DIN EN ISO 27953-1:2012-09

In order to increase patients' safety many countries require the exchange of information on product safety between the different stakeholders in the medical field. Currently, many products agencies record the individual case reports provided by users, pharmaceutical companies and qualified persons working in the health sector on unwanted adverse events, side effects, infections, contaminations and other incidents. Part 1 of this standard seeks to establish an international framework for data exchange and information sharing by providing a common messaging format for transmission of individual case safety reports (ICRSs) 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. Part 1 is based upon the HL7 Reference Information Model and can be extended or constrained to accommodate a variety of reporting use cases that are based on prEN ISO27953-2 and other regional and international requirements summarized in the storyboard section of this ballot. It should be taken into account that Part 1 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 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 standard are for demonstration purposes only and help to demonstrate the scalability and interoperability of the standard across multiple stakeholders and product types. It is possible that future editions of this standard will be developed to include conformance profiles or vocabulary for all, or a limited subset, of the use cases. It shall be taken into account that the data elements used consistently across many of the use cases are compiled as generic transmission use case data elements in this part of the standard. These data elements can be considered a generic set of data elements which can be applied for each report scenario. Specific reporting requirements within organizations or regions use all or only a subset of these data elements. It shall be taken into account that this standard does not specify a vocabulary subset for these data elements in this edition. The committee responsible for this standard is NA 063-07-03 AA "Terminologie" ("Terminology") at DIN.