DS/EN ISO/HL7 27953-1:2012 Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 1: Framework for adverse event reporting
This part of ISO 27953 seeks to establish an international framework for data exchange and information sharing by providing a common messaging format for transmission of ICSRs for adverse drug reactions (ADR), adverse events (AE), product problems and consumer complaints that can occur upon the administration or use of one or more products.The messaging format is based upon the HL7 Reference Information Model (RIM) and can be extended or constrained to accommodate a variety of reporting use cases, as described in the storyboard section of this ballot. This part of ISO 27953 will be harmonized over time with other HL7 public health and patient safety reporti
DS/EN ISO/HL7 27953-1:2012 history
2012DS/EN ISO/HL7 27953-1:2012 Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 1: Framework for adverse event reporting