• Title/Summary/Keyword: risk process

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Development of Guideline for Heuristic Based Usability Evaluation on SaMD (SaMD에 대한 휴리스틱 기반 사용적합성 평가 가이드라인 개발)

  • Jong Yeop Kim;Junghyun Kim;Zero Kim;Myung Jin Chung
    • Journal of Biomedical Engineering Research
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    • v.44 no.6
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    • pp.428-442
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    • 2023
  • In this study, we have a goal to develop usability evaluation guidelines for heuristic-based artificial intelligence-based Software as a Medical Device (SaMD) in the medical field. We conducted a gap analysis between medical hardware (H/W) and non-medical software (S/W) based on ten heuristic principles. Through severity assessments, we identified 69 evaluation domains and 112 evaluation criteria aligned with the ten heuristic principles. Subsequently, we categorized each evaluation domain into five types, including user safety, data integrity, regulatory compliance, patient therapeutic effectiveness, and user convenience. We proposed usability evaluation guidelines that apply the newly derived heuristic-based Software as a Medical Device (SaMD) evaluation factors to the risk management process. In the discussion, we also have proposed the potential applications of the research findings and directions for future research. We have emphasized the importance of the judicious application of AI technology in the medical field and the evaluation of usability evaluation and offered valuable guidelines for various stakeholders, including medical device manufacturers, healthcare professionals, and regulatory authorities.

A Study on the Application for Domestic Remote Operator Licensing System for Maritime Autonomous Surface Ships Using the AHP (AHP를 활용한 자율운항선박 원격운영자의 국내 면허체계 적용방안에 관한 연구)

  • HanKyu PARK;MinJae HA
    • Journal of the Korean Society of Marine Environment & Safety
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    • v.29 no.6
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    • pp.628-638
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    • 2023
  • Maritime Autonomous Surface ships(MASS) are gradually gaining importance. Until fully autonomous ships are developed, they will likely be controlled by remote operators who are based in a Remote Operations Center. However, there is currently no internationally or domestically established licensing for them. This issue can potentially pose a risk to navigation safety due to operations being handled by unqualified remote operators. We conducted a literature review and proposed criteria for the adoption of a licensing system for remote operators. We have futher offered alternatives to integrate this license into the existing officer licensing system, and analyzed them using Analytic Hierarchy Process(AHP). Subsequently,, theprimary need to enact legislation for remote operators is observed. The most preferred approach is to include the occupation of a remote operator in the Ship Officer Act, Article 4: Occupational Categories and Class of Licenses. Therefore, it would be logical for the organizational structure of the Remote Operation Center to mirror the traditional Bridge Resource Management. This study will contribute to the efficient training of remote operators and the safe navigation of autonomous ships with a focus on human resource management.

Students' Performance Prediction in Higher Education Using Multi-Agent Framework Based Distributed Data Mining Approach: A Review

  • M.Nazir;A.Noraziah;M.Rahmah
    • International Journal of Computer Science & Network Security
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    • v.23 no.10
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    • pp.135-146
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    • 2023
  • An effective educational program warrants the inclusion of an innovative construction which enhances the higher education efficacy in such a way that accelerates the achievement of desired results and reduces the risk of failures. Educational Decision Support System (EDSS) has currently been a hot topic in educational systems, facilitating the pupil result monitoring and evaluation to be performed during their development. Insufficient information systems encounter trouble and hurdles in making the sufficient advantage from EDSS owing to the deficit of accuracy, incorrect analysis study of the characteristic, and inadequate database. DMTs (Data Mining Techniques) provide helpful tools in finding the models or forms of data and are extremely useful in the decision-making process. Several researchers have participated in the research involving distributed data mining with multi-agent technology. The rapid growth of network technology and IT use has led to the widespread use of distributed databases. This article explains the available data mining technology and the distributed data mining system framework. Distributed Data Mining approach is utilized for this work so that a classifier capable of predicting the success of students in the economic domain can be constructed. This research also discusses the Intelligent Knowledge Base Distributed Data Mining framework to assess the performance of the students through a mid-term exam and final-term exam employing Multi-agent system-based educational mining techniques. Using single and ensemble-based classifiers, this study intends to investigate the factors that influence student performance in higher education and construct a classification model that can predict academic achievement. We also discussed the importance of multi-agent systems and comparative machine learning approaches in EDSS development.

AN APPROACH FOR ESTIMATING TOTAL COST OF OCCUPATIONAL SAFETY FOR BUILDING CONSTRUCTIONS

  • Gurkan Emre Gurcanli;Nesimi Teoman Korkutan;Ugur Mungen
    • International conference on construction engineering and project management
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    • 2011.02a
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    • pp.168-175
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    • 2011
  • Construction accidents are major problem in Turkish Construction industry and especially fatally rates are very high. Current legislative system on occupational safety in Turkey enforces employers to implement safety measures as well as safety management systems. However level of consciousness in the industry is unsatisfactory and safety are perceived as extra cost and unnecessary expenditure. Moreover, especially in small residential building constructions which have a big share in the industry and unfortunately safety measures to mitigate or abate construction risks do not exist. The study focuses on small residential building construction sites and in the scope of this study, thirty building projects are examined. For each building project, project cost including labour and material costs, service and consultancy costs for mechanical, electrical systems as well as architectural and structural services, costs for supervision and finally general expenditures for construction site facilities were calculated. On the other hand, occupational safety costs for personal protective equipment, collective protective measures, consultancy and training were determined. Work breakdown structures were established and for each work item firstly occupational risks were evaluated and furthermore according to risk scores safety measures to be implemented were defined and related costs were calculated. The study gave results for total safety cost on average, in terms of percentage of total project cost (3.73% of total project cost), safety cost per man-hour (0.40 USD) and safety cost in terms of unit construction area (11.60 USD per square meter). Since safety management is a part of whole project management process, study gives suggestions and techniques to calculate safety costs and implement safety measures as a part of project management service for professionals. Authors believe that suggested approach may easily developed by the usage of more data to establish a model for estimation not only for building construction sites but also for all construction projects.

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A Study on Crack of Hydrogen Filling Pressure Vessel Using Finite Element Method (유한요소법을 이용한 수소충전용 압력용기의 균열에 관한 연구)

  • Ha Young Choi;Sung Kwang Byon;Seunghyun Cho
    • Journal of the Korean Institute of Gas
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    • v.27 no.3
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    • pp.116-122
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    • 2023
  • As the number of hydrogen filling stations for hydrogen supply increases with the progress of low-carbon eco-friendly energy policies, the risk of accidents is also increasing. Actual pressure vessels may have defects such as notches, pores, and inclusions that may occur during the manufacturing process. Therefore, it is necessary to evaluate the integrity of pressure vessels in the case where cracks exist in pressure vessels under internal pressure. In this paper, 3D finite element analysis was used to evaluate the structural safety of hydrogen-filled pressure vessels with surface cracks, and the shape of surface cracks was compared with the commonly used semi-elliptical shape. In the future, these results will be used to predict the remaining life of the pressure vessel in consideration of fracture mechanics.

Development of Highly Efficient Oil-Water Separation Materials Utilizing the Self-Bonding and Microstructuring Characteristics of Aluminum Nitride Nanopowders (질화알루미늄 나노분말의 자가 접착과 미세구조화 특성을 활용한 고효율 유수분리 소재 개발)

  • Heon-Ju Choi;Handong Cho
    • Journal of the Korean Society of Industry Convergence
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    • v.27 no.3
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    • pp.601-607
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    • 2024
  • The discharge of oily wastewater into water bodies and soil poses a serious hazard to the environment and public health. Various conventional techniques have been employed to treat oil-water mixtures and emulsions; Unfortunately, these approaches are frequently expensive, time-consuming, and unsatisfactory outcomes. Porous materials and adsorbents are commonly used for purification, but their use is limited by low separation efficiencies and the risk of secondary contamination. Recent advancements in nanotechnology have driven the development of innovative materials and technologies for oil-contaminated wastewater treatment. Nanomaterials can offer enhanced oil-water separation properties due to their high surface area and tunable surface chemistry. The fabrication of nanofiber membranes with precise pore sizes and surface properties can further improve separation efficiency. Notably, novel technologies have emerged utilizing nanomaterials with special surface wetting properties, such as superhydrophobicity, to selectively separate oil from oil-water mixtures or emulsions. These special wetting surfaces are promising for high-efficiency oil separation in emulsions and allow the use of materials with relatively large pores, enhancing throughput and separation efficiency. In this study, we introduce a facile and scalable method for fabrication of superhydrophobic-superoleophilic felt fabrics for oil/water mixture and emulsion separation. AlN nanopowders are hydrolyzed to create the desired microstructures, which firmly adhere to the fabric surface without the need for a binder resin, enabling specialized wetting properties. This approach is applicable regardless of the material's size and shape, enabling efficient separation of oil and water from oil-water mixtures and emulsions. The oil-water separation materials proposed in this study exhibit low cost, high scalability, and efficiency, demonstrating their potential for broad industrial applications.

Changes and Perspects in the Regulation on Medical Device Approval Report Review, etc. : Focus on Traditional Korean Medical Devices (의료기기 허가·신고·심사 등에 관한 규정 변화와 전망 : 한의 의료기기 중심으로)

  • DaeJin Kim;Byunghee Choi;Taeyeung Kim;Sunghee Jung;Woosuk Kang
    • Journal of Society of Preventive Korean Medicine
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    • v.28 no.1
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    • pp.31-42
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    • 2024
  • Objective : In order to understand the changes in domestic approval regulations applicable to traditional Korean medical device companies, this article will explain the major amendments 「Regulation on Medical Device Approval Report Review, etc.」 from 2005 to the present on a year-by-year basis, and provide a counter plan to the recent changes in approval regulations. Methods : We analysed the changes in approval regulatory amendments related to the traditional Korean medical devices from 2005 to the present. Results : The Ministry of Food and Drug Safety is continuously improving medical device approval regulations to ensure the global competitiveness of domestic medical devices and contribute to the improvement of public health. Recent major approval regulatory amendments include the establishment of a review system for software medical devices and digital therapeutics, the recognition of real world evidence materials, the introduction of a biological evaluation of medical devices within a risk management process and a medical device approval licence renewal system. Conclusions : It is expected that the range of medical devices available to Korean medicine doctors will continue to expand in the future through the provision of non-face-to-face medical services and the development of advanced and new medical devices, as well as wearable medical devices and digital therapeutics. In order to increase the market entry potential of traditional Korean medical devices that incorporate advanced technologies such as digital technology and AI-based diagnosis and prediction technology, it is urgent that the government provide significant support to traditional Korean medical device companies to improve approval regulatory compliance.

Lessons from constructing and operating the national ecological observatory network

  • Christopher McKay
    • Journal of Ecology and Environment
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    • v.47 no.4
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    • pp.187-192
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    • 2023
  • The United States (US) National Science Foundation's (NSF's) National Ecological Observatory Network (NEON) is a continental-scale observation facility, constructed and operated by Battelle, that collects long-term ecological data to better understand and forecast how US ecosystems are changing. All data and samples are collected using standardized methods at 81 field sites across the US and are freely and openly available through the NEON data portal, application programming interface (API), and the NEON Biorepository. NSF led a decade-long design process with the research community, including numerous workshops to inform the key features of NEON, culminating in a formal final design review with an expert panel in 2009. The NEON construction phase began in 2012 and was completed in May 2019, when the observatory began the full operations phase. Full operations are defined as all 81 NEON sites completely built and fully operational, with data being collected using instrumented and observational methods. The intent of the NSF is for NEON operations to continue over a 30-year period. Each challenge encountered, problem solved, and risk realized on NEON offers up lessons learned for constructing and operating distributed ecological data collection infrastructure and data networks. NEON's construction phase included offices, labs, towers, aquatic instrumentation, terrestrial sampling plots, permits, development and testing of the instrumentation and associated cyberinfrastructure, and the development of community-supported collection plans. Although colocation of some sites with existing research sites and use of mostly "off the shelf" instrumentation was part of the design, successful completion of the construction phase required the development of new technologies and software for collecting and processing the hundreds of samples and 5.6 billion data records a day produced across NEON. Continued operation of NEON involves reexamining the decisions made in the past and using the input of the scientific community to evolve, upgrade, and improve data collection and resiliency at the field sites. Successes to date include improvements in flexibility and resilience for aquatic infrastructure designs, improved engagement with the scientific community that uses NEON data, and enhanced methods to deal with obsolescence of the instrumentation and infrastructure across the observatory.

Online Network Analysis of the Impact of Local Market-based Communities on Regional Revitalization (시골장터 기반 로컬 커뮤니티가 지역활성화에 미치는 영향에 대한 온라인 네트워크 분석)

  • Park, Jeong Sun;Park, Sang Hyeok;Oh, Seung Hee
    • The Journal of Information Systems
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    • v.33 no.1
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    • pp.45-68
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    • 2024
  • Purpose This paper examines the role of local market-based communities in driving regional revitalization, using detailed analysis of online networks. We aim to dissect a local community's communication network, highlighting members with high engagement levels and exploring their characteristics. Our goal is to identify the conditions that allow local community networks to grow independently and to demonstrate how the activation of these networks contributes to regional revitalization. Design/methodology/approach We employ a mixed-methods approach, combining social network analysis with statistical techniques to investigate the structure of online communication networks. Specifically, we use ANOVA to determine the statistical significance of our findings, ensuring their reliability. To complement our quantitative data, we include qualitative insights from interviews, adding depth and context to our analysis. Findings Our results show that individuals with high centrality in the online network are crucial for maintaining active local communities. We find that leveraging local resources to create a supportive and adaptable environment is essential for the communities' sustainability and expansion. Importantly, our research draws a direct connection between the vitality of local community networks and the broader process of regional revitalization. We argue that energizing local communities is an effective way to address the risk of regional decline. By integrating quantitative analysis with qualitative feedback, this study contributes to the understanding of local market-based communities as key drivers of regional development. It emphasizes the importance of building vibrant, resourceful community networks to revitalize areas experiencing socio-economic challenges.

Privacy model for DTC genetic testing using fully homomorphic encryption (동형암호를 활용한 DTC유전자검사 프라이버시모델)

  • Hye-hyeon Jin;Chae-ry Kang;Seung-hyeon Lee;Gee-hee Yun;Kyoung-jin Kim
    • Convergence Security Journal
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    • v.24 no.2
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    • pp.133-140
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    • 2024
  • The spread of Direct-to-Consumer (DTC) genetic testing, where users request tests directly, has been increasing. With growing demand, certification systems have been implemented to grant testing qualifications to non-medical institutions, and the scope of tests has been expanded. However, unlike cases in less regulated foreign countries, disease-related tests are still excluded from the domestic regulations. The existing de-identification method does not adequately ensure the uniqueness and familial sharing of genomic information, limiting its practical utility. Therefore, this study proposes the application of fully homomorphic encryption in the analysis process to guarantee the usefulness of genomic information while minimizing the risk of leakage. Additionally, to safeguard the individual's right to self-determination, a privacy preservation model based on Opt-out is suggested. This aims to balance genomic information protection with maintainability of usability, ensuring the availability of information in line with the user's preferences.