• Sara Albolino, Tommaso Bellandi, Simone Cappelletti, Marco Di Paolo, Vittorio Fineschi, Paola Frati, Caterina Offidani, Michela Tanzini, Riccardo Tartaglia, and Emanuela Turillazzi.
• Regional Centre for Clinical Risk Management and Patient Safety, Florence, Italy.
• Curr Pharm Biotechnol. 2019 Jan 1; 20 (8): 615-624.

BackgroundThe phenomenon of clinical negligence claims has rapidly spread to United States, Canada and Europe assuming the dimensions and the severity of a pandemia. Consequently, the issues related to medical malpractice need to be studied from a transnational perspective since they raise similar problems in different legal systems.MethodsOver the last two decades, medical liability has become a prominent issue in healthcare policy and a major concern for healthcare economics in Italy. The failures of the liability system and the high cost of healthcare have led to considerable legislative activity concerning medical malpractice liability, and a law was enacted in 2012 (Law no. 189/2012), known as the "Balduzzi Law".ResultsThe law tackles the mounting concern over litigation related to medical malpractice and calls for Italian physicians to follow guidelines. Briefly, the law provided for the decriminalisation of simple negligence of a physician on condition that he/she followed the guidelines and "good medical practice" while carrying out his/her duties, whilst the obligation for compensation, as defined by the Italian Civil Code, remained. Judges had to consider that the physician followed the provisions of the guidelines but nevertheless caused injury to the patient.ConclusionHowever, since the emission of the law, thorny questions remain which have attracted renewed interest and criticism both in the Italian courts and legal literature. Since then, several bills have been presented on the topic and these have been merged into a single text entitled "Regulations for healthcare and patient safety and for the professional responsibility of healthcare providers".Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.

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