• Journal of Biomedical Engineering Research
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• v.44 no.4
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• pp.264-274
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• 2023

Purpose: The objective is to extract insights that can contribute to the formulation of harmonized international policies and support measures for innovative medical devices and management systems. This study aims to propose effective strategies for future medical device innovation and healthcare delivery. Results: It investigates technological advancements, regulatory approval systems, insurance policies, and successful commercialization cases in South Korea, the United States, and the European Union. In 2018, the FDA implemented insurance coverage for Software as a Medical Device (SaMD) and recognized insurance coverage for Digital Therapeutics (DTx). Germany is a country that ensures permanent reimbursement for healthcare applications since 2020, making it the first country to provide legal health insurance coverage for fostering a digital ecosystem. Conclusion: The findings of this research highlight the importance of cultivating a supportive regulatory and environmental framework to facilitate the adoption of innovative medical devices. Continuous support for research and development (R&D) efforts by companies, along with the validation of clinical effectiveness, is crucial.

• Proceedings of the IEEK Conference
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• 2001.10a
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• pp.19-23
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• 2001

In addition to landfilling and incineration, waste minimization and recycling have become priorities in Taiwan's municipal waste management strategies over the past 10 years. Major recycling initiatives being implemented in Taiwan include producer responsibility, "pay-as-you-throw, " and mandatory sorting provisions. Currently, the producer responsibility regime established under the Waste Disposal Act and administered by the Environmental Protection Administration (EPA) requires that manufacturers or importers of listed items, including containers, batteries. cars, motorcycles ("scooters"), tires, oil, televisions, refrigerators, air conditioners, washing machines, computers, and printers, pay recycling fees to government recycling funds. EPA then uses the recycling funds to subsidize collection and recycling. The 2001 recycling fund budget totals NT$57 billion (NT$35 = US$l). Under the producer responsibility regime, EPA-designated retailers ("sellers") must accept end-of-life items returned to them by the consumers. At the local level, Taipei City implements a pay-as-you-throw program, whereby citizens pay waste collection and treatment fees through the purchase of special trash bags approved by the Taipei City Government. However. recyclables that are separated by citizens are collected free-of-charge by the City. Taichung City and Kaohsiung City, on the other hand, enforce mandatory sorting schemes, whereby citizens face penalties if they don't separate recyclables from the trash before pick-up. These programs have resulted in a significant reduction in municipal waste. Per capita waste collected per day has dropped from 1.143 kg in 1997 to 0.978 kg in 2000. Targeting a 10% recycling rate for municipal waste in 2001. EPA plans to research and develop new recycling techniques, expand the scope of producer responsibilities, and strengthen existing municipal recyclable collection programs. To this end, among other initiatives, EPA has prepared a draft "Resource Recycling and Reuse Act" that would complement the existing producer responsibility programs by incorporating into the current recycling framework the concept of product life-cycle management.

• Journal of Forest and Environmental Science
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• v.25 no.3
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• pp.139-146
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• 2009

Forest parks are regarded as one of the scientific ways to keep the forest sustainably developed, meanwhile deliver the benefits to the general public. The development of forest parks in China has experienced simply more than 20 years and both the exploitation and management institutions haven't been set up systematically, which, in reality, reflects as inadequate legislative and policy framework. Without the regulatory guidance and collaborating assistance of environment relating governmental sectors at both national and local levels, it's inevitable that the development of forest parks in the country would face constant problems and conflicts. Therefore, it might be helpful to sort out this conflicts and problems and further more to work out how to solve the barriers. The research in this report started with introducing the IUCN Protected Areas Categories, the overall current situations in China and compared the definition of forest parks in the country and that in international experience. It is to aim to find out the real usufruct rights conflicts during the exploitation and management of forest parks and the method used in this report is field visit, previous investigation, collecting secondary materials, interview, analysis and comparison. The research result in this report couldn't cover all the conflict situations during the forest parks' exploitation and management in China but will provide the analysis of this problem from the legal perspective. Practical application and concerning suggestion will be fully discussed in Part 5 in terms of legislative, social and environmental effects.

• Journal of Ship and Ocean Technology
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• v.12 no.4
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• pp.32-39
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• 2008

According to the increase of the requirement for the safety and environmental protection at sea, safety is a core design factor of maritime systems. Safety is defined as a perceived quality that determines to what extent the management, engineering and operation of a system is free of danger to life, property and the environment. There are many possible approaches in dealing with the safety of ships. The risk-based approach is one of the most systematic and reasonable way currently in design, operation and regulatory works for ship safety. This paper proposes a concept of total risk management for ship safety, and introduces a prototype system implemented based on this concept as a framework of design and operation of ships.

• Advances in environmental research
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• v.12 no.1
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• pp.41-49
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• 2023

In developing countries, solid waste is typically disposed of inappropriately, which has a negative impact on the environment and healthcare. One of the most serious environmental issues is the management of municipal solid waste because of the huge increase in waste generation brought on by industrialization, economic development, urbanization, and the exponential growth of Gurugram City's population. Municipal Corporation Gurugram (MCG) handles solid waste collection, transportation, and disposal. The city generates over 1100 tons of solid waste per day. In consideration of this, the current study employed the strengths, weaknesses, opportunities, and threats framework called SWOT analysis to critically examine the city's current methods for the management of municipal solid waste to provide more effective policy solutions. For conducting the analysis, the questionnaires and other interviews were conducted to gather information from households and officials in the city, and the observation made during field visits were recorded. The analysis shows that the waste management issue is getting worse for a variety of causes, including a lack of regulatory enforcement, insufficient technical and financial resources, insufficient people's participation, inadequate execution of policies, a lack of political priorities, and poor coordination between authorities.

• Journal of Korean Society on Water Environment
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• v.23 no.5
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• pp.766-775
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• 2007

The use of toxic chemicals was extended as the industry in Korea has grown dramatically during the last three decades. However, list of toxic substances and limit concentrations in the water environment are not consistent within management of ambient water, drinking water and industrial effluent. This article suggests the systematic framework to classify toxic substances in the water environment and deriving their effluent limits. The most important factor for decision-making to classify toxic substances is whether their concentrations in the water environment are higher than the reference concentrations, estimated by considering human health risk and ecological risk. Using a risk-based reference concentration, the ambient water quality criterion, it is possible to derive the regulatory limit concentrations of toxic substances in drinking water and in industrial effluent. The goal concentrations in the effluent, which guarantee the human and ecological safety, should be determined with scientific investigation, balancing environmental benefit and economical effect, considering availability of treatment technology and identifying characteristics of wastewater from different industries.

• Journal of Science and Technology Studies
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• v.10 no.2
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• pp.143-174
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• 2010

How can a regulatory policy to address potential hazards be made legitimate in the face of scientific uncertainty? The precautionary principle has been gradually regarded as the most persuasive answer to this intricate question in Europe since the 1970s and generally recognized as a guiding principle in international environmental law. This principle, however, has often been subject to diverse concerns and criticisms due to its vague definition. This article tries to elaborate the precautionary principle while reviewing both the validity and unreasonableness of these criticisms over this principle. Then, this article explores the policy relevance of this principle by applying this elaborated definition to the concrete case of risk governance such as the risk assesment of food safety. In the end, this paper emphasizes the fact that the precautionary principle can be applied in the field of risk governance, refuting the argument that the precautionary principle is only a moral attitude or a political position.

• Journal of Nuclear Fuel Cycle and Waste Technology(JNFCWT)
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• v.6 no.4
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• pp.357-368
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• 2008

On July 31, 2008, the Government issued the construction and operation permit for the first low and intermediate level radioactive waste disposal facility in the Republic of Korea. In this paper, the fundamental regulatory framework, regulatory requirements and technical standards of the disposal facility are introduced, and the phased review process adopted for evaluation of the safety of the facility is briefly described. The Atomic Energy Act sets forth a stepwise regulatory framework for the whole life-cycle of the disposal facility such as siting, design, construction, operation, closure and institutional control. More detailed regulatory requirements and technical standards are stipulated in the subsequent regulations of the Atomic Energy Act and a series of Notices issued by the Ministry of Eduction, Science and Technology. The Korea Institute of Nuclear Safety, as entrusted by the Ministry under the Atomic Energy Act, conducted safety review on the disposal facility, and evaluated the compliance with relevant criteria in all technical elements(i.e. siting and structural safety, radiological environmental impact, operational safety, systems and components, quality assurance, and total systematic performance assessment, etc.). The overall safety review process can be phased into inception phase, initial review phase, main review phase and completion phase. The review results were reported to and deliberated by the five Sub-committees of the Special Committee on Nuclear Safety, and then reported to the Ministry. The Ministry issued the construction and operation permit of the disposal facility through the deliberation of the review results by the Nuclear Safety Commission. Hereafter, the safety of the repository will be reassured by a series of subsequent regulatory inspections and reviews under the Atomic Energy Act. In addition, the licensee's continuous implementation of the "Safety Promotion Plan" may also enhance the long-term safety of the repository and contribute to build-up the confidence of the safety case.

• Safety and Health at Work
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• v.12 no.4
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• pp.462-470
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• 2021

Background: Fatigue is pervasive, under-reported, and potentially deadly where flight operations are concerned. The aviation industry appears to lack a standardized, practical, and easily replicable protocol for fatigue risk assessment which can be consistently applied across operators. Aim: Our paper sought to present a framework, supported by real-world data with subjective and objective parameters, to monitor aircrew fatigue and performance, and to determine the safe crew configuration for commercial airline operations. Methods: Our protocol identified risk factors for fatigue-induced performance degradation as triggers for fatigue risk and performance assessment. Using both subjective and objective measurements of sleep, fatigue, and performance in the form of instruments such as the Karolinska Sleepiness Scale, Samn-Perelli Crew Status Check, Psychomotor Vigilance Task, sleep logs, and a wearable actigraph for sleep log correlation and sleep duration and quality charting, a workflow flagging fatigue-prone flight operations for risk mitigation was developed and trialed. Results: In an operational study aimed at occupational assessment of fatigue and performance in airline pilots on a three-men crew versus a four-men crew for a long-haul flight, we affirmed the technical feasibility of our proposed framework and approach, the validity of the battery of assessment instruments, and the meaningful interpretation of fatigue and work performance indicators to enable the formulation of safe work recommendations. Conclusion: A standardized occupational assessment protocol like ours is useful to achieve consistency and objectivity in the occupational assessment of fatigue and work performance.

• Nuclear Engineering and Technology
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• v.50 no.8
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• pp.1199-1209
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• 2018

After the Fukushima-Daiichi accident in 2011, the multi-unit risk, i.e., the risk due to several nuclear power plants (NPPs) in a site has become an important issue in several countries such as Korea, Canada, and China. However, the multi-unit risk has been discussed for a long time in the nuclear community before the Fukushima-Daiichi nuclear accident occurred. The regulatory authorities around the world and the international organizations had proposed requirements or guidelines to reduce the multi-unit risk. The concerns regarding the multi-unit risk can be summarized in the following three questions: How much the accident of an NPP in a site affects the safety of other NPPs in the same site? What is the total risk of a site with many NPPs? Will the risk of the simultaneous accidents at several NPPs in a site such as the Fukushima Daiichi accident be low enough? The multi-unit risk assessment (MURA) in an integrated framework is a practical approach to obtain the answers for the above questions. Even though there were few studies to assess the multi-unit risk before the Fukushima-Daiichi nuclear accident, there are still several issues to be resolved to perform the complete MURA. This article aims to provide an overview of the multi-unit risk issues and its assessment. We discuss the several critical issues in the current MURA to get useful insights regarding the multi-unit risk with the current state art of probabilistic safety assessment (PSA) technologies. Also, the qualitative answers for the above questions are addressed.