실리콘 수지 혼합비율에 따른 Pre-form 형광체 막 특성 변화에 관한 연구

박정연,윤길상,진형준,Park, Jeong Yeon,Yoon, Gil Sang,Jin, Hyoung-Joon 한국섬유공학회 2016 한국섬유공학회지 Vol.53 No.1

The effect of the viscosity of phosphor slurry prepared by mixing two types of silicone resins with different viscosities in various ratios on the properties of pre-formed phosphor films was investigated. The pre-formed phosphor films manufactured using these phosphor slurries were evaluated for curing characteristics, breaking strength, shear strength, and optical properties. The test results demonstrated that increasing the amount of high-viscosity silicone resin in the composite resin resulted in decreased curing reaction rate, decreased breaking strength, and correlated color temperature, whereas the viscosity and adhesion strength of the composite resin increased. Among seven different mixing ratios of the low- and high-viscosity silicone resins prepared for the composite resin, white-light emission was realized for the ratio 70:30, and the pre-formed phosphor film with this ratio exhibited high breaking strength and low adhesion strength. The breaking strength thus obtained was 24.0 MPa, the adhesion strength was 0.17 MPa, the color temperature was 5,650 K, and the two chromaticity coordinates (CIE(x, y) (1931)) were (0.3293, 0.3251).

동일 유동거리 런너를 가진 LSR 성형품의 변형에 관한 연구

박정연,윤길상,이정원,최종명,Park, Jeong-Yeon,Yoon, Gil-Sang,Lee, Jeong-Won,Choi, Jong Myeong 한국금형공학회 2013 한국금형공학회지 Vol.7 No.1

Recently, Silicone that one of the thermo-sets is used to making optical products such as LED lenses because of excellent thermal properties. LED lenses are required to keep the precise dimensions, so they must be molded to have the minimum deformation. Thermo-sets have the expansion characteristic on the part of thermal property, it is important to optimize the cure condition so that the deformation of the part become minimum. In this study, to investigate the relationship between the shrinkage by the curing and expansion by the thermal properties of the resin, reactive injection experiment was performed by setting the variables such as mold setting temperature, cure time. As a result, it was confirmed that there was a interval while the thermal properties were transferred to more active during the cure process. It is expected to help in determining the reactive injection molding conditions of the thermo-set parts as well as LED lens in order to reduce the amount of deformation.

혈관모사 마이크로채널이 장착된 3D 종양 세포 배양 시스템의 제작 및 검증 연구

박정연,고범석,김기영,이동목,윤길상,Park, Jeong-Yeon,Koh, Byum-seok,Kim, Ki-Young,Lee, Dong-Mok,Yoon, Gil-Sang 한국금형공학회 2021 한국금형공학회지 Vol.15 No.2

Recently, three-dimensional (3D) cell culture systems, which are superior to conventional two-dimensional (2D) vascular systems that mimic the in vivo environment, are being actively studied to reproduce drug responses and cell differentiation in organisms. Conventional two-dimensional cell culture methods (scaffold-based and non-scaffold-based) have a limited cell growth rate because the culture cannot supply the culture medium as consistently as microvessels. To solve this problem, we would like to propose a 3D culture system with an environment similar to living cells by continuously supplying the culture medium to the bottom of the 3D cell support. The 3D culture system is a structure in which microvascular structures are combined under a scaffold (agar, collagen, etc.) where cells can settle and grow. First, we have manufactured molds for the formation of four types of microvessel-mimicking chips: width / height ①100 ㎛ / 100 ㎛, ②100 ㎛ / 50 ㎛, ③ 150 ㎛ / 100 ㎛, and ④ 200 ㎛ / 100 ㎛. By injection molding, four types of microfluidic chips were made with GPPS (general purpose polystyrene), and a 100㎛-thick PDMS (polydimethylsiloxane) film was attached to the top of each microfluidic chip. As a result of observing the flow of the culture medium in the microchannel, it was confirmed that when the aspect ratio (height/width) of the microchannel is 1.5 or more, the fluid flows from the inlet to the outlet without a backflow phenomenon. In addition, the culture efficiency experiments of colorectal cancer cells (SW490) were performed in a 3D culture system in which PDMS films with different pore diameters (1/25/45 ㎛) were combined on a microfluidic chip. As a result, it was found that the cell growth rate increased up to 1.3 times and the cell death rate decreased by 71% as a result of the 3D culture system having a hole membrane with a diameter of 10 ㎛ or more compared to the conventional commercial. Based on the results of this study, it is possible to expand and build various 3D cell culture systems that can maximize cell culture efficiency by cell type by adjusting the shape of the microchannel, the size of the film hole, and the flow rate of the inlet.

진료비청구 및 심사사례

박정연,Park, Jeong-Yeon 대한병원협회 1998 대한병원협회지 Vol.27 No.6

제네릭 의약품 약가 조정 고시에 대한 비판적 고찰

박정연,Park, Jeong Yeon 대한의료법학회 2021 의료법학 Vol.22 No.1

2019년 5월 식약처는 원료의약품 등록 및 자체 생동성 시험 요건 충족 여부에 따라 제네릭 의약품의 가격을 차등 산정하는 것을 내용으로 하는 「약제의 결정 및 조정 기준」 고시를 개정하였다. 이는 기허가 제네릭 의약품에 대해서조차 자체 생동성 시험을 시행하지 않는 경우 기존 약가를 인하하는 것으로서 과연 그 입법목적과 수단에 관한 충분한 공법적 고려 하에 도입된 것인가 하는 의문이 든다. 이 글은 실질적으로는 위탁·공동 생동 시험을 제한하고자 자체 생동성 여부를 기준으로 제네릭 의약품의 약가를 결정·조정하는 개정 고시의 배경을 소개한 후 입법목적의 정당성 및 비례원칙의 관점에서 이를 비판적으로 검토하였다. 첫째, 목적의 정당성 측면에서 제네릭 의약품 난립 방지라는 목적이 과연 그 입법목적으로서 정당한 것인지에 대한 검토가 부족하였다는 점을 지적하였다. 둘째, '자체 생동 요건 미충족시 약가 인하'라는 내용의 개정 고시가 적합성 원칙에 부합하려면 위탁·공동 생동으로는 안전성·유효성을 인정하기 어렵다거나 적어도 위탁·공동 생동이 자체 생동에 비해 안전성·유효성 검증에 있어서 불충분하다는 전제가 성립해야 한다. 그럼에도 이에 대한 검토가 이루어지지 않은 것으로 보이는바, 안전성·유효성 확보라는 목적 달성을 위해서는 자체 생동이냐 위탁·공동 생동이냐보다 '생동성 인정 기준 및 생동성 시험자체의 관리 강화'에 초점이 맞추어져야 한다. 셋째, 필요성 및 상당성 판단에 있어서 품목허가 후 상당한 기간이 지나 충분히 안전성·유효성에 대한 검증이 이루어졌다고 볼 수 있는 제품에 대해서까지 일률적으로 개정된 고시 기준을 적용하는 것은 필요성 및 상당성 원칙에 반할 소지가 있다고 판단하였다. 개정 고시와 같은 행정입법은 많은 경우 법리적 검토나 공감대 형성이 부족한 상태에서 제·개정이 이루어지는 반면, 그에 따른 규제 효과는 피규제자에게 상당히 직접적이고 구체적이다. 이러한 점에서 행정입법 과정에 대해서도 규제목적과 수단에 대한 실질적인 검토가 요구되면, 사전통제로서 이해관계인 등의 절차참여제도가 보완되어야 함을 강조하였다. In May 2019, the Ministry of Food and Drug Safety revised the "Pharmaceutical Determination and Adjustment Criteria" with the content of differentially calculating the price of generic drugs according to the registration of the drug substance and meeting the requirements for their own bioequivalence test. According to this revised rule, if their own bioequivalence test is not conducted, even the generic drugs that have already been approved would be lowered in price. I wondered whether this system was introduced with sufficient public legal considerations regarding its legislative purposes and means. Therefore, I reviewed the contents of the revised notice based on whether or not it is valid to determine and adjust the price of generic drugs in terms of the legitimacy of legislative purposes and the proportionality principle after introducing the history and background of the rule. First, I raised a question as to whether the purpose of preventing the overrun of generic drugs is indeed legitimate in terms of the legitimacy of the purpose. In order for the revised notice of "reduction of drug prices when the test requirements are not met," to meet the conformity principle, the premise that it is difficult to recognize safety and effectiveness through consignment (joint) bioequivalence test or that these tests are insufficient in safety and efficacy verification than their own test must be established. Nevertheless, it seems that suffficient review has not been carried out. In order to achieve the purpose of securing safety and effectiveness, the focus should be on 'reinforcement of the standards for bioequivalence test and the management of the bioequivalence test itself' rather than whether it is a their own test or a consignment (joint) test. Third, it is contrary to the necessity and substantiality principle that strict standards are uniformly applied to the products that can be considered to have been sufficiently verified for safety and effectiveness after a considerable period of time has passed after the product approval. In many cases, revised administrative legislations quickly enacted and amended in the state of lack of legal review or consensus, while the regulatory effects resulting from it are quite direct and specific to the regulated person. In this respect, I emphasized that the administrative legislative process also requires substantial review and prior control of the regulatory purposes and means, and that the participation of stakeholders in the legislative procedure is to be strengthened.

의료보험(醫療保險) 실시이후(實施以後) 지역주민(地域住民)의 의료기관이용행태(醫療機關利用行態) 변화(變化) 추이(推移)와 그 요인(要因)에 관한 조사연구(調査硏究)

박정연,Park, Jung-Yeon 한국보건간호학회 1989 韓國保健看護學會誌 Vol.3 No.2

The objectives of this study was to analyze the major causes of decreasing utilization rate of health care institutios in pilot-project area of regional medical insurance, Kwang-hwa and Kun-wi country. After the implementation of medical insurance, utilization rate of health institutions turned out' to be lower than it was estimated, when the pilot-project of regional medical insurance was planned. It might be due to changes in inhabitant's behavioral attitude toward medical insurance. So this study was made to find measures for financial stability by increasing utilization rate of health care institutions and to be available for basic demand-supply program of medical care. The hypothesis of this study was as follows; First. there is difference in understanding health care institutions between Kun-wi and Kwang-hwa. Second. respondesnts of inquiry survey have exact knowledge of their past experience of treatment taken prior to enforcement of medical insurance, Questionaire survey was made as to each 700 household among total 11, 884 households in Kun-wi and 20,919 households in Kwang-hwa. In case of Kun-wi, 70% of inquired households (491) gave their answers. In Kwang-hwa, the number was 560 households (80% of inquireds). Dollected data was processed and analyzed by way of using SPSS batch system. To evaluate facto rs distribution aspects of data and to make comparison between two area, percentage and $X^2$ distribution were applied. The results were as follows; L The utilization rate of health care institutions in Kun-wi and Kwang-hwa was lower than it was estimated. when pilot-project of medical insurance was planned. 2. Prior to the implementation of medical insurance. inhabitants in two area chose the medical institutions considering such factors. First was medical care fee cheap. second in habitant's residence, Third was the institutions conveniently easy of access. 3. After the implementation of medical insurance. 26.1% of inqurieds in Kun-wi and 41.6% in Kwang-hwa, changed medical institutions. In case of Kwn-wi, from health care institution (p 0.05), and in case of Kwang-hwa, vice versa, from general medical institutions to health care institutions. 4. Evaluation by factors were made such as follows. Inquired gave high marks to following facts: In case of Kun-wi, general medical institutions were difficult of access and relation between patients: was not friendly, but burden of medical expenditure was light. Effects of treatment and facilities was good. In case of Kwang-hwa, inquired gave high evaluation marks to the follow ing facts; facilities of medical institutions was not good, but the burden of medical expenditure was light. 5. After the implementation of medical insurance, the services was evaluated as good, but inquired hopec for lessening the burden of medical expenditure. 6. In case of exact understanding of cost-sharing, the evaluation rate in Kwang-hwa was higher than that of Kun-wi (p < 0.005). And positive attitude toward necessity of medical insurance was also good in Kwang-hwa (p < 0.05). 7. In case of inquired's attitude toward medical institutions, Kwang-hwa showed positive response (p < 0.05) 8. In the case of comparison between general medical institution and health care institution, two area showed similar positive response; medical manpower, facilities of medical institutions and effest: of treatement was good. 9. In comprehensive evaluation of benefit-service; the general medical institution's positiveness was higher than that of health care institutions in Kun-wi. But in Kwang-hwa vice-versa. 10. If the medical expenditure of general medical institution and health care institutions was equal 77% of inquireds in Kun-wi and 59.1% in Kwang-hwa answered that they chose general medical insurance. Considering results above mentioned, the conclusion of this study was made as follows. 1. In Kwang-hwa county, where the understanding of health care institutions's was good, the utilization's of h

액체 종류에 따른 식물의 성장 특성 기초 실험

박정연,김정배,Park, Jeong-Yeon,Kim, Jeongbae 한국교통대학교 융복합기술연구소 2014 융ㆍ복합기술연구소 논문집 Vol.4 No.1

This study was experimentally performed to show the growth characteristics of one specified plant with various liquids, which can be purchased easily. To do that, this study measured the number of leaves attached to the plant sample and the height of liquids everyday during almost 15 days on summer season in the laboratory room. From the experiments, we revealed that the remained number of leaves can be related with the liquid height.

요양병원에서의 의료 질 관리를 위한 법적 규제

박정연(Park, Jeong Yeon) 이화여자대학교 생명의료법연구소 2021 Asia Pacific Journal of Health Law & Ethics Vol.14 No.3

우리나라에서 요양병원은 노인성 질환자 및 만성질환자 등에 대한 의료 제공에서 중요한 역할을 하지만 요양병원 수의 증가와 사회적 입원 및 낮은 수가 등으로 인해 의료 질이 낮다는 비판을 받아왔다. 요양병원은 다른 의료기관에 비해 의료적 기능이 미약하며 고령의 환자들이 많아의료와 요양에 대한 욕구가 복합적으로 나타나므로 국가는 이러한 특성을 반영하여 질 관리 방향을 설정해야 한다. 이 글은 요양병원이 의료적 욕구가 비교적 낮은 노인 환자들을 주된 이용대상자로 하는 요양병원의 기능과 특성에 대한 이해를 통해 요양병원에서의 의료 질 관리에 관한 현행 제도를 검토하고 개선 방향을 제시하고자 하였다. 이를 위해 의료 질에 대한 공적 관리의 정당성을 국가의 보장책임의 관점에서 분석하였으며, 적정한 서비스 제공에 대한 국가책임으로부터 의료 질 관리임무를 도출하였다. 의료 질 관리에 관한 국가적 임무의 수행은 현행법상 의료기관 인증제도, 수가제도의 보완 및 급여적정성 평가로 구체화 된 것으로 볼 수 있다. 따라서 이들 제도에 있어서 과연 요양병원 의료의 특성이 제대로 반영되어야 하며, 규제의 일반원칙과 한계를 준수해야 한다. 이러한 관점에서, 먼저 요양병원에서의 환자안전확보의 중요성에 기초하여 요양병원 인증기준을 살펴보았으며, 요양병원 환자의 복합적 욕구에 따른 인증기준의 개선과 사후관리 강화를 제언하였다. 또한, 의료 질에 관한 공적 관리에서 있어서도 일정 부분 의료기관의 자율성을 보장해 주어야 하는바, 요양병원 의무인증제나 인증취소에 관한 최근 의료법 개정안이 요양병원의 자율성을 지나치게 침해하는 것은 아닌지 검토하였다. 마지막으로, 의료 질 관점에서 요양병원에 대한 일당정액제의 한계를 논하고, 급여적정성 평가의 평가 기준에 관한 문제와 평가 결과에 따른 환류처분이 위법한지 여부를 검토하였다. Although long-term care hospitals play an important role in the elderly medical delivery system in Korea, they have been criticized for the poor quality of care. In long-term care hospitals, the medical function is weaker compared to other medical institutions, and the need for medical care and nursing care is complex because there are many elderly long-stay patients. Therefore, the government should set the quality management direction by reflecting these characteristics. In this article, I tried to review the current quality management system in long-term care hospitals and suggested some directions for improvement through understanding the functions and characteristics of these hospitals. According to this purpose, I tried to analyze the legitimacy of public quality management from the point of view of the national responsibility for a guarantee and derived the quality management tasks from the national responsibility for providing appropriate services. The performance of these national duties is embodied as improvements of the Medical Institution Accreditation System, Medical Price System, and National Quality Assessment Program under the current law. First, based on the importance of securing patient safety in long-term care hospitals, I examined the accreditation standards for these hospitals, and suggested improving the accreditation standards according to the complex needs of patients and reinforce the follow-up management. In addition, since the autonomy of medical institutions should be guaranteed to some extent in the public quality management system, I reviewed the amendment of the Medical Act on the compulsory accreditation system applied to long-term care hospitals and the revocation of accreditation. Finally, I discussed the problems of the per diem payment applied to long-term care hospitals from the perspective of quality of care, and reviewed the issue of National Quality Assessment Program and redemption of pay expense.

신기술기반 의료기기와 규제개선 ― 연구개발과의 연계적 관점에서 ―

박정연 ( Park Jeong Yeon ) 한양대학교 법학연구소 2021 법학논총 Vol.38 No.3

신기술기반 의료기기 산업은 국가경제에서 중요한 전략 분야로서, 최근 막대한 연구개발비가 투입되고 있다. 그러나 현실에서는 규제문제로 인해 연구개발이 종료한 후에도 사업화에 실패하거나 연구개발 성과를 확산시키지 못하는 경우가 많다. 이 글은 신기술기반 의료기기의 연구개발 단계, 즉 ‘연구개발 기획→연구개발 수행→사업화 및 확산’ 단계에 따라 어떠한 규제개선 활동이 필요한지를 검토하였다. 단계별 개선과제 검토에 앞서서 먼저 신기술기반 의료기기를 분석하고, 그 특징이 규제에 미치는 영향을 토대로 규제개선 방향을 탐색하였다. 연구개발 기획단계에서는, 모든 관련 주체의 참여와 협력에 기한반 규제거버넌스의 법적 프레임을 제시하는 것을 최우선 과제로 삼아, 이를 통해 규제의 유연성 확보해야 한다. 또한 연구개발자 및 업체의 니즈에 따른 법적 지원활동을 제도화해야 한다. 연구개발 수행단계에서는, 사업화 과정에서 발생하는 주요 규제문제에 대한 구체적인 개선방안을 도출해야 한다. 신기술 의료기기 분야에서 규제기준의 명확성과 규제의 효율성 확보를 위해서는 모든 주체의 협력과 참여가 제도적으로 확보되어야 한다. 나아가, 신기술 의료기기의 수가적용에 관한 기준 마련과 표준화 법제 지원이 이루어져야 한다. 사업화 및 확산 단계에서는, 규범조화를 고려하여 개선입법을 완료하고, 판매·유통에 대한 공적 지원을 제도화해야 한다. 결론에서는, 신기술기반 의료기기 분야에서 생기는 규제문제는 결국은 규제기관 간, 규제자-피규제자 간 협력과 참여를 통해 중복규제를 해소하고 유연한 규제기준을 마련하며 개선 입법에 대한 피드백이 원활히 이루어지는 규제거버넌스를 통해 개선이 이루어질 수 있음을 재차 강조하였다. The new technology-based medical device industry is an important strategic area for the national economy, and huge R&D costs have recently been invested. However, in reality, regulatory problems often prevent commercialization or R&D Result Diffusion even after R&D ends. In this article, I reviewed what regulatory improvement activities are needed in accordance with R&D stage of new technology-based medical devices, i.e., R&D planning-R&D performance-commercialization and result diffusion. Since the causes of regulatory delays and their countermeasures are different in each field, I first explored the direction of regulatory improvement based on the impact of features of new technology-based medical devices on regulation before reviewing step-by-step improvement tasks. In the R&D planning phase, presenting a legal frame of regulatory governance should be a top priority for the participation and cooperation of all relevant entities, thereby ensuring flexibility in regulation. In addition, legal support should be institutionalized in accordance with R&D and the needs of the company. In the R&D implementation phase, improvements to key regulatory issues arising from commercialization should be derived. In order to ensure clarity of regulatory standards and efficiency of regulation in the field of new technologies and medical devices, cooperation and participation of all entities must be secured systematically. Furthermore, standards for insurance application of new medical devices and support for standardization legislation should be provided. In the commercialization and result diffusion phase, the improvement legislation shall be completed in consideration of the harmonization of norms and the public support for sales and distribution shall be institutionalized. In conclusion, I reiterate that regulatory issues arising in the field of new technology-based medical devices can eventually be improved through regulatory governance, in which all entities cooperate and engage to gain flexibility in regulation and feedback on improved legislation.

장기요양기관의 지위에 관한 행정법적 고찰

박정연(Park, Jeong-Yeon) 숭실대학교 법학연구소 2015 法學論叢 Vol.34 No.-

최근 사인(私人)에 의해 복지서비스가 제공되는 현상이 광범위하게 나타나고 있으며, 이용자와 서비스 제공기관 간 별도의 계약을 필요로 하는 경우도 증가하고 있음에도 불구하고, 이와 같은 복지서비스 제공방식의 법적 규율에 대한 연구는 아직 충분하지 못하다. 본고는 그러한 연구의 첫걸음으로 장기요양서비스 제공업무를 수행하는 사인으로서 장기요양기관의 법적 지위를 밝히는 것을 목적으로, 먼저 장기요양서비스에 대한 이해를 돕기 위하여 현행 노인장기요양보험제도를 개관하였다. 다음으로 사인에 의한 공무수행 방식에 관한 종래의 이론, 행정사무의 민간위탁에 관한 현행법령 및 장기요양기관 지정의 성격을 분석하고 공무민간위탁에 관한 새로운 유형체계 구성을 시도하였다. 이를 통해 장기요양서비스 제공 업무는 그 자체로 국민의 권리 · 의무에 대한 법적 처분을 포함하지 않는 사실상 서비스를 제공하는 것이지만, 이 서비스가 국가임무의 수행에 해당한다는 점에서 장기요양기관 지정은 공무민간위탁, 특히 행정사무의 민간위탁에 해당한다는 결론을 내렸다. 나아가 공무민간위탁에 관한 입법의 미비점을 분석하고, 장기요양서비스 이용계약에 대한 공법적 규제의 필요성과 정보제공 및 서비스의 계속적 이행 확보를 위한 구체적 방안을 제시하였다. 또한 공무민간위탁에 있어 국가배상책임을 제한적으로 적용할 필요가 있음을 전제로, 장기요양서비스 제공 중 발생한 불법행위 대한 국가배상의 문제를 검토하였다. The phenomenon of providing welfare services by the private sector has appeared extensively in various fields these days, and the cases required a separate contract between the user and the public service provider have increased continuously. Nevertheless, study on the legal status of these private institutions is insufficient. The long-term care service is one of the public welfare services provided by private institutions. The purpose of this study is clarifying the legal status of the long-term care institutions as the private institutions providing the public welfare services. First, I gave an overview of the current Long-term Care Insurance to assist understanding of the long-term care service. Next, I analyzed the conventional theories about public affairs performed by the private institutions and the current legislations about contracting-out of administrative affairs, tried to describe the types of the contracting-out of administrative affairs systematically and concluded that designation of the long-term care institutions is applicable to the contracting-out of administrative affairs. Furthermore, I pointed out the lack of legislations on the contracting-out of public affairs, proposed the need for legal regulations and specific plans focusing on the providing information and ensuring ongoing services. Also, I reviewed whether service users who suffered damages in tort by the long-term care institutions can charge national compensation on the view of that we have to restrictively apply the National Compensation Act for tort committed by the public service provider.