scope:

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 reporting standards to help ensure that messaging constructs and vocabulary are harmonized in the HL7 Public Health and Regulatory Reporting domains. Furthermore, this part of ISO 27953 does not govern or dictate reporting requirements for any product. However, the regulatory use cases (storyboards) described in this part of ISO 27953 were derived from a variety of data sources, including draft and final versions of internationally harmonized guidelines from the International Conference on Harmonisation, the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) GL 42, and the Global Harmonization Task Force (GHTF) Study Group 2 N87 guideline. The storyboards are for demonstration purposes only and help to demonstrate the scalability and interoperability of this International Standard across multiple stakeholders and product types. It is possible that future editions of this International Standard will be developed to include conformance profiles (templates) and vocabulary for all, or a limited subset, of the use cases. The data elements used in this part of ISO 27953 were identified as consistent across many of the use cases and can be applied to a variety of reporting scenarios. Specific reporting requirements within organizations or regions might vary; this International Standard does not specify a vocabulary subset for these data elements in this edition.