<status value="draft"/> <date value="2026-04-19"/> <publisher value="Omi HealthTech / VN Core FHIR Community Initiative"/> <contact> <name value="Omi HealthTech / VN Core FHIR Community Initiative"/> <telecom> <system value="url"/> <value value="https://hl7.org.vn"/> </telecom> <telecom> <system value="email"/> <value value="info@hl7.org.vn"/> </telecom> </contact> <contact> <name value="Omi HealthTech (OmiGroup)"/> <telecom> <system value="url"/> <value value="https://omihealthtech.vn"/> </telecom> <telecom> <system value="url"/> <value value="https://omigroup.vn"/> </telecom> <telecom> <system value="email"/> <value value="healthtech@omigroup.vn"/> </telecom> </contact> <description value="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."/> <jurisdiction> <coding> <system value="urn:iso:std:iso:3166"/> <code value="VN"/> <display value="Viet Nam"/> </coding> </jurisdiction> <copyright value="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."/> <fhirVersion value="4.0.1"/> <mapping> <identity value="rim"/> <uri value="http://hl7.org/v3"/> <name value="RIM Mapping"/> </mapping> <mapping> <identity value="w5"/> <uri value="http://hl7.org/fhir/fivews"/> <name value="FiveWs Pattern Mapping"/> </mapping> <mapping> <identity value="udi"/> <uri value="http://fda.gov/UDI"/> <name value="UDI Mapping"/> </mapping> <kind value="resource"/> <abstract value="false"/> <type value="Device"/> <baseDefinition value="http://fhir.hl7.org.vn/core/StructureDefinition/vn-core-device"/> <derivation value="constraint"/> <snapshot> <extension url="http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version"> <valueString value="0.5.0"/> </extension> <element id="Device"> <path value="Device"/> <short value="Item used in healthcare"/> <definition value="A type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device."/> <min value="0"/> <max value="*"/> <base> <path value="Device"/> <min value="0"/> <max value="*"/> </base> <constraint> <key value="dom-2"/> <severity value="error"/> <human value="If the resource is contained in another resource, it SHALL NOT contain nested Resources"/> <expression value="contained.contained.empty()"/> <xpath value="not(parent::f:contained and f:contained)"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <key value="dom-3"/> <severity value="error"/> <human value="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"/> <expression value="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()"/> <xpath value="not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <key value="dom-4"/> <severity value="error"/> <human value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated"/> <expression value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"/> <xpath value="not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <key value="dom-5"/> <severity value="error"/> <human value="If a resource is contained in another resource, it SHALL NOT have a security label"/> <expression value="contained.meta.security.empty()"/> <xpath value="not(exists(f:contained/*/f:meta/f:security))"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice"> <valueBoolean value="true"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation"> <valueMarkdown value="When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."/> </extension> <key value="dom-6"/> <severity value="warning"/> <human value="A resource should have narrative for robust management"/> <expression value="text.`div`.exists()"/> <xpath value="exists(f:text/h:div)"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <key value="vn-implant-udi-carrier-content"/> <severity value="warning"/> <human value="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."/> <expression value="udiCarrier.empty() or udiCarrier.all(carrierHRF.exists() or carrierAIDC.exists())"/> <source value="http://fhir.hl7.org.vn/core/StructureDefinition/vn-core-implantable-device"/> </constraint> <constraint> <key value="vn-implant-regnum-class-cd"/> <severity value="warning"/> <human value="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."/> <expression value="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()"/> <source value="http://fhir.hl7.org.vn/core/StructureDefinition/vn-core-implantable-device"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="Entity. Role, or Act"/> </mapping> <mapping> <identity value="rim"/> <map value="Device"/> </mapping> </element> <element id="Device.id"> <path value="Device.id"/> <short value="Logical id of this artifact"/> <definition value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes."/> <comment value="The only time that a resource does not have an id is when it is being submitted to the server using a create operation."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.id"/> <min value="0"/> <max value="1"/> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="id"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="Device.meta"> <path value="Device.meta"/> <short value="Metadata about the resource"/> <definition value="The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.meta"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Meta"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="Device.implicitRules"> <path value="Device.implicitRules"/> <short value="A set of rules under which this content was created"/> <definition value="A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc."/> <comment value="Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.implicitRules"/> <min value="0"/> <max value="1"/> </base> <type> <code value="uri"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="true"/> <isModifierReason value="This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation"/> <isSummary value="true"/> </element> <element id="Device.language"> <path value="Device.language"/> <short value="Language of the resource content"/> <definition value="The base language in which the resource is written."/> <comment value="Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute)."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.language"/> <min value="0"/> <max value="1"/> </base> <type> <code value="code"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet"> <valueCanonical value="http://hl7.org/fhir/ValueSet/all-languages"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="Language"/> </extension> <strength value="preferred"/> <description value="A human language."/> <valueSet value="http://hl7.org/fhir/ValueSet/languages|4.0.1"/> </binding> </element> <element id="Device.text"> <path value="Device.text"/> <short value="Text summary of the resource, for human interpretation"/> <definition value="A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety."/> <comment value="Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later."/> <alias value="narrative"/> <alias value="html"/> <alias value="xhtml"/> <alias value="display"/> <min value="0"/> <max value="1"/> <base> <path value="DomainResource.text"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Narrative"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="Act.text?"/> </mapping> </element> <element id="Device.contained"> <path value="Device.contained"/> <short value="Contained, inline Resources"/> <definition value="These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope."/> <comment value="This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels."/> <alias value="inline resources"/> <alias value="anonymous resources"/> <alias value="contained resources"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.contained"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Resource"/> </type> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="Device.extension"> <path value="Device.extension"/> <slicing> <discriminator> <type value="value"/> <path value="url"/> </discriminator> <ordered value="false"/> <rules value="open"/> </slicing> <short value="Extension"/> <definition value="An Extension"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="Device.extension:deviceGroup"> <path value="Device.extension"/> <sliceName value="deviceGroup"/> <short value="Nhóm TBYT BHYT N01-N09"/> <definition value="Nhóm thiết bị y tế theo TT 04/2017/TT-BYT Phụ lục 01, sửa đổi bởi TT 24/2025/TT-BYT và văn bản hợp nhất hiện hành. Đây là phân loại phục vụ thanh toán/đối soát BHYT; khi đang biểu diễn một dòng chi phí, ưu tiên đặt tại Claim.item.extension[deviceGroup] thay vì coi là thuộc tính nội tại bắt buộc của Device."/> <min value="0"/> <max value="1"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-group"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="Device.extension:riskClass"> <path value="Device.extension"/> <sliceName value="riskClass"/> <short value="Phân loại rủi ro A/B/C/D — Must Support cho thiết bị cấy ghép"/> <definition value="Phân loại rủi ro thiết bị y tế A/B/C/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) và TT 05/2022/TT-BYT (đã được sửa đổi, bổ sung bởi TT 59/2025/TT-BYT). Extension này là tùy chọn trên Device vì risk class là thuộc tính pháp lý ở mức sản phẩm/model/regulatory context; không bắt buộc cho mọi Device instance trong trao đổi lâm sàng hoặc BHYT. Phân biệt rõ với các dimension độc lập KHÔNG dùng extension này: - Nhóm TBYT BHYT N01-N09 (TT 04/2017/TT-BYT Phụ lục 01) → dùng VNCoreExtDeviceGroup; - Danh pháp thiết bị y tế (QĐ 3107/2024, QĐ 847/2025) → dùng Device.type với hệ danh pháp; - 6 nhóm phân loại tiêu chuẩn kỹ thuật/chất lượng phục vụ đấu thầu theo TT 57/2025/TT-BYT (31/12/2025, hiệu lực 15/02/2026, triển khai 01/01/2027, căn cứ NĐ 214/2025/NĐ-CP về Luật Đấu thầu) → nếu cần biểu diễn, dùng extension riêng trong package procurement, KHÔNG dùng extension này."/> <min value="0"/> <max value="1"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-risk-class"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <mustSupport value="true"/> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="Device.extension:registrationNumber"> <path value="Device.extension"/> <sliceName value="registrationNumber"/> <short value="Số lưu hành TBYT — Must Support cho thiết bị cấy ghép C/D"/> <definition value="Số lưu hành (registration number) của thiết bị y tế tại Việt Nam. **Căn cứ pháp lý**: NĐ 98/2021/NĐ-CP Điều 21 (Phân nhóm số lưu hành), Chương III (Điều 17-33) về đăng ký lưu hành TBYT, 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). **Phân nhóm theo NĐ 98/2021 Điều 21**: 1. **Loại A & B — Số công bố tiêu chuẩn áp dụng** (Sở Y tế tỉnh/TP tiếp nhận): - Format: `[STT tiếp nhận]/[Năm tiếp nhận 2 số]/[Mã ký hiệu Sở Y tế]-PCBA` (loại A) - Format: `[STT tiếp nhận]/[Năm tiếp nhận 2 số]/[Mã ký hiệu Sở Y tế]-PCBB` (loại B) - PCBA/PCBB = Phiếu công bố loại A / loại B - Ví dụ: `2300001/23/HN-PCBA` (Hồ sơ số 1 năm 2023, Sở Y tế Hà Nội tiếp nhận) 2. **Loại C & D — Số Giấy chứng nhận đăng ký lưu hành** (Bộ Y tế cấp): - Format chuẩn: `[STT cấp]/[Năm cấp 2 số]/BYT-ĐKLH` - Format rút gọn: `[STT cấp]/BYT-ĐKLH` - ĐKLH = Đăng ký lưu hành - Ví dụ: `2300055/BYT-ĐKLH` hoặc `2300055/23/BYT-ĐKLH` **Phạm vi**: - Bắt buộc cho loại B/C/D trước khi đưa ra thị trường - Loại A chỉ công bố tiêu chuẩn áp dụng (vẫn dùng PCBA format) - Đây là định danh ở mức sản phẩm/model/regulatory context, KHÔNG phải định danh per-instance **Lưu ý phân biệt**: Extension này độc lập với: - UDI (định danh per-instance theo HL7 best practice) - MA_VAT_TU (mã nghiệp vụ BHYT theo QĐ 3176) - Serial number (per-instance physical) - Mã tài sản BV (internal facility code)"/> <min value="0"/> <max value="1"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-registration-number"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <mustSupport value="true"/> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="Device.extension:isIVD"> <path value="Device.extension"/> <sliceName value="isIVD"/> <short value="Cờ IVD (chẩn đoán in vitro)"/> <definition value="Cờ boolean phân biệt TBYT IVD (chẩn đoán in vitro: sinh phẩm, thuốc thử, máy xét nghiệm) với TBYT thông thường theo VBHN 08/2026/VBHN-BYT. Tùy chọn — chỉ đặt khi cần phân biệt rõ trong ngữ cảnh đăng ký lưu hành/đấu thầu/BHYT."/> <min value="0"/> <max value="1"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-ivd"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="Device.modifierExtension"> <path value="Device.modifierExtension"/> <short value="Extensions that cannot be ignored"/> <definition value="May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="Device.identifier"> <path value="Device.identifier"/> <slicing> <discriminator> <type value="value"/> <path value="system"/> </discriminator> <description value="Phân loại identifier theo system"/> <rules value="open"/> </slicing> <short value="Định danh TBYT (mã vật tư/thiết bị, serial number)"/> <definition value="Unique instance identifiers assigned to a device by manufacturers other organizations or owners."/> <comment value="The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used."/> <min value="0"/> <max value="*"/> <base> <path value="Device.identifier"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Identifier"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="true"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="w5"/> <map value="FiveWs.identifier"/> </mapping> <mapping> <identity value="rim"/> <map value=".id"/> </mapping> <mapping> <identity value="udi"/> <map value="The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty."/> </mapping> </element> <element id="Device.identifier:medicalDeviceItemCode"> <path value="Device.identifier"/> <sliceName value="medicalDeviceItemCode"/> <short value="Mã vật tư/thiết bị y tế (MA_VAT_TU)"/> <definition value="Mã vật tư/thiết bị y tế dùng trong XML dữ liệu đầu ra KCB và thanh toán BHYT. Mapping QĐ 3176/QĐ-BYT: MA_VAT_TU. Đây là mã nghiệp vụ/legacy; không phải UDI, serial number, số lưu hành hoặc mã tài sản. Khi mã này được dùng như product/service code của dòng chi phí, ưu tiên biểu diễn ở Claim.item.productOrService."/> <comment value="The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used."/> <min value="0"/> <max value="1"/> <base> <path value="Device.identifier"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Identifier"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="true"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="w5"/> <map value="FiveWs.identifier"/> </mapping> <mapping> <identity value="rim"/> <map value=".id"/> </mapping> <mapping> <identity value="udi"/> <map value="The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty."/> </mapping> </element> <element id="Device.identifier:medicalDeviceItemCode.id"> <path value="Device.identifier.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Device.identifier:medicalDeviceItemCode.extension"> <path value="Device.identifier.extension"/> <slicing> <discriminator> <type value="value"/> <path value="url"/> </discriminator> <description value="Extensions are always sliced by (at least) url"/> <rules value="open"/> </slicing> <short value="Additional content defined by implementations"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Device.identifier:medicalDeviceItemCode.use"> <path value="Device.identifier.use"/> <short value="usual | official | temp | secondary | old (If known)"/> <definition value="The purpose of this identifier."/> <comment value="Applications can assume that an identifier is permanent unless it explicitly says that it is temporary."/> <requirements value="Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers."/> <min value="0"/> <max value="1"/> <base> <path value="Identifier.use"/> <min value="0"/> <max value="1"/> </base> <type> <code value="code"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="true"/> <isModifierReason value="This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one."/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="IdentifierUse"/> </extension> <strength value="required"/> <description value="Identifies the purpose for this identifier, if known ."/> <valueSet value="http://hl7.org/fhir/ValueSet/identifier-use|4.0.1"/> </binding> <mapping> <identity value="v2"/> <map value="N/A"/> </mapping> <mapping> <identity value="rim"/> <map value="Role.code or implied by context"/> </mapping> </element> <element id="Device.identifier:medicalDeviceItemCode.type"> <path value="Device.identifier.type"/> <short value="Description of identifier"/> <definition value="A coded type for the identifier that can be used to determine which identifier to use for a specific purpose."/> <comment value="This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type."/> <requirements value="Allows users to make use of identifiers when the identifier system is not known."/> <min value="0"/> <max value="1"/> <base> <path value="Identifier.type"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="IdentifierType"/> </extension> <strength value="extensible"/> <description value="A coded type for an identifier that can be used to determine which identifier to use for a specific purpose."/> <valueSet value="http://hl7.org/fhir/ValueSet/identifier-type|4.0.1"/> </binding> <mapping> <identity value="v2"/> <map value="CX.5"/> </mapping> <mapping> <identity value="rim"/> <map value="Role.code or implied by context"/> </mapping> </element> <element id="Device.identifier:medicalDeviceItemCode.type.id"> <path value="Device.identifier.type.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Device.identifier:medicalDeviceItemCode.type.extension"> <path value="Device.identifier.type.extension"/> <slicing> <discriminator> <type value="value"/> <path value="url"/> </discriminator> <description value="Extensions are always sliced by (at least) url"/> <rules value="open"/> </slicing> <short value="Additional content defined by implementations"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Device.identifier:medicalDeviceItemCode.type.coding"> <path value="Device.identifier.type.coding"/> <short value="Code defined by a terminology system"/> <definition value="A reference to a code defined by a terminology system."/> <comment value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true."/> <requirements value="Allows for alternative encodings within a code system, and translations to other code systems."/> <min value="0"/> <max value="*"/> <base> <path value="CodeableConcept.coding"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Coding"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="C*E.1-8, C*E.10-22"/> </mapping> <mapping> <identity value="rim"/> <map value="union(., ./translation)"/> </mapping> <mapping> <identity value="orim"/> <map value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"/> </mapping> </element> <element id="Device.identifier:medicalDeviceItemCode.type.text"> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable"> <valueBoolean value="true"/> </extension> <path value="Device.identifier.type.text"/> <short value="Plain text representation of the concept"/> <definition value="A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user."/> <comment value="Very often the text is the same as a displayName of one of the codings."/> <requirements value="The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source."/> <min value="0"/> <max value="1"/> <base> <path value="CodeableConcept.text"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <patternString value="Mã vật tư/thiết bị y tế"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="C*E.9. But note many systems use C*E.2 for this"/> </mapping> <mapping> <identity value="rim"/> <map value="./originalText[mediaType/code="text/plain"]/data"/> </mapping> <mapping> <identity value="orim"/> <map value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"/> </mapping> </element> <element id="Device.identifier:medicalDeviceItemCode.system"> <path value="Device.identifier.system"/> <short value="The namespace for the identifier value"/> <definition value="Establishes the namespace for the value - that is, a URL that describes a set values that are unique."/> <comment value="Identifier.system is always case sensitive."/> <requirements value="There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers."/> <min value="1"/> <max value="1"/> <base> <path value="Identifier.system"/> <min value="0"/> <max value="1"/> </base> <type> <code value="uri"/> </type> <fixedUri value="http://fhir.hl7.org.vn/core/sid/medical-device-item-code"/> <example> <label value="General"/> <valueUri value="http://www.acme.com/identifiers/patient"/> </example> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="CX.4 / EI-2-4"/> </mapping> <mapping> <identity value="rim"/> <map value="II.root or Role.id.root"/> </mapping> <mapping> <identity value="servd"/> <map value="./IdentifierType"/> </mapping> </element> <element id="Device.identifier:medicalDeviceItemCode.value"> <path value="Device.identifier.value"/> <short value="Giá trị MA_VAT_TU"/> <definition value="The portion of the identifier typically relevant to the user and which is unique within the context of the system."/> <comment value="If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [Rendered Value extension](http://hl7.org/fhir/R4/extension-rendered-value.html). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe."/> <min value="1"/> <max value="1"/> <base> <path value="Identifier.value"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <example> <label value="General"/> <valueString value="123456"/> </example> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="true"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="CX.1 / EI.1"/> </mapping> <mapping> <identity value="rim"/> <map value="II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)"/> </mapping> <mapping> <identity value="servd"/> <map value="./Value"/> </mapping> </element> <element id="Device.identifier:medicalDeviceItemCode.period"> <path value="Device.identifier.period"/> <short value="Time period when id is/was valid for use"/> <definition value="Time period during which identifier is/was valid for use."/> <min value="0"/> <max value="1"/> <base> <path value="Identifier.period"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Period"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="CX.7 + CX.8"/> </mapping> <mapping> <identity value="rim"/> <map value="Role.effectiveTime or implied by context"/> </mapping> <mapping> <identity value="servd"/> <map value="./StartDate and ./EndDate"/> </mapping> </element> <element id="Device.identifier:medicalDeviceItemCode.assigner"> <path value="Device.identifier.assigner"/> <short value="Organization that issued id (may be just text)"/> <definition value="Organization that issued/manages the identifier."/> <comment value="The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization."/> <min value="0"/> <max value="1"/> <base> <path value="Identifier.assigner"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization|4.0.1"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="CX.4 / (CX.4,CX.9,CX.10)"/> </mapping> <mapping> <identity value="rim"/> <map value="II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper"/> </mapping> <mapping> <identity value="servd"/> <map value="./IdentifierIssuingAuthority"/> </mapping> </element> <element id="Device.identifier:serialNumber"> <path value="Device.identifier"/> <sliceName value="serialNumber"/> <short value="Số serial dạng Identifier"/> <definition value="Số serial khi hệ thống trao đổi dưới dạng Identifier. Device.serialNumber vẫn là vị trí FHIR chính để ghi serial number."/> <comment value="The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used."/> <min value="0"/> <max value="1"/> <base> <path value="Device.identifier"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Identifier"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="true"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="w5"/> <map value="FiveWs.identifier"/> </mapping> <mapping> <identity value="rim"/> <map value=".id"/> </mapping> <mapping> <identity value="udi"/> <map value="The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty."/> </mapping> </element> <element id="Device.identifier:serialNumber.id"> <path value="Device.identifier.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Device.identifier:serialNumber.extension"> <path value="Device.identifier.extension"/> <slicing> <discriminator> <type value="value"/> <path value="url"/> </discriminator> <description value="Extensions are always sliced by (at least) url"/> <rules value="open"/> </slicing> <short value="Additional content defined by implementations"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Device.identifier:serialNumber.use"> <path value="Device.identifier.use"/> <short value="usual | official | temp | secondary | old (If known)"/> <definition value="The purpose of this identifier."/> <comment value="Applications can assume that an identifier is permanent unless it explicitly says that it is temporary."/> <requirements value="Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers."/> <min value="0"/> <max value="1"/> <base> <path value="Identifier.use"/> <min value="0"/> <max value="1"/> </base> <type> <code value="code"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="true"/> <isModifierReason value="This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one."/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="IdentifierUse"/> </extension> <strength value="required"/> <description value="Identifies the purpose for this identifier, if known ."/> <valueSet value="http://hl7.org/fhir/ValueSet/identifier-use|4.0.1"/> </binding> <mapping> <identity value="v2"/> <map value="N/A"/> </mapping> <mapping> <identity value="rim"/> <map value="Role.code or implied by context"/> </mapping> </element> <element id="Device.identifier:serialNumber.type"> <path value="Device.identifier.type"/> <short value="Description of identifier"/> <definition value="A coded type for the identifier that can be used to determine which identifier to use for a specific purpose."/> <comment value="This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type."/> <requirements value="Allows users to make use of identifiers when the identifier system is not known."/> <min value="0"/> <max value="1"/> <base> <path value="Identifier.type"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <patternCodeableConcept> <coding> <system value="http://terminology.hl7.org/CodeSystem/v2-0203"/> <code value="SNO"/> </coding> </patternCodeableConcept> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="IdentifierType"/> </extension> <strength value="extensible"/> <description value="A coded type for an identifier that can be used to determine which identifier to use for a specific purpose."/> <valueSet value="http://hl7.org/fhir/ValueSet/identifier-type|4.0.1"/> </binding> <mapping> <identity value="v2"/> <map value="CX.5"/> </mapping> <mapping> <identity value="rim"/> <map value="Role.code or implied by context"/> </mapping> </element> <element id="Device.identifier:serialNumber.system"> <path value="Device.identifier.system"/> <short value="The namespace for the identifier value"/> <definition value="Establishes the namespace for the value - that is, a URL that describes a set values that are unique."/> <comment value="Identifier.system is always case sensitive."/> <requirements value="There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers."/> <min value="1"/> <max value="1"/> <base> <path value="Identifier.system"/> <min value="0"/> <max value="1"/> </base> <type> <code value="uri"/> </type> <fixedUri value="http://fhir.hl7.org.vn/core/sid/device-serial-number"/> <example> <label value="General"/> <valueUri value="http://www.acme.com/identifiers/patient"/> </example> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="CX.4 / EI-2-4"/> </mapping> <mapping> <identity value="rim"/> <map value="II.root or Role.id.root"/> </mapping> <mapping> <identity value="servd"/> <map value="./IdentifierType"/> </mapping> </element> <element id="Device.identifier:serialNumber.value"> <path value="Device.identifier.value"/> <short value="Số serial"/> <definition value="The portion of the identifier typically relevant to the user and which is unique within the context of the system."/> <comment value="If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [Rendered Value extension](http://hl7.org/fhir/R4/extension-rendered-value.html). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe."/> <min value="1"/> <max value="1"/> <base> <path value="Identifier.value"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <example> <label value="General"/> <valueString value="123456"/> </example> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="true"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="CX.1 / EI.1"/> </mapping> <mapping> <identity value="rim"/> <map value="II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)"/> </mapping> <mapping> <identity value="servd"/> <map value="./Value"/> </mapping> </element> <element id="Device.identifier:serialNumber.period"> <path value="Device.identifier.period"/> <short value="Time period when id is/was valid for use"/> <definition value="Time period during which identifier is/was valid for use."/> <min value="0"/> <max value="1"/> <base> <path value="Identifier.period"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Period"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="CX.7 + CX.8"/> </mapping> <mapping> <identity value="rim"/> <map value="Role.effectiveTime or implied by context"/> </mapping> <mapping> <identity value="servd"/> <map value="./StartDate and ./EndDate"/> </mapping> </element> <element id="Device.identifier:serialNumber.assigner"> <path value="Device.identifier.assigner"/> <short value="Organization that issued id (may be just text)"/> <definition value="Organization that issued/manages the identifier."/> <comment value="The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization."/> <min value="0"/> <max value="1"/> <base> <path value="Identifier.assigner"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization|4.0.1"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="CX.4 / (CX.4,CX.9,CX.10)"/> </mapping> <mapping> <identity value="rim"/> <map value="II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper"/> </mapping> <mapping> <identity value="servd"/> <map value="./IdentifierIssuingAuthority"/> </mapping> </element> <element id="Device.definition"> <path value="Device.definition"/> <short value="The reference to the definition for the device"/> <definition value="The reference to the definition for the device."/> <min value="0"/> <max value="1"/> <base> <path value="Device.definition"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/DeviceDefinition|4.0.1"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="Device.udiCarrier"> <path value="Device.udiCarrier"/> <short value="UDI carrier của thiết bị cấy ghép khi có"/> <definition value="Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold."/> <comment value="UDI may identify an unique instance of a device, or it may only identify the type of the device. See [UDI mappings](http://hl7.org/fhir/R4/device-mappings.html#udi) for a complete mapping of UDI parts to Device."/> <min value="0"/> <max value="*"/> <base> <path value="Device.udiCarrier"/> <min value="0"/> <max value="*"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="true"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="w5"/> <map value="FiveWs.identifier"/> </mapping> <mapping> <identity value="rim"/> <map value=".id and .code"/> </mapping> </element> <element id="Device.udiCarrier.id"> <path value="Device.udiCarrier.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Device.udiCarrier.extension"> <path value="Device.udiCarrier.extension"/> <short value="Additional content defined by implementations"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Device.udiCarrier.modifierExtension"> <path value="Device.udiCarrier.modifierExtension"/> <short value="Extensions that cannot be ignored even if unrecognized"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/> <alias value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneElement.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="Device.udiCarrier.deviceIdentifier"> <path value="Device.udiCarrier.deviceIdentifier"/> <short value="UDI Device Identifier"/> <definition value="The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device."/> <alias value="DI"/> <min value="0"/> <max value="1"/> <base> <path value="Device.udiCarrier.deviceIdentifier"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="true"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="w5"/> <map value="FiveWs.what[x]"/> </mapping> <mapping> <identity value="rim"/> <map value="Role.id.extension"/> </mapping> <mapping> <identity value="udi"/> <map value="The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device."/> </mapping> </element> <element id="Device.udiCarrier.issuer"> <path value="Device.udiCarrier.issuer"/> <short value="UDI Issuing Organization"/> <definition value="Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : 1) GS1: http://hl7.org/fhir/NamingSystem/gs1-di, 2) HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, 3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, 4) ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di."/> <alias value="Barcode System"/> <min value="0"/> <max value="1"/> <base> <path value="Device.udiCarrier.issuer"/> <min value="0"/> <max value="1"/> </base> <type> <code value="uri"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="Role.id.root"/> </mapping> <mapping> <identity value="udi"/> <map value="All UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency. GS1 DIs: http://hl7.org/fhir/NamingSystem/gs1 HIBCC DIs: http://hl7.org/fhir/NamingSystem/hibcc ICCBBA DIs for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood ICCBA DIs for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other"/> </mapping> </element> <element id="Device.udiCarrier.jurisdiction"> <path value="Device.udiCarrier.jurisdiction"/> <short value="Regional UDI authority"/> <definition value="The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi."/> <requirements value="Allows a recipient of a UDI to know which database will contain the UDI-associated metadata."/> <min value="0"/> <max value="1"/> <base> <path value="Device.udiCarrier.jurisdiction"/> <min value="0"/> <max value="1"/> </base> <type> <code value="uri"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="Role.scoper"/> </mapping> </element> <element id="Device.udiCarrier.carrierAIDC"> <path value="Device.udiCarrier.carrierAIDC"/> <short value="UDI automatic identification and data capture"/> <definition value="The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - e.g., a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats *SHALL* be base64 encoded."/> <comment value="The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label."/> <alias value="Automatic Identification and Data Capture"/> <min value="0"/> <max value="1"/> <base> <path value="Device.udiCarrier.carrierAIDC"/> <min value="0"/> <max value="1"/> </base> <type> <code value="base64Binary"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="true"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="Role.id.extension"/> </mapping> <mapping> <identity value="udi"/> <map value="A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology."/> </mapping> </element> <element id="Device.udiCarrier.carrierHRF"> <path value="Device.udiCarrier.carrierHRF"/> <short value="UDI human-readable form"/> <definition value="The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device."/> <comment value="If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label."/> <alias value="Human Readable Form"/> <min value="0"/> <max value="1"/> <base> <path value="Device.udiCarrier.carrierHRF"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="true"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="Role.id.extension"/> </mapping> <mapping> <identity value="udi"/> <map value="A unique device identifier (UDI) on a device label in plain text"/> </mapping> </element> <element id="Device.udiCarrier.entryType"> <path value="Device.udiCarrier.entryType"/> <short value="barcode | rfid | manual +"/> <definition value="A coded entry to indicate how the data was entered."/> <requirements value="Supports a way to distinguish hand entered from machine read data."/> <min value="0"/> <max value="1"/> <base> <path value="Device.udiCarrier.entryType"/> <min value="0"/> <max value="1"/> </base> <type> <code value="code"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="UDIEntryType"/> </extension> <strength value="required"/> <description value="Codes to identify how UDI data was entered."/> <valueSet value="http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1"/> </binding> <mapping> <identity value="rim"/> <map value="NA"/> </mapping> </element> <element id="Device.status"> <path value="Device.status"/> <short value="Trạng thái thiết bị cấy ghép"/> <definition value="Status of the Device availability."/> <comment value="This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid."/> <min value="1"/> <max value="1"/> <base> <path value="Device.status"/> <min value="0"/> <max value="1"/> </base> <type> <code value="code"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="true"/> <isModifier value="true"/> <isModifierReason value="This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="FHIRDeviceStatus"/> </extension> <strength value="required"/> <description value="The availability status of the device."/> <valueSet value="http://hl7.org/fhir/ValueSet/device-status|4.0.1"/> </binding> <mapping> <identity value="w5"/> <map value="FiveWs.status"/> </mapping> <mapping> <identity value="rim"/> <map value=".statusCode"/> </mapping> </element> <element id="Device.statusReason"> <path value="Device.statusReason"/> <short value="online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off"/> <definition value="Reason for the dtatus of the Device availability."/> <min value="0"/> <max value="*"/> <base> <path value="Device.statusReason"/> <min value="0"/> <max value="*"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="FHIRDeviceStatusReason"/> </extension> <strength value="extensible"/> <description value="The availability status reason of the device."/> <valueSet value="http://hl7.org/fhir/ValueSet/device-status-reason|4.0.1"/> </binding> <mapping> <identity value="w5"/> <map value="FiveWs.status"/> </mapping> </element> <element id="Device.distinctIdentifier"> <path value="Device.distinctIdentifier"/> <short value="Định danh phân biệt thiết bị cấy ghép"/> <definition value="The distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based product."/> <comment value="For example, this applies to devices in the United States regulated under *Code of Federal Regulation 21CFR§1271.290(c)*."/> <alias value="Distinct Identification Code (DIC)"/> <min value="0"/> <max value="1"/> <base> <path value="Device.distinctIdentifier"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="true"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="w5"/> <map value="FiveWs.what[x]"/> </mapping> <mapping> <identity value="rim"/> <map value=".lotNumberText"/> </mapping> <mapping> <identity value="udi"/> <map value="The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI."/> </mapping> </element> <element id="Device.manufacturer"> <path value="Device.manufacturer"/> <short value="Hãng sản xuất"/> <definition value="Tên hãng sản xuất. Các QĐ 5086/QĐ-BYT, 637/2022, 1844/2022, 3181/2022 liên quan mã hãng sản xuất VTYT/TBYT; không model thành mã hàng TBYT đầy đủ trong v0.3."/> <min value="0"/> <max value="1"/> <base> <path value="Device.manufacturer"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="true"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="w5"/> <map value="FiveWs.what[x]"/> </mapping> <mapping> <identity value="rim"/> <map value=".playedRole[typeCode=MANU].scoper.name"/> </mapping> <mapping> <identity value="udi"/> <map value="N/A"/> </mapping> </element> <element id="Device.manufactureDate"> <path value="Device.manufactureDate"/> <short value="Ngày sản xuất"/> <definition value="The date and time when the device was manufactured."/> <min value="0"/> <max value="1"/> <base> <path value="Device.manufactureDate"/> <min value="0"/> <max value="1"/> </base> <type> <code value="dateTime"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="true"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="w5"/> <map value="FiveWs.what[x]"/> </mapping> <mapping> <identity value="rim"/> <map value=".existenceTime.low"/> </mapping> <mapping> <identity value="udi"/> <map value="The date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”."/> </mapping> </element> <element id="Device.expirationDate"> <path value="Device.expirationDate"/> <short value="Hạn sử dụng"/> <definition value="The date and time beyond which this device is no longer valid or should not be used (if applicable)."/> <min value="0"/> <max value="1"/> <base> <path value="Device.expirationDate"/> <min value="0"/> <max value="1"/> </base> <type> <code value="dateTime"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="true"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="w5"/> <map value="FiveWs.what[x]"/> </mapping> <mapping> <identity value="rim"/> <map value=".expirationTime"/> </mapping> <mapping> <identity value="udi"/> <map value="the expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”."/> </mapping> </element> <element id="Device.lotNumber"> <path value="Device.lotNumber"/> <short value="Số lô"/> <definition value="Lot number assigned by the manufacturer."/> <min value="0"/> <max value="1"/> <base> <path value="Device.lotNumber"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="true"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="w5"/> <map value="FiveWs.what[x]"/> </mapping> <mapping> <identity value="rim"/> <map value=".lotNumberText"/> </mapping> <mapping> <identity value="udi"/> <map value="The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI."/> </mapping> </element> <element id="Device.serialNumber"> <path value="Device.serialNumber"/> <short value="Số serial"/> <definition value="The serial number assigned by the organization when the device was manufactured."/> <comment value="Alphanumeric Maximum 20."/> <min value="0"/> <max value="1"/> <base> <path value="Device.serialNumber"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="true"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="w5"/> <map value="FiveWs.what[x]"/> </mapping> <mapping> <identity value="rim"/> <map value=".playedRole[typeCode=MANU].id"/> </mapping> </element> <element id="Device.deviceName"> <path value="Device.deviceName"/> <short value="The name of the device as given by the manufacturer"/> <definition value="This represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition."/> <min value="0"/> <max value="*"/> <base> <path value="Device.deviceName"/> <min value="0"/> <max value="*"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="Device.deviceName.id"> <path value="Device.deviceName.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Device.deviceName.extension"> <path value="Device.deviceName.extension"/> <short value="Additional content defined by implementations"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Device.deviceName.modifierExtension"> <path value="Device.deviceName.modifierExtension"/> <short value="Extensions that cannot be ignored even if unrecognized"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/> <alias value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneElement.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="Device.deviceName.name"> <path value="Device.deviceName.name"/> <short value="The name of the device"/> <definition value="The name of the device."/> <alias value="Σ"/> <min value="1"/> <max value="1"/> <base> <path value="Device.deviceName.name"/> <min value="1"/> <max value="1"/> </base> <type> <code value="string"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="Device.deviceName.type"> <path value="Device.deviceName.type"/> <short value="udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other"/> <definition value="The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName."/> <min value="1"/> <max value="1"/> <base> <path value="Device.deviceName.type"/> <min value="1"/> <max value="1"/> </base> <type> <code value="code"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="DeviceNameType"/> </extension> <strength value="required"/> <description value="The type of name the device is referred by."/> <valueSet value="http://hl7.org/fhir/ValueSet/device-nametype|4.0.1"/> </binding> <mapping> <identity value="w5"/> <map value="FiveWs.what[x]"/> </mapping> <mapping> <identity value="rim"/> <map value=".playedRole[typeCode=MANU].code"/> </mapping> </element> <element id="Device.modelNumber"> <path value="Device.modelNumber"/> <short value="Model / quy cách"/> <definition value="The model number for the device."/> <min value="0"/> <max value="1"/> <base> <path value="Device.modelNumber"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="true"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="w5"/> <map value="FiveWs.what[x]"/> </mapping> <mapping> <identity value="rim"/> <map value=".softwareName (included as part)"/> </mapping> </element> <element id="Device.partNumber"> <path value="Device.partNumber"/> <short value="The part number of the device"/> <definition value="The part number of the device."/> <comment value="Alphanumeric Maximum 20."/> <min value="0"/> <max value="1"/> <base> <path value="Device.partNumber"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="w5"/> <map value="FiveWs.what[x]"/> </mapping> <mapping> <identity value="rim"/> <map value=".playedRole[typeCode=MANU].id"/> </mapping> </element> <element id="Device.type"> <path value="Device.type"/> <short value="Loại thiết bị cấy ghép"/> <definition value="Loại thiết bị cấy ghép, nên mã hóa bằng SNOMED CT hoặc hệ danh pháp thiết bị đã được governance. Chưa required binding vào QĐ 847/QĐ 3107 trong v0.4."/> <min value="1"/> <max value="1"/> <base> <path value="Device.type"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="true"/> <isModifier value="false"/> <isSummary value="false"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="DeviceType"/> </extension> <strength value="example"/> <description value="Codes to identify medical devices."/> <valueSet value="http://hl7.org/fhir/ValueSet/device-type|4.0.1"/> </binding> </element> <element id="Device.specialization"> <path value="Device.specialization"/> <short value="The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication"/> <definition value="The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication."/> <min value="0"/> <max value="*"/> <base> <path value="Device.specialization"/> <min value="0"/> <max value="*"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="Device.specialization.id"> <path value="Device.specialization.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Device.specialization.extension"> <path value="Device.specialization.extension"/> <short value="Additional content defined by implementations"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Device.specialization.modifierExtension"> <path value="Device.specialization.modifierExtension"/> <short value="Extensions that cannot be ignored even if unrecognized"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/> <alias value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneElement.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="Device.specialization.systemType"> <path value="Device.specialization.systemType"/> <short value="The standard that is used to operate and communicate"/> <definition value="The standard that is used to operate and communicate."/> <alias value="Σ"/> <min value="1"/> <max value="1"/> <base> <path value="Device.specialization.systemType"/> <min value="1"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="Device.specialization.version"> <path value="Device.specialization.version"/> <short value="The version of the standard that is used to operate and communicate"/> <definition value="The version of the standard that is used to operate and communicate."/> <min value="0"/> <max value="1"/> <base> <path value="Device.specialization.version"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="w5"/> <map value="FiveWs.what[x]"/> </mapping> </element> <element id="Device.version"> <path value="Device.version"/> <short value="The actual design of the device or software version running on the device"/> <definition value="The actual design of the device or software version running on the device."/> <min value="0"/> <max value="*"/> <base> <path value="Device.version"/> <min value="0"/> <max value="*"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="Device.version.id"> <path value="Device.version.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Device.version.extension"> <path value="Device.version.extension"/> <short value="Additional content defined by implementations"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Device.version.modifierExtension"> <path value="Device.version.modifierExtension"/> <short value="Extensions that cannot be ignored even if unrecognized"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/> <alias value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneElement.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="Device.version.type"> <path value="Device.version.type"/> <short value="The type of the device version"/> <definition value="The type of the device version."/> <alias value="Σ"/> <min value="0"/> <max value="1"/> <base> <path value="Device.version.type"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="Device.version.component"> <path value="Device.version.component"/> <short value="A single component of the device version"/> <definition value="A single component of the device version."/> <min value="0"/> <max value="1"/> <base> <path value="Device.version.component"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Identifier"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="w5"/> <map value="FiveWs.what[x]"/> </mapping> </element> <element id="Device.version.value"> <path value="Device.version.value"/> <short value="The version text"/> <definition value="The version text."/> <min value="1"/> <max value="1"/> <base> <path value="Device.version.value"/> <min value="1"/> <max value="1"/> </base> <type> <code value="string"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="Device.property"> <path value="Device.property"/> <short value="The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties"/> <definition value="The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties."/> <min value="0"/> <max value="*"/> <base> <path value="Device.property"/> <min value="0"/> <max value="*"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="Device.property.id"> <path value="Device.property.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Device.property.extension"> <path value="Device.property.extension"/> <short value="Additional content defined by implementations"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="Device.property.modifierExtension"> <path value="Device.property.modifierExtension"/> <short value="Extensions that cannot be ignored even if unrecognized"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/> <alias value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneElement.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="Device.property.type"> <path value="Device.property.type"/> <short value="Code that specifies the property DeviceDefinitionPropetyCode (Extensible)"/> <definition value="Code that specifies the property DeviceDefinitionPropetyCode (Extensible)."/> <min value="1"/> <max value="1"/> <base> <path value="Device.property.type"/> <min value="1"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="Device.property.valueQuantity"> <path value="Device.property.valueQuantity"/> <short value="Property value as a quantity"/> <definition value="Property value as a quantity."/> <min value="0"/> <max value="*"/> <base> <path value="Device.property.valueQuantity"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Quantity"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="Device.property.valueCode"> <path value="Device.property.valueCode"/> <short value="Property value as a code, e.g., NTP4 (synced to NTP)"/> <definition value="Property value as a code, e.g., NTP4 (synced to NTP)."/> <min value="0"/> <max value="*"/> <base> <path value="Device.property.valueCode"/> <min value="0"/> <max value="*"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="Device.patient"> <path value="Device.patient"/> <short value="Bệnh nhân đang/đã được cấy ghép thiết bị"/> <definition value="Bệnh nhân gắn với thiết bị cấy ghép. Đây là điểm khác với VNCoreDevice nền, vốn vẫn hỗ trợ thiết bị chưa gắn người bệnh hoặc vật tư/thiết bị trong dữ liệu thanh toán."/> <requirements value="If the device is implanted in a patient, then need to associate the device to the patient."/> <min value="1"/> <max value="1"/> <base> <path value="Device.patient"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://fhir.hl7.org.vn/core/StructureDefinition/vn-core-patient"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="true"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="w5"/> <map value="FiveWs.subject[x]"/> </mapping> <mapping> <identity value="rim"/> <map value=".playedRole[typeCode=USED].scoper.playedRole[typeCode=PAT]"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.subject"/> </mapping> </element> <element id="Device.owner"> <path value="Device.owner"/> <short value="Organization responsible for device"/> <definition value="An organization that is responsible for the provision and ongoing maintenance of the device."/> <min value="0"/> <max value="1"/> <base> <path value="Device.owner"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization|4.0.1"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="w5"/> <map value="FiveWs.source"/> </mapping> <mapping> <identity value="rim"/> <map value=".playedRole[typeCode=OWN].scoper"/> </mapping> </element> <element id="Device.contact"> <path value="Device.contact"/> <short value="Details for human/organization for support"/> <definition value="Contact details for an organization or a particular human that is responsible for the device."/> <comment value="used for troubleshooting etc."/> <min value="0"/> <max value="*"/> <base> <path value="Device.contact"/> <min value="0"/> <max value="*"/> </base> <type> <code value="ContactPoint"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="w5"/> <map value="FiveWs.source"/> </mapping> <mapping> <identity value="rim"/> <map value=".scopedRole[typeCode=CON].player"/> </mapping> </element> <element id="Device.location"> <path value="Device.location"/> <short value="Where the device is found"/> <definition value="The place where the device can be found."/> <requirements value="Device.location can be used to track device location."/> <min value="0"/> <max value="1"/> <base> <path value="Device.location"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Location|4.0.1"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="w5"/> <map value="FiveWs.where[x]"/> </mapping> <mapping> <identity value="rim"/> <map value=".playedRole[typeCode=LOCE].scoper"/> </mapping> </element> <element id="Device.url"> <path value="Device.url"/> <short value="Network address to contact device"/> <definition value="A network address on which the device may be contacted directly."/> <comment value="If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved."/> <min value="0"/> <max value="1"/> <base> <path value="Device.url"/> <min value="0"/> <max value="1"/> </base> <type> <code value="uri"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="w5"/> <map value="FiveWs.where[x]"/> </mapping> <mapping> <identity value="rim"/> <map value=".telecom"/> </mapping> </element> <element id="Device.note"> <path value="Device.note"/> <short value="Ghi chú (tên VTYT, quy cách...)"/> <definition value="Descriptive information, usage information or implantation information that is not captured in an existing element."/> <min value="0"/> <max value="*"/> <base> <path value="Device.note"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Annotation"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value=".text"/> </mapping> </element> <element id="Device.safety"> <path value="Device.safety"/> <short value="Thông tin an toàn của thiết bị cấy ghép"/> <definition value="Provides additional safety characteristics about a medical device. For example devices containing latex."/> <min value="0"/> <max value="*"/> <base> <path value="Device.safety"/> <min value="0"/> <max value="*"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="true"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="NA"/> </mapping> </element> <element id="Device.parent"> <path value="Device.parent"/> <short value="The parent device"/> <definition value="The parent device."/> <min value="0"/> <max value="1"/> <base> <path value="Device.parent"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Device|4.0.1"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> </element> </snapshot> <differential> <element id="Device"> <path value="Device"/> <constraint> <key value="vn-implant-udi-carrier-content"/> <severity value="warning"/> <human value="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."/> <expression value="udiCarrier.empty() or udiCarrier.all(carrierHRF.exists() or carrierAIDC.exists())"/> <source value="http://fhir.hl7.org.vn/core/StructureDefinition/vn-core-implantable-device"/> </constraint> <constraint> <key value="vn-implant-regnum-class-cd"/> <severity value="warning"/> <human value="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."/> <expression value="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()"/> <source value="http://fhir.hl7.org.vn/core/StructureDefinition/vn-core-implantable-device"/> </constraint> </element> <element id="Device.extension:riskClass"> <path value="Device.extension"/> <sliceName value="riskClass"/> <short value="Phân loại rủi ro A/B/C/D — Must Support cho thiết bị cấy ghép"/> <mustSupport value="true"/> </element> <element id="Device.extension:registrationNumber"> <path value="Device.extension"/> <sliceName value="registrationNumber"/> <short value="Số lưu hành TBYT — Must Support cho thiết bị cấy ghép C/D"/> <mustSupport value="true"/> </element> <element id="Device.udiCarrier"> <path value="Device.udiCarrier"/> <short value="UDI carrier của thiết bị cấy ghép khi có"/> </element> <element id="Device.udiCarrier.carrierAIDC"> <path value="Device.udiCarrier.carrierAIDC"/> <short value="UDI automatic identification and data capture"/> <mustSupport value="true"/> </element> <element id="Device.status"> <path value="Device.status"/> <short value="Trạng thái thiết bị cấy ghép"/> </element> <element id="Device.modelNumber"> <path value="Device.modelNumber"/> <short value="Model / quy cách"/> </element> <element id="Device.type"> <path value="Device.type"/> <short value="Loại thiết bị cấy ghép"/> <definition value="Loại thiết bị cấy ghép, nên mã hóa bằng SNOMED CT hoặc hệ danh pháp thiết bị đã được governance. Chưa required binding vào QĐ 847/QĐ 3107 trong v0.4."/> <min value="1"/> </element> <element id="Device.patient"> <path value="Device.patient"/> <short value="Bệnh nhân đang/đã được cấy ghép thiết bị"/> <definition value="Bệnh nhân gắn với thiết bị cấy ghép. Đây là điểm khác với VNCoreDevice nền, vốn vẫn hỗ trợ thiết bị chưa gắn người bệnh hoặc vật tư/thiết bị trong dữ liệu thanh toán."/> <min value="1"/> </element> <element id="Device.safety"> <path value="Device.safety"/> <short value="Thông tin an toàn của thiết bị cấy ghép"/> <mustSupport value="true"/> </element> </differential> </StructureDefinition>

Generated Narrative: StructureDefinition vn-core-implantable-device

Name	Flags	Card.	Type	Description & Constraints
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
modelNumber		0..1	string	Model / quy cách
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
Documentation for this format


  
    
      
      
    
  
  
    
      
      
    
  
  
    
      
      
    
  
  
    
      
      
    
  
  
    
      
      
    
  
  
    
      
      
    
  
  
    
      
      
    
  
  
  
  
  
  <status value="draft"/>
  <date value="2026-04-19"/>
  <publisher value="Omi HealthTech / VN Core FHIR Community Initiative"/>
  <contact>
    <name value="Omi HealthTech / VN Core FHIR Community Initiative"/>
    <telecom>
      <system value="url"/>
      <value value="https://hl7.org.vn"/>
    </telecom>
    <telecom>
      <system value="email"/>
      <value value="info@hl7.org.vn"/>
    </telecom>
  </contact>
  <contact>
    <name value="Omi HealthTech (OmiGroup)"/>
    <telecom>
      <system value="url"/>
      <value value="https://omihealthtech.vn"/>
    </telecom>
    <telecom>
      <system value="url"/>
      <value value="https://omigroup.vn"/>
    </telecom>
    <telecom>
      <system value="email"/>
      <value value="healthtech@omigroup.vn"/>
    </telecom>
  </contact>
  <description value="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."/>
  <jurisdiction>
    <coding>
      <system value="urn:iso:std:iso:3166"/>
      <code value="VN"/>
      <display value="Viet Nam"/>
    </coding>
  </jurisdiction>
  <copyright value="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."/>
  <fhirVersion value="4.0.1"/>
  <mapping>
    <identity value="rim"/>
    <uri value="http://hl7.org/v3"/>
    <name value="RIM Mapping"/>
  </mapping>
  <mapping>
    <identity value="w5"/>
    <uri value="http://hl7.org/fhir/fivews"/>
    <name value="FiveWs Pattern Mapping"/>
  </mapping>
  <mapping>
    <identity value="udi"/>
    <uri value="http://fda.gov/UDI"/>
    <name value="UDI Mapping"/>
  </mapping>
  <kind value="resource"/>
  <abstract value="false"/>
  <type value="Device"/>
  <baseDefinition value="http://fhir.hl7.org.vn/core/StructureDefinition/vn-core-device"/>
  <derivation value="constraint"/>
  <snapshot>
    <extension url="http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version">
      <valueString value="0.5.0"/>
    </extension>
    <element id="Device">
      <path value="Device"/>
      <short value="Item used in healthcare"/>
      <definition value="A type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Device"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <constraint>
        <key value="dom-2"/>
        <severity value="error"/>
        <human value="If the resource is contained in another resource, it SHALL NOT contain nested Resources"/>
        <expression value="contained.contained.empty()"/>
        <xpath value="not(parent::f:contained and f:contained)"/>
        <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
      </constraint>
      <constraint>
        <key value="dom-3"/>
        <severity value="error"/>
        <human value="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"/>
        <expression value="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()"/>
        <xpath value="not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))"/>
        <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
      </constraint>
      <constraint>
        <key value="dom-4"/>
        <severity value="error"/>
        <human value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated"/>
        <expression value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"/>
        <xpath value="not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))"/>
        <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
      </constraint>
      <constraint>
        <key value="dom-5"/>
        <severity value="error"/>
        <human value="If a resource is contained in another resource, it SHALL NOT have a security label"/>
        <expression value="contained.meta.security.empty()"/>
        <xpath value="not(exists(f:contained/*/f:meta/f:security))"/>
        <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
      </constraint>
      <constraint>
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice">
          <valueBoolean value="true"/>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation">
          <valueMarkdown value="When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."/>
        </extension>
        <key value="dom-6"/>
        <severity value="warning"/>
        <human value="A resource should have narrative for robust management"/>
        <expression value="text.`div`.exists()"/>
        <xpath value="exists(f:text/h:div)"/>
        <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
      </constraint>
      <constraint>
        <key value="vn-implant-udi-carrier-content"/>
        <severity value="warning"/>
        <human value="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."/>
        <expression value="udiCarrier.empty() or udiCarrier.all(carrierHRF.exists() or carrierAIDC.exists())"/>
        <source value="http://fhir.hl7.org.vn/core/StructureDefinition/vn-core-implantable-device"/>
      </constraint>
      <constraint>
        <key value="vn-implant-regnum-class-cd"/>
        <severity value="warning"/>
        <human value="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."/>
        <expression value="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()"/>
        <source value="http://fhir.hl7.org.vn/core/StructureDefinition/vn-core-implantable-device"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="Entity. Role, or Act"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Device"/>
      </mapping>
    </element>
    <element id="Device.id">
      <path value="Device.id"/>
      <short value="Logical id of this artifact"/>
      <definition value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes."/>
      <comment value="The only time that a resource does not have an id is when it is being submitted to the server using a create operation."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Resource.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="true"/>
    </element>
    <element id="Device.meta">
      <path value="Device.meta"/>
      <short value="Metadata about the resource"/>
      <definition value="The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Resource.meta"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Meta"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
    </element>
    <element id="Device.implicitRules">
      <path value="Device.implicitRules"/>
      <short value="A set of rules under which this content was created"/>
      <definition value="A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc."/>
      <comment value="Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Resource.implicitRules"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="uri"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason value="This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation"/>
      <isSummary value="true"/>
    </element>
    <element id="Device.language">
      <path value="Device.language"/>
      <short value="Language of the resource content"/>
      <definition value="The base language in which the resource is written."/>
      <comment value="Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies  to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Resource.language"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <binding>
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet">
          <valueCanonical value="http://hl7.org/fhir/ValueSet/all-languages"/>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="Language"/>
        </extension>
        <strength value="preferred"/>
        <description value="A human language."/>
        <valueSet value="http://hl7.org/fhir/ValueSet/languages|4.0.1"/>
      </binding>
    </element>
    <element id="Device.text">
      <path value="Device.text"/>
      <short value="Text summary of the resource, for human interpretation"/>
      <definition value="A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety."/>
      <comment value="Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied).  This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later."/>
      <alias value="narrative"/>
      <alias value="html"/>
      <alias value="xhtml"/>
      <alias value="display"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.text"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Narrative"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="Act.text?"/>
      </mapping>
    </element>
    <element id="Device.contained">
      <path value="Device.contained"/>
      <short value="Contained, inline Resources"/>
      <definition value="These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope."/>
      <comment value="This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels."/>
      <alias value="inline resources"/>
      <alias value="anonymous resources"/>
      <alias value="contained resources"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.contained"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Resource"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Device.extension">
      <path value="Device.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <ordered value="false"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Device.extension:deviceGroup">
      <path value="Device.extension"/>
      <sliceName value="deviceGroup"/>
      <short value="Nhóm TBYT BHYT N01-N09"/>
      <definition value="Nhóm thiết bị y tế theo TT 04/2017/TT-BYT Phụ lục 01, sửa đổi bởi TT 24/2025/TT-BYT và văn bản hợp nhất hiện hành. Đây là phân loại phục vụ thanh toán/đối soát BHYT; khi đang biểu diễn một dòng chi phí, ưu tiên đặt tại Claim.item.extension[deviceGroup] thay vì coi là thuộc tính nội tại bắt buộc của Device."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile value="http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-group"/>
      </type>
      <condition value="ele-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Device.extension:riskClass">
      <path value="Device.extension"/>
      <sliceName value="riskClass"/>
      <short value="Phân loại rủi ro A/B/C/D — Must Support cho thiết bị cấy ghép"/>
      <definition value="Phân loại rủi ro thiết bị y tế A/B/C/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) và TT 05/2022/TT-BYT (đã được sửa đổi, bổ sung bởi TT 59/2025/TT-BYT).
Extension này là tùy chọn trên Device vì risk class là thuộc tính pháp lý ở mức sản phẩm/model/regulatory context; không bắt buộc cho mọi Device instance trong trao đổi lâm sàng hoặc BHYT.
Phân biệt rõ với các dimension độc lập KHÔNG dùng extension này:
- Nhóm TBYT BHYT N01-N09 (TT 04/2017/TT-BYT Phụ lục 01) → dùng VNCoreExtDeviceGroup;
- Danh pháp thiết bị y tế (QĐ 3107/2024, QĐ 847/2025) → dùng Device.type với hệ danh pháp;
- 6 nhóm phân loại tiêu chuẩn kỹ thuật/chất lượng phục vụ đấu thầu theo TT 57/2025/TT-BYT (31/12/2025, hiệu lực 15/02/2026, triển khai 01/01/2027, căn cứ NĐ 214/2025/NĐ-CP về Luật Đấu thầu) → nếu cần biểu diễn, dùng extension riêng trong package procurement, KHÔNG dùng extension này."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile value="http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-risk-class"/>
      </type>
      <condition value="ele-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Device.extension:registrationNumber">
      <path value="Device.extension"/>
      <sliceName value="registrationNumber"/>
      <short value="Số lưu hành TBYT — Must Support cho thiết bị cấy ghép C/D"/>
      <definition value="Số lưu hành (registration number) của thiết bị y tế tại Việt Nam.

**Căn cứ pháp lý**: NĐ 98/2021/NĐ-CP Điều 21 (Phân nhóm số lưu hành), Chương III (Điều 17-33) về đăng ký lưu hành TBYT, 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).

**Phân nhóm theo NĐ 98/2021 Điều 21**:

1. **Loại A & B — Số công bố tiêu chuẩn áp dụng** (Sở Y tế tỉnh/TP tiếp nhận):
   - Format: `[STT tiếp nhận]/[Năm tiếp nhận 2 số]/[Mã ký hiệu Sở Y tế]-PCBA` (loại A)
   - Format: `[STT tiếp nhận]/[Năm tiếp nhận 2 số]/[Mã ký hiệu Sở Y tế]-PCBB` (loại B)
   - PCBA/PCBB = Phiếu công bố loại A / loại B
   - Ví dụ: `2300001/23/HN-PCBA` (Hồ sơ số 1 năm 2023, Sở Y tế Hà Nội tiếp nhận)

2. **Loại C & D — Số Giấy chứng nhận đăng ký lưu hành** (Bộ Y tế cấp):
   - Format chuẩn: `[STT cấp]/[Năm cấp 2 số]/BYT-ĐKLH`
   - Format rút gọn: `[STT cấp]/BYT-ĐKLH`
   - ĐKLH = Đăng ký lưu hành
   - Ví dụ: `2300055/BYT-ĐKLH` hoặc `2300055/23/BYT-ĐKLH`

**Phạm vi**:
- Bắt buộc cho loại B/C/D trước khi đưa ra thị trường
- Loại A chỉ công bố tiêu chuẩn áp dụng (vẫn dùng PCBA format)
- Đây là định danh ở mức sản phẩm/model/regulatory context, KHÔNG phải định danh per-instance

**Lưu ý phân biệt**: Extension này độc lập với:
- UDI (định danh per-instance theo HL7 best practice)
- MA_VAT_TU (mã nghiệp vụ BHYT theo QĐ 3176)
- Serial number (per-instance physical)
- Mã tài sản BV (internal facility code)"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile value="http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-registration-number"/>
      </type>
      <condition value="ele-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Device.extension:isIVD">
      <path value="Device.extension"/>
      <sliceName value="isIVD"/>
      <short value="Cờ IVD (chẩn đoán in vitro)"/>
      <definition value="Cờ boolean phân biệt TBYT IVD (chẩn đoán in vitro: sinh phẩm, thuốc thử, máy xét nghiệm) với TBYT thông thường theo VBHN 08/2026/VBHN-BYT. Tùy chọn — chỉ đặt khi cần phân biệt rõ trong ngữ cảnh đăng ký lưu hành/đấu thầu/BHYT."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile value="http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-ivd"/>
      </type>
      <condition value="ele-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Device.modifierExtension">
      <path value="Device.modifierExtension"/>
      <short value="Extensions that cannot be ignored"/>
      <definition value="May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
      <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.modifierExtension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Device.identifier">
      <path value="Device.identifier"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="system"/>
        </discriminator>
        <description value="Phân loại identifier theo system"/>
        <rules value="open"/>
      </slicing>
      <short value="Định danh TBYT (mã vật tư/thiết bị, serial number)"/>
      <definition value="Unique instance identifiers assigned to a device by manufacturers other organizations or owners."/>
      <comment value="The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Device.identifier"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Identifier"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.identifier"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".id"/>
      </mapping>
      <mapping>
        <identity value="udi"/>
        <map value="The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI.   The identifier.type code should be set to “SNO”(Serial Number) and the system left empty."/>
      </mapping>
    </element>
    <element id="Device.identifier:medicalDeviceItemCode">
      <path value="Device.identifier"/>
      <sliceName value="medicalDeviceItemCode"/>
      <short value="Mã vật tư/thiết bị y tế (MA_VAT_TU)"/>
      <definition value="Mã vật tư/thiết bị y tế dùng trong XML dữ liệu đầu ra KCB và thanh toán BHYT. Mapping QĐ 3176/QĐ-BYT: MA_VAT_TU. Đây là mã nghiệp vụ/legacy; không phải UDI, serial number, số lưu hành hoặc mã tài sản. Khi mã này được dùng như product/service code của dòng chi phí, ưu tiên biểu diễn ở Claim.item.productOrService."/>
      <comment value="The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.identifier"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Identifier"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.identifier"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".id"/>
      </mapping>
      <mapping>
        <identity value="udi"/>
        <map value="The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI.   The identifier.type code should be set to “SNO”(Serial Number) and the system left empty."/>
      </mapping>
    </element>
    <element id="Device.identifier:medicalDeviceItemCode.id">
      <path value="Device.identifier.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Device.identifier:medicalDeviceItemCode.extension">
      <path value="Device.identifier.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional content defined by implementations"/>
      <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Device.identifier:medicalDeviceItemCode.use">
      <path value="Device.identifier.use"/>
      <short value="usual | official | temp | secondary | old (If known)"/>
      <definition value="The purpose of this identifier."/>
      <comment value="Applications can assume that an identifier is permanent unless it explicitly says that it is temporary."/>
      <requirements value="Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.use"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason value="This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one."/>
      <isSummary value="true"/>
      <binding>
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="IdentifierUse"/>
        </extension>
        <strength value="required"/>
        <description value="Identifies the purpose for this identifier, if known ."/>
        <valueSet value="http://hl7.org/fhir/ValueSet/identifier-use|4.0.1"/>
      </binding>
      <mapping>
        <identity value="v2"/>
        <map value="N/A"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Role.code or implied by context"/>
      </mapping>
    </element>
    <element id="Device.identifier:medicalDeviceItemCode.type">
      <path value="Device.identifier.type"/>
      <short value="Description of identifier"/>
      <definition value="A coded type for the identifier that can be used to determine which identifier to use for a specific purpose."/>
      <comment value="This element deals only with general categories of identifiers.  It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage.   Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type."/>
      <requirements value="Allows users to make use of identifiers when the identifier system is not known."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.type"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="IdentifierType"/>
        </extension>
        <strength value="extensible"/>
        <description value="A coded type for an identifier that can be used to determine which identifier to use for a specific purpose."/>
        <valueSet value="http://hl7.org/fhir/ValueSet/identifier-type|4.0.1"/>
      </binding>
      <mapping>
        <identity value="v2"/>
        <map value="CX.5"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Role.code or implied by context"/>
      </mapping>
    </element>
    <element id="Device.identifier:medicalDeviceItemCode.type.id">
      <path value="Device.identifier.type.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Device.identifier:medicalDeviceItemCode.type.extension">
      <path value="Device.identifier.type.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional content defined by implementations"/>
      <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Device.identifier:medicalDeviceItemCode.type.coding">
      <path value="Device.identifier.type.coding"/>
      <short value="Code defined by a terminology system"/>
      <definition value="A reference to a code defined by a terminology system."/>
      <comment value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true."/>
      <requirements value="Allows for alternative encodings within a code system, and translations to other code systems."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="CodeableConcept.coding"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Coding"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="C*E.1-8, C*E.10-22"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="union(., ./translation)"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"/>
      </mapping>
    </element>
    <element id="Device.identifier:medicalDeviceItemCode.type.text">
      <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
        <valueBoolean value="true"/>
      </extension>
      <path value="Device.identifier.type.text"/>
      <short value="Plain text representation of the concept"/>
      <definition value="A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user."/>
      <comment value="Very often the text is the same as a displayName of one of the codings."/>
      <requirements value="The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="CodeableConcept.text"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <patternString value="Mã vật tư/thiết bị y tế"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="C*E.9. But note many systems use C*E.2 for this"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="./originalText[mediaType/code="text/plain"]/data"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"/>
      </mapping>
    </element>
    <element id="Device.identifier:medicalDeviceItemCode.system">
      <path value="Device.identifier.system"/>
      <short value="The namespace for the identifier value"/>
      <definition value="Establishes the namespace for the value - that is, a URL that describes a set values that are unique."/>
      <comment value="Identifier.system is always case sensitive."/>
      <requirements value="There are many sets  of identifiers.  To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Identifier.system"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="uri"/>
      </type>
      <fixedUri value="http://fhir.hl7.org.vn/core/sid/medical-device-item-code"/>
      <example>
        <label value="General"/>
        <valueUri value="http://www.acme.com/identifiers/patient"/>
      </example>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.4 / EI-2-4"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="II.root or Role.id.root"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./IdentifierType"/>
      </mapping>
    </element>
    <element id="Device.identifier:medicalDeviceItemCode.value">
      <path value="Device.identifier.value"/>
      <short value="Giá trị MA_VAT_TU"/>
      <definition value="The portion of the identifier typically relevant to the user and which is unique within the context of the system."/>
      <comment value="If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986.  The value's primary purpose is computational mapping.  As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.)  A value formatted for human display can be conveyed using the [Rendered Value extension](http://hl7.org/fhir/R4/extension-rendered-value.html). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Identifier.value"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <example>
        <label value="General"/>
        <valueString value="123456"/>
      </example>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.1 / EI.1"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./Value"/>
      </mapping>
    </element>
    <element id="Device.identifier:medicalDeviceItemCode.period">
      <path value="Device.identifier.period"/>
      <short value="Time period when id is/was valid for use"/>
      <definition value="Time period during which identifier is/was valid for use."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.period"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Period"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.7 + CX.8"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Role.effectiveTime or implied by context"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./StartDate and ./EndDate"/>
      </mapping>
    </element>
    <element id="Device.identifier:medicalDeviceItemCode.assigner">
      <path value="Device.identifier.assigner"/>
      <short value="Organization that issued id (may be just text)"/>
      <definition value="Organization that issued/manages the identifier."/>
      <comment value="The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.assigner"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Reference"/>
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization|4.0.1"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.4 / (CX.4,CX.9,CX.10)"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="II.assigningAuthorityName but note that this is an improper use by the definition of the field.  Also Role.scoper"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./IdentifierIssuingAuthority"/>
      </mapping>
    </element>
    <element id="Device.identifier:serialNumber">
      <path value="Device.identifier"/>
      <sliceName value="serialNumber"/>
      <short value="Số serial dạng Identifier"/>
      <definition value="Số serial khi hệ thống trao đổi dưới dạng Identifier. Device.serialNumber vẫn là vị trí FHIR chính để ghi serial number."/>
      <comment value="The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.identifier"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Identifier"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.identifier"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".id"/>
      </mapping>
      <mapping>
        <identity value="udi"/>
        <map value="The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI.   The identifier.type code should be set to “SNO”(Serial Number) and the system left empty."/>
      </mapping>
    </element>
    <element id="Device.identifier:serialNumber.id">
      <path value="Device.identifier.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Device.identifier:serialNumber.extension">
      <path value="Device.identifier.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <rules value="open"/>
      </slicing>
      <short value="Additional content defined by implementations"/>
      <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Device.identifier:serialNumber.use">
      <path value="Device.identifier.use"/>
      <short value="usual | official | temp | secondary | old (If known)"/>
      <definition value="The purpose of this identifier."/>
      <comment value="Applications can assume that an identifier is permanent unless it explicitly says that it is temporary."/>
      <requirements value="Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.use"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason value="This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one."/>
      <isSummary value="true"/>
      <binding>
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="IdentifierUse"/>
        </extension>
        <strength value="required"/>
        <description value="Identifies the purpose for this identifier, if known ."/>
        <valueSet value="http://hl7.org/fhir/ValueSet/identifier-use|4.0.1"/>
      </binding>
      <mapping>
        <identity value="v2"/>
        <map value="N/A"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Role.code or implied by context"/>
      </mapping>
    </element>
    <element id="Device.identifier:serialNumber.type">
      <path value="Device.identifier.type"/>
      <short value="Description of identifier"/>
      <definition value="A coded type for the identifier that can be used to determine which identifier to use for a specific purpose."/>
      <comment value="This element deals only with general categories of identifiers.  It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage.   Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type."/>
      <requirements value="Allows users to make use of identifiers when the identifier system is not known."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.type"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <patternCodeableConcept>
        <coding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0203"/>
          <code value="SNO"/>
        </coding>
      </patternCodeableConcept>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="IdentifierType"/>
        </extension>
        <strength value="extensible"/>
        <description value="A coded type for an identifier that can be used to determine which identifier to use for a specific purpose."/>
        <valueSet value="http://hl7.org/fhir/ValueSet/identifier-type|4.0.1"/>
      </binding>
      <mapping>
        <identity value="v2"/>
        <map value="CX.5"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Role.code or implied by context"/>
      </mapping>
    </element>
    <element id="Device.identifier:serialNumber.system">
      <path value="Device.identifier.system"/>
      <short value="The namespace for the identifier value"/>
      <definition value="Establishes the namespace for the value - that is, a URL that describes a set values that are unique."/>
      <comment value="Identifier.system is always case sensitive."/>
      <requirements value="There are many sets  of identifiers.  To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Identifier.system"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="uri"/>
      </type>
      <fixedUri value="http://fhir.hl7.org.vn/core/sid/device-serial-number"/>
      <example>
        <label value="General"/>
        <valueUri value="http://www.acme.com/identifiers/patient"/>
      </example>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.4 / EI-2-4"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="II.root or Role.id.root"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./IdentifierType"/>
      </mapping>
    </element>
    <element id="Device.identifier:serialNumber.value">
      <path value="Device.identifier.value"/>
      <short value="Số serial"/>
      <definition value="The portion of the identifier typically relevant to the user and which is unique within the context of the system."/>
      <comment value="If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986.  The value's primary purpose is computational mapping.  As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.)  A value formatted for human display can be conveyed using the [Rendered Value extension](http://hl7.org/fhir/R4/extension-rendered-value.html). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Identifier.value"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <example>
        <label value="General"/>
        <valueString value="123456"/>
      </example>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.1 / EI.1"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./Value"/>
      </mapping>
    </element>
    <element id="Device.identifier:serialNumber.period">
      <path value="Device.identifier.period"/>
      <short value="Time period when id is/was valid for use"/>
      <definition value="Time period during which identifier is/was valid for use."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.period"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Period"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.7 + CX.8"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Role.effectiveTime or implied by context"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./StartDate and ./EndDate"/>
      </mapping>
    </element>
    <element id="Device.identifier:serialNumber.assigner">
      <path value="Device.identifier.assigner"/>
      <short value="Organization that issued id (may be just text)"/>
      <definition value="Organization that issued/manages the identifier."/>
      <comment value="The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Identifier.assigner"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Reference"/>
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization|4.0.1"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="CX.4 / (CX.4,CX.9,CX.10)"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="II.assigningAuthorityName but note that this is an improper use by the definition of the field.  Also Role.scoper"/>
      </mapping>
      <mapping>
        <identity value="servd"/>
        <map value="./IdentifierIssuingAuthority"/>
      </mapping>
    </element>
    <element id="Device.definition">
      <path value="Device.definition"/>
      <short value="The reference to the definition for the device"/>
      <definition value="The reference to the definition for the device."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.definition"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Reference"/>
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/DeviceDefinition|4.0.1"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Device.udiCarrier">
      <path value="Device.udiCarrier"/>
      <short value="UDI carrier của thiết bị cấy ghép khi có"/>
      <definition value="Unique device identifier (UDI) assigned to device label or package.  Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold."/>
      <comment value="UDI may identify an unique instance of a device, or it may only identify the type of the device.  See [UDI mappings](http://hl7.org/fhir/R4/device-mappings.html#udi) for a complete mapping of UDI parts to Device."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Device.udiCarrier"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="BackboneElement"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.identifier"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".id and .code"/>
      </mapping>
    </element>
    <element id="Device.udiCarrier.id">
      <path value="Device.udiCarrier.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Device.udiCarrier.extension">
      <path value="Device.udiCarrier.extension"/>
      <short value="Additional content defined by implementations"/>
      <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Device.udiCarrier.modifierExtension">
      <path value="Device.udiCarrier.modifierExtension"/>
      <short value="Extensions that cannot be ignored even if unrecognized"/>
      <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
      <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <alias value="modifiers"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="BackboneElement.modifierExtension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Device.udiCarrier.deviceIdentifier">
      <path value="Device.udiCarrier.deviceIdentifier"/>
      <short value="UDI Device Identifier"/>
      <definition value="The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device."/>
      <alias value="DI"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.udiCarrier.deviceIdentifier"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.what[x]"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Role.id.extension"/>
      </mapping>
      <mapping>
        <identity value="udi"/>
        <map value="The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device."/>
      </mapping>
    </element>
    <element id="Device.udiCarrier.issuer">
      <path value="Device.udiCarrier.issuer"/>
      <short value="UDI Issuing Organization"/>
      <definition value="Organization that is charged with issuing UDIs for devices.  For example, the US FDA issuers include :
1) GS1: 
http://hl7.org/fhir/NamingSystem/gs1-di, 
2) HIBCC:
http://hl7.org/fhir/NamingSystem/hibcc-dI, 
3) ICCBBA for blood containers:
http://hl7.org/fhir/NamingSystem/iccbba-blood-di, 
4) ICCBA for other devices:
http://hl7.org/fhir/NamingSystem/iccbba-other-di."/>
      <alias value="Barcode System"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.udiCarrier.issuer"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="uri"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="Role.id.root"/>
      </mapping>
      <mapping>
        <identity value="udi"/>
        <map value="All UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency.
GS1 DIs: 
 http://hl7.org/fhir/NamingSystem/gs1
HIBCC DIs:
 http://hl7.org/fhir/NamingSystem/hibcc
ICCBBA DIs for blood containers:
 http://hl7.org/fhir/NamingSystem/iccbba-blood
ICCBA DIs for other devices:
 http://hl7.org/fhir/NamingSystem/iccbba-other"/>
      </mapping>
    </element>
    <element id="Device.udiCarrier.jurisdiction">
      <path value="Device.udiCarrier.jurisdiction"/>
      <short value="Regional UDI authority"/>
      <definition value="The identity of the authoritative source for UDI generation within a  jurisdiction.  All UDIs are globally unique within a single namespace with the appropriate repository uri as the system.  For example,  UDIs of devices managed in the U.S. by the FDA, the value is  http://hl7.org/fhir/NamingSystem/fda-udi."/>
      <requirements value="Allows a recipient of a UDI to know which database will contain the UDI-associated metadata."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.udiCarrier.jurisdiction"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="uri"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="Role.scoper"/>
      </mapping>
    </element>
    <element id="Device.udiCarrier.carrierAIDC">
      <path value="Device.udiCarrier.carrierAIDC"/>
      <short value="UDI automatic identification and data capture"/>
      <definition value="The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - e.g., a barcode or RFID.   Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats *SHALL* be base64 encoded."/>
      <comment value="The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label."/>
      <alias value="Automatic Identification and Data Capture"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.udiCarrier.carrierAIDC"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="base64Binary"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="Role.id.extension"/>
      </mapping>
      <mapping>
        <identity value="udi"/>
        <map value="A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology."/>
      </mapping>
    </element>
    <element id="Device.udiCarrier.carrierHRF">
      <path value="Device.udiCarrier.carrierHRF"/>
      <short value="UDI human-readable form"/>
      <definition value="The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device."/>
      <comment value="If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label."/>
      <alias value="Human Readable Form"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.udiCarrier.carrierHRF"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="Role.id.extension"/>
      </mapping>
      <mapping>
        <identity value="udi"/>
        <map value="A unique device identifier (UDI) on a device label in plain text"/>
      </mapping>
    </element>
    <element id="Device.udiCarrier.entryType">
      <path value="Device.udiCarrier.entryType"/>
      <short value="barcode | rfid | manual +"/>
      <definition value="A coded entry to indicate how the data was entered."/>
      <requirements value="Supports a way to distinguish hand entered from machine read data."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.udiCarrier.entryType"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <binding>
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="UDIEntryType"/>
        </extension>
        <strength value="required"/>
        <description value="Codes to identify how UDI data was entered."/>
        <valueSet value="http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1"/>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value="NA"/>
      </mapping>
    </element>
    <element id="Device.status">
      <path value="Device.status"/>
      <short value="Trạng thái thiết bị cấy ghép"/>
      <definition value="Status of the Device availability."/>
      <comment value="This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Device.status"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="true"/>
      <isModifierReason value="This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid"/>
      <isSummary value="true"/>
      <binding>
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="FHIRDeviceStatus"/>
        </extension>
        <strength value="required"/>
        <description value="The availability status of the device."/>
        <valueSet value="http://hl7.org/fhir/ValueSet/device-status|4.0.1"/>
      </binding>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.status"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".statusCode"/>
      </mapping>
    </element>
    <element id="Device.statusReason">
      <path value="Device.statusReason"/>
      <short value="online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off"/>
      <definition value="Reason for the dtatus of the Device availability."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Device.statusReason"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <binding>
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="FHIRDeviceStatusReason"/>
        </extension>
        <strength value="extensible"/>
        <description value="The availability status reason of the device."/>
        <valueSet value="http://hl7.org/fhir/ValueSet/device-status-reason|4.0.1"/>
      </binding>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.status"/>
      </mapping>
    </element>
    <element id="Device.distinctIdentifier">
      <path value="Device.distinctIdentifier"/>
      <short value="Định danh phân biệt thiết bị cấy ghép"/>
      <definition value="The distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based product."/>
      <comment value="For example, this applies to devices in the United States regulated under *Code of Federal Regulation 21CFR§1271.290(c)*."/>
      <alias value="Distinct Identification Code (DIC)"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.distinctIdentifier"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.what[x]"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".lotNumberText"/>
      </mapping>
      <mapping>
        <identity value="udi"/>
        <map value="The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI."/>
      </mapping>
    </element>
    <element id="Device.manufacturer">
      <path value="Device.manufacturer"/>
      <short value="Hãng sản xuất"/>
      <definition value="Tên hãng sản xuất. Các QĐ 5086/QĐ-BYT, 637/2022, 1844/2022, 3181/2022 liên quan mã hãng sản xuất VTYT/TBYT; không model thành mã hàng TBYT đầy đủ trong v0.3."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.manufacturer"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.what[x]"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".playedRole[typeCode=MANU].scoper.name"/>
      </mapping>
      <mapping>
        <identity value="udi"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Device.manufactureDate">
      <path value="Device.manufactureDate"/>
      <short value="Ngày sản xuất"/>
      <definition value="The date and time when the device was manufactured."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.manufactureDate"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="dateTime"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.what[x]"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".existenceTime.low"/>
      </mapping>
      <mapping>
        <identity value="udi"/>
        <map value="The date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.  For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS].  If hour is present, the minutes and seconds should both be set to “00”."/>
      </mapping>
    </element>
    <element id="Device.expirationDate">
      <path value="Device.expirationDate"/>
      <short value="Hạn sử dụng"/>
      <definition value="The date and time beyond which this device is no longer valid or should not be used (if applicable)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.expirationDate"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="dateTime"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.what[x]"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".expirationTime"/>
      </mapping>
      <mapping>
        <identity value="udi"/>
        <map value="the expiration date of a specific device -  which is a component of the production identifier (PI), a conditional, variable portion of a UDI.  For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS].  If hour is present, the minutes and seconds should both be set to “00”."/>
      </mapping>
    </element>
    <element id="Device.lotNumber">
      <path value="Device.lotNumber"/>
      <short value="Số lô"/>
      <definition value="Lot number assigned by the manufacturer."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.lotNumber"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.what[x]"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".lotNumberText"/>
      </mapping>
      <mapping>
        <identity value="udi"/>
        <map value="The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI."/>
      </mapping>
    </element>
    <element id="Device.serialNumber">
      <path value="Device.serialNumber"/>
      <short value="Số serial"/>
      <definition value="The serial number assigned by the organization when the device was manufactured."/>
      <comment value="Alphanumeric Maximum 20."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.serialNumber"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.what[x]"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".playedRole[typeCode=MANU].id"/>
      </mapping>
    </element>
    <element id="Device.deviceName">
      <path value="Device.deviceName"/>
      <short value="The name of the device as given by the manufacturer"/>
      <definition value="This represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device.  This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Device.deviceName"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="BackboneElement"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Device.deviceName.id">
      <path value="Device.deviceName.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Device.deviceName.extension">
      <path value="Device.deviceName.extension"/>
      <short value="Additional content defined by implementations"/>
      <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Device.deviceName.modifierExtension">
      <path value="Device.deviceName.modifierExtension"/>
      <short value="Extensions that cannot be ignored even if unrecognized"/>
      <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
      <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <alias value="modifiers"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="BackboneElement.modifierExtension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Device.deviceName.name">
      <path value="Device.deviceName.name"/>
      <short value="The name of the device"/>
      <definition value="The name of the device."/>
      <alias value="Σ"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Device.deviceName.name"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Device.deviceName.type">
      <path value="Device.deviceName.type"/>
      <short value="udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other"/>
      <definition value="The type of deviceName.
UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Device.deviceName.type"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <binding>
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="DeviceNameType"/>
        </extension>
        <strength value="required"/>
        <description value="The type of name the device is referred by."/>
        <valueSet value="http://hl7.org/fhir/ValueSet/device-nametype|4.0.1"/>
      </binding>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.what[x]"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".playedRole[typeCode=MANU].code"/>
      </mapping>
    </element>
    <element id="Device.modelNumber">
      <path value="Device.modelNumber"/>
      <short value="Model / quy cách"/>
      <definition value="The model number for the device."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.modelNumber"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.what[x]"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".softwareName (included as part)"/>
      </mapping>
    </element>
    <element id="Device.partNumber">
      <path value="Device.partNumber"/>
      <short value="The part number of the device"/>
      <definition value="The part number of the device."/>
      <comment value="Alphanumeric Maximum 20."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.partNumber"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.what[x]"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".playedRole[typeCode=MANU].id"/>
      </mapping>
    </element>
    <element id="Device.type">
      <path value="Device.type"/>
      <short value="Loại thiết bị cấy ghép"/>
      <definition value="Loại thiết bị cấy ghép, nên mã hóa bằng SNOMED CT hoặc hệ danh pháp thiết bị đã được governance. Chưa required binding vào QĐ 847/QĐ 3107 trong v0.4."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Device.type"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <binding>
        <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="DeviceType"/>
        </extension>
        <strength value="example"/>
        <description value="Codes to identify medical devices."/>
        <valueSet value="http://hl7.org/fhir/ValueSet/device-type|4.0.1"/>
      </binding>
    </element>
    <element id="Device.specialization">
      <path value="Device.specialization"/>
      <short value="The capabilities supported on a  device, the standards to which the device conforms for a particular purpose, and used for the communication"/>
      <definition value="The capabilities supported on a  device, the standards to which the device conforms for a particular purpose, and used for the communication."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Device.specialization"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="BackboneElement"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Device.specialization.id">
      <path value="Device.specialization.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Device.specialization.extension">
      <path value="Device.specialization.extension"/>
      <short value="Additional content defined by implementations"/>
      <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Device.specialization.modifierExtension">
      <path value="Device.specialization.modifierExtension"/>
      <short value="Extensions that cannot be ignored even if unrecognized"/>
      <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
      <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <alias value="modifiers"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="BackboneElement.modifierExtension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Device.specialization.systemType">
      <path value="Device.specialization.systemType"/>
      <short value="The standard that is used to operate and communicate"/>
      <definition value="The standard that is used to operate and communicate."/>
      <alias value="Σ"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Device.specialization.systemType"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Device.specialization.version">
      <path value="Device.specialization.version"/>
      <short value="The version of the standard that is used to operate and communicate"/>
      <definition value="The version of the standard that is used to operate and communicate."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.specialization.version"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.what[x]"/>
      </mapping>
    </element>
    <element id="Device.version">
      <path value="Device.version"/>
      <short value="The actual design of the device or software version running on the device"/>
      <definition value="The actual design of the device or software version running on the device."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Device.version"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="BackboneElement"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Device.version.id">
      <path value="Device.version.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Device.version.extension">
      <path value="Device.version.extension"/>
      <short value="Additional content defined by implementations"/>
      <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Device.version.modifierExtension">
      <path value="Device.version.modifierExtension"/>
      <short value="Extensions that cannot be ignored even if unrecognized"/>
      <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
      <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <alias value="modifiers"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="BackboneElement.modifierExtension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Device.version.type">
      <path value="Device.version.type"/>
      <short value="The type of the device version"/>
      <definition value="The type of the device version."/>
      <alias value="Σ"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.version.type"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Device.version.component">
      <path value="Device.version.component"/>
      <short value="A single component of the device version"/>
      <definition value="A single component of the device version."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.version.component"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Identifier"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.what[x]"/>
      </mapping>
    </element>
    <element id="Device.version.value">
      <path value="Device.version.value"/>
      <short value="The version text"/>
      <definition value="The version text."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Device.version.value"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Device.property">
      <path value="Device.property"/>
      <short value="The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties"/>
      <definition value="The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Device.property"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="BackboneElement"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Device.property.id">
      <path value="Device.property.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Device.property.extension">
      <path value="Device.property.extension"/>
      <short value="Additional content defined by implementations"/>
      <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="Device.property.modifierExtension">
      <path value="Device.property.modifierExtension"/>
      <short value="Extensions that cannot be ignored even if unrecognized"/>
      <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
      <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <alias value="modifiers"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="BackboneElement.modifierExtension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="Device.property.type">
      <path value="Device.property.type"/>
      <short value="Code that specifies the property DeviceDefinitionPropetyCode (Extensible)"/>
      <definition value="Code that specifies the property DeviceDefinitionPropetyCode (Extensible)."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Device.property.type"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Device.property.valueQuantity">
      <path value="Device.property.valueQuantity"/>
      <short value="Property value as a quantity"/>
      <definition value="Property value as a quantity."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Device.property.valueQuantity"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Quantity"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Device.property.valueCode">
      <path value="Device.property.valueCode"/>
      <short value="Property value as a code, e.g., NTP4 (synced to NTP)"/>
      <definition value="Property value as a code, e.g., NTP4 (synced to NTP)."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Device.property.valueCode"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="Device.patient">
      <path value="Device.patient"/>
      <short value="Bệnh nhân đang/đã được cấy ghép thiết bị"/>
      <definition value="Bệnh nhân gắn với thiết bị cấy ghép. Đây là điểm khác với VNCoreDevice nền, vốn vẫn hỗ trợ thiết bị chưa gắn người bệnh hoặc vật tư/thiết bị trong dữ liệu thanh toán."/>
      <requirements value="If the device is implanted in a patient, then need to associate the device to the patient."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="Device.patient"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Reference"/>
        <targetProfile value="http://fhir.hl7.org.vn/core/StructureDefinition/vn-core-patient"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.subject[x]"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".playedRole[typeCode=USED].scoper.playedRole[typeCode=PAT]"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.subject"/>
      </mapping>
    </element>
    <element id="Device.owner">
      <path value="Device.owner"/>
      <short value="Organization responsible for device"/>
      <definition value="An organization that is responsible for the provision and ongoing maintenance of the device."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.owner"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Reference"/>
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization|4.0.1"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.source"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".playedRole[typeCode=OWN].scoper"/>
      </mapping>
    </element>
    <element id="Device.contact">
      <path value="Device.contact"/>
      <short value="Details for human/organization for support"/>
      <definition value="Contact details for an organization or a particular human that is responsible for the device."/>
      <comment value="used for troubleshooting etc."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Device.contact"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="ContactPoint"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.source"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".scopedRole[typeCode=CON].player"/>
      </mapping>
    </element>
    <element id="Device.location">
      <path value="Device.location"/>
      <short value="Where the device is found"/>
      <definition value="The place where the device can be found."/>
      <requirements value="Device.location can be used to track device location."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.location"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Reference"/>
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/Location|4.0.1"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.where[x]"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".playedRole[typeCode=LOCE].scoper"/>
      </mapping>
    </element>
    <element id="Device.url">
      <path value="Device.url"/>
      <short value="Network address to contact device"/>
      <definition value="A network address on which the device may be contacted directly."/>
      <comment value="If the device is running a FHIR server, the network address should  be the Base URL from which a conformance statement may be retrieved."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.url"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="uri"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.where[x]"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".telecom"/>
      </mapping>
    </element>
    <element id="Device.note">
      <path value="Device.note"/>
      <short value="Ghi chú (tên VTYT, quy cách...)"/>
      <definition value="Descriptive information, usage information or implantation information that is not captured in an existing element."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Device.note"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Annotation"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value=".text"/>
      </mapping>
    </element>
    <element id="Device.safety">
      <path value="Device.safety"/>
      <short value="Thông tin an toàn của thiết bị cấy ghép"/>
      <definition value="Provides additional safety characteristics about a medical device.  For example devices containing latex."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Device.safety"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <mustSupport value="true"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="NA"/>
      </mapping>
    </element>
    <element id="Device.parent">
      <path value="Device.parent"/>
      <short value="The parent device"/>
      <definition value="The parent device."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Device.parent"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Reference"/>
        <targetProfile value="http://hl7.org/fhir/StructureDefinition/Device|4.0.1"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() > id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
  </snapshot>
  <differential>
    <element id="Device">
      <path value="Device"/>
      <constraint>
        <key value="vn-implant-udi-carrier-content"/>
        <severity value="warning"/>
        <human value="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."/>
        <expression value="udiCarrier.empty() or udiCarrier.all(carrierHRF.exists() or carrierAIDC.exists())"/>
        <source value="http://fhir.hl7.org.vn/core/StructureDefinition/vn-core-implantable-device"/>
      </constraint>
      <constraint>
        <key value="vn-implant-regnum-class-cd"/>
        <severity value="warning"/>
        <human value="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."/>
        <expression value="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()"/>
        <source value="http://fhir.hl7.org.vn/core/StructureDefinition/vn-core-implantable-device"/>
      </constraint>
    </element>
    <element id="Device.extension:riskClass">
      <path value="Device.extension"/>
      <sliceName value="riskClass"/>
      <short value="Phân loại rủi ro A/B/C/D — Must Support cho thiết bị cấy ghép"/>
      <mustSupport value="true"/>
    </element>
    <element id="Device.extension:registrationNumber">
      <path value="Device.extension"/>
      <sliceName value="registrationNumber"/>
      <short value="Số lưu hành TBYT — Must Support cho thiết bị cấy ghép C/D"/>
      <mustSupport value="true"/>
    </element>
    <element id="Device.udiCarrier">
      <path value="Device.udiCarrier"/>
      <short value="UDI carrier của thiết bị cấy ghép khi có"/>
    </element>
    <element id="Device.udiCarrier.carrierAIDC">
      <path value="Device.udiCarrier.carrierAIDC"/>
      <short value="UDI automatic identification and data capture"/>
      <mustSupport value="true"/>
    </element>
    <element id="Device.status">
      <path value="Device.status"/>
      <short value="Trạng thái thiết bị cấy ghép"/>
    </element>
    <element id="Device.modelNumber">
      <path value="Device.modelNumber"/>
      <short value="Model / quy cách"/>
    </element>
    <element id="Device.type">
      <path value="Device.type"/>
      <short value="Loại thiết bị cấy ghép"/>
      <definition value="Loại thiết bị cấy ghép, nên mã hóa bằng SNOMED CT hoặc hệ danh pháp thiết bị đã được governance. Chưa required binding vào QĐ 847/QĐ 3107 trong v0.4."/>
      <min value="1"/>
    </element>
    <element id="Device.patient">
      <path value="Device.patient"/>
      <short value="Bệnh nhân đang/đã được cấy ghép thiết bị"/>
      <definition value="Bệnh nhân gắn với thiết bị cấy ghép. Đây là điểm khác với VNCoreDevice nền, vốn vẫn hỗ trợ thiết bị chưa gắn người bệnh hoặc vật tư/thiết bị trong dữ liệu thanh toán."/>
      <min value="1"/>
    </element>
    <element id="Device.safety">
      <path value="Device.safety"/>
      <short value="Thông tin an toàn của thiết bị cấy ghép"/>
      <mustSupport value="true"/>
    </element>
  </differential>
</StructureDefinition>