• Journal of Biomedical Engineering Research
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• v.44 no.2
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• pp.99-108
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• 2023

According to the COVID-19, development of various medical software based on IoT(Internet of Things) was accelerated. Especially, interest in a central software system that can remotely monitor and control ventilators is increasing to solve problems related to the continuous increase in severe COVID-19 patients. Since medical device software is closely related to human life, this study aims to develop central monitoring system that can remotely monitor and control multiple ventilators in compliance with medical device software development standards and to verify performance of system. In addition, to ensure the safety and reliability of this central monitoring system, this study also specifies risk management requirements that can identify hazardous situations and evaluate potential hazards and confirms the implementation of cybersecurity to protect against potential cyber threats, which can have serious consequences for patient safety. As a result, we obtained medical device software manufacturing certificates from MFDS(Ministry of Food and Drug Safety) through technical documents about performance verification, risk management and cybersecurity application.

• Journal of Information Technology Services
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• v.22 no.4
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• pp.21-35
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• 2023

Software as Medical Devices (SaMD) is a growing category of medical devices that are composed of software to perform one or more medical purposes. SaMD is less likely to cause physical harm compared to conventional medical devices, particularly medical electrical equipments, and may be more vulnerable to privacy issues. This difference was acknowledged and resulted in introducing new regulation guidance specifically for cybersecurity of SaMD. It guides stakeholders of SaMD what to consider in what context in terms of cybersecurity. This study examines the current guidance of how cybersecurity is considered for SaMD by analyzing current medical device standards, then suggest which concept or details beyond current medical device standards may be applicable through analysis of international standards documents published for software in general.

• International Journal of Internet, Broadcasting and Communication
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• v.15 no.3
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• pp.32-42
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• 2023

There are serious problems worldwide, such as a pandemic due to an unprecedented infection caused by COVID-19. On previous approaches, they invented medical vaccines and preemptive testing tools for medical engineering. However, it is difficult to access poor medical systems and medical institutions due to disparities between countries and regions. In advanced nations, the damage was even greater due to high medical and examination costs because they did not go to the hospital. Therefore, from a software engineering-based perspective, we propose a learning model for determining coronavirus infection through symptom data-based software prediction models and tools. After a comparative analysis of various models (decision tree, Naive Bayes, KNN, multi-perceptron neural network), we decide to choose an appropriate decision tree model. Due to a lack of data, additional survey data and overseas symptom data are applied and built into the judgment model. To protect from thiswe also adapt human normalization approach with traditional Korean medicin approach. We expect to be possible to determine coronavirus, flu, allergy, and cold without medical examination and diagnosis tools through data collection and analysis by applying decision trees.

• Proceedings of the Korean Institute of Information and Commucation Sciences Conference
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• 2012.10a
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• pp.495-497
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• 2012

Development of application risk management for medical device software test. First, Through questionnaires, Medical device manufacturers, Analysis of software validation and risk management status. Second, Analyzed by comparing the difference between black box testing and white box testing. Third, After analyzing the potential for software analysis tools using code derived factors were quantified, Finally, Medical device risk management process so that it can be applied to build the framework by FMEA(Failure Mode and Effect Analysis) technique. Through this Difficult to build software validation and risk management processes for manufacturers to take advantage of support in medical device GMP(Good Manufacture Practice).

• The KIPS Transactions:PartD
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• v.10D no.5
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• pp.781-792
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• 2003

We medical software is becoming important means to secure competitive power of medical service by explosive increase of medical device based on software, and the quality of medical service is affected to quality of medical software as well as medical devices. But domestic related study and development is not sufficient for quality of medical software, and a falling-off in medical software quality can induce a falling-off in quality of medical service. Therefore, it is necessary to raise qualitative level of medical service by progress and quality improvement of medical devices. Therefore, in this paper, we developed test module and qualify inspection table which can test medical software and produce result based on ISO/1EC 12119.

• Journal of Information Technology Services
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• v.17 no.2
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• pp.49-67
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• 2018

This study compares economic impact between Software and Medical industry through Input Output Table by Bank of Korea. We classify Software and Medical industry by The ninth Korea Standard Industry Classification and use linkage effects, value added inducement coefficient, and labor inducement coefficient to analyze economic impact. First, software and medical industry have different linkage effects between backward and forward. Second, They have higher value added inducement coefficient than average of all industry. Third, They not only have higher labor inducement coefficient than average of all industry but also simillar effect on labor induction. According to the result of this study, software and medical industry have high economic impact on Korea economy, and therefore are intensively fostered by policy support.

• The KIPS Transactions:PartD
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• v.13D no.2 s.105
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• pp.259-270
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• 2006

Because a medical embedded software is the software that control the medical devices that are relevant to a human life, it requires high qualify level. It is requires to develop and apply the quality test module that suitable for the requirements to meet the high quality requirements of the medical embedded software. Also, it needs to develop the process that complement the quality defects of software by feedback of the test result. In this study, we developed test module and quality inspection table which can test medical embedded software and produce result based on ISO/IEC 12119.

• Convergence Security Journal
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• v.13 no.6
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• pp.35-41
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• 2013

What is an alternative to medical information security of medical information more secure preservation and safety of various types of security threats should be taken, starting from the software design. Interspersed with medical information systems medical information to be able to integrate the real-time exchange of medical information must be reliable data communication. The software architecture design of medical information systems and sharing of medical information security issues and communication phase allows the user to identify the requirements reflected in the software design. Software framework design, message standard design, design a web-based inter-process communication procedures, access control algorithm design, architecture, writing descriptions, evaluation of various will procedure the establishing architecture. The initial decision is a software architecture design, development, testing, maintenance, ongoing impact. In addition, the project will be based on the decision in detail. Medical information security method based on the design software architecture of today's medical information security has become an important task of the framework will be able to provide.

• KIPS Transactions on Software and Data Engineering
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• v.6 no.12
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• pp.543-548
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• 2017

In recent years, the importance of the safety of medical device software has been emphasized because of the function and role of the software among components of the medical device, and because the operation of the medical device software is directly related to the life and safety of the user. To this end, various standards have been set up that provide activities that can effectively ensure the safety of medical devices and provide their respective requirements. The activities that standards provide to ensure the safety of medical device software are largely divided into the development life cycle of medical device software and the risk management process. These two activities should be concurrent with the development process, but there is a limitation that the risk management requirements to be performed at each stage of the medical device software development life cycle are not classified. As a result, developers must analyze the association of standards directly to develop risk management activities during the development of medical devices. Therefore, in this paper, we analyze the relationship between medical device software development life cycle and risk management process, and extract risk management requirement items. It enables efficient and systematic risk management during the development of medical device software by mapping the extracted risk management requirement items to the development life cycle based on the analyzed associations.

• Journal of Applied Reliability
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• v.16 no.3
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• pp.216-223
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• 2016

Purpose: This paper suggests the procedure to enhance the reliability of the software of the medical device that is to cure, treat, diagnose, and prevent a disease or an abnormal health conditions. Methods: After test requirements are classified by the software requirements specification for safety and backgrounds, reliability assessment methods are suggested. Results: Verification and validation for function and safety can be performed whether the medical device software are implemented as intended. Conclusion: Procedure on the static analysis, unit test, integration test, and system test are provided for the medical device software.