Testbed for Medical Cyber-Physical Systems Insup Lee PRECISE Center Department of Computer and Information Science University of Pennsylvania NSF PI Meeting October 17, 2013

Why Testbed for Medical CPS? A typical medical systems brings together multiple facets of the CPS field Physiology Sensor technology Networking Dynamic changes Human in the loop MCPS Testbed is needed for development and evaluation of safe, secure, and effective clinically relevant MCPS technologies. Create a MCPS Test Bed for the evaluation of safety, security, and effectiveness of a variety of clinically relevant technologies, such as networked medical devices, clinical workflows and executable guidelines, data fusion and learning algorithms, patient and caregiver models, etc.

MCPS Ingredients MCPS Clinical guidelines Patient modeling Decision support and smart alarms Medical devices Caregiver interfaces Interoperability protocols

Research Challenges in MCPS Development of (new) medical devices Medical device interoperability Compositional safety platform Ad-hoc assembly at bedside Security & Privacy Closed-loop control Data-driven personalized care Smart alarms & clinical decision support Physiological closed-loop control Safety Assurance Usability Certification We are trying to develop high-confidence medical software systems using formal methods. We are working on interoperability platform that facilitates compositional safety. We are also developing smart medical alarms as well as closed loop control algorithms to manage medications that administer to the patients. OS: General challenges: High-assurance medical devices Interoperability between medical devices Network introduces new patient hazards Ad-hoc assembly at bedside Security vulnerabilities Usability challenges Challenges in closed-loop control Control design under extreme uncertainty Safety of closed-loop systems RM: Patient models needed at appropriate abstraction levels Realistic dynamics, parametric variability Capable of sophisticated control-theoretic analysis Safety in dynamically created scenarios Compositional reasoning? Safety case construction Modeling of clinical scenarios Workflows, requirements for devices, safety criteria Sensor fusion of physiological sensors Better reliability, faster detection Safe operation with unreliable networks Glucose Meter Network Patient Caregiver Controller Alert Infusion pump Network 4

Organization and Deployment A collection of open-access repositories Data repository Physiological data and device traces Patient model repository Device repository Device models and interfaces (virtual devices) Remote access to web-enabled devices Certification/regulatory artifacts Regulatory submissions Open-access computing infrastructure Simulation of ICU/OR environment The data and device models should be available for both research as well as education. Data:both clean and dirty data with/without annotations, time synched, etc. Include context information (condition of patients, …) Model: High level models and detailed models that can be parameterized for specific patients The science of MCPS should include the certification dimension. Certification - Samples, standards

Testbed for Technology Components Modeling and analysis tools and artifacts Models of medical devices Patient physiology Clinical workflows Medical device integration Physical or virtual implementation of multi-device treatment scenarios Real-time network/middleware infrastructure Data analysis, mining, and visualization Evaluation of individual projects Cross-correlation of results between projects

Testbed for Cross-domain Fertilization Access to caregivers for clinically relevant problems operational feedback Access to regulators Access to medical device industry Community challenge problems e.g., pacemaker challenge problem Regulators how to improve the process and/or help the process what are relevant evidence and how to collect and use them

Acknowledgements John Hatcliff (KSU) Margie Fortino (UPHS) Steve Patek (UVA) PRECISE center members (Penn)

THANK YOU! http://precise.seas.upenn.edu