耳鼻咽喉科領域에서의 抗炎症劑投與

金在善 藥業新聞社 1980 (月刊) 醫藥情報 Vol.1980 No.2

Current Status of Vaccine Compensation Legislation and Major Legal Issues

김재선 한국법제연구원 2022 KLRI journal of law and legislation Vol.12 No.2

As vaccination after break of COVID-19 has been performed, discussions have continued in each country to introduce a justifiable vaccine compensation law. In addition to mandatory vaccinations stipulated by existing laws, COVID-19 vaccines have been urgently vaccinated, and various compensation methods have been introduced in addition to the existing vaccination laws. Among them, the implications of overseas compensation legislation are summarized as follows. First, it is a mitigating interpretation of the causal relationship between action and damage. In the case of the United States, the United Kingdom, and France, a no-fault compensation system that recognizes compensation even if direct causal relations are not identified, and in the case of Germany, the review of causal relations is eased at the screening stage. In the case of Japan and Korea, general theories on causal relations are applied, but experts from separate organizations are participating to ease the criteria for compensation review. Second, compensation through a separate compensation fund is institutionalized. Typically, NVICP and CICP in the U.S. compensate according to the standards stipulated in the vaccine table if they fall under the objective facts of vaccination and damage, and France's National Compensation Office operates a compensation system with funds prepared by vaccine manufacturers and vaccine administrators at the time of vaccination. Third, the scope of damage compensation generally introduces the principle of full compensation. In practice, compensation differs in ways such as following the vaccine table stipulated in the special fund in the United States or compensation based on social security benefits in the United Kingdom, but includes medical expenses as well as lost damages and family compensation. Fourth, an arbitration system or an expert participation system is used in the compensation procedure. In the United States, the ADR system, which calculates the compensation amount led by a special master, is used by the National Secretariat (ONIAM) in the U.K., the Disease and Disability Review Board in Japan, and the Vaccination Damage Compensation Committee in Korea.

허위정보 규제를 위한 행정법적 대응방안 - 영국의 규제 논의를 중심으로 -

김재선 ( Jae-sun Kim ) 이화여자대학교 법학연구소 2020 法學論集 Vol.24 No.3

영국의 경우, 2016년 브렉시트 국민투표 이후 허위정보(가짜뉴스)에 대한 규제논의가 이루어졌다. 영국 행정부는 규제부처인 DCMS부가 중심이 된 인터넷안전위원회, 방송통신 규제기관인 오프콤, 선거관련 기구인 선거위원회 등이 중심이 되며, 의회의 경우 하원 정보보호위원회, DCMS 위원회가 중심이 되었다. 영국의 허위정보 규제방안으로는 (i) 온라인 피해(online harm) 규제 논의, (ii) 허위정보에 해당하는 전달된 전보(inferred data)에 대한 개인정보보호법제 적용 논의, (iii) 선거법제 적용 논의, (iv) 디지털 리터러시 논의 등이 주요 쟁점으로 논의되고 있다. 마지막으로 허위정보를 규제하기 위한 입법적 대안으로는, (i) 기존 법률 해석 방안(명예훼손법, 통신법, 데이터보호법), (ii) 새로운 법률 도입 방안(디지털날인의무화법, 온라인안전법), (iii) 가이드라인 도입 방안, (iv) 독립규제기구의 윤리기준 강화방안, (v) 플랫폼 사업자의 책임 강화방안 등으로 논의된다. 영국의 경우 디지털날인의무화법안이 도입되지 못한 이후, 2017년 이후 세계에서 최초로 온라인 플랫폼 사업자에 대한 직접적. 법적 책임을 규정한 온라인안전법안이 논의되고 있다. 온라인안전법에 따르면 온라인서비스사업자는 적정한 주의의무를 다하여야 하므로 온라인 피해(폭력, 자살유발, 허위정보, 사이버폭력 등)에 해당하는 경우 삭제 등의 조치를 취하여야 하며, 허위정보의 경우 유포를 최소화하여야 한다. 한편, 영국 정부는 간접적인 대응방안으로 허위정보대응가이드라인을 통하여 허위정보를 분별하고, 온라인 내에서 스스로 정화하는 방안을 제안하고 있다. 대표적으로 RESIST(“Counter-Disinformation Toolkit”), SHARE 체크리스트 등 허위정보를 이용자 스스로 분별하고 자제하도록 유도하는 가이드라인이 제안되고 있다. 플랫폼사업자에 대한 직접규제방안 외에 과세 또는 기금마련 방안, 미국의 페이스북과 연방통상위원회의 동의의결(“consent decree”)과 같이 행정부와 기업이 직접 세부사항을 합의하는 방식 등이 제안되고 있다. 영국에서의 논의 중 새로운 법안을 통한 규제는 정부가 소셜미디어 등 온라인에 게시된 내용에 대한 삭제 또는 삭제권고를 하여야 한다는 점에서 표현의 자유를 침해한다는 점, 실효성있는 규제권한을 행사하기 힘들다는 점에서 여러 비판을 받았으며 이러한 논의의 흐름은 우리나라에서도 유사하게 이해된다. 영국에서의 논의와 같이 직접적 규제보다는 간접적 규제방식이 바람직할 것으로 이해되며 이 중 플랫폼사업자의 자율규제방안, 소비자의 디지털 이해도를 높이도록 하는 디지털 리터러시 강화방안은 우리나라에서도 참조할 수 있다. In UK, regulatory discussions have been brought up by the Brexit referendum of 2016. The UK governments has approached diversely including (i) DCMS of the UK Council for Internet Safety as an administrative regulatory department; (ii) Ofcom as a broadcasting and telecommunication regulatory government; and (3) Electoral Commission as a regulatory system to prevent disseminating disinformation in the course of the election. The UK’s regulatory methods includes (i) interpreting existing laws(Defamation law, Communication Law, Data Protection Law), (ii) establishing new law(Digital Signature law, Online Safety Law), (iii) establishing detailed guideline, (iv) strengthening ethical standard of the independent regulatory institute, (v) requiring more responsibility of the service providers. Moreover, indirect guidelines are discussed including RESIST(“Counter-Disinformation Toolkit”), SHARE checklists. Currently, new direct regulatory methods including making new laws seems not be welcomed because these could interfere the freedom of the people in the cyberspace and these could not be so effective ways of preventing disinformation issues. Rather, indirect but strong regulatory alternatives are introducing such as self-regulatory methods of the service providers, strengthening digital literacy of the users. These indirect ways could include disclosing information flows in the cyberspace, methods of the data analysis, or online users’ right(access, revise, refuse to automatic decision etc), which would be good references in South Korea.

대형연구시설을 활용한 연구에 관한 공법적 쟁점 검토 - 미국의 대형연구시설 관련 법제도 연구를 중심으로 -

김재선 충북대학교 법학연구소 2022 法學硏究 Vol.33 No.2

As the need for research using advanced facilities increased, the need for safe and efficient management of large research facilities used by research institutes increased. In particular, in the case of large research facilities, efficient and reasonable legalization measures are required in the use of large research facilities due to overlapping installation, disposal of idle or underutilized facilities, and temporary treatment. In Korea, the Basic Law on Science and Technology, the Enforcement Decree of the Framework Act on Science and Technology, and the 「Basic Research and Development Support Act」, the Industrial Technology Innovation Promotion Act」, and the 협동Cooperative Research and Development Promotion Act have been enacted and applied. However, research on overseas cases with a more systematic management system is required because individual laws regulate different contents according to legislative purposes, and in some cases, the contents required by practice cannot be more specifically defined. In the case of the United States, since World War II, systematic laws, procedures, and guidelines have been operated on specific science and technology policies, funding for technology development, and facility operation plans. The federal government (Energy Bureau, Science Bureau, National Science Foundation, National Health Agency, etc.) centered on the presidential office systematically operates using related laws and guidelines. First, federal law proposes standards for funding for future strategy establishment under the American Innovation and Competition Act, Federal Grant and Cooperative Agreement, and guidelines for the Budget Administration (OMB Circular A-110) and Large Research Foundation (DNS) Guidelines for Energy Agency (DNS). Meanwhile, universities or research institutes operate individual guidelines for equipment management of large research facilities, and Stanford University has a systematic management and operation system for accelerator operation and management organization. Accordingly, the following implications are drawn for the laws related to research facilities in the United States. First, systematic governance is prepared for research promotion, and active support from the federal government is being provided around the presidential office. In the case of the American Innovation and Competition Act, which is under discussion for revision in 2021, six key industries (Artificial Intelligence, Semiconductor, Quantum Computing, Advanced Communication, Biotechnology, Energy Improvement) have been proposed. This U.S. governance system is consistent with the U.S. federal government's policy direction, which actively supports science and technology policies after World War II, and is thought to have implications in Korea in terms of actively and systematically supporting federal-managed industries. Second, there are detailed regulations and guidelines for budget allocation and management of research facilities. For example, the OMB Circular A-110, DOE 413.3A, and the Large Facility Manual of the National Science Foundation (NSF) stipulate not only the allocation of research funds but also the factors that need to be checked by the National Science Foundation (NSF) in detail. Third, various verification procedures such as external verification procedures and cost-benefit analysis are prepared. It seems that a management system is in place as predictable verification procedures for selecting research topics and initial design, such as verifying the Director's Review Board (DRB) of the Energy Agency and reviewing the National Science Board of the NSF are stipulated. In addition, it can be considered that the Large Facility Manual stipulates cost-benefit procedures and provides management improvement procedures through reasonable compensation for research and cost-benefit analysis.

갈대 외 1편

김재선 고요아침 2022 시조시학 Vol.85 No.-

도시환경 개선을 위한 스마트그리드 활용에 관한 공법적 과제

김재선 ( Kim Jae Sun ) 한국환경법학회 2021 環境法 硏究 Vol.43 No.1

교통과 산업, 보건과 환경 등 사회 및 인구구조가 변화함에 따라 2050년에는 인구의 70%가 도시에 거주할 것임이 예상되는 상황에서 인구의 도시집중은 도시환경 측면에서 도로·교통·주거환경 등에서 문제가 나타나면서 도시환경 개선을 위한 논의가 발전하게 되었다. 특히 에너지의 효율적 관리와 배분체계는 스마트도시의 환경보전을 위한 주요 수단이 되면서 에너지 활용을 위한 신기술로 스마트그리드의 법제도적 쟁점이 논의된다. 스마트그리드는 스마트시티 건설의 주요 목적 중 하나인 도시환경 개선방안의 중요한 수단으로 “기존의 전력망에 정보통신 기술을 접목하여 실시간으로 에너지 정보를 교환하여 호율적으로 사용할 수 있도록 하는 체계”로 “전력망에 정보통신기술을 적용하여 전기의 공급자와 사용자가 실시간으로 정보를 교환하는 등의 방법으로 전기를 공급함으로써 에너지 이용효율을 극대화하는 전력망”으로 정의된다. 스마트그리드는 지능형전력망의 구축 및 이용촉진에 관한 법률에 근거하며, 「도시재생 활성화 및 지원에 관한 특별법」, 「스마트도시 조성 및 산업진흥 등에 관한 법률」 등에서 에너지 활용의 효율화를 위한 법적 기반을 마련하였다. 스마트그리드는 우리나라에서 정보기술활용 촉진과 정보보호, 사회보장 관점에서 접근되어 왔으나 도시 내 에너지 관리체계가 변화하면서 수자원 관리, 대기자원 관리, 주거환경 관리 등 개별 영역과 관련하여 공법적 관점에서 변화가 나타나고 있다. 민간 기술 활용을 촉진하여 기술역량을 강화하는 방안, 스마트그리드 기술 활용을 위하여 소비자의 적극적 참여를 유인하기 위한 방안(다양한 요금제 도입, 소비자 선택권 보장), 실증 기술 도입(IoT, 빅데이터, 인공지능 등)을 통한 소비자의 관심을 유도하는 방안, 정보의 활용 및 보호에 관한 근거를 명확히 하는 방안, 기술개발 원칙의 지침화를 통한 체계적 관리체계 마련, 민간과 정부(중앙 및 지방)의 역할을 강화하는 방안, 에너지 보호를 위한 입법 프레임워크를 활용하는 방안을 고려할 수 있다. As the society and demographic structure change including transportation, industry, health and environment, while the population would be centered in the mega cities the, it would occur various problems including roads, traffic, residential environments. Especially, as the efficient management and distribution system of energy would become a significant tools to conserve environment in smart cities, the legal issues in utilizing energy would be discussed. While the main purpose of constructing the smart city is to improve urban environment, smartgrid is regarded as an significant tool in improving the environment. The smartgrid is defined as “a power grid that maximizes energy use efficiency by providing electricity”. The smart grid is based on the Act on the Promotion of Construction and Utilization of Intelligent Power Grids (2011), under the 「Special Act on promotion of and support for urban regeneration」 and 「Act on the Promotion of Smart City Development and Industry」. The smart grid has been approached under the perspective of promoting information technology utilization, information protection, and social security. As the perspectives has been changed and diversified, public policy considerations are needed including strengthen technological capabilities by allowing the use of private technology, allowing consumer’s participation in using smart grid technology (various rate plans, guarantee of consumer choice), and introducing of empirical technology (IoT, big data, artificial intelligence, etc.).

내시경 검사시 Phenol Red 분무에 의한 Helicobacter pylori 감염 진단의 의의

김종극(Jong Guk Kim),이창홍(Chang Hong Lee),박영태(Young Tae Bak),김진호(Jin Ho Kim),원남희(Nam Hee Won),김재선(Jae Seon Kim),변관수(Kwan Soo byun) 대한소화기학회 1993 대한소화기학회지 Vol.25 No.1

N/A A strong association between Helicobacter pylori (H. pylori) and chronic active inflammation of the gastric antrum and duodenal ulceration has been recognized. Although various rnethods have been proposed to detect this microorganism, no unanimity exists among investigators concerning which method represents a gold standard. H. pylori producee urease that converts urea to ammonia which then raises the pH, therefore we have utilized an endoscopic spray technique using phenol red (pH indicator) in vivo to assess H. pylori infection itself and its distribution. 87 patients with dyspepsia were pre-medicated with ranitidine 150 mg p.o. 3 houre before endoscopy to maintain a gastric pH between 3-6. During endoscopy, 20 ml of a mixture containing 0.05% phenol red and 0.5% urea was sprayed over the antral mucosa using a spray catheter. It was defined as positivc if any area of the mucosa turned red within 3 min after spraying. Antral biopsies were taken from all patients. Biopsies were assessed in a blind fashion after H&E, Giemsa and Warthin-Starry silver stain. The phenol red positive patients were 54.0%, and diffuse pattern of positive staining was 85.1% and regional pattern was 14.9%. Diagnostic sensitivity and specificity of the endoscoic spray technique were 87.2%. and 85.0% respectively. In conclusion, the endoscopic phenol red spray technique may be one of the simple and useful screening tests for diagnosis of H. pylori infection and for dilineating its probahle pattern of distributionvn gastric mucosa in vivo, but this method seems not useful for confirmatory diagnosis of H. pylori infection and needs further study.

반복되는 담도성 산통을 호소하는 환자에서 담관내압검사와 담낭스캔의 의의

김재선(Jae Seon Kim),정문기(Moon Gi Chun),이성준(Seong Jun Lee),김경민(Kyoung Min Kim),변관수(Kwan Soo byun),박영태(Young Tae Bak),김진호(Jin Ho Kim),김종극(Jong Guk Kim),이창홍(Chang Hong Lee) 대한소화기학회 1995 대한소화기학회지 Vol.27 No.5

N/A Background/Aims: Tbis study was aimed to evaluate the clinical significance of the sphincter of Oddi manometry (SOM), cholescintigraphy, endoscopic sphincterotomy(EST), and cholecystectomy in patients complaining of recurrent biliary-type abdominal pain. Methods: 20 patients with recurrent biliary-type abdominal pain not explained by conventional diagnostic studies were sampled. All the patients with manometrically verified sphincter of Oddi dystunction(SOD) and some patients with normal or failed manometry underwent EST. Among those with normal or failed manometry laparoscopic cholecystectomy was performed to patients with acalcu)ous cholecystopathy(ACP) diagnosed by cholescintigraphy. Results: Of 26 sessions of SOM tried in all the 20 cases, 2l sessions in 17 cases were technically successful. Among those 17 patients, SOM was abnormal in 9 cases(6:sphincter of Oddi dyskinesia; 3:sphincter of Oddi stenosis). Four of five patients undergoing cholescintigraphy in patients with normal or t'ailed manometry were verified as ACP. The procedure-related pancreatitis occurred in 7/26 sessions after SOM and in 3/12 sessions after EST. In 1 case, a micro-perforation followed EST. All these patients with complications recovered uneventfully. Mean duration of fo]low-up was 13.5(range 7 -24) months. EST was of benefit to 7 of 9 patients with manometrically verified SOD and also to all 3 patients with normal or failed manometry undergoing EST. Laparoscopic cholecystectomy was of henefit to all 3 patients with ACP undergoing cholecystectomy. Conclusions: Extensive diagnostic procedures such as SOM and cholescintigraphy and proper therapy according to their results should be considered with patients complaining of recurrent biliary-type abdominal pain not explained by other conventional diagnostic studies. (Korean J Gastroenterol 1995;27: 563 - 572)

Legislative Issues in Disclosing Financial Conflicts of Interest to Participants in Biomedical Research: Effectiveness and Methodology

김재선 대한의학회 2017 Journal of Korean medical science Vol.32 No.12

This research focuses on the analysis regarding disclosure of financial conflicts of interest (FCOI) after Gelsinger v. University of Pennsylvania (Penn). The main legal issue was that the participants did not have enough opportunity to make an autonomous decision about participating in the research because he was not informed about the researchers' and the institution's substantial FCOI. The disclosure system was adopted by the Code of Federal Regulations. Under the regulation, researchers and institutions need to report FCOI over $5,000 to the institution, and the internal review boards have to report to the federal authority if needed. In case of human research, the disclosure to Food and Drug Administration is mandatory. FCOI disclosure system would help participants to make an autonomous decision, and increase trust to the research process and researchers. Moreover, the system would let researchers keep fiduciary duty while (possibly) lowering legal liability in case of a lawsuit. There were discussions about the disclosure methodology in the United States. However, there have not been a lot of discussions in Korea even after the “Humidifier Disinfectant” case. Therefore, new legislations need to be considered. First, the system requires disclosure funded by not only government but also private institutions. Second, like California Supreme Court, the subject would be reviewed under the reasonable person standard by participants, including patents, equity, and stock. Third, the disclosure needs to include simple or brief explanation to the FCOI to be better understood by the participants. Fourth, the disclosure should be in the informed consent process.

實驗計劃에 있어서의 要因分析

김재선 成均館大學校 經商大學 1974 經商論集 Vol.25 No.1