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The introduction of automated vehicles promises an increase in traffic safety. Prior to its launch proof of the anticipated reduction in the sense of a positive risk balance compared with human driving performance is required from various stakeholders such as the European Union Commission, the German Ethic Commission, and the ISO TR 4804. To meet this requirement and to generate acceptance by the public and the regulatory authorities, a qualitative Risk- Benefit framework has been defined. This framework is based on literature research on approaches applied in other disciplines. This report depicts the framework, adapted from the pharmaceutical sector called PROACT-URL which serves as a structured procedure to demonstrate a positive risk balance in an understandable and transparent manner. The qualitative framework needs to be turned in quantitative methods once it should be applied. Therefore, two steps of the framework are discussed in more detail: First, the definition of adequate development thresholds that are required at an early stage of the development. Second the simulation-based assessment to prove the positive risk balance prior to the market introduction.

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