Category Standard Organisation International Organization for Standardization (ISO) ID ISO/HL7 27953-2:2011 Type Standard Version 1 Access Fees apply to access Status Active Created Dec-11 Updated Oct-12 This standard refers to individual case safety reports (ICSRs) for adverse drug reactions (ADR), adverse events (AE), infections, and incidents that can occur from the administration of one or more human pharmaceutical products to a patient, regardless of source and destination. It seeks to create a standardised framework for international regulatory reporting and information sharing by providing a common set of data elements and a messaging format for transmitting ICSRs relating to these issues.This standard is part 2 of 2 in Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance.