Prototyping closed loop physiologic control with the medical device coordination framework

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 on-demand 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. we propose a formal speci cation 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 speci cations. We illustrate the applicability of our approach through a case study of a closed-loop patient controlled analgesia system.

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“…While PCA lets patients manage their own pain-levels e ectively [15] it also creates an opportunity for overdose. Opiod [26,19].…”

Section: Motivating Examplementioning

confidence: 99%

A Modal Specification Approach for On-Demand Medical Systems

King

Sokolsky

et al. 2014

Foundations of Health Information Engineering and Systems

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“…In addition to the simple apps included in the distribution, the MDCF has been used to develop some more significant examples including an app which provides closed-loop control of a PCA pump [12], a generic smart alarm framework that uses fuzzy set classification to generate more precise alarms by aggregating physiological readings from a multiparameter monitor [1].…”

Section: Resources and Applicationsmentioning

confidence: 99%

Rationale and Architecture Principles for Medical Application Platforms

Hatcliff

King

Lee

et al. 2012

2012 IEEE/ACM Third International Conference on Cyber-Physical Systems

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The concept of "system of systems" architecture is increasingly prevalent in many critical domains. Such systems allow information to be pulled from a variety of sources, analyzed to discover correlations and trends, stored to enable realtime and post-hoc assessment, mined to better inform decisionmaking, and leveraged to automate control of system units. In contrast, medical devices typically have been developed as monolithic stand-alone units. However, a vision is emerging of a notion of a medical application platform (MAP) that would provide device and health information systems (HIS) interoperability, safety critical network middleware, and an execution environment for clinical applications ("apps") that offer numerous advantages for safety and effectiveness in health care delivery.In this paper, we present the clinical safety/effectiveness and economic motivations for MAPs, and describe key characteristics of MAPs that are guiding the search for appropriate technology, regulatory, and ecosystem solutions. We give an overview of the Integrated Clinical Environment (ICE) -one particular achitecture for MAPs, and the Medical Device Coordination Framework -a prototype implementation of the ICE architecture. Abstract-The concept of "system of systems" architecture is increasingly prevalent in many critical domains. Such systems allow information to be pulled from a variety of sources, analyzed to discover correlations and trends, stored to enable realtime and post-hoc assessment, mined to better inform decisionmaking, and leveraged to automate control of system units. In contrast, medical devices typically have been developed as monolithic stand-alone units. However, a vision is emerging of a notion of a medical application platform (MAP) that would provide device and health information systems (HIS) interoperability, safety critical network middleware, and an execution environment for clinical applications ("apps") that offer numerous advantages for safety and effectiveness in health care delivery.In this paper, we present the clinical safety/effectiveness and economic motivations for MAPs, and describe key characteristics of MAPs that are guiding the search for appropriate technology, regulatory, and ecosystem solutions. We give an overview of the Integrated Clinical Environment (ICE) -one particular achitecture for MAPs, and the Medical Device Coordination Framework -a prototype implementation of the ICE architecture.

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“…The infrastructure, together with the supervisor, needs to be approved as a medical device, since its operation directly affects patient's safety. We are designing a prototype of such a network infrastructure [19,18] and expect to use it in developing approaches to VMD certification.…”

Section: Certification Of Virtual Devicesmentioning

confidence: 99%

Challenges in the regulatory approval of medical cyber-physical systems

Sokolsky

Lee

Heimdahl

2011

Proceedings of the Ninth ACM International Conference on Embedded Software

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We are considering the challenges that regulators face in approving modern medical devices, which are software intensive and increasingly network enabled. We then consider assurance cases, which o er the means of organizing the evidence into a coherent argument demonstrating the level of assurance provided by a system, and discuss research directions that promise to make construction and evaluation of assurance cases easier and more precise. Finally, we discuss some recent trends that will further complicate the regulatory approval of medical cyber-physical systems. ABSTRACTWe are considering the challenges that regulators face in approving modern medical devices, which are software intensive and increasingly network enabled. We then consider assurance cases, which offer the means of organizing the evidence into a coherent argument demonstrating the level of assurance provided by a system, and discuss research directions that promise to make construction and evaluation of assurance cases easier and more precise. Finally, we discuss some recent trends that will further complicate the regulatory approval of medical cyber-physical systems.

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Prototyping closed loop physiologic control with the medical device coordination framework

Cited by 31 publications

References 19 publications

A Modal Specification Approach for On-Demand Medical Systems

A Modal Specification Approach for On-Demand Medical Systems

Rationale and Architecture Principles for Medical Application Platforms

Challenges in the regulatory approval of medical cyber-physical systems

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