Individual Case Safety Reports

Description:  The HL7 Individual Case Safety Report (ICSR) captures information needed to support reporting of adverse events, product problems and consumer complaints associated with the use of FDA regulated products. 

ICSR Release 2 was completed December 2011 as an SDO Joint Initiative Project between the International Standards Organization (ISO), the European Committee for Standardization (CEN) and HL7.  Information about the SDO Joint Initiative can be found at: http://www.jointinitiativecouncil.org/. The ICSR specification, ISO/HL7 27953 is a multi-part standard created to consolidate work efforts in ISO and HL7 as follows:

1. ISO new work item proposal N545: Health informatics - Pharmacovigilance - Structure and data elements of individual case safety report (reclassified as ISO 27953);

2. Health Level Seven (HL7) Individual Case Safety Report (ICSR) Release 1, Normative Standard;

3. HL7 ICSR Release 2, Draft Standard for Trial Use (DSTU)ISO/HL7 27953-1 (Part 1) is designed to address areas of overlap across the work items and form a messaging framework reference. This framework can be applied to support data exchange requirements described in the many different use cases presented as storyboards in this International Standard. This framework allows for future development work to be carried out so that additional use cases that are not currently addressed in this edition can be added in the future as new parts to this International Standard.

• ·Biologics and Vaccines Adverse Events
• ·Food Adverse Events
• ·Human Drugs Adverse Events
• ·Medical Device Adverse Events
• ·Veterinary Adverse Events
• ·Tobacco Adverse Events