ISO/HL7 27953-1:2011

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

Publication date:   Nov 21, 2011

General information

90.93 Standard confirmed   Jul 26, 2022

ISO/HL7

ISO/TC 215 Health informatics

International Standard

35.240.80   IT applications in health care technology

Buying

  Published

PDF - €261.36

  English   French  



Buy

Scope

ISO 27953-1:2011 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. ISO 27953-1:2011 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 Heath and Regulatory Reporting domains.
The data elements used in ISO 27953-1:2011 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.

Life cycle

NOW

PUBLISHED
ISO/HL7 27953-1:2011
90.93 Standard confirmed
Jul 26, 2022