Profile Comparison between http://fhir.hl7.org.vn/core/StructureDefinition/vn-core-implantable-device vs http://fhir.hl7.org.vn/core/StructureDefinition/vn-core-implantable-device

Messages

Metadata

Name	Value		Comments
abstract	false
baseDefinition	http://fhir.hl7.org.vn/core/StructureDefinition/vn-core-device
copyright	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.
date	2026-04-19
description	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.
experimental
fhirVersion	4.0.1
jurisdiction
jurisdiction[0]	urn:iso:std:iso:3166#VN
kind	resource
name	VNCoreImplantableDevice
publisher	Omi HealthTech / VN Core FHIR Community Initiative
purpose
status	draft
title	Thiết bị cấy ghép VN Core — VN Core Implantable Device Profile
type	Device
url	http://fhir.hl7.org.vn/core/StructureDefinition/vn-core-implantable-device
version	0.5.0	0.5.1	Values Differ

Structure

Name	L Flags	L Card.	L Type	L Description & Constraints	R Flags	R Card.	R Type	R Description & Constraints	Comments
Device	C	0..*	VNCoreDevice	Item used in healthcare Constraints: vn-implant-udi-carrier-content, vn-implant-regnum-class-cd	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	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: ?? (preferred): A human language. Additional Bindings Purpose ?? Max Binding		0..1	code	Language of the resource content Binding: ?? (preferred): A human language. Additional Bindings Purpose ?? 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		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		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url		0..*	Extension	Extension Slice: Unordered, Open by value:url
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored	?!	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	S	0..*	Identifier	Định danh TBYT (mã vật tư/thiết bị, serial number) Slice: Unordered, Open by value:system
definition		0..1	Reference(DeviceDefinition)	The reference to the definition for the device		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	SΣ	0..*	BackboneElement	UDI carrier của thiết bị cấy ghép khi có
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
deviceIdentifier	SΣ	0..1	string	UDI Device Identifier	SΣ	0..1	string	UDI Device Identifier
issuer		0..1	uri	UDI Issuing Organization		0..1	uri	UDI Issuing Organization
jurisdiction		0..1	uri	Regional UDI authority		0..1	uri	Regional UDI authority
carrierAIDC	SΣ	0..1	base64Binary	UDI automatic identification and data capture	SΣ	0..1	base64Binary	UDI automatic identification and data capture
carrierHRF	SΣ	0..1	string	UDI human-readable form	SΣ	0..1	string	UDI human-readable form
entryType		0..1	code	barcode | rfid | manual + Binding: ?? (required): Codes to identify how UDI data was entered.		0..1	code	barcode | rfid | manual + Binding: ?? (required): Codes to identify how UDI data was entered.
status	?!SΣ	1..1	code	Trạng thái thiết bị cấy ghép Binding: ?? (required): The availability status of the device.	?!SΣ	1..1	code	Trạng thái thiết bị cấy ghép Binding: ?? (required): The availability status of the device.
statusReason		0..*	CodeableConcept	online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Binding: ?? (extensible): The availability status reason of the device.		0..*	CodeableConcept	online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Binding: ?? (extensible): The availability status reason of the device.
distinctIdentifier	S	0..1	string	Định danh phân biệt thiết bị cấy ghép	S	0..1	string	Định danh phân biệt thiết bị cấy ghép
manufacturer	S	0..1	string	Hãng sản xuất	S	0..1	string	Hãng sản xuất
manufactureDate	S	0..1	dateTime	Ngày sản xuất	S	0..1	dateTime	Ngày sản xuất
expirationDate	S	0..1	dateTime	Hạn sử dụng	S	0..1	dateTime	Hạn sử dụng
lotNumber	S	0..1	string	Số lô	S	0..1	string	Số lô
serialNumber	S	0..1	string	Số serial	S	0..1	string	Số serial
deviceName		0..*	BackboneElement	The name of the device as given by the manufacturer		0..*	BackboneElement	The name of the device as given by the manufacturer
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name		1..1	string	The name of the device		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: ?? (required): The type of name the device is referred by.		1..1	code	udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Binding: ?? (required): The type of name the device is referred by.
modelNumber	S	0..1	string	Model / quy cách	S	0..1	string	Model / quy cách
partNumber		0..1	string	The part number of the device		0..1	string	The part number of the device
type	S	1..1	CodeableConcept	Loại thiết bị cấy ghép Binding: ?? (example): Codes to identify medical devices.	S	1..1	CodeableConcept	Loại thiết bị cấy ghép Binding: ?? (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		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		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
systemType		1..1	CodeableConcept	The standard that is used to operate and communicate		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		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		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		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type		0..1	CodeableConcept	The type of the device version		0..1	CodeableConcept	The type of the device version
component		0..1	Identifier	A single component of the device version		0..1	Identifier	A single component of the device version
value		1..1	string	The version text		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		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		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type		1..1	CodeableConcept	Code that specifies the property DeviceDefinitionPropetyCode (Extensible)		1..1	CodeableConcept	Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
valueQuantity		0..*	Quantity	Property value as a quantity		0..*	Quantity	Property value as a quantity
valueCode		0..*	CodeableConcept	Property value as a code, e.g., NTP4 (synced to NTP)		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	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		0..1	Reference(Organization)	Organization responsible for device
contact		0..*	ContactPoint	Details for human/organization for support		0..*	ContactPoint	Details for human/organization for support
location		0..1	Reference(Location)	Where the device is found		0..1	Reference(Location)	Where the device is found
url		0..1	uri	Network address to contact device		0..1	uri	Network address to contact device
note		0..*	Annotation	Ghi chú (tên VTYT, quy cách...)		0..*	Annotation	Ghi chú (tên VTYT, quy cách...)
safety	SΣ	0..*	CodeableConcept	Thông tin an toàn của thiết bị cấy ghép	SΣ	0..*	CodeableConcept	Thông tin an toàn của thiết bị cấy ghép
parent		0..1	Reference(Device)	The parent device		0..1	Reference(Device)	The parent device
Documentation for this format