• 한국항공운항학회지
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• 제23권4호
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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.

• 한국산업보건학회지
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• 제29권1호
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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.

• 대한예방한의학회지
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• 제28권1호
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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.

• 한국발생생물학회지:발생과생식
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• 제25권2호
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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.

• 한국산학기술학회논문지
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• 제20권11호
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• pp.33-43
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• 2019

기후변화 문제를 해결하기 위해 세계 각국은 온실가스 감축 의무를 이행하기 위해 노력하고 있다. 건물부문은 국가 온실가스 배출량의 약 25%를 차지하며, 향후 40%까지 증가할 것으로 전망하는 만큼 정부는 에너지 절감 계획에 대한 정책을 수립하여 추진 중이다. 건물부문의 에너지 절감을 위한 정책의 일환으로 녹색건축인증제도 시행을 통해 보다 에너지 절감형 건축물 설계와 시공을 유도하고 있다. 본 연구는 G-SEED 인증 건축물과 비인증 건축물의 에너지 소비량에 영향을 미치는 원인에 대한 분석과 결과를 바탕으로 현행 제도의 실효성과 문제점을 파악하고 향후 G-SEED 제도의 개선 방향에 대해 논의하고자 한다. 이를 위해 서울시에 소재하고 있는 인증 업무시설 135동과 비인증 업무시설 142동을 대상으로 건축물 정보와 에너지 소비량 데이터를 수집하였으며, 분석결과 다음과 같은 결론을 도출하였다. 인증 업무시설은 비인증 업무시설에 비해 연간 50% 이상의 에너지 절감효과가 있는 것으로 나타났다. 계절에 따른 에너지 소비량은 난방 도일과 높은 상관관계가 있는 것으로 나타났다. 사용승인연도가 높을수록 인증 업무시설의 에너지 소비량은 감소하며, 비인증 업무시설은 오히려 증가하는 경향을 보였다. 규모와 인증등급에 따른 에너지 소비량은 상관관계가 미미한 것으로 드러났다. 본 연구는 이상의 분석을 통하여 G-SEED 인증제도 개선을 위한 기초자료로서 의의가 있다. 또한 건축물의 에너지성능 기준이 강화되는 추세를 감안하여, 분야별 점수를 공개적인 자료로 전환하는 것을 제시한다.

• 한국임상약학회지
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• 제26권2호
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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.

• 한국병원경영학회지
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• 제2권1호
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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.

• 한국임상수의학회지
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• 제35권4호
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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.

• 인터넷정보학회논문지
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• 제22권4호
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• pp.123-134
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• 2021

본 논문은 넷플릭스와 SK브로드밴드 소송의 핵심 쟁점인 인터넷의 유상성에 관해 논증하고 있다. 인터넷 연결 관련 당사자 간 기밀유지협약이 일반적인 시장의 특성으로 인해 거래 데이터 수집 한계가 있어 연구방법론으로 사례연구 및 판례분석을 채택하였다. 즉 CP를 중심으로 한 일부에서 인터넷은 무료로 고안된 망이기 때문에, 그리고 시장에서 무료로 이용하고 있는 경우가 많으므로 ISP가 CP를 포함한 이용자들에게 요금을 부과할 권리가 없다고 하는 주장에 대해 인터넷이 무료가 아님을 미국 인터넷 역사와 2016년 Charter 합병 관련 소송 분석 등 두 가지 접근방법을 통해 검토한다. 첫째, 미국 인터넷의 시작이라 알려진 ARPANET부터 백본 상용화까지의 초기 인터넷 망을 고안할 당시 인터넷의 무상성은 고려되거나 시행된 바가 없으며 NSFNET 백본의 망 운영비 확보를 위해 연방정부가 지원금을 부담하거나 기관들이 요금을 부담하고 있었다. 인터넷 초기에도 인터넷망 이용에 따른 대가 지불이 있었다. 더불어 Free Peering의 free는 무상이 아니라 물물교환(Barter)을 의미한다. 둘째, 미국 연방정부 행정명령서 및 법원의 판결문과 같은 공문서를 분석하여 인터넷의 유상성을 입증하고 있다. 2016년 미 CATV 사업자 차터(Charter)의 합병승인 조건 명령서와 동 명령 관련한 소송 판결문에서 현재 미국 인터넷 시장 내 ISP-CP(OTT 포함) 간 유료 정산을 하고 있으며, 망 이용대가와 망 중립성 규제는 무관하다는 점을 공식적으로 확인할 수 있었다. 결론적으로 인터넷의 기술적 특성, 망 구조, 망 운용, 제도 측면에서 인터넷이 무료인 적은 없음을 논증하고 있으며 국내 정책 및 규제 차원에서 제도 개선을 제안하고 있다.

• 한국산업보건학회지
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• 제19권3호
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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.