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 
Mappings for the ibm-fda-icsr-faers-messageheader resource profile.
| FAERSMessageHeader | ||
| MessageHeader | MSH / MSA / ERR | |
| event[x] | MSH-9.2 | |
| destination | ||
| name | MSH-5 | |
| endpoint | MSH-25 (or MSH-6) | |
| receiver | PRT-5:PRT-4='WAYR' / PRT-8:PRT-4='WAYR' | |
| sender | PRT-5:PRT-4='WAYR' / PRT-8:PRT-4='WAYR' | |
| enterer | EVN-5 / ORC-10 / PRT-5:PRT-4='EP' / ROL where ROL.3 is EP or ORC.10 | |
| author | ORC-19 / PRT-5:PRT-4='AUT' / ROL where ROL.3 is IP or ORC.12 | |
| source | ||
| name | MSH-3 | |
| software | SFT-3 ( +SFT-1) | |
| version | SFT-2 | |
| contact | (MSH-22?) | |
| endpoint | MSH-24 | |
| responsible | ORC-12 / PRT-5:PRT-4='OP' / PRT-8:PRT-4='OP' / ROL where ROL.3 is RO or ORC.11 | |
| reason | EVN.4 / ORC.16 / OBR-31-reason for study / BPO-13-BP indication for use / RXO-20-indication / RXE-27-give indication / RXD-21-indication / RXG-22-indication / RXA-19-indication | |
| response | MSA | |
| identifier | MSA-2 | |
| code | MSA-1 | |
| details | ERR | |
| FAERSMessageHeader | ||
| MessageHeader | Entity. Role, or Act, Message | |
| text | Act.text? | |
| contained | N/A | |
| modifierExtension | N/A | |
| event[x] | ./payload[classCode="CACT" and moodCode="EVN" and isNormalAct()]/code[isNormalDatatype()]/code | |
| destination | ./communicationFunction[typeCode="RCV"] | |
| id | n/a | |
| extension | n/a | |
| modifierExtension | N/A | |
| name | unique(./entity[determinerCode="INST" and (classCode=("DEV", "PSN", "ORG"]/name[type='ST' and isNormalDatatype()]) | |
| target | unique(./entity[determinerCode="INST" and (classCode=("DEV", "PSN", "ORG"] | |
| endpoint | ./telecom | |
| receiver | Not directly supported. Could be shared using attentionLine.value with an appropriate keyWordText | |
| sender | Not directly supported. Could be shared using attentionLine.value with an appropriate keyWordText | |
| enterer | unique(./controlAct[classCode="CACT" and classCode="EVN" and isNormalAct()]/participation[typeCode="ENT" and isNormalParticipation]/role[classCode="ASSIGNED" and isNormalRole()]/player[isNormalEntity() and classCode=("DEV", "PSN") and determinerCode="INST"]) | |
| author | unique(./controlAct[classCode="CACT" and classCode="EVN" and isNormalAct()]/participation[isHighest(priorityCode) and typeCode="AUT" and isNormalParticipation]/role[classCode="ASSIGNED" and isNormalRole()]/player[isNormalEntity() and classCode=("DEV", "PSN") and determinerCode="INST"]) | |
| source | unique(./communicationFunction[typeCode="SND"]) | |
| id | n/a | |
| extension | n/a | |
| modifierExtension | N/A | |
| name | unique(./entity[determinerCode="INST" and classCode="DEV"]/name[type='ST' and isNormalDatatype()]) | |
| software | unique(./entity[determinerCode="INST" and classCode="DEV"]/softwareName[isNormalDatatype()]) | |
| version | (Not supported) | |
| contact | unique(./entity[determinerCode="INST" and classCode="DEV"]/scopesRole[normalRole() and classCode="CON" and layer[classCode="PSN"]/telecom[isNormalDatatype()]) | |
| endpoint | ./telecom[isNormalDatatype()] | |
| responsible | unique(./controlAct[classCode="CACT" and classCode="EVN" and isNormalAct()]/participation[isHighest(priorityCode) and typeCode="RESP" and isNormalParticipation]/role[classCode="ASSIGNED" and isNormalRole()]/player[isNormalEntity() and classCode="PSN" and determinerCode="INST"] or ./controlAct[classCode="CACT" and classCode="EVN" and isNormalAct()]/participation[isHighest(priorityCode) and typeCode="RESP" and isNormalParticipation]/role[classCode="ASSIGNED" and isNormalRole()]/scoper[isNormalEntity() and classCode="ORG" and determinerCode="INST"]) | |
| reason | unique(./controlAct[classCode="CACT" and classCode="EVN" and isNormalAct()]/reasonCode[isNormalDatatype()]) | |
| response | ./conveyedAcknowledgement | |
| id | n/a | |
| extension | n/a | |
| modifierExtension | N/A | |
| identifier | ./acknowledges.id[isNormalDatatype()] | |
| code | ./typeCode[isNormalDatatype()] | |
| details | AcknowledgementDetail or Observation[classCode="ALRT" and moodCode="EVN"] | |
| focus | unique(./controlAct[classCode="CACT" and classCode="EVN" and isNormalAct()]/participation[typeCode="SUBJ" and isNormalParticipation]/role or ./controlAct[classCode="CACT" and classCode="EVN" and isNormalAct()]/outboundRelationship[typeCode="SBJ" and isNormalActRelatoinship]/target) | |
| definition | Not directly supported. | |
| FAERSMessageHeader | ||
| MessageHeader | ||
| event[x] | FiveWs.what[x] | |
| destination | FiveWs.subject[x], FiveWs.subject | |
| receiver | FiveWs.subject[x], FiveWs.subject | |
| sender | FiveWs.subject[x], FiveWs.subject | |
| enterer | FiveWs.author | |
| author | FiveWs.author | |
| source | FiveWs.actor | |
| responsible | FiveWs.witness | |
| reason | FiveWs.why[x] | |
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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