Verkkokauppa
SFS-EN ISO 27953-1:2012:en (zip)
Health informatics. Individual case safety reports (ICSRs) in pharmacovigilance. Part 1: Framework for adverse event reporting (ISO 27953-1:2011)
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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.
Tämän julkaisun valmistelusta Suomessa vastaa SFS Suomen Standardit, puh. 09 149 9331.
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.
Tämän julkaisun valmistelusta Suomessa vastaa SFS Suomen Standardit, puh. 09 149 9331.
Tuoteryhmä(t)
Sidokset
Velvoittavat viittaukset
ISO 21090:2011 Health informatics — Harmonized data types for information interchange
ISO/HL7 21731:2006 Health informatics — HL7 version 3 — Reference information model — Release 1
ISO/TS 22224:2009 Health informatics — Electronic reporting of adverse drug reactions
ISO/HL7 21731:2006 Health informatics — HL7 version 3 — Reference information model — Release 1
ISO/TS 22224:2009 Health informatics — Electronic reporting of adverse drug reactions
Tekninen komitea
Vahvistuspäivä
13.08.2012
Julkaisupäivä
29.10.2024
Painos
2012
Sivumäärä
1
Julkaisun kieli
englanti
Lisätiedot
Julkaisun aineisto on html-muotoinen kokonaisuus.