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Section 1c: FHIR®
Section 3: Implementation Guides

HL7 FHIR Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting, Release 1 - US Realm

DESCRIPTION

The FHIR Implementation Guide provides a set of profiles for detection, validation, reporting, and ultimately recording/persisting Adverse Events associated with blood transfusions and vaccinations.

 

See the specification at www.hl7.org/fhir/us/icsr-ae-reporting/STU1

ALTERNATIVE NAMES

HL7 FHIR Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting, Release 1 - US Realm may also go by the following names or acronyms:

"HL7 FHIR® IG: Transfusion and Vaccination Adverse Event Reporting, Release 1 - US Realm", ICSR AE Reporting

BENEFITS

  • Facilitates electronic reporting of adverse events, and interoperability of data for patients experiencing these events
  • Offers guidance on the data elements needed for detection, validation, and reporting of biologics-related adverse events, including data elements needed to capture the granular details of exposure to the suspect drug/biologic, along with documenting the adverse event/outcome associated with the suspect drug/biologic.

IMPLEMENTATIONS/CASE STUDIES

  • IBM BEST C2 Project
  • MedStar

RELATED DOCUMENTS

HL7 FHIR Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting, Release 1 - US Realm

STU DOCUMENTS

HL7 FHIR Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting, Release 1 STU 1- US Realm See the standard at http://hl7.org/fhir/us/icsr-ae-reporting/STU1. (Submit Feedback on STU)

TOPIC

  • Public Health

BALLOT TYPE

  • STU

STATUS DATE

2022-01-19

RESPONSIBLE WORK GROUP

Biomedical Research and Regulation

PRODUCT TYPE

  • Implementation Guide

STAKEHOLDERS

  • EHR, PHR Vendors
  • Healthcare Institutions
  • Pharmaceutical Vendors
  • Regulatory Agency

FAMILY

  • FHIR

CURRENT STATE

  • Active

REALM

  • US Realm