The French Institute for Public Health Surveillance (InVS) was tasked by a decree dated April 25, 2006, with conducting a pilot program for the reporting of serious adverse events (SAEs) related to healthcare, as provided for in Section III of Article 117 of the Law of August 9, 2004, on public health policy. This pilot program was conducted between January 2009 and June 2010 at 82 volunteer healthcare and medical-social facilities in four pilot regions (Aquitaine, Île-de-France, Rhône-Alpes, and Franche-Comté), with the support of the Regional Support Units (CRA) for clinical risk management and the Regional Health Agencies (ARS). Following the pilot, the InVS led the evaluation efforts, in close collaboration with an expert group comprising risk management specialists from the participating facilities, the CRAs and ARS of the pilot regions, the High Authority for Health (HAS), and the High Council for Public Health (HCSP). The evaluation indicators were developed based on an analysis of the database of reported EIGs during the 18-month pilot period (quantitative component), self-administered questionnaires completed by participating institutions (quantitative-qualitative component), and a focus group meeting with regional partners (qualitative component). This report presents the findings and results of the evaluation, as well as recommendations for the widespread implementation of the program. (R.A.)