Several countries are conducting dedicated initiatives at the national level aimed at decreasing the risk of harm associated with healthcare. Such activities are closely related to the healthcare system operating in the country and the role of the government within the system. In Italy, as part of the national model for quality and clinical governance policy, the Ministry of Health has conducted, in agreement with the Regions, many activities related to patient safety and risk management. Over the last 5 years, significant improvements on patient safety have been made in Italy with the creation of the national sentinel event reporting system, the implementation of nine recommendations and solutions, the development of training, education and patient safety tools, the fostering of stakeholders' involvement and the study of legal and insurance issues. The agreement signed in 2008 between the Central Government and the Regions is an important step towards the governance of patient safety at the national level as well as for the clinical management at the hospital level, and it will underpin the implementation of future actions in Italy. In addition, the Ministry of Health has elaborated a national program that will be developed over the next 2 years. Italian initiatives are now in progress and further efforts will be aimed at ensuring a flow of cyclical processes, so as to ensure continuity of action and promote a renewed interest in patient safety. This will entail not only a simple series of steps, but also the involvement of the complex array of stakeholders, in order to implement a cultural change in patient safety.