Data-driven Design of Context-aware Monitors for Hazard Prediction in Artificial Pancreas Systems

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 (F1score) 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.

[1]  John A. Stankovic,et al.  FSTPA-I: A formal approach to hazard identification via system theoretic process analysis , 2013, 2013 ACM/IEEE International Conference on Cyber-Physical Systems (ICCPS).

[2]  Subutai Ahmad,et al.  Evaluating Real-Time Anomaly Detection Algorithms -- The Numenta Anomaly Benchmark , 2015, 2015 IEEE 14th International Conference on Machine Learning and Applications (ICMLA).

[3]  B Wayne Bequette,et al.  Fault Detection and Safety in Closed-Loop Artificial Pancreas Systems , 2014, Journal of diabetes science and technology.

[4]  Xianzhe Zhou,et al.  Range Based Confusion Matrix for Imbalanced Time Series Classification , 2020, 2020 6th Conference on Data Science and Machine Learning Applications (CDMA).

[5]  Dejan Nickovic,et al.  Specification-Based Monitoring of Cyber-Physical Systems: A Survey on Theory, Tools and Applications , 2018, Lectures on Runtime Verification.

[6]  Calin Belta,et al.  Anomaly detection in cyber-physical systems: A formal methods approach , 2014, 53rd IEEE Conference on Decision and Control.

[7]  Nancy G. Leveson,et al.  Engineering a Safer World: Systems Thinking Applied to Safety , 2012 .

[8]  L. Heinemann,et al.  Open source automated insulin delivery: addressing the challenge. , 2019, NPJ digital medicine.

[9]  Alvaro A. Cárdenas,et al.  Attacks against process control systems: risk assessment, detection, and response , 2011, ASIACCS '11.

[10]  Meng Wu,et al.  Safety Guard: Runtime Enforcement for Safety-Critical Cyber-Physical Systems: Invited , 2017, DAC.

[11]  Lyvia Biagi,et al.  Modeling the Error of the Medtronic Paradigm Veo Enlite Glucose Sensor , 2017, Sensors.

[12]  Ravishankar K. Iyer,et al.  Analysis of Safety-Critical Computer Failures in Medical Devices , 2013, IEEE Security & Privacy.

[13]  Alberto Camacho,et al.  Learning Interpretable Models Expressed in Linear Temporal Logic , 2019, ICAPS.

[14]  Lu Feng,et al.  A Logic-Based Learning Approach to Explore Diabetes Patient Behaviors , 2019, CMSB.

[15]  Alberto L. Sangiovanni-Vincentelli,et al.  Model predictive control with signal temporal logic specifications , 2014, 53rd IEEE Conference on Decision and Control.

[16]  Subutai Ahmad,et al.  Unsupervised real-time anomaly detection for streaming data , 2017, Neurocomputing.

[17]  David C Klonoff,et al.  Cybersecurity for Connected Diabetes Devices , 2015, Journal of diabetes science and technology.

[18]  C. Cobelli,et al.  The UVA/PADOVA Type 1 Diabetes Simulator , 2014, Journal of diabetes science and technology.

[19]  B. Curtis,et al.  Insulin use in long term care settings for patients with type 2 diabetes mellitus: a systematic review of the literature. , 2013, Journal of the American Medical Directors Association.

[20]  Giovanni Sparacino,et al.  Development of an Error Model for a Factory-Calibrated Continuous Glucose Monitoring Sensor with 10-Day Lifetime , 2019, Sensors.

[21]  W. Kenneth Ward,et al.  Modeling the Glucose Sensor Error , 2014, IEEE Transactions on Biomedical Engineering.

[22]  Junjie Yan,et al.  To Make a Robot Secure: An Experimental Analysis of Cyber Security Threats Against Teleoperated Surgical Robots , 2015, ArXiv.

[23]  Insup Lee,et al.  Clinician-in-the-Loop Annotation of ICU Bedside Alarm Data , 2016, 2016 IEEE First International Conference on Connected Health: Applications, Systems and Engineering Technologies (CHASE).

[24]  Erik Scharwachter,et al.  Statistical Evaluation of Anomaly Detectors for Sequences , 2020 .

[25]  Sanjit A. Seshia,et al.  A theory of formal synthesis via inductive learning , 2015, Acta Informatica.

[26]  Eric Chien,et al.  W32.Duqu: The Precursor to the Next Stuxnet , 2012, LEET.

[27]  Junjie Yan,et al.  Experimental analysis of denial-of-service attacks on teleoperated robotic systems , 2015, ICCPS.

[28]  Ravishankar K. Iyer,et al.  Towards resiliency in embedded medical monitoring devices , 2012, IEEE/IFIP International Conference on Dependable Systems and Networks Workshops (DSN 2012).

[29]  Insup Lee,et al.  Correct-by-Construction Implementation of Runtime Monitors Using Stepwise Refinement , 2018, SETTA.

[30]  Boris Kovatchev,et al.  Statistical tools to analyze continuous glucose monitor data. , 2009, Diabetes technology & therapeutics.

[31]  Ravishankar K. Iyer,et al.  ML-Based Fault Injection for Autonomous Vehicles: A Case for Bayesian Fault Injection , 2019, 2019 49th Annual IEEE/IFIP International Conference on Dependable Systems and Networks (DSN).

[32]  M. Marcovecchio Complications of acute and chronic hyperglycemia , 2017 .

[33]  Yliès Falcone,et al.  What can you verify and enforce at runtime? , 2012, International Journal on Software Tools for Technology Transfer.

[34]  Roummel F. Marcia,et al.  Solving Limited-Memory BFGS Systems with Generalized Diagonal Updates , 2012 .

[35]  Jorge Nocedal,et al.  Remark on “algorithm 778: L-BFGS-B: Fortran subroutines for large-scale bound constrained optimization” , 2011, TOMS.

[36]  Insup Lee,et al.  Context-Aware Detection in Medical Cyber-Physical Systems , 2018, 2018 ACM/IEEE 9th International Conference on Cyber-Physical Systems (ICCPS).

[37]  Giovanni Sparacino,et al.  Model of glucose sensor error components: identification and assessment for new Dexcom G4 generation devices , 2014, Medical & Biological Engineering & Computing.

[38]  Patrick Keith-Hynes,et al.  A Review of Safety and Design Requirements of the Artificial Pancreas , 2016, Annals of Biomedical Engineering.

[39]  Alaa Tharwat,et al.  Classification assessment methods , 2020, Applied Computing and Informatics.

[40]  Roman L. Lysecky,et al.  Probabilistic Threat Detection for Risk Management in Cyber-physical Medical Systems , 2017, IEEE Software.

[41]  Mahesh Viswanathan,et al.  Runtime Assurance Based On Formal Specifications , 1999, PDPTA.

[42]  Giuseppe De Pietro,et al.  A mobile system for real-time context-aware monitoring of patients' health and fainting , 2014, Int. J. Data Min. Bioinform..

[43]  B. Bequette,et al.  A Review of Safety and Hazards Associated With the Artificial Pancreas , 2017, IEEE Reviews in Biomedical Engineering.

[44]  Partha S. Roop,et al.  Runtime Enforcement of Cyber-Physical Systems , 2017, ACM Trans. Embed. Comput. Syst..

[45]  N. Schwartz,et al.  Glycemic control with a basal-bolus insulin protocol in hospitalized diabetic patients treated with glucocorticoids: a retrospective cohort study , 2018, BMC Endocrine Disorders.

[46]  Aryan Mokhtari,et al.  A Primal-Dual Quasi-Newton Method for Exact Consensus Optimization , 2018, IEEE Transactions on Signal Processing.

[47]  Kevin Fu,et al.  Pacemakers and Implantable Cardiac Defibrillators: Software Radio Attacks and Zero-Power Defenses , 2008, 2008 IEEE Symposium on Security and Privacy (sp 2008).

[48]  H. Alemzadeh,et al.  Real-Time Context-Aware Detection of Unsafe Events in Robot-Assisted Surgery , 2020, 2020 50th Annual IEEE/IFIP International Conference on Dependable Systems and Networks (DSN).

[49]  Jimmy Ba,et al.  Adam: A Method for Stochastic Optimization , 2014, ICLR.

[50]  B P Kovatchev,et al.  Assessment of risk for severe hypoglycemia among adults with IDDM: validation of the low blood glucose index. , 1998, Diabetes care.

[51]  Gian Antonio Susto,et al.  Detection of Insulin Pump Malfunctioning to Improve Safety in Artificial Pancreas Using Unsupervised Algorithms , 2019, Journal of diabetes science and technology.

[52]  Giovanni Sparacino,et al.  Type-1 Diabetes Patient Decision Simulator for In Silico Testing Safety and Effectiveness of Insulin Treatments , 2018, IEEE Transactions on Biomedical Engineering.

[53]  Thenkurussi Kesavadas,et al.  Targeted Attacks on Teleoperated Surgical Robots: Dynamic Model-Based Detection and Mitigation , 2016, 2016 46th Annual IEEE/IFIP International Conference on Dependable Systems and Networks (DSN).

[54]  Lu Feng,et al.  DAMON: A Data Authenticity Monitoring System for Diabetes Management , 2018, 2018 IEEE/ACM Third International Conference on Internet-of-Things Design and Implementation (IoTDI).

[55]  L. Heinemann,et al.  Open source automated insulin delivery: addressing the challenge , 2019, npj Digital Medicine.

[56]  Saman Zonouz,et al.  On-board Deep-learning-based Unmanned Aerial Vehicle Fault Cause Detection and Identification , 2020, 2020 IEEE International Conference on Robotics and Automation (ICRA).

[57]  Felice Andrea Pellegrino,et al.  Model Predictive Control of glucose concentration based on Signal Temporal Logic specifications , 2019, 2019 6th International Conference on Control, Decision and Information Technologies (CoDIT).

[58]  Matthias Althoff,et al.  Online Verification of Automated Road Vehicles Using Reachability Analysis , 2014, IEEE Transactions on Robotics.

[59]  Jonathon Shlens,et al.  Explaining and Harnessing Adversarial Examples , 2014, ICLR.

[60]  Garry M. Steil,et al.  Identification of Intraday Metabolic Profiles during Closed-Loop Glucose Control in Individuals with Type 1 Diabetes , 2009, Journal of diabetes science and technology.

[61]  Chao Wang,et al.  Shield Synthesis for Real: Enforcing Safety in Cyber-Physical Systems , 2019, 2019 Formal Methods in Computer Aided Design (FMCAD).

[62]  Stanley B. Zdonik,et al.  Precision and Recall for Time Series , 2018, NeurIPS.

[63]  Wen-Chuan Lee,et al.  Detecting Attacks Against Robotic Vehicles: A Control Invariant Approach , 2018, CCS.

[64]  Karthik Pattabiraman,et al.  ARTINALI: dynamic invariant detection for cyber-physical system security , 2017, ESEC/SIGSOFT FSE.

[65]  Ashish Tiwari,et al.  TeLEx: learning signal temporal logic from positive examples using tightness metric , 2019, Formal Methods Syst. Des..

[66]  John P. Thomas,et al.  Extending and automating a systems-theoretic hazard analysis for requirements generation and analysis , 2013 .

[67]  Garvit Juniwal,et al.  Robust online monitoring of signal temporal logic , 2015, Formal Methods in System Design.

[68]  Zbigniew Kalbarczyk,et al.  Challenges and Opportunities in the Detection of Safety-Critical Cyberphysical Attacks , 2020, Computer.

[69]  Wanli Zuo,et al.  Learning from Positive and Unlabeled Examples: A Survey , 2008, 2008 International Symposiums on Information Processing.

[70]  STPA Primer,et al.  An STPA Primer , 2013 .

[71]  Øyvind Stavdahl,et al.  Risk analysis for the design of a safe artificial pancreas control system , 2018, Health and Technology.

[72]  Boris P. Kovatchev,et al.  Metrics for glycaemic control — from HbA1c to continuous glucose monitoring , 2017, Nature Reviews Endocrinology.

[73]  Jugal K. Kalita,et al.  Network Anomaly Detection: Methods, Systems and Tools , 2014, IEEE Communications Surveys & Tutorials.

[74]  Niraj K. Jha,et al.  Hijacking an insulin pump: Security attacks and defenses for a diabetes therapy system , 2011, 2011 IEEE 13th International Conference on e-Health Networking, Applications and Services.

[75]  Homa Alemzadeh,et al.  Context-aware Monitoring in Robotic Surgery , 2019, 2019 International Symposium on Medical Robotics (ISMR).

[76]  Michael Eickenberg,et al.  Machine learning for neuroimaging with scikit-learn , 2014, Front. Neuroinform..

[77]  Ezio Bartocci Monitoring, Learning and Control of Cyber-Physical Systems with STL (Tutorial) , 2018, RV.

[78]  Cristina C. Oliveira,et al.  A fuzzy logic approach for highly dependable medical wearable systems , 2015, 2015 IEEE 20th International Mixed-Signals Testing Workshop (IMSTW).

[79]  Smitha Gautham,et al.  Multilevel Runtime Security and Safety Monitoring for Cyber Physical Systems Using Model-Based Engineering , 2020, SAFECOMP Workshops.