• Title/Summary/Keyword: Software as Medical Device

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Software Platform for Stability Assure of Sensor Network in u-Health Environment (유헬스 환경에서 센서네트워크의 안정성 보장을 위한 소프트웨어 플랫폼)

  • Jung, Min Woo;Cho, Jeonghun
    • IEMEK Journal of Embedded Systems and Applications
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    • v.7 no.5
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    • pp.219-226
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    • 2012
  • The rises of the life index quality together with the medical technology improvement lead to a longer life expectancy. Then a better health care program, especially for elderly, is needed. The common health problems facing those senior citizens are changed from acute diseases to chronic diseases, such as diabetes, hypertension. Then u-Health takes center stage in medical industry. Although u- Health medical device manufacturers have been improving their instruments, these instruments still rely on proprietary technologies without fixed platform. Even if the interface has been provided by the manufacturer, there is no widely-accepted uniform data model to access data of various u-Health devices. IEEE 11073 is a standard attempting to unify the interfaces of all medical devices. In this paper we have proposed a conversion software platform that assures interoperability among medical devices for ubiquitous sensor network. This module uses in order to develop a standard platform of medical system.

Electropulsegraph and Wave Classification Framework (Electropulsegraph 및 파형분류 프레임워크)

  • Park, JinSoo;Choi, Dong Hag;Min, Se Dong;Park, Doo-Soon
    • Annual Conference of KIPS
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    • 2015.10a
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    • pp.1388-1389
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    • 2015
  • Electropulsegraphy is a medical device that was invented by an orient medical physician and a few engineers to help the physicians to diagnose patients in more systematic way by analyzing waveforms generated from the device. Data generated form the device has been collected for over several decades, and undergoes functional upgrades today. The device generates 33 waveforms that reflect the states of patients. As one of those upgrading efforts, we strive to develop an intelligent algorithm that makes the diagnostic process automatically, which was previously done manually for a long period of time. The logistic regression algorithm is used for our classification problems, which is one of those well-known algorithms for various classification problems such as character recognition systems. Out of the 33 waveforms, we only use 5 waveform data (Type1 toType5) as training data sets to estimate the parameters of the logistic regression. And the parameters are used to classify waveform inputs chosen at random.

A Study on the Development of Abnormal Power Source Generator to Evaluate Electronic Appliances (시험용 이상전원(異狀電源) 발생장치의 개발에 관한 연구)

  • Park, Chan-Won;Rho, Jea-Kwan
    • Journal of Industrial Technology
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    • v.24 no.A
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    • pp.83-90
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    • 2004
  • Generally, electronic appliances are used on the basis of normal power source supply. The power source inevitably includes the abnormal condition, such as, sudden voltage sagging, power interrupt, and induced noises. As the electronic appliances which include micro-controller-based circuits are being increased recently, the controller circuit sometimes malfunctions by the abnormal condition of the power source. This situation causes serious problems such as hitch of electric appliance, fire and medical instrument glitch, which produces serious situations. In this paper, development of power interrupt tester which is highly suitable for an endurance test device under abnormal power source to microprocessor-based circuits is proposed 89C2051 microcontroller is performed to make power interrupt signal, and software controls peripheral hardwares and built-in functions. Experimental results of this study will offer a good application to electronic appliance maker as a test device of hardware and software debugging use.

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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.

A Distributed Coexistence Mitigation Scheme for IoT-Based Smart Medical Systems

  • Kim, BeomSeok
    • Journal of Information Processing Systems
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    • v.13 no.6
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    • pp.1602-1612
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    • 2017
  • Since rapidly disseminating of Internet of Things (IoT) as the new communication paradigm, a number of studies for various applications is being carried out. Especially, interest in the smart medical system is rising. In the smart medical system, a number of medical devices are distributed in popular area such as station and medical center, and this high density of medical device distribution can cause serious performance degradation of communication, referred to as the coexistence problem. When coexistence problem occurs in smart medical system, reliable transmitting of patient's biological information may not be guaranteed and patient's life can be jeopardized. Therefore, coexistence problem in smart medical system should be resolved. In this paper, we propose a distributed coexistence mitigation scheme for IoT-based smart medical system which can dynamically avoid interference in coexistence situation and can guarantee reliable communication. To evaluate the performance of the proposed scheme, we perform extensive simulations by comparing with IEEE 802.15.4 MAC protocol which is a traditional low-power communication technology.

Key Principles of Clinical Validation, Device Approval, and Insurance Coverage Decisions of Artificial Intelligence

  • Seong Ho Park;Jaesoon Choi;Jeong-Sik Byeon
    • Korean Journal of Radiology
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    • v.22 no.3
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    • pp.442-453
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    • 2021
  • Artificial intelligence (AI) will likely affect various fields of medicine. This article aims to explain the fundamental principles of clinical validation, device approval, and insurance coverage decisions of AI algorithms for medical diagnosis and prediction. Discrimination accuracy of AI algorithms is often evaluated with the Dice similarity coefficient, sensitivity, specificity, and traditional or free-response receiver operating characteristic curves. Calibration accuracy should also be assessed, especially for algorithms that provide probabilities to users. As current AI algorithms have limited generalizability to real-world practice, clinical validation of AI should put it to proper external testing and assisting roles. External testing could adopt diagnostic case-control or diagnostic cohort designs. A diagnostic case-control study evaluates the technical validity/accuracy of AI while the latter tests the clinical validity/accuracy of AI in samples representing target patients in real-world clinical scenarios. Ultimate clinical validation of AI requires evaluations of its impact on patient outcomes, referred to as clinical utility, and for which randomized clinical trials are ideal. Device approval of AI is typically granted with proof of technical validity/accuracy and thus does not intend to directly indicate if AI is beneficial for patient care or if it improves patient outcomes. Neither can it categorically address the issue of limited generalizability of AI. After achieving device approval, it is up to medical professionals to determine if the approved AI algorithms are beneficial for real-world patient care. Insurance coverage decisions generally require a demonstration of clinical utility that the use of AI has improved patient outcomes.

A Safety Process Guideline of Medical Device System Based on STPA (STPA를 적용한 의료기기 시스템의 안전성 프로세스 가이드라인)

  • Choi, Bo-yoon;Lee, Byong-gul
    • Journal of Internet Computing and Services
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    • v.22 no.6
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    • pp.59-69
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    • 2021
  • Malfunctions and failures linked to medical devices may result in significant damage for human being. Thus, in order to ensure that safety of medical device is achieved, it should be established and applied the international standard. It is required to integrate and customize activities at standards, owing to reference relationship between standards, especially, activities based safety analysis is too expensive. This paper proposes a integration process that integrate activities of development lifecycle and safety process. Additionally, we derived a guidance based on STPA for integration process. As a result, we can be performed systematically from early stage of the development and increased effectiveness of integration process by the guidance.

A Study on Implementation of System Improvement for Medical Information Processing (의료정보처리를 위한 시스템 개선에 관한 연구)

  • Yoo, Jinho
    • Journal of Digital Convergence
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    • v.14 no.11
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    • pp.283-288
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    • 2016
  • This research is to study IoT based implementation of system and network for medical information processing. This paper's configuration environment consists of sensor node, gateway and server node as a basic IoT architecture. Medical terminal as a sensor node asks connect request to his server, and the server accepts the request if the medical device is already registered. Wearable medical device sends its collected sensing data to server, and server processes the received data for data visualization or saves them for usage in the future. This paper describes overall processes and their algorithms and suggests their software processing architecture.

Implementation of Dynamic Situation Authentication System for Accessing Medical Information (의료정보 접근을 위한 동적상황인증시스템의 구현)

  • Ham, Gyu-Sung;Seo, Own-jeong;Jung, Hoill;Joo, Su-Chong
    • Journal of Internet Computing and Services
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    • v.19 no.6
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    • pp.31-40
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    • 2018
  • With the development of IT technology recently, medical information systems are being constructed in an integrated u-health environment through cloud services, IoT technologies, and mobile applications. These kinds of medical information systems should provide the medical staff with authorities to access patients' medical information for emergency status treatments or therapeutic purposes. Therefore, in the medical information systems, the reliable and prompt authentication processes are necessary to access the biometric information and the medical information of the patients in charge of the medical staff. However, medical information systems are accessing with simple and static user authentication mechanism using only medical ID / PWD in the present system environment. For this reason, in this paper, we suggest a dynamic situation authentication mechanism that provides transparency of medical information access including various authentication factors considering patient's emergency status condition and dynamic situation authentication system supporting it. Our dynamic Situation Authentication is a combination of user authentication and mobile device authentication, which includes various authentication factor attributes such as emergency status, role of medical staff, their working hours, and their working positions and so forth. We designed and implemented a dynamic situation authentication system including emergency status decision, dynamic situation authentication, and authentication support DB construction. Finally, in order to verify the serviceability of the suggested dynamic situation authentication system, the medical staffs download the mobile application from the medical information server to the medical staff's own mobile device together with the dynamic situation authentication process and the permission to access medical information to the patient and showed access to medical information.

Determination of Flow Rate and Stability of 5-Fluorouracil in Disposal Infusion Device, $Anapa^{(R)}$ (일회용 약물 주입기구를 이용한 5-Fluorouracil의 지속주입효과와 용기 내 안정성 평가)

  • Kim, Jung-Tae;Chung, Sung-Hyun
    • Korean Journal of Clinical Pharmacy
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    • v.19 no.1
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    • pp.65-68
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    • 2009
  • Disposal infusion device is known to be useful for chemotherapy. Anti-cancer drug can be released by the force of carbon dioxide or balloon. In this study, we compared the$Anapa^{(R)}$ (LC0020) with B Company (LV2 ml) in terms of infusion rate and stability. Infusion rate was determined every six minute using software, MSI08IH. Stability of 5-fluorouracil was examined periodically using a High Performance Liquid Chromatography. Infusion rates of gas-derived $Anapa^{(R)}$ device were 2.29, 1.86, 1.98 ml/hr and those of balloon-derived B Company device were 1.71, 1.58, 1.37 ml/min. There were no significant differences in stability of 5-fluorouracil between $Anapa^{(R)}$ and B Company devices. In summary, gas-derived $Anapa^{(R)}$ device is thought to be comparable or superior to balloon-derived B Company device as far as infusion rate and stability are concerned. We expect that $Anapa^{(R)}$ as a home infusion device can be employed to improve a quality of life and compliance of cancer patients.

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