấp. Cảnh báo nếu thiếu. extension('http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-risk-class').value.coding.where(code = 'C' or code = 'D').empty() or extension('http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-registration-number').exists()
vn-implant-udi-carrier-content warning Device Nếu ghi nhận UDI carrier cho thiết bị cấy ghép, nên có ít nhất HRF hoặc AIDC để hỗ trợ truy xuất và quét mã. udiCarrier.empty() or udiCarrier.all(carrierHRF.exists() or carrierAIDC.exists())

Summary

Mandatory: 2 elements
Must-Support: 4 elements

Dạng xem phần tử chính

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device C 0..* VNCoreDevice Item used in healthcare
Constraints: vn-implant-udi-carrier-content, vn-implant-regnum-class-cd
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... Slices for extension Content/Rules for all slices
.... extension:deviceGroup 0..1 CodeableConcept Nhóm TBYT BHYT N01-N09
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-group
Binding: Nhóm thiết bị y tế theo danh mục BHYT — VN Device Group VS (extensible)
.... extension:riskClass S 0..1 CodeableConcept Phân loại rủi ro A/B/C/D — Must Support cho thiết bị cấy ghép
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-risk-class
Binding: Phân loại rủi ro thiết bị y tế — VN Device Risk Class VS (required)
.... extension:registrationNumber S 0..1 Identifier Số lưu hành TBYT — Must Support cho thiết bị cấy ghép C/D
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-registration-number
.... extension:isIVD 0..1 boolean Cờ IVD (chẩn đoán in vitro)
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-ivd
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
.... identifier:medicalDeviceItemCode S 0..1 Identifier Mã vật tư/thiết bị y tế (MA_VAT_TU)
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... system Σ 1..1 uri The namespace for the identifier value
Fixed Value: http://fhir.hl7.org.vn/core/sid/medical-device-item-code
..... value SΣ 1..1 string Giá trị MA_VAT_TU
Example General: 123456
.... identifier:serialNumber S 0..1 Identifier Số serial dạng Identifier
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: SNO
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... system Σ 1..1 uri The namespace for the identifier value
Fixed Value: http://fhir.hl7.org.vn/core/sid/device-serial-number
..... value SΣ 1..1 string Số serial
Example General: 123456
... udiCarrier SΣ 0..* BackboneElement UDI carrier của thiết bị cấy ghép khi có
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... deviceIdentifier SΣ 0..1 string UDI Device Identifier
.... carrierAIDC SΣ 0..1 base64Binary UDI automatic identification and data capture
.... carrierHRF SΣ 0..1 string UDI human-readable form
... status ?!SΣ 1..1 code Trạng thái thiết bị cấy ghép
Binding: FHIRDeviceStatus (required): The availability status of the device.
... distinctIdentifier S 0..1 string Định danh phân biệt thiết bị cấy ghép
... manufacturer S 0..1 string Hãng sản xuất
... manufactureDate S 0..1 dateTime Ngày sản xuất
... expirationDate S 0..1 dateTime Hạn sử dụng
... lotNumber S 0..1 string Số lô
... serialNumber S 0..1 string Số serial
... modelNumber S 0..1 string Model / quy cách
... type S 1..1 CodeableConcept Loại thiết bị cấy ghép
Binding: DeviceType (example): Codes to identify medical devices.
... patient S 1..1 Reference(Bệnh nhân VN Core — VN Core Patient Profile) Bệnh nhân đang/đã được cấy ghép thiết bị
... safety SΣ 0..* CodeableConcept Thông tin an toàn của thiết bị cấy ghép

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Device.identifier:medicalDeviceItemCode.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
Device.identifier:serialNumber.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
Device.identifier:serialNumber.​type Base extensible IdentifierType 📍4.0.1 FHIR Std.
Device.status Base required FHIRDeviceStatus 📍4.0.1 FHIR Std.
Device.type Base example Device Type 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Device If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Device If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error Device If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error Device If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Device A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
vn-implant-regnum-class-cd warning Device Thiết bị cấy ghép loại C hoặc D theo NĐ 98/2021/NĐ-CP Điều 4 (đã được sửa đổi, bổ sung bởi NĐ 07/2023/NĐ-CP và NĐ 04/2025/NĐ-CP) phải có số lưu hành TBYT do Bộ Y tế cấp. Cảnh báo nếu thiếu. extension('http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-risk-class').value.coding.where(code = 'C' or code = 'D').empty() or extension('http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-registration-number').exists()
vn-implant-udi-carrier-content warning Device Nếu ghi nhận UDI carrier cho thiết bị cấy ghép, nên có ít nhất HRF hoặc AIDC để hỗ trợ truy xuất và quét mã. udiCarrier.empty() or udiCarrier.all(carrierHRF.exists() or carrierAIDC.exists())

Dạng xem Differential

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device C 0..* VNCoreDevice Item used in healthcare
Constraints: vn-implant-udi-carrier-content, vn-implant-regnum-class-cd
... Slices for extension Content/Rules for all slices
.... extension:riskClass S 0..1 VNCoreExtDeviceRiskClass Phân loại rủi ro A/B/C/D — Must Support cho thiết bị cấy ghép
.... extension:registrationNumber S 0..1 VNCoreExtDeviceRegistrationNumber Số lưu hành TBYT — Must Support cho thiết bị cấy ghép C/D
... udiCarrier 0..* BackboneElement UDI carrier của thiết bị cấy ghép khi có
.... carrierAIDC S 0..1 base64Binary UDI automatic identification and data capture
... status 1..1 code Trạng thái thiết bị cấy ghép
... type 1..1 CodeableConcept Loại thiết bị cấy ghép
... patient 1..1 Reference(Bệnh nhân VN Core — VN Core Patient Profile) Bệnh nhân đang/đã được cấy ghép thiết bị
... safety S 0..* CodeableConcept Thông tin an toàn của thiết bị cấy ghép

doco Documentation for this format

Constraints

Id Grade Path(s) Description Expression
vn-implant-regnum-class-cd warning Device Thiết bị cấy ghép loại C hoặc D theo NĐ 98/2021/NĐ-CP Điều 4 (đã được sửa đổi, bổ sung bởi NĐ 07/2023/NĐ-CP và NĐ 04/2025/NĐ-CP) phải có số lưu hành TBYT do Bộ Y tế cấp. Cảnh báo nếu thiếu. extension('http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-risk-class').value.coding.where(code = 'C' or code = 'D').empty() or extension('http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-registration-number').exists()
vn-implant-udi-carrier-content warning Device Nếu ghi nhận UDI carrier cho thiết bị cấy ghép, nên có ít nhất HRF hoặc AIDC để hỗ trợ truy xuất và quét mã. udiCarrier.empty() or udiCarrier.all(carrierHRF.exists() or carrierAIDC.exists())

Dạng xem SnapshotView

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device C 0..* VNCoreDevice Item used in healthcare
Constraints: vn-implant-udi-carrier-content, vn-implant-regnum-class-cd
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:deviceGroup 0..1 CodeableConcept Nhóm TBYT BHYT N01-N09
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-group
Binding: Nhóm thiết bị y tế theo danh mục BHYT — VN Device Group VS (extensible)
.... extension:riskClass S 0..1 CodeableConcept Phân loại rủi ro A/B/C/D — Must Support cho thiết bị cấy ghép
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-risk-class
Binding: Phân loại rủi ro thiết bị y tế — VN Device Risk Class VS (required)
.... extension:registrationNumber S 0..1 Identifier Số lưu hành TBYT — Must Support cho thiết bị cấy ghép C/D
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-registration-number
.... extension:isIVD 0..1 boolean Cờ IVD (chẩn đoán in vitro)
URL: http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-ivd
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... Slices for identifier S 0..* Identifier Định danh TBYT (mã vật tư/thiết bị, serial number)
Slice: Unordered, Open by value:system
.... identifier:medicalDeviceItemCode S 0..1 Identifier Mã vật tư/thiết bị y tế (MA_VAT_TU)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 0..* Coding Code defined by a terminology system
...... text Σ 0..1 string Plain text representation of the concept
Required Pattern: Mã vật tư/thiết bị y tế
..... system Σ 1..1 uri The namespace for the identifier value
Fixed Value: http://fhir.hl7.org.vn/core/sid/medical-device-item-code
..... value SΣ 1..1 string Giá trị MA_VAT_TU
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
.... identifier:serialNumber S 0..1 Identifier Số serial dạng Identifier
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: SNO
....... display 0..1 string Representation defined by the system
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... system Σ 1..1 uri The namespace for the identifier value
Fixed Value: http://fhir.hl7.org.vn/core/sid/device-serial-number
..... value SΣ 1..1 string Số serial
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
... definition 0..1 Reference(DeviceDefinition) The reference to the definition for the device
... udiCarrier SΣ 0..* BackboneElement UDI carrier của thiết bị cấy ghép khi có
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... deviceIdentifier SΣ 0..1 string UDI Device Identifier
.... issuer 0..1 uri UDI Issuing Organization
.... jurisdiction 0..1 uri Regional UDI authority
.... carrierAIDC SΣ 0..1 base64Binary UDI automatic identification and data capture
.... carrierHRF SΣ 0..1 string UDI human-readable form
.... entryType 0..1 code barcode | rfid | manual +
Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
... status ?!SΣ 1..1 code Trạng thái thiết bị cấy ghép
Binding: FHIRDeviceStatus (required): The availability status of the device.
... statusReason 0..* CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.
... distinctIdentifier S 0..1 string Định danh phân biệt thiết bị cấy ghép
... manufacturer S 0..1 string Hãng sản xuất
... manufactureDate S 0..1 dateTime Ngày sản xuất
... expirationDate S 0..1 dateTime Hạn sử dụng
... lotNumber S 0..1 string Số lô
... serialNumber S 0..1 string Số serial
... deviceName 0..* BackboneElement The name of the device as given by the manufacturer
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name 1..1 string The name of the device
.... type 1..1 code udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Binding: DeviceNameType (required): The type of name the device is referred by.
... modelNumber S 0..1 string Model / quy cách
... partNumber 0..1 string The part number of the device
... type S 1..1 CodeableConcept Loại thiết bị cấy ghép
Binding: DeviceType (example): Codes to identify medical devices.
... specialization 0..* BackboneElement The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... systemType 1..1 CodeableConcept The standard that is used to operate and communicate
.... version 0..1 string The version of the standard that is used to operate and communicate
... version 0..* BackboneElement The actual design of the device or software version running on the device
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 0..1 CodeableConcept The type of the device version
.... component 0..1 Identifier A single component of the device version
.... value 1..1 string The version text
... property 0..* BackboneElement The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 1..1 CodeableConcept Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuantity 0..* Quantity Property value as a quantity
.... valueCode 0..* CodeableConcept Property value as a code, e.g., NTP4 (synced to NTP)
... patient S 1..1 Reference(Bệnh nhân VN Core — VN Core Patient Profile) Bệnh nhân đang/đã được cấy ghép thiết bị
... owner 0..1 Reference(Organization) Organization responsible for device
... contact 0..* ContactPoint Details for human/organization for support
... location 0..1 Reference(Location) Where the device is found
... url 0..1 uri Network address to contact device
... note 0..* Annotation Ghi chú (tên VTYT, quy cách...)
... safety SΣ 0..* CodeableConcept Thông tin an toàn của thiết bị cấy ghép
... parent 0..1 Reference(Device) The parent device

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Device.language Base preferred Common Languages 📍4.0.1 FHIR Std.
Device.identifier:medicalDeviceItemCode.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
Device.identifier:medicalDeviceItemCode.​type Base extensible IdentifierType 📍4.0.1 FHIR Std.
Device.identifier:serialNumber.​use Base required IdentifierUse 📍4.0.1 FHIR Std.
Device.identifier:serialNumber.​type Base extensible IdentifierType 📍4.0.1 FHIR Std.
Device.udiCarrier.entryType Base required UDIEntryType 📍4.0.1 FHIR Std.
Device.status Base required FHIRDeviceStatus 📍4.0.1 FHIR Std.
Device.statusReason Base extensible FHIRDeviceStatusReason 📍4.0.1 FHIR Std.
Device.deviceName.type Base required DeviceNameType 📍4.0.1 FHIR Std.
Device.type Base example Device Type 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Device If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Device If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error Device If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error Device If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Device A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
vn-implant-regnum-class-cd warning Device Thiết bị cấy ghép loại C hoặc D theo NĐ 98/2021/NĐ-CP Điều 4 (đã được sửa đổi, bổ sung bởi NĐ 07/2023/NĐ-CP và NĐ 04/2025/NĐ-CP) phải có số lưu hành TBYT do Bộ Y tế cấp. Cảnh báo nếu thiếu. extension('http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-risk-class').value.coding.where(code = 'C' or code = 'D').empty() or extension('http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-registration-number').exists()
vn-implant-udi-carrier-content warning Device Nếu ghi nhận UDI carrier cho thiết bị cấy ghép, nên có ít nhất HRF hoặc AIDC để hỗ trợ truy xuất và quét mã. udiCarrier.empty() or udiCarrier.all(carrierHRF.exists() or carrierAIDC.exists())

Summary

Mandatory: 2 elements
Must-Support: 4 elements

 

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