Background: The 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.
Methods: Over 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”.
Results: The 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.
Conclusion: However, 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”.