Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance – Part 1: Framework for adverse event reporting

This standard refers to individual case safety reports (ICSRs) for adverse drug reactions (ADR), adverse events (AE), product problems and consumer complaints that can occur from the administration or use of one or more products. It seeks to establish an international framework for data exchange and information sharing by providing a common messaging format for transmitting ICSRs relating to these issues.

The messaging format is based on the HL7 Reference Information Model (RIM) and can be extended or constrained to accommodate a variety of reporting use cases. This standard will be harmonised with other HL7 public health and patient safety reporting standards to help ensure that messaging constructs and vocabulary are harmonised in the HL7 Public Health and Regulatory Reporting domains.

The data elements used in this standard were identified as consistent across many of the use cases and can be applied to a variety of reporting scenarios. Specific reporting requirements within organisations or regions might vary.

This standard is part 1 of 2 in Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance.