对抗性手术机器人故障中的解剖责任：国家（丹麦）和欧洲法律视角
Dissecting liabilities in adversarial surgical robot failures: A national (Danish) and European law perspective
摘要：
在过去的十年中，手术机器人的重要性和使用率都有所上升。对于手术机器人来说，连接性对于接受软件更新、接受指令和传输传感数据是必要的，但它也会使机器人暴露于网络攻击，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引起的，就像工业机器人的事故一样，但网络攻击是由安全故障引起的。我们在本文中专门针对手术机器人创建了这两种类型故障的分类法。这些机器人越来越多地在欧盟（EU）销售和使用;因此，我们考虑欧盟法律如何看待和对待手术机器人。具体而言，如果伤害是由无法明确识别的对手造成的安全故障造成的，监管机构和制造商拥有哪些权利，以及患者或制造商在欧盟的单一国家法律体系中将拥有哪些法律救济和行动。我们发现，选定的国家法律制度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病人。这是因为它的灵活性;第二，对故障原因的安全性与安全性之间明显缺乏区分，而是侧重于有害影响，从而使患者受益;第三，如果患者选择单独的公法措施来恢复损害赔偿，则可以通过撤销其作为当事人的地位来免除制造商的责任。此外，我们发现，目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，没有通过字面措辞提及，但它也增加了手术机器人制造商的大量责任和责任，赋予患者特殊权利，并赋予监管机构巨大的权力。
英文摘要：
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.
机构、总结、中文摘要均由AI分析而来，可能存在错误，请以论文正文为准。
