This award is funded in whole or in part under the American Rescue Plan Act of 2021 (Public Law 117-2).

Medical Cyber-Physical Systems (MCPS) increasingly rely on complex and connected software and artificial intelligence for control and decision making in various diagnostic and therapeutic applications. But contrary to other CPS, they often depend on advanced medical knowledge and human expertise for real-time operation. Tele-operated surgical robots for minimally invasive surgery are an example of the most complex human-in-the-loop MCPS, envisioned to enable remote operations in inaccessible areas, low-resource populations, and extreme environments. However, an increasing number of recalls and adverse event reports have shown the vulnerability of MCPS to accidental or maliciously-crafted faults and human errors with potential negative impacts on patients. The objective of this research is to investigate the fundamental problem of runtime safety assurance in human-in-the-loop MCPS, and to develop integrated model and data-driven capabilities for timely detection and mitigation of safety hazards and reducing the risk of harm to patients.

The proposed research will advance the state-of-the-art in runtime verification and anomaly detection by introducing three novel principles for design of context-aware safety engines for MCPS: (i) Formal specification and learning of human-cyber-physical system contexts and their relationship with potentially unsafe control actions that lead to hazards and accidents; (ii) Real-time inference of the human-cyber-physical context through multi-level monitoring and model-based state estimation to detect the likelihood, timing, and risk of impending hazards; (iii) Risk-aware hazard mitigation through the context-aware generation of safe and corrective response actions that prevent adverse consequences in the physical layer. The research activities will be integrated with education through multi-disciplinary curriculum development and hands-on training for graduate students, research experience for undergraduates, and engagement activities, including summer internships, Girls? Geek Days, tech camps, and hackathons for K-12 students. These activities aim to broaden the participation of students from underrepresented groups and minorities in CPS and engineering in medicine research and train the next generation of diverse CPS professionals with expertise in areas such as healthcare, robotics, safety, and security that have the potential for significant societal impact.