• 의료법학
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• 제22권4호
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• pp.159-184
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• 2021

첨단재생바이오법의 제정 의의는 본질적으로 '이식'이라는 의료행위인 재생의료를 약사법 규제에서 벗어나 의료기술적 접근으로 환자치료기회를 확대하는 데 있다. 그러나, 법이 시행된 지 1년여가 지난 상황에서 식약처가 승인하는 고위험연구는 1건도 승인되지 않고 있는 등 임상연구가 활성화되지 않고 있다. 그 이유는 환자치료기회 확대를 위한 법률 취지에도 불구하고 법률적 근거가 미흡함에도 임상연구 승인을 위한 자료요건을 의약품 개발과 연결하여 정하고 있어 많은 연구자들이 자료요건을 맞추기가 어려운 실정이다. 법 제정 이전 약사법 체계 내의 세포치료제 임상연구를 위한 제출자료는 품질 및 비임상시험 자료가 상당히 면제되었지만, 첨단재생바이오법이 시행되면서 임상연구 계획 승인신청 시 품질 및 비임상시험자료를 의약품에 준해 요구하고 있다. 이를 바로잡으려면 치료기회 확대를 위한 첨단재생의료 임상연구의 정체성을 고려할 때 의약품 개발과 연결하는 데는 제한점이 있음을 인식하고 첨단재생의료 임상연구의 정체성을 지키고, 한편으로 품목허가 시 임상연구 결과를 활용할 수 있도록 하면서 활용요건을 구체화하여 시장의 힘으로, 임상연구자의 자발적인 동기로 임상연구 승인을 위한 기본요건보다 필요한 자료를 스스로 준비할 수 있도록 해야 한다.

• 의료법학
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• 제23권4호
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• pp.75-102
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• 2022

본 글에서는 보건의료관련 법령 중 「연명의료결정법」, 「정신건강복지법」, 「장기이식법」, 「인체조직법」, 「약사법」, 「에이즈예방법」, 「결핵예방법」, 「감염병예방법」을 검토하였다. 이들 법률에 민법적 사고가 필요한 부분은 환자의 자기결정권과 동의에 관한 부분이다. 그리고 환자가족을 통한 의사결정이 환자의 의사결정을 대행하는 것인지 환자가족이 환자를 위하여 고유의 권한으로 의사를 결정하는 것인지와 관련하여 성년후견제도에서 후견인의 동의대행과 비교하여 이해할 필요가 있다. 보건의료관련 법령은 환자의 자기결정권과 그 실현을 위한 동의대행의 문제에서 민법과 깊게 연관되어 있음에도 불구하고 개개 법률의 관련 규정은 민법의 동의에 관한 원칙이나 성년후견제도와 별개로 규정되어 있음을 확인할 수 있다. 보건의료관련법령의 일차적 목적이 환자의 자기결정권 실현에 있지 않다고 하더라도 의료관련 행정이 통일적으로 운영되기 위해서는 민법의 의사결정 및 그 대행에 관한 원칙을 이해할 필요가 있다.

• 의료법학
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• 제18권1호
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• pp.297-341
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• 2017

2016년에 선고된 의료관련 판결들을 법원도서관 검색사이트와 법률전문기사를 통해 검색하여 다음과 같이 분석 소개하였다. 의료민사와 관련하여 (1) 제왕절개 수술 시 불임수술도 함께 청약하였으나 불임수술은 하지 아니한 사례에서는 의료계약체결과정에 판시의 결여에 대한 아쉬움과 함께 침해되는 권리 및 배상범위를, (2) 의료과실 추정 관련에서는 과실추정법리의 한계를 벗어난다는 점과 한의사의 협진의무를 매우 높은 정도로 요구했다는 점을, (3) 병원측 책임을 100% 인정한 사건에서는 의료행위의 선의성과 불확실성에 대한 간과를 지적하면서, (4) 정신과 환자 관련 사고에서 병원책임을 인정한 사건들을 관련판결과 함께 소개하였다. 의료형사와 관련해서는 치과의사의 안면 보톡스 시술이 면허범위 내 의료행위인지 여부에 대한 대법원 전원합의체 판결을 다수의견의 해석이 법문언의 가능한 범위 내에 있는지의 관점에서 분석하였다. 그리고 의료행정과 관련하여 (1) 의료인이 다중으로 의료기관을 운영한 경우 이에 대하여 국민건강보험법상 환수처분을 할 수 있는지 여부를 다중으로 운영된 의료기관이 의료법에 따라 개설된 의료기관에 해당하는지의 관점에서 분석하고, (2) 임의비급여진료 동의의 전제로서 설명의무에 관한 판결을 설명의 대상, 정도, 주체의 면에서 검토하였다. 마지막으로 정신질환자 보호입원 사건에서 제청된 보호의무자 2인의 동의와 정신건강의학과전문의 1인의 진단에 의하여 정신질환자를 입원시킬 수 있도록 한 정신보건법 제24조에 대하여 위헌법률심판결정에 대해 소개하면서 개정된 정신보건법에 대한 문제점을 아울러 제시하였다.

• 대한한방내과학회지
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• 제40권4호
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• pp.597-611
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• 2019

Objective: The goals of this study were to analyze each of the reasons adopted by the Constitutional Court or the Courts for Decisions determined to permit the use of medical devices by Korean medicine doctors and to look at the medical devices from a Korean medical perspective. Materials and Methods: For this study, several judicial precedent databases were used for searching judicial precedents that handle the usage of medical devices by Korean medicine doctors. Prior studies on similar issues were considered. The Korean medicine textbooks and related research studies were also used in this study. Results: From 2000 to 2018, a large number of lawsuits were filed regarding the legality of Korean medicine doctors using medical devices; approximately 20 final judgments or decisions were made. Among them, only two cases determined that Korean medicine doctors could legally use medical devices. Conclusion: The decisions in both cases could be interpreted as the judgments that Korean medicine doctors were allowed to use a medical device whose use or operating principles were commonly incorporated with Korean medical principles. That was provided that training was sufficient in the use of the medical device, to the extent that it could be used and that such use of the medical device was not feared to pose a health hazard.

• 대한약학회:학술대회논문집
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• 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.1
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• pp.315.1-315.1
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• 2003

After beginning the new medical system separating the prescription from the drug dispensary, the demand of bioequivalence test significantly increases to show the equivalence between the test and reference drugs as a result of amendment of the pharmaceutical affairs law which allows a generic substitution. Accordingly the standard protocols provided by the government are required for reducing the period andthe cost to perform the bioequivalence study. (omitted)

• 한국컴퓨터정보학회논문지
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• 제25권3호
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• pp.177-183
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• 2020

연구의 목적은 학부별 눈높이에서 치과위생사의 의료인화에 대한 의견을 수집하여 정책 반영에 기초자료로 제시하고자 한다. 이를 위해 비보건계열인 유아교육과, 미용예술과, 보건계열의 치위생과 전공자 중 2학년 여대생 180명을 대상으로 설문조사를 시행한 후 빈도분석과 교차분석을 통한 카이제곱 검정을 실시하였다. 전공별로 치과위생사의 법적 업무와 법적 외 업무에 대한 인식정도는 통계적으로 유의적인 차이가 있었고, 유아교육과 전공자들은 96.7%, 미용예술과 전공자들은 73.3%, 치위생과 전공자들은 85.0%가 치과위생사를 의료인이라고 생각하고 있었다. 그 이유로는 유아교육과 치위생과 전공자들의 경우는 1순위로 국가시험을 통해 보건복지부 장관이 면허증을 교부하기 때문에 각각 32.8%, 41.2%로 가장 높았으나, 미용예술 전공의 전공자들은 치과의사의 지도하에 시행하는 진료의 보조가 31.8%로 가장 높게 나타나 학과별로 통계적으로 유의한 차이가 있었다.

• 지역사회간호학회지
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• 제9권2호
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• pp.303-312
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• 1998

The purpose of this study was to survey the knowledge level, attitude and practice of nurses toward their work. The subjects of the study were composed of 98 nurses from 3 general hospitals, 1 oriental medical hospital, 2 health centers and several community health posts and schools. Data were collected from May to October, 1998. In data analysis, an SPSS PC program was utilized for descriptions. 1) 16 nurses (16.3%) experienced medical accidents on the 7 nurses(7.1%) 1 time, 6 nurses (6.1%) 2 times, and 3 nurses(3.1%) 3 times. 2) Concerning knowledge of their legal obligations ; the prohibition of telling secrets was .89, the prohibition of reading medical records was .58, the keeping of medical records was 1.0 and the teaching of recuperation was. 79. The total mean score was. 86. Concerning attitude and practice; the prohibition of telling secrets was 81.6%, 63.3%. The prohibition of reading medical records was 61.2%, 60.2%. The keeping of medical records was 98%, 98%. The explanation for treatment, care and test was 91.8%, 66.3%. The teaching for recuperation was 63.3%, 63.3%. 3) Knowledge of their legal responsibilities; 29. 6% of the subjects thought that they should report a medical accident to their headnurse, but 75.5% of the subjects actually reported to the headnurse. 39.8% of the subjects thought that nurses were liable for the faults of nursing aides. The total mean score was .45. 46% of the subjects asked a senior staff's advide on difficult affairs. Nurses obeyed legal obligations when concern ing the protection of a client, but were passive when concerning self protection. Also, headnurses were required as adviser, guide and advocate.

• 대한한방내과학회지
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• 제42권6호
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• pp.1303-1318
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• 2021

Objectives: The aim of this study was to examine the debate on the use of medical devices between Western Medicine and Korean Medicine, as this is one of the greatest conflicts in Korea's medical profession. Judicial precedents and interpretations of authority serve as regulations because medical affairs law states that Korean Medicine practices are ambiguous. Method: We conducted a search in the Korean RISS, OASIS, and DBPIA databases using several keywords associated with medical devices, Korean Medicine, and Korean Medicine Doctors. The search period was until November 5 2021. The retrieved papers were classified according to the selection and exclusion criteria by checking the title, abstract, and text. For precedents, searches were done regarding comprehensive legal information, etc., and in the case of non-disclosure precedents, we requested access to the precedents by web-court requests. Results: A total of 80 documents were found as a result of the search, and 13 publications were included in the study. The selected publications were classified and analyzed by this research team into Korean medicine, Western medicine, and legal or state agency research. In the existing literature and judgments, the arguments that played a major role changed depending on the time the judgment was made. "Social conventions", "curriculum", "academic principles", and "health and hygiene dangers" were the key arguments. Conclusions: Further studies will be needed that can comprehensively arrange the existing literature and clinical results, and continuous study will be needed to verify that the use of medical devices by Korean medicine doctors is helpful for prognosis and accurate treatment of their patients.

• 보건행정학회지
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• 제19권1호
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• pp.1-30
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• 2009

Korean medical fee contract system between the insurer and healthproviders was introduced in 2000. However, a continuous discord among contracting parties concerned and an irrational operation of an arbitration committee of Ministry for Health, Welfare and Family Affairs (MIHWAF) have made it difficult for them to reach to an agreement over last 8 years. The purpose of this study is to observe the current problems of contract system from the view of health insurance law and actual examples. Furthermore, I examined the of breakdown of negotiation by analyzing the eligibility of contracting parties, rationality of Resource Based Relative Value System (RBRVS) and contracting method and fairness of arbitration method in case of negotiation rupture. The results were as follows: First, since the introduction of medical fee contract system, there has been a problem in that both the president of National Health Insurance Corporation (NHIC) and health care provider association have not held strong negotiation power. Second, the frequent changes and notifications of Relative Value Units (RVUs) without any mutual consent between the insurer and provider association negatively have influenced the conversion factors and finally hindered the agreement of contract. Third, a current process that the conversion factors are mediated and determined at the arbitration committee of MIHWAF in the case of contract breakdown between contracting parties has some flaw in that the irrational composition of committee provoked the lack of fairness and objectivity of mediation. Fourth, we can not prospect a satisfactory outcome of arbitration committee because the mediation always has failed to proceed smoothly due to boycott of both committee members from insurer and providers over last 8 years. As a result, we have to make an every effort to resolve problems mentioned above and then dream of an advanced national health insurance system.

• Perspectives in Nursing Science
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• 제6권1호
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• pp.67-76
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• 2009

Recently, small and medium-sized hospitals which are located in rural areas have many difficulties in securing high quality nurses. That is because working environments for nurses in small and medium-sized hospitals in rural areas are poor compared with those of big hospitals in urban. As a result, the migration of nurses from small and medium-sized hospitals in rural areas to big hospitals in urban is continuously happening. In general, big hospitals provide nurses with high level of salary and fringe benefits. To prevent the migration of nurses, chief executive officers of small & medium hospitals in rural areas have been interested in improving nurses' working conditions including wages. Also, they have raised nurses' salary and improved working conditions. But, basically these individualized efforts have some limit. In connection with this, medical interest groups have produced various voices in terms of interpretation and solutions for these issues. However, from the future perspectives, it seems evident that two approaches for both manpower supply and demand plans of nurses are necessary. They should contain not only accurate estimation of the supply-demand of nursing manpower but also the improvement of working conditions and wages of nurses. Estimation of nursing manpower supply-demand depends on the standards and criteria being used. Supply and demand may be met or not in accordance with the points emphasized on the decision. In the articles, issues regarding nursing manpower, levels of salary, other working conditions and social support system for child care are discussed. According to Joe's report (2005), most health institutions did not meet the guidelines of nurse staffing in Medical Law. The wages of nurse vary on every hospital and there is a big difference in wages' range. The average starting salary for a nurse is 22 million won a year. In case of tertiary hospitals, it reaches up to 30 million won a year. Nurse as a profession should have a strong responsibility and should take care of the patients for 24 hours with three working shifts. Also, most of them are female who have the burden of child rearing. Therefore, it is suggested to increase the salary, to provide comfortable working conditions, and to have social support system for nurses with household affairs.