• Title/Summary/Keyword: 소프트웨어 의료기기

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Principles for evaluating the clinical implementation of novel digital healthcare devices (첨단 디지털 헬스케어 의료기기를 진료에 도입할 때 평가원칙)

  • Park, Seong Ho;Do, Kyung-Hyun;Choi, Joon-Il;Sim, Jung Suk;Yang, Dal Mo;Eo, Hong;Woo, Hyunsik;Lee, Jeong Min;Jung, Seung Eun;Oh, Joo Hyeong
    • Journal of the Korean Medical Association
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    • v.61 no.12
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    • pp.765-775
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    • 2018
  • With growing interest in novel digital healthcare devices, such as artificial intelligence (AI) software for medical diagnosis and prediction, and their potential impacts on healthcare, discussions have taken place regarding the regulatory approval, coverage, and clinical implementation of these devices. Despite their potential, 'digital exceptionalism' (i.e., skipping the rigorous clinical validation of such digital tools) is creating significant concerns for patients and healthcare stakeholders. This white paper presents the positions of the Korean Society of Radiology, a leader in medical imaging and digital medicine, on the clinical validation, regulatory approval, coverage decisions, and clinical implementation of novel digital healthcare devices, especially AI software for medical diagnosis and prediction, and explains the scientific principles underlying those positions. Mere regulatory approval by the Food and Drug Administration of Korea, the United States, or other countries should be distinguished from coverage decisions and widespread clinical implementation, as regulatory approval only indicates that a digital tool is allowed for use in patients, not that the device is beneficial or recommended for patient care. Coverage or widespread clinical adoption of AI software tools should require a thorough clinical validation of safety, high accuracy proven by robust external validation, documented benefits for patient outcomes, and cost-effectiveness. The Korean Society of Radiology puts patients first when considering novel digital healthcare tools, and as an impartial professional organization that follows scientific principles and evidence, strives to provide correct information to the public, make reasonable policy suggestions, and build collaborative partnerships with industry and government for the good of our patients.

Development of a Metamodel-Based Healthcare Service System using OSGi Component Platform (OSGi 컴포넌트 플랫폼을 이용한 메타모델 기반의 건강관리 서비스 시스템 개발)

  • Kim, Tae-Woong;Kim, Hee-Cheol
    • Journal of Korea Multimedia Society
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    • v.14 no.1
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    • pp.121-132
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    • 2011
  • A healthcare system is a type of medical information system that performs early detection and prevention in diseases by checking one's health condition periodically. Such a healthcare system is based on the signal obtained from the body. However, the developed existing system represents certain differences in the storage and description of vital signs according to medicare devices and the evaluation method of the system. It brings some disadvantages, such as lacks in the interoperability between systems, increases in the development cost of systems, and absence of a unified system. Thus, this study develops a healthcare system based on a meta model. For establishing this objective, this study describes and stores vital sign data based on the standard meta model of HL7 and applies OCL, which is a mathematical specification language, for defining wellness indexes and extracting data in order to evaluate health risk appraisals in health. In addition, this study implements components based on OSGi and assemble them in order to easily extend various devices and systems. By describing vital data based on the meta model, it represents some advantages that it makes possible to ensure the interoperability between systems and introduce the standardization of the evaluation method of health conditions through defining the wellness index using OCL. Also, it provides dear specifications.

A Study on the Implementation of the Multi-Process Structured ISDN Terminal Adaptor for Sending the Ultra Sound Medical Images (다중처리 구조를 갖는 초음파 의료영상 전송용 ISDN(Integrated Services Digital Network) TA(Terminal Adaptor) 구현에 관한 연구)

  • 남상규;이영후
    • Journal of Biomedical Engineering Research
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    • v.15 no.3
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    • pp.317-324
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    • 1994
  • This paper proposed a new method in the implementation of ISDN (integrated services digital network) LAPD (link access procedure on the D-channel) and LAPB (link access procedure on the B-channel) protocols. The proposed method in this paper implement ISDW LAPD protocol through multi-tasking operating system and adopt a kernel part that is changed operating system to target board. The features of implemented system are (1) the para.llel processing of the events generated at each layer, as follows (2) the supporting necessary timers for the implementation of ISDW LAPD protocol from the kernel part by using software, (3) the recommanded SAP (Service Access Point) from CCITT was composed by using port function in the operating system. With the proposed method, the protocols of ISDH layerl, layer2 and layer3 (call control) were implemented by using the kernel part and related tests were carried out by connecting the ISDH terminal simulator to ISDN S-interface system using the ISDN LAPD protocol The results showed that ISDW S-interface terminals could be discriminated by TEI (Terminal Equipment Identifier) assignment in layer 2 (LAPD) and the message transmission of layer 3 was verified by establishing the multi-frame transmission and then through the path established by the LAPD protocol, a user data was tranfered and received on B-channel with LAPB protocol Thererfore, as new efficient ISDN S-interface environment was implemented in the thesis, it was verified that the implemented system can be utilized by connecting ISDW in the future to transfer a medical image data.

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A Study on the Comparison of Learning Performance in Capsule Endoscopy by Generating of PSR-Weigted Image (폴립 가중치 영상 생성을 통한 캡슐내시경 영상의 학습 성능 비교 연구)

  • Lim, Changnam;Park, Ye-Seul;Lee, Jung-Won
    • KIPS Transactions on Software and Data Engineering
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    • v.8 no.6
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    • pp.251-256
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    • 2019
  • A capsule endoscopy is a medical device that can capture an entire digestive organ from the esophagus to the anus at one time. It produces a vast amount of images consisted of about 8~12 hours in length and more than 50,000 frames on a single examination. However, since the analysis of endoscopic images is performed manually by a medical imaging specialist, the automation requirements of the analysis are increasing to assist diagnosis of the disease in the image. Among them, this study focused on automatic detection of polyp images. A polyp is a protruding lesion that can be found in the gastrointestinal tract. In this paper, we propose a weighted-image generation method to enhance the polyp image learning by multi-scale analysis. It is a way to extract the suspicious region of the polyp through the multi-scale analysis and combine it with the original image to generate a weighted image, that can enhance the polyp image learning. We experimented with SVM and RF which is one of the machine learning methods for 452 pieces of collected data. The F1-score of detecting the polyp with only original images was 89.3%, but when combined with the weighted images generated by the proposed method, the F1-score was improved to about 93.1%.

Mutual Authentication Method for Hash Chain Based Sensors in IoT Environment (IoT 환경에서 해시 체인 기반 센서 상호 인증 기법)

  • Lee, Kwang-Hyoung;Lee, Jae-Seung
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.19 no.11
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    • pp.303-309
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    • 2018
  • Internet of Things technology is an intelligent service that connects all objects to the Internet and interacts with them. It is a technology that can be used in various fields, such as device management, process management, monitoring of restricted areas for industrial systems, as well as for navigation in military theaters of operation. However, because all devices are connected to the Internet, various attacks using security vulnerabilities can cause a variety of damage, such as economic loss, personal information leaks, and risks to life from vulnerability attacks against medical services or for military purposes. Therefore, in this paper, a mutual authentication method and a key-generation and update system are applied by applying S/Key technology based on a hash chain in the communications process. A mutual authentication method is studied, which can cope with various security threats. The proposed protocol can be applied to inter-peer security communications, and we confirm it is robust against replay attacks and man-in-the-middle attacks, providing data integrity against well-known attacks in the IoT environment.

Development of Holter ECG Monitor with Improved ECG R-peak Detection Accuracy (R 피크 검출 정확도를 개선한 홀터 심전도 모니터의 개발)

  • Junghyeon Choi;Minho Kang;Junho Park;Keekoo Kwon;Taewuk Bae;Jun-Mo Park
    • Journal of the Institute of Convergence Signal Processing
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    • v.23 no.2
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    • pp.62-69
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    • 2022
  • An electrocardiogram (ECG) is one of the most important biosignals, and in particular, continuous ECG monitoring is very important in patients with arrhythmia. There are many different types of arrhythmia (sinus node, sinus tachycardia, atrial premature beat (APB), and ventricular fibrillation) depending on the cause, and continuous ECG monitoring during daily life is very important for early diagnosis of arrhythmias and setting treatment directions. The ECG signal of arrhythmia patients is very unstable, and it is difficult to detect the R-peak point, which is a key feature for automatic arrhythmias detection. In this study, we develped a continuous measuring Holter ECG monitoring device and software for analysis and confirmed the utility of R-peak of the ECG signal with MIT-BIH arrhythmia database. In future studies, it needs the validation of algorithms and clinical data for morphological classification and prediction of arrhythmias due to various etiologies.

An Empirical Study on the Economical Competition Factors of Internet Retailers (인터넷 소매상의 경제적 경쟁요인에 관한 실증연구)

  • 이수정;남순해;고석하
    • Proceedings of the Korea Society for Industrial Systems Conference
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    • 2002.11a
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    • pp.3-13
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    • 2002
  • 고석하 등(2002)은 인터넷 소매상이 상품 품목의 명목 가격과 배송료를 이용해서 고객의 일회 총 구매 비용을 조절한다는 것을 밝혔다. 고석하 등(2002)은 같은 내용의 상품 조합을 인터넷 시장에서 구매하기 위한 비용과 전통 시장에서 구매하기 위한 비용을 비교하였다. 분석 결과, 그 교호작용과 함께, 상품 종류와 일회 구매액/가격의 크기의 두 요소가 인터넷 시장의 전통 시장에 대한 총 구매비용 할인율의 변동의 약 60%내지 80%를 설명할 수 있다는 것을 보여주었다. 한편, 구매액/가격은 인터넷 시장에서의 해당 산포도(전통 시장의 그것에 대비한)에는 거의 영향을 미치지 못하며, 상품의 종류도 산포도에는 할인율에서와 같이 큰 영향을 미치지 않았다. 인터넷 시장의 가격이나 구매비용 산포도는 상품 특성이나 구매액 크기 이외의 다른 요인에 의해서 주로 영향을 받는 것으로 나타났다. 따라서, 본 논문에서는 가격 요인 이외의 경제적 경쟁요인에 관한 실증연구로서, 2002년 6월 17일부터 20일까지, 소프트웨어, PC와 주변기기, 휴대폰, 가전제품, CD, 화장품, 그리고 책의 7가지 산업 전문 쇼핑몰과 종합 쇼핑몰을 대상으로, 인터넷 시장에서 수행되고 있는 경제적인 비 가격 경쟁요인에 관한 실증 조사를 실시하였다. 조사 결과, 인터넷 시장에서 수행되고 있는 경제적인 비 가격 경쟁요인은 매우 다양하며, 상품별로도 다른 특성을 보이고 있는 것으로 밝혀졌다. 인터넷 소매상의 경제적인 비 가격 경쟁요인은 크게 배송료 면제와 배송료 외 인센티브 제도로 구분된다 본 논문에서는 경제적인 비 가격 경쟁요인의 모든 경우의 수를 고려할 수 있도록, 코드표를 작성하여 정리하고 분석하였다.전체 분석정보의 공유가 필수적으로 발생하게 됨으로, 유전체 정보와 임상정보의 통합은 미래 의료환경에 필수기능이 될 것이다. 3) 각 생명공학 연구소에서 사용하는 첨단 분석 장비와 생명공학 정보시스템의 자동 연계가 필요하다. 현재 국내에는 전국적인 초고속정보망이 가동되어 웹을 기반으로 하는 생명정보의 공유는 기술적으로 문제가 될 수 없으나 임상정보의 유전체연구에 그리고 유전체연구정보의 임상활용은 다양한 문제를 내포하고 있다. 이에 영상을 포함한 환자정보의 유전체연구센터와 병원정보시스템과의 효율적인 연계통합 운영을 위해 국내에서는 초기 도입단계에 있는 국제적인 보건의료정보의 표준인 Health Level 7 (textural information 공유), DICOM (image 및 wave 공유), 관련 ISO표준, WHO의 ICD9/10 (질병분류), LOINC (검사 및 관련용어), SNOMED International (의학용어) 등을 활용하여야 한다.matrix. The prediction system gives about 50% of sensitivity and 98% of specificity, Based on the PID matrix, we develop a system providing several interaction information-finding services in the Internet. The system, named PreDIN (Prediction-oriented Database of Interaction Network) provides interacting domain finding services and interacting protein

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Design and Implementation of an Intelligent Medical Expert System for TMA(Tissue Mineral Analysis) (TMA 분석을 위한 지능적 의학 전문가 시스템의 설계 및 구현)

  • 조영임;한근식
    • Journal of KIISE:Software and Applications
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    • v.31 no.2
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    • pp.137-152
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    • 2004
  • Assesment of 30 nutritional minerals and 8 toxic elements in hair are very important not only for determining adequacy, deficiencies and unbalance, but also for assessing their relative relationships in the body. A test has been developed that serves this purpose exceedingly well. This test is known as tissue mineral analysis(TMA). TMA is very popular method in hair mineral analysis for health care professionals in over 46 countries' medical center. However, there are some problems. First, they do not have database which is suitable for korean to do analyze. Second, as the TMA results from TEI-USA is composed of english documents and graphic files prohibited to open, its usability is very low. Third, some of them has low level database which is related to TMA, so hairs are sent to TEI-USA for analyzing and medical services. it bring about an severe outflow of dollars. Finally, TMA results are based on the database of american health and mineral standards, it is possibly mislead korean mineral standards. The purposes of this research is to develope the first Intelligent Medical Expert System(IMES) of TMA, in Korea, which makes clear the problems mentioned earlier IMES can analyze the tissue mineral data with multiple stage decision tree classifier. It is also constructed with multiple fuzzy rule base and hence analyze the complex data from Korean database by fuzzy inference methods. Pilot test of this systems are increased of business efficiency and business satisfaction 86% and 92% respectively.

Importance and requirements for dental prosthesis order platform services: a survey of dental professionals (치과 보철물 거래 플랫폼 서비스의 중요성과 요구사항: 치과 전문가 설문조사)

  • Gyu-Ri Kim;Keunbada Son;Du-Hyeong Lee;So-Yeun Kim;Myoung-Uk Jin;Kyu-Bok Lee
    • Journal of Dental Rehabilitation and Applied Science
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    • v.39 no.3
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    • pp.105-118
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    • 2023
  • Purpose: This study aimed to gain better understanding of the importance of dental prosthesis order platform services and to identify the essential elements for their enhancement and wider adoption among dental professionals. Materials and Methods: A survey was conducted to assess the perspectives of dentists, dental technicians, dental hygienists, and dental industry professionals toward dental prosthesis ordering and associated platform services (a total of 53 respondents). The questionnaire was devised after an expert review and assessed for reliability using Cronbach's alpha coefficient. Factor analysis revealed that 57 factors across five categories accounted for 88.417% of the total variance. The survey was administered through an online questionnaire platform, and data analysis was conducted using a statistical software, employing one-way analysis of variance and Tukey's honestly significant difference test (α = 0.05). Results: The essential elements identified were accurate information input, effective communication, delivery of distortion-free impressions, convenience in data transmission and storage, development of stable and affordable platform services (P < 0.05). Furthermore, significant differences were observed in the importance of these items based on age, dental profession, and career experience (P < 0.05). Conclusion: The dental prosthesis ordering platform services, the requirements of dental personnel were stability, economic efficiency, and ease of transmitting and storing prosthesis data. The findings can serve as important indicators for the development and improvement of dental prosthesis order platform services.

Ex vivo Morphometric Analysis of Coronary Stent using Micro-Computed Tomography (미세단층촬영기법을 이용한 관상동맥 스텐트의 동물 모델 분석)

  • Bae, In-Ho;Koh, Jeong-Tae;Lim, Kyung-Seob;Park, Dae-Sung;Kim, Jong-Min;Jeong, Myung-Ho
    • Journal of the Korean Society of Radiology
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    • v.6 no.2
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    • pp.93-98
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    • 2012
  • Micro-computed tomography (microCT) is an important tool for preclinical vascular imaging, with micron-level resolution. This non-destructive means of imaging allows for rapid collection of 2D and 3D reconstructions to visualize specimens prior to destructive analysis such as pathological analysis. Objectives. The aim of this study was to suggest a method for ex vivo, postmortem examination of stented arterial segments with microCT. And ex vivo evaluation of stents such as bare metal or drug eluting stents on in-stent restenosis (ISR) in rabbit model was performed. The bare metal stent (BMS) and drug eluting stent (DES, paclitaxel) were implanted in the left or right iliac arteries alternatively in eight New Zealand white rabbits. After 4 weeks of post-implantation, the part of iliac arteries surrounding the stent were removed carefully and processed for microCT. Prior to microCT analysis, a contrast medium was loaded to lumen of stents. All samples were subjected to an X-ray source operating at 50 kV and 200 ${\mu}A$ by using a 3D isotropic resolution. The region of interest was traced and measured by CTAN analytical software. Objects being exposed to radiation had different Hounsfield unit each other with values of approximately 1.2 at stent area, 0.12 ~ 0.17 at a contrast medium and 0 ~ 0.06 at outer area of stent. Based on above, further analyses were performed. As a result, the difference of lengths and volumes between expanded stents, which may relate to injury score in pathological analysis, was not different significantly. Moreover, ISR area of BMS was 1.6 times higher than that of DES, indicating that paclitaxel has inhibitory effect on cell proliferation and prevent infiltration of restenosis into lumen of stent. And ISR area of BMS was higher ($1.52{\pm}0.48mm^2$) than that of DES ($0.94{\pm}0.42mm^2$), indicating that paclitaxel has inhibitory effect on cell proliferation and prevent infiltration of restenosis into lumen of stent. Though it was not statistically significant, it showed that the extent of neointema of mid-region of stents was relatively higher than that of anterior and posterior region in parts of BMS as showing cross-sectional 2-D image. suggest that microCT can be utilized as an accessorial tool for pathological analysis.