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U.S. Department of Health and Human Services

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Research Project: Developing a Safety Assurance Framework

Safety Assurance Cases are the application of an analytical assurance case procedure to the determination of safety assurance. The use of Safety Cases has the potential to enhance public safety and speed review cycles by allowing flawed assertions and incomplete evidence to be exposed, often before they are submitted. This technique is increasingly being used in other industries for the regulatory approval of very complex systems, particularly for systems where the traditional protections of quality management systems and design controls do not provide the necessary structure for expeditious review of compliance. This research will also determine whether the generalized use of Assurance Cases can be applied to formally define the uncertainties of other regulatory activities such as Standards adoption, Compliance actions and Regulatory coverage.