# US Core AllergyIntolerance Profile - Health eData 1 Sandbox v0.1.0

* [**Table of Contents**](toc.md)
* [**Artifacts Summary**](artifacts.md)
* **US Core AllergyIntolerance Profile**

## Resource Profile: US Core AllergyIntolerance Profile 

| | | |
| :--- | :--- | :--- |
| *Official URL*:http://hl7.org/fhir/us/core/StructureDefinition/us-core-allergyintolerance | *Version*:0.1.0 | |
| Active as of 2026-05-19 | [Maturity Level](http://hl7.org/fhir/versions.html#maturity): 5 | *Computable Name*:USCoreAllergyIntolerance |
| *Other Identifiers:*OID:2.16.840.1.113883.4.642.40.2.42.5 | | |

 
The US Core AllergyIntolerance Profile inherits from the FHIR [AllergyIntolerance](https://hl7.org/fhir/R4/allergyintolerance.html) resource; refer to it for scope and usage definitions. This profile meets the requirements of the U.S. Core Data for Interoperability (USCDI) **Allergies and Intolerances Data Class** and its **Allergy Intolerance Criticality Data Element**. It sets minimum expectations for the AllergyIntolerance resource to record, search, and fetch allergies and adverse reactions associated with a patient. It specifies which core elements, extensions, vocabularies, and value sets **SHALL** be present in the resource and constrains how the elements are used. Providing the floor for standards development for specific use cases promotes interoperability and adoption. 

**Example Usage Scenarios:**

The following are example usage scenarios for the US Core AllergyIntolerance profile:

* Query for Allergies belonging to a Patient
* [Record or update] a Patient Allergy

### Mandatory and Must Support Data Elements

The following data elements must always be present ([Mandatory] definition) or must be supported if the data is present in the sending system ([Must Support] definition). They are presented below in a simple human-readable explanation. Profile specific guidance and examples are provided as well. The [Formal Views] below provides the formal summary, definitions, and terminology requirements.

**Each AllergyIntolerance Must Have:**

1. a clinical status of the allergy (e.g., active or resolved)1
1. a code that tells you what the patient is allergic to
1. a patient

**Each AllergyIntolerance Must Support:**

1. a verification status
1. an estimate of the potential clinical harm of the reaction (e.g., low, high, or unable-to-assess)
1. a reaction manifestation

**Additional USCDI Requirements:**

These [Additional USCDI Requirements] elements are not Mandatory or Must Support but are required for ONC Health IT certification testing and are included in the formal definition of the profile and the AllergyIntolerance examples.

1. a recorder2

1,2 see guidance below

### Profile Specific Implementation Guidance

This section provides detailed implementation guidance for the US Core Profile to support implementation and certification.

* 1 The `AllergyIntolerance.clinicalStatus` element has the following constraints: **SHALL** be present if verification status is not "entered-in-error"[§][CONF-0302] and **SHALL NOT** be present if verification Status is "entered-in-error".[§][CONF-0303]
* **No Known Allergies** **MAY** be represented using the US Core-AllergyIntolerance profile[§][CONF-0305] with the appropriate negation code in `AllergyIntolerance.code`[§][CONF-0306] and the appropriate verification status in `AllergyIntolerance.verificationStatus`.[§][CONF-0307]


  If a patient has not been asked about their allergies, this would be represented as:[§][CONF-0308]


  If a patient has been asked, but has indicated they have no known allergies, this would be represented as:[§][CONF-0309]
* **FOO**

### Liquid Script to Generate StructureDefinition All Nice N Pretty Like

{% include structure-table.md sd=sd source="differential" show_must_support=true show_uscdi=true %}

## USCoreAllergyIntolerance — US Core AllergyIntolerance Profile

The US Core AllergyIntolerance Profile inherits from the FHIR [AllergyIntolerance](https://hl7.org/fhir/R4/allergyintolerance.html) resource; refer to it for scope and usage definitions. This profile meets the requirements of the U.S. Core Data for Interoperability (USCDI) **Allergies and Intolerances Data Class** and its **Allergy Intolerance Criticality Data Element**. It sets minimum expectations for the AllergyIntolerance resource to record, search, and fetch allergies and adverse reactions associated with a patient. It specifies which core elements, extensions, vocabularies, and value sets **SHALL** be present in the resource and constrains how the elements are used. Providing the floor for standards development for specific use cases promotes interoperability and adoption.

* **URL:** `http://hl7.org/fhir/us/core/StructureDefinition/us-core-allergyintolerance`
* **Version:** 0.1.0
* **Status:** active
* **Kind:** resource
* **Type:** `AllergyIntolerance`
* **Base Definition:** `http://hl7.org/fhir/StructureDefinition/AllergyIntolerance`
* **Derivation:** constraint

### Elements (differential)

| | | | | | |
| :--- | :--- | :--- | :--- | :--- | :--- |
| `AllergyIntolerance` |   |   | 0..* |   | **Allergy or Intolerance (generally: Risk of adverse reaction to a substance)**Risk of harmful or undesirable, physiological response which is unique to an individual and associated with exposure to a substance. |
| ↳`clinicalStatus` | ✅ |   | 0..1 | `CodeableConcept` | **active | inactive | resolved**The clinical status of the allergy or intolerance.**Binding:** `http://hl7.org/fhir/ValueSet/allergyintolerance-clinical` (required) |
| ↳`verificationStatus` | ✅ |   | 0..1 | `CodeableConcept` | **unconfirmed | confirmed | refuted | entered-in-error**Assertion about certainty associated with the propensity, or potential risk, of a reaction to the identified substance (including pharmaceutical product).**Binding:** `http://hl7.org/fhir/ValueSet/allergyintolerance-verification` (required) |
| ↳`criticality` | ✅ |   | 0..1 | `code` | **low | high | unable-to-assess**Estimate of the potential clinical harm, or seriousness, of the reaction to the identified substance.**Binding:** `http://hl7.org/fhir/ValueSet/allergy-intolerance-criticality` (required) |
| ↳`code` | ✅ |   | 1..1 | `CodeableConcept` | **Code that identifies the allergy or intolerance**Code for an allergy or intolerance statement (either a positive or a negated/excluded statement). This may be a code for a substance or pharmaceutical product that is considered to be responsible for the adverse reaction risk (e.g., "Latex"), an allergy or intolerance condition (e.g., "Latex allergy"), or a negated/excluded code for a specific substance or class (e.g., "No latex allergy") or a general or categorical negated statement (e.g., "No known allergy", "No known drug allergies"). Note: the substance for a specific reaction may be different from the substance identified as the cause of the risk, but it must be consistent with it. For instance, it may be a more specific substance (e.g. a brand medication) or a composite product that includes the identified substance. It must be clinically safe to only process the 'code' and ignore the 'reaction.substance'. If a receiving system is unable to confirm that AllergyIntolerance.reaction.substance falls within the semantic scope of AllergyIntolerance.code, then the receiving system should ignore AllergyIntolerance.reaction.substance.**Binding:** `http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1267.43` (extensible) |
| ↳`patient` | ✅ |   | 1..1 | `Reference`target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-patient | **Who the sensitivity is for**The patient who has the allergy or intolerance. |
| ↳`recorder` |   | ✅ | 0..1 | `Reference`target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-practitionertarget: http://hl7.org/fhir/us/core/StructureDefinition/us-core-patienttarget: http://hl7.org/fhir/StructureDefinition/PractitionerRoletarget: http://hl7.org/fhir/us/core/StructureDefinition/us-core-relatedperson | **Who recorded the sensitivity**Individual who recorded the record and takes responsibility for its content. |
| ↳`reaction` | ✅ |   | 0..* | `BackboneElement` | **Adverse Reaction Events linked to exposure to substance**Details about each adverse reaction event linked to exposure to the identified substance. |
| ↳`manifestation` | ✅ |   | 1..* | `CodeableConcept` | **Clinical symptoms/signs associated with the Event**Clinical symptoms and/or signs that are observed or associated with the adverse reaction event.**Binding:** `http://hl7.org/fhir/ValueSet/clinical-findings` (extensible) |

```


## USCoreAllergyIntolerance — US Core AllergyIntolerance Profile

The US Core AllergyIntolerance Profile inherits from the FHIR [AllergyIntolerance](https://hl7.org/fhir/R4/allergyintolerance.html) resource; refer to it for scope and usage definitions. This profile meets the requirements of the U.S. Core Data for Interoperability (USCDI) *Allergies and Intolerances Data Class* and its *Allergy Intolerance Criticality Data Element*. It sets minimum expectations for the AllergyIntolerance resource to record, search, and fetch allergies and adverse reactions associated with a patient. It specifies which core elements, extensions, vocabularies, and value sets **SHALL** be present in the resource and constrains how the elements are used. Providing the floor for standards development for specific use cases promotes interoperability and adoption.

- **URL:** `http://hl7.org/fhir/us/core/StructureDefinition/us-core-allergyintolerance`
- **Version:** 0.1.0
- **Status:** active
- **Kind:** resource
- **Type:** `AllergyIntolerance`
- **Base Definition:** `http://hl7.org/fhir/StructureDefinition/AllergyIntolerance`
- **Derivation:** constraint


### Elements (differential)

| Element | Must Support | Add'l USCDI | Cardinality | Type | Description |
|---|:---:|:---:|---|---|---|
| `AllergyIntolerance` |  |  | 0..* |  | **Allergy or Intolerance (generally: Risk of adverse reaction to a substance)**<br/>Risk of harmful or undesirable, physiological response which is unique to an individual and associated with exposure to a substance. |
| <span style="padding-left: 1.5em;">↳</span> `clinicalStatus` | ✅ |  | 0..1 | `CodeableConcept` | **active \| inactive \| resolved**<br/>The clinical status of the allergy or intolerance.<br/><span style="font-size: 0.85em;">**Binding:** `http://hl7.org/fhir/ValueSet/allergyintolerance-clinical` (required)</span> |
| <span style="padding-left: 1.5em;">↳</span> `verificationStatus` | ✅ |  | 0..1 | `CodeableConcept` | **unconfirmed \| confirmed \| refuted \| entered-in-error**<br/>Assertion about certainty associated with the propensity, or potential risk, of a reaction to the identified substance (including pharmaceutical product).<br/><span style="font-size: 0.85em;">**Binding:** `http://hl7.org/fhir/ValueSet/allergyintolerance-verification` (required)</span> |
| <span style="padding-left: 1.5em;">↳</span> `criticality` | ✅ |  | 0..1 | `code` | **low \| high \| unable-to-assess**<br/>Estimate of the potential clinical harm, or seriousness, of the reaction to the identified substance.<br/><span style="font-size: 0.85em;">**Binding:** `http://hl7.org/fhir/ValueSet/allergy-intolerance-criticality` (required)</span> |
| <span style="padding-left: 1.5em;">↳</span> `code` | ✅ |  | 1..1 | `CodeableConcept` | **Code that identifies the allergy or intolerance**<br/>Code for an allergy or intolerance statement (either a positive or a negated/excluded statement).  This may be a code for a substance or pharmaceutical product that is considered to be responsible for the adverse reaction risk (e.g., "Latex"), an allergy or intolerance condition (e.g., "Latex allergy"), or a negated/excluded code for a specific substance or class (e.g., "No latex allergy") or a general or categorical negated statement (e.g.,  "No known allergy", "No known drug allergies").  Note: the substance for a specific reaction may be different from the substance identified as the cause of the risk, but it must be consistent with it. For instance, it may be a more specific substance (e.g. a brand medication) or a composite product that includes the identified substance. It must be clinically safe to only process the 'code' and ignore the 'reaction.substance'.  If a receiving system is unable to confirm that AllergyIntolerance.reaction.substance falls within the semantic scope of AllergyIntolerance.code, then the receiving system should ignore AllergyIntolerance.reaction.substance.<br/><span style="font-size: 0.85em;">**Binding:** `http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1267.43` (extensible)</span> |
| <span style="padding-left: 1.5em;">↳</span> `patient` | ✅ |  | 1..1 | `Reference`<br/><span style="font-size: 0.85em;">target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-patient</span> | **Who the sensitivity is for**<br/>The patient who has the allergy or intolerance. |
| <span style="padding-left: 1.5em;">↳</span> `recorder` |  | ✅ | 0..1 | `Reference`<br/><span style="font-size: 0.85em;">target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-practitioner</span><br/><span style="font-size: 0.85em;">target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-patient</span><br/><span style="font-size: 0.85em;">target: http://hl7.org/fhir/StructureDefinition/PractitionerRole</span><br/><span style="font-size: 0.85em;">target: http://hl7.org/fhir/us/core/StructureDefinition/us-core-relatedperson</span> | **Who recorded the sensitivity**<br/>Individual who recorded the record and takes responsibility for its content. |
| <span style="padding-left: 1.5em;">↳</span> `reaction` | ✅ |  | 0..* | `BackboneElement` | **Adverse Reaction Events linked to exposure to substance**<br/>Details about each adverse reaction event linked to exposure to the identified substance. |
| <span style="padding-left: 3.0em;">↳</span> `manifestation` | ✅ |  | 1..* | `CodeableConcept` | **Clinical symptoms/signs associated with the Event**<br/>Clinical symptoms and/or signs that are observed or associated with the adverse reaction event.<br/><span style="font-size: 0.85em;">**Binding:** `http://hl7.org/fhir/ValueSet/clinical-findings` (extensible)</span> |





```

**Usages:**

* Examples for this Profile: [AllergyIntolerance/low-criticality](AllergyIntolerance-low-criticality.md) and [AllergyIntolerance/unable-to-assess-criticality](AllergyIntolerance-unable-to-assess-criticality.md)
* CapabilityStatements using this Profile: [US Core Client CapabilityStatement](http://hl7.org/fhir/us/core/2026Jan/CapabilityStatement-us-core-client.html) and [US Core Server CapabilityStatement](http://hl7.org/fhir/us/core/2026Jan/CapabilityStatement-us-core-server.html)

You can also check for [usages in the FHIR IG Statistics](https://packages2.fhir.org/xig/resource/hl7.fhir.us.healthedata1-sandbox|current/StructureDefinition/StructureDefinition-us-core-allergyintolerance.json)

### Formal Views of Profile Content

 [Description of Profiles, Differentials, Snapshots and how the different presentations work](http://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#structure-definitions). 

 

Other representations of profile: [CSV](StructureDefinition-us-core-allergyintolerance.csv), [Excel](StructureDefinition-us-core-allergyintolerance.xlsx), [Schematron](StructureDefinition-us-core-allergyintolerance.sch) 



## Resource Content

```json
{
  "resourceType" : "StructureDefinition",
  "id" : "us-core-allergyintolerance",
  "extension" : [{
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
    "valueInteger" : 5
  }],
  "url" : "http://hl7.org/fhir/us/core/StructureDefinition/us-core-allergyintolerance",
  "identifier" : [{
    "system" : "urn:ietf:rfc:3986",
    "value" : "urn:oid:2.16.840.1.113883.4.642.40.2.42.5"
  }],
  "version" : "0.1.0",
  "name" : "USCoreAllergyIntolerance",
  "title" : "US Core AllergyIntolerance Profile",
  "status" : "active",
  "experimental" : false,
  "date" : "2026-05-19",
  "publisher" : "HL7 International / Cross-Group Projects",
  "contact" : [{
    "name" : "HL7 International / Cross-Group Projects",
    "telecom" : [{
      "system" : "url",
      "value" : "http://www.hl7.org/Special/committees/cgp"
    },
    {
      "system" : "email",
      "value" : "cgp@lists.HL7.org"
    }]
  }],
  "description" : "The US Core AllergyIntolerance Profile inherits from the FHIR [AllergyIntolerance](https://hl7.org/fhir/R4/allergyintolerance.html) resource; refer to it for scope and usage definitions. This profile meets the requirements of the U.S. Core Data for Interoperability (USCDI) *Allergies and Intolerances Data Class* and its *Allergy Intolerance Criticality Data Element*. It sets minimum expectations for the AllergyIntolerance resource to record, search, and fetch allergies and adverse reactions associated with a patient. It specifies which core elements, extensions, vocabularies, and value sets **SHALL** be present in the resource and constrains how the elements are used. Providing the floor for standards development for specific use cases promotes interoperability and adoption.",
  "jurisdiction" : [{
    "coding" : [{
      "system" : "urn:iso:std:iso:3166",
      "code" : "US"
    }]
  }],
  "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" : "v2",
    "uri" : "http://hl7.org/v2",
    "name" : "HL7 v2 Mapping"
  }],
  "kind" : "resource",
  "abstract" : false,
  "type" : "AllergyIntolerance",
  "baseDefinition" : "http://hl7.org/fhir/StructureDefinition/AllergyIntolerance",
  "derivation" : "constraint",
  "differential" : {
    "element" : [{
      "id" : "AllergyIntolerance",
      "path" : "AllergyIntolerance",
      "mustSupport" : false
    },
    {
      "id" : "AllergyIntolerance.clinicalStatus",
      "path" : "AllergyIntolerance.clinicalStatus",
      "mustSupport" : true,
      "binding" : {
        "strength" : "required",
        "valueSet" : "http://hl7.org/fhir/ValueSet/allergyintolerance-clinical"
      }
    },
    {
      "id" : "AllergyIntolerance.verificationStatus",
      "path" : "AllergyIntolerance.verificationStatus",
      "mustSupport" : true,
      "binding" : {
        "strength" : "required",
        "valueSet" : "http://hl7.org/fhir/ValueSet/allergyintolerance-verification"
      }
    },
    {
      "id" : "AllergyIntolerance.criticality",
      "path" : "AllergyIntolerance.criticality",
      "mustSupport" : true,
      "binding" : {
        "strength" : "required",
        "valueSet" : "http://hl7.org/fhir/ValueSet/allergy-intolerance-criticality"
      }
    },
    {
      "id" : "AllergyIntolerance.code",
      "path" : "AllergyIntolerance.code",
      "min" : 1,
      "mustSupport" : true,
      "binding" : {
        "strength" : "extensible",
        "valueSet" : "http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1267.43"
      }
    },
    {
      "id" : "AllergyIntolerance.patient",
      "path" : "AllergyIntolerance.patient",
      "type" : [{
        "code" : "Reference",
        "targetProfile" : ["http://hl7.org/fhir/us/core/StructureDefinition/us-core-patient"]
      }],
      "mustSupport" : true
    },
    {
      "id" : "AllergyIntolerance.recorder",
      "extension" : [{
        "url" : "http://hl7.org/fhir/us/core/StructureDefinition/uscdi-requirement",
        "valueBoolean" : true
      }],
      "path" : "AllergyIntolerance.recorder",
      "short" : "𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Who recorded the sensitivity",
      "type" : [{
        "code" : "Reference",
        "targetProfile" : ["http://hl7.org/fhir/us/core/StructureDefinition/us-core-practitioner",
        "http://hl7.org/fhir/us/core/StructureDefinition/us-core-patient",
        "http://hl7.org/fhir/StructureDefinition/PractitionerRole",
        "http://hl7.org/fhir/us/core/StructureDefinition/us-core-relatedperson"],
        "_targetProfile" : [{
          "extension" : [{
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-type-must-support",
            "valueBoolean" : false
          }]
        },
        {
          "extension" : [{
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-type-must-support",
            "valueBoolean" : false
          }]
        },
        {
          "extension" : [{
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-type-must-support",
            "valueBoolean" : false
          }]
        },
        {
          "extension" : [{
            "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-type-must-support",
            "valueBoolean" : false
          }]
        }]
      }]
    },
    {
      "id" : "AllergyIntolerance.reaction",
      "path" : "AllergyIntolerance.reaction",
      "mustSupport" : true
    },
    {
      "id" : "AllergyIntolerance.reaction.manifestation",
      "path" : "AllergyIntolerance.reaction.manifestation",
      "mustSupport" : true,
      "binding" : {
        "strength" : "extensible",
        "valueSet" : "http://hl7.org/fhir/ValueSet/clinical-findings"
      }
    }]
  }
}

```
