• 대한한의학회지
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• 제40권3호
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• pp.59-75
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• 2019

Objectives: The purpose of this study is to examine the current status of Korean medicine health technology assessment and explore realistic plans to activate it. Methods: We investigated all the applications for new health technology assessment related to Korean medicine from 2007 to 2016. The several expert meetings were held to draw out the barriers and improvement strategies of the new health technology assessment of Korean medicine field. Results: There were 31 cases in total except for duplications or reapplies falling into 3 main types. First, 19 of them were to try to enter a medical market and be covered by National Health Insurance. Eight cases were to apply western medicine technology as new health technology in Korean medicine area. The rest was 4 cases, which were totally not appropriate for the purpose of new health technology assessment system. According to the expert opinion, the obstacles of activation in new health technology assessment of Korean medicine were application of unstandardized technology, lack of understanding and experience, lack of clinical trial supporting system for Korean medicine, lack of committee members within the nHTA(new Health Technology Assessment) review board, ambiguous definition of medical practice and sharp conflict between western medicine and Korean medicine. Conclusions: Several suggestions were derived. First of all, to activate Korean medicine in the nHTA system, the existing system should be used sufficiently, and multifaceted efforts are needed to upgrade the system, if necessary. Also, self-help efforts, Korean medicine clinical trial supporting system and increasing R&D investment, establishing extra-committee for Korean medicine in nHTA could be needed. Finally, long-term strategy for improving collaboration between Korean medicine and western medicine should be considered.

• 한방재활의학과학회지
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• 제32권3호
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• pp.141-151
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• 2022

Objectives The purpose of this study is to improve the accessibility of Korean medicine by standardizing managements, improving quality of medical services, and reducing medical costs in ankle sprain by develop clinical pathway (CP). Methods The development of CP in this study is based on clinical practice guideline (CPG) for ankle sprain, and aims to maximize the quality of treatment, such as reducing treatment time and medical costs, and increasing patient satisfaction through standardized pathway. The CP was revised after consultation and review by the advisory committee. The advisory committee is consisted of a stakeholder group applying the CP. Results In previous research studies, there were no Korean medicine CP studies on ankle sprain. Based on CPG for ankle sprain and analysis of medical records, 6 types of time task matrix type CP (for Korean medicine doctors, medical assistant, patients) and 4 types of algorithm type CP (for Korean medicine clinics, Korean medicine hospitals, and cooperative practicing hospitals, public medical centers) were derived as a result. Conclusions Ankle sprain CP is expected to not only increase patient satisfaction and maximize the quality of treatment, but also reduce the financial burden of health insurance by reducing medical costs.

• 한국의료질향상학회지
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• 제4권1호
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• pp.82-103
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• 1997

Background : With increased concerns about variation among physician's practice pattern and their impact on the quality of care, clinical practice guidelines have been developed by many different organizations, with differing aims and incentives. From the same point of view, there is growing interest in the development of clinical practice guidelines in Korea, but with only a few examples. As a result, there is not much exploration on the incentive and barrier to develop guidelines as well as description on the development process. The purposes of this study are to describe the process of the four different clinical practice guidelines in a hospital setting, and to identify incentives and barriers in the development of guidelines. Methods : For this research, a clinical practice guideline development committee and four clinical practice guideline development teams were organized in a university hospital which has more than 1,200 bead. Twenty eight doctors, three nurses, and one technician participated as members of development teams for eight months. Four to six meetings were held, and three to seven departments in the hospital were involved. Results : The topics which developed into clinical practice guidelines were cardiopulmonary resuscitation(CPR), blood transfusion, anticoagulation, and angiography. The main goals set by teams were education(CPR, angiography), risk management(blood transfusion), and to enhance quality of care(anticoagulation). Among four teams, only in the team for anticoagulation guideline medical record review and pilot-testing were performed. Also literature review was not carried out systematically. However, all the guidelines were developed by multidisciplinary be used as standard protocols in the practice. Conclusion : Experience and skill in developing process has to be improved to have a more valid and useful practice guideline. In particular, literature review and problem identification by examining medical record should be emphasized. Also further studies on the clinical outcomes of the guidelines application and changes in physicians' behaviors would be required.

• 보건행정학회지
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• 제23권1호
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• pp.3-18
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• 2013

This paper investigates the possibility of expanding pay-for-performance (P4P) program as a provider payment system, in terms of financial, economical, and political sustainability. In order to expand the sustainable P4P, P4P should have usefulness in terms of economic value as well as efficiency in the financial aspects of health care. More importantly, the P4P would be politically sustainable only when both providers and consumers can accept. Korea's healthcare system seems to have logical ground for the P4P program financially and economically. However, how well the P4P can work remains to be proven in its implementation. After 43 tertiary hospitals applied the P4P program for acute myocardial infarction (AMI) and C-section in 2007, the number of hospitals adopting the P4P program for AMI and C-section has increased to 316 in 2011, and an incentive for hospitals applying the P4P has risen to 2% from 1% of health insurance benefits. This shows that the P4P program introduced by Health Insurance Review and Assessment Service is quite successful. In addition, people are aware of the need for improved P4P program and policy alternatives have been already made. Therefore, it is very important to come up with politically supportable strategies that can make providers and consumers accept the P4P program while maintaining the governance of the existing health insurance policy. To this end, there are some tasks to be considered. First, the expansion of the P4P program should be placed on the agenda of the Health Insurance Policy Review Committee, the highest decision-making body, and a separate agency for P4P planning should be established. Second, for more efficient P4P program, the processes of review and assessment, currently carried out separately, should be integrated into a single process. Third, infrastructure to measure the quality of medical services should be sharply expanded. Fourth, the current paradigm for the assessment should be changed. Lastly, a P4P program for consumers should be considered. Given that the consumers in Korea can use medical services freely, the National Health Insurance Corporation could initiate the P4P program for consumers as a means of controlling excessive use of medical services and adjusting consumer's moral hazard.

• 의료법학
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• 제13권2호
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• pp.79-113
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• 2012

This study focuses on the protection of trial subjects, who participate in clinical trials for new drug. It takes long time to develop new drugs and the clinical trials are required. Usually, pharmaceutical company, which develop new drug, request a research institution(usually, hospital) to investigate the examination of security and side effects of new drug. The institution recruit trial subject to participate in the trials. The contract for clinical research of investigational new drug is concluded between the pharmaceutical company and the institution. This thesis studies the legal regulations for protection of participants of clinical research for new drug. In this respect the first matter of this study is to seek which relation between pharmaceutical firm and participants of clinical trials. Especially, there is a question which the trial subject is entitled to demand the pharmaceutical company which requested clinical trials the institution to supply the investigational new drug, after the contract for clinical trials had terminated or cancelled. This study take into account the liability of the pharmaceutical company to trial subject. Secondly, it is researched the roles and authority of Institutional Review Board(IRB). IRB is Research Ethics Committee of the institution, in which clinical trials for new drug are conducted. According to the rule of Korea good clinical practice(KGCP), IRB is the mandatory organization which is authorized to approve, secure approval or disapprove the clinical trials for investigational new drug in the institution. The important roles are the review of ethical perspective of trial research and the protection of trial subject. Thirdly, this paper focuses if the participants are to be paid for the participation for clinical research. This is ethical aspect of clinical trials. It is resonable that the participant is reimbursed for expenditure such as travels, and other expenses incurred in participation in trials. It is not allowed that the benefit of clinical trials is paid to trial subject. The payment should not function as financial inducements for participations of trials. Finally, the voluntary consent of the trial subject is required. The institution ought to inform the subject, who would like to participate in trials, and it ought to received informed consent in writing for subject. In this regard, it is matter that trial subject has ability of consent. It is principle that the subject as severely psychogeriatric patient has not ability of consent. However, it is required that not only healthy people but also patients are allowed to take part in clinical trials of new drug, in order to confirm which the investigation new drug is secure. Therefore there are cases, in which the legal representative of subject consent the participation of the trials. In addition, it is very important that the regulations concerning clinical trials of new drug is to be systematically well-modified. The approach of legal and political approach is needed to achieve this purpose.

• 항공우주정책ㆍ법학회지
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• 제35권3호
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• pp.127-150
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• 2020

우주개발진흥 기본계획(이하 "기본계획"이라 한다)은 우주개발진흥법에 따라 5년마다 수립되는 우리나라 우주개발에 관한 중장기 정책 목표 및 기본 방향을 정하는 국가계획으로서 우주개발에 관한 우리나라 최고 심의기관인 국가우주위원회의 심의 대상이다. 2018년 2월 국가우주위원회에서 제3차 기본계획이 확정되었다. 제2차 기본계획 및 우주개발 중장기 계획과 비교 시 제3차 기본계획의 두드러진 특징 중 하나는 '한국형 위성항법시스템 구축'이 중점 전략으로 채택되었다는 점이다. 그간 우리나라를 비롯하여 전 세계의 모든 국가가 미국의 글로벌 위성항법시스템인 GPS(Global Positioning System)에 의존해 왔다. 미국은 1983년 소련의 대한항공 007기 격추를 계기로 GPS의 표준위치결정서비스를 전 세계에 무료로 제공해 왔다. 그러나 GPS의 기술적 장애가 발생하거나 국제관계에서 국가 간 이해 충돌로 GPS의 표준위치결정서비스의 무상 제공이 중단될 경우 교통, 에너지, 통신, 금융 등의 국가 기반시설의 통상적인 운영이 불가능하게 되어 궁극적으로 국가의 경제·사회·안보에 큰 피해를 야기할 수 있다. 러시아의 GLONASS, 유럽연합의 Galileo, 중국의 Beidou, 인도의 NavIC 및 인도의 QZSS와 같은 글로벌 또는 지역 위성항법시스템의 등장이 상기와 같은 배경에서 비롯되었다고 할 수 있다. 한국형 위성항법시스템 구축도 마찬가지다. 즉 "국민이 사용하는 IT 기반 기기들과 국가 기간시설이 미국 GPS 등 해외 항법위성에 의존하고 있어 국가 책임하의 안정적 인프라 구축"이 필요하기 때문이다. 현재 위성항법시스템은 도로, 항공, 해양, 재난, 국방, 건설, 물류, 통신, 농축산업 등 국가 전 분야에 활용되고 있다. 다시 말하면 지구관측 목적인 아리랑위성 및 차세대중형위성, 통신 및 해양·기상·환경 관측 목적인 천리안위성 등과는 달리, 한국형 위성항법시스템의 개발, 운영, 활용 등에 있어서 범정부 차원의 역량 집중이 필요하다. 이를 위해서는 위성항법시스템의 종합적·체계적 구축을 비롯하여 활용 관련 각 부처의 주요 정책과 계획을 조정할 수 있는 범정부적 거버넌스가 요구된다. 아울러 위성항법시스템은 수명을 다한 인공위성을 주기적으로 대체해야할 뿐만 아니라 시스템 구축 후 지속적인 운영과 성능 개선을 수반하기 때문에 거버넌스는 법에 근거를 두어야 한다. 우리나라는 아리랑위성, 천리안위성 등과 같이 인공위성을 개별적으로 개발하고 운영한 경험은 풍부하지만, 한국형 위성항법시스템처럼 위성·지상·사용자 시스템을 동시에 개발·운영한 경험, 이른바 거버넌스 경험은 없다. 그러므로 개발·운영에 관한 시행착오를 최소화하기 위해서는 해외 사례의 검토가 요구된다. 미국의 GPS 거버넌스가 대표적인 본보기이다.

• 한국중재학회지:중재연구
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• 제19권2호
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• pp.95-126
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• 2009

One of the controversial issues in investor-state investment arbitration is the interpretation of "umbrella clause" that is found in most BIT and FTAs. This treaty clause requires on Contracting State of treaty to observe all investment obligations entered into with foreign investors from the other Contracting State. This clause did not receive in-depth attention until SGS v. Pakistan and SGS v. Philippines cases produced starkly different conclusions on the relations about treaty-based jurisdiction and contract-based jurisdiction. More recent decisions by other arbitral tribunals continue to show different approaches in their interpretation of umbrella clauses. Following the SGS v. Philippines decision, some recent decisions understand that all contracts are covered by umbrella clause, for example, in Siemens A.G. v. Argentina, LG&E Energy Corp. v. Argentina, Sempra Energy Int'l v. Argentina and Enron Corp. V. Argentina. However, other recent decisions have found a different approach that only certain kinds of public contracts are covered by umbrella clauses, for example, in El Paso Energy Int'l Co. v. Argentina, Pan American Energy LLC v. Argentina and CMS Gas Transmission Co. v. Argentina. With relation to the exhaustion of domestic remedies, most of tribunals have the position that the contractual remedy should not affect the jurisdiction of BIT tribunal. Even some tribunals considered that there is no need to exhaust contract remedies before bringing BIT arbitration, provoking suspicion of the validity of sanctity of contract in front of treaty obligation. The decision of the Annulment Committee In CMS case in 2007 was an extraordinarily surprising one and poured oil on the debate. The Committee composed of the three respected international lawyers, Gilbert Guillaume and Nabil Elaraby, both from the ICJ, and professor James Crawford, the Rapportuer of the International Law Commission on the Draft Articles on the Responsibility of States for Internationally Wrongful Acts, observed that the arbitral tribunal made critical errors of law, however, noting that it has limited power to review and overturn the award. The position of the Committee was a direct attack on ICSID system showing as an internal recognition of ICSID itself that the current system of investor-state arbitration is problematic. States are coming to limit the scope of umbrella clauses. For example, the 2004 U.S. Model BIT detailed definition of the type of contracts for which breach of contract claims may be submitted to arbitration, to increase certainty and predictability. Latin American countries, in particular, Argentina, are feeling collectively victims of these pro-investor interpretations of the ICSID tribunals. In fact, BIT between developed and developing countries are negotiated to protect foreign investment from developing countries. This general characteristic of BIT reflects naturally on the provisions making them extremely protective for foreign investors. Naturally, developing countries seek to interpret restrictively BIT provisions, whereas developed countries try to interpret more expansively. As most of cases arising out of alleged violation of BIT are administered in the ICSID, a forum under the auspices of the World Bank, these Latin American countries have been raising the legitimacy deficit of the ICSID. The Argentine cases have been provoking many legal issues of international law, predicting crisis almost coming in actual investor-state arbitration system. Some Latin American countries, such as Bolivia, Venezuela, Ecuador, Argentina, already showed their dissatisfaction with the ICSID system considering withdrawing from it to minimize the eventual investor-state dispute. Thus the disagreement over umbrella clauses in their interpretation is becoming interpreted as an historical reflection on the continued tension between developing and developed countries on foreign investment. There is an academic and political discussion on the possible return of the Calvo Doctrine in Latin America. The paper will comment on these problems related to the interpretation of umbrella clause. The paper analyses ICSID cases involving principally Latin American countries to identify the critical legal issues arising between developing and developed countries. And the paper discusses alternatives in improving actual investor-State investment arbitration; inter alia, the introduction of an appellate system and treaty interpretation rules.

• 기록학연구
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• 제18호
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• pp.257-280
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• 2008

이 글은 국가기록원의 형사고발로 야기된 이른바 '기록물유출사건'을 검토하면서 사건의 진실을 넘어, 이런 사태가 발생하는 근본적인 이유를 점검해보자 한 것이다. 전직대통령은 자신의 재임 기간 중에 생산된 대통령기록물을 언제라도 볼 수 있는 권리가 법률적으로 보장되어 있는데, 이를 확대해석하여 재임시 복제해갔다. 이를 불법이라고 보고 형사고발한 것은 형식상 국가기록원이지만, 실제로는 현정부의 청와대측이었다. 이 사건의 결과가 어떻게 나든가를 차치하고, 이 사건이 기록관리에서 중시되는 것은, 대통령기록물에 대한 보호벽이 무너질지 모르기 때문이다. 그러나 이번 사건을 발생시킨 근본적 원인을 더듬어보면, 기록관리기구가 여전히 정치적으로 독립성을 갖고 있지 못한데 있다. 그런데 국가기록원이 최근 제출한 기록관리법률 개정안을 보면 국가기록관리위원회의 위상을 국무총리 직속에서 행정안정부 장관 직속의 기관을 하향조정하고 있다. 이는 기록관리기구의 정치적 독립을 더욱 어렵게하는 조치를 크게 우려하지 않을 수 없는 일이다. 기록관리에 있어 기록관리기구의 정치적 독립 이외에 또 하나의 중요한, 어찌보면 더 중요한 요소가 있으니, 기록관리의 전문성을 확보하는 것이다. 기록관리기구가 전문성을 확보하는 구체적인 조치는 개방형직위제의 도입과 전문가의 임용이라고 할 수 있다. 그런데 새정부 들어서서 이루어진 국가기록원의 조직개편을 보면, 기록관리의 전문성이 확대되기는 커녕 축소되고 있음을 알 수 있다. 새정부 들어서서 전개되고 있는 기록관리에 관한 제정책들이 우려를 낳게 하는 것이지만, 어찌보면 이는 지난 정부의 소산이기도 하다. 따라서 새정부가 지난 정부에서 이루지 못했던 기록관리기구의 정치적 독립성을 제도적으로 마련하고, 전문인력의 확충을 지방으로까지 확대시킨다면, 이는 새정부의 책임이자 나아가 업적이 될 수도 있을 것이다.

• 한국중재학회지:중재연구
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• 제29권2호
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• pp.239-282
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• 2019

The importance of ADR(Alternative Dispute Resolution), which has the advantage of expertise, speed and neutrality due to the increase of arbitration cases due to domestic and foreign construction disputes, has emerged. Therefore, in order for the nation's arbitration system and the arbitration Organization to jump into the ranks of advanced international mediators, it is necessary to research the characteristics and advantages of these arbitration Organization through a study of prior domestic and foreign research and operation of international arbitration Organization. As a problem, First, education for the efficient promotion of arbitrators (compulsory education, maintenance education, specialized education, seminars, etc.). second, The effectiveness of arbitration in resolving construction disputes (hearing methods, composition of the tribunal, and speed). third, The issue of flexibility and diversity of arbitration solutions (the real problem of methodologies such as mediation and arbitration) needs to be drawn on the Arbitration laws and practical problems, such as laws, rules and guidelines. Therefore, Identify the problems presented in the preceding literature and diagnosis of the defects and problems of the KCAB by drawing features and benefits from the arbitration system operated by the international arbitration Institution. As an improvement, the results of an empirical analysis are derived for "arbitrator" simultaneously through a recognition survey. As a method of improvement, First, as an optimal combination of arbitration hearing and judgment in the settlement of construction disputes,(to improve speed). (1) A plan to improve the composition of the audit department according to the complexity, specificity, and magnification of the arbitration cases - (1)Methods to cope with the increased role of the non-lawyer(Specialist, technical expert). (2)Securing technical mediators for each specialized expert according to the large and special corporation arbitration cases. (2) Improving the method of writing by area of the arbitration guidelines, second, Introduction of the intensive hearing system for psychological efficiency and the institutional improvement plan (1) Problems of optimizing the arbitration decision hearing procedure and resolution of arbitration, and (2) Problems of the management of technical arbitrators of arbitration tribunals. (1)A plan to expand hearing work of technical arbitrator(Review on the introduction of the Assistant System as a member of the arbitration tribunals). (2)Improved use of alternative appraisers by tribunals(cost analysis and utilization of the specialized institution for calculating construction costs), Direct management of technical arbitrators : A Study on the Improvement of the Assessment Reliability of the Appraisal and the Appraisal Period. third, Improvement of expert committee system and new method, (1) Creating a non-executive technical committee : Special technology affairs, etc.(Major, supports pre-qualification of special events and coordinating work between parties). (2) Expanding the standing committee.(Added expert technicians : important, special, large affairs / pre-consultations, pre-coordination and mediation-arbitration). This has been shown to be an improvement. In addition, institutional differentiation to enhance the flexibility and diversity of arbitration. In addition, as an institutional differentiation to enhance the flexibility and diversity of arbitration, First, The options for "Med-Arb", "Arb-Med" and "Arb-Med-Arb" are selected. second, By revising the Agreement Act [Article 28, 2 (Agreement on Dispute Resolution)], which is to be amended by the National Parties, the revision of the arbitration settlement clause under the Act, to expand the method to resolve arbitration. third, 2017.6.28. Measures to strengthen the status role and activities of expert technical arbitrators under enforcement, such as the Act on Promotion of Interestments Industry and the Information of Enforcement Decree. Fourth, a measure to increase the role of expert technical Arbitrators by enacting laws on the promotion of the arbitration industry is needed. Especially, the establishment of the Act on Promotion of Intermediation Industry should be established as an international arbitration agency for the arbitration system. Therefore, it proposes a study of improvement and differentiation measures in the details and a policy, legal and institutional improvement and legislation.

• Journal of the Korean Academy of Child and Adolescent Psychiatry
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• 제18권1호
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• pp.3-9
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• 2007

Based on the broad and in-depth literature review, the dedicated members of the committee for the development of Korean attention-deficit hyperactivity disorder (ADHD) practice parameter develop the Korean practice parameter for ADHD. Members of the Korean Academy of child and Adolescent Psychiatry (KACAP) had reviewed the drafts through off-line and on-line access to the drafts. Feedbacks from the members of KACAP were carefully integrated into the current practice parameter. This article presents the state of the art knowledge regarding the assessment and the management of ADHD. Recommendations in the end of the practice parameter may help clinician to make decisions in clinical practice, but are not likely to override the clinician's decision in natural settings. Future directions to complement the limitation of the current practice parameter is suggested.