prCEN ISO/TR 29322

Health informatics - Guidance on the management of clinical risk relating to the deployment and use of health software systems (ISO/TR 29322:2008)

Scope

This TR will provide guidance on the evaluation and management of risk in the implementation and use of health software in the user domain. It will provide a methodology/methodologies for the evaluation of risk and provide examples of the application of such evaluations in user environments.The technical scope covers recommended methods and techniques for the identification of potential hazards, the evaluation and mitigation of risks and in particular the development of appropriate safety cases to provide justifications of the acceptability of residual risks and a verification of the resulting operational processes. Guidance on the structure and content of a Risk Management File will be provided.