论文标题
在对抗性手术机器人失败中解剖责任：民族（丹麦）和欧洲法律的观点
Dissecting liabilities in adversarial surgical robot failures: A national (Danish) and European law perspective
论文作者
论文摘要
在过去的十年中，外科机器人的突出和用法上升。对于手术机器人，需要连接以接受软件更新，接受说明和传输感官数据，但也将机器人暴露于网络攻击中，这可能会损害患者或外科医生。这些伤害通常是由安全故障造成的，如工业机器人的事故所见，但是网络攻击是由安全失败引起的。我们为本文专门针对手术机器人创建了两种失败的分类学。这些机器人越来越多地在欧盟（EU）出售和使用；因此，我们考虑欧盟法律如何看待和处理外科机器人。具体来说，如果哪些权利监管机构和制造商拥有哪些法律补救措施和行动，则患者或制造商在联盟的一个国家法律制度中会有哪些伤害是由于无法明确识别的对手造成的安全失败而受伤的。我们发现，选定的国家法律体系可以充分处理对手术机器人的攻击，因为它可以有效地补偿患者。这是因为它的灵活性；其次，在安全与故障的安全原因之间存在明显的区别，而将注意力集中在有害影响上，从而使患者受益。第三，如果患者选择单独的公法措施以追回损害赔偿，则可以通过撤回其作为一方的地位来从制造商中撤消责任。此外，我们发现当前的欧盟法律确实考虑了手术机器人的安全性和安全性方面，而没有通过字面的措辞提及它，但它还为外科机器人制造商增加了实质性的责任和责任，赋予了患者的特殊权利，并赋予监管机构的巨大权力。
Over the last decade, surgical robots have risen in prominence and usage. For surgical robots, connectivity is necessary to accept software updates, accept instructions, and transfer sensory data, but it also exposes the robot to cyberattacks, which can damage the patient or the surgeon. These injuries are normally caused by safety failures, as seen in accidents with industrial robots, but cyberattacks are caused by security failures instead. We create a taxonomy for both types of failures in this paper specifically for surgical robots. These robots are increasingly sold and used in the European Union (EU); we therefore consider how surgical robots are viewed and treated by EU law. Specifically, which rights regulators and manufacturers have, and which legal remedies and actions a patient or manufacturer would have in a single national legal system in the union, if injuries were to occur from a security failure caused by an adversary that cannot be unambiguously identified. We find that the selected national legal system can adequately deal with attacks on surgical robots, because it can on one hand efficiently compensate the patient. This is because of its flexibility; secondly, a remarkable absence of distinction between safety vs security causes of failure and focusing instead on the detrimental effects, thus benefiting the patient; and third, liability can be removed from the manufacturer by withdrawing its status as party if the patient chooses a separate public law measure to recover damages. Furthermore, we find that current EU law does consider both security and safety aspects of surgical robots, without it mentioning it through literal wording, but it also adds substantial liabilities and responsibilities to the manufacturers of surgical robots, gives the patient special rights and confers immense powers on the regulators.
