The Medical Cyber-Physical Systems (MCPS) workshop provides a forum for the presentation of research and development towards a new generation of smart medical systems that integrate human, cyber, and physical elements in closed-loop control. Such systems are essential to support innovative, networked medical device systems to improve safety and efficiency in health care. Designing safe and effective MCPS involves the work of a multi-disciplinary team of engineers, medical domain experts, and human factors specialists. This work needs to be supported by rigorous development processes and tools, as substantial evidence needs to be documented and integrated to justify design choices and ease the review process mandated by regulation. The MCPS workshop aims to bring together different stakeholders involved in the design, development, acquisition, and regulation of Medical CPS, and provide them with a stage that facilitates discussion of ideas, cross-pollination, and collaboration.

The 8th MCPS workshop will be an one-day event co-located with CPS Week 2018 in Portugal. The objectives of the workshop are to provide opportunities for researchers, industrial practitioners, caregivers, and government agencies to demonstrate innovative development methods and tools, present experience reports, discuss open challenges, and explore ideas for future development of MCPS. Contributions are welcome on all aspects of system development, including specification, design, analysis, implementation, documentation, and certification of Medical CPS. Demonstrations of existing tools for design and analysis of Medical CPS are also encouraged. Topics of interest include, but are not limited to, the following:

• Foundations for Integration of Medical Device Systems/Models: Component-based technologies for accelerated design and verifiable system integration, Systems of systems, Medical devices plug-and-play to support interoperability of heterogeneous systems;
• Enabling Technologies for Future Medical Devices: Implantable regulatory devices, networked biosensors, tele-surgery, robotic surgery, physiologic signal QoS (Quality of Service), Medical CPS in developing countries;
• Distributed Control & Sensing of Networked Medical Device Systems: Robust, verifiable, fault-tolerant control of uncertain, multi-modal systems;
• Medical Device Plug-and-Play Ecosystem: Requirements and emerging standards for supporting interoperability in the clinical environment, including "black box" data recording, device authorization, and data security;
• Human-Machine Interfaces: Identification of use-related safety requirements, model-based analysis of medical user interface design, user studies involving medical devices, modelling and analysis of use-errors with medical devices;
• Patient Modeling & Simulation: Large scale, high fidelity organ/patient models for design and testing;
• Embedded, Real-Time, Networked System Infrastructures for High Confidence Medical Devices: Architecture, platform, middleware, resource management, QoS (Quality of Service), Dynamic interoperation, including plug-and-play operation;
• High Confidence Medical Device Software Development & Assurance: Care-giver requirements solicitation and capture, design and implementation, V&V (Verification and Validation), Heterogeneity in environment, architecture, platforms in medical devices;
• Internet of Medical Things (IoMT): Mobile medical Apps, data analytics, security, logging, forensics, and privacy;
• Medical Practice-driven Models and Requirements: User-centric design, risk understanding, and use/misuse modeling in medical practice, management of failures in a clinical environment, modeling of operational scenarios, including medical devices, care-givers, patients;
• Certification of medical devices: Quantifiable incremental certification of medical devices and interoperable medical systems, role of design tools and COTS (Commercial Off-The-Shelf) components, challenges with self-adaptive medical systems.

Abstract

Building safe and secure interoperable medical devices with accompanying assurance artifacts can often be challenging task. In industry, many start-up companies have great ideas for innovation, but are not familiar with appropriate safety/security-critical engineering processes, architecture principles, risk management, and assurance techniques. Larger, more experienced, companies may face hurdles in re-engineering their devices for interoperability and greater security. In academia, researchers often have good techniques for addressing some of the issues above, but are not familiar with how a realistic medical device is developed and assured. Building a prototype medical device for a classroom project or research work to validate proposed techniques is often a huge effort.

In this talk, I will describe a open-source reference architecture developed by Adventium Labs and Kansas State University for interoperable medical devices and the Open PCA Pump built using the reference architecture and associated hardware. The Intrinsically Secure, Open and Safe Cyber-Physically Enabled, Life-Critical Essential Services (ISOSCELES) architecture is a reference implementation for future mixed-criticality medical and Internet of Things (IoT) system designs. By the use of a partitioning architecture based on hypervisor technology, the reference implementation enables manufacturers to focus on the clinical side of their product, reducing the time and effort spent ensuring that security vulnerabilities in the resulting platform minimize adverse impacts on patient safety. The Open PCA Pump illustrates a full suite of realistic development artifacts that academic researchers can leverage in their work including use cases, requirements, architecture models, verified source code, testing and simulation infrastructure, risk management artifacts, and assurance cases.

This work is sponsored by the US Department of Homeland Security and the US National Science Foundation Food and Drug Administration Scholar-in-Residence program.

Speaker Bio:

Dr. John Hatcliff is a University Distinguished Professor at Kansas State University working in the areas of safety-critical systems, software architectures, and software verification and certification. He leads the Laboratory on Static Analysis and Transformation of Software (SAnToS Lab), which emphasizes developer-centric formal methods tools. SAnToS research has been funded by from a number of sources including US Department of Homeland Security, Department of Defense, the National Institutes of Health, NASA, the US National Science Foundation, Lockheed-Martin, Rockwell Collins, IBM, and Intel. Dr. Hatcliff co-chairs the Architecture Requirements Working Group of the AAMI / UL 2800 Joint Committee that is developing safety standards for medical device interoperability.