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

Messages

Metadata

Name	Value		Comments
abstract	false
baseDefinition	http://hl7.org/fhir/StructureDefinition/Device
copyright	Căn cứ pháp lý Việt Nam: VBHN 08/2026/VBHN-BYT (01/2026) hợp nhất NĐ 98/2021/NĐ-CP ngày 08/11/2021 + NĐ 07/2023/NĐ-CP ngày 03/03/2023 + NĐ 04/2025/NĐ-CP hiệu lực 01/01/2025 (bao gồm phân biệt TBYT thông thường và TBYT IVD); VBHN 04/2026/VBHN-BYT (01/2026) hợp nhất TT 05/2022/TT-BYT ngày 01/03/2022 + TT 59/2025/TT-BYT; TT 04/2017/TT-BYT ngày 14/04/2017, Phụ lục 01; TT 24/2025/TT-BYT ngày 30/06/2025, hiệu lực 01/09/2025; VBHN 14/VBHN-BYT năm 2025 hợp nhất TT 04/2017/TT-BYT + TT 24/2025/TT-BYT; QĐ 3176/QĐ-BYT ngày 29/10/2024; QĐ 5086/QĐ-BYT, QĐ 637/QĐ-BYT (2022), QĐ 1844/QĐ-BYT (2022), QĐ 3181/QĐ-BYT (2022); QĐ 3107/QĐ-BYT (2024); QĐ 847/QĐ-BYT (2025).	Căn cứ pháp lý Việt Nam: VBHN 08/2026/VBHN-BYT (01/2026) hợp nhất NĐ 98/2021/NĐ-CP ngày 08/11/2021 + NĐ 07/2023/NĐ-CP ngày 03/03/2023 + NĐ 04/2025/NĐ-CP hiệu lực 01/01/2025 (bao gồm phân biệt TBYT thông thường và TBYT IVD); VBHN 04/2026/VBHN-BYT (01/2026) hợp nhất TT 05/2022/TT-BYT ngày 01/03/2022 + TT 59/2025/TT-BYT; TT 04/2017/TT-BYT ngày 14/04/2017, Phụ lục 01; TT 24/2025/TT-BYT ngày 30/06/2025, hiệu lực 01/09/2025; TT 44/2025/TT-BYT (phân cấp thủ tục hành chính TBYT); TT 46/2025/TT-BYT (định mức máy móc, thiết bị y tế); TT 57/2025/TT-BYT (phân nhóm TBYT đấu thầu — package procurement riêng); VBHN 14/VBHN-BYT năm 2025 hợp nhất TT 04/2017/TT-BYT + TT 24/2025/TT-BYT; QĐ 3176/QĐ-BYT ngày 29/10/2024; QĐ 5086/QĐ-BYT, QĐ 637/QĐ-BYT (2022), QĐ 1844/QĐ-BYT (2022), QĐ 3181/QĐ-BYT (2022); QĐ 3107/QĐ-BYT (2024); QĐ 847/QĐ-BYT (2025); NĐ 214/2025/NĐ-CP (Luật Đấu thầu — căn cứ TT 57/2025).	Values Differ
date	2026-04-14	2026-05-10	Values Differ
description	Profile Device cho thiết bị y tế (TBYT), bao gồm vật tư tiêu hao, thiết bị dùng trong chăm sóc và thiết bị cấy ghép tại Việt Nam. Giữ định danh thiết bị/vật tư (MA_VAT_TU khi legacy cần trao đổi như identifier), UDI, thông tin nhận dạng và vòng đời thiết bị. Thông tin thanh toán BHYT theo từng dòng chi phí như nhóm TBYT, phạm vi, tỷ lệ thanh toán và mức hưởng phải ưu tiên đặt tại Claim.item; Device chỉ giữ dữ liệu thiết bị hoặc fallback legacy khi chưa có Claim. Liên kết với Claim.item (chi phí TBYT) và DeviceUseStatement (ghi nhận sử dụng lâm sàng). Căn cứ pháp lý Việt Nam: - VBHN 08/2026/VBHN-BYT (01/2026) — Văn bản hợp nhất chính thức NĐ 98/2021/NĐ-CP (08/11/2021) + NĐ 07/2023/NĐ-CP (03/03/2023) + NĐ 04/2025/NĐ-CP (hiệu lực 01/01/2025) về quản lý thiết bị y tế (bao gồm phân biệt TBYT thông thường và TBYT IVD chẩn đoán in vitro) - VBHN 04/2026/VBHN-BYT (01/2026) — Văn bản hợp nhất TT 05/2022/TT-BYT (01/03/2022) + TT 59/2025/TT-BYT về phân loại TBYT và kiểm định - TT 04/2017/TT-BYT (14/4/2017) Phụ lục 01 — 9 nhóm TBYT BHYT - TT 24/2025/TT-BYT (30/6/2025, hiệu lực 01/9/2025) — sửa đổi TT 04/2017/TT-BYT, thống nhất thuật ngữ VTYT → TBYT - VBHN 14/VBHN-BYT năm 2025 hợp nhất TT 04/2017/TT-BYT + TT 24/2025/TT-BYT: https://thuvienphapluat.vn/van-ban/The-thao-Y-te/Van-ban-hop-nhat-14-VBHN-BYT-2025-Thong-tu-dieu-kien-thanh-toan-doi-voi-vat-tu-y-te-thuoc-bao-hiem-y-te-670262.aspx - QĐ 3176/QĐ-BYT — trường MA_VAT_TU trong XML dữ liệu đầu ra KCB - QĐ 5086/QĐ-BYT, QĐ 637/QĐ-BYT (2022), QĐ 1844/QĐ-BYT (2022), QĐ 3181/QĐ-BYT (2022) — mã hãng sản xuất VTYT/TBYT, không phải danh mục mã hàng đầy đủ - QĐ 3107/QĐ-BYT (2024) và QĐ 847/QĐ-BYT (2025) — danh pháp TBYT, package hl7.fhir.vn.device tách riêng, dùng tham chiếu tùy chọn khi cần chuẩn hóa tên gọi. Ghi chú: - UDI carrier là best practice quốc tế của HL7/FHIR, không được trình bày như căn cứ bắt buộc trong pháp luật Việt Nam. - Phân loại rủi ro A/B/C/D theo VBHN 08/2026/VBHN-BYT (hợp nhất NĐ 98/2021 + NĐ 07/2023 + NĐ 04/2025) được hỗ trợ bằng extension tùy chọn, không bắt buộc cho mọi Device. - Cờ IVD (vn-ext-device-ivd) phân biệt TBYT chẩn đoán in vitro với TBYT thông thường theo VBHN 08/2026/VBHN-BYT, là dimension regulatory tùy chọn ở mức sản phẩm/model. - TT 57/2025/TT-BYT (31/12/2025, hiệu lực 15/02/2026, triển khai 01/01/2027) phân nhóm TBYT theo tiêu chuẩn kỹ thuật/chất lượng phục vụ đấu thầu (căn cứ NĐ 214/2025/NĐ-CP về Luật Đấu thầu) là dimension procurement độc lập, không thuộc VN Core; nếu cần, dùng package hl7.fhir.vn.procurement riêng.
experimental
fhirVersion	4.0.1
jurisdiction
jurisdiction[0]	urn:iso:std:iso:3166#VN
kind	resource
name	VNCoreDevice
publisher	Omi HealthTech / VN Core FHIR Community Initiative
purpose
status	draft
title	Thiết bị y tế VN Core — VN Core Device Profile
type	Device
url	http://fhir.hl7.org.vn/core/StructureDefinition/vn-core-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		0..*	Device	Item used in healthcare		0..*	Device	Item used in healthcare
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	SΣ	0..*	BackboneElement	UDI carrier
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	Σ	0..1	base64Binary	UDI Machine Readable Barcode String	Σ	0..1	base64Binary	UDI Machine Readable Barcode String
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: active | inactive Binding: ?? (required): The availability status of the device.	?!SΣ	1..1	code	Trạng thái: active | inactive 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	0..1	CodeableConcept	Loại TBYT Binding: ?? (example): Codes to identify medical devices.	S	0..1	CodeableConcept	Loại TBYT 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	0..1	Reference(Bệnh nhân VN Core — VN Core Patient Profile)	Bệnh nhân đang/đã sử dụng thiết bị	S	0..1	Reference(Bệnh nhân VN Core — VN Core Patient Profile)	Bệnh nhân đang/đã sử dụng 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	Σ	0..*	CodeableConcept	Safety Characteristics of Device	Σ	0..*	CodeableConcept	Safety Characteristics of Device
parent		0..1	Reference(Device)	The parent device		0..1	Reference(Device)	The parent device
Documentation for this format