ISO/HL7 27953-1:2011

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

Standard Details

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.

General Information

Status : Published

Standard Type: Main

Document No: ISO/HL7 27953-1:2011

Document Year: 2011

Edition: 1

Section Volume:
ISO/TC 215. Health informatics

ICS:
35.240.80 IT applications in health care technology

Life Cycle

Currently Viewing

Published

ISO/HL7 27953-1:2011

ISO/HL7 27953-1:2011

Standard Details

General Information

Life Cycle

Add Standards To Trackedge

Enquiry Form