Homa Alemzadeh

Mohammadreza Hallajiyan, Xueren Ge, Athish Pranav Dharmalingam et al.

The growing integration of artificial intelligence (AI) and machine learning (ML) in medical systems requires effective measures to address emerging security risks. One such risk is that of adversaries introducing false data through vulnerable system components during inference, causing misdiagnosis and wrong treatments. These risks are challenging to anticipate and address in the design phase, as the system assembly partially occurs during actual use by end users. To address this concern, we introduce SAMD, an automated tool for performing System Theoretic Process Analysis for Security (STPA-Sec) on AI/ML-enabled medical devices during the design phase. SAMD models the medical system as a control structure, treating all system components as potential points for injecting false data into the ML engine. It leverages state-of-the-art vulnerability databases and Large Language Models (LLMs) to automate vulnerability discovery and generate a list of potential attack scenarios. We demonstrate SAMD's effectiveness through case studies on five FDA-cleared medical devices, showcasing its ability to identify vulnerable points and potential attack paths. We find that SAMD has 100% precision in identifying target device technologies in the case studies' documents, retrieves the known vulnerabilities linked to them (with 63.2% precision), and generates highly relevant attack scenarios on the ML model, including detailed steps that an adversary might take (with 95.3% accuracy, and the highest time taken being 191.64s).

Lahiru Wijayasingha, Homa Alemzadeh, John A. Stankovic

Monocular depth estimation is an important step in many downstream tasks in machine vision. We address the topic of estimating monocular depth from defocus blur which can yield more accurate results than the semantic based depth estimation methods. The existing monocular depth from defocus techniques are sensitive to the particular camera that the images are taken from. We show how several camera-related parameters affect the defocus blur using optical physics equations and how they make the defocus blur depend on these parameters. The simple correction procedure we propose can alleviate this problem which does not require any retraining of the original model. We created a synthetic dataset which can be used to test the camera independent performance of depth from defocus blur models. We evaluate our model on both synthetic and real datasets (DDFF12 and NYU depth V2) obtained with different cameras and show that our methods are significantly more robust to the changes of cameras. Code: https://github.com/sleekEagle/defocus_camind.git

Saurabh Bagchi, Hyunseung Kim, Tarek Abdelzaher et al.

Resilience in cyber-physical systems (CPS) is the fundamental ability to maintain safety and critical functionality despite adverse "perturbations," which includes security attacks, environmental disruptions, and hardware or software failures. This survey provides a comprehensive review of CPS resilience, framing the field through five interconnected themes that are required in an integrated whole to achieve real-world resilience. The article first posits that resilience is a system-wide property emerging from interactions between hardware, software, and human users. Second, it addresses the challenges of learning-enabled CPS, which often operate in data-scarce environments characterized by imbalanced or noisy data, requiring innovative solutions like synthetic data generation and foundation model adaptation. Third, the survey examines proactive measures for resilience, which include distinctive aspects of verification, testing, and redundancy. Fourth, it explores recovery mechanisms, moving beyond traditional fault models to design "just good enough" recovery strategies that prioritize safety-critical functions during perturbations. Finally, it highlights the central role of the human, focusing on the different levels of human intervention, the necessity of trust calibration, and the requirement for explainable AI to support human-CPS teaming. These themes are illustrated through representative application domains, primarily Connected and Autonomous Transportation Systems (CATS) and Medical CPS (MCPS). By integrating the five interconnected themes, this survey provides a systematic roadmap for achieving the resilient CPS in increasingly complex and adversarial environments.

Keshara Weerasinghe, Seyed Hamid Reza Roodabeh, Andrew Hawkins et al.

Background: Robot-assisted minimally invasive surgery (RMIS) research increasingly relies on multimodal data, yet access to proprietary robot telemetry remains a major barrier. We introduce MiDAS, an open-source, platform-agnostic system enabling time-synchronized, non-invasive multimodal data acquisition across surgical robotic platforms. Methods: MiDAS integrates electromagnetic and RGB-D hand tracking, foot pedal sensing, and surgical video capturing without requiring proprietary robot interfaces. We validated MiDAS on the open-source Raven-II and the clinical da Vinci Xi by collecting multimodal datasets of peg transfer and hernia repair suturing tasks performed by surgical residents. Correlation analysis and downstream gesture recognition experiments were conducted. Results: External hand and foot sensing closely approximated internal robot kinematics and non-invasive motion signals achieved gesture recognition performance comparable to proprietary telemetry. Conclusion: MiDAS enables reproducible multimodal RMIS data collection and is released with annotated datasets, including the first multimodal dataset capturing hernia repair suturing on high-fidelity simulation models.

Keshara Weerasinghe, Xueren Ge, Tessa Heick et al.

Emergency Medical Services (EMS) are critical to patient survival in emergencies, but first responders often face intense cognitive demands in high-stakes situations. AI cognitive assistants, acting as virtual partners, have the potential to ease this burden by supporting real-time data collection and decision making. In pursuit of this vision, we introduce EgoEMS, the first end-to-end, high-fidelity, multimodal, multiperson dataset capturing over 20 hours of realistic, procedural EMS activities from an egocentric view in 233 simulated emergency scenarios performed by 62 participants, including 46 EMS professionals. Developed in collaboration with EMS experts and aligned with national standards, EgoEMS is captured using an open-source, low-cost, and replicable data collection system and is annotated with keysteps, timestamped audio transcripts with speaker diarization, action quality metrics, and bounding boxes with segmentation masks. Emphasizing realism, the dataset includes responder-patient interactions reflecting real-world emergency dynamics. We also present a suite of benchmarks for real-time multimodal keystep recognition and action quality estimation, essential for developing AI support tools for EMS. We hope EgoEMS inspires the research community to push the boundaries of intelligent EMS systems and ultimately contribute to improved patient outcomes.

Xugui Zhou, Anqi Chen, Maxfield Kouzel et al.

Adaptive Cruise Control (ACC) is a widely used driver assistance technology for maintaining the desired speed and safe distance to the leading vehicle. This paper evaluates the security of the deep neural network (DNN) based ACC systems under runtime stealthy perception attacks that strategically inject perturbations into camera data to cause forward collisions. We present a context-aware strategy for the selection of the most critical times for triggering the attacks and a novel optimization-based method for the adaptive generation of image perturbations at runtime. We evaluate the effectiveness of the proposed attack using an actual vehicle, a publicly available driving dataset, and a realistic simulation platform with the control software from a production ACC system, a physical-world driving simulator, and interventions by the human driver and safety features such as Advanced Emergency Braking System (AEBS). Experimental results show that the proposed attack achieves 142.9 times higher success rate in causing hazards and 82.6% higher evasion rate than baselines, while being stealthy and robust to real-world factors and dynamic changes in the environment. This study highlights the role of human drivers and basic safety mechanisms in preventing attacks.

Xugui Zhou, Maxfield Kouzel, Homa Alemzadeh

The growing complexity of Cyber-Physical Systems (CPS) and challenges in ensuring safety and security have led to the increasing use of deep learning methods for accurate and scalable anomaly detection. However, machine learning (ML) models often suffer from low performance in predicting unexpected data and are vulnerable to accidental or malicious perturbations. Although robustness testing of deep learning models has been extensively explored in applications such as image classification and speech recognition, less attention has been paid to ML-driven safety monitoring in CPS. This paper presents the preliminary results on evaluating the robustness of ML-based anomaly detection methods in safety-critical CPS against two types of accidental and malicious input perturbations, generated using a Gaussian-based noise model and the Fast Gradient Sign Method (FGSM). We test the hypothesis of whether integrating the domain knowledge (e.g., on unsafe system behavior) with the ML models can improve the robustness of anomaly detection without sacrificing accuracy and transparency. Experimental results with two case studies of Artificial Pancreas Systems (APS) for diabetes management show that ML-based safety monitors trained with domain knowledge can reduce on average up to 54.2% of robustness error and keep the average F1 scores high while improving transparency.

Zongyu Li, Kay Hutchinson, Homa Alemzadeh

Despite significant developments in the design of surgical robots and automated techniques for objective evaluation of surgical skills, there are still challenges in ensuring safety in robot-assisted minimally-invasive surgery (RMIS). This paper presents a runtime monitoring system for the detection of executional errors during surgical tasks through the analysis of kinematic data. The proposed system incorporates dual Siamese neural networks and knowledge of surgical context, including surgical tasks and gestures, their distributional similarities, and common error modes, to learn the differences between normal and erroneous surgical trajectories from small training datasets. We evaluate the performance of the error detection using Siamese networks compared to single CNN and LSTM networks trained with different levels of contextual knowledge and training data, using the dry-lab demonstrations of the Suturing and Needle Passing tasks from the JIGSAWS dataset. Our results show that gesture specific task nonspecific Siamese networks obtain micro F1 scores of 0.94 (Siamese-CNN) and 0.95 (Siamese-LSTM), and perform better than single CNN (0.86) and LSTM (0.87) networks. These Siamese networks also outperform gesture nonspecific task specific Siamese-CNN and Siamese-LSTM models for Suturing and Needle Passing.

Xueren Ge, Satpathy Abhishek, Ronald Dean Williams et al.

Multi-label text classification (MLTC) tasks in the medical domain often face the long-tail label distribution problem. Prior works have explored hierarchical label structures to find relevant information for few-shot classes, but mostly neglected to incorporate external knowledge from medical guidelines. This paper presents DKEC, Domain Knowledge Enhanced Classification for diagnosis prediction with two innovations: (1) automated construction of heterogeneous knowledge graphs from external sources to capture semantic relations among diverse medical entities, (2) incorporating the heterogeneous knowledge graphs in few-shot classification using a label-wise attention mechanism. We construct DKEC using three online medical knowledge sources and evaluate it on a real-world Emergency Medical Services (EMS) dataset and a public electronic health record (EHR) dataset. Results show that DKEC outperforms the state-of-the-art label-wise attention networks and transformer models of different sizes, particularly for the few-shot classes. More importantly, it helps the smaller language models achieve comparable performance to large language models.

Maryam Bagheri, Josephine Lamp, Xugui Zhou et al.

Machine Learning (ML) technologies have been increasingly adopted in Medical Cyber-Physical Systems (MCPS) to enable smart healthcare. Assuring the safety and effectiveness of learning-enabled MCPS is challenging, as such systems must account for diverse patient profiles and physiological dynamics and handle operational uncertainties. In this paper, we develop a safety assurance case for ML controllers in learning-enabled MCPS, with an emphasis on establishing confidence in the ML-based predictions. We present the safety assurance case in detail for Artificial Pancreas Systems (APS) as a representative application of learning-enabled MCPS, and provide a detailed analysis by implementing a deep neural network for the prediction in APS. We check the sufficiency of the ML data and analyze the correctness of the ML-based prediction using formal verification. Finally, we outline open research problems based on our experience in this paper.

Kay Hutchinson, Zongyu Li, Ian Reyes et al.

Manual labeling of gestures in robot-assisted surgery is labor intensive, prone to errors, and requires expertise or training. We propose a method for automated and explainable generation of gesture transcripts that leverages the abundance of data for image segmentation. Surgical context is detected using segmentation masks by examining the distances and intersections between the tools and objects. Next, context labels are translated into gesture transcripts using knowledge-based Finite State Machine (FSM) and data-driven Long Short Term Memory (LSTM) models. We evaluate the performance of each stage of our method by comparing the results with the ground truth segmentation masks, the consensus context labels, and the gesture labels in the JIGSAWS dataset. Our results show that our segmentation models achieve state-of-the-art performance in recognizing needle and thread in Suturing and we can automatically detect important surgical states with high agreement with crowd-sourced labels (e.g., contact between graspers and objects in Suturing). We also find that the FSM models are more robust to poor segmentation and labeling performance than LSTMs. Our proposed method can significantly shorten the gesture labeling process (~2.8 times).

Xugui Zhou, Maxfield Kouzel, Chloe Smith et al.

Significant progress has been made in anomaly detection and run-time monitoring to improve the safety and security of cyber-physical systems (CPS). However, less attention has been paid to hazard mitigation. This paper proposes a combined knowledge and data driven approach, KnowSafe, for the design of safety engines that can predict and mitigate safety hazards resulting from safety-critical malicious attacks or accidental faults targeting a CPS controller. We integrate domain-specific knowledge of safety constraints and context-specific mitigation actions with machine learning (ML) techniques to estimate system trajectories in the far and near future, infer potential hazards, and generate optimal corrective actions to keep the system safe. Experimental evaluation on two realistic closed-loop testbeds for artificial pancreas systems (APS) and a real-world clinical trial dataset for diabetes treatment demonstrates that KnowSafe outperforms the state-of-the-art by achieving higher accuracy in predicting system state trajectories and potential hazards, a low false positive rate, and no false negatives. It also maintains the safe operation of the simulated APS despite faults or attacks without introducing any new hazards, with a hazard mitigation success rate of 92.8%, which is at least 76% higher than solely rule-based (50.9%) and data-driven (52.7%) methods.

Zongyu Li, Ian Reyes, Homa Alemzadeh

Surgical context inference has recently garnered significant attention in robot-assisted surgery as it can facilitate workflow analysis, skill assessment, and error detection. However, runtime context inference is challenging since it requires timely and accurate detection of the interactions among the tools and objects in the surgical scene based on the segmentation of video data. On the other hand, existing state-of-the-art video segmentation methods are often biased against infrequent classes and fail to provide temporal consistency for segmented masks. This can negatively impact the context inference and accurate detection of critical states. In this study, we propose a solution to these challenges using a Space Time Correspondence Network (STCN). STCN is a memory network that performs binary segmentation and minimizes the effects of class imbalance. The use of a memory bank in STCN allows for the utilization of past image and segmentation information, thereby ensuring consistency of the masks. Our experiments using the publicly available JIGSAWS dataset demonstrate that STCN achieves superior segmentation performance for objects that are difficult to segment, such as needle and thread, and improves context inference compared to the state-of-the-art. We also demonstrate that segmentation and context inference can be performed at runtime without compromising performance.

Xueren Ge, Sahil Murtaza, Anthony Cortez et al.

Conversational diagnosis prediction requires models to track evolving evidence in streaming clinical conversations and decide when to commit to a diagnosis. Existing medical dialogue corpora are largely dyadic or lack the multi-party workflow and annotations needed for this setting. We introduce an ePCR-grounded, topic-flow-based multi-agent generation pipeline that iteratively plans, generates, and self-refines dialogues with rule-based factual and topic flow checks. The pipeline yields EMSDialog, a dataset of 4,414 synthetic multi-speaker EMS conversations based on a real-world ePCR dataset, annotated with 43 diagnoses, speaker roles, and turn-level topics. Human and LLM evaluations confirm high quality and realism of EMSDialog using both utterance- and conversation-level metrics. Results show that EMSDialog-augmented training improves accuracy, timeliness, and stability of EMS conversational diagnosis prediction.

Chloe Smith, Maxfield Kouzel, Xugui Zhou et al.

Significant advancements in type 1 diabetes treatment have been made in the development of state-of-the-art Artificial Pancreas Systems (APS). However, lapses currently exist in the timely treatment of unsafe blood glucose (BG) levels, especially in the case of rebound hyperglycemia. We propose a machine learning (ML) method for predictive BG scenario categorization that outputs messages alerting the patient to upcoming BG trends to allow for earlier, educated treatment. In addition to standard notifications of predicted hypoglycemia and hyperglycemia, we introduce BG scenario-specific alert messages and the preliminary steps toward precise basal suggestions for the prevention of rebound hyperglycemia. Experimental evaluation on the DCLP3 clinical dataset achieves >98% accuracy and >79% precision for predicting rebound high events for patient alerts.

Xueren Ge, Sahil Murtaza, Anthony Cortez et al.

Large language models (LLMs) have shown promise in medical question answering, yet they often overlook the domain-specific expertise that professionals depend on, such as the clinical subject areas (e.g., trauma, airway) and the certification level (e.g., EMT, Paramedic). Existing approaches typically apply general-purpose prompting or retrieval strategies without leveraging this structured context, limiting performance in high-stakes settings. We address this gap with EMSQA, an 24.3K-question multiple-choice dataset spanning 10 clinical subject areas and 4 certification levels, accompanied by curated, subject area-aligned knowledge bases (40K documents and 2M tokens). Building on EMSQA, we introduce (i) Expert-CoT, a prompting strategy that conditions chain-of-thought (CoT) reasoning on specific clinical subject area and certification level, and (ii) ExpertRAG, a retrieval-augmented generation pipeline that grounds responses in subject area-aligned documents and real-world patient data. Experiments on 4 LLMs show that Expert-CoT improves up to 2.05% over vanilla CoT prompting. Additionally, combining Expert-CoT with ExpertRAG yields up to a 4.59% accuracy gain over standard RAG baselines. Notably, the 32B expertise-augmented LLMs pass all the computer-adaptive EMS certification simulation exams.

Abu Hasnat Mohammad Rubaiyat, Yongming Qin, Homa Alemzadeh

Autonomous vehicles (AV) depend on the sensors like RADAR and camera for the perception of the environment, path planning, and control. With the increasing autonomy and interactions with the complex environment, there have been growing concerns regarding the safety and reliability of AVs. This paper presents a Systems-Theoretic Process Analysis (STPA) based fault injection framework to assess the resilience of an open-source driving agent, called openpilot, under different environmental conditions and faults affecting sensor data. To increase the coverage of unsafe scenarios during testing, we use a strategic software fault-injection approach where the triggers for injecting the faults are derived from the unsafe scenarios identified during the high-level hazard analysis of the system. The experimental results show that the proposed strategic fault injection approach increases the hazard coverage compared to random fault injection and, thus, can help with more effective simulation of safety-critical faults and testing of AVs. In addition, the paper provides insights on the performance of openpilot safety mechanisms and its ability in timely detection and recovery from faulty inputs.

Homa Alemzadeh, Daniel Chen, Andrew Lewis et al.

Robotic telesurgical systems are one of the most complex medical cyber-physical systems on the market, and have been used in over 1.75 million procedures during the last decade. Despite significant improvements in design of robotic surgical systems through the years, there have been ongoing occurrences of safety incidents during procedures that negatively impact patients. This paper presents an approach for systems-theoretic safety assessment of robotic telesurgical systems using software-implemented fault-injection. We used a systemstheoretic hazard analysis technique (STPA) to identify the potential safety hazard scenarios and their contributing causes in RAVEN II robot, an open-source robotic surgical platform. We integrated the robot control software with a softwareimplemented fault-injection engine which measures the resilience of the system to the identified safety hazard scenarios by automatically inserting faults into different parts of the robot control software. Representative hazard scenarios from real robotic surgery incidents reported to the U.S. Food and Drug Administration (FDA) MAUDE database were used to demonstrate the feasibility of the proposed approach for safety-based design of robotic telesurgical systems.

Keshara Weerasinghe, Saahith Janapati, Xueren Ge et al.

Emergency Medical Services (EMS) responders often operate under time-sensitive conditions, facing cognitive overload and inherent risks, requiring essential skills in critical thinking and rapid decision-making. This paper presents CognitiveEMS, an end-to-end wearable cognitive assistant system that can act as a collaborative virtual partner engaging in the real-time acquisition and analysis of multimodal data from an emergency scene and interacting with EMS responders through Augmented Reality (AR) smart glasses. CognitiveEMS processes the continuous streams of data in real-time and leverages edge computing to provide assistance in EMS protocol selection and intervention recognition. We address key technical challenges in real-time cognitive assistance by introducing three novel components: (i) a Speech Recognition model that is fine-tuned for real-world medical emergency conversations using simulated EMS audio recordings, augmented with synthetic data generated by large language models (LLMs); (ii) an EMS Protocol Prediction model that combines state-of-the-art (SOTA) tiny language models with EMS domain knowledge using graph-based attention mechanisms; (iii) an EMS Action Recognition module which leverages multimodal audio and video data and protocol predictions to infer the intervention/treatment actions taken by the responders at the incident scene. Our results show that for speech recognition we achieve superior performance compared to SOTA (WER of 0.290 vs. 0.618) on conversational data. Our protocol prediction component also significantly outperforms SOTA (top-3 accuracy of 0.800 vs. 0.200) and the action recognition achieves an accuracy of 0.727, while maintaining an end-to-end latency of 3.78s for protocol prediction on the edge and 0.31s on the server.

Gargi Mitra, Mohammadreza Hallajiyan, Inji Kim et al.

The integration of AI/ML into medical devices is rapidly transforming healthcare by enhancing diagnostic and treatment facilities. However, this advancement also introduces serious cybersecurity risks due to the use of complex and often opaque models, extensive interconnectivity, interoperability with third-party peripheral devices, Internet connectivity, and vulnerabilities in the underlying technologies. These factors contribute to a broad attack surface and make threat prevention, detection, and mitigation challenging. Given the highly safety-critical nature of these devices, a cyberattack on these devices can cause the ML models to mispredict, thereby posing significant safety risks to patients. Therefore, ensuring the security of these devices from the time of design is essential. This paper underscores the urgency of addressing the cybersecurity challenges in ML-enabled medical devices at the pre-market phase. We begin by analyzing publicly available data on device recalls and adverse events, and known vulnerabilities, to understand the threat landscape of AI/ML-enabled medical devices and their repercussions on patient safety. Building on this analysis, we introduce a suite of tools and techniques designed by us to assist security analysts in conducting comprehensive premarket risk assessments. Our work aims to empower manufacturers to embed cybersecurity as a core design principle in AI/ML-enabled medical devices, thereby making them safe for patients.

Kay Hutchinson, Zongyu Li, Leigh A. Cantrell et al.

Background Analyzing kinematic and video data can help identify potentially erroneous motions that lead to sub-optimal surgeon performance and safety-critical events in robot-assisted surgery. Methods We develop a rubric for identifying task and gesture-specific Executional and Procedural errors and evaluate dry-lab demonstrations of Suturing and Needle Passing tasks from the JIGSAWS dataset. We characterize erroneous parts of demonstrations by labeling video data, and use distribution similarity analysis and trajectory averaging on kinematic data to identify parameters that distinguish erroneous gestures. Results Executional error frequency varies by task and gesture, and correlates with skill level. Some predominant error modes in each gesture are distinguishable by analyzing error-specific kinematic parameters. Procedural errors could lead to lower performance scores and increased demonstration times but also depend on surgical style. Conclusions This study provides insights into context-dependent errors that can be used to design automated error detection mechanisms and improve training and skill assessment.

Xugui Zhou, Bulbul Ahmed, James H. Aylor et al.

Medical Cyber-physical Systems (MCPS) are vulnerable to accidental or malicious faults that can target their controllers and cause safety hazards and harm to patients. This paper proposes a combined model and data-driven approach for designing context-aware monitors that can detect early signs of hazards and mitigate them in MCPS. We present a framework for formal specification of unsafe system context using Signal Temporal Logic (STL) combined with an optimization method for patient-specific refinement of STL formulas based on real or simulated faulty data from the closed-loop system for the generation of monitor logic. We evaluate our approach in simulation using two state-of-the-art closed-loop Artificial Pancreas Systems (APS). The results show the context-aware monitor achieves up to 1.4 times increase in average hazard prediction accuracy (F1-score) over several baseline monitors, reduces false-positive and false-negative rates, and enables hazard mitigation with a 54% success rate while decreasing the average risk for patients.

Kay Hutchinson, Mohammad Samin Yasar, Harshneet Bhatia et al.

The endoscopic camera of a surgical robot provides surgeons with a magnified 3D view of the surgical field, but repositioning it increases mental workload and operation time. Poor camera placement contributes to safety-critical events when surgical tools move out of the view of the camera. This paper presents a proof of concept of an autonomous camera system for the Raven II surgical robot that aims to reduce surgeon workload and improve safety by providing an optimal view of the workspace showing all objects of interest. This system uses transfer learning to localize and classify objects of interest within the view of a stereoscopic camera. The positions and centroid of the objects are estimated and a set of control rules determines the movement of the camera towards a more desired view. Our perception module had an accuracy of 61.21% overall for identifying objects of interest and was able to localize both graspers and multiple blocks in the environment. Comparison of the commands proposed by our system with the desired commands from a survey of 13 participants indicates that the autonomous camera system proposes appropriate movements for the tilt and pan of the camera.

Mohammad Samin Yasar, Homa Alemzadeh

Cyber-physical systems for robotic surgery have enabled minimally invasive procedures with increased precision and shorter hospitalization. However, with increasing complexity and connectivity of software and major involvement of human operators in the supervision of surgical robots, there remain significant challenges in ensuring patient safety. This paper presents a safety monitoring system that, given the knowledge of the surgical task being performed by the surgeon, can detect safety-critical events in real-time. Our approach integrates a surgical gesture classifier that infers the operational context from the time-series kinematics data of the robot with a library of erroneous gesture classifiers that given a surgical gesture can detect unsafe events. Our experiments using data from two surgical platforms show that the proposed system can detect unsafe events caused by accidental or malicious faults within an average reaction time window of 1,693 milliseconds and F1 score of 0.88 and human errors within an average reaction time window of 57 milliseconds and F1 score of 0.76.

Mohammad Samin Yasar, David Evans, Homa Alemzadeh

Robotic-assisted minimally invasive surgery (MIS) has enabled procedures with increased precision and dexterity, but surgical robots are still open loop and require surgeons to work with a tele-operation console providing only limited visual feedback. In this setting, mechanical failures, software faults, or human errors might lead to adverse events resulting in patient complications or fatalities. We argue that impending adverse events could be detected and mitigated by applying context-specific safety constraints on the motions of the robot. We present a context-aware safety monitoring system which segments a surgical task into subtasks using kinematics data and monitors safety constraints specific to each subtask. To test our hypothesis about context specificity of safety constraints, we analyze recorded demonstrations of dry-lab surgical tasks collected from the JIGSAWS database as well as from experiments we conducted on a Raven II surgical robot. Analysis of the trajectory data shows that each subtask of a given surgical procedure has consistent safety constraints across multiple demonstrations by different subjects. Our preliminary results show that violations of these safety constraints lead to unsafe events, and there is often sufficient time between the constraint violation and the safety-critical event to allow for a corrective action.

Kush R. Varshney, Homa Alemzadeh

Machine learning algorithms increasingly influence our decisions and interact with us in all parts of our daily lives. Therefore, just as we consider the safety of power plants, highways, and a variety of other engineered socio-technical systems, we must also take into account the safety of systems involving machine learning. Heretofore, the definition of safety has not been formalized in a machine learning context. In this paper, we do so by defining machine learning safety in terms of risk, epistemic uncertainty, and the harm incurred by unwanted outcomes. We then use this definition to examine safety in all sorts of applications in cyber-physical systems, decision sciences, and data products. We find that the foundational principle of modern statistical machine learning, empirical risk minimization, is not always a sufficient objective. Finally, we discuss how four different categories of strategies for achieving safety in engineering, including inherently safe design, safety reserves, safe fail, and procedural safeguards can be mapped to a machine learning context. We then discuss example techniques that can be adopted in each category, such as considering interpretability and causality of predictive models, objective functions beyond expected prediction accuracy, human involvement for labeling difficult or rare examples, and user experience design of software and open data.

Homa Alemzadeh, Ravishankar K. Iyer, Zbigniew Kalbarczyk et al.

Understanding the causes and patient impacts of surgical adverse events will help improve systems and operational practices to avoid incidents in the future. We analyzed the adverse events data related to robotic systems and instruments used in minimally invasive surgery, reported to the U.S. FDA MAUDE database from January 2000 to December 2013. We determined the number of events reported per procedure and per surgical specialty, the most common types of device malfunctions and their impact on patients, and the causes for catastrophic events such as major complications, patient injuries, and deaths. During the study period, 144 deaths (1.4% of the 10,624 reports), 1,391 patient injuries (13.1%), and 8,061 device malfunctions (75.9%) were reported. The numbers of injury and death events per procedure have stayed relatively constant since 2007 (mean = 83.4, 95% CI, 74.2-92.7). Surgical specialties, for which robots are extensively used, such as gynecology and urology, had lower number of injuries, deaths, and conversions per procedure than more complex surgeries, such as cardiothoracic and head and neck (106.3 vs. 232.9, Risk Ratio = 2.2, 95% CI, 1.9-2.6). Device and instrument malfunctions, such as falling of burnt/broken pieces of instruments into the patient (14.7%), electrical arcing of instruments (10.5%), unintended operation of instruments (8.6%), system errors (5%), and video/imaging problems (2.6%), constituted a major part of the reports. Device malfunctions impacted patients in terms of injuries or procedure interruptions. In 1,104 (10.4%) of the events, the procedure was interrupted to restart the system (3.1%), to convert the procedure to non-robotic techniques (7.3%), or to reschedule it to a later time (2.5%). Adoption of advanced techniques in design and operation of robotic surgical systems may reduce these preventable incidents in the future.