<?xml version="1.0" encoding="UTF-8"?>
<!-- 
 * #%L
 * org.hl7.fhir.r5
 * %%
 * Copyright (C) 2014 - 2019 Health Level 7
 * %%
 * Licensed under the Apache License, Version 2.0 (the "License");
 * you may not use this file except in compliance with the License.
 * You may obtain a copy of the License at
 * 
 *      http://www.apache.org/licenses/LICENSE-2.0
 * 
 * Unless required by applicable law or agreed to in writing, software
 * distributed under the License is distributed on an "AS IS" BASIS,
 * WITHOUT WARRANTIES OR CONDITIONS OF ANY KIND, either express or implied.
 * See the License for the specific language governing permissions and
 * limitations under the License.
 * #L%
 */

/*
  Copyright (c) 2011+, HL7, Inc.
  All rights reserved.
  
  Redistribution and use in source and binary forms, with or without modification, 
  are permitted provided that the following conditions are met:
  
   * Redistributions of source code must retain the above copyright notice, this 
     list of conditions and the following disclaimer.
   * Redistributions in binary form must reproduce the above copyright notice, 
     this list of conditions and the following disclaimer in the documentation 
     and/or other materials provided with the distribution.
   * Neither the name of HL7 nor the names of its contributors may be used to 
     endorse or promote products derived from this software without specific 
     prior written permission.
  
  THIS SOFTWARE IS PROVIDED BY THE COPYRIGHT HOLDERS AND CONTRIBUTORS "AS IS" AND 
  ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED 
  WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. 
  IN NO EVENT SHALL THE COPYRIGHT HOLDER OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, 
  INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT 
  NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR 
  PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, 
  WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) 
  ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE 
  POSSIBILITY OF SUCH DAMAGE.
  

  Generated on Tue, May 19, 2026 20:26+0000 for FHIR v6.0.0-ballot4 

  Note: the schemas &amp; schematrons do not contain all of the rules about what makes resources
  valid. Implementers will still need to be familiar with the content of the specification and with
  any profiles that apply to the resources in order to make a conformant implementation.

-->
<xs:schema xmlns:xs="http://www.w3.org/2001/XMLSchema" xmlns="http://hl7.org/fhir" xmlns:xhtml="http://www.w3.org/1999/xhtml" targetNamespace="http://hl7.org/fhir" elementFormDefault="qualified" version="1.0">
  <xs:include schemaLocation="fhir-base.xsd"/>
  <xs:element name="ClinicalUseDefinition" type="ClinicalUseDefinition">
    <xs:annotation>
      <xs:documentation xml:lang="en">A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure.</xs:documentation>
    </xs:annotation>
  </xs:element>
  <xs:complexType name="ClinicalUseDefinition">
    <xs:annotation>
      <xs:documentation xml:lang="en">A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure.</xs:documentation>
      <xs:documentation xml:lang="en">If the element is present, it must have either a @value, an @id, or extensions</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="DomainResource">
        <xs:sequence>
          <xs:element name="identifier" minOccurs="0" maxOccurs="unbounded" type="Identifier">
            <xs:annotation>
              <xs:documentation xml:lang="en">Business identifier for this issue.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="type" minOccurs="1" maxOccurs="1" type="ClinicalUseDefinitionType">
            <xs:annotation>
              <xs:documentation xml:lang="en">indication | contraindication | interaction | undesirable-effect | warning.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="category" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">A categorisation of the issue, primarily for dividing warnings into subject heading areas such as &quot;Pregnancy and Lactation&quot;, &quot;Overdose&quot;, &quot;Effects on Ability to Drive and Use Machines&quot;.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="subject" minOccurs="1" maxOccurs="unbounded" type="CodeableReference">
            <xs:annotation>
              <xs:documentation xml:lang="en">The medication, product, substance, device, procedure etc. for which this is an indication, contraindication, interaction, undesirable effect, or warning.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="status" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Whether this is a current issue or one that has been retired etc.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="undesirableEffect" type="ClinicalUseDefinition.UndesirableEffect" minOccurs="0" maxOccurs="1">
            <xs:annotation>
              <xs:documentation xml:lang="en">Describe the possible undesirable effects (negative outcomes) from the use of the medicinal product as treatment.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="indication" type="ClinicalUseDefinition.Indication" minOccurs="0" maxOccurs="1">
            <xs:annotation>
              <xs:documentation xml:lang="en">Specifics for when this is an indication.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="contraindication" type="ClinicalUseDefinition.Contraindication" minOccurs="0" maxOccurs="1">
            <xs:annotation>
              <xs:documentation xml:lang="en">Specifics for when this is a contraindication.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="interaction" type="ClinicalUseDefinition.Interaction" minOccurs="0" maxOccurs="1">
            <xs:annotation>
              <xs:documentation xml:lang="en">Specifics for when this is an interaction.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="population" minOccurs="0" maxOccurs="unbounded" type="Reference">
            <xs:annotation>
              <xs:documentation xml:lang="en">The population group to which this applies.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="library" minOccurs="0" maxOccurs="unbounded" type="canonical">
            <xs:annotation>
              <xs:documentation xml:lang="en">Logic used by the clinical use definition.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="warning" type="ClinicalUseDefinition.Warning" minOccurs="0" maxOccurs="1">
            <xs:annotation>
              <xs:documentation xml:lang="en">A critical piece of information about environmental, health or physical risks or hazards that serve as caution to the user. For example 'Do not operate heavy machinery', 'May cause drowsiness', or 'Get medical advice/attention if you feel unwell'.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="ClinicalUseDefinition.UndesirableEffect">
    <xs:annotation>
      <xs:documentation xml:lang="en">A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="symptomConditionEffect" minOccurs="0" maxOccurs="1" type="CodeableReference">
            <xs:annotation>
              <xs:documentation xml:lang="en">The situation in which the undesirable effect may manifest.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="classification" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">High level classification of the effect.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="frequencyOfOccurrence" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">How often the effect is seen.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="management" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Actions for managing the undesirable effect.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="ClinicalUseDefinition.Indication">
    <xs:annotation>
      <xs:documentation xml:lang="en">A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="diseaseSymptomProcedure" minOccurs="0" maxOccurs="1" type="CodeableReference">
            <xs:annotation>
              <xs:documentation xml:lang="en">The situation that is being documented as an indication for this item.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="diseaseStatus" minOccurs="0" maxOccurs="1" type="CodeableReference">
            <xs:annotation>
              <xs:documentation xml:lang="en">The status of the disease or symptom for the indication, for example &quot;chronic&quot; or &quot;metastatic&quot;.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="comorbidity" minOccurs="0" maxOccurs="unbounded" type="CodeableReference">
            <xs:annotation>
              <xs:documentation xml:lang="en">A comorbidity (concurrent condition) or coinfection as part of the indication. Where this repeats it means that any one of these is relevant, rather than all of them needing to be present.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="intendedEffect" minOccurs="0" maxOccurs="unbounded" type="CodeableReference">
            <xs:annotation>
              <xs:documentation xml:lang="en">The intended effect, aim or strategy to be achieved.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:choice minOccurs="0" maxOccurs="1" >
            <xs:annotation>
              <xs:documentation xml:lang="en">Timing or duration information, that may be associated with use with the indicated condition e.g. Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months).</xs:documentation>
            </xs:annotation>
            <xs:element name="durationRange" type="Range"/>
            <xs:element name="durationString" type="string"/>
          </xs:choice>
          <xs:element name="undesirableEffect" type="ClinicalUseDefinition.UndesirableEffect" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">An unwanted side effect or negative outcome that may happen if you use the drug (or other subject of this resource) for this indication.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="applicability" minOccurs="0" maxOccurs="1" type="Expression">
            <xs:annotation>
              <xs:documentation xml:lang="en">An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="otherTherapy" type="ClinicalUseDefinition.OtherTherapy" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">Information about the use of the medicinal product in relation to other therapies described as part of the contraindication.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="ClinicalUseDefinition.OtherTherapy">
    <xs:annotation>
      <xs:documentation xml:lang="en">A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="relationshipType" minOccurs="1" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">The type of relationship between the medicinal product indication or contraindication and another therapy.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="treatment" minOccurs="1" maxOccurs="1" type="CodeableReference">
            <xs:annotation>
              <xs:documentation xml:lang="en">Reference to a specific medication (active substance, medicinal product or class of products, biological, food etc.) as part of an indication or contraindication.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="ClinicalUseDefinition.Contraindication">
    <xs:annotation>
      <xs:documentation xml:lang="en">A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="diseaseSymptomProcedure" minOccurs="0" maxOccurs="1" type="CodeableReference">
            <xs:annotation>
              <xs:documentation xml:lang="en">The situation that is being documented as contraindicating against this item.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="diseaseStatus" minOccurs="0" maxOccurs="1" type="CodeableReference">
            <xs:annotation>
              <xs:documentation xml:lang="en">The status of the disease or symptom for the contraindication, for example &quot;chronic&quot; or &quot;metastatic&quot;.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="comorbidity" minOccurs="0" maxOccurs="unbounded" type="CodeableReference">
            <xs:annotation>
              <xs:documentation xml:lang="en">A comorbidity (concurrent condition) or coinfection. Where this repeats it means that any one of these is relevant, rather than all of them needing to be present.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="indication" type="ClinicalUseDefinition.Indication" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">The indication which this is a contraindication for.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="applicability" minOccurs="0" maxOccurs="1" type="Expression">
            <xs:annotation>
              <xs:documentation xml:lang="en">An expression that returns true or false, indicating whether the indication is applicable or not, after having applied its other elements.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="management" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Actions for managing the contraindication.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="otherTherapy" type="ClinicalUseDefinition.OtherTherapy" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">Information about the use of the medicinal product in relation to other therapies described as part of the contraindication.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="ClinicalUseDefinition.Interaction">
    <xs:annotation>
      <xs:documentation xml:lang="en">A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="interactant" type="ClinicalUseDefinition.Interactant" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">The specific medication, product, food, substance etc. or laboratory test that interacts.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="type" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">The type of the interaction e.g. drug-drug interaction, drug-food interaction, drug-lab test interaction.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="effect" minOccurs="0" maxOccurs="1" type="CodeableReference">
            <xs:annotation>
              <xs:documentation xml:lang="en">The effect of the interaction, for example &quot;reduced gastric absorption of primary medication&quot;.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="incidence" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">The incidence of the interaction, e.g. theoretical, observed.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="management" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Actions for managing the interaction.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="severity" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">The severity of the interaction.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="ClinicalUseDefinition.Interactant">
    <xs:annotation>
      <xs:documentation xml:lang="en">A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:choice minOccurs="1" maxOccurs="1" >
            <xs:annotation>
              <xs:documentation xml:lang="en">The specific medication, product, food, substance etc. or laboratory test that interacts.</xs:documentation>
            </xs:annotation>
            <xs:element name="itemReference" type="Reference"/>
            <xs:element name="itemCodeableConcept" type="CodeableConcept"/>
          </xs:choice>
          <xs:element name="route" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">The route by which the item is administered to cause the interaction.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="ClinicalUseDefinition.Warning">
    <xs:annotation>
      <xs:documentation xml:lang="en">A single issue - either an indication, contraindication, interaction or an undesirable effect for a medicinal product, medication, device or procedure.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="description" minOccurs="0" maxOccurs="1" type="markdown">
            <xs:annotation>
              <xs:documentation xml:lang="en">A textual definition of this warning, with formatting.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="code" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">A coded or unformatted textual definition of this warning.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:simpleType name="ClinicalUseDefinitionTypeEnum">
    <xs:restriction base="code-primitive">
      <xs:enumeration value="indication">
        <xs:annotation>
          <xs:documentation xml:lang="en">Indication</xs:documentation>
        </xs:annotation>
      </xs:enumeration>
      <xs:enumeration value="contraindication">
        <xs:annotation>
          <xs:documentation xml:lang="en">Contraindication</xs:documentation>
        </xs:annotation>
      </xs:enumeration>
      <xs:enumeration value="interaction">
        <xs:annotation>
          <xs:documentation xml:lang="en">Interaction</xs:documentation>
        </xs:annotation>
      </xs:enumeration>
      <xs:enumeration value="undesirable-effect">
        <xs:annotation>
          <xs:documentation xml:lang="en">Undesirable Effect</xs:documentation>
        </xs:annotation>
      </xs:enumeration>
      <xs:enumeration value="warning">
        <xs:annotation>
          <xs:documentation xml:lang="en">Warning</xs:documentation>
        </xs:annotation>
      </xs:enumeration>
    </xs:restriction>
  </xs:simpleType>
  <xs:complexType name="ClinicalUseDefinitionType">
    <xs:annotation>
      <xs:documentation xml:lang="en"></xs:documentation>
      <xs:documentation xml:lang="en">If the element is present, it must have either a @value, an @id, or extensions</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="Element">
        <xs:attribute name="value" type="ClinicalUseDefinitionTypeEnum" use="optional"/>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
</xs:schema>
