• Journal of the Institute of Electronics and Information Engineers
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• v.50 no.3
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• pp.187-202
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• 2013

The electronic medical device industry and the relevant market have been greatly expanded owing to various factors, such as the advent of the aged society and the spread of the desire for well-being in developed countries, and rapid development of China, India and other emerging markets. The electrical stimulator is one of electronic medical devices most commonly used in homes. The electrical stimulator is widely used for pain relief, rehabilitation, muscle conditioning and others. Since it is mainly used in homes, it is very important to assure the safety and performance for protection of users. However, there is no guideline on evaluation of safety and performance of such electrical stimulator for home use. In this study, various local and foreign references were reviewed to develop the internationally harmonized procedures for safety and performance evaluation of the electrical stimulator and test items, specifications and methods are proposed. In addition, such proposed test items were validated to decide the internationally harmonized tests for safety and performance evaluation. This study will contribute to improvement of quality and safety of electrical stimulators for home use and help the Korean medical device industry have the international competitiveness.

• Convergence Security Journal
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• v.19 no.4
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• pp.151-163
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• 2019

As smart devices and communication technologies have developed rapidly, the healthcare industry in the globe is seeing remarkable issues on medical security. At the same time, personal medical records are being shared in the network, which would raise the risk of information security. This thesis aims to develop the curriculum to raise the awareness of information security among workers in medical institutions by referring to NCS(National Competency Standards) International standards, medical institutions' requirements and educational institutions' curriculums on information security based on proven results from medical devices and systems introduced in the public health centers, territorial branches, community health posts and primary, secondary, tertiary hospitals. Thus, this thesis offers the method to improve information security in healthcare institutions through validation testing conducted by medical practitioners and ICT experts.

• Journal of Korea Society of Digital Industry and Information Management
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• v.11 no.4
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• pp.25-31
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• 2015

Smart healthcare environments which merge medical and IT technology are getting ready for the third generation centering EHR from current second generation. As a basic technology for the introduction and activation of EHR systems it requires heterogeneous network interworking techniques between various wired and wireless medical devices. Interworking technology for heterogeneous network among various medical devices is needed to introduce EHR system. The heterogeneous network interworking technology is needed for construction of a reliable data system to convert each of unstructured data into structured data. Therefore, in this paper, we identify the domestic and international trends of smart medical field and analyze the characteristics of wired and wireless communication technology that is used in a heterogeneous network. and also suggest requirements needed for interworking technology and provide interworking technology based on them. we expect that proposed method which is designed for smart healthcare environments would provide a basic architecture needed for third smart medical technology generation.

• Journal of Biomedical Engineering Research
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• v.44 no.3
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• pp.204-210
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• 2023

This study focuses on analyzing medical device standards and regulatory requirements in the medical device industry, based on the Medical Device Act in Korea. The objective of this analysis is to determine whether the domestic standards for medical devices in Korea align with international and regional standards. Furthermore, it aims to identify the current application of domestic standards in ensuring the safety and essential performance of medical devices. The analysis revealed that out of a total of 281 domestic standards, 127 standards reference international standards. In terms of the application of domestic standards to specific items, there were 473 types of instruments/machines, 30 types of medical supplies, and 45 types of dental materials. However, the level of compliance with international standards among the domestic medical device standards was only 21%. Upon detailed analysis, general and collateral standards accounted for 24%, while particular standards accounted for 19%. This indicates a significant deviation from the latest international standards. On the other hand, the level of compliance with international standards was analyzed to be 60% for particular standards and 72% for general and collateral standards in Korean industrial standards (KS). Considering these results, the disparities between domestic standards and international standards underscore the need for discussions on domestic medical device regulation and standardization. In conclusion, this study emphasizes the significance of maintaining up-to-date medical device standards and ensuring their alignment with international standards to ensure the safety and quality of medical devices. The findings highlight the necessity for further efforts to strengthen the domestic standardization system in order to promote the development of safe and high-quality medical devices.

• Journal of the Korea Society of Computer and Information
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• v.22 no.6
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• pp.79-86
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• 2017

In this paper, we implement a common module that can integrate multiple biometric information for integrated patient monitoring system. Conventional biomedical instruments have many devices attached to each patient, making it difficult to monitor abnormality signs of many patients in real time. In this paper, we propose a module for an integrated monitoring system that can perform centralized monitoring using a common module that integrates multiple measurement devices. A protocol for sending and receiving packets between the measuring device and the common module is designed, and the packets transmitted through the network are stored and managed through the integrated monitoring system and provide information to various users such as medical staff. The results of this study are expected to contribute to the management of patients and efficient medical services in hospitals.

• Journal of Korea Society of Industrial Information Systems
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• v.12 no.5
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• pp.14-22
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• 2007

PACS is an integrated communication network system which is consists of image acquisition devices, storage archiving units, display stations, computer processors, and database management systems. In medical industry, they have been introduced the medical equipments through PACS systems based on the DICOM standard. In this paper, we have reviewed the visual quality performance of various JPEG and JPEG2000 compression options for medical images. Through the realized the transmission mode on DICOM standard, the developed DICOM viewer has been shown in medical applications.

• Journal of Advanced Navigation Technology
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• v.16 no.1
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• pp.103-108
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• 2012

The basic service model is to be process transmting patient health information from various medical devices to evacuation hospital through gateway collecting it in aerial emergency medicine environments. In this paper, we study on the most secure transmission scheme in case that personal patient informations are transmitted from medical devices to gateway. Moreover we compare and analyze existing methods on secure transmission and suggest an optimal alternative on the basis of international standard, ISO/IEEE 11073.

• Proceedings of the Korea Society of Information Technology Applications Conference
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• 2005.11a
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• pp.157-160
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• 2005

PACS is an integrated communication network system which is consists of image acquisition devices, storage archiving units, display stations, computer processors, and database management systems. In medical industry, they have been introduced the medical equipments through PACS systems based on the DICOM standard. In this paper, we have reviewed the performance of JPEG and JPEG2000 used as medical image compression and realized the transmission mode on DICOM standard.

• YAKHAK HOEJI
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• v.55 no.4
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• pp.345-351
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• 2011

Gastritis is the most common disease among Korean. The demand for the development of gastritis drugs has been increasing. Currently, however, there is no guideline available for the clinical evaluation of gastritis drugs worldwide. As a consequence, domestic and international pharmaceutical companies make errors in the drug development processes, and it becomes difficult for them to establish the scientific validity and objectivity of newly developed drugs. The objective of this study was to develop the Guideline for Clinical Trials Evaluation of Gastritis which can be used in improving the quality and consistency of clinical trials. First, we collected and reviewed the clinical trials on gastritis drugs that were available from Japan Pharmaceuticals and Medical Devices Agency and Korea Food and Drug Administration (KFDA), and investigated the recent research trends on clinical trials of gastritis drugs. Reviewers from KFDA and National Institute of Food and Drug Safety Evaluation and scientific experts from the pharmaceutical industries developed the guidelines through regularly scheduled meetings. Opinions and consultation from academic fields and industry experts were also obtained. This project will provide the clinical trial practitioners, investigator and reviewers the scientific and rational guidelines for performance and evaluation of clinical trials for gastritis drugs. Furthermore, we hope this guideline contributes to establishing the national competitiveness, improving the quality of clinical trial, and encouraging researches on drug development for gastritis.

• Asia pacific journal of information systems
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• v.29 no.4
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• pp.817-837
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• 2019

The medical industry is rapidly evolving into a combination of artificial intelligence (AI) and ICT technology, such as mobile health, wireless medical, telemedicine and precision medical care. Medical artificial intelligence can be diagnosed and treated, and autonomous surgical robots can be operated. For smart medical services, data such as medical information and personal medical information are needed. AI is being developed to integrate with companies such as Google, Facebook, IBM and others in the health care field. Telemedicine services are also becoming available. However, security issues of medical information for smart medical industry are becoming important. It can have a devastating impact on life through hacking of medical devices through vulnerable areas. Research on medical information is proceeding on the necessity of privacy and privacy protection. However, there is a lack of research on the practical measures for protecting medical information and the seriousness of security threats. Therefore, in this study, we want to confirm the research trend by collecting data related to medical information in recent 5 years. In this study, smart medical related papers from 2014 to 2018 were collected using smart medical topics, and the medical information papers were rearranged based on this. Research trend analysis uses topic modeling technique for topic information. The result constructs topic network based on relation of topics and grasps main trend through topic.