HL7 FHIR Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting
0.1.0 - STU 1 Ballot
HL7 FHIR Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting
0.1.0 - STU 1 Ballot
This page is part of the Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting (v0.1.0: STU 1 Ballot 1) based on FHIR R4. The current version which supercedes this version is 1.0.0. For a full list of available versions, see the Directory of published versions 
| Defining URL: | http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-faers-bundle |
| Version: | 0.1.0 |
| Name: | FAERSBundle |
| Title: | FAERS Bundle |
| Status: | Active as of 2021-08-05T14:34:06+00:00 |
| Definition: | The fields needed to create a Bundle for a FAERS ICSR Report. |
| Publisher: | Biomedical Research & Regulation WG |
| Source Resource: | XML / JSON / Turtle |
The official URL for this profile is:
http://hl7.org/fhir/us/icsr-ae-reporting/StructureDefinition/ibm-fda-icsr-faers-bundle
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from USPublicHealthReportingBundle
Summary
Mandatory: 2 elements
Must-Support: 1 element
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
This structure is derived from USPublicHealthReportingBundle
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  Bundle | 0..* | USPublicHealthReportingBundle | USPH Reporting Bundle | |
  Slices for entry | 1..* | BackboneElement | Entry in the bundle - will have a resource or information Slice: Unordered, Open by type:resource | |
   entry:Message | S | 1..1 | BackboneElement | Entry in the bundle - will have a resource or information |
 resource | 0..1 | FAERSMessageHeader | US Public Health MessageHeader | |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Bundle | I | 0..* | USPublicHealthReportingBundle | USPH Reporting Bundle |
  id | Σ | 0..1 | string | Logical id of this artifact |
 meta | Σ | 0..1 | Meta | Metadata about the resource |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred) Max Binding: AllLanguages: A human language. | |
| identifier | Σ | 0..1 | Identifier | Persistent identifier for the bundle |
| type | SΣ | 1..1 | code | document | message | transaction | transaction-response | batch | batch-response | history | searchset | collection Binding: BundleType (required): Indicates the purpose of a bundle - how it is intended to be used. Fixed Value: message |
| timestamp | SΣ | 0..1 | instant | When the bundle was assembled |
| total | ΣI | 0..1 | unsignedInt | If search, the total number of matches |
 link | Σ | 0..* | BackboneElement | Links related to this Bundle |
 id | 0..1 | string | Unique id for inter-element referencing | |
 extension | 0..* | Extension | Additional content defined by implementations | |
 modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| relation | Σ | 1..1 | string | See http://www.iana.org/assignments/link-relations/link-relations.xhtml#link-relations-1 |
 url | Σ | 1..1 | uri | Reference details for the link |
| Slices for entry | ΣI | 1..* | BackboneElement | Entry in the bundle - will have a resource or information Slice: Unordered, Open by type:resource This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type |
  entry:All Slices | Content/Rules for all slices | |||
  id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| link | Σ | 0..* | See link (Bundle) | Links related to this entry |
| fullUrl | Σ | 0..1 | uri | URI for resource (Absolute URL server address or URI for UUID/OID) |
| resource | Σ | 0..1 | Resource | A resource in the bundle |
| search | ΣI | 0..1 | BackboneElement | Search related information |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| mode | Σ | 0..1 | code | match | include | outcome - why this is in the result set Binding: SearchEntryMode (required): Why an entry is in the result set - whether it's included as a match or because of an _include requirement, or to convey information or warning information about the search process. |
| score | Σ | 0..1 | decimal | Search ranking (between 0 and 1) |
| request | ΣI | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method | Σ | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| ifNoneMatch | Σ | 0..1 | string | For managing cache currency |
| ifModifiedSince | Σ | 0..1 | instant | For managing cache currency |
| ifMatch | Σ | 0..1 | string | For managing update contention |
| ifNoneExist | Σ | 0..1 | string | For conditional creates |
| response | ΣI | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status | Σ | 1..1 | string | Status response code (text optional) |
| location | Σ | 0..1 | uri | The location (if the operation returns a location) |
| etag | Σ | 0..1 | string | The Etag for the resource (if relevant) |
| lastModified | Σ | 0..1 | instant | Server's date time modified |
| outcome | Σ | 0..1 | Resource | OperationOutcome with hints and warnings (for batch/transaction) |
| entry:Message | SΣI | 1..1 | BackboneElement | Entry in the bundle - will have a resource or information This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type |
 id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| link | Σ | 0..* | See link (Bundle) | Links related to this entry |
| fullUrl | Σ | 0..1 | uri | URI for resource (Absolute URL server address or URI for UUID/OID) |
| resource | 0..1 | FAERSMessageHeader | US Public Health MessageHeader | |
 search | ΣI | 0..1 | BackboneElement | Search related information |
 id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| mode | Σ | 0..1 | code | match | include | outcome - why this is in the result set Binding: SearchEntryMode (required): Why an entry is in the result set - whether it's included as a match or because of an _include requirement, or to convey information or warning information about the search process. |
| score | Σ | 0..1 | decimal | Search ranking (between 0 and 1) |
| request | ΣI | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method | Σ | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| ifNoneMatch | Σ | 0..1 | string | For managing cache currency |
| ifModifiedSince | Σ | 0..1 | instant | For managing cache currency |
| ifMatch | Σ | 0..1 | string | For managing update contention |
| ifNoneExist | Σ | 0..1 | string | For conditional creates |
 response | ΣI | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status | Σ | 1..1 | string | Status response code (text optional) |
| location | Σ | 0..1 | uri | The location (if the operation returns a location) |
| etag | Σ | 0..1 | string | The Etag for the resource (if relevant) |
| lastModified | Σ | 0..1 | instant | Server's date time modified |
| outcome | Σ | 0..1 | Resource | OperationOutcome with hints and warnings (for batch/transaction) |
| signature | Σ | 0..1 | Signature | Digital Signature |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Bundle | I | 0..* | USPublicHealthReportingBundle | USPH Reporting Bundle |
| type | Σ | 1..1 | code | document | message | transaction | transaction-response | batch | batch-response | history | searchset | collection Binding: BundleType (required): Indicates the purpose of a bundle - how it is intended to be used. Fixed Value: message |
| timestamp | Σ | 0..1 | instant | When the bundle was assembled |
| entry:Message | ΣI | 1..1 | BackboneElement | Entry in the bundle - will have a resource or information This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type |
| Documentation for this format | ||||
This structure is derived from USPublicHealthReportingBundle
Summary
Mandatory: 2 elements
Must-Support: 1 element
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
Differential View
This structure is derived from USPublicHealthReportingBundle
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Bundle | 0..* | USPublicHealthReportingBundle | USPH Reporting Bundle | |
| Slices for entry | 1..* | BackboneElement | Entry in the bundle - will have a resource or information Slice: Unordered, Open by type:resource | |
| entry:Message | S | 1..1 | BackboneElement | Entry in the bundle - will have a resource or information |
| resource | 0..1 | FAERSMessageHeader | US Public Health MessageHeader | |
| Documentation for this format | ||||
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Bundle | I | 0..* | USPublicHealthReportingBundle | USPH Reporting Bundle |
| id | Σ | 0..1 | string | Logical id of this artifact |
| meta | Σ | 0..1 | Meta | Metadata about the resource |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred) Max Binding: AllLanguages: A human language. | |
| identifier | Σ | 0..1 | Identifier | Persistent identifier for the bundle |
| type | SΣ | 1..1 | code | document | message | transaction | transaction-response | batch | batch-response | history | searchset | collection Binding: BundleType (required): Indicates the purpose of a bundle - how it is intended to be used. Fixed Value: message |
| timestamp | SΣ | 0..1 | instant | When the bundle was assembled |
| total | ΣI | 0..1 | unsignedInt | If search, the total number of matches |
| link | Σ | 0..* | BackboneElement | Links related to this Bundle |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| relation | Σ | 1..1 | string | See http://www.iana.org/assignments/link-relations/link-relations.xhtml#link-relations-1 |
| url | Σ | 1..1 | uri | Reference details for the link |
| Slices for entry | ΣI | 1..* | BackboneElement | Entry in the bundle - will have a resource or information Slice: Unordered, Open by type:resource This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type |
| entry:All Slices | Content/Rules for all slices | |||
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| link | Σ | 0..* | See link (Bundle) | Links related to this entry |
| fullUrl | Σ | 0..1 | uri | URI for resource (Absolute URL server address or URI for UUID/OID) |
| resource | Σ | 0..1 | Resource | A resource in the bundle |
| search | ΣI | 0..1 | BackboneElement | Search related information |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| mode | Σ | 0..1 | code | match | include | outcome - why this is in the result set Binding: SearchEntryMode (required): Why an entry is in the result set - whether it's included as a match or because of an _include requirement, or to convey information or warning information about the search process. |
| score | Σ | 0..1 | decimal | Search ranking (between 0 and 1) |
| request | ΣI | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method | Σ | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| ifNoneMatch | Σ | 0..1 | string | For managing cache currency |
| ifModifiedSince | Σ | 0..1 | instant | For managing cache currency |
| ifMatch | Σ | 0..1 | string | For managing update contention |
| ifNoneExist | Σ | 0..1 | string | For conditional creates |
| response | ΣI | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status | Σ | 1..1 | string | Status response code (text optional) |
| location | Σ | 0..1 | uri | The location (if the operation returns a location) |
| etag | Σ | 0..1 | string | The Etag for the resource (if relevant) |
| lastModified | Σ | 0..1 | instant | Server's date time modified |
| outcome | Σ | 0..1 | Resource | OperationOutcome with hints and warnings (for batch/transaction) |
| entry:Message | SΣI | 1..1 | BackboneElement | Entry in the bundle - will have a resource or information This repeating element order: For bundles of type 'document' and 'message', the first resource is special (must be Composition or MessageHeader respectively). For all bundles, the meaning of the order of entries depends on the bundle type |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| link | Σ | 0..* | See link (Bundle) | Links related to this entry |
| fullUrl | Σ | 0..1 | uri | URI for resource (Absolute URL server address or URI for UUID/OID) |
| resource | 0..1 | FAERSMessageHeader | US Public Health MessageHeader | |
| search | ΣI | 0..1 | BackboneElement | Search related information |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| mode | Σ | 0..1 | code | match | include | outcome - why this is in the result set Binding: SearchEntryMode (required): Why an entry is in the result set - whether it's included as a match or because of an _include requirement, or to convey information or warning information about the search process. |
| score | Σ | 0..1 | decimal | Search ranking (between 0 and 1) |
| request | ΣI | 0..1 | BackboneElement | Additional execution information (transaction/batch/history) |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| method | Σ | 1..1 | code | GET | HEAD | POST | PUT | DELETE | PATCH Binding: HTTPVerb (required): HTTP verbs (in the HTTP command line). See HTTP rfc for details. |
| url | Σ | 1..1 | uri | URL for HTTP equivalent of this entry |
| ifNoneMatch | Σ | 0..1 | string | For managing cache currency |
| ifModifiedSince | Σ | 0..1 | instant | For managing cache currency |
| ifMatch | Σ | 0..1 | string | For managing update contention |
| ifNoneExist | Σ | 0..1 | string | For conditional creates |
| response | ΣI | 0..1 | BackboneElement | Results of execution (transaction/batch/history) |
| id | 0..1 | string | Unique id for inter-element referencing | |
| extension | 0..* | Extension | Additional content defined by implementations | |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status | Σ | 1..1 | string | Status response code (text optional) |
| location | Σ | 0..1 | uri | The location (if the operation returns a location) |
| etag | Σ | 0..1 | string | The Etag for the resource (if relevant) |
| lastModified | Σ | 0..1 | instant | Server's date time modified |
| outcome | Σ | 0..1 | Resource | OperationOutcome with hints and warnings (for batch/transaction) |
| signature | Σ | 0..1 | Signature | Digital Signature |
| Documentation for this format | ||||
Other representations of profile: CSV, Excel, Schematron
| Path | Conformance | ValueSet / Code |
| Bundle.language | preferred | CommonLanguages Max Binding: AllLanguages |
| Bundle.type | required | Fixed Value: message |
| Bundle.entry.search.mode | required | SearchEntryMode |
| Bundle.entry.request.method | required | HTTPVerb |
| Bundle.entry:Message.search.mode | required | SearchEntryMode |
| Bundle.entry:Message.request.method | required | HTTPVerb |
IG © 2020+ Biomedical Research & Regulation WG. Package hl7.fhir.us.icsr-ae-reporting#0.1.0 based on FHIR 4.0.1. Generated 2021-08-05
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