Medical robotics-Regulatory, ethical, and legal considerations for increasing levels of autonomy

借鉴自动驾驶技术自主化等级的划分，大佬们对医疗机器人领域中的自主化（自治化）等级进行了划分和表述。非常有参考意义，可以尝试把自己的机器人归入其中哪一类，提升等级~

医疗机器人-对提升的自主化等级的规范，道德，法律考虑
Medical robotics-Regulatory, ethical, and legal considerations for increasing levels of autonomy [1]
Paper Link
Authors:Yang G Z, et al.
2017, Science Robotics

加于医疗机器人的规则，道德和法律障碍有必要对不同等级的自动化有仔细的考虑，以及使用的内容。对于自动化车辆，自主化的等级被定义，还没有对医疗机器人的这样的定义。为了刺激讨论，我们提出用于医疗机器人的六种自主化等级，作为一个可能的框架。
The regulatory, ethical, and legal barriers imposed on medical robots necessitate careful consideration of different levels of autonomy, as well as the context for use. For autonomous vehicles, levels of automation for on-road vehicles are defined, yet no such definitions exist for medical robots. To stimulate discussions, we propose six levels of autonomy for medical robotics as one possible framework

Level0:无自主化。这个等级包含远程控制机器人或者对用户指令作出反应和跟随的假肢设备。
Level1：机器人辅助。在一个任务中当人类对系统有连续控制时，机器人提供一些机械引导和辅助。
Level2：任务自动化。机器人对于由人类初始化的特定任务是自主化的。
Level3：有条件自主化。系统产生任务策略但是依赖于人类去不同决策中选择或者去同意自主选择的策略。
Level4：高度自主化。机器人能够在有资质医生的监管下作出医疗决定。
Level5：完全自主化（不需要人类）。这是一个能够进行完整手术的“机器人手术医生”
Level 0: No autonomy. This level includes tele-operated robots or prosthetic devices that respond to and follow the user’s command.
Level 1: Robot assistance. The robot provides some mechanical guidance or assistance during a task while the human has continuous control of the system.
Level 2: Task autonomy. The robot is autonomous for specific tasks initiated by a human.
Level 3: Conditional autonomy. A system generates task strategies but relies on the human to select from among different strategies orto approve an autonomously selected strategy.
Level 4: High autonomy. The robot can make medical decisions but under the supervision of a qualified doctor.
Level 5: Full autonomy(no human needed). This is a “robotic surgeon” that can perform an entire surgery.

对于更高等级的自主化，手术机器人系统对大量传感器数据作出反应的能力需要更复杂。完全自主化的关键要求是复制一个手术专家的感知运动技巧的技术。随着减少人类监管和增加机器人感知，决策，和执行（传统的感知，思考，行动范例）,能导致病人受伤的故障风险将增加。网络安全和隐私也是需要考虑的首要问题。
For higher levels of autonomy, the ability of the surgical robotic system to respond to a variety of sensory data will need to be more sophisticated. A key requirement for full autonomy will be technology that replicates the sensorimotor skills of an expert surgeon.With decreasing human oversight and increasing robotic perception, decision-making, and action (the traditional “sense-think-act paradigm”), the risk of malfunction that can cause patient harm will increase. Cybersecurity and privacy are also major issues to consider.

在高等级的自主化（特别是Level5，可能包含Level4），机器人不仅仅是一个医疗设备，也是执业医学。
At the higher levels of autonomy (specifically Level 5 and possibly Level 4), the robot is not only a medical device but is also practicing medicine.

一种可能性是，FDA可以验证外科手术机器人设计的安全性，但需要医疗机构对机器人外科医生进行许可和/或认证，就像目前对人类外科医生所做的那样。
One possibility is for the FDA to certify the safety of a surgical robot design but require licensing and/or certification of the robotic surgeon by the medical establishment, as is currently done for human surgeons.

随着医疗机器人技术自主能力的增强，医疗专家的大部分角色将转向诊断和决策。这种转变可能意味着，随着技术的引入，灵活性和基本手术技能可能会下降，这对培训和认证产生了影响。
As the autonomous capabilities of medical robotics grow, most of the role of the medical specialists will shift toward diagnosis and decision-making. This shift may mean that dexterity and basic surgical skills may decline as the technologies are introduced, with implications for training and accreditation.

对于某些设备和过程，我们已经处于第3级，因此，挑战将在于将应用程序扩展到更复杂的过程和环境。对于外科手术机器人，级别1到4的一个关键方面是主治医生仍然在很大程度上在控制中。机器人设备本质上是按照医生的命令去做的，而不同级别的细节则留给自动化系统。除了不断发展的技术外，对自主机器人的风险承受能力也有望发生变化。随着无人驾驶汽车（例如自动驾驶汽车）的普及，我们预计医疗应用中自主机器人对风险的接受度也会增加。
We are already at Level 3 for some devices and procedures, and therefore, the challenge will be in broadening the applications to more complex procedures and environments. For surgical robots, one key aspect of Levels 1 to 4 is that the treating physician is still in control to a significant extent. The robotic devices are essentially doing what the physician commands, with varying levels of detail being left to the automated system. Aside from evolving technology, the risk tolerance to autonomous robots is expected to change. As autonomous machines such as self-driving cars become commonplace, we anticipate that acceptance of risk from autonomous robots for medical applications will also increase.

[1]: Yang G Z, Cambias J, Cleary K, et al. Medical robotics—Regulatory, ethical, and legal considerations for increasing levels of autonomy[J]. Science Robotics, 2017, 2(4): 8638.

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