Safety critical medical systems increasingly aim to incorporate learning-enabled components that are developed using machine learning and AI. While the impact of these learning-enabled medical cyber-physical systems (LE-MCPS) are revolutionizing personalized patient care and health outcomes, assuring their safety and efficacy remains a formidable challenge. Existing model-based design paradigms for learning-enabled cyber-physical systems require an abundance of ?clean? data or high-fidelity simulators ? unfortunately, LE-MCPS do not have that luxury. Consequently, LE-MCPS development strongly depends on experimentation to generate data for design and assurance. The ethical and economic constraints of working in safety-critical medical applications necessitate experimentation efficiency. Yet, experimental design and learning-enabled component design are often weakly coupled -- which contributes to inefficiencies, increased development costs, and increased patient risk. This CAREER proposal aims to develop foundations and tools for assuring learning-enabled medical cyber physical systems (MCPS) by bridging-the-gap between experimentation and model-based design. Specifically, the research focuses on leveraging model-based design techniques to address foundational challenges associated with experimental design (ante-experimentation), protocol execution (during experimentation), and system assurance (post-experimentation). The project?s broader significance will advance the state-of-the-art in medical system design, accelerate learning-enabled CPS (LE-CPS) innovation, and provide abundant interdisciplinary and use-inspired education opportunities and outreach activities.

The goal of this project is to develop foundations and tools for assuring LE-MCPS by bridging-the-gap between experimentation and model-based design. The proposed research will result in a high-assurance LE-CPS design framework spanning ante-, intra-, and post-experimentation. Prior to experimentation, this work will develop foundational techniques to address gaps in traditional experimental designed exposed by high-assurance LE-CPS design. During experimentation, new platforms and capabilities will be realized that can support tamper-evident run-time experimental data curation for assuring LE-CPS. After experimentation, techniques that leverage historical evidence and experimental data will maximally assure LE-CPS designs. Foundations developed in the project are prospectively evaluated in industrial LE-MCPS applications. While the research is motivated by medical scenarios, the developed technologies are immediately applicable to a wide range of LE-CPS applications.