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{
  "resourceType": "StructureDefinition",
  "id": "icsr-adverseevent",
  "text": {
    "status": "extensions",
    "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">Placeholder</div>"
  },
  "url": "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-adverseevent",
  "version": "1.0.1",
  "name": "ICSRAdverseEvent",
  "title": "ICSR Adverse Event",
  "status": "draft",
  "date": "2023-08-29T21:18:01+00:00",
  "publisher": "Biomedical Research & Regulation WG",
  "contact": [
    {
      "name": "Biomedical Research & Regulation WG",
      "telecom": [
        {
          "system": "url",
          "value": "http://hl7.org/Special/committees/rcrim"
        }
      ]
    },
    {
      "name": "Jean Duteau",
      "telecom": [
        {
          "system": "email",
          "value": "mailto:jean.duteau@ibm.com"
        }
      ]
    }
  ],
  "description": "The fields needed to submit an AdverseEvent for a ICSR Report.",
  "jurisdiction": [
    {
      "coding": [
        {
          "system": "urn:iso:std:iso:3166",
          "code": "US",
          "display": "United States of America"
        }
      ]
    }
  ],
  "fhirVersion": "4.0.1",
  "mapping": [
    {
      "identity": "w5",
      "uri": "http://hl7.org/fhir/fivews",
      "name": "FiveWs Pattern Mapping"
    },
    {
      "identity": "rim",
      "uri": "http://hl7.org/v3",
      "name": "RIM Mapping"
    }
  ],
  "kind": "resource",
  "abstract": true,
  "type": "AdverseEvent",
  "baseDefinition": "http://hl7.org/fhir/StructureDefinition/AdverseEvent",
  "derivation": "constraint",
  "snapshot": {
    "element": [
      {
        "id": "AdverseEvent",
        "path": "AdverseEvent",
        "short": "Medical care, research study or other healthcare event causing physical injury",
        "definition": "Actual or  potential/avoided event causing unintended physical injury resulting from or contributed to by medical care, a research study or other healthcare setting factors that requires additional monitoring, treatment, or hospitalization, or that results in death.",
        "alias": [
          "AE"
        ],
        "min": 0,
        "max": "*",
        "base": {
          "path": "AdverseEvent",
          "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"
          }
        ],
        "isModifier": false,
        "isSummary": false,
        "mapping": [
          {
            "identity": "rim",
            "map": "Entity. Role, or Act"
          }
        ]
      },
      {
        "id": "AdverseEvent.id",
        "path": "AdverseEvent.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": "AdverseEvent.meta",
        "path": "AdverseEvent.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": "AdverseEvent.implicitRules",
        "path": "AdverseEvent.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": "AdverseEvent.language",
        "path": "AdverseEvent.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"
            },
            {
              "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
              "valueBoolean": true
            }
          ],
          "strength": "preferred",
          "description": "A human language.",
          "valueSet": "http://hl7.org/fhir/ValueSet/languages"
        }
      },
      {
        "id": "AdverseEvent.text",
        "path": "AdverseEvent.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": "AdverseEvent.contained",
        "path": "AdverseEvent.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": "AdverseEvent.extension",
        "path": "AdverseEvent.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": "AdverseEvent.extension:ageAtTimeOfOnset",
        "path": "AdverseEvent.extension",
        "sliceName": "ageAtTimeOfOnset",
        "short": "Extension",
        "definition": "The age of the patient when the event occurred.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "DomainResource.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension",
            "profile": [
              "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-ageattimeofonset"
            ]
          }
        ],
        "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
      },
      {
        "id": "AdverseEvent.modifierExtension",
        "path": "AdverseEvent.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": "AdverseEvent.identifier",
        "path": "AdverseEvent.identifier",
        "short": "Business identifier for the event",
        "definition": "Business identifiers assigned to this adverse event by the performer or other systems which remain constant as the resource is updated and propagates from server to server.",
        "comment": "This is a business identifier, not a resource identifier (see [discussion](http://hl7.org/fhir/R4/resource.html#identifiers)).  It is best practice for the identifier to only appear on a single resource instance, however business practices may occasionally dictate that multiple resource instances with the same identifier can exist - possibly even with different resource types.  For example, multiple Patient and a Person resource instance might share the same social insurance number.",
        "requirements": "Allows identification of the adverse event as it is known by various participating systems and in a way that remains consistent across servers.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "AdverseEvent.identifier",
          "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"
          }
        ],
        "mustSupport": true,
        "isModifier": false,
        "isSummary": true
      },
      {
        "id": "AdverseEvent.actuality",
        "path": "AdverseEvent.actuality",
        "short": "actual | potential",
        "definition": "Whether the event actually happened, or just had the potential to. Note that this is independent of whether anyone was affected or harmed or how severely.",
        "min": 1,
        "max": "1",
        "base": {
          "path": "AdverseEvent.actuality",
          "min": 1,
          "max": "1"
        },
        "type": [
          {
            "code": "code"
          }
        ],
        "fixedCode": "actual",
        "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 labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen.",
        "isSummary": true,
        "binding": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString": "AdverseEventActuality"
            }
          ],
          "strength": "required",
          "description": "Overall nature of the adverse event, e.g. real or potential.",
          "valueSet": "http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1"
        },
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.class"
          }
        ]
      },
      {
        "id": "AdverseEvent.category",
        "path": "AdverseEvent.category",
        "short": "product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment",
        "definition": "The overall type of event, intended for search and filtering purposes.",
        "min": 0,
        "max": "*",
        "base": {
          "path": "AdverseEvent.category",
          "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,
        "binding": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString": "AdverseEventCategory"
            }
          ],
          "strength": "extensible",
          "description": "Overall categorization of the event, e.g. product-related or situational.",
          "valueSet": "http://hl7.org/fhir/ValueSet/adverse-event-category"
        },
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.class"
          }
        ]
      },
      {
        "id": "AdverseEvent.event",
        "path": "AdverseEvent.event",
        "short": "Type of the event itself in relation to the subject",
        "definition": "This element defines the specific type of event that occurred or that was prevented from occurring.",
        "min": 1,
        "max": "1",
        "base": {
          "path": "AdverseEvent.event",
          "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": true,
        "binding": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString": "AdverseEventType"
            }
          ],
          "strength": "example",
          "description": "Detailed type of event.",
          "valueSet": "http://hl7.org/fhir/ValueSet/adverse-event-type"
        },
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.what[x]"
          }
        ]
      },
      {
        "id": "AdverseEvent.event.id",
        "path": "AdverseEvent.event.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": "AdverseEvent.event.extension",
        "path": "AdverseEvent.event.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": "AdverseEvent.event.coding",
        "path": "AdverseEvent.event.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": "AdverseEvent.event.coding.id",
        "path": "AdverseEvent.event.coding.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": "AdverseEvent.event.coding.extension",
        "path": "AdverseEvent.event.coding.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": "AdverseEvent.event.coding.system",
        "path": "AdverseEvent.event.coding.system",
        "short": "Identity of the terminology system",
        "definition": "The identification of the code system that defines the meaning of the symbol in the code.",
        "comment": "The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...).  OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.",
        "requirements": "Need to be unambiguous about the source of the definition of the symbol.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Coding.system",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "code": "uri"
          }
        ],
        "fixedUri": "http://meddra.org",
        "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.3"
          },
          {
            "identity": "rim",
            "map": "./codeSystem"
          },
          {
            "identity": "orim",
            "map": "fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem"
          }
        ]
      },
      {
        "id": "AdverseEvent.event.coding.version",
        "path": "AdverseEvent.event.coding.version",
        "short": "Version of the system - if relevant",
        "definition": "The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.",
        "comment": "Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Coding.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": true,
        "mapping": [
          {
            "identity": "v2",
            "map": "C*E.7"
          },
          {
            "identity": "rim",
            "map": "./codeSystemVersion"
          },
          {
            "identity": "orim",
            "map": "fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion"
          }
        ]
      },
      {
        "id": "AdverseEvent.event.coding.code",
        "path": "AdverseEvent.event.coding.code",
        "short": "Symbol in syntax defined by the system",
        "definition": "A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).",
        "requirements": "Need to refer to a particular code in the system.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Coding.code",
          "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": true,
        "mapping": [
          {
            "identity": "v2",
            "map": "C*E.1"
          },
          {
            "identity": "rim",
            "map": "./code"
          },
          {
            "identity": "orim",
            "map": "fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code"
          }
        ]
      },
      {
        "id": "AdverseEvent.event.coding.display",
        "extension": [
          {
            "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean": true
          }
        ],
        "path": "AdverseEvent.event.coding.display",
        "short": "Representation defined by the system",
        "definition": "A representation of the meaning of the code in the system, following the rules of the system.",
        "requirements": "Need to be able to carry a human-readable meaning of the code for readers that do not know  the system.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Coding.display",
          "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": true,
        "mapping": [
          {
            "identity": "v2",
            "map": "C*E.2 - but note this is not well followed"
          },
          {
            "identity": "rim",
            "map": "CV.displayName"
          },
          {
            "identity": "orim",
            "map": "fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName"
          }
        ]
      },
      {
        "id": "AdverseEvent.event.coding.userSelected",
        "path": "AdverseEvent.event.coding.userSelected",
        "short": "If this coding was chosen directly by the user",
        "definition": "Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).",
        "comment": "Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.",
        "requirements": "This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Coding.userSelected",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "code": "boolean"
          }
        ],
        "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": "Sometimes implied by being first"
          },
          {
            "identity": "rim",
            "map": "CD.codingRationale"
          },
          {
            "identity": "orim",
            "map": "fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map;   fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\\#true a [     fhir:source \"true\";     fhir:target dt:CDCoding.codingRationale\\#O   ]"
          }
        ]
      },
      {
        "id": "AdverseEvent.event.text",
        "extension": [
          {
            "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean": true
          }
        ],
        "path": "AdverseEvent.event.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"
          }
        ],
        "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": "AdverseEvent.subject",
        "path": "AdverseEvent.subject",
        "short": "Subject impacted by event",
        "definition": "This subject or group impacted by the event.",
        "comment": "If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject.",
        "requirements": "Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital.",
        "alias": [
          "patient"
        ],
        "min": 1,
        "max": "1",
        "base": {
          "path": "AdverseEvent.subject",
          "min": 1,
          "max": "1"
        },
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-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": true,
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.who"
          }
        ]
      },
      {
        "id": "AdverseEvent.encounter",
        "path": "AdverseEvent.encounter",
        "short": "Encounter created as part of",
        "definition": "The Encounter during which AdverseEvent was created or to which the creation of this record is tightly associated.",
        "comment": "This will typically be the encounter the event occurred within, but some activities may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter.  For example, if a medication administration was considered an adverse event because it resulted in a rash, then the encounter when the medication administration was given is the context.  If the patient reports the AdverseEvent during a second encounter, that second encounter is not the context.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "AdverseEvent.encounter",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/us/core/StructureDefinition/us-core-encounter"
            ]
          }
        ],
        "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.context"
          }
        ]
      },
      {
        "id": "AdverseEvent.date",
        "path": "AdverseEvent.date",
        "short": "When the event occurred",
        "definition": "The date (and perhaps time) when the adverse event occurred.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "AdverseEvent.date",
          "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": true,
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.init"
          }
        ]
      },
      {
        "id": "AdverseEvent.date.id",
        "path": "AdverseEvent.date.id",
        "representation": [
          "xmlAttr"
        ],
        "short": "xml:id (or equivalent in JSON)",
        "definition": "unique id for the element within a resource (for internal references)",
        "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
      },
      {
        "id": "AdverseEvent.date.extension",
        "path": "AdverseEvent.date.extension",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "url"
            }
          ],
          "ordered": false,
          "rules": "open"
        },
        "short": "Extension",
        "definition": "An Extension",
        "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
      },
      {
        "id": "AdverseEvent.date.extension:eventDuration",
        "path": "AdverseEvent.date.extension",
        "sliceName": "eventDuration",
        "short": "Extension",
        "definition": "The duration of the adverse event.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension",
            "profile": [
              "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventduration"
            ]
          }
        ],
        "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
      },
      {
        "id": "AdverseEvent.date.extension:endDate",
        "path": "AdverseEvent.date.extension",
        "sliceName": "endDate",
        "short": "Extension",
        "definition": "When the event ended.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension",
            "profile": [
              "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventenddate"
            ]
          }
        ],
        "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
      },
      {
        "id": "AdverseEvent.date.value",
        "path": "AdverseEvent.date.value",
        "representation": [
          "xmlAttr"
        ],
        "short": "Primitive value for dateTime",
        "definition": "The actual value",
        "min": 0,
        "max": "1",
        "base": {
          "path": "dateTime.value",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
                "valueUrl": "dateTime"
              },
              {
                "url": "http://hl7.org/fhir/StructureDefinition/regex",
                "valueString": "([0-9]([0-9]([0-9][1-9]|[1-9]0)|[1-9]00)|[1-9]000)(-(0[1-9]|1[0-2])(-(0[1-9]|[1-2][0-9]|3[0-1])(T([01][0-9]|2[0-3]):[0-5][0-9]:([0-5][0-9]|60)(\\.[0-9]+)?(Z|(\\+|-)((0[0-9]|1[0-3]):[0-5][0-9]|14:00)))?)?)?"
              }
            ],
            "code": "http://hl7.org/fhirpath/System.DateTime"
          }
        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "AdverseEvent.detected",
        "path": "AdverseEvent.detected",
        "short": "When the event was detected",
        "definition": "Estimated or actual date the AdverseEvent began, in the opinion of the reporter.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "AdverseEvent.detected",
          "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"
          }
        ],
        "isModifier": false,
        "isSummary": true
      },
      {
        "id": "AdverseEvent.recordedDate",
        "path": "AdverseEvent.recordedDate",
        "short": "When the event was recorded",
        "definition": "The date on which the existence of the AdverseEvent was first recorded.",
        "comment": "The recordedDate represents the date when this particular AdverseEvent record was created in the system, not the date of the most recent update.  The date of the last record modification can be retrieved from the resource metadata.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "AdverseEvent.recordedDate",
          "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"
          }
        ],
        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "w5",
            "map": "FiveWs.recorded"
          }
        ]
      },
      {
        "id": "AdverseEvent.resultingCondition",
        "path": "AdverseEvent.resultingCondition",
        "short": "Effect on the subject due to this event",
        "definition": "Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical).",
        "min": 0,
        "max": "*",
        "base": {
          "path": "AdverseEvent.resultingCondition",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/StructureDefinition/Condition"
            ]
          }
        ],
        "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": "AdverseEvent.location",
        "path": "AdverseEvent.location",
        "short": "Location where adverse event occurred",
        "definition": "The information about where the adverse event occurred.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "AdverseEvent.location",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/us/core/StructureDefinition/us-core-location"
            ]
          }
        ],
        "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
      },
      {
        "id": "AdverseEvent.seriousness",
        "path": "AdverseEvent.seriousness",
        "short": "Seriousness of the event",
        "definition": "Assessment whether this event was of real importance.",
        "min": 1,
        "max": "1",
        "base": {
          "path": "AdverseEvent.seriousness",
          "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": true,
        "binding": {
          "strength": "required",
          "valueSet": "http://hl7.org/fhir/us/icsr-ae-reporting/ValueSet/ICSRAESeriousness"
        }
      },
      {
        "id": "AdverseEvent.seriousness.id",
        "path": "AdverseEvent.seriousness.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": "AdverseEvent.seriousness.extension",
        "path": "AdverseEvent.seriousness.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": "AdverseEvent.seriousness.extension:seriousness",
        "path": "AdverseEvent.seriousness.extension",
        "sliceName": "seriousness",
        "short": "Extension",
        "definition": "Additional codes that give more detail around the adverse event seriousness.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Extension",
            "profile": [
              "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventseriousness"
            ]
          }
        ],
        "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": "AdverseEvent.seriousness.coding",
        "path": "AdverseEvent.seriousness.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": "AdverseEvent.seriousness.text",
        "extension": [
          {
            "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
            "valueBoolean": true
          }
        ],
        "path": "AdverseEvent.seriousness.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"
          }
        ],
        "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": "AdverseEvent.severity",
        "path": "AdverseEvent.severity",
        "short": "mild | moderate | severe",
        "definition": "Describes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.seriousness - a severe rash might not be serious, but a mild heart problem is.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "AdverseEvent.severity",
          "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": "AdverseEventSeverity"
            }
          ],
          "strength": "required",
          "description": "The severity of the adverse event itself, in direct relation to the subject.",
          "valueSet": "http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1"
        }
      },
      {
        "id": "AdverseEvent.outcome",
        "path": "AdverseEvent.outcome",
        "short": "resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown",
        "definition": "Describes the type of outcome from the adverse event.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "AdverseEvent.outcome",
          "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": true,
        "binding": {
          "extension": [
            {
              "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString": "AdverseEventOutcome"
            }
          ],
          "strength": "required",
          "description": "TODO (and should this be required?).",
          "valueSet": "http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1"
        }
      },
      {
        "id": "AdverseEvent.recorder",
        "path": "AdverseEvent.recorder",
        "short": "Who recorded the adverse event",
        "definition": "Information on who recorded the adverse event.  May be the patient or a practitioner.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "AdverseEvent.recorder",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-authorpractitioner"
            ]
          }
        ],
        "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.author"
          }
        ]
      },
      {
        "id": "AdverseEvent.contributor",
        "path": "AdverseEvent.contributor",
        "short": "Who  was involved in the adverse event or the potential adverse event",
        "definition": "Parties that may or should contribute or have contributed information to the adverse event, which can consist of one or more activities.  Such information includes information leading to the decision to perform the activity and how to perform the activity (e.g. consultant), information that the activity itself seeks to reveal (e.g. informant of clinical history), or information about what activity was performed (e.g. informant witness).",
        "min": 0,
        "max": "*",
        "base": {
          "path": "AdverseEvent.contributor",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/StructureDefinition/Practitioner",
              "http://hl7.org/fhir/StructureDefinition/PractitionerRole",
              "http://hl7.org/fhir/StructureDefinition/Device"
            ]
          }
        ],
        "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": "AdverseEvent.suspectEntity",
        "path": "AdverseEvent.suspectEntity",
        "short": "The suspected agent causing the adverse event",
        "definition": "Describes the entity that is suspected to have caused the adverse event.",
        "min": 1,
        "max": "*",
        "base": {
          "path": "AdverseEvent.suspectEntity",
          "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
      },
      {
        "id": "AdverseEvent.suspectEntity.id",
        "path": "AdverseEvent.suspectEntity.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": "AdverseEvent.suspectEntity.extension",
        "path": "AdverseEvent.suspectEntity.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": "AdverseEvent.suspectEntity.modifierExtension",
        "path": "AdverseEvent.suspectEntity.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": "AdverseEvent.suspectEntity.instance",
        "path": "AdverseEvent.suspectEntity.instance",
        "short": "Refers to the specific entity that caused the adverse event",
        "definition": "Identifies the actual instance of what caused the adverse event.  May be a substance, medication, medication administration, medication statement or a device.",
        "alias": [
          "Substance or Medication or Device"
        ],
        "min": 1,
        "max": "1",
        "base": {
          "path": "AdverseEvent.suspectEntity.instance",
          "min": 1,
          "max": "1"
        },
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-immunization",
              "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-medicationadministration",
              "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-transfusion"
            ]
          }
        ],
        "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
      },
      {
        "id": "AdverseEvent.suspectEntity.causality",
        "path": "AdverseEvent.suspectEntity.causality",
        "short": "Information on the possible cause of the event",
        "definition": "Information on the possible cause of the event.",
        "min": 1,
        "max": "1",
        "base": {
          "path": "AdverseEvent.suspectEntity.causality",
          "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
      },
      {
        "id": "AdverseEvent.suspectEntity.causality.id",
        "path": "AdverseEvent.suspectEntity.causality.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": "AdverseEvent.suspectEntity.causality.extension",
        "path": "AdverseEvent.suspectEntity.causality.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": "AdverseEvent.suspectEntity.causality.modifierExtension",
        "path": "AdverseEvent.suspectEntity.causality.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": "AdverseEvent.suspectEntity.causality.assessment",
        "path": "AdverseEvent.suspectEntity.causality.assessment",
        "short": "Assessment of if the entity caused the event",
        "definition": "Assessment of if the entity caused the event.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "AdverseEvent.suspectEntity.causality.assessment",
          "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": "AdverseEventCausalityAssessment"
            }
          ],
          "strength": "example",
          "description": "Codes for the assessment of whether the entity caused the event.",
          "valueSet": "http://hl7.org/fhir/ValueSet/adverse-event-causality-assess"
        }
      },
      {
        "id": "AdverseEvent.suspectEntity.causality.productRelatedness",
        "path": "AdverseEvent.suspectEntity.causality.productRelatedness",
        "short": "AdverseEvent.suspectEntity.causalityProductRelatedness",
        "definition": "AdverseEvent.suspectEntity.causalityProductRelatedness.",
        "min": 1,
        "max": "1",
        "base": {
          "path": "AdverseEvent.suspectEntity.causality.productRelatedness",
          "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
      },
      {
        "id": "AdverseEvent.suspectEntity.causality.author",
        "path": "AdverseEvent.suspectEntity.causality.author",
        "short": "AdverseEvent.suspectEntity.causalityAuthor",
        "definition": "AdverseEvent.suspectEntity.causalityAuthor.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "AdverseEvent.suspectEntity.causality.author",
          "min": 0,
          "max": "1"
        },
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/StructureDefinition/Practitioner",
              "http://hl7.org/fhir/StructureDefinition/PractitionerRole"
            ]
          }
        ],
        "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": "AdverseEvent.suspectEntity.causality.method",
        "path": "AdverseEvent.suspectEntity.causality.method",
        "short": "ProbabilityScale | Bayesian | Checklist",
        "definition": "ProbabilityScale | Bayesian | Checklist.",
        "min": 0,
        "max": "1",
        "base": {
          "path": "AdverseEvent.suspectEntity.causality.method",
          "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": "AdverseEventCausalityMethod"
            }
          ],
          "strength": "example",
          "description": "TODO.",
          "valueSet": "http://hl7.org/fhir/ValueSet/adverse-event-causality-method"
        }
      },
      {
        "id": "AdverseEvent.subjectMedicalHistory",
        "path": "AdverseEvent.subjectMedicalHistory",
        "short": "AdverseEvent.subjectMedicalHistory",
        "definition": "AdverseEvent.subjectMedicalHistory.",
        "min": 0,
        "max": "*",
        "base": {
          "path": "AdverseEvent.subjectMedicalHistory",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/StructureDefinition/Condition",
              "http://hl7.org/fhir/StructureDefinition/Observation",
              "http://hl7.org/fhir/StructureDefinition/AllergyIntolerance",
              "http://hl7.org/fhir/StructureDefinition/FamilyMemberHistory",
              "http://hl7.org/fhir/StructureDefinition/Immunization",
              "http://hl7.org/fhir/StructureDefinition/Procedure",
              "http://hl7.org/fhir/StructureDefinition/Media",
              "http://hl7.org/fhir/StructureDefinition/DocumentReference"
            ]
          }
        ],
        "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": "AdverseEvent.referenceDocument",
        "path": "AdverseEvent.referenceDocument",
        "short": "AdverseEvent.referenceDocument",
        "definition": "AdverseEvent.referenceDocument.",
        "min": 0,
        "max": "*",
        "base": {
          "path": "AdverseEvent.referenceDocument",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/StructureDefinition/DocumentReference"
            ]
          }
        ],
        "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": "AdverseEvent.study",
        "path": "AdverseEvent.study",
        "short": "AdverseEvent.study",
        "definition": "AdverseEvent.study.",
        "min": 0,
        "max": "*",
        "base": {
          "path": "AdverseEvent.study",
          "min": 0,
          "max": "*"
        },
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/StructureDefinition/ResearchStudy"
            ]
          }
        ],
        "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
      }
    ]
  },
  "differential": {
    "element": [
      {
        "id": "AdverseEvent",
        "path": "AdverseEvent"
      },
      {
        "id": "AdverseEvent.extension",
        "path": "AdverseEvent.extension",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "url"
            }
          ],
          "ordered": false,
          "rules": "open"
        }
      },
      {
        "id": "AdverseEvent.extension:ageAtTimeOfOnset",
        "path": "AdverseEvent.extension",
        "sliceName": "ageAtTimeOfOnset",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "Extension",
            "profile": [
              "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-ageattimeofonset"
            ]
          }
        ]
      },
      {
        "id": "AdverseEvent.identifier",
        "path": "AdverseEvent.identifier",
        "mustSupport": true
      },
      {
        "id": "AdverseEvent.actuality",
        "path": "AdverseEvent.actuality",
        "fixedCode": "actual",
        "mustSupport": true
      },
      {
        "id": "AdverseEvent.category",
        "path": "AdverseEvent.category",
        "mustSupport": true
      },
      {
        "id": "AdverseEvent.event",
        "path": "AdverseEvent.event",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "AdverseEvent.event.coding.system",
        "path": "AdverseEvent.event.coding.system",
        "fixedUri": "http://meddra.org"
      },
      {
        "id": "AdverseEvent.subject",
        "path": "AdverseEvent.subject",
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-patient"
            ]
          }
        ],
        "mustSupport": true
      },
      {
        "id": "AdverseEvent.encounter",
        "path": "AdverseEvent.encounter",
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/us/core/StructureDefinition/us-core-encounter"
            ]
          }
        ],
        "mustSupport": true
      },
      {
        "id": "AdverseEvent.date",
        "path": "AdverseEvent.date",
        "mustSupport": true
      },
      {
        "id": "AdverseEvent.date.extension",
        "path": "AdverseEvent.date.extension",
        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "url"
            }
          ],
          "ordered": false,
          "rules": "open"
        }
      },
      {
        "id": "AdverseEvent.date.extension:eventDuration",
        "path": "AdverseEvent.date.extension",
        "sliceName": "eventDuration",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "Extension",
            "profile": [
              "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventduration"
            ]
          }
        ],
        "mustSupport": true
      },
      {
        "id": "AdverseEvent.date.extension:endDate",
        "path": "AdverseEvent.date.extension",
        "sliceName": "endDate",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "Extension",
            "profile": [
              "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventenddate"
            ]
          }
        ],
        "mustSupport": true
      },
      {
        "id": "AdverseEvent.location",
        "path": "AdverseEvent.location",
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/us/core/StructureDefinition/us-core-location"
            ]
          }
        ],
        "mustSupport": true
      },
      {
        "id": "AdverseEvent.seriousness",
        "path": "AdverseEvent.seriousness",
        "min": 1,
        "mustSupport": true,
        "binding": {
          "strength": "required",
          "valueSet": "http://hl7.org/fhir/us/icsr-ae-reporting/ValueSet/ICSRAESeriousness"
        }
      },
      {
        "id": "AdverseEvent.seriousness.extension:seriousness",
        "path": "AdverseEvent.seriousness.extension",
        "sliceName": "seriousness",
        "min": 0,
        "max": "1",
        "type": [
          {
            "code": "Extension",
            "profile": [
              "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-ext-eventseriousness"
            ]
          }
        ],
        "mustSupport": true
      },
      {
        "id": "AdverseEvent.outcome",
        "path": "AdverseEvent.outcome",
        "mustSupport": true
      },
      {
        "id": "AdverseEvent.recorder",
        "path": "AdverseEvent.recorder",
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-authorpractitioner"
            ]
          }
        ],
        "mustSupport": true
      },
      {
        "id": "AdverseEvent.suspectEntity",
        "path": "AdverseEvent.suspectEntity",
        "min": 1,
        "mustSupport": true
      },
      {
        "id": "AdverseEvent.suspectEntity.instance",
        "path": "AdverseEvent.suspectEntity.instance",
        "type": [
          {
            "code": "Reference",
            "targetProfile": [
              "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-immunization",
              "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-medicationadministration",
              "http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/icsr-transfusion"
            ]
          }
        ],
        "mustSupport": true
      },
      {
        "id": "AdverseEvent.suspectEntity.causality",
        "path": "AdverseEvent.suspectEntity.causality",
        "min": 1,
        "max": "1",
        "mustSupport": true
      },
      {
        "id": "AdverseEvent.suspectEntity.causality.productRelatedness",
        "path": "AdverseEvent.suspectEntity.causality.productRelatedness",
        "min": 1,
        "mustSupport": true
      }
    ]
  }
}

name : ICSRAdverseEvent

{

}