Model-driven development of high-assurance active medical devices

Mashkoor, Atif

doi:10.1007/s11219-015-9288-0

Cited by 11 publications

(10 citation statements)

References 39 publications

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“…Failures may induce physicians errors during diagnosis, monitoring, and treatment of patients. In this context, formal modeling languages are tools that can aid designers to improve the confidence on the specification of the system under development [ 19 ]. Coloured Petri nets (CPN) is an example of a formal language used to specify behaviors of complex systems [ 20 ].…”

Section: Introductionmentioning

confidence: 99%

Design and evaluation of a mobile application to assist the self-monitoring of the chronic kidney disease in developing countries

Sobrinho

Silva

Perkusich

et al. 2018

BMC Med Inform Decis Mak

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BackgroundThe chronic kidney disease (CKD) is a worldwide critical problem, especially in developing countries. CKD patients usually begin their treatment in advanced stages, which requires dialysis and kidney transplantation, and consequently, affects mortality rates. This issue is faced by a mobile health (mHealth) application (app) that aims to assist the early diagnosis and self-monitoring of the disease progression.MethodsA user-centered design (UCD) approach involving health professionals (nurse and nephrologists) and target users guided the development process of the app between 2012 and 2016. In-depth interviews and prototyping were conducted along with healthcare professionals throughout the requirements elicitation process. Elicited requirements were translated into a native mHealth app targeting the Android platform. Afterward, the Cohen’s Kappa coefficient statistics was applied to evaluate the agreement between the app and three nephrologists who analyzed test results collected from 60 medical records. Finally, eight users tested the app and were interviewed about usability and user perceptions.ResultsA mHealth app was designed to assist the CKD early diagnosis and self-monitoring considering quality attributes such as safety, effectiveness, and usability. A global Kappa value of 0.7119 showed a substantial degree of agreement between the app and three nephrologists. Results of face-to-face interviews with target users indicated a good user satisfaction. However, the task of CKD self-monitoring proved difficult because most of the users did not fully understand the meaning of specific biomarkers (e.g., creatinine).ConclusionThe UCD approach provided mechanisms to develop the app based on the real needs of users. Even with no perfect Kappa degree of agreement, results are satisfactory because it aims to refer patients to nephrologists in early stages, where they may confirm the CKD diagnosis.

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Section: Introductionmentioning

confidence: 99%

Design and evaluation of a mobile application to assist the self-monitoring of the chronic kidney disease in developing countries

Sobrinho

Silva

Perkusich

et al. 2018

BMC Med Inform Decis Mak

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“…The approach also lets the specification be validated using animation and Domain Specific Visualizations (DSVs). A similar Event-B based solution is also presented in [49,50]. In this work, the requirements are specified using a refinement-based modeling approach, and are then checked for consistency and conformance using the standard theorem proving, model checking, and animation techniques.…”

Section: Related Work and Comparison With Other Approachesmentioning

confidence: 99%

Integrating formal methods into medical software development: The ASM approach

Arcaini

Bonfanti

Gargantini

et al. 2018

Science of Computer Programming

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Medical devices are safety-critical systems since their malfunctions can seriously compromise human safety. Correct operation of a medical device depends upon the controlling software, whose development should adhere to certification standards. However, these standards provide general descriptions of common software engineering activities without any indication regarding particular methods and techniques to assure safety and reliability. This paper discusses how to integrate the use of a formal approach into the current normative for the medical software development. The rigorous process is based on the Abstract State Machine (ASM) formal method, its refinement principle, and model analysis approaches the method supports. The hemodialysis machine case study is used to show how the ASM-based design process covers most of the engineering activities required by the related standards, and provides rigorous approaches for medical software validation and verification.

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“…The hemodialysis machine case study is modeled by literature. () Some of them perform validation() and verification. () Mashkoor and Biro generate the machine code starting from formal specification, and Arcaini et al define a set of characteristics to fit formal methods with the standards for medical software development process.…”

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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Model-driven development of high-assurance active medical devices

Cited by 11 publications

References 39 publications

Design and evaluation of a mobile application to assist the self-monitoring of the chronic kidney disease in developing countries

Design and evaluation of a mobile application to assist the self-monitoring of the chronic kidney disease in developing countries

Integrating formal methods into medical software development: The ASM approach

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

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