• Title/Summary/Keyword: regulatory guidelines

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Study on the Impact of XAI Explanation Levels on Cognitive Load and User Satisfaction : Focusing on Risk Levels in Financial AI Systems

  • No-Ah Han;Yoo-Jin Hwang;Zoon-Ky Lee
    • Journal of the Korea Society of Computer and Information
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    • v.29 no.9
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    • pp.49-59
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    • 2024
  • In this paper, we examine the impact of XAI explanations on user satisfaction and cognitive load according to the risk levels defined in the EU AI Act. XAI aims to make the internal processes of complex AI models understandable to humans and is widely used in both academia and industry. The importance and value of XAI are continuously rising; however, there has been little research determining the necessary level of explanation according to AI system risk levels. To address this gap, we designed an experiment with 120 participants, divided into 8 groups, each exposed to one of four levels of explainability(XAI) within low-risk and high-risk financial AI systems. A quantitative approach was used to measure cognitive load, user satisfaction, mental effort, and the clarity of the material design across the different AI system interfaces. The results indicate that the amount of information in explanations significantly affects cognitive load and user satisfaction, depending on the risk level. However, the impact of the level of explanation on user satisfaction was mediated by the material design, which determined how easily the information was understood. This research provides practical, regulatory, and academic contributions by offering guidelines for determining the necessary level of explanation based on AI system risk levels.

Revision of The Korean Pharmceutical Codex, The Third Edition (의약품 등 기준 및 시험방법(제 3개정) 소개)

  • Choi, Myoeng-Sin;Yang, Ji-Sun;Yoo, Tae-Moo;Kim, In-Kyu;Kim, Hye-Soo;Lee, Sun-Hee;Chang, Seung-Yeup;Cho, Jung-Hee;Lee, Su-Jung;Kim, Young-Lim;Kim, Mi-Jeong;Kim, Eun-Jung;Lee, Jong-Pil;Kim, Do-Hoon;Baek, Kyung-Min;Kim, Hee-Sung;Park, Sang-Aeh;Kang, In-Ho;Kim, Eun-Kyung
    • Journal of Pharmaceutical Investigation
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    • v.35 no.3
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    • pp.201-205
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    • 2005
  • The aim of publishing the Korean Pharmaceutical Codex is to update and set specification of essential drugs for humane health. In accordance with speedy development of new drugs and improvement of science and technology, the need of revision of drug specification through the ICH guidelines and discussions between regulatory agency and pharmaceutical industry for the quality assurance of safer and efficient drugs is getting higher. The first edition of Korean Pharmaceutical Codex was published in 1983. Now, the third revision of the Codex is prepared because of the revision of domestic and foreign Pharmacopeias, changes of drug control environment, improvement of science and technology and so on. The aim of 3th edition is to improve the quality of essential drugs through the setting of the required specifications and discussions between the regulatory agency and pharmaceutical industry.

Reviews of Radiation Protection and Shielding for Computed Tomography in Foreign Countries (외국의 컴퓨터 단층촬영 장치의 방어시설 문헌 조사)

  • Jahng, Geon-Ho;Yang, Dal-Mo;Sung, Dong-Wook;Lee, Kwang-Yong;Kim, Hyeog-Ju
    • Progress in Medical Physics
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    • v.19 no.4
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    • pp.276-284
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    • 2008
  • A computed tomography (CT) is a powerful system for the effectively fast and accurate diagnosis. The CT system, therefore, has used substantially and developed for improving the performance over the past decade, resulting in growing concerns over the radiation dose from the CT. Advanced CT techniques, such as a multidetector row CT scanner and dual energy or dual source CT, have led to new clinical applications that could result in further increases of radiation does for both patients and workers. The objective of this study was to review the international guidelines of the shielding requirements for a CT facility required for a new installation or when modifying an existing one. We used Google Search Engine to search the following keywords: computed tomography, CT regulation or shield or protection, dual energy or dual source CT, multidetector CT, CT radiation protection, and regulatory or legislation or regulation CT. In addition, we searched some special websites, that were provided for sources of radiation protection, shielding, and regulation, RSNA, AAPM, FDA, NIH, RCR, ICRP, IRPA, ICRP, IAEA, WHO (See in Table 1 for full explanations of the abbreviations). We finally summarized results of the investigated materials for each country. The shielding requirement of the CT room design was very well documented in the countries of Canada, United States of America, and United Kingdom. The wall thickness of the CT room could be obtained by the iso-exposure contour or the point source method. Most of documents provided by international organizations were explained in importance of radiation reduction in patients and workers. However, there were no directly-related documents of shielding and patient exposure dose for the dual energy CT system. Based international guidelines, the guideline of the CT room shielding and radiation reduction in patients and workers should be specified for all kinds of CT systems, included in the dual energy CT. We proposed some possible strategies in this paper.

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Evaluation of Hydrogeological Characteristic of Natural Barrier in Korea for Establishing Safety Guidelines of Deep Geological High-Level Radioactive Waste Disposal Site (고준위방사성폐기물 심층처분 부지 수리 지질 안전 규제를 위한 국내 지질환경 수리 특성 평가)

  • Suwan So;Jiho Jeong;Jaesung Park;Hyeongmok Lee;Subi Lee;Sujin Kim;Sinda Mbarki;Jina Jeong
    • Economic and Environmental Geology
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    • v.57 no.4
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    • pp.397-416
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    • 2024
  • This study assessed the hydrogeological properties of the deep geological environment to develop safety criteria for the natural barriers used in the deep geological disposal of high-level radioactive waste in Korea. The assessment focused on the distribution and trends of hydraulic conductivity and permeability properties appropriate for the domestic geological environment, using various in-situ hydraulic test data collected for groundwater development and management. To develop a depth-hydrogeological property relationship model suitable for domestic conditions, the study reviewed various international research examples and applied a representative model that explains the trends of hydraulic conductivity and permeability with depth. The development of the model suitable for Korea involved applying ensemble regression analysis to account for the uncertainty of various factors in the collected data. The results confirmed that existing international depth-hydrogeological property relationship models adequately describe the characteristics of the domestic geological environment. Considering the preferred hydrogeological criteria suggested by countries like Sweden, Germany, and Canada, there is a high likelihood that a suitable geological environment exists in Korea. Additionally, the application of hydrogeological criteria indicative of low-permeability environments showed that suitable conditions for disposal construction increase at depths greater than 300 m, where the influence of fractures on groundwater flow might be minimal at depths exceeding 500 m. This research can serve as foundational information for establishing hydrogeological safety standards for natural barriers in Korea according to international regulatory guidelines.

A Basic Study on the Radiological Characteristics and Disposal Methods of NORM Wastes (공정부산물의 방사선적 특성과 처분방안에 관한 기본 연구)

  • Jeong, Jongtae;Baik, Min-Hoon;Park, Chung-Kyun;Park, Tae-Jin;Ko, Nak-Youl;Yoon, Ki Hoon
    • Journal of Nuclear Fuel Cycle and Waste Technology(JNFCWT)
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    • v.12 no.3
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    • pp.217-233
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    • 2014
  • Securing the radiological safety is a prerequisite for the safe management of the naturally occurring radioactive materials (NORM) which cannot be reused. This becomes a crucial focus of our R&D efforts upon the implementation of the Act on Protective Action Guidelines against Radiation in the Natural Environment. To secure the safety, the establishment of technical bases and procedures for securing radiological safety related to the disposal of NORM is required. Thus, it is necessary to analyze the characteristics, to collect the data, to have the radiological safety assessment methodologies and tools, to investigate disposal methods and facilities, and to study the effects of the input data on the safety for the NORM wastes. Here, we assess the environmental impact of the NORM waste disposal with respect to the major domestic and foreign NORM characteristics. The data associated with major industries are collected/analyzed and the status of disposal facilities and methodologies relevant to the NORM wastes is investigated. We also suggest the conceptual design concept of a landfill disposal facility and the management plan with respect to the major NORM wastes characteristics. The radionuclide pathways are identified for the atmospheric transport and leachate release and the environmental impact assessment methodology for the NORM waste disposal is established using a relevant code. The assessment and analysis on the exposure doses and excessive cancer risks for the NORM waste disposal are performed using the characteristics of the representative domestic NORM wastes including flying ash, phosphor gypsum, and redmud. The results show that the exposure dose and the excessive cancer risks are very low to consider any radiation effects. This study will contribute to development in the areas of the regulatory technology for securing radiological safety relevant to NORM waste disposal and to the implementation technology for the Act.

A Study on Practices and Improvement Factors of Financial Disclosures in early stages of IFRS Adoption - An Integrative Approach of Korean Cases: Embracing Views of Reporting Entities and Users of Financial Statements (IFRS 공시 실태 개선방안에 대한 소고 - 보고기업, 정보이용자 요인을 고려한 통합적 접근 -)

  • Kim, Hee-Suk
    • Asia-Pacific Journal of Business Venturing and Entrepreneurship
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    • v.7 no.2
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    • pp.113-127
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    • 2012
  • From the end of 1st quarter of 2012, Korean mandatory firms had started releasing financial reports conforming to the K-IFRS(Korean adopted International Financial Reporting Standards). Major characteristics of IFRS, such as 'principles based' features, consolidated reporting, 'fair value' measurement, increased pressure for non-financial disclosures have resulted in brief and various disclosure practices regarding the main body of each statements and vast amount of note description requirements. Meanwhile, a host of previous studies on IFRS disclosures have incorporated regulatory and/or 'compete information' perspectives, mainly focusing on suggesting further enforcement of strengthened requirements and providing guidelines for specific treatments. Thus, as an extension of prior findings and suggestions this study had explored to conduct an integrative approach embracing views of the reporting entities and the users of financial information. In spite of all the state-driven efforts for faithful representation and comparability of corporate financial reports, an overhaul of disclosure practices of fiscal year 2010 and 2011 had revealed numerous cases of insufficiency and discordance in terms of mandatory norms and market expectations. As to the causes of such shortcomings, this study identified several factors from the corporate side and the users of the information; some inherent aspects of IFRS, industry/corporate-specific context, expenditures related to internalizing IFRS system, reduced time frame for presentation. lack of clarity and details to meet the quality of information - understandability, comparability etc. - commonly requested by the user group. In order to improve current disclosure practices, dual approach had been suggested; Firstly, to encourage and facilitate implementation, (1) further segmentation and differentiation of mandates among companies, (2) redefining the scope and depth of note descriptions, (3) diversification and coordination of reporting periods, (4) providing support for equipping disclosure systems and granting incentives for best practices had been discussed. Secondly, as for the hard measures, (5) regularizing active involvement of corporate and user group delegations in the establishment and amendment process of K-IFRS (6) enforcing detailed and standardized disclosure on reporting entities had been recommended.

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Non-invasive Brain Stimulation and its Legal Regulation - Devices using Techniques of TMS and tDCS - (비침습적 뇌자극기술과 법적 규제 - TMS와 tDCS기술을 이용한 기기를 중심으로 -)

  • Choi, Min-Young
    • The Korean Society of Law and Medicine
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    • v.21 no.2
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    • pp.209-244
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    • 2020
  • TMS and tDCS are non-invasive devices that treat the diseases of patients or individual users, and manage or improve their health by applying stimulation to a brain through magnetism and electricity. The effect and safety of these devices have proved to be valid in several diseases, but research in this area is still much going on. Despite increasing cases of their application, legislations directly regulating TMS and tDCS are hard to find. Legal regulation regarding TMS and tDCS in the United States, Germany and Japan reveals that while TMS has been approved as a medical device with a moderate risk, tDCS has not yet earned approval as a medical device. However, the recent FDA guidance, European MDR changes, recalls in the US, and relevant legal provisions of Germany and Japan, as well as recommendations from expert groups all show signs of tDCS growing closer to getting approved as a medical device. Of course, safety and efficacy of tDCS can still be regulated as a general product instead of as a medical device. Considering multiple potential impacts on a human brain, however, the need for independent regulation is urgent. South Korea also lacks legal provisions explicitly regulating TMS and tDCS, but they fall into the category of the grade 3 medical devices according to the notifications of the Korean Ministry of Food and Drug Safety. And safety and efficacy of TMS are to be evaluated in compliance with the US FDA guidance. But no specific guidelines exist for tDCS yet. Given that tDCS devices are used in some hospitals in reality, and also at home by individual buyers, such a regulatory gap must quickly be addressed. In a longer term, legal system needs to be in place capable of independently regulating non-invasive brain stimulating devices.

An Empirical Study on the Influencing Factors for Big Data Intented Adoption: Focusing on the Strategic Value Recognition and TOE Framework (빅데이터 도입의도에 미치는 영향요인에 관한 연구: 전략적 가치인식과 TOE(Technology Organizational Environment) Framework을 중심으로)

  • Ka, Hoi-Kwang;Kim, Jin-soo
    • Asia pacific journal of information systems
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    • v.24 no.4
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    • pp.443-472
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    • 2014
  • To survive in the global competitive environment, enterprise should be able to solve various problems and find the optimal solution effectively. The big-data is being perceived as a tool for solving enterprise problems effectively and improve competitiveness with its' various problem solving and advanced predictive capabilities. Due to its remarkable performance, the implementation of big data systems has been increased through many enterprises around the world. Currently the big-data is called the 'crude oil' of the 21st century and is expected to provide competitive superiority. The reason why the big data is in the limelight is because while the conventional IT technology has been falling behind much in its possibility level, the big data has gone beyond the technological possibility and has the advantage of being utilized to create new values such as business optimization and new business creation through analysis of big data. Since the big data has been introduced too hastily without considering the strategic value deduction and achievement obtained through the big data, however, there are difficulties in the strategic value deduction and data utilization that can be gained through big data. According to the survey result of 1,800 IT professionals from 18 countries world wide, the percentage of the corporation where the big data is being utilized well was only 28%, and many of them responded that they are having difficulties in strategic value deduction and operation through big data. The strategic value should be deducted and environment phases like corporate internal and external related regulations and systems should be considered in order to introduce big data, but these factors were not well being reflected. The cause of the failure turned out to be that the big data was introduced by way of the IT trend and surrounding environment, but it was introduced hastily in the situation where the introduction condition was not well arranged. The strategic value which can be obtained through big data should be clearly comprehended and systematic environment analysis is very important about applicability in order to introduce successful big data, but since the corporations are considering only partial achievements and technological phases that can be obtained through big data, the successful introduction is not being made. Previous study shows that most of big data researches are focused on big data concept, cases, and practical suggestions without empirical study. The purpose of this study is provide the theoretically and practically useful implementation framework and strategies of big data systems with conducting comprehensive literature review, finding influencing factors for successful big data systems implementation, and analysing empirical models. To do this, the elements which can affect the introduction intention of big data were deducted by reviewing the information system's successful factors, strategic value perception factors, considering factors for the information system introduction environment and big data related literature in order to comprehend the effect factors when the corporations introduce big data and structured questionnaire was developed. After that, the questionnaire and the statistical analysis were performed with the people in charge of the big data inside the corporations as objects. According to the statistical analysis, it was shown that the strategic value perception factor and the inside-industry environmental factors affected positively the introduction intention of big data. The theoretical, practical and political implications deducted from the study result is as follows. The frist theoretical implication is that this study has proposed theoretically effect factors which affect the introduction intention of big data by reviewing the strategic value perception and environmental factors and big data related precedent studies and proposed the variables and measurement items which were analyzed empirically and verified. This study has meaning in that it has measured the influence of each variable on the introduction intention by verifying the relationship between the independent variables and the dependent variables through structural equation model. Second, this study has defined the independent variable(strategic value perception, environment), dependent variable(introduction intention) and regulatory variable(type of business and corporate size) about big data introduction intention and has arranged theoretical base in studying big data related field empirically afterwards by developing measurement items which has obtained credibility and validity. Third, by verifying the strategic value perception factors and the significance about environmental factors proposed in the conventional precedent studies, this study will be able to give aid to the afterwards empirical study about effect factors on big data introduction. The operational implications are as follows. First, this study has arranged the empirical study base about big data field by investigating the cause and effect relationship about the influence of the strategic value perception factor and environmental factor on the introduction intention and proposing the measurement items which has obtained the justice, credibility and validity etc. Second, this study has proposed the study result that the strategic value perception factor affects positively the big data introduction intention and it has meaning in that the importance of the strategic value perception has been presented. Third, the study has proposed that the corporation which introduces big data should consider the big data introduction through precise analysis about industry's internal environment. Fourth, this study has proposed the point that the size and type of business of the corresponding corporation should be considered in introducing the big data by presenting the difference of the effect factors of big data introduction depending on the size and type of business of the corporation. The political implications are as follows. First, variety of utilization of big data is needed. The strategic value that big data has can be accessed in various ways in the product, service field, productivity field, decision making field etc and can be utilized in all the business fields based on that, but the parts that main domestic corporations are considering are limited to some parts of the products and service fields. Accordingly, in introducing big data, reviewing the phase about utilization in detail and design the big data system in a form which can maximize the utilization rate will be necessary. Second, the study is proposing the burden of the cost of the system introduction, difficulty in utilization in the system and lack of credibility in the supply corporations etc in the big data introduction phase by corporations. Since the world IT corporations are predominating the big data market, the big data introduction of domestic corporations can not but to be dependent on the foreign corporations. When considering that fact, that our country does not have global IT corporations even though it is world powerful IT country, the big data can be thought to be the chance to rear world level corporations. Accordingly, the government shall need to rear star corporations through active political support. Third, the corporations' internal and external professional manpower for the big data introduction and operation lacks. Big data is a system where how valuable data can be deducted utilizing data is more important than the system construction itself. For this, talent who are equipped with academic knowledge and experience in various fields like IT, statistics, strategy and management etc and manpower training should be implemented through systematic education for these talents. This study has arranged theoretical base for empirical studies about big data related fields by comprehending the main variables which affect the big data introduction intention and verifying them and is expected to be able to propose useful guidelines for the corporations and policy developers who are considering big data implementationby analyzing empirically that theoretical base.