Bộ Hướng dẫn Triển khai Core FHIR cho Việt Nam
0.5.0 - Draft for Community Review
Bộ Hướng dẫn Triển khai Core FHIR cho Việt Nam - Draft for Community Review (v0.5.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
| Draft tại thời điểm 2026-04-27 |
Các định nghĩa cho vn-ext-device-ivd phần mở rộng
Guidance on how to interpret the contents of this table can be foundhere
| 0. Extension | |
| Definition | Cờ boolean phân biệt TBYT chẩn đoán in vitro (IVD — In Vitro Diagnostic) với TBYT thông thường, theo VBHN 08/2026/VBHN-BYT (hợp nhất NĐ 98/2021 + NĐ 07/2023 + NĐ 04/2025). TBYT IVD có quy định riêng về phân loại rủi ro, đăng ký lưu hành, kiểm định và quản lý chất lượng so với TBYT thông thường. Đây là cờ regulatory ở mức sản phẩm/model, không bắt buộc cho mọi Device instance trong trao đổi lâm sàng/BHYT. Khi có giá trị true: Device là sinh phẩm/thuốc thử/máy phân tích chẩn đoán in vitro (vd: máy xét nghiệm sinh hóa, test nhanh COVID-19, sinh phẩm xét nghiệm). Khi false hoặc không có: Device là TBYT thông thường (non-IVD). Optional Extension Element - found in all resources. |
| Short | Thiết bị y tế chẩn đoán in vitro (IVD) — Device IVD Flag ExtensionOptional Extensions Element |
| Control | 0..* This element is affected by the following invariants: ele-1 |
| Is Modifier | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists())ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 2. Extension.extension | |
| Definition | An Extension 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. |
| Short | ExtensionAdditional content defined by implementations |
| Comments | 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. |
| Control | 0..0* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on Extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 4. Extension.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| Comments | The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-ivd |
| 6. Extension.value[x] | |
| Definition | true nếu Device thuộc nhóm IVD (chẩn đoán in vitro) theo VBHN 08/2026/VBHN-BYT; false hoặc absent nếu là TBYT thông thường. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Là thiết bị IVD?Value of extension |
| Control | 0..1 |
| Type | boolean, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, Expression, Signature, unsignedInt, time |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
Guidance on how to interpret the contents of this table can be foundhere
| 0. Extension | |
| Definition | Cờ boolean phân biệt TBYT chẩn đoán in vitro (IVD — In Vitro Diagnostic) với TBYT thông thường, theo VBHN 08/2026/VBHN-BYT (hợp nhất NĐ 98/2021 + NĐ 07/2023 + NĐ 04/2025). TBYT IVD có quy định riêng về phân loại rủi ro, đăng ký lưu hành, kiểm định và quản lý chất lượng so với TBYT thông thường. Đây là cờ regulatory ở mức sản phẩm/model, không bắt buộc cho mọi Device instance trong trao đổi lâm sàng/BHYT. Khi có giá trị true: Device là sinh phẩm/thuốc thử/máy phân tích chẩn đoán in vitro (vd: máy xét nghiệm sinh hóa, test nhanh COVID-19, sinh phẩm xét nghiệm). Khi false hoặc không có: Device là TBYT thông thường (non-IVD). |
| Short | Thiết bị y tế chẩn đoán in vitro (IVD) — Device IVD Flag Extension |
| 2. Extension.extension | |
| Control | 0..0 |
| 4. Extension.url | |
| Fixed Value | http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-ivd |
| 6. Extension.value[x] | |
| Definition | true nếu Device thuộc nhóm IVD (chẩn đoán in vitro) theo VBHN 08/2026/VBHN-BYT; false hoặc absent nếu là TBYT thông thường. |
| Short | Là thiết bị IVD? |
| Type | boolean, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, Expression, Signature, unsignedInt, time |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Guidance on how to interpret the contents of this table can be foundhere
| 0. Extension | |
| Definition | Cờ boolean phân biệt TBYT chẩn đoán in vitro (IVD — In Vitro Diagnostic) với TBYT thông thường, theo VBHN 08/2026/VBHN-BYT (hợp nhất NĐ 98/2021 + NĐ 07/2023 + NĐ 04/2025). TBYT IVD có quy định riêng về phân loại rủi ro, đăng ký lưu hành, kiểm định và quản lý chất lượng so với TBYT thông thường. Đây là cờ regulatory ở mức sản phẩm/model, không bắt buộc cho mọi Device instance trong trao đổi lâm sàng/BHYT. Khi có giá trị true: Device là sinh phẩm/thuốc thử/máy phân tích chẩn đoán in vitro (vd: máy xét nghiệm sinh hóa, test nhanh COVID-19, sinh phẩm xét nghiệm). Khi false hoặc không có: Device là TBYT thông thường (non-IVD). |
| Short | Thiết bị y tế chẩn đoán in vitro (IVD) — Device IVD Flag Extension |
| Control | 0..* This element is affected by the following invariants: ele-1 |
| Is Modifier | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 2. Extension.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 4. Extension.extension | |
| Definition | An Extension |
| Short | Extension |
| Control | 0..0 |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on Extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 6. Extension.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| Comments | The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-ivd |
| 8. Extension.value[x] | |
| Definition | true nếu Device thuộc nhóm IVD (chẩn đoán in vitro) theo VBHN 08/2026/VBHN-BYT; false hoặc absent nếu là TBYT thông thường. |
| Short | Là thiết bị IVD? |
| Control | 0..1 |
| Type | boolean |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
