THERAPEUTICAL INNOVATIONS AND MEDICAL RESPONSIBILITY: WHAT’S NEW IN OTO- LARYNGOLOGY

GIACOMO SPINATO¹, GIORGIO CAZZATO², SALVATORE FERLITO³, GIANCARLO TIRELLI⁴, PAOLO BOSCOLO RIZZO⁵, MARIA CRISTINA DA MOSTO⁵, BRUNO GALLETTI⁶, GIOVANNI TONOLI¹, DORIANO POLITI², ANGELO CONTI³, GIANLUCA CAMPIONE³, MILENA DI LUCA³, ANNALISA GATTO⁴, MARCO PIOVESANA⁴ , AGOSTINO SERRA³

¹Ear, Nose and Throat Department, Rovigo Provincial Hospital, I-45100 Rovigo - ²Provincial Ear, Nose and Throat Department of Venice, Mestre Hospital, I-30174 Venice - ³Ear, Nose and Throat Department, University of Catania, I-95125 Catania - ⁴Ear, Nose and Throat Department, Cattinara Hospital, University of Trieste, I-34149 Trieste - ⁵Department of Neurosciences, Ear, Nose and Throat Clinic and Regional Center for Head and Neck Cancer, University of Padua, Treviso Provincial Hospital, I-35122 Padua - ⁶Department of Otolaryngology, University of Messina, Messina, Italy

On one hand the incessant and constant technological and instrumental progress in the medical fieldhas allowed to increase knowledge and to reach new objectives. On the other hand, however, it has also raised the risk linked to professional responsibility, regarding informed consent and law 24/2017 of the Italian Republic, better known as Gelli Bianco. In this work an analysis of rele- vant literature will be presented, followed by a study on the role of new devices on responsibility profiles in otolaryngology. According to the analysis of the Italian law and considering the weaknesses ofthe above mentioned guidelines, pending legal admini- strative clarifications, we believe an operational protocol can be proposed in case of application of therapeutical innovations, espe- cially about experimental introductions. Consequently, in our opinion, the risk of incrimination persists in case of use of innovative procedures in the absence of a formal shared opinion expressed in guidelines or in good practices, which still need a satisfactory definition.