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CONCLUSIONS The regulation and sanitary actions directed to patient safety in Brazil have increased after the creation of ANVISA. In the face of this activities, the social role played by the Brazilian Health Regulatory System toward the advancement in the field of risk minimization in health services can be highlighted as a protagonist in the process of promoting patient safety.OBJECTIVES The aim of the study was to evaluate clinical outcomes and adverse events (AEs) experienced by patients treated within the Hospital in the Home (HITH)