基于FHIR标准的健康档案共享文档实施指南
0.8.0.2022705 - 持续集成版
基于FHIR标准的健康档案共享文档实施指南
0.8.0.2022705 - 持续集成版
基于FHIR的健康档案共享文档实施时必须严格遵循本实施指南的规定。
| Defining URL: | http://hl7.org.cn/fhir/sd/ehr/StructureDefinition/profile-medical-adr |
| Version: | 0.8.0.2022705 |
| Name: | MedicationADR |
| Title: | 药物不良反应结构定义 |
| Status: | Active as of 2022-07-05T13:46:42+08:00 |
| Definition: | 药物不良反应资源本地化定义。 |
| Publisher: | CHIMA&HL7中国委员会 |
| Source Resource: | XML / JSON / Turtle |
药物不良反应结构定义的正式唯一标识为:
http://hl7.org.cn/fhir/sd/ehr/StructureDefinition/profile-medical-adr
药物不良反应使用Observation资源进行表示。该资源的本地化结构定义声明了对适用于健康医疗信息平台中药物不良反应的最低要求。它确定在使用此资源时应包含哪些核心元素、扩展和术语。
药物不良反应是以布尔值的形式记录在valueBoolean元素中。当存在药物不良反应时，将药物不良反应描述信息记录在note元素中。
药物不良反应结构定义是在FHIR标准的AllergyIntolerance基础上进行更加详细的规则约束，下表展示了药物不良反应结构定义的结构表示。
这种结构源自 AllergyIntolerance
这种结构源自 AllergyIntolerance
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  AllergyIntolerance | 0..* | AllergyIntolerance | Allergy or Intolerance (generally: Risk of adverse reaction to a substance) | |
  clinicalStatus | S | 0..1 | CodeableConcept | 临床状态。取值可能有：活跃、不活跃、已解决 |
| type | S | 1..1 | code | 类型。取值可能有：过敏、不良反应 |
| category | S | 1..1 | code | 分类。取值固定为药物 Required Pattern: medication |
| criticality | S | 0..1 | code | 严重程度。取值可能有：低、高、无法评估 |
| code | 1..1 | CodeableConcept | 药物不良反应的编码或名称 | |
| patient | 1..1 | Reference(Patient) | 患者 | |
| encounter | 1..1 | Reference(Encounter) | 记录药物不良反应所属的诊疗活动 | |
  onset[x] | S | 0..1 | 药物不良反应发生的时间点或者时间区间 | |
  onsetDateTime | dateTime | |||
  onsetPeriod | Period | |||
| recordedDate | 1..1 | dateTime | 记录患者药物不良反应的时间 | |
 recorder | 1..1 | Reference(Practitioner | PractitionerRole) | 记录患者药物不良反应的医师 | |
 reaction | S | 0..* | BackboneElement | 记录药物不良反应的症状表现 |
 substance | 0..1 | CodeableConcept | 引发不良反应的药物 | |
| description | 0..1 | string | 不良反应症状表现的文本描述 | |
| severity | 0..1 | code | 不良反应症状表现的严重性 | |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| AllergyIntolerance | I | 0..* | AllergyIntolerance | Allergy or Intolerance (generally: Risk of adverse reaction to a substance) |
| id | Σ | 0..1 | string | Logical id of this artifact |
| meta | Σ | 0..1 | Meta | Metadata about the resource |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred) Max Binding: AllLanguages: A human language. | |
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |
| contained | 0..* | Resource | Contained, inline Resources | |
 extension | 0..* | Extension | Additional content defined by implementations | |
 modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
| identifier | Σ | 0..* | Identifier | External ids for this item |
| clinicalStatus | ?!SΣI | 0..1 | CodeableConcept | 临床状态。取值可能有：活跃、不活跃、已解决 Binding: AllergyIntoleranceClinicalStatusCodes (required): The clinical status of the allergy or intolerance. |
| verificationStatus | ?!ΣI | 0..1 | CodeableConcept | unconfirmed | confirmed | refuted | entered-in-error Binding: AllergyIntoleranceVerificationStatusCodes (required): Assertion about certainty associated with a propensity, or potential risk, of a reaction to the identified substance. |
| type | SΣ | 1..1 | code | 类型。取值可能有：过敏、不良反应 Binding: AllergyIntoleranceType (required): Identification of the underlying physiological mechanism for a Reaction Risk. |
| category | SΣ | 1..1 | code | 分类。取值固定为药物 Binding: AllergyIntoleranceCategory (required): Category of an identified substance associated with allergies or intolerances. Required Pattern: medication |
| criticality | SΣ | 0..1 | code | 严重程度。取值可能有：低、高、无法评估 Binding: AllergyIntoleranceCriticality (required): Estimate of the potential clinical harm, or seriousness, of a reaction to an identified substance. |
| code | Σ | 1..1 | CodeableConcept | 药物不良反应的编码或名称 Binding: AllergyIntoleranceSubstance/Product,ConditionAndNegationCodes (example): Type of the substance/product, allergy or intolerance condition, or negation/exclusion codes for reporting no known allergies. |
| patient | Σ | 1..1 | Reference(Patient) | 患者 |
| encounter | 1..1 | Reference(Encounter) | 记录药物不良反应所属的诊疗活动 | |
| onset[x] | S | 0..1 | 药物不良反应发生的时间点或者时间区间 | |
| onsetDateTime | dateTime | |||
| onsetPeriod | Period | |||
| recordedDate | 1..1 | dateTime | 记录患者药物不良反应的时间 | |
| recorder | 1..1 | Reference(Practitioner | PractitionerRole) | 记录患者药物不良反应的医师 | |
| asserter | Σ | 0..1 | Reference(Patient | RelatedPerson | Practitioner | PractitionerRole) | Source of the information about the allergy |
| lastOccurrence | 0..1 | dateTime | Date(/time) of last known occurrence of a reaction | |
| note | 0..* | Annotation | Additional text not captured in other fields | |
| reaction | S | 0..* | BackboneElement | 记录药物不良反应的症状表现 |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| substance | 0..1 | CodeableConcept | 引发不良反应的药物 Binding: SubstanceCode (example): Codes defining the type of the substance (including pharmaceutical products). | |
| manifestation | 1..* | CodeableConcept | Clinical symptoms/signs associated with the Event Binding: SNOMEDCTClinicalFindings (example): Clinical symptoms and/or signs that are observed or associated with an Adverse Reaction Event. | |
| description | 0..1 | string | 不良反应症状表现的文本描述 | |
| onset | 0..1 | dateTime | Date(/time) when manifestations showed | |
| severity | 0..1 | code | 不良反应症状表现的严重性 Binding: AllergyIntoleranceSeverity (required): Clinical assessment of the severity of a reaction event as a whole, potentially considering multiple different manifestations. | |
| exposureRoute | 0..1 | CodeableConcept | How the subject was exposed to the substance Binding: SNOMEDCTRouteCodes (example): A coded concept describing the route or physiological path of administration of a therapeutic agent into or onto the body of a subject. | |
| note | 0..* | Annotation | Text about event not captured in other fields | |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| AllergyIntolerance | I | 0..* | AllergyIntolerance | Allergy or Intolerance (generally: Risk of adverse reaction to a substance) |
| clinicalStatus | ?!ΣI | 0..1 | CodeableConcept | 临床状态。取值可能有：活跃、不活跃、已解决 Binding: AllergyIntoleranceClinicalStatusCodes (required): The clinical status of the allergy or intolerance. |
| type | Σ | 1..1 | code | 类型。取值可能有：过敏、不良反应 Binding: AllergyIntoleranceType (required): Identification of the underlying physiological mechanism for a Reaction Risk. |
| category | Σ | 1..1 | code | 分类。取值固定为药物 Binding: AllergyIntoleranceCategory (required): Category of an identified substance associated with allergies or intolerances. Required Pattern: medication |
| criticality | Σ | 0..1 | code | 严重程度。取值可能有：低、高、无法评估 Binding: AllergyIntoleranceCriticality (required): Estimate of the potential clinical harm, or seriousness, of a reaction to an identified substance. |
| onset[x] | 0..1 | 药物不良反应发生的时间点或者时间区间 | ||
| onsetDateTime | dateTime | |||
| onsetPeriod | Period | |||
| reaction | 0..* | BackboneElement | 记录药物不良反应的症状表现 | |
| Documentation for this format | ||||
这种结构源自 AllergyIntolerance
差异视图
这种结构源自 AllergyIntolerance
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| AllergyIntolerance | 0..* | AllergyIntolerance | Allergy or Intolerance (generally: Risk of adverse reaction to a substance) | |
| clinicalStatus | S | 0..1 | CodeableConcept | 临床状态。取值可能有：活跃、不活跃、已解决 |
| type | S | 1..1 | code | 类型。取值可能有：过敏、不良反应 |
| category | S | 1..1 | code | 分类。取值固定为药物 Required Pattern: medication |
| criticality | S | 0..1 | code | 严重程度。取值可能有：低、高、无法评估 |
| code | 1..1 | CodeableConcept | 药物不良反应的编码或名称 | |
| patient | 1..1 | Reference(Patient) | 患者 | |
| encounter | 1..1 | Reference(Encounter) | 记录药物不良反应所属的诊疗活动 | |
| onset[x] | S | 0..1 | 药物不良反应发生的时间点或者时间区间 | |
| onsetDateTime | dateTime | |||
| onsetPeriod | Period | |||
| recordedDate | 1..1 | dateTime | 记录患者药物不良反应的时间 | |
| recorder | 1..1 | Reference(Practitioner | PractitionerRole) | 记录患者药物不良反应的医师 | |
| reaction | S | 0..* | BackboneElement | 记录药物不良反应的症状表现 |
| substance | 0..1 | CodeableConcept | 引发不良反应的药物 | |
| description | 0..1 | string | 不良反应症状表现的文本描述 | |
| severity | 0..1 | code | 不良反应症状表现的严重性 | |
| Documentation for this format | ||||
快照视图
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| AllergyIntolerance | I | 0..* | AllergyIntolerance | Allergy or Intolerance (generally: Risk of adverse reaction to a substance) |
| id | Σ | 0..1 | string | Logical id of this artifact |
| meta | Σ | 0..1 | Meta | Metadata about the resource |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred) Max Binding: AllLanguages: A human language. | |
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |
| contained | 0..* | Resource | Contained, inline Resources | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
| identifier | Σ | 0..* | Identifier | External ids for this item |
| clinicalStatus | ?!SΣI | 0..1 | CodeableConcept | 临床状态。取值可能有：活跃、不活跃、已解决 Binding: AllergyIntoleranceClinicalStatusCodes (required): The clinical status of the allergy or intolerance. |
| verificationStatus | ?!ΣI | 0..1 | CodeableConcept | unconfirmed | confirmed | refuted | entered-in-error Binding: AllergyIntoleranceVerificationStatusCodes (required): Assertion about certainty associated with a propensity, or potential risk, of a reaction to the identified substance. |
| type | SΣ | 1..1 | code | 类型。取值可能有：过敏、不良反应 Binding: AllergyIntoleranceType (required): Identification of the underlying physiological mechanism for a Reaction Risk. |
| category | SΣ | 1..1 | code | 分类。取值固定为药物 Binding: AllergyIntoleranceCategory (required): Category of an identified substance associated with allergies or intolerances. Required Pattern: medication |
| criticality | SΣ | 0..1 | code | 严重程度。取值可能有：低、高、无法评估 Binding: AllergyIntoleranceCriticality (required): Estimate of the potential clinical harm, or seriousness, of a reaction to an identified substance. |
| code | Σ | 1..1 | CodeableConcept | 药物不良反应的编码或名称 Binding: AllergyIntoleranceSubstance/Product,ConditionAndNegationCodes (example): Type of the substance/product, allergy or intolerance condition, or negation/exclusion codes for reporting no known allergies. |
| patient | Σ | 1..1 | Reference(Patient) | 患者 |
| encounter | 1..1 | Reference(Encounter) | 记录药物不良反应所属的诊疗活动 | |
| onset[x] | S | 0..1 | 药物不良反应发生的时间点或者时间区间 | |
| onsetDateTime | dateTime | |||
| onsetPeriod | Period | |||
| recordedDate | 1..1 | dateTime | 记录患者药物不良反应的时间 | |
| recorder | 1..1 | Reference(Practitioner | PractitionerRole) | 记录患者药物不良反应的医师 | |
| asserter | Σ | 0..1 | Reference(Patient | RelatedPerson | Practitioner | PractitionerRole) | Source of the information about the allergy |
| lastOccurrence | 0..1 | dateTime | Date(/time) of last known occurrence of a reaction | |
| note | 0..* | Annotation | Additional text not captured in other fields | |
| reaction | S | 0..* | BackboneElement | 记录药物不良反应的症状表现 |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| substance | 0..1 | CodeableConcept | 引发不良反应的药物 Binding: SubstanceCode (example): Codes defining the type of the substance (including pharmaceutical products). | |
| manifestation | 1..* | CodeableConcept | Clinical symptoms/signs associated with the Event Binding: SNOMEDCTClinicalFindings (example): Clinical symptoms and/or signs that are observed or associated with an Adverse Reaction Event. | |
| description | 0..1 | string | 不良反应症状表现的文本描述 | |
| onset | 0..1 | dateTime | Date(/time) when manifestations showed | |
| severity | 0..1 | code | 不良反应症状表现的严重性 Binding: AllergyIntoleranceSeverity (required): Clinical assessment of the severity of a reaction event as a whole, potentially considering multiple different manifestations. | |
| exposureRoute | 0..1 | CodeableConcept | How the subject was exposed to the substance Binding: SNOMEDCTRouteCodes (example): A coded concept describing the route or physiological path of administration of a therapeutic agent into or onto the body of a subject. | |
| note | 0..* | Annotation | Text about event not captured in other fields | |
| Documentation for this format | ||||
本定义的其它表示法: Schematron
| Path | Conformance | ValueSet / Code |
| AllergyIntolerance.language | preferred | CommonLanguages Max Binding: AllLanguages |
| AllergyIntolerance.clinicalStatus | required | AllergyIntoleranceClinicalStatusCodes |
| AllergyIntolerance.verificationStatus | required | AllergyIntoleranceVerificationStatusCodes |
| AllergyIntolerance.type | required | AllergyIntoleranceType |
| AllergyIntolerance.category | required | Pattern: medication |
| AllergyIntolerance.criticality | required | AllergyIntoleranceCriticality |
| AllergyIntolerance.code | example | AllergyIntoleranceSubstance/Product,ConditionAndNegationCodes |
| AllergyIntolerance.reaction.substance | example | SubstanceCode |
| AllergyIntolerance.reaction.manifestation | example | SNOMEDCTClinicalFindings |
| AllergyIntolerance.reaction.severity | required | AllergyIntoleranceSeverity |
| AllergyIntolerance.reaction.exposureRoute | example | SNOMEDCTRouteCodes |
| Id | Path | Details | Requirements |
| ait-1 | AllergyIntolerance | AllergyIntolerance.clinicalStatus SHALL be present if verificationStatus is not entered-in-error. : verificationStatus.coding.where(system = 'http://terminology.hl7.org/CodeSystem/allergyintolerance-verification' and code = 'entered-in-error').exists() or clinicalStatus.exists() | |
| ait-2 | AllergyIntolerance | AllergyIntolerance.clinicalStatus SHALL NOT be present if verification Status is entered-in-error : verificationStatus.coding.where(system = 'http://terminology.hl7.org/CodeSystem/allergyintolerance-verification' and code = 'entered-in-error').empty() or clinicalStatus.empty() | |
| dom-2 | AllergyIntolerance | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | AllergyIntolerance | 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 : 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() | |
| dom-4 | AllergyIntolerance | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | AllergyIntolerance | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | AllergyIntolerance | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | AllergyIntolerance.meta | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AllergyIntolerance.implicitRules | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AllergyIntolerance.language | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AllergyIntolerance.text | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AllergyIntolerance.extension | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | AllergyIntolerance.extension | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| ele-1 | AllergyIntolerance.modifierExtension | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | AllergyIntolerance.modifierExtension | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| ele-1 | AllergyIntolerance.identifier | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AllergyIntolerance.clinicalStatus | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AllergyIntolerance.verificationStatus | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AllergyIntolerance.type | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AllergyIntolerance.category | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AllergyIntolerance.criticality | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AllergyIntolerance.code | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AllergyIntolerance.patient | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AllergyIntolerance.encounter | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AllergyIntolerance.onset[x] | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AllergyIntolerance.recordedDate | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AllergyIntolerance.recorder | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AllergyIntolerance.asserter | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AllergyIntolerance.lastOccurrence | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AllergyIntolerance.note | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AllergyIntolerance.reaction | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AllergyIntolerance.reaction.extension | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | AllergyIntolerance.reaction.extension | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| ele-1 | AllergyIntolerance.reaction.modifierExtension | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | AllergyIntolerance.reaction.modifierExtension | Must have either extensions or value[x], not both : extension.exists() != value.exists() | |
| ele-1 | AllergyIntolerance.reaction.substance | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AllergyIntolerance.reaction.manifestation | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AllergyIntolerance.reaction.description | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AllergyIntolerance.reaction.onset | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AllergyIntolerance.reaction.severity | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AllergyIntolerance.reaction.exposureRoute | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ele-1 | AllergyIntolerance.reaction.note | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |