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A Study on the Establishment and Operation of a Regulatory Response Framework in connection with the Regulatory Strength of the Licensing Policy for New Medical Devices -Focusing on the Application of FMEA- (의료기기 신제품의 인허가정책 규제강도에 연계한 규제대응 프레임워크 수립 및 운영에 관한 연구 - FMEA 적용을 중심으로 -)

  • Kim, Gyosu;Ru, Gyuha;Kim, Yeonhee
    • Journal of Technology Innovation
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    • v.28 no.4
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    • pp.1-26
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    • 2020
  • Due to the spread of Corona 19 around the world, Infectious Disease Medicine and New Medical Devices such as Diagnostic Agent are being rapidly developed and launched, and for the fast supply and demand of these, each country has eased import regulations or has implemented policies for fast approval(NIDS, 2020). On the other hand, New Developed Medical Devices that are not related to New Infectious Diseases, they are still entering the market through strict licensing and licensing regulations, such as delay and cancellation in the test inspection process, etc. Therefore, This Study specialized in the government-managed laws encountered when New Medical Devices enter the market, derive Factors influencing the Strength of Regulations, analyzes the Strength of Regulations, and proposes a Regulatory Response Framework. The Research Method was conducted by Literature Research, was applied by Failure Mode and Effects Analysis(FMEA) Method, Expert Interview(1st): Idea Collection, Expert Interview(2nd): Validation, and Priority through the Application Process of FMEA Method. A Method of Quantifying the Intensity of Regulation was proposed by multiplying the Impact of the Influencing Factors for each stage of regulation and the Burden Impact for each type of Regulatory Affairs to find the Importance of the Regulatory Factors and multiplying the Severity of the Regulatory Impact. The Implications are that major overseas countries and the Korean government are actively responding with Special Regulatory Policies and Mitigation Policies for fast licensing of New Developed Medical Devices in accordance with Corona 19. It is expected that the direction for improvement of regulations and measures to respond to regulations will be implemented so that a more proactive and preemptive response to the regulatory process of the licensing policy for New Devices can be achieved.

Compensation Criteria for Investigation Services and Strengthening Normative Force Plans for Detailed Qualification Criteria for Examination of Archaeological Heritage (매장문화재 조사용역 대가기준과 적격심사 세부기준 제도의 규범력 강화 방안)

  • Choi, Min-jeong
    • Korean Journal of Heritage: History & Science
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    • v.52 no.2
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    • pp.240-253
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    • 2019
  • Archaeological heritages are precious cultural relics and public assets that must be preserved, conserved, and shared with people all over the world. Investigating archaeological heritage is valuable and plays an important role for the public good; our ancestors' cultures can be restored, and it helps with developing a clear understanding of the cultural and social aspects of a historical period as well as teaches about historical factors unreported in the literature. One of the most basic and important conditions necessary for recognizing the value and importance of archaeological heritage investigation, expertise, and quality improvement is to establish detailed criteria for investigation services and the qualification examination of archaeological heritage. Observation of detailed criteria and the qualification examination of archaeological heritage can partially demonstrate society's recognition of strengthening transparency, public property, and the objectivity of the investigation of archaeological heritage. However, the detailed criteria for investigation services and the qualification examination of archaeological heritage currently implemented as administrative rules are neither followed by all institutes in the public and private sectors nor the government. Thus, there are serious problems in terms of the effectiveness and stability of institutions. The detailed criteria for the qualification examination breach the principle of statutory reservation, the principle of statutory regulation, and regulations on the announcement and management of orders and rules. Non-compliance with compensation criteria for investigation services or with detailed criteria for the qualification examination of archaeological heritage will be one of the reasons for the failure of the investigation foundation for archaeological heritage in the future. That is, it will result in the expansion, reproduction, and repetition of a vicious cycle of conflict between developers, who are the decision-makers responsible for selecting an investigating organization for archaeological heritage and determining the cost, and investigating organizations. This includes the impractical shortening of investigation periods and reducing costs by developers, distrust of the values and the importance of investigations of archaeological heritage, a decrease in quality, accidents caused by a lack of safety, a lack of occupational ethics, and non-recruitment of new experts, etc. Therefore, it is necessary to change the structure from a vicious cycle to a virtuous cycle, and promote the enactment of regulations that will ensure effectiveness and stability in the process of attaining the goals of the institution and application of the institution, as well as the continuous advancement of work to fill the gaps with reality.

A New Relationship between Poetry and Music - music as Creative Principle of Poetry in Mallarmé's World (시와 음악 간의 새로운 관계 - 말라르메에게 있어 시 창작원리로서의 음악)

  • Do, Yoon-Jung
    • Cross-Cultural Studies
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    • v.44
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    • pp.211-237
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    • 2016
  • This paper seeks to explore the new relationship between music and poetry established in the beginning of the Modern Era. This was a period when reading silently was the dominant culture rather than reading aloud and orality was limited due to the emergence of literacy and print culture. A poet sensitive to the characteristics of the period, $Mallarm{\acute{e}}$ created his own concept of music and new creative principles of poetry from it. We analyze his "Divigation" and letters, in particular, the "Crisis of vers", "Music and Literature", "Mystery in the letters", and "About the book." Firstly, $Mallarm{\acute{e}}$ connects music with the mystery and the sacred: the mystery surrounds the music and the music is oriented with the sacred. The sanctity is that of the human race and has existed within humans since the beginning. Transposing the characteristics of this music to the poetry is his first creative principle of poetry. However, $Mallarm{\acute{e}}$ called music a totality of relationships that exist between objects without reducing the dimension to only the instruments or the sound. His definition is abstract, regarding music as a complete rhythm, the atmosphere and the air. Secondly, we have the question of how to realize music in a poem. As the music is surrounded by the mystery, $Mallarm{\acute{e}}$ can transpose the sacred to a poem in mysterious ways. This leads to his second principle of poetry: make a poem as a structure. In other words, 'musically', based on the disappearance of real objects and the initiative of the poet, he created a structure with only the words. We can create an acoustic structure but $Mallarm{\acute{e}}$ created a visible structure to overcome the incompleteness of the sound of a word in the diffusion of print culture. In this manner, the use of silence as much as sound and the use of visual as much as aural components were introduced in poetry as important motifs and the essentials of creation. This new relationship between poetry and music and the creative principles drawn from it appear to be the areas to which attention should be focused in the research of poetry.

Clinical Practice Guideline for Cardiac Rehabilitation in Korea

  • Kim, Chul;Sung, Jidong;Lee, Jong Hwa;Kim, Won-Seok;Lee, Goo Joo;Jee, Sungju;Jung, Il-Young;Rah, Ueon Woo;Kim, Byung Ok;Choi, Kyoung Hyo;Kwon, Bum Sun;Yoo, Seung Don;Bang, Heui Je;Shin, Hyung-Ik;Kim, Yong Wook;Jung, Heeyoune;Kim, Eung Ju;Lee, Jung Hwan;Jung, In Hyun;Jung, Jae-Seung;Lee, Jong-Young;Han, Jae-Young;Han, Eun Young;Won, Yu Hui;Han, Woosik;Baek, Sora;Joa, Kyung-Lim;Lee, Sook Joung;Kim, Ae Ryoung;Lee, So Young;Kim, Jihee;Choi, Hee Eun;Lee, Byeong-Ju;Kim, Soon
    • Journal of Chest Surgery
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    • v.52 no.4
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    • pp.248-329
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    • 2019
  • Background: Though clinical practice guidelines (CPGs) for cardiac rehabilitation (CR) are an effective and widely used treatment method worldwide, they are as yet not widely accepted in Korea. Given that cardiovascular disease is the second leading cause of death in Korea, it is urgent that CR programs be developed. In 2008, the Government of Korea implemented CR programs at 11 university hospitals as part of its Regional Cardio-Cerebrovascular Center Project, and 3 additional medical facilities will be added in 2019. In addition, owing to the promotion of CR nationwide and the introduction of CR insurance benefits, 40 medical institutions nationwide have begun CR programs even as a growing number of medical institutions are preparing to offer CR. The purpose of this research was to develop evidence-based CPGs to support CR implementation in Korea. Methods: This study is based on an analysis of CPGs elsewhere in the world, an extensive literature search, a systematic analysis of multiple randomized control trials, and a CPG management, development, and assessment committee comprised of 33 authors-primarily rehabilitation specialists, cardiologists, and thoracic surgeons in 21 university hospitals and 2 general hospitals. Twelve consultants, primarily rehabilitation, sports medicine, and preventive medicine specialists, CPG experts, nurses, physical therapists, clinical nutritionists, and library and information experts participated in the research and development of these CPGs. After the draft guidelines were developed, 3 rounds of public hearings were held with staff members from relevant academic societies and stakeholders, after which the guidelines were further reviewed and modified. Results: CR involves a more cost-effective use of healthcare resources relative to that of general treatments, and the exercise component of CR lowers cardiovascular mortality and readmission rates, regardless of the type of coronary heart disease and type and setting of CR. Conclusion: Individualized CR programs should be considered together with various factors, including differences in heart function and lifestyle, and doing so will boost participation and adherence with the CR program, ultimately meeting the final goals of the program, namely reducing the recurrence of myocardial infarction and mortality rates.

A Study on Social Security Platform and Non-face-to-face Care (사회보장플랫폼과 비대면 돌봄에 관한 고찰)

  • Jang, Bong-Seok;Kim, Young-mun;Kim, Yun-Duck
    • Journal of the Korea Convergence Society
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    • v.11 no.12
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    • pp.329-341
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    • 2020
  • As COVID-19 pandemic sweeps across the world, more than 45 million confirmed cases and over 1,000,000 deaths have occurred till now, and this situation is expected to continue for some time. In particular, more than half of the infections in European countries such as Italy and Spain occurred in nursing homes, and it is reported that over 4,000 people died in nursing homes for older adults in the United States. Therefore, the issues that need to be addressed after the COVID-19 crisis include finding a fundamental solution to group care and shifting to family-centered care. More specifically, it is expected that there will be ever more lively discussion on establishing and expanding hyper-technology based community care, that is, family-centered care integrated with ICT and other Industry 4.0 technologies. This poses a challenge of how to combine social security and social welfare with Industry 4.0 in concrete ways that go beyond the abstract suggestions made in the past. A case in point is the proposal involving smart welfare cities. Given this background, the present paper examined the concept, scope, and content of non-face-to-face care in the context of previous literature on the function and scope of the social security platform, and the concept and expandability of the smart welfare city. Implementing a smart city to realize the kind of social security and welfare that our society seeks to provide has significant bearing on the implementation of community care or aging in place. One limitation of this paper, however, is that it does not address concrete measures for implementing non-face-to-face care from the policy and legal/institutional perspectives, and further studies are needed to explore such measures in the future. It is expected that the findings of this paper will provide the future course and vision not only for the smart welfare city but also for the social security and welfare system in administrative, practical, and legislative aspects, and ultimately contribute to improving the quality of human life.

Extracorporeal Membrane Oxygenation for Coronavirus Disease 2019: Expert Recommendations from The Korean Society for Thoracic and Cardiovascular Surgery

  • Jeong, In Seok;Kim, Woong-Han;Baek, Jong Hyun;Choi, Chang-Hyu;Choi, Chang Woo;Chung, Euy Suk;Jang, Jae Seok;Jang, Woo Sung;Jung, Hanna;Jung, Jae-Seung;Kang, Pil Je;Kim, Dong Jung;Kim, Do Wan;Kim, Hyoung Soo;Kim, Jae Bum;Kim, Woo-Shik;Kim, Young Sam;Kwak, Jae Gun;Lee, Haeyoung;Lee, Seok In;Lim, Jae Woong;Oh, Se Jin;Oh, Tak-Hyuck;Park, Chun Soo;Ryu, Kyoung Min;Shim, Man-Shik;Son, Joohyung;Son, Kuk Hui;Song, Seunghwan;The Korean Society for Thoracic and Cardiovascular Surgery COVID-19 ECMO Task Force Team
    • Journal of Chest Surgery
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    • v.54 no.1
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    • pp.2-8
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    • 2021
  • Since the first reported case of coronavirus disease 2019 (COVID-19) in December 2019, the numbers of confirmed cases and deaths have continued to increase exponentially despite multi-factorial efforts. Although various attempts have been made to improve the level of evidence for extracorporeal membrane oxygenation (ECMO) treatment over the past 10 years, most experts still hesitate to take an active position on whether to apply ECMO in COVID-19 patients. Several ECMO management guidelines have been published recently, but they reflect some important differences from the Korean medical system and aspects of real-world medical practice in Korea. We aimed to find evidence on the efficacy of ECMO for COVID-19 patients by reviewing the published literature and to propose expert recommendations by analyzing the Korean COVID-19 ECMO registry data.

Okdong Lee Seo's Historical View Examined through Yeokdaega (「역대가(歷代歌)」를 통해 본 옥동(玉洞) 이서(李漵)의 역사인식(歷史認識))

  • Yoon, Jaehwan
    • (The)Study of the Eastern Classic
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    • no.57
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    • pp.331-357
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    • 2014
  • This paper is to examine Okdong Lee Seo's historical view through analyzing Yeokdaega("歷代歌"), Okdong's full-length historical epic. As long as Okdong Lee Seo was a Confucian scholar holding moral cultivation as the highest value, his Yeokdaega is hard to explain separately from the Confucian world view. Okdong's Yeokdaega is a long old-style sino-korean poem consisting of 526 7-syllable verses, yet it considerably differs in structure from other historical epics known so far. Okdong's Yeokdaega consists of two parts: the first narrates Chinese historical facts from the beginning to the fall of Ming dynasty, and the second describes the social irrationality of the time and reveals his strong social criticism. It is very different from an ordinary historical epic piece narrating the orders and disorders and the rise and fall of historical facts. It is thought that Okdong's Yeokdaega was written based on his Confucian historical view. It seems that for Okdong the rise and fall of Chinese historical dynasties did not merely mean historical facts but functioned as a tool explaining the reason for people to persue moral cultivation. Okdong summed up his knowledge of the rise and fall of Chinese historical dynasties, his sharp criticism on social irrationality, and his stimulation about the necessity of moral cultivation, and then created a long 526-verse historical epic Yeokdaega. For the reasons, it is not easy to say that Okdong's Yeokdaega is the result of pure literary activities only for artistry. However, Okdong's Yeokdaega is not inferior to other historical epic pieces written by the time in literary value. Especially, Okdong's Yeokdaega can be said to be more meaningful since it was, over its literary value, not only a tool to strengthen his own study and will but also a educational tool for others around himself.

Study on The Chinese Poems Composed by Mi-Am Yu Hee Choon (미암(眉巖) 유희춘(柳希春)의 한시(漢詩) 연구(硏究))

  • Song, Jae-yong
    • (The)Study of the Eastern Classic
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    • no.57
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    • pp.383-406
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    • 2014
  • Mi-Am Yu Hee Choon (1513~1577) considered poetry as a part of his life. Therefore, this writer specifically focused on Mi-Am Yu Hee Choon's Chinese poems. The following is the conclusion from the materials discussed in this article. Mi-Am tried to understand literature in ethical perspective. The number of Chinese poems composed by Mi-Am is estimated to be about 300, and the number of pieces that this writer could find was 285. Also, Mi-Am took poem composition seriously, and put emphasis on content more than structure. Among Go Shi, Yul Shi, and Jul gu, Jul gu (especially Chil Un) is the largest in quantity, and it is presumed that he preferred Chil(seven) Un over Oh(five) Un. With regards to Go Shi, there are relatively many Jeon-Go. With regards to Jul gu, which was a poetry composing structure that Mi-Am could make the best use of, they were mostly about the daily lives. And with regards to Yul Shi, there were many poems that expressed his feelings about the real world and self-examination. Mi-Am's poems can be categorized into ones that he wrote when he was on exile, and ones that he wrote while serving for the king again after he got released from exile. During the exile period, self-discipline through learning, friendship, and love for the people were the main themes of his poems, and after being released and started serving for the king again, his poems were mostly about loyalty to the king, interaction with acquaintances, emotions, ancestor worship, self-examination, and conjugal affection through literary communion. Among Mi-Am's poems, there are many that have Eum Song Cha Un included in their titles, and the mainstream of his poems were related to daily lives or experiences. Also, most of them naturally and calmly expressed the fact itself without exaggerating. Mi-Am considered poetry as a part of his life and the fact that he practiced literary communion with his wife by writing poems about the ordinary things happened between him and his wife, Song Duk Bong, is worthy of notice.

Dam-Heon Hong Dae Yong's : A part of the BukHak School's Understanding on The Great Learning (담헌 홍대용의 <대학문의(大學問疑)> : 북학파의 『대학』 이해의 일단(一端))

  • Ahn, Woe Soon
    • (The)Study of the Eastern Classic
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    • no.33
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    • pp.385-411
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    • 2008
  • This thesis aims at examining his understandings about the The Great Learning centering on the of the founder of the YiYongHuSaeng School (利用厚生學派: A school who pursued prosperous economy and welfare of people) orthe BukHak School(北學派: A positive school that pursued mercantilism) from the Joseon Dynasty, Dam-Heon Hong Dae Yong (1731-1783). 1) From what is indicated in the , his studies mainly focused on the annotations from DaeHakJangGuDaeJeonJipJu ("大學章句大全集註": A book that edited different phrases from the Great Learning into chapters and paragraphs), Questioning of the Great Learning", and "JuJaUhRyu (朱子語類: A book of Confucian literature written by Yeo Jung Deok" of Zhu Xi who was a representative scholar of the Neo-Confucianism in the Song Dynasty. 2) Acknowledging entirely the arguing points of Zhu Xi, he is taking a critical position in a way that partial doubts are divided into seven chapters and questioned. 3) For the main characteristic and direction of the questioning, he is estimating that Zhu Xi only stressed the 'means' and 'interior' out of the world of 'means and ends' and 'interior and exterior' in Zhu Xi's recognizing and handling cases; instead, he emphasized putting equivalent value on the 'ends' and 'exterior' as well. 4) In fact, such questions raised partially were misconceived since they were not carried out through profound understanding nor systematic logic expansion of what Zhu Xi insisted. 5) Despite this, at the point where Neo-Confucian thoughts were fixed and weakened only with its form left in the late Joseon Dynasty, his perspective on the study of Confucian classics that the 'ends' and 'exterior' should be as equally valued as the 'means' and 'interior' by examining through the core text of the Neo-Confucianism, The Great Learning has its significance in his YiYongHuSaeng dogma that says politicians, by all means, should provide the ruled with economic convenience and welfare and this is their very right virtue.

Study on the Design Ideas and Planning Method of the Gameunsa Temple Architecture in Silla (신라감은사건축의 계획이념과 설계기술 고찰)

  • Lee, Jeongmin
    • Korean Journal of Heritage: History & Science
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    • v.54 no.1
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    • pp.238-259
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    • 2021
  • Gameunsa Temple is a Buddhist temple from the mid-Silla period. Construction began during the reign of King Munmu and was completed during the second year of King Sinmun's reign (682). This study is based on the results of excavations at the Gameunsa Temple site, exploring the findings presented in the literature in the field of history. This study also investigates the characteristics of the construction plan of Gameunsa Temple and its correlation with the political, social, and religious environment of the time. The results of the study are as follows: (1) First, it is confirmed that all of the buildings in the central block of Gameunsa Temple, such as the pagoda and corridor, the central gate, and the auditorium, fit within 216 cheoks by 216 cheoks (Goguryeo unit of measurement, estimated dimensions 353.30 mm), in terms of the base structure. This fact is highly significant considering the intent of the King in the mid-Silla period to advocate Confucian political ideals at the Donghaegu sites (Daewangam, Igyeondae Pavilion, and Gameunsa Temple), as confirmed by the relationship between the 'Manpasikjeok legend' and the Confucianism of the etiquette and the music; the relationship between the name of the 'Igyeondae Pavilion' and the 'I Ching'; and the relationship between the 'Taegeuk stones excavated from the Gameunsa Temple site' and the 'I Ching.' Additionally, it may be presumed that the number in the "Qian 216" on the Xici shang of 'I Ching' was used as a basis for determining the size of the central block in the early stages of the design of Gameunsa Temple. The layout of the halls and pagodas of Gameunsa Temple was planned to be within a 216-cheok-by-216-cheok area, from the edge to the center, i.e., on the central axis of the temple, in the following order: the central gate and auditorium, the north-south position of Geumdang Hall, the south corridor, the east-west buildings of the auditorium and the winged corridor, the east-west corridor, and the central position of the east-west stone pagoda. (2) Second, the coexistence of Confucianism and Buddhism in the architecture of Gameunsa Temple is based on the understanding of the Golden Light Sutra, originating from the aspirations of King Munmu to obtain the immeasurable merits (陰陽調和時不越序 日月星宿不失常度 風雨隨時無諸災横) and the light of the Buddha, which is metaphorically represented by the sun and the moon illuminating the whole world of Silla, a new nation with a Confucian political ideology, for a long time by "circumambulating the Buddha (旋繞)". It is also presumed that Gyeongheung, who was appointed by King Munmu to be the Guksa in his will and appointed as the Gukro after the enthronement of King Sinmun, was deeply involved in the conception and realization of the syncretism of Confucianism and Buddhism.