CAREER: Enabling "White-Box" Autonomy in Medical Cyber-Physical Systems

尽管在重症患者护理中的自动化方面进行了长期的努力，但是由于以下几个限制，现有的自动化能力对于现实世界的使用还没有适当地成熟：（1）自动化的决定/动作不能容易地由临床医生解释，从而阻止临床医生与自动化的有效交互以及对自动化的监督以用于安全的患者护理;（2）自动化设计用于执行感兴趣的特定任务，而不考虑患者的整体生理状态;（3）多个自动化功能通常不协调，以避免患者治疗中可能的冲突;（4）自动化易于在医疗器械中出错;以及（5）缺乏用于评估和批准安全关键自动化能力的监管科学。 该研究计划旨在通过研究新的方法来解决这些基本挑战，这些方法用于（1）以便于临床医生解释的方式数学表示患者生理学，以及（2）设计自动化功能，可以促进临床医生的互动和监督，协调多个治疗目标和功能，以及对设备错误和故障的恢复能力。 此外，这项研究计划将有利于社会和科学，技术，工程和数学（STEM）教育，通过创建一个广泛的自动化系统，可以提高重症患者的护理质量，加快部署具有先进自动化功能的新医疗设备，促进新兴医疗自动化功能的评估和批准，培训STEM劳动力，特别是来自代表性不足的少数民族的劳动力。 通过推进医疗网络物理系统（M-CPS）的可推广方法，实现医疗保健中可解释的白盒自治的长期愿景，该CAREER计划的目标是研究生理建模，协调和弹性多变量闭环控制以及循环复苏中的监管科学方法。 一个综合的研究，教育和推广计划，提出了实现这一目标。 在研究方面，将研究适用于广泛循环复苏场景中白盒自主性的生理建模和闭环控制方法。 具体而言，将开发用于（1）患者生理学和药理学建模以及（2）协调和弹性多变量闭环控制的可推广方法。 这些方法的价值将通过开发用于循环复苏的可解释白盒生理闭环控制算法来证明。 在教育和外展方面，下一代M-CPS员工队伍的成员将接受培训，评估重症监护自主能力的监管科学将得到推进。 具体而言，（1）研究生，本科生和K-12学生将被吸引到STEM和M-CPS，（2）与美国食品药品监督管理局合作，通过其医疗器械开发工具计划，研究生理模型和闭环M-CPS的测试方法和工具，（3）新知识的传播将进一步推动M-CPS研究和教育。该奖项反映了NSF的法定使命，并已被认为是值得通过评估使用基金会的知识优点和更广泛的影响审查标准。

Despite a long-standing effort on the automation in the care of critically ill patients, prior automation capabilities have not been suitably mature for real-world use due to a few limitations: (1) the decisions/actions of the automation could not be easily interpreted by clinicians, preventing clinicians' effective interaction with and supervision of the automation for safe patient care; (2) the automation was designed to perform a particular task of interest without accounting for the overall physiological state of the patient; (3) multiple automation functions were not often coordinated to avoid possible conflicts in patient treatment; (4) automation was prone to errors in the medical devices; and (5) regulatory science for evaluation and approval of safety-critical automation capabilities was lacking. This research program seeks to address these fundamental challenges by studying novel methodologies for (1) mathematically representing the patient physiology in a way to facilitate the interpretation of clinicians and (2) designing automation capabilities that can facilitate clinician interaction and supervision, coordination of multiple treatment goals and functions, and resilience to device errors and faults. In addition, this research program will benefit society and Science, Technology, Engineering and Mathematics (STEM) education by creating a wide range of automation systems that can improve the quality of care of critically ill patients, expediting the deployment of new medical devices with advanced automation capabilities, facilitating the evaluation and approval of emerging healthcare automation capabilities, and training STEM workforce especially from underrepresented minorities. With the long-term vision of enabling interpretable white-box autonomy in healthcare by advancing generalizable methodologies for medical cyber-physical systems (M-CPS), the objective of this CAREER program is to investigate physiological modeling, coordinated and resilient multivariable closed-loop control, and regulatory science methodologies in circulatory resuscitation. An integrated research, education, and outreach program is proposed to achieve this objective. On the research front, physiological modeling and closed-loop control methodologies applicable to white-box autonomy in a wide range of circulatory resuscitation scenarios will be investigated. Specifically, generalizable methodologies for (1) patient physiology and pharmacology modeling and (2) coordinated and resilient multivariable closed-loop control will be developed. The value of these methodologies will be demonstrated by developing interpretable white-box physiological closed-loop control algorithms for circulatory resuscitation. On the education and outreach front, members of the next-generation M-CPS workforce will be trained and regulatory science for evaluating critical care autonomy capabilities will be advanced. Specifically, (1) graduate, undergraduate, and K-12 students will be attracted into STEM and M-CPS, (2) collaboration with the US Food and Drug Administration will be performed to investigate testing methodologies and tools for physiological models and closed-loop M-CPS via its Medical Device Development Tools Program, and (3) newly created knowledge will be disseminated to further advance M-CPS research and education.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.