Formal Verification of Medical Device User Interfaces Using PVS

Masci, Paolo; Zhang, Yi; Jones, Paul; Curzon, Paul; Thimbleby, Harold

doi:10.1007/978-3-642-54804-8_14

Cited by 32 publications

(28 citation statements)

References 17 publications

(24 reference statements)

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“…We extended the example by developing a new controller that allows an operator to drive manually the robot using a joypad-like controller. The logic of operation of the new controller is entirely specified in PVS, which allows the use of the PVS theorem prover to verify use-related safety properties of the human-machine interface of the system, e.g., consistency of response to user actions, visibility of operating modes, and predictability of response to user commands (see also [11,20,21]) .…”

Section: Discussionmentioning

confidence: 99%

Co-simulation of Semi-autonomous Systems: The Line Follower Robot Case Study

Palmieri

Bernardeschi

Masci

2018

Software Engineering and Formal Methods

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Semi-autonomous systems are capable of sensing their environment and perform their tasks autonomously, but they may also be supervised by humans. The shared manual/automatic control makes the dynamics of such systems more complex, and undesirable and hardly predictable behaviours can arise from human-machine interaction. When these systems are used in critical applications, such as autonomous driving or robotic surgery, the identification of conditions that may lead the system to violate safety requirements is of main concern, since people actually entrust their life on them. In this paper, we extend an FMI-based co-simulation framework for cyber-physical systems with the possibility of modelling semi-autonomous robots. Co-simulation can be used to gain more insights on the system under analysis at early stages of system development, and to highlight the impact of human interaction on safety. This approach is applied to the Line Follower Robot case study, available in the INTO-CPS project.

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Section: Discussionmentioning

confidence: 99%

Co-simulation of Semi-autonomous Systems: The Line Follower Robot Case Study

Palmieri

Bernardeschi

Masci

2018

Software Engineering and Formal Methods

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“…() The pacemaker software is validated in papers, () while previous studies() contribute to develop a new step that consists in translating the model into machine code. The infusion pump case study is modeled, (), verified, () and validated() by using different tools and languages. Masci et al and Mauro et al present an approach for generating the machine code starting from the formal model, and in other studies,() authors use different approaches to validate software.…”

Section: Classification and Analysismentioning

confidence: 99%

A systematic literature review of the use of formal methods in medical software systems

Bonfanti

Gargantini

Mashkoor

2018

J Software Evolu Process

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The use of formal methods is often recommended to guarantee the provision of necessary services and to assess the correctness of critical properties, such as functional safety, cybersecurity, and reliability, in medical and health care devices. In the past, several formal and rigorous methods have been proposed and consequently applied for trustworthy development of medical software and systems. In this paper, we perform a systematic literature review on the available state of the art in this domain. We collect the relevant literature on the use of formal methods for modeling, design, development, verification, and validation of software-intensive medical systems. We apply standard systematic literature review techniques and run several queries in well-known repositories to obtain information that can be useful for people who are either already working in this field or planning to start. Our study covers both quantitative and qualitative aspects of the subject. KEYWORDSformal methods, systematic literature review, medical device software INTRODUCTIONIn modern medical devices, human safety depends upon the correct operation of software controlling the device: Software malfunctioning can cause injuries to, or even the death of, patients. A crucial issue is how to guarantee that medical software has all the qualities (eg, safety, security, and dependability) expected for critical components. One way to improve and assess software quality, as suggested by literature, 1-3 is to use formal methods or in general rigorous methods for design, validation, and verification of medical software. Some processes for improvement of medical standards, based on formal approaches, have already been proposed, 4-6 although their adoption in industrial applications is rather limited.The overall aim of this paper is twofold: (1) to provide guidance to researchers starting to work on this topic and (2) to assess the state of the art that is more useful for researchers already working on this subject. We have applied a systematic literature review (SLR) process to the topic of rigorous methods for designing and validation of medical software and systems by following the guidelines presented in literature 7-9 with slight improvements such as a wider range of repositories is queried for information retrieval and the subject is covered from both quantitative and qualitative aspects. Through this analysis, we give an overview of the research literature about formal methods applications to model, to verify, and to validate medical systems. Moreover, we include processes and tools that translate models written using formal languages in machine code. We would like to underline that the SLR carried out in this work considers only formal methods applied to medical device/software. Other processes applied to medical device/software are outside of our goal (eg, code implementation, testing, 8 and hardware configuration).The goals of our SLR are (1) to gather a sufficient number of relevant articles, (2) to perform a series of analyses, and (3) to p...

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“…The typed higher-order logic of the Prototype Verification System (PVS) [8] has been used for the formal specification of many kinds of systems, including medical devices [3,7,6]. In the PVS, a system is modeled by a theory, i.e., a set of statements in the PVS logic language describing the system by means of variable, constant, and function definitions, and of axioms and theorems about them.…”

Section: Formalizationmentioning

confidence: 99%

Towards a Formalization of System Requirements for an Integrated Clinical Environment

Bernardeschi¹,

Domenici²,

Masci³

2015

Proceedings of the 5th EAI International Conference on Wireless Mobile Communication and Healthcare - "Transforming Healthcare

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Interoperability of medical devices, and their interface to clinicians and patients, are critical issues for the safety and effectiveness of patient care. Ongoing efforts strive at establishing standards for integrated clinical environments, which may connect and co-ordinate several medical devices and interface them to patients, clinicians, and hospital information systems. In this paper, an approach to the formalization of system requirements for an integrated clinical environment is presented. The formalization relies on the higher-order logic language of the Prototype Verification System.

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Formal Verification of Medical Device User Interfaces Using PVS

Cited by 32 publications

References 17 publications

Co-simulation of Semi-autonomous Systems: The Line Follower Robot Case Study

Co-simulation of Semi-autonomous Systems: The Line Follower Robot Case Study

A systematic literature review of the use of formal methods in medical software systems

Towards a Formalization of System Requirements for an Integrated Clinical Environment

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