Malfunctions of the robot and digital evidence. In case of a malfunctioning of the robot unrelated to the conduct of the surgeon, the hospital can claim damages from the manufacturer or importer of the machine. To this aim, the plaintiff must support his action with the evidence of the malfunctioning and therefore he shall have the right to access the digital data elaborated by the robot, and collected in a kind of internal “black box”, which records every command given and every process executed, together with the incidental system errors. According to the actual terms of sale, this data is not accessible by the hospital, even when it is the owner of the robot, and they can be extracted only with the intervention of a technician sent by the manufacturer or the importer. The robot is also connected with an external monitoring system managed by the producer or the import company, which controls all the activities of the machine and signals any error; however, this information is inaccessible for the robot’s owner as well. This inconvenience is a serious constraint for the hospital to advance its rights, since that data allows to determine whether a certain action may be attributed to the robot or to the operator, and consequently establish if the cost of damages must be borne by the producer or by the hospital. European law should prescribe the obligation for the manufacturer to install on the robot a software which enables the user to retrieve these data strings and decode them, or, alternatively, the obligation for both the manufacturer and the importer to provide the same data upon request of the robot’s owner or holder. It shall be further stressed that the digital data must not only be made available, but also unequivocally decrypted, perhaps through the intervention of a third independent subject like the notified bodies identified for the purposes of the MDD.
