Andrew L. King

Challenges and Research Directions in Medical Cyber–Physical Systems

Medical cyber-physical systems (MCPS) are life-critical, context-aware, networked systems of medical devices. These systems are increasingly used in hospitals to provide high-quality continuous care for patients. The need to design complex MCPS that are both safe and effective has presented numerous challenges, including achieving high assurance in system software, intoperability, context-aware intelligence, autonomy, security and privacy, and device certifiability. In this paper, we discuss these challenges in developing MCPS, some of our work in addressing them, and several open research issues.

An open test bed for medical device integration and coordination

Medical devices historically have been monolithic units — developed, validated, and approved by regulatory authorities as stand-alone entities. Modern medical devices increasingly incorporate connectivity mechanisms that offer the potential to stream device data into electronic health records, integrate information from multiple devices into single customizable displays, and coordinate the actions of groups of cooperating devices to realize “closed loop” scenarios and automate clinical workflows. However, it is not clear what middleware and integration architectures may be best suited for these possibly numerous scenarios. More troubling, current verification and validation techniques used in the device industry are not targeted to assuring groups of integrated devices. In this paper, we propose a publish-subscribe architecture for medical device integration based on the Java Messaging Service, and we report on our experience with this architecture in multiple scenarios that we believe represent the types of deployments that will benefit from rapid device integration. This implementation and the experiments presented in this paper are offered as an open test bed for exploring development, quality assurance, and regulatory issues related to medical device coordination.

On effective testing of health care simulation software

Health care professionals rely on software to simulate anatomical and physiological elements of the human body for purposes of training, prototyping, and decision making. Software can also be used to simulate medical processes and protocols to measure cost effectiveness and resource utilization. Whereas much of the software engineering research into simulation software focuses on validation (determining that the simulation accurately models real-world activity), to date there has been little investigation into the testing of simulation software itself, that is, the ability to effectively search for errors in the implementation. This is particularly challenging because often there is no test oracle to indicate whether the results of the simulation are correct. In this paper, we present an approach to systematically testing simulation software in the absence of test oracles, and evaluate the effectiveness of the technique.

The MIDdleware Assurance Substrate: Enabling Strong Real-Time Guarantees in Open Systems with OpenFlow

Middleware designed for use in Distributed Real-Time and Embedded (DRE) systems enable cost and development time reductions by providing simple communications abstractions and hiding operating system-level networking API details from developers. While current middleware technologies can hide many low-level details, designers must provide a static configuration for the systems underlying network in order to achieve required performance characteristics. This has not been a problem for many types of DRE systems where the configuration of the system is relatively fixed from the factory (e.g., aircraft or naval vessels). However for truly open systems (i.e., systems where end users can add or substract components at runtime)the standard static network configuration approach cannot guarantee that required performance will be met because network resource demands are not fully known a priori. Open systems with stringent performance requirements need middleware that can dynamically manage the underlying network configuration automatically in response to changing demands. Fortunately, recent trends in networking have resulted in a wide variety of networking equipment that expose a standardized low-level interface to their configuration via the OpenFlow protocol. In this paper we discuss how OpenFlow can be leveraged by DRE middleware to automatically provide performance guarantees. In order to make the discussion concrete, we describe the architecture of our prototype middleware MIDAS as well as the details of one example network resource management strategy. We demonstrate the feasibility of our approach via performance assesment of a simple DRE application using our MIDAS and commerically available OpenFlow hardware.

Assuring the safety of on-demand medical cyber-physical systems

We present an approach to establish safety of on-demand medical cyber-physical systems which are assembled to treat a patient in a specific clinical scenario. We treat such a system as a virtual medial device (VMD) and propose a model-based framework that includes a modeling language with formal semantics and a medical application platform (MAP) that provides the necessary deployment support for the VMD models.

A Modal Specification Approach for On-Demand Medical Systems

The on-demand approach, where systems are assembled from components by lay users, has seen success in the consumer electronics industry. Currently, there is growing demand for on-demand capabilities in medical systems so caregivers can create larger medical systems from smaller medical devices. Unlike consumer electronics, medical systems pose challenges for the on-demand approach due to attributes such as device complexity, device variability and safety requirements. In this paper, we propose a formal specification language for on-demand medical systems. Our approach is based on the formalism of Modal I/O Automata, which allows system designers to express complex device requirements and can be used to reason about safety and liveness properties of ondemand medical systems directly from their specifications. We illustrate the applicability of our approach through a case study of a closed-loop patient controlled analgesia system.

Smart alarms: multivariate medical alarm integration for post CABG surgery patients

In order to monitor patients in the Intensive Care Unit, healthcare practitioners set threshold alarms on each of many individual vital sign monitors. The current alarm algorithms elicit numerous false positive alarms producing an inefficient healthcare system, where nurses habitually ignore low level alarms due to their overabundance. In this paper, we describe an algorithm that considers multiple vital signs when monitoring a post coronary artery bypass graft (post-CABG) surgery patient. The algorithm employs a Fuzzy Expert System to mimic the decision processes of nurses. In addition, it includes a Clinical Decision Support tool that uses Bayesian theory to display the possible CABG-related complications the patient might be undergoing at any point in time, as well as the most relevant risk factors. As a result, this multivariate approach decreases clinical alarms by an average of 59% with a standard deviation of 17% (Sample of 32 patients, 1,451 hours of vital sign data). Interviews comparing our proposed system with the approach currently used in hospitals have also confirmed the potential efficiency gains from this approach.

Demo Abstract: ROSLab --- A Modular Programming Environment for Robotic Applications

We propose a simplified high-level programming language based on blocks and links dragged on a workspace which generates the skeleton code for robotic applications involving different types of robots. In order to develop such a high-level programming language that still can guarantee flexibility in term of implementation, our approach takes advantage of the robot operating system (ROS). ROS is a open source meta-operating system that provides a message passing structure between different processes (or nodes) across a network (inter-process communication). In our framework, we consider a hierarchical approach in which at the base there is ROS that allows inter-process communication between nodes in a robot and on the top we create a high-level language that interacts with ROS and thus with the real robot. The high-level language can be viewed as an extra layer added to simplify lower level code generation.

The medical device dongle: an open-source standards-based platform for interoperable medical device connectivity

Emerging medical applications require device coordination, increasing the need to connect devices in an interoperable manner. However, many of the existing health devices in use were not originally developed for network connectivity and those devices with networking capabilities either use proprietary protocols or implementations of standard protocols that are unavailable to the end user. The first set of devices are unsuitable for device coordination applications and the second set are unsuitable for research in medical device interoperability. We propose the Medical Device Dongle (MDD), a low-cost, open-source platform that addresses both issues.

GSA: a framework for rapid prototyping of smart alarm systems

We describe the Generic Smart Alarm, an architectural framework for the development of decision support modules for a variety of clinical applications. The need to quickly process patient vital signs and detect patient health events arises in many clinical scenarios, from clinical decision support to tele-health systems to home-care applications. The events detected during monitoring can be used as caregiver alarms, as triggers for further downstream processing or logging, or as discrete inputs to decision support systems or physiological closed-loop applications. We believe that all of these scenarios are similar, and share a common framework of design. In attempting to solve a particular instance of the problem, that of device alarm fatigue due to numerous false alarms, we devised a modular system based around this framework. This modular design allows us to easily customize the framework to address the specific needs of the various applications, and at the same time enables us to perform checking of consistency of the system. In this paper we discuss potential specific clinical applications of a generic smart alarm framework, present the proposed architecture of such a framework, and motivate the benefits of a generic framework for the development of new smart alarm or clinical decision support systems.