• Title/Summary/Keyword: Legal Compliance

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Concerning the Constitution Court's constitutional decision and the direction of supplemental legislation concerning Article 33 paragraph 8 of the Medical Service Act - With a focus on legitimacy of a system that prohibits multiple opening of medical instituion, in the content of 2014Hun-Ba212, August 29, 2019, 2014Hun-Ga15, 2015Hun-Ma561, 2016Hun-Ba21(amalgamation), Constitutional Court of Korea - ('의료법 제33조 제8항 관련 헌법재판소의 합헌결정'에 대한 평가 및 보완 입법 방향에 대하여 -헌법재판소 2019. 8. 29. 2014헌바212, 2014헌가15, 2015헌마561, 2016헌바21(병합) 결정의 내용 중 의료기관 복수 개설금지 제도의 당위성 및 필요성을 중심으로-)

  • KIM, JOON RAE
    • The Korean Society of Law and Medicine
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    • v.20 no.3
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    • pp.143-174
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    • 2019
  • Our Constitution obliges the state to protect the health of the people, and the Medical Law, which embodied Constitution, sets out in detail the matters related to open the medical institution, and one of them is to prohibit the operation of multiple medical institutions. By the way, virtually multiple medical institutions could be opened and operated because the Supreme Court had interpreted that several medical institutions could be opened if medical activities were not performed directly at the additional medical institution which was opened under the another doctor's license. However, some health care providers opened the several medical institutions with another doctor's license for the purpose of the maximization of profit, and did illegal medical cares like the unfair luring of patients, over-treatment, and commission treatment. Also, realistic problems such as the infringed health rights have arisen. Accordingly, lawmakers had come to amend the Medical Law to readjust the system of opening for medical institution so that medical personnel could not open or operate more than one medical institution for any reason. For this reason, the Constitutional Court recently declared a constitutional decision through a long period of in-depth deliberation because the constitutional petition and the adjudication on the constitutionality of statutes had been filed on whether Article 33 paragraph 8 of the revised medical law is unconstitutional. The Constitutional Court acknowledged the "justice of purpose" in view of the importance of public medical institutions, of the prevention from seduction of for-profit patients and from over-treatment, and of the fact that health care should not be the object of commercial transactions. Given the risk that medical personnel might be subject to outside capital, the concern that the holder of the medical institution's opening certificate and the actual operator may be separated, the principle that the human body and life should not be just a means, and the current system's inability to identify over-treatment, it also acknowledged the 'minimum infringement'. Furthermore, The Constitutional Court judged it is constitutional in compliance with the principle of restricting fundamental rights, such as 'balance of legal interests'. In this regard, legislative complements are needed in order to effectively prevent the for-profit management and the over-treatment the Constitutional Court is concerned about. In this regard, consumer groups actively support the need for legislation, and health care providers groups also agree on the need for legislation. Therefore, the legislators should respect the recent Constitutional Court's decision and in the near future complete the complementary legislation to reflect the people's interests.

E-Commerce in the Historical Approach to Usage and Practice of International Trade ("무역상무(貿易商務)에의 역사적(歷史的) 어프로치와 무역취인(貿易取引)의 전자화(電子化)")

  • Tsubaki, Koji
    • THE INTERNATIONAL COMMERCE & LAW REVIEW
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    • v.19
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    • pp.224-242
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    • 2003
  • The author believes that the main task of study in international trade usage and practice is the management of transactional risks involved in international sale of goods. They are foreign exchange risks, transportation risks, credit risk, risk of miscommunication, etc. In most cases, these risks are more serious and enormous than those involved in domestic sales. Historically, the merchant adventurers organized the voyage abroad, secured trade finance, and went around the ocean with their own or consigned cargo until around the $mid-19^{th}$ century. They did business faceto-face at the trade fair or the open port where they maintained the local offices, so-called "Trading House"(商館). Thererfore, the transactional risks might have been one-sided either with the seller or the buyer. The bottomry seemed a typical arrangement for risk sharing among the interested parties to the adventure. In this way, such organizational arrangements coped with or bore the transactional risks. With the advent of ocean liner services and wireless communication across the national border in the $19^{th}$ century, the business of merchant adventurers developed toward the clear division of labor; sales by mercantile agents, and ocean transportation by the steam ship companies. The international banking helped the process to be accelerated. Then, bills of lading backed up by the statute made it possible to conduct documentary sales with a foreign partner in different country. Thus, FOB terms including ocean freight and CIF terms emerged gradually as standard trade terms in which transactional risks were allocated through negotiation between the seller and the buyer located in different countries. Both of them did not have to go abroad with their cargo. Instead, documentation in compliance with the terms of the contract(plus an L/C in some cases) must by 'strictly' fulfilled. In other words, the set of contractual documents must be tendered in advance of the arrival of the goods at port of discharge. Trust or reliance is placed on such contractual paper documents. However, the container transport services introduced as international intermodal transport since the late 1960s frequently caused the earlier arrival of the goods at the destination before the presentation of the set of paper documents, which may take 5 to 10% of the amount of transaction. In addition, the size of the container vessel required the speedy transport documentation before sailing from the port of loading. In these circumstances, computerized processing of transport related documents became essential for inexpensive transaction cost and uninterrupted distribution of the goods. Such computerization does not stop at the phase of transportation but extends to cover the whole process of international trade, transforming the documentary sales into less-paper trade and further into paperless trade, i.e., EDI or E-Commerce. Now we face the other side of the coin, which is data security and paperless transfer of legal rights and obligations. Unfortunately, these issues are not effectively covered by a set of contracts only. Obviously, EDI or E-Commerce is based on the common business process and harmonized system of various data codes as well as the standard message formats. This essential feature of E-Commerce needs effective coordination of different divisions of business and tight control over credit arrangements in addition to the standard contract of sales. In a few word, information does not alway invite "trust". Credit flows from people, or close organizational tie-ups. It is our common understanding that, without well-orchestrated organizational arrangements made by leading companies, E-Commerce does not work well for paperless trade. With such arrangements well in place, participating E-business members do not need to seriously care for credit risk. Finally, it is also clear that E-International Commerce must be linked up with a set of government EDIs such as NACCS, Port EDI, JETRAS, etc, in Japan. Therefore, there is still a long way before us to go for E-Commerce in practice, not on the top of information manager's desk.

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The Fiduciary Duties of Doctor in Clinical Trials (임상시험에서 의사의 선량한 관리자의 주의의무)

  • Lee, Jiyoun
    • The Korean Society of Law and Medicine
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    • v.21 no.2
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    • pp.163-207
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    • 2020
  • Korea has been positioned as the leading country in the industry of clinical trials as the clinical trail of Korea has developed for the recent 10 years. Clinical trial has plays a significant role in the development of medicine and the increase of curability. However, it has inevitable risk as the purpose of the clinical trial is to prove the safety and effectiveness of new drugs. Therefore, the clinical trial should be controlled properly to protect the health of the subjects of clinical trial and to ensure that they exercise a right of self-determination. In this context, the fiduciary duties of doctors who conduct clinical trials is especially important. The Pharmaceutical Affairs Act and the relevant regulations define several duties of doctors who conduct clinical trials. In particular, the duty to protection of subjects and the duty to provide information constitute the main fiduciary duties to the subjects. Those are essentially similar to the fiduciary duties of doctors in usual treatment from the perspective of the values promoted by the law and the content of the law. Nonetheless, clinical trials put more emphasis on the duties to provide explanation than in usual treatment. Further research and study are required to establish the concrete standard for the duty of care. However, if the blind pursuit of higher standards for the duty of care or to pass the burden of proof to doctors may result in disrupting the development of clinical trials, limiting the accessibility of patients to new treatment and even violating the principle of sharing damage equally and properly. In addition to these duties, the laws of clinical trials define several duties of doctors. Any decision on whether the violation of the law constitutes the violation of the fiduciary duty and justifies the demand for compensation of damages should be based on whether relevant law aims to protect the safety and benefit of subjects, even if in an incidental way, the degree to which such violation breaches the values promoted by the law and the concrete of violation of benefit of law, the detailed acts of such violation. The legal interests of the subjects can be protected effectively by guaranteeing compliance with those duties and establishing judicial and administrative controls to ensure that the benefit of subjects are protected properly in individual cases.

A Study on Major Safety Problems and Improvement Measures of Personal Mobility (개인형 이동장치의 안전 주요 문제점 및 개선방안 연구)

  • Kang, Seung Shik;Kang, Seong Kyung
    • Journal of the Society of Disaster Information
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    • v.18 no.1
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    • pp.202-217
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    • 2022
  • Purpose: The recent increased use of Personal Mobility (PM) has been accompanied by a rise in the annual number of accidents. Accordingly, the safety requirements for PM use are being strengthened, but the laws/systems, infrastructure, and management systems remain insufficient for fostering a safe environment. Therefore, this study comprehensively searches the main problems and improvement methods through a review of previous studies that are related to PM. Then the priorities according to the importance of the improvement methods are presented through the Delphi survey. Method: The research method is mainly composed of a literature study and an expert survey (Delphi survey). Prior research and improvement cases (local governments, government departments, companies, etc.) are reviewed to derive problems and improvements, and a problem/improvement classification table is created based on keywords. Based on the classification contents, an expert survey is conducted to derive a priority improvement plan. Result: The PM-related problems were in 'non-compliance with traffic laws, lack of knowledge, inexperienced operation, and lack of safety awareness' in relation to human factors, and 'device characteristics, road-drivable space, road facilities, parking facilities' in relation to physical factors. 'Management/supervision, product management, user management, education/training' as administrative factors and legal factors are divided into 'absence/sufficiency of law, confusion/duplication, reduced effectiveness'. Improvement tasks related to this include 'PM education/public relations, parking/return, road improvement, PM registration/management, insurance, safety standards, traffic standards, PM device safety, PM supplementary facilities, enforcement/management, dedicated organization, service providers, management system, and related laws/institutional improvement', and 42 detailed tasks are derived for these 14 core tasks. The results for the importance evaluation of detailed tasks show that the tasks with a high overall average for the evaluation items of cost, time, effect, urgency, and feasibility were 'strengthening crackdown/instruction activities, education publicity/campaign, truancy PM management, and clarification of traffic rules'. Conclusion: The PM market is experiencing gradual growth based on shared services and a safe environment for PM use must be ensured along with industrial revitalization. In this respect, this study seeks out the major problems and improvement plans related to PM from a comprehensive point of view and prioritizes the necessary improvement measures. Therefore, it can serve as a basis of data for future policy establishment. In the future, in-depth data supplementation will be required for each key improvement area for practical policy application.

A Study on Air Operator Certification and Safety Oversight Audit Program in light of the Convention on International Civil Aviation (시카고협약체계에서의 항공안전평가제도에 관한 연구)

  • Lee, Koo-Hee;Park, Won-Hwa
    • The Korean Journal of Air & Space Law and Policy
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    • v.28 no.1
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    • pp.115-157
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    • 2013
  • Some contracting States of the Convention on International Civil Aviation (commonly known as the Chicago Convention) issue FAOC(Foreign AOC and/or Operations Specifications) and conduct various safety audits for the foreign operators. These FAOC and safety audits on the foreign operators are being expanded to other parts of the world. While this trend is the strengthening measure of aviation safety resulting in the reduction of aircraft accident, it is the source of concern from the legal as well as economic perspectives. FAOC of the USA doubly burdens the other contracting States to the Chicago Convention because it is the requirement other than that prescribed by the Chicago Convention of which provisions are faithfully observed by almost all the contracting States. The Chicago Convention in its Article 33 stipulates that each contracting State recognize the validity of the certificates of airworthiness and licenses issued by other contracting States as long as they meet the minimum standards of the ICAO. Consequently, it is submitted that the unilateral action of the USA, China, Mongolia, Australia, and the Philippines issuing the FOAC to the aircraft of other States is against the Convention. It is worry some that this breach of international law is likely to be followed by the European Union which is believed to be in preparation for its own unilateral application. The ICAO established by the Chicago Convention to be in charge of safe and orderly development of the international civil aviation has been in hard work to both upgrade and emphasize the safe operation of aircraft. As the result of these endeavors, it prepared a new Annex 19 to the Chicago Convention with the title of "Safety Management" and with the applicable date 14 November 2013. It is this Annex and other ICAO documents relevant to the safety that the contracting States to the Chicago Convention have to observe. Otherwise, it is the economical burden due to probable delay in issuing the FOAC and bureaucracies combined with many different paperworks and regulations depending on where the aircraft is flown. It is exactly to avoid this type of confusion and waste that the Chicago Convention aimed at when it was adopted in 1944. The State of the operator shall establish a system for both the certification and the continued surveillance of the operator in accordance with ICAO SARPs to ensure that the required standards of operations are maintained. Certainly the operator shall meet and maintain the requirements established by the States in which it operate. The authority of a State stops where the authority of another State intervenes or where the former has yielded its power by an international agreement for the sake of international cooperation. Hence, it is not within the realm of the State to issue FAOC towards foreign operators for the reason that these foreign operators are flying in and out of the State. Furthermore, there are other safety audits such as ICAO USOAP, IATA IOSA, FAA IASA, and EU SAFA that assure the safe operation of the aircraft, but within the limit of their power and in compliance with the ICAO SARPs. If the safety level of any operator is not satisfactory, the operator could be banned to operate in the contracting States with watchful eyes until the ICAO SARPs are met. This time-honoured practice has been applied without any serious problems. Besides, we have the new Annex 19 to strengthen and upgrade with easy reference for contracting States. We don't have no reason to introduce additional burden to the States by unilateral actions of some States. These actions have to be corrected. On the other hand, when it comes to the carriage of the Personal or Pilot Log Book, the Korean regulation requiring it is in contrast with other relevant provisions of USA, USOAP, IOSA, and SAFA. The Chicago Convention requires in its Articles 29 and 34 only the carriage of the Journey Log Book and some other certificates, but do not mention the Personal Log Book at all. Paragraph 5.1.1.1 of Annex 1 to the Chicago Convention even makes it clear that the carriage in the aircraft of the Personal Log Book is not required on international flights. The unique Korean regulation in this regards giving the unnecessary burden to the national flag air carriers has to be lifted at once.

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The Requirement and Effect of the Document of Carriage in Respect of the International Carriage of Cargo by Air (국제항공화물운송에 관한 운송증서의 요건 및 효력)

  • Lee, Kang-Bin
    • The Korean Journal of Air & Space Law and Policy
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    • v.23 no.2
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    • pp.67-92
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    • 2008
  • The purpose of this paper is to research the requirements and effect of the document of carriage in respect of the carriage of cargo by air under the Montreal Convention of 1999, IATA Conditions of Carriage for Cargo, and the judicial precedents of Korea and foreign countries. Under the Article 4 of Montreal Convention, in respect of the carriage of cargo, an air waybill shall be delivered. If any other means which preserves a record of the carriage are used, the carrier shall, if so requested by the consignor, deliver to the consignor a cargo receipt. Under the Article 7 of Montreal convention, the air waybill shall be made out by the consignor. If, at the request of the consignor, the carrier makes it out, the carrier shall be deemed to have done so on behalf of the consignor. The air waybill shall be made out in three original parts. The first part shall be marked "for the carrier", and shall be signed by the consignor. The second part shall be marked "for the consignee", and shall be signed by the consignor and by the carrier. The third part shall be signed by the carrier who shall hand it to the consignor after the goods have been accepted. Under the Article 5 of Montreal Convention, the air waybill or the cargo receipt shall include (a) an indication of the places of departure and destination, (b) an indication of at least one agreed stopping place, (c) an indication of the weight of the consignment. Under the Article 10 of Montreal Convention, the consignor shall indemnify the carrier against all damages suffered by the carrier or any other person to whom the carrier is liable, by reason of the irregularity, incorrectness or incompleteness of the particulars and statement furnished by the consignor or on its behalf. Under the Article 9 of Montreal Convention, non-compliance with the Article 4 to 8 of Montreal Convention shall not affect the existence of the validity of the contract, which shall be subject to the rules of Montreal Convention including those relating to limitation of liability. The air waybill is not a document of title or negotiable instrument. Under the Article 11 of Montreal Convention, the air waybill or cargo receipt is prima facie evidence of the conclusion of the contract, of the acceptance of the cargo and of the conditions of carriage. Under the Article 12 of Montreal Convention, if the carrier carries out the instructions of the consignor for the disposition of the cargo without requiring the production of the part of the air waybill or the cargo receipt, the carrier will be liable, for any damage which may be accused thereby to any person who is lawfully in possession of that part of the air waybill or the cargo receipt. According to the precedent of Korea Supreme Court sentenced on 22 July 2004, the freight forwarder as carrier was not liable for the illegal delivery of cargo to the notify party (actual importer) on the air waybill by the operator of the bonded warehouse because the freighter did not designate the boned warehouse and did not hold the position of employer to the operator of the bonded warehouse. In conclusion, as the Korea Customs Authorities will drive the e-Freight project for the carriage of cargo by air, the carrier and freight forwarder should pay attention to the requirements and legal effect of the electronic documentation of the carriage of cargo by air.

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APPLICATION OF FUZZY SET THEORY IN SAFEGUARDS

  • Fattah, A.;Nishiwaki, Y.
    • Proceedings of the Korean Institute of Intelligent Systems Conference
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    • 1993.06a
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    • pp.1051-1054
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    • 1993
  • The International Atomic Energy Agency's Statute in Article III.A.5 allows it“to establish and administer safeguards designed to ensure that special fissionable and other materials, services, equipment, facilities and information made available by the Agency or at its request or under its supervision or control are not used in such a way as to further any military purpose; and to apply safeguards, at the request of the parties, to any bilateral or multilateral arrangement, or at the request of a State, to any of that State's activities in the field of atomic energy”. Safeguards are essentially a technical means of verifying the fulfilment of political obligations undertaken by States and given a legal force in international agreements relating to the peaceful uses of nuclear energy. The main political objectives are: to assure the international community that States are complying with their non-proliferation and other peaceful undertakings; and to deter (a) the diversion of afeguarded nuclear materials to the production of nuclear explosives or for military purposes and (b) the misuse of safeguarded facilities with the aim of producing unsafeguarded nuclear material. It is clear that no international safeguards system can physically prevent diversion. The IAEA safeguards system is basically a verification measure designed to provide assurance in those cases in which diversion has not occurred. Verification is accomplished by two basic means: material accountancy and containment and surveillance measures. Nuclear material accountancy is the fundamental IAEA safeguards mechanism, while containment and surveillance serve as important complementary measures. Material accountancy refers to a collection of measurements and other determinations which enable the State and the Agency to maintain a current picture of the location and movement of nuclear material into and out of material balance areas, i. e. areas where all material entering or leaving is measurab e. A containment measure is one that is designed by taking advantage of structural characteristics, such as containers, tanks or pipes, etc. To establish the physical integrity of an area or item by preventing the undetected movement of nuclear material or equipment. Such measures involve the application of tamper-indicating or surveillance devices. Surveillance refers to both human and instrumental observation aimed at indicating the movement of nuclear material. The verification process consists of three over-lapping elements: (a) Provision by the State of information such as - design information describing nuclear installations; - accounting reports listing nuclear material inventories, receipts and shipments; - documents amplifying and clarifying reports, as applicable; - notification of international transfers of nuclear material. (b) Collection by the IAEA of information through inspection activities such as - verification of design information - examination of records and repo ts - measurement of nuclear material - examination of containment and surveillance measures - follow-up activities in case of unusual findings. (c) Evaluation of the information provided by the State and of that collected by inspectors to determine the completeness, accuracy and validity of the information provided by the State and to resolve any anomalies and discrepancies. To design an effective verification system, one must identify possible ways and means by which nuclear material could be diverted from peaceful uses, including means to conceal such diversions. These theoretical ways and means, which have become known as diversion strategies, are used as one of the basic inputs for the development of safeguards procedures, equipment and instrumentation. For analysis of implementation strategy purposes, it is assumed that non-compliance cannot be excluded a priori and that consequently there is a low but non-zero probability that a diversion could be attempted in all safeguards ituations. An important element of diversion strategies is the identification of various possible diversion paths; the amount, type and location of nuclear material involved, the physical route and conversion of the material that may take place, rate of removal and concealment methods, as appropriate. With regard to the physical route and conversion of nuclear material the following main categories may be considered: - unreported removal of nuclear material from an installation or during transit - unreported introduction of nuclear material into an installation - unreported transfer of nuclear material from one material balance area to another - unreported production of nuclear material, e. g. enrichment of uranium or production of plutonium - undeclared uses of the material within the installation. With respect to the amount of nuclear material that might be diverted in a given time (the diversion rate), the continuum between the following two limiting cases is cons dered: - one significant quantity or more in a short time, often known as abrupt diversion; and - one significant quantity or more per year, for example, by accumulation of smaller amounts each time to add up to a significant quantity over a period of one year, often called protracted diversion. Concealment methods may include: - restriction of access of inspectors - falsification of records, reports and other material balance areas - replacement of nuclear material, e. g. use of dummy objects - falsification of measurements or of their evaluation - interference with IAEA installed equipment.As a result of diversion and its concealment or other actions, anomalies will occur. All reasonable diversion routes, scenarios/strategies and concealment methods have to be taken into account in designing safeguards implementation strategies so as to provide sufficient opportunities for the IAEA to observe such anomalies. The safeguards approach for each facility will make a different use of these procedures, equipment and instrumentation according to the various diversion strategies which could be applicable to that facility and according to the detection and inspection goals which are applied. Postulated pathways sets of scenarios comprise those elements of diversion strategies which might be carried out at a facility or across a State's fuel cycle with declared or undeclared activities. All such factors, however, contain a degree of fuzziness that need a human judgment to make the ultimate conclusion that all material is being used for peaceful purposes. Safeguards has been traditionally based on verification of declared material and facilities using material accountancy as a fundamental measure. The strength of material accountancy is based on the fact that it allows to detect any diversion independent of the diversion route taken. Material accountancy detects a diversion after it actually happened and thus is powerless to physically prevent it and can only deter by the risk of early detection any contemplation by State authorities to carry out a diversion. Recently the IAEA has been faced with new challenges. To deal with these, various measures are being reconsidered to strengthen the safeguards system such as enhanced assessment of the completeness of the State's initial declaration of nuclear material and installations under its jurisdiction enhanced monitoring and analysis of open information and analysis of open information that may indicate inconsistencies with the State's safeguards obligations. Precise information vital for such enhanced assessments and analyses is normally not available or, if available, difficult and expensive collection of information would be necessary. Above all, realistic appraisal of truth needs sound human judgment.

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