Medical guidelines reconciling medical software and electronic devices: Imatinib case-study

Simalatsar, Alena; Micheli, Giovanni De

doi:10.1109/bibe.2012.6399700

Cited by 4 publications

(3 citation statements)

References 16 publications

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“…Interoperability and guideline standardization within telemonitoring services are crucial for fully utilizing the service. 17 In contrast to the national approach of WHO member states, the European Union (EU) understands the importance of supranational organizations on standardization in EHR systems. As a result, using existing standards and creating new standardized approaches have been a large focus of the EU to achieve healthcare interoperability across national borders.…”

Section: Leading Initiatives Abroadmentioning

confidence: 99%

Surmounting Barriers to Healthcare Data and Information: International Case Studies

Perugu, MBA,

Wadhwa, BS,

Kim, ME

et al. 2023

THMT

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Objective: In this article, the authors review the progress in healthcare interoperability from 2010 to 2023 from an international perspective. Countries covered here include the Republic of China (Taiwan), the Republic of Croatia, the Republic of Estonia, and the Commonwealth of Australia. Interoperability, in the context of this paper, is “the ability to share information across time and space from multiple devices, sources, and organizations,” as defined by the Institute of Electrical and Electronic Engineers (IEEE). This is followed by recommendations for future work toward improving the standardization of heterogeneous data in the healthcare setting. Methodology: A literature review was conducted on established interoperability standards and systems in healthcare based on information obtained from journal publications, government, academy reports, published materials, and publicly available websites. Examples of specific interoperability efforts and an evaluation of their feasibility were conducted at three levels of healthcare interoperability, as defined by the National Academy of Medicine: 1) inter-facility (macro-tier) interoperability, 2) intra-facility (meso-tier) interoperability, and 3) Point-of-Care (micro-tier) interoperability. The authors assessed the adoption levels of each standard by looking at factors that support or limit its systemic adoption. Estimations on the number of users—medical professionals and patients—for each system were made in instances where verifiable data are available. Results: Presented here is an evaluation of four interoperability parameters: 1) device/equipment interoperability, 2) compatibility issues, 3) involved organizations, and 4) migration and conversion issues. Conclusions: Despite many parallel ongoing efforts to improve the standardization of healthcare information in the mobile devices, Internet of Things (IoT), and electronic health records (HER) sectors, there remains space for improvement. The recent development of the Trusted Exchange Framework and Common Agreement (TEFCA) framework has significantly reduced the friction of data exchange in many healthcare contexts. In addition, funding architectures for mediating data between separate healthcare organizations, or middleware architectures, may also be an effective strategy for consolidating healthcare data and improving information exchange.

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Section: Leading Initiatives Abroadmentioning

confidence: 99%

Surmounting Barriers to Healthcare Data and Information: International Case Studies

Perugu, MBA,

Wadhwa, BS,

Kim, ME

et al. 2023

THMT

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“…Pulse oximeter is modeled in Carneiro et al and verified in Carneiro et al and Cordeiro et al models() of medical device connections are verified () and validated. () Modelling and verification techniques are applied to imatinib dose in Simalatsar et al() Model validation, model verification, and modeling activities are performed for left ventricular assist device . A formal model is defined for clinical neutron therapy system, and for syringe pump, furthermore syringe pumps are validated in Sun and Meseguer and Bowen and Reeves .…”

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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“…Other approaches use models of clinical contexts to validate and verify the control of software. Kang et al [ 18 ], King et al [ 19 ], Simalatsar and De Micheli [ 20 ] and Li et al [ 21 ] focused on MCPS design issues. They coupled their solutions to specific formalisms and associated tools.…”

Section: Introductionmentioning

confidence: 99%

A Model-Based Approach to Support Validation of Medical Cyber-Physical Systems

Silva

Almeida

Perkusich

et al. 2015

Sensors

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Medical Cyber-Physical Systems (MCPS) are context-aware, life-critical systems with patient safety as the main concern, demanding rigorous processes for validation to guarantee user requirement compliance and specification-oriented correctness. In this article, we propose a model-based approach for early validation of MCPS, focusing on promoting reusability and productivity. It enables system developers to build MCPS formal models based on a library of patient and medical device models, and simulate the MCPS to identify undesirable behaviors at design time. Our approach has been applied to three different clinical scenarios to evaluate its reusability potential for different contexts. We have also validated our approach through an empirical evaluation with developers to assess productivity and reusability. Finally, our models have been formally verified considering functional and safety requirements and model coverage.

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Medical guidelines reconciling medical software and electronic devices: Imatinib case-study

Cited by 4 publications

References 16 publications

Surmounting Barriers to Healthcare Data and Information: International Case Studies

Surmounting Barriers to Healthcare Data and Information: International Case Studies

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

A Model-Based Approach to Support Validation of Medical Cyber-Physical Systems

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