第 13 課：設定檔、擴充和實施指南

HL7 FHIR - 基礎到進階醫療資料標準

第 4 部分：資料類型、術語和設定文件

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1. 設定檔－綁定資源

一 公司簡介 (StructureDefinition) 增加了對基本 FHIR 資源的限制 — 必需的元素、有限的基數、綁定術語、新增的擴充。

使用 FHIR 簡寫 (FSH) 的設定檔範例

Profile: VNPatient
Parent: Patient
Id: vn-patient
Title: "VN Core Patient Profile"
Description: "Patient profile cho y tế Việt Nam, yêu cầu CCCD, ngày sinh, giới tính"

// Bắt buộc các elements
* identifier 1..* MS
* identifier ^slicing.discriminator.type = #pattern
* identifier ^slicing.discriminator.path = "type"
* identifier ^slicing.rules = #open

* identifier contains
    cccd 0..1 MS and
    bhyt 0..1 MS

* identifier[cccd].system = "http://cccd.gov.vn" (exactly)
* identifier[cccd].type = http://terminology.hl7.org/CodeSystem/v2-0203#NI
* identifier[cccd].value 1..1

* identifier[bhyt].system = "http://bhxh.gov.vn/bhyt" (exactly)
* identifier[bhyt].type = http://terminology.hl7.org/CodeSystem/v2-0203#SB

* name 1..* MS
* gender 1..1 MS
* birthDate 1..1 MS

// Extension
* extension contains
    VNEthnicity named ethnicity 0..1 MS and
    VNNationality named nationality 0..1 MS

// Binding
* maritalStatus from http://hl7.org/fhir/ValueSet/marital-status (extensible)

結構定義 (JSON)

{
  "resourceType": "StructureDefinition",
  "url": "http://fhir.vn/StructureDefinition/vn-patient",
  "name": "VNPatient",
  "title": "VN Core Patient Profile",
  "status": "active",
  "kind": "resource",
  "abstract": false,
  "type": "Patient",
  "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Patient",
  "derivation": "constraint",
  "differential": {
    "element": [
      {
        "id": "Patient.identifier",
        "path": "Patient.identifier",
        "min": 1,
        "mustSupport": true,
        "slicing": {
          "discriminator": [
            {"type": "pattern", "path": "type"}
          ],
          "rules": "open"
        }
      },
      {
        "id": "Patient.identifier:cccd",
        "path": "Patient.identifier",
        "sliceName": "cccd",
        "min": 0,
        "max": "1",
        "mustSupport": true
      },
      {
        "id": "Patient.identifier:cccd.system",
        "path": "Patient.identifier.system",
        "fixedUri": "http://cccd.gov.vn"
      },
      {
        "id": "Patient.identifier:cccd.value",
        "path": "Patient.identifier.value",
        "min": 1
      },
      {
        "id": "Patient.name",
        "path": "Patient.name",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Patient.gender",
        "path": "Patient.gender",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "Patient.birthDate",
        "path": "Patient.birthDate",
        "min": 1,
        "mustSupport": true
      }
    ]
  }
}

2. 擴展

擴展允許添加基本 FHIR 資源沒有的數據 - 這就是機制 可擴展性 核心。

簡單的擴展

Extension: VNEthnicity
Id: vn-ethnicity
Title: "Dân tộc Việt Nam"
Description: "Mã dân tộc theo danh mục 54 dân tộc Việt Nam"
Context: Patient
* value[x] only CodeableConcept
* valueCodeableConcept from VNEthnicityVS (required)

{
  "resourceType": "Patient",
  "extension": [
    {
      "url": "http://fhir.vn/StructureDefinition/vn-ethnicity",
      "valueCodeableConcept": {
        "coding": [
          {
            "system": "http://fhir.vn/CodeSystem/vn-ethnicity",
            "code": "01",
            "display": "Kinh"
          }
        ]
      }
    }
  ]
}

複雜擴展

Extension: VNAddress
Id: vn-address
Title: "Địa chỉ hành chính Việt Nam"
Context: Address
* extension contains
    province 1..1 MS and
    district 1..1 MS and
    ward 0..1 MS
* extension[province].value[x] only CodeableConcept
* extension[province].valueCodeableConcept from VNProvinceVS (required)
* extension[district].value[x] only CodeableConcept
* extension[district].valueCodeableConcept from VNDistrictVS (required)
* extension[ward].value[x] only CodeableConcept
* extension[ward].valueCodeableConcept from VNWardVS (required)

修飾符擴充

修飾符擴充 改變意義 包含它的元素的名稱 - 接收者必須理解這個擴充。

{
  "resourceType": "AllergyIntolerance",
  "modifierExtension": [
    {
      "url": "http://hospital.vn/fhir/StructureDefinition/allergy-certainty",
      "valueCode": "unconfirmed"
    }
  ]
}

3. 切片

切片將重複元素（基數 0..*）劃分為具有不同約束的單獨「切片」。

* identifier ^slicing.discriminator.type = #pattern
* identifier ^slicing.discriminator.path = "type"
* identifier ^slicing.rules = #open
* identifier ^slicing.ordered = false

* identifier contains
    cccd 0..1 MS and    // Slice cho CCCD
    bhyt 0..1 MS and    // Slice cho BHYT
    mrn 1..1 MS         // Slice cho MRN (bắt buộc)

鑑別器類型	描述
值。值	以具體數值區分
模式。圖案	使用模式匹配進行區分
類型	按類型區分（選擇類型）
簡介。簡介	按外形區分
存在	以存在區分

4. 不變量（FHIRPath 約束）

Invariant: vn-patient-1
Description: "Phải có ít nhất CCCD hoặc BHYT"
Expression: "identifier.where(system='http://cccd.gov.vn').exists() or identifier.where(system='http://bhxh.gov.vn/bhyt').exists()"
Severity: #error

Invariant: vn-patient-2
Description: "Nếu có CCCD thì phải có 12 chữ số"
Expression: "identifier.where(system='http://cccd.gov.vn').value.matches('^[0-9]{12}$')"
Severity: #error

5. 實施指南（IG）

IG 是一個完整的套件：設定檔、擴充、ValueSets、CodeSystems、範例、敘述性文件。

IG專案結構

vn-core-ig/
├── sushi-config.yaml        # SUSHI config
├── input/
│   ├── fsh/
│   │   ├── profiles/
│   │   │   ├── VNPatient.fsh
│   │   │   ├── VNEncounter.fsh
│   │   │   └── VNObservation.fsh
│   │   ├── extensions/
│   │   │   ├── VNEthnicity.fsh
│   │   │   └── VNAddress.fsh
│   │   ├── terminology/
│   │   │   ├── VNEthnicityCS.fsh
│   │   │   └── VNEthnicityVS.fsh
│   │   └── examples/
│   │       └── ExamplePatient.fsh
│   └── pagecontent/
│       ├── index.md
│       └── design.md
├── ig.ini
└── _genonce.sh

sushi-config.yaml

id: vn.fhir.core
canonical: http://fhir.vn/ig/core
name: VNCoreIG
title: "Vietnam Core FHIR Implementation Guide"
status: active
version: 0.1.0
fhirVersion: 5.0.0
copyrightYear: 2025+
releaseLabel: ci-build
publisher:
  name: Vietnam Health IT Association
dependencies:
  hl7.fhir.r5.core: 5.0.0

建立IG

# Install SUSHI
npm install -g fsh-sushi

# Compile FSH → FHIR JSON
sushi .

# Run IG Publisher
./_genonce.sh
# Output: output/ directory with HTML pages

6. US Core和IPS作為參考

免疫組化	描述	型材
美國核心	美國，21 世紀治癒法案所要求的	患者、遭遇、病情、觀察、藥物治療…
IPS	國際病患摘要，ISO 27269	患者、藥物、過敏、問題、免疫接種…
非盟基地	澳洲	非盟患者、非盟從業者、...

七、總結

• 公司簡介 — 資源綁定（必需元素、綁定、基底數）

• 擴充 — 新增基礎中沒有的資料（簡單、複雜、修飾符）

• 切片 — 將重複元素劃分為具有單獨約束的切片

• 不變數 — 使用 FHIRPath 的業務規則

• 卵泡刺激素+壽司 — 用於編寫簡潔的設定檔/擴充的 DSL 語言

• IG出版商 — 從 FSH/JSON 建立網站文檔