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 2026-04-19 |
Biểu diễn JSON của vn-core-implantable-device hồ sơ tài nguyên.
{
"resourceType" : "StructureDefinition",
"id" : "vn-core-implantable-device",
"language" : "vi",
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: StructureDefinition vn-core-implantable-device</b></p><a name=\"vn-core-implantable-device\"> </a><a name=\"hcvn-core-implantable-device\"> </a><table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;\"><tr style=\"border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top\"><th style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"The logical name of the element\">Name</a></th><th style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Information about the use of the element\">Flags</a></th><th style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Minimum and Maximum # of times the element can appear in the instance\">Card.</a></th><th style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px; width: 100px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Reference to the type of the element\">Type</a></th><th style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Additional information about the element\">Description & Constraints</a><span style=\"float: right\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Legend for this format\"><img src=\"data:image/png;base64,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\" alt=\"doco\" style=\"background-color: inherit\"/></a></span></th></tr><tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_resource.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Resource\" class=\"hierarchy\"/> <a href=\"StructureDefinition-vn-core-implantable-device-definitions.html#Device\">Device</a><a name=\"Device\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;; padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;\" href=\"http://hl7.org/fhir/R4/conformance-rules.html#constraints\" title=\"This element has or is affected by constraints ( vn-implant-udi-carrier-content, vn-implant-regnum-class-cd )\">C</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"StructureDefinition-vn-core-device.html\">VNCoreDevice</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">Item used in healthcare</span><br class=\"constraint\"/><span title=\"null\" class=\"constraint\">Constraints: </span><span style=\"font-weight:bold\" title=\"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.\" class=\"constraint\">vn-implant-udi-carrier-content</span><span title=\"null\" class=\"constraint\">, </span><span style=\"font-weight:bold\" title=\"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.\" class=\"constraint\">vn-implant-regnum-class-cd</span></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Definition\" class=\"hierarchy\"/> Slices for extension<a name=\"Device.extension\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Content/Rules for all slices</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-vn-core-implantable-device-definitions.html#Device.extension:riskClass\" title=\"Slice riskClass\">extension:riskClass</a><a name=\"Device.extension.2\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"StructureDefinition-vn-ext-device-risk-class.html\" title=\"Extension\">VNCoreExtDeviceRiskClass</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Phân loại rủi ro A/B/C/D — Must Support cho thiết bị cấy ghép</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck124.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end_slicer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_slice_item.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Slice Item\" class=\"hierarchy\"/> <a href=\"StructureDefinition-vn-core-implantable-device-definitions.html#Device.extension:registrationNumber\" title=\"Slice registrationNumber\">extension:registrationNumber</a><a name=\"Device.extension.3\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"StructureDefinition-vn-ext-device-registration-number.html\" title=\"Extension\">VNCoreExtDeviceRegistrationNumber</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Số lưu hành TBYT — Must Support cho thiết bị cấy ghép C/D</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-vn-core-implantable-device-definitions.html#Device.udiCarrier\">udiCarrier</a><a name=\"Device.udiCarrier\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R4/datatypes.html#BackboneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">UDI carrier của thiết bị cấy ghép khi có</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-vn-core-implantable-device-definitions.html#Device.udiCarrier.carrierAIDC\">carrierAIDC</a><a name=\"Device.udiCarrier.carrierAIDC\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R4/datatypes.html#base64Binary\">base64Binary</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">UDI automatic identification and data capture</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-vn-core-implantable-device-definitions.html#Device.status\">status</a><a name=\"Device.status\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">1</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R4/datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Trạng thái thiết bị cấy ghép</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-vn-core-implantable-device-definitions.html#Device.modelNumber\">modelNumber</a><a name=\"Device.modelNumber\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R4/datatypes.html#string\">string</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Model / quy cách</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-vn-core-implantable-device-definitions.html#Device.type\" title=\"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.\">type</a><a name=\"Device.type\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R4/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Loại thiết bị cấy ghép</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-vn-core-implantable-device-definitions.html#Device.patient\" title=\"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.\">patient</a><a name=\"Device.patient\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..<span style=\"opacity: 0.5\">1</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/references.html\">Reference</a>(<a style=\"opacity: 0.5; opacity: 0.5\" href=\"StructureDefinition-vn-core-patient.html\">Bệnh nhân VN Core — VN Core Patient Profile</a>)</td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Bệnh nhân đang/đã được cấy ghép thiết bị</td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck00.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-vn-core-implantable-device-definitions.html#Device.safety\">safety</a><a name=\"Device.safety\"> </a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">*</span></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"opacity: 0.5; opacity: 0.5\" href=\"http://hl7.org/fhir/R4/datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Thông tin an toàn của thiết bị cấy ghép</td></tr>\r\n<tr><td colspan=\"5\" class=\"hierarchy\"><br/><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Legend for this format\"><img src=\"data:image/png;base64,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\" alt=\"doco\" style=\"background-color: inherit\"/> Documentation for this format</a></td></tr></table></div>"
},
"extension" : [
{
"url" : "http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-legal-basis",
"valueCoding" : {
"system" : "http://fhir.hl7.org.vn/core/CodeSystem/vn-legal-document-ref-cs",
"code" : "ND-98-2021"
}
},
{
"url" : "http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-legal-basis",
"valueCoding" : {
"system" : "http://fhir.hl7.org.vn/core/CodeSystem/vn-legal-document-ref-cs",
"code" : "ND-07-2023"
}
},
{
"url" : "http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-legal-basis",
"valueCoding" : {
"system" : "http://fhir.hl7.org.vn/core/CodeSystem/vn-legal-document-ref-cs",
"code" : "ND-04-2025"
}
},
{
"url" : "http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-legal-basis",
"valueCoding" : {
"system" : "http://fhir.hl7.org.vn/core/CodeSystem/vn-legal-document-ref-cs",
"code" : "TT-05-2022"
}
},
{
"url" : "http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-legal-basis",
"valueCoding" : {
"system" : "http://fhir.hl7.org.vn/core/CodeSystem/vn-legal-document-ref-cs",
"code" : "TT-59-2025"
}
},
{
"url" : "http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-legal-basis",
"valueCoding" : {
"system" : "http://fhir.hl7.org.vn/core/CodeSystem/vn-legal-document-ref-cs",
"code" : "TT-04-2017"
}
},
{
"url" : "http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-legal-basis",
"valueCoding" : {
"system" : "http://fhir.hl7.org.vn/core/CodeSystem/vn-legal-document-ref-cs",
"code" : "TT-24-2025"
}
},
{
"url" : "http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-legal-basis",
"valueCoding" : {
"system" : "http://fhir.hl7.org.vn/core/CodeSystem/vn-legal-document-ref-cs",
"code" : "QD-3176-2024"
}
}
],
"url" : "http://fhir.hl7.org.vn/core/StructureDefinition/vn-core-implantable-device",
"version" : "0.5.0",
"name" : "VNCoreImplantableDevice",
"title" : "Thiết bị cấy ghép VN Core — VN Core Implantable Device Profile",
"status" : "draft",
"date" : "2026-04-19",
"publisher" : "Omi HealthTech / VN Core FHIR Community Initiative",
"contact" : [
{
"name" : "Omi HealthTech / VN Core FHIR Community Initiative",
"telecom" : [
{
"system" : "url",
"value" : "https://hl7.org.vn"
},
{
"system" : "email",
"value" : "[email protected]"
}
]
},
{
"name" : "Omi HealthTech (OmiGroup)",
"telecom" : [
{
"system" : "url",
"value" : "https://omihealthtech.vn"
},
{
"system" : "url",
"value" : "https://omigroup.vn"
},
{
"system" : "email",
"value" : "[email protected]"
}
]
}
],
"description" : "Profile Device chuyên cho thiết bị cấy ghép gắn với người bệnh tại Việt Nam.\nKế 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.\nUDI 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.\nQĐ 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.\nCăn 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" : "urn:iso:std:iso:3166",
"code" : "VN",
"display" : "Viet Nam"
}
]
}
],
"copyright" : "Căn cứ thiết kế: FHIR R4 Device, US Core Implantable Device pattern, TT 04/2017/TT-BYT, TT 24/2025/TT-BYT, VBHN 14/VBHN-BYT, QĐ 3176/QĐ-BYT, NĐ 98/2021/NĐ-CP đã được sửa đổi, bổ sung bởi NĐ 07/2023/NĐ-CP (03/03/2023) và NĐ 04/2025/NĐ-CP (hiệu lực 01/01/2025), TT 05/2022/TT-BYT đã được sửa đổi, bổ sung bởi TT 59/2025/TT-BYT, TCVN 13995:2024 và TCVN 13996:2024. QĐ 3107/QĐ-BYT (2024) và QĐ 847/QĐ-BYT (2025) là nguồn terminology/provenance ứng viên, chưa là required binding.",
"fhirVersion" : "4.0.1",
"mapping" : [
{
"identity" : "rim",
"uri" : "http://hl7.org/v3",
"name" : "RIM Mapping"
},
{
"identity" : "w5",
"uri" : "http://hl7.org/fhir/fivews",
"name" : "FiveWs Pattern Mapping"
},
{
"identity" : "udi",
"uri" : "http://fda.gov/UDI",
"name" : "UDI Mapping"
}
],
"kind" : "resource",
"abstract" : false,
"type" : "Device",
"baseDefinition" : "http://fhir.hl7.org.vn/core/StructureDefinition/vn-core-device",
"derivation" : "constraint",
"snapshot" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version",
"valueString" : "0.5.0"
}
],
"element" : [
{
"id" : "Device",
"path" : "Device",
"short" : "Item used in healthcare",
"definition" : "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" : 0,
"max" : "*",
"base" : {
"path" : "Device",
"min" : 0,
"max" : "*"
},
"constraint" : [
{
"key" : "dom-2",
"severity" : "error",
"human" : "If the resource is contained in another resource, it SHALL NOT contain nested Resources",
"expression" : "contained.contained.empty()",
"xpath" : "not(parent::f:contained and f:contained)",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "dom-3",
"severity" : "error",
"human" : "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" : "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" : "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" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "dom-4",
"severity" : "error",
"human" : "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
"expression" : "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()",
"xpath" : "not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "dom-5",
"severity" : "error",
"human" : "If a resource is contained in another resource, it SHALL NOT have a security label",
"expression" : "contained.meta.security.empty()",
"xpath" : "not(exists(f:contained/*/f:meta/f:security))",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation",
"valueMarkdown" : "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."
}
],
"key" : "dom-6",
"severity" : "warning",
"human" : "A resource should have narrative for robust management",
"expression" : "text.`div`.exists()",
"xpath" : "exists(f:text/h:div)",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "vn-implant-udi-carrier-content",
"severity" : "warning",
"human" : "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" : "udiCarrier.empty() or udiCarrier.all(carrierHRF.exists() or carrierAIDC.exists())",
"source" : "http://fhir.hl7.org.vn/core/StructureDefinition/vn-core-implantable-device"
},
{
"key" : "vn-implant-regnum-class-cd",
"severity" : "warning",
"human" : "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" : "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" : "http://fhir.hl7.org.vn/core/StructureDefinition/vn-core-implantable-device"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "Entity. Role, or Act"
},
{
"identity" : "rim",
"map" : "Device"
}
]
},
{
"id" : "Device.id",
"path" : "Device.id",
"short" : "Logical id of this artifact",
"definition" : "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
"comment" : "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" : 0,
"max" : "1",
"base" : {
"path" : "Resource.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "id"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "Device.meta",
"path" : "Device.meta",
"short" : "Metadata about the resource",
"definition" : "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" : 0,
"max" : "1",
"base" : {
"path" : "Resource.meta",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Meta"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "Device.implicitRules",
"path" : "Device.implicitRules",
"short" : "A set of rules under which this content was created",
"definition" : "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" : "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" : 0,
"max" : "1",
"base" : {
"path" : "Resource.implicitRules",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "uri"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : true,
"isModifierReason" : "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" : true
},
{
"id" : "Device.language",
"path" : "Device.language",
"short" : "Language of the resource content",
"definition" : "The base language in which the resource is written.",
"comment" : "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" : 0,
"max" : "1",
"base" : {
"path" : "Resource.language",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet",
"valueCanonical" : "http://hl7.org/fhir/ValueSet/all-languages"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "Language"
}
],
"strength" : "preferred",
"description" : "A human language.",
"valueSet" : "http://hl7.org/fhir/ValueSet/languages|4.0.1"
}
},
{
"id" : "Device.text",
"path" : "Device.text",
"short" : "Text summary of the resource, for human interpretation",
"definition" : "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" : "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" : [
"narrative",
"html",
"xhtml",
"display"
],
"min" : 0,
"max" : "1",
"base" : {
"path" : "DomainResource.text",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Narrative"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "Act.text?"
}
]
},
{
"id" : "Device.contained",
"path" : "Device.contained",
"short" : "Contained, inline Resources",
"definition" : "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" : "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" : [
"inline resources",
"anonymous resources",
"contained resources"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.contained",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Resource"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "Device.extension",
"path" : "Device.extension",
"slicing" : {
"discriminator" : [
{
"type" : "value",
"path" : "url"
}
],
"ordered" : false,
"rules" : "open"
},
"short" : "Extension",
"definition" : "An Extension",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "Device.extension:deviceGroup",
"path" : "Device.extension",
"sliceName" : "deviceGroup",
"short" : "Nhóm TBYT BHYT N01-N09",
"definition" : "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" : 0,
"max" : "1",
"base" : {
"path" : "DomainResource.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension",
"profile" : [
🔗 "http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-group"
]
}
],
"condition" : [
"ele-1"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "Device.extension:riskClass",
"path" : "Device.extension",
"sliceName" : "riskClass",
"short" : "Phân loại rủi ro A/B/C/D — Must Support cho thiết bị cấy ghép",
"definition" : "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).\nExtension 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.\nPhân biệt rõ với các dimension độc lập KHÔNG dùng extension này:\n- Nhóm TBYT BHYT N01-N09 (TT 04/2017/TT-BYT Phụ lục 01) → dùng VNCoreExtDeviceGroup;\n- Danh pháp thiết bị y tế (QĐ 3107/2024, QĐ 847/2025) → dùng Device.type với hệ danh pháp;\n- 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" : 0,
"max" : "1",
"base" : {
"path" : "DomainResource.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension",
"profile" : [
🔗 "http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-risk-class"
]
}
],
"condition" : [
"ele-1"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "Device.extension:registrationNumber",
"path" : "Device.extension",
"sliceName" : "registrationNumber",
"short" : "Số lưu hành TBYT — Must Support cho thiết bị cấy ghép C/D",
"definition" : "Số lưu hành (registration number) của thiết bị y tế tại Việt Nam.\n\n**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).\n\n**Phân nhóm theo NĐ 98/2021 Điều 21**:\n\n1. **Loại A & B — Số công bố tiêu chuẩn áp dụng** (Sở Y tế tỉnh/TP tiếp nhận):\n - Format: `[STT tiếp nhận]/[Năm tiếp nhận 2 số]/[Mã ký hiệu Sở Y tế]-PCBA` (loại A)\n - Format: `[STT tiếp nhận]/[Năm tiếp nhận 2 số]/[Mã ký hiệu Sở Y tế]-PCBB` (loại B)\n - PCBA/PCBB = Phiếu công bố loại A / loại B\n - Ví dụ: `2300001/23/HN-PCBA` (Hồ sơ số 1 năm 2023, Sở Y tế Hà Nội tiếp nhận)\n\n2. **Loại C & D — Số Giấy chứng nhận đăng ký lưu hành** (Bộ Y tế cấp):\n - Format chuẩn: `[STT cấp]/[Năm cấp 2 số]/BYT-ĐKLH`\n - Format rút gọn: `[STT cấp]/BYT-ĐKLH`\n - ĐKLH = Đăng ký lưu hành\n - Ví dụ: `2300055/BYT-ĐKLH` hoặc `2300055/23/BYT-ĐKLH`\n\n**Phạm vi**:\n- Bắt buộc cho loại B/C/D trước khi đưa ra thị trường\n- Loại A chỉ công bố tiêu chuẩn áp dụng (vẫn dùng PCBA format)\n- Đây là định danh ở mức sản phẩm/model/regulatory context, KHÔNG phải định danh per-instance\n\n**Lưu ý phân biệt**: Extension này độc lập với:\n- UDI (định danh per-instance theo HL7 best practice)\n- MA_VAT_TU (mã nghiệp vụ BHYT theo QĐ 3176)\n- Serial number (per-instance physical)\n- Mã tài sản BV (internal facility code)",
"min" : 0,
"max" : "1",
"base" : {
"path" : "DomainResource.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension",
"profile" : [
🔗 "http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-registration-number"
]
}
],
"condition" : [
"ele-1"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "Device.extension:isIVD",
"path" : "Device.extension",
"sliceName" : "isIVD",
"short" : "Cờ IVD (chẩn đoán in vitro)",
"definition" : "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" : 0,
"max" : "1",
"base" : {
"path" : "DomainResource.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension",
"profile" : [
🔗 "http://fhir.hl7.org.vn/core/StructureDefinition/vn-ext-device-ivd"
]
}
],
"condition" : [
"ele-1"
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "Device.modifierExtension",
"path" : "Device.modifierExtension",
"short" : "Extensions that cannot be ignored",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them",
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "Device.identifier",
"path" : "Device.identifier",
"slicing" : {
"discriminator" : [
{
"type" : "value",
"path" : "system"
}
],
"description" : "Phân loại identifier theo system",
"rules" : "open"
},
"short" : "Định danh TBYT (mã vật tư/thiết bị, serial number)",
"definition" : "Unique instance identifiers assigned to a device by manufacturers other organizations or owners.",
"comment" : "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" : 0,
"max" : "*",
"base" : {
"path" : "Device.identifier",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Identifier"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "w5",
"map" : "FiveWs.identifier"
},
{
"identity" : "rim",
"map" : ".id"
},
{
"identity" : "udi",
"map" : "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."
}
]
},
{
"id" : "Device.identifier:medicalDeviceItemCode",
"path" : "Device.identifier",
"sliceName" : "medicalDeviceItemCode",
"short" : "Mã vật tư/thiết bị y tế (MA_VAT_TU)",
"definition" : "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" : "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" : 0,
"max" : "1",
"base" : {
"path" : "Device.identifier",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Identifier"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "w5",
"map" : "FiveWs.identifier"
},
{
"identity" : "rim",
"map" : ".id"
},
{
"identity" : "udi",
"map" : "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."
}
]
},
{
"id" : "Device.identifier:medicalDeviceItemCode.id",
"path" : "Device.identifier.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "Device.identifier:medicalDeviceItemCode.extension",
"path" : "Device.identifier.extension",
"slicing" : {
"discriminator" : [
{
"type" : "value",
"path" : "url"
}
],
"description" : "Extensions are always sliced by (at least) url",
"rules" : "open"
},
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "Device.identifier:medicalDeviceItemCode.use",
"path" : "Device.identifier.use",
"short" : "usual | official | temp | secondary | old (If known)",
"definition" : "The purpose of this identifier.",
"comment" : "Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.",
"requirements" : "Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Identifier.use",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : true,
"isModifierReason" : "This is labeled as \"Is Modifier\" because applications should not mistake a temporary id for a permanent one.",
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "IdentifierUse"
}
],
"strength" : "required",
"description" : "Identifies the purpose for this identifier, if known .",
"valueSet" : "http://hl7.org/fhir/ValueSet/identifier-use|4.0.1"
},
"mapping" : [
{
"identity" : "v2",
"map" : "N/A"
},
{
"identity" : "rim",
"map" : "Role.code or implied by context"
}
]
},
{
"id" : "Device.identifier:medicalDeviceItemCode.type",
"path" : "Device.identifier.type",
"short" : "Description of identifier",
"definition" : "A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.",
"comment" : "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" : "Allows users to make use of identifiers when the identifier system is not known.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Identifier.type",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "IdentifierType"
}
],
"strength" : "extensible",
"description" : "A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.",
"valueSet" : "http://hl7.org/fhir/ValueSet/identifier-type|4.0.1"
},
"mapping" : [
{
"identity" : "v2",
"map" : "CX.5"
},
{
"identity" : "rim",
"map" : "Role.code or implied by context"
}
]
},
{
"id" : "Device.identifier:medicalDeviceItemCode.type.id",
"path" : "Device.identifier.type.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "Device.identifier:medicalDeviceItemCode.type.extension",
"path" : "Device.identifier.type.extension",
"slicing" : {
"discriminator" : [
{
"type" : "value",
"path" : "url"
}
],
"description" : "Extensions are always sliced by (at least) url",
"rules" : "open"
},
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "Device.identifier:medicalDeviceItemCode.type.coding",
"path" : "Device.identifier.type.coding",
"short" : "Code defined by a terminology system",
"definition" : "A reference to a code defined by a terminology system.",
"comment" : "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" : "Allows for alternative encodings within a code system, and translations to other code systems.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "CodeableConcept.coding",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Coding"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "v2",
"map" : "C*E.1-8, C*E.10-22"
},
{
"identity" : "rim",
"map" : "union(., ./translation)"
},
{
"identity" : "orim",
"map" : "fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"
}
]
},
{
"id" : "Device.identifier:medicalDeviceItemCode.type.text",
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
"valueBoolean" : true
}
],
"path" : "Device.identifier.type.text",
"short" : "Plain text representation of the concept",
"definition" : "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" : "Very often the text is the same as a displayName of one of the codings.",
"requirements" : "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" : 0,
"max" : "1",
"base" : {
"path" : "CodeableConcept.text",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"patternString" : "Mã vật tư/thiết bị y tế",
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "v2",
"map" : "C*E.9. But note many systems use C*E.2 for this"
},
{
"identity" : "rim",
"map" : "./originalText[mediaType/code=\"text/plain\"]/data"
},
{
"identity" : "orim",
"map" : "fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"
}
]
},
{
"id" : "Device.identifier:medicalDeviceItemCode.system",
"path" : "Device.identifier.system",
"short" : "The namespace for the identifier value",
"definition" : "Establishes the namespace for the value - that is, a URL that describes a set values that are unique.",
"comment" : "Identifier.system is always case sensitive.",
"requirements" : "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" : 1,
"max" : "1",
"base" : {
"path" : "Identifier.system",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "uri"
}
],
"fixedUri" : "http://fhir.hl7.org.vn/core/sid/medical-device-item-code",
"example" : [
{
"label" : "General",
"valueUri" : "http://www.acme.com/identifiers/patient"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "v2",
"map" : "CX.4 / EI-2-4"
},
{
"identity" : "rim",
"map" : "II.root or Role.id.root"
},
{
"identity" : "servd",
"map" : "./IdentifierType"
}
]
},
{
"id" : "Device.identifier:medicalDeviceItemCode.value",
"path" : "Device.identifier.value",
"short" : "Giá trị MA_VAT_TU",
"definition" : "The portion of the identifier typically relevant to the user and which is unique within the context of the system.",
"comment" : "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" : 1,
"max" : "1",
"base" : {
"path" : "Identifier.value",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"example" : [
{
"label" : "General",
"valueString" : "123456"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "v2",
"map" : "CX.1 / EI.1"
},
{
"identity" : "rim",
"map" : "II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)"
},
{
"identity" : "servd",
"map" : "./Value"
}
]
},
{
"id" : "Device.identifier:medicalDeviceItemCode.period",
"path" : "Device.identifier.period",
"short" : "Time period when id is/was valid for use",
"definition" : "Time period during which identifier is/was valid for use.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Identifier.period",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Period"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "v2",
"map" : "CX.7 + CX.8"
},
{
"identity" : "rim",
"map" : "Role.effectiveTime or implied by context"
},
{
"identity" : "servd",
"map" : "./StartDate and ./EndDate"
}
]
},
{
"id" : "Device.identifier:medicalDeviceItemCode.assigner",
"path" : "Device.identifier.assigner",
"short" : "Organization that issued id (may be just text)",
"definition" : "Organization that issued/manages the identifier.",
"comment" : "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" : 0,
"max" : "1",
"base" : {
"path" : "Identifier.assigner",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Reference",
"targetProfile" : [
🔗 "http://hl7.org/fhir/StructureDefinition/Organization|4.0.1"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "v2",
"map" : "CX.4 / (CX.4,CX.9,CX.10)"
},
{
"identity" : "rim",
"map" : "II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper"
},
{
"identity" : "servd",
"map" : "./IdentifierIssuingAuthority"
}
]
},
{
"id" : "Device.identifier:serialNumber",
"path" : "Device.identifier",
"sliceName" : "serialNumber",
"short" : "Số serial dạng Identifier",
"definition" : "Số serial khi hệ thống trao đổi dưới dạng Identifier. Device.serialNumber vẫn là vị trí FHIR chính để ghi serial number.",
"comment" : "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" : 0,
"max" : "1",
"base" : {
"path" : "Device.identifier",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Identifier"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "w5",
"map" : "FiveWs.identifier"
},
{
"identity" : "rim",
"map" : ".id"
},
{
"identity" : "udi",
"map" : "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."
}
]
},
{
"id" : "Device.identifier:serialNumber.id",
"path" : "Device.identifier.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "Device.identifier:serialNumber.extension",
"path" : "Device.identifier.extension",
"slicing" : {
"discriminator" : [
{
"type" : "value",
"path" : "url"
}
],
"description" : "Extensions are always sliced by (at least) url",
"rules" : "open"
},
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "Device.identifier:serialNumber.use",
"path" : "Device.identifier.use",
"short" : "usual | official | temp | secondary | old (If known)",
"definition" : "The purpose of this identifier.",
"comment" : "Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.",
"requirements" : "Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Identifier.use",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : true,
"isModifierReason" : "This is labeled as \"Is Modifier\" because applications should not mistake a temporary id for a permanent one.",
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "IdentifierUse"
}
],
"strength" : "required",
"description" : "Identifies the purpose for this identifier, if known .",
"valueSet" : "http://hl7.org/fhir/ValueSet/identifier-use|4.0.1"
},
"mapping" : [
{
"identity" : "v2",
"map" : "N/A"
},
{
"identity" : "rim",
"map" : "Role.code or implied by context"
}
]
},
{
"id" : "Device.identifier:serialNumber.type",
"path" : "Device.identifier.type",
"short" : "Description of identifier",
"definition" : "A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.",
"comment" : "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" : "Allows users to make use of identifiers when the identifier system is not known.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Identifier.type",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"patternCodeableConcept" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
"code" : "SNO"
}
]
},
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "IdentifierType"
}
],
"strength" : "extensible",
"description" : "A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.",
"valueSet" : "http://hl7.org/fhir/ValueSet/identifier-type|4.0.1"
},
"mapping" : [
{
"identity" : "v2",
"map" : "CX.5"
},
{
"identity" : "rim",
"map" : "Role.code or implied by context"
}
]
},
{
"id" : "Device.identifier:serialNumber.system",
"path" : "Device.identifier.system",
"short" : "The namespace for the identifier value",
"definition" : "Establishes the namespace for the value - that is, a URL that describes a set values that are unique.",
"comment" : "Identifier.system is always case sensitive.",
"requirements" : "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" : 1,
"max" : "1",
"base" : {
"path" : "Identifier.system",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "uri"
}
],
"fixedUri" : "http://fhir.hl7.org.vn/core/sid/device-serial-number",
"example" : [
{
"label" : "General",
"valueUri" : "http://www.acme.com/identifiers/patient"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "v2",
"map" : "CX.4 / EI-2-4"
},
{
"identity" : "rim",
"map" : "II.root or Role.id.root"
},
{
"identity" : "servd",
"map" : "./IdentifierType"
}
]
},
{
"id" : "Device.identifier:serialNumber.value",
"path" : "Device.identifier.value",
"short" : "Số serial",
"definition" : "The portion of the identifier typically relevant to the user and which is unique within the context of the system.",
"comment" : "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" : 1,
"max" : "1",
"base" : {
"path" : "Identifier.value",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"example" : [
{
"label" : "General",
"valueString" : "123456"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "v2",
"map" : "CX.1 / EI.1"
},
{
"identity" : "rim",
"map" : "II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)"
},
{
"identity" : "servd",
"map" : "./Value"
}
]
},
{
"id" : "Device.identifier:serialNumber.period",
"path" : "Device.identifier.period",
"short" : "Time period when id is/was valid for use",
"definition" : "Time period during which identifier is/was valid for use.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Identifier.period",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Period"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "v2",
"map" : "CX.7 + CX.8"
},
{
"identity" : "rim",
"map" : "Role.effectiveTime or implied by context"
},
{
"identity" : "servd",
"map" : "./StartDate and ./EndDate"
}
]
},
{
"id" : "Device.identifier:serialNumber.assigner",
"path" : "Device.identifier.assigner",
"short" : "Organization that issued id (may be just text)",
"definition" : "Organization that issued/manages the identifier.",
"comment" : "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" : 0,
"max" : "1",
"base" : {
"path" : "Identifier.assigner",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Reference",
"targetProfile" : [
🔗 "http://hl7.org/fhir/StructureDefinition/Organization|4.0.1"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "v2",
"map" : "CX.4 / (CX.4,CX.9,CX.10)"
},
{
"identity" : "rim",
"map" : "II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper"
},
{
"identity" : "servd",
"map" : "./IdentifierIssuingAuthority"
}
]
},
{
"id" : "Device.definition",
"path" : "Device.definition",
"short" : "The reference to the definition for the device",
"definition" : "The reference to the definition for the device.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.definition",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Reference",
"targetProfile" : [
🔗 "http://hl7.org/fhir/StructureDefinition/DeviceDefinition|4.0.1"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "Device.udiCarrier",
"path" : "Device.udiCarrier",
"short" : "UDI carrier của thiết bị cấy ghép khi có",
"definition" : "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" : "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" : 0,
"max" : "*",
"base" : {
"path" : "Device.udiCarrier",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "BackboneElement"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "w5",
"map" : "FiveWs.identifier"
},
{
"identity" : "rim",
"map" : ".id and .code"
}
]
},
{
"id" : "Device.udiCarrier.id",
"path" : "Device.udiCarrier.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "Device.udiCarrier.extension",
"path" : "Device.udiCarrier.extension",
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "Device.udiCarrier.modifierExtension",
"path" : "Device.udiCarrier.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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" : "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" : [
"extensions",
"user content",
"modifiers"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "Device.udiCarrier.deviceIdentifier",
"path" : "Device.udiCarrier.deviceIdentifier",
"short" : "UDI Device Identifier",
"definition" : "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" : [
"DI"
],
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.udiCarrier.deviceIdentifier",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "w5",
"map" : "FiveWs.what[x]"
},
{
"identity" : "rim",
"map" : "Role.id.extension"
},
{
"identity" : "udi",
"map" : "The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device."
}
]
},
{
"id" : "Device.udiCarrier.issuer",
"path" : "Device.udiCarrier.issuer",
"short" : "UDI Issuing Organization",
"definition" : "Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include :\n1) GS1: \nhttp://hl7.org/fhir/NamingSystem/gs1-di, \n2) HIBCC:\nhttp://hl7.org/fhir/NamingSystem/hibcc-dI, \n3) ICCBBA for blood containers:\nhttp://hl7.org/fhir/NamingSystem/iccbba-blood-di, \n4) ICCBA for other devices:\nhttp://hl7.org/fhir/NamingSystem/iccbba-other-di.",
"alias" : [
"Barcode System"
],
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.udiCarrier.issuer",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "uri"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "Role.id.root"
},
{
"identity" : "udi",
"map" : "All UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency.\nGS1 DIs: \n http://hl7.org/fhir/NamingSystem/gs1\nHIBCC DIs:\n http://hl7.org/fhir/NamingSystem/hibcc\nICCBBA DIs for blood containers:\n http://hl7.org/fhir/NamingSystem/iccbba-blood\nICCBA DIs for other devices:\n http://hl7.org/fhir/NamingSystem/iccbba-other"
}
]
},
{
"id" : "Device.udiCarrier.jurisdiction",
"path" : "Device.udiCarrier.jurisdiction",
"short" : "Regional UDI authority",
"definition" : "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" : "Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.udiCarrier.jurisdiction",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "uri"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "Role.scoper"
}
]
},
{
"id" : "Device.udiCarrier.carrierAIDC",
"path" : "Device.udiCarrier.carrierAIDC",
"short" : "UDI automatic identification and data capture",
"definition" : "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" : "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" : [
"Automatic Identification and Data Capture"
],
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.udiCarrier.carrierAIDC",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "base64Binary"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "Role.id.extension"
},
{
"identity" : "udi",
"map" : "A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology."
}
]
},
{
"id" : "Device.udiCarrier.carrierHRF",
"path" : "Device.udiCarrier.carrierHRF",
"short" : "UDI human-readable form",
"definition" : "The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.",
"comment" : "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" : [
"Human Readable Form"
],
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.udiCarrier.carrierHRF",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "Role.id.extension"
},
{
"identity" : "udi",
"map" : "A unique device identifier (UDI) on a device label in plain text"
}
]
},
{
"id" : "Device.udiCarrier.entryType",
"path" : "Device.udiCarrier.entryType",
"short" : "barcode | rfid | manual +",
"definition" : "A coded entry to indicate how the data was entered.",
"requirements" : "Supports a way to distinguish hand entered from machine read data.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.udiCarrier.entryType",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "UDIEntryType"
}
],
"strength" : "required",
"description" : "Codes to identify how UDI data was entered.",
"valueSet" : "http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1"
},
"mapping" : [
{
"identity" : "rim",
"map" : "NA"
}
]
},
{
"id" : "Device.status",
"path" : "Device.status",
"short" : "Trạng thái thiết bị cấy ghép",
"definition" : "Status of the Device availability.",
"comment" : "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" : 1,
"max" : "1",
"base" : {
"path" : "Device.status",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : true,
"isModifierReason" : "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" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "FHIRDeviceStatus"
}
],
"strength" : "required",
"description" : "The availability status of the device.",
"valueSet" : "http://hl7.org/fhir/ValueSet/device-status|4.0.1"
},
"mapping" : [
{
"identity" : "w5",
"map" : "FiveWs.status"
},
{
"identity" : "rim",
"map" : ".statusCode"
}
]
},
{
"id" : "Device.statusReason",
"path" : "Device.statusReason",
"short" : "online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off",
"definition" : "Reason for the dtatus of the Device availability.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "Device.statusReason",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "FHIRDeviceStatusReason"
}
],
"strength" : "extensible",
"description" : "The availability status reason of the device.",
"valueSet" : "http://hl7.org/fhir/ValueSet/device-status-reason|4.0.1"
},
"mapping" : [
{
"identity" : "w5",
"map" : "FiveWs.status"
}
]
},
{
"id" : "Device.distinctIdentifier",
"path" : "Device.distinctIdentifier",
"short" : "Định danh phân biệt thiết bị cấy ghép",
"definition" : "The distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based product.",
"comment" : "For example, this applies to devices in the United States regulated under *Code of Federal Regulation 21CFR§1271.290(c)*.",
"alias" : [
"Distinct Identification Code (DIC)"
],
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.distinctIdentifier",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "w5",
"map" : "FiveWs.what[x]"
},
{
"identity" : "rim",
"map" : ".lotNumberText"
},
{
"identity" : "udi",
"map" : "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."
}
]
},
{
"id" : "Device.manufacturer",
"path" : "Device.manufacturer",
"short" : "Hãng sản xuất",
"definition" : "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" : 0,
"max" : "1",
"base" : {
"path" : "Device.manufacturer",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "w5",
"map" : "FiveWs.what[x]"
},
{
"identity" : "rim",
"map" : ".playedRole[typeCode=MANU].scoper.name"
},
{
"identity" : "udi",
"map" : "N/A"
}
]
},
{
"id" : "Device.manufactureDate",
"path" : "Device.manufactureDate",
"short" : "Ngày sản xuất",
"definition" : "The date and time when the device was manufactured.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.manufactureDate",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "dateTime"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "w5",
"map" : "FiveWs.what[x]"
},
{
"identity" : "rim",
"map" : ".existenceTime.low"
},
{
"identity" : "udi",
"map" : "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”."
}
]
},
{
"id" : "Device.expirationDate",
"path" : "Device.expirationDate",
"short" : "Hạn sử dụng",
"definition" : "The date and time beyond which this device is no longer valid or should not be used (if applicable).",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.expirationDate",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "dateTime"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "w5",
"map" : "FiveWs.what[x]"
},
{
"identity" : "rim",
"map" : ".expirationTime"
},
{
"identity" : "udi",
"map" : "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”."
}
]
},
{
"id" : "Device.lotNumber",
"path" : "Device.lotNumber",
"short" : "Số lô",
"definition" : "Lot number assigned by the manufacturer.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.lotNumber",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "w5",
"map" : "FiveWs.what[x]"
},
{
"identity" : "rim",
"map" : ".lotNumberText"
},
{
"identity" : "udi",
"map" : "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."
}
]
},
{
"id" : "Device.serialNumber",
"path" : "Device.serialNumber",
"short" : "Số serial",
"definition" : "The serial number assigned by the organization when the device was manufactured.",
"comment" : "Alphanumeric Maximum 20.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.serialNumber",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "w5",
"map" : "FiveWs.what[x]"
},
{
"identity" : "rim",
"map" : ".playedRole[typeCode=MANU].id"
}
]
},
{
"id" : "Device.deviceName",
"path" : "Device.deviceName",
"short" : "The name of the device as given by the manufacturer",
"definition" : "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" : 0,
"max" : "*",
"base" : {
"path" : "Device.deviceName",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "BackboneElement"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "Device.deviceName.id",
"path" : "Device.deviceName.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "Device.deviceName.extension",
"path" : "Device.deviceName.extension",
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "Device.deviceName.modifierExtension",
"path" : "Device.deviceName.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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" : "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" : [
"extensions",
"user content",
"modifiers"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "Device.deviceName.name",
"path" : "Device.deviceName.name",
"short" : "The name of the device",
"definition" : "The name of the device.",
"alias" : [
"Σ"
],
"min" : 1,
"max" : "1",
"base" : {
"path" : "Device.deviceName.name",
"min" : 1,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "Device.deviceName.type",
"path" : "Device.deviceName.type",
"short" : "udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other",
"definition" : "The type of deviceName.\nUDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "Device.deviceName.type",
"min" : 1,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "DeviceNameType"
}
],
"strength" : "required",
"description" : "The type of name the device is referred by.",
"valueSet" : "http://hl7.org/fhir/ValueSet/device-nametype|4.0.1"
},
"mapping" : [
{
"identity" : "w5",
"map" : "FiveWs.what[x]"
},
{
"identity" : "rim",
"map" : ".playedRole[typeCode=MANU].code"
}
]
},
{
"id" : "Device.modelNumber",
"path" : "Device.modelNumber",
"short" : "Model / quy cách",
"definition" : "The model number for the device.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.modelNumber",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "w5",
"map" : "FiveWs.what[x]"
},
{
"identity" : "rim",
"map" : ".softwareName (included as part)"
}
]
},
{
"id" : "Device.partNumber",
"path" : "Device.partNumber",
"short" : "The part number of the device",
"definition" : "The part number of the device.",
"comment" : "Alphanumeric Maximum 20.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.partNumber",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "w5",
"map" : "FiveWs.what[x]"
},
{
"identity" : "rim",
"map" : ".playedRole[typeCode=MANU].id"
}
]
},
{
"id" : "Device.type",
"path" : "Device.type",
"short" : "Loại thiết bị cấy ghép",
"definition" : "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" : 1,
"max" : "1",
"base" : {
"path" : "Device.type",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "DeviceType"
}
],
"strength" : "example",
"description" : "Codes to identify medical devices.",
"valueSet" : "http://hl7.org/fhir/ValueSet/device-type|4.0.1"
}
},
{
"id" : "Device.specialization",
"path" : "Device.specialization",
"short" : "The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication",
"definition" : "The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "Device.specialization",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "BackboneElement"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "Device.specialization.id",
"path" : "Device.specialization.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "Device.specialization.extension",
"path" : "Device.specialization.extension",
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "Device.specialization.modifierExtension",
"path" : "Device.specialization.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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" : "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" : [
"extensions",
"user content",
"modifiers"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "Device.specialization.systemType",
"path" : "Device.specialization.systemType",
"short" : "The standard that is used to operate and communicate",
"definition" : "The standard that is used to operate and communicate.",
"alias" : [
"Σ"
],
"min" : 1,
"max" : "1",
"base" : {
"path" : "Device.specialization.systemType",
"min" : 1,
"max" : "1"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "Device.specialization.version",
"path" : "Device.specialization.version",
"short" : "The version of the standard that is used to operate and communicate",
"definition" : "The version of the standard that is used to operate and communicate.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.specialization.version",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "w5",
"map" : "FiveWs.what[x]"
}
]
},
{
"id" : "Device.version",
"path" : "Device.version",
"short" : "The actual design of the device or software version running on the device",
"definition" : "The actual design of the device or software version running on the device.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "Device.version",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "BackboneElement"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "Device.version.id",
"path" : "Device.version.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "Device.version.extension",
"path" : "Device.version.extension",
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "Device.version.modifierExtension",
"path" : "Device.version.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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" : "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" : [
"extensions",
"user content",
"modifiers"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "Device.version.type",
"path" : "Device.version.type",
"short" : "The type of the device version",
"definition" : "The type of the device version.",
"alias" : [
"Σ"
],
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.version.type",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "Device.version.component",
"path" : "Device.version.component",
"short" : "A single component of the device version",
"definition" : "A single component of the device version.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.version.component",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Identifier"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "w5",
"map" : "FiveWs.what[x]"
}
]
},
{
"id" : "Device.version.value",
"path" : "Device.version.value",
"short" : "The version text",
"definition" : "The version text.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "Device.version.value",
"min" : 1,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "Device.property",
"path" : "Device.property",
"short" : "The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties",
"definition" : "The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "Device.property",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "BackboneElement"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "Device.property.id",
"path" : "Device.property.id",
"representation" : [
"xmlAttr"
],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "Device.property.extension",
"path" : "Device.property.extension",
"short" : "Additional content defined by implementations",
"definition" : "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" : "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" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "Device.property.modifierExtension",
"path" : "Device.property.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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" : "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" : [
"extensions",
"user content",
"modifiers"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "Device.property.type",
"path" : "Device.property.type",
"short" : "Code that specifies the property DeviceDefinitionPropetyCode (Extensible)",
"definition" : "Code that specifies the property DeviceDefinitionPropetyCode (Extensible).",
"min" : 1,
"max" : "1",
"base" : {
"path" : "Device.property.type",
"min" : 1,
"max" : "1"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "Device.property.valueQuantity",
"path" : "Device.property.valueQuantity",
"short" : "Property value as a quantity",
"definition" : "Property value as a quantity.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "Device.property.valueQuantity",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Quantity"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "Device.property.valueCode",
"path" : "Device.property.valueCode",
"short" : "Property value as a code, e.g., NTP4 (synced to NTP)",
"definition" : "Property value as a code, e.g., NTP4 (synced to NTP).",
"min" : 0,
"max" : "*",
"base" : {
"path" : "Device.property.valueCode",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false
},
{
"id" : "Device.patient",
"path" : "Device.patient",
"short" : "Bệnh nhân đang/đã được cấy ghép thiết bị",
"definition" : "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" : "If the device is implanted in a patient, then need to associate the device to the patient.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "Device.patient",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Reference",
"targetProfile" : [
🔗 "http://fhir.hl7.org.vn/core/StructureDefinition/vn-core-patient"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "w5",
"map" : "FiveWs.subject[x]"
},
{
"identity" : "rim",
"map" : ".playedRole[typeCode=USED].scoper.playedRole[typeCode=PAT]"
},
{
"identity" : "w5",
"map" : "FiveWs.subject"
}
]
},
{
"id" : "Device.owner",
"path" : "Device.owner",
"short" : "Organization responsible for device",
"definition" : "An organization that is responsible for the provision and ongoing maintenance of the device.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.owner",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Reference",
"targetProfile" : [
🔗 "http://hl7.org/fhir/StructureDefinition/Organization|4.0.1"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "w5",
"map" : "FiveWs.source"
},
{
"identity" : "rim",
"map" : ".playedRole[typeCode=OWN].scoper"
}
]
},
{
"id" : "Device.contact",
"path" : "Device.contact",
"short" : "Details for human/organization for support",
"definition" : "Contact details for an organization or a particular human that is responsible for the device.",
"comment" : "used for troubleshooting etc.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "Device.contact",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "ContactPoint"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "w5",
"map" : "FiveWs.source"
},
{
"identity" : "rim",
"map" : ".scopedRole[typeCode=CON].player"
}
]
},
{
"id" : "Device.location",
"path" : "Device.location",
"short" : "Where the device is found",
"definition" : "The place where the device can be found.",
"requirements" : "Device.location can be used to track device location.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.location",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Reference",
"targetProfile" : [
🔗 "http://hl7.org/fhir/StructureDefinition/Location|4.0.1"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "w5",
"map" : "FiveWs.where[x]"
},
{
"identity" : "rim",
"map" : ".playedRole[typeCode=LOCE].scoper"
}
]
},
{
"id" : "Device.url",
"path" : "Device.url",
"short" : "Network address to contact device",
"definition" : "A network address on which the device may be contacted directly.",
"comment" : "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" : 0,
"max" : "1",
"base" : {
"path" : "Device.url",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "uri"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "w5",
"map" : "FiveWs.where[x]"
},
{
"identity" : "rim",
"map" : ".telecom"
}
]
},
{
"id" : "Device.note",
"path" : "Device.note",
"short" : "Ghi chú (tên VTYT, quy cách...)",
"definition" : "Descriptive information, usage information or implantation information that is not captured in an existing element.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "Device.note",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Annotation"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : ".text"
}
]
},
{
"id" : "Device.safety",
"path" : "Device.safety",
"short" : "Thông tin an toàn của thiết bị cấy ghép",
"definition" : "Provides additional safety characteristics about a medical device. For example devices containing latex.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "Device.safety",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "rim",
"map" : "NA"
}
]
},
{
"id" : "Device.parent",
"path" : "Device.parent",
"short" : "The parent device",
"definition" : "The parent device.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Device.parent",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Reference",
"targetProfile" : [
🔗 "http://hl7.org/fhir/StructureDefinition/Device|4.0.1"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false
}
]
},
"differential" : {
"element" : [
{
"id" : "Device",
"path" : "Device",
"constraint" : [
{
"key" : "vn-implant-udi-carrier-content",
"severity" : "warning",
"human" : "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" : "udiCarrier.empty() or udiCarrier.all(carrierHRF.exists() or carrierAIDC.exists())",
"source" : "http://fhir.hl7.org.vn/core/StructureDefinition/vn-core-implantable-device"
},
{
"key" : "vn-implant-regnum-class-cd",
"severity" : "warning",
"human" : "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" : "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" : "http://fhir.hl7.org.vn/core/StructureDefinition/vn-core-implantable-device"
}
]
},
{
"id" : "Device.extension:riskClass",
"path" : "Device.extension",
"sliceName" : "riskClass",
"short" : "Phân loại rủi ro A/B/C/D — Must Support cho thiết bị cấy ghép",
"mustSupport" : true
},
{
"id" : "Device.extension:registrationNumber",
"path" : "Device.extension",
"sliceName" : "registrationNumber",
"short" : "Số lưu hành TBYT — Must Support cho thiết bị cấy ghép C/D",
"mustSupport" : true
},
{
"id" : "Device.udiCarrier",
"path" : "Device.udiCarrier",
"short" : "UDI carrier của thiết bị cấy ghép khi có"
},
{
"id" : "Device.udiCarrier.carrierAIDC",
"path" : "Device.udiCarrier.carrierAIDC",
"short" : "UDI automatic identification and data capture",
"mustSupport" : true
},
{
"id" : "Device.status",
"path" : "Device.status",
"short" : "Trạng thái thiết bị cấy ghép"
},
{
"id" : "Device.modelNumber",
"path" : "Device.modelNumber",
"short" : "Model / quy cách"
},
{
"id" : "Device.type",
"path" : "Device.type",
"short" : "Loại thiết bị cấy ghép",
"definition" : "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" : 1
},
{
"id" : "Device.patient",
"path" : "Device.patient",
"short" : "Bệnh nhân đang/đã được cấy ghép thiết bị",
"definition" : "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" : 1
},
{
"id" : "Device.safety",
"path" : "Device.safety",
"short" : "Thông tin an toàn của thiết bị cấy ghép",
"mustSupport" : true
}
]
}
}