ISO/HL7 27953-1:2011 (HL7) Preview

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

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
    Publication date : 2011-12
    Corrected version (en) : 2012-10
  • Edition : 1
    Number of pages : 597
  • :
    ISO/TC 215
    Health informatics
  • 35.240.80
    IT applications in health care technology

Buy this standard

Format Language
HTML
HTML on CD
  • CHF198

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

Keep up to date with ISO

Sign up to our newsletter for the latest news, views and product information

 Subscribe