• Title/Summary/Keyword: non-public approval

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Analysis of ADS-B ground trajectory data using non-aviation approval public data (공공용 정보를 이용한 ADS-B 지상 항적 자료 분석)

  • Ku, SungKwan;Baik, Hojong
    • Journal of the Korean Society for Aviation and Aeronautics
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    • v.23 no.4
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    • pp.6-11
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    • 2015
  • In this study, we surveyed analysis of ADS-B ground trajectory data using non-aviation approval public data. For analysis used non-aviation public data and commercial ADS-B receiver. The study result is available using ADS-B ground trajectory data for airfield surveillance on limited range. Also, to confirmed of available using non-aviation public data for aviation research.

Study on the Status of Application of Trade Secrets in MSDS Provided in Workplaces (산업체 규모와 업종에 따른 MSDS 영업비밀 적용 실태조사 연구)

  • Lee, Kwon Seob;Choi, Heung Koo;Lee, In Seop
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.29 no.1
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    • pp.27-33
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    • 2019
  • Objective: This study analyzed the status of the application of trade secrets in MSDSs according to size and type of industry. The contents of the MSDS non-public approval policy are summarized. We suggest proactive improvement requirements related to the operation of the MSDS non-public approval policy. Methods: To review this subject, we selected 153 manufacturers and six importers in such fields as organic chemical production. The trade secrets application status and ratio (%) of MSDSs by industry size and industry classification were investigated. Improvements toward a proactive system related to the operation of the MSDS non-public approval policy under the Occupational Safety and Health Act(OSHA) were summarized. Results and Conclusions: According to the results, the trade secret ratio in MSDSs by industry size was 33% in workplaces with less than 50 employees, 23.1% in workplaces with more than 50 but less than 100 workers, 73% in workplaces with more than 100 workers, and 83.4% in workplaces with 300 or more workers. For the trade secret writing rate for MSDSs by industry, the highest was MOCCP (Manufacture of ink, paint, coating and similar products) at 80.9%. MOC (Manufacture of other chemicals) was the lowest at 16.2%. We propose four proactive efforts to minimize the administrative burden of implementation of the MSDS non-public approval policy. The results of this study can be used as basic data for policy improvements to make more effective use of MSDS.

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.

A Normative Review on Non-Invasive Prenatal Diagnosis (NIPD): Focusing on the German Discussion on PrenaTest®

  • Kim, Na-Kyoung
    • Development and Reproduction
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    • v.25 no.2
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    • pp.113-121
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    • 2021
  • This article aims to introduce German discussion on the approval of the non-invasive prenatal diagnosis (NIPD), which started with the development of PrenaTest® by LifeCodexx AG. The discussion started with the concern that the non-invasive nature of NIPD, such as PrenaTest®, may rapidly expand the use and scope of similar tests, thus leading to a new era of eugenics. Based on this concern, the need for clear clinical guidelines on specific indications for NIPD has been suggested. Along the same line, it was discussed whether PrenaTest® is against the Basic Law prohibiting discrimination on grounds of disability and whether the test is outside the scope of the purpose of gene testing limited by Genetic Diagnosis Act. Through such discussion, the Federal Ministry of Health of Germany established the preconditions for inclusion of NIPD in the German public health insurance system. For this, the German motherhood guideline was amended and the information for the insured persons provided to pregnant women was included in the amended guideline. Such discussion made in Germany provides insight on which points should be considered when various gene testings are accepted in Korea, in which genetic communication has not been systematized yet. In particular, German counseling system for pregnant women will provide valuable insights for Korea where the direction for regulations on abortion has not been established even after the ruling by the Constitutional Court that charges for abortion are against the constitution.

A Study on the Comparison for Energy Consumption Characteristics between G-SEED certified and non-certified Office Buildings in Korea (G-SEED 인증 건축물과 비인증 건축물의 에너지 소비량 특성에 관한 연구 : 업무시설을 대상으로)

  • Kim, Jong-Hyun;Kim, Jin-Ho
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.20 no.11
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    • pp.33-43
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    • 2019
  • Considerable efforts have been made to reduce greenhouse gas emission around the world to cope with climate change. The government is implementing G-SEED certification to promote energy efficient building design. This study aims to verify the effectiveness of the G-SEED certification system by analyzing the actual energy use of certified and non-certified office buildings. For this purpose, the energy consumption of 135 certified and 142 non-certified office buildings was analyzed according to the seasonal characteristics, building size and number of floors, approval year, and certification grade. The energy saving effects of certified buildings was about 50% higher than that of non-certified buildings. The seasonal energy consumption of buildings is closely related to the heating degree-days. The energy consumption of certified and non-certified buildings decreases with increasing approval year. On the other hand, the energy consumption according to building size and certification grade is not related. This study provides meaningful basic data of G-SEED certification system for future improvement. As the building energy performance standards are strengthened over the years, it is necessary to make the individual score of G-SEED certified projects open to the public to configure the factors of energy efficiency.

Survey on Pharmacist's Awareness of E-commerce for Non-prescription Medicine (일반의약품의 전자상거래에 대한 약사의 인식도 고찰)

  • Park, Young-Dal;Bang, Joon Seok;Min, Young Sil;Sohn, Uy Dong
    • Korean Journal of Clinical Pharmacy
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    • v.26 no.2
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    • pp.137-149
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    • 2016
  • Objective: Online pharmacies were introduced in some countries such as United States of America or Canada. They can provide benefits to consumer because they can buy and take conveniently drugs without limitation of location or time. In Korea, online pharmacies are illegal and only pharmacists can sell drugs to consumers or patients. Therefore, we investigated the knowledge of online pharmacy and the possible problem in Korea to survey pharmacists. Methods: We developed questionnaire based on previous articles about online pharmacy and surveyed nation-wide pharmacists by mail or e-mail. The data was analyzed by SPSS and Microsoft Excel. P-values less than 0.05 were statistically significant. Results: 175 pharmacists involved in this study. About introduction of online pharmacies, 53.1% were opposition while 10.3% were approval and 36.6% were conditional. Although online pharmacies were introduced, 46.3% pharmacists do not have a plan to start online pharmacy. However, the approval and tends about starting online pharmacies were higher in younger pharmacists (20s, 30s) (p < 0.05). The criteria of permission about opening online pharmacies were 100% pharmacist license regardless of holding off-line pharmacy. 53.7% pharmacists responded education about taking medication is impossible. When online pharmacies are introduced, 65.1% pharmacists responded traditional pharmacies are affected negatively. Pharmacists concerned that the competition with large-sized distribution corporations, reduced reliance between pharmacists and patients, illegal transaction of counterfeit drugs, increased misuse of drugs. Conclusion: These results showed that Korea pharmacists have negative standard on online pharmacies. Therefore it is required to be more cautious before introducing online pharmacy and it need strict watching system and continuous education and study for safety after introducing online pharmacy.

Analysis of utilization and profit for CT and MRI after implementation of insurance coverage for CT (CT 보험급여 전후의 CT 및 MRI검사의 이용량과 수익성 변화)

  • Suh, Chong-Rock;Yu, Seung-Hum;Chun, Ki-Hong;Nam, Chung-Mo
    • Korea Journal of Hospital Management
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    • v.2 no.1
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    • pp.1-21
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    • 1997
  • In order to analyze the shifts in the volume and profits of Computed Tomography(CT) and Magnetic Resonance Imaging(MRI) utilization for a year before and after the implementation of insurance coverage for CT, this study has been undertaken examining CT and MRI cost data from 'Y' University Hospital situated in Seoul, Korea. Following are the results of this study: 1. The medical insurance payment for CT, implemented on January 1, 1996, increased CT utilization from January 1996 to April 1996 due to low insurance premiums: however, from May 1996 the number of CT cases significantly decreased as a result of strengthened medical cost reviews and the new 'Detailed standards for approval of CT' announced near the end of April 1996 by the insurer. 2. Since the implementation of insurance coverage for CT, CT fee reduction rates for reimbursements by the insurer to the hospital were 50% and 40% for January and February, respectively, and 31% and 15% for March and April. A significant point in the lowering of the reduction rate was reached in May at 11%; furthermore, since June the reduction rate fell below the average reduction rate for reimbursements for all procedures. If the 'Detailed standards for approval of CT' had been announced before the implementation of insurance coverage for CT, CT utilization would not have been so high due to the need to meet those 'standards'. In addition, loss of hospital profits resulting from the reduction for reimbursements would not have occurred. 3. The shifts in MRI utilization showed that there was no particular change with the beginning of insurance coverage for CT, and the introduction of the 'Detailed standards for approval of CT' made MRI utilization increase because MRI is free of restrictions imposed by the insurer. 4. The relationship between CT utilization and MRI utilization showed that they were supplementary to each other before insurance coverage for CT, but that CT was substituted for MRI because of strengthened medical cost reviews after t~e beginning of insurance coverage for CT. 5. The shifts in volume by patient characteristics showed that the number of inappropriate case patients, according to the insurer's "Standards for approval", decreased more than the number of appropriate case patients after the introduction of insurance coverage for CT. Therefore, the health insurance fee schemes for CT have influenced patient care. 6. The shifts in profits from CT utilization showed a net profit decrease of 31.6%. In order to match the pre-coverage profit level, 5,471 more cases would need to be seen and productivity would need to be increased by 32.7%. This profit decrease resulted from a decrease of CT utilization and low reimbursements. With insurance coverage, net profits from CT were 24.4%, and a margin of safety ratio was 39.6%. Because of the net profits and margin of safety ratio, CT utilization fees for insured appropriate cases could not be considered inappropriate. 7. The shifts in profits from MRI utilization before and after the introduction of CT coverage showed that in order to match pre-CT coverage profit levels, 2,011 more cases would need to be seen and productivity would need to be increased by 9.2%. The reasons for needing to increase the number of cases and productivity result from cost burdens created by adding new MRI units. But with CT coverage already begun, MRI utilization increased. Combined with a minor increase in the MRI fee schedule, MRI utilization showed a net profit increase of 18.5%. Net profits of 62.8% and a 'margin of safety ratio' of 43.1% for MRI utilization showed that the hospital relied on this non-covered procedure for profits. 8. The shifts in profits from CT and MRI utilization showed the net profits from CT decreased by 2.33billion Won while the net profits from MRI increased by 815.7million Won. Overall, these two together showed a net profit decrease of 1.51billion Won. The shifts in utilization showed a functional substitutionary relationship, but the shifts in profits did not show a substitutionary relationship. From these results, We can conclude that if insurance is to be expanded to include previously uncovered procedures using expensive medical equipment, detailed standards should be prepared in advance. The decrease in profits from the shifts in coverage and changes in fees is a difficult burden that should be shared, not carried by the hospital alone. Also, a new or improved fee schedule system should include revised standards between items listed and the appropriateness of the fee schedule should constantly be ensured. This study focused on one university hospital in Seoul and is therefore limited in general applicability. But it is valuable for considering current issues and problems, such as the influence of CT coverage on hospital management. Future studies will hopefully expand the scope of the issues considered here.

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Trends of Market and Approval Management System for in vitro Diagnostic Veterinary Medical Reagents in Korea

  • Kang, Kyoung-Mook;Kang, Min-Hee;Suh, Tae-Young;Kang, Hwan-Goo;Moon, Jin-San
    • Journal of Veterinary Clinics
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    • v.35 no.4
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    • pp.119-125
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    • 2018
  • In vitro diagnostic veterinary medical reagents (IVDVMRs) were diverted the medical devices from medicine by the revision of the pharmaceutical affairs act enforcement regulations in 2015 in Korea. It classified into class I-IV according to risks of individual and public health. However, good manufacturing practices requirements on IVDVMRs were exempted from the current system. The registration of IVDVMRs by the Animal and Plant Quarantine Agency has gradually increased since 2012, and total of 584 products from 68 companies were registered from 1978 to 2017. Most of these items are clinical immunochemistry (infection disease), clinical immunochemistry (non-infection disease), molecular genetics, endocrinology, blood gas analysis, clinical microbiology, toxin, heavy metal and drug of abuse, other etc. The market size of IVDVMRs reported from the Korea Animal Health Products Association was estimated to be approximately 51.9 billion won in 2017. The domestic consumption and the export sales were approximately 31.2 and 20.7 billion won, respectively. They are increasing 23.9% (CAGR) in domestic consumption and 40.4% (CAGR) in export from 2011 to 2017.

A Study on the Charge of Using the Internet Network - Focusing on U.S. Internet History and Charter Merger Approval Conditions Litigation - (인터넷 망 이용의 유상성에 대한 고찰 - 미국 인터넷 역사 및 Charter 합병승인조건 소송 중심으로 -)

  • Cho, Dae-Keun
    • Journal of Internet Computing and Services
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    • v.22 no.4
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    • pp.123-134
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    • 2021
  • This paper suggests that the Internet is not free through analysis of U.S. Internet history and lawsuits related to the Charter merger in 2016. Generally speaking, the players in internet connectivity market agree to Non-Disclosure Agreement, when connecting their facilities and networks each other. So, I adopted the case study & analysis as research methodologies due to limitation of collecting the transaction data between them. The former finds that Internet access has never been free in U.S Internet history. As we know, some including Content Providers(CPs) argue that the Internet is a free network and there are many cases to use the internet for free, so they came to conclusion that ISPs have no right to charge the users like CPs. This study refutes these arguments in two ways. One is that using the internet has never been free. From ARPANET, known as the beginning of the U.S. Internet, to the commercialization of backbone, no Internet has been considered or implemented for free since the early Internet network was devised. Also, the U.S government was paying subsidies or institutions were paying fees to secure network operations for the NSFNET backbone. the other is that "free peering" refers to barter transactions between ISPs, not to free access to counterpart internet networks. Second, this study analyze the FCC' executive order of conditioned merger approval and the court's related ruling and verify that using the internet is not free. According to the analysis, this study finds that it's real situation to make paid settlements between ISP-CPs (including OTTs) in the US Internet market at the moment. This study concludes that the Internet has never been free in terms of its technical characteristics, network structure, network operation, and system. Also it proposes how to improve the domestic settlement system between ISPs-CPs in terms of policy and regulation.

Review on asbestos analysis (석면 분석방법에 대한 고찰)

  • Ham, Seung hon;Hwang, Sung Ho;Yoon, Chungsik;Park, Donguk
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.19 no.3
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    • pp.213-232
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    • 2009
  • This document was prepared to review and summarize the analytical methods for airborne and bulk asbestos. Basic principles, shortcomings and advantages for asbestos analytical instruments using phase contrast microscopy(PCM), polarized light microscopy(PLM), X-ray diffractometer (XRD), transmission electron microscopy(TEM), scanning electron microscopy(SEM) were reviewed. Both PCM and PLM are principal instrument for airborne and bulk asbestos analysis, respectively. If needed, analytical electron microscopy is employed to confirm asbestos identification. PCM is used originally for workplace airborne asbestos fiber and its application has been expanded to measure airborne fiber. Shortcoming of PCM is that it cannot differentiate true asbestos from non asbestos fiber form and its low resolution limit ($0.2{\sim}0.25{\mu}m$). The measurement of airborne asbestos fiber can be performed by EPA's Asbestos Hazard Emergency Response Act (AHERA) method, World Health Organization (WHO) method, International Standard Organization (ISO) 10312 method, Japan's Environmental Asbestos Monitoring method, and Standard method of Indoor Air Quality of Korea. The measurement of airborne asbestos fiber in workplace can be performed by National Institute for Occupational Safety and Health (NIOSH) 7400 method, NIOSH 7402 method, Occupational Safety and Health Administration (OSHA) ID-160 method, UK's Health and Safety Executive(HSE) Methods for the determination of hazardous substances (MDHS) 39/4 method and Korea Occupational Safety and Health Agency (KOSHA) CODE-A-1-2004 method of Korea. To analyze the bulk asbestos, stereo microscope (SM) and PLM is required by EPA -600/R-93/116 method. Most bulk asbestos can be identified by SM and PLM but one limitation of PLM is that it can not see very thin fiber (i.e., < $0.25{\mu}m$). Bulk asbestos analytical methods, including EPA-600/M4-82-020, EPA-600/R-93/116, OSHA ID-191, Laboratory approval program of New York were reviewed. Also, analytical methods for asbestos in soil, dust, water were briefly discussed. Analytical electron microscope, a transmission electron microscope equipped with selected area electron diffraction (SAED) and energy dispersive X-ray analyser(EDXA), has been known to be better to identify asbestiform than scanning electron microscope(SEM). Though there is no standard SEM procedures, SEM is known to be more suitable to analyze long, thin fiber and more cost-effective. Field emission scanning electron microscope (FE-SEM) imaging protocol was developed to identify asbestos fiber. Although many asbestos analytical methods are available, there is no method that can be applied to all type of samples. In order to detect asbestos with confidence, all advantages and disadvantages of each instrument and method for given sample should be considered.