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The term “healthcare-associated infections” (HAIs) has long replaced earlier terms such as “nosocomial infections” and “hospital infections”, as the evidence shows that infections may occur within any care setting. Among the several existing scien­tic and lay denitions of HAIs, the Italian Ministry of Health has adopted the following:

HAIs account for a particularly signicant number of adverse events, such as to cause constant concern within the scientic community, both because they represent an extremely complex public health issue and because they entail a considerable social and economic burden. The problem has therefore been addressed by issuing guidelines and recommendations (both national and international) which, while undoubtedly providing useful tools for the prevention and control of HAIs, have not been able to prevent the adoption of widely differing policies at the regional and local level.

tory liability (haftungsausfüllenden Kausalität)” [2].

Generally speaking, a person may be held liable for a tort or for a crime if a specic event has occurred as a result of his/her conduct. This direct connection is the causal link. If the conduct (an act or omission) is held to be reprehensible, however, it will rst be necessary to establish the probability that the given conduct is or is not the cause of the event. In this respect, there is a considerable difference in the principles governing ascertainment of the causal link: in criminal liability the “beyond reason­able doubt” principle applies, whereas in civil liability the “more likely than not” principle applies. In practice, however, the degree of probability required within civil law proceedings is much lower than that found in criminal law proceedings.

In the event that the causal link between an infection and the provision of specic healthcare services is established, the healthcare facility will need to rebut the “pre­sumption” of liability by providing proof of its innocence with regard to the hypoth­esis of not having complied with the rules of HAI prevention and management. For a considerable period of time, the question was what proof the healthcare facility should give other than the obvious provision of documentation of all internal proce­dures aimed at preventing and managing infections. This, in fact, proved to be effec­tive in demonstrating that the healthcare facility had correctly implemented all the appropriate prevention measures to combat hospital infections; basically, with the easily imaginable differences between the various settings, these prevention mea­sures include actions concerning sterilization and ventilation systems, constant monitoring of staff, patient and environmental hygiene, an appropriate information ow enabling the identication and quantication of infections in the various facili­ties, the training of the staff involved in patient care and especially in the critical areas of intensive care and surgery. However, over time such documentation proved to be totally insufcient to discharge the burden of proof falling to the healthcare facility, since recent rulings have almost constantly tended to demand that the healthcare facility provide exonerating proof (a requirement dened “diabolical” by some), i.e., the facility has to demonstrate that the documented protocols were actu­ally applied.

In practice, recent years have seen a new trend in case law (even in the absence of any formal and explicit recognition to this effect) to congure hypotheses of lia­bility that some have dened as a ‘true hypothesis of strict liability’ (i.e., that liabil­ity placed on the subject without any blame or malice being attributed to them, sanctioned by Article 42 of the Italian Penal Code [4]), thus solving the issue of ascertaining the fault of the healthcare facility with arguments that can be summa­rized essentially as follows:

guaranteed;