• 제목/요약/키워드: Need for Approval

검색결과 114건 처리시간 0.019초

비침습적 뇌자극기술과 법적 규제 - TMS와 tDCS기술을 이용한 기기를 중심으로 - (Non-invasive Brain Stimulation and its Legal Regulation - Devices using Techniques of TMS and tDCS -)

  • 최민영
    • 의료법학
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    • 제21권2호
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    • pp.209-244
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    • 2020
  • TMS와 tDCS는 자기와 전류를 통하여 뇌에 자극을 가함으로서 환자나 개별 이용자의 질병을 치료하고, 이외에도 건강을 관리하거나 증진시킬 수 있는 비침습적 기기를 말한다. 이들 기기의 효과와 안전성은 몇몇 질병에서 입증되고 있으나, 아직도 이에 대한 연구는 진행 중이다. 점차 증가하고 있는 이들 기기의 활용도에 비해 TMS와 tDCS를 직접 규율하는 입법례를 찾기는 어렵다. 미국, 독일, 일본의 TMS와 tDCS에 대한 법적 규율을 살펴보면, TMS는 중등도의 위해도를 가진 의료기기로 승인되어 있는 반면, tDCS는 아직 의료기기로 승인된 상태는 아니다. 하지만, 최근 FDA 가이드집이나 유럽 MDR 규정의 변화, 미국의 리콜사례, 독일과 일본의 관련 법 규정, 전문가 그룹의 제언 등을 검토하면, tDCS도 조만간 의료기기로 승인되어 규율될 것으로 보인다. 물론, tDCS를 의료기기가 아닌 일반제품으로 보더라도 다른 법률과 제도를 통하여 제품의 안전성과 효과를 규제할 수는 있다. 그러나 이 기기가 인간의 뇌에 미칠 수 있는 여러 영향을 고려할 때, 이를 독자적으로 규율할 필요성이 크다. 우리도 TMS와 tDCS를 규율하는 명시적 법률은 없으나, 이 두 기기는 식약처 고시에 따라 3등급 의료기기로 판정된다. 그리고 TMS는 가이드 라인에 따라 미국 FDA 지침에 의해 안전성과 성능을 평가하도록 하고 있다. 하지만, tDCS는 아직 이에 대한 구체적 지침은 존재하지 않는다. tDCS 기기가 일부 병원에서, 그리고 개별 구매자를 통하여 가정에서 사용되고 있는 현실을 고려하면, 이러한 규제의 공백은 신속히 보완되어야 한다. 장기적으로는 비침습적 뇌자극기기를 독자적으로 규율할 수 있는 법적 시스템의 정비가 필요하다.

북한 공역의 통일 후 지위 (The Status of North Korean Airspace after Reunification)

  • 권창영
    • 항공우주정책ㆍ법학회지
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    • 제32권1호
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    • pp.287-325
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    • 2017
  • 20세기 이후 항공우주 군사과학기술의 발달과정에 비추어 보면, 국가의 존립과 번영을 위해서 하늘은 매우 중요하다. "하늘을 지배하는 자, 세계를 지배한다!"는 격언이 제공권(制空權)의 필요성을 강조하고 있다. 이 글은 남북의 통일 과정과 통일 이후 공역(空域, airspace)의 지위에 관한 최초의 연구로서, 이를 요약하면 다음과 같다. 첫째, 영공(領空)은 영토와 영해의 상공으로 국경선과 영해선에 의하여 그 수평적 범위가 결정된다. 국경문제에 관하여 역사적 진실규명을 통한 재조정의 시도보다는 현질서의 수용이 가장 합리적이고, 통일전후과정에서 인접 국가의 지지를 받을 수 있으며, 동북아 평화를 위해서 통일한국은 북한과 중국 러시아 사이의 기존 국경협정을 그대로 존중할 필요가 있다. 그러나 현재 북한이 동해 황해에 설정한 직선기선은 국제법상 직선기선이 적용될 수 있는 사정을 갖추지 못하였기 때문에 이를 폐기하고, 통일한국은 국제법에 부합하는 기선을 다시 정하여 그 바깥쪽 12해리의 선까지에 이르는 수역을 영해로 결정하는 것이 바람직하다. 둘째, 비행정보구역(Flight Information Region)은 항공기의 안전하고 효율적인 비행과 항공기의 수색 구조에 필요한 정보를 제공하기 위하여 국제민간항공기구(ICAO)에서 획정한 구역이므로 국제법상 효력이 있다. 현재 한반도 일대에는 남한이 관할하는 인천 FIR과 북한이 관할하는 평양 FIR로 나누어져 있다. 급변사태가 발생하여 북한에서 일시적으로 평양 FIR의 관제권을 행사할 수 없는 경우에는 원칙적으로 남한이 평양 FIR의 관제권을 행사하고, 부득이한 경우에는 ICAO가 일시적으로 이를 행사하는 것이 바람직하다. 통일한국에서는 FIR의 체계적 관리와 통제, 항로개설 관리의 효율성 등을 감안하여, ICAO의 승인을 얻어 평양 FIR을 폐지하고 인천 FIR로 통합하여 운용하는 것이 바람직하다. 셋째, 방공식별구역(Air Defense Identification Zone)은 국가안전보장 목적상항공기의 용이한 식별, 위치 확인 및 통제가 요구되는 공역으로서, 해당 국가가 일방적으로 설정한다. 미국은 1951. 3. 22. 전시포고령에 의하여 한국방공식별구역(KADIZ)을 일방적으로 설정하였는데, 국방부는 2013. 12. 8. 이어도 상공을 포함하는 지역까지 확장한 새로운 KADIZ를 선포하였다. 현재 북한의 군사경계수역은 동해 황해 등 해상경계선으로만 설정되어 있는 점, 중국 러시아와의 관계에서 ADIZ로서 기능을 수행하기에 부족한 점에 비추어 보면, 통일한국이 이를 승계할 의무는 없다. 한반도의 경우에는 종심(縱深)이 짧기 때문에 영공보다 외곽에 ADIZ 경계선을 설정하여야 ADIZ 본래 목적을 달성할 수 있으므로, 통일한국의 인천 FIR과 일치하는 경계선으로 통일한국의 KADIZ를 새로 설정하여 이를 선포하는 것이 타당하다. 다만, 인접국가의 ADIZ와 중첩되거나 경계선을 같이하여 완충지역이 존재하지 않는 경우에는 군사적 긴장감이 고조될 수 있으므로, 동북아 평화를 위해서는 상호간 협상을 통하여 해상에서는 인접국가의 ADIZ 사이에 완충공간을 설정하는 것이 바람직하다.

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초, 중, 고등학생의 방사선조사식품, 원자력발전, 의료방사선에 대한 인식, 지식, 태도 차이 (Different Perceptions, Knowledge, and Attitudes of Elementary, Middle, and High School Students regarding Irradiated Food, Nuclear Power Generation, and Medical Radiation)

  • 한은옥;김재록;최윤석
    • Journal of Radiation Protection and Research
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    • 제39권2호
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    • pp.118-126
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    • 2014
  • 향후 여론의 주도층이 될 일부 초, 중, 고등학생을 대상으로 방사선이용 분야 중 일반적으로 사회적 수용성이 절실히 필요한 방사선조사식품, 원자력발전, 의료방사선에 대한 인식, 지식 및 태도를 설문 조사한 결과 사회적 수용성 증진을 위한 교육적 근거가 일부 도출되었다. 첫째, 여학생 중심의 수업과 남학생 중심의 수업설계에 차별화된 전략이 필요하다. 여학생 보다 남학생이 방사선조사식품의 객관적 지식수준(p<0.039), 원자력발전의 필요성(p<0.001) 및 객관적 지식(p<0.001), 우리나라 원자력발전소 건설 찬성태도 (p<0.000), 의료방사선의 필요성(p<0.001) 및 객관적 지식(p<0.001), 의료방사선 이용 태도(p<0.007, p<0.001)가 모두 높기 때문이다. 둘째, 원자력발전의 필요성, 안전성에 대한 국민 이해를 돕기 위한 설명에서는 의료방사선의 필요성과 안전성에 대한 정보를 함께 제공하는 것이 교육효과를 높일 수 있다. 남, 여학생 모두 의료방사선이 가장 필요하며(p<0.001), 의료방사선이 가장 안전하며(p<0.001), 원자력 발전이 가장 안전하지 않다고(p<0.013) 인식하고 있다. 또한 의료방사선과 원자력 발전의 상관관계가 가장 높게 나타났기 때문이다. 셋째, 초, 중, 고등학생이 방사선이용 분야별로 인식의 패턴이 다르므로 학급별로 차별화된 강의내용이 필요하다. 초등학생은 원자력발전에 대한 교육흥미도가 높고(p<0.005), 방사선조사식품이 안전하다고 인식하고 있으며(p<0.001), 방사선조사식품을 섭취하겠다는 태도가 가장 높았다(p<0.001). 중학생은 의료방사선에 대한 교육흥미도가 높고(p<0.018), 원자력발전(p<0.001)과 의료방사선(p<0.002)에 대해 안전하다고 인식하고 있으며, 치료 방사선이용 태도가 가장 높았다(p<0.001). 고등학생은 원자력발전(p<0.001)과 의료방사선(p<0.001)에 대한 객관적 지식수준이 가장 높고, 의료방사선이 가장 필요하다고 인식하고 있으나(p<0.017), 원자력발전이 가장 안전하지 않다고 인식하고 있다(p<0.001). 방사선조사식품 섭취 태도(p<0.001), 거주지에 원자력발전 건설을 찬성하는 태도(p<0.001) 모두 낮았다. 넷째, 객관적 지식 중심의 교육제공보다 인식변화 및 태도증진을 위한 교육프로그램이 제공되어야 한다. 객관적 지식과 방사선조사식품의 필요성, 객관적 지식과 원자력발전에 대한 안전성 및 교육흥미도, 객관적 지식과 의료방사선의 교육흥미도 및 정보습득에는 상관관계가 없었다. 특히, 고등학생의 경우 객관적 지식수준은 가장 높았으나 거주지의 원자력발전 건설에 대해 찬성하는 태도와 방사선조사식품 섭취태도가 가장 낮았기 때문이다. 국내에서 원자력 및 방사선이용에 대한 사회적 수용성을 향상시키기 위해 필요성과 안전성에 대한 인식과 지식 및 태도 향상에 관한 교육프로그램을 전략적으로 제공하는 것이 바람직하다.

농촌(農村) 주민(住民)들의 의료필요도(醫療必要度)에 관(關)한 연구(硏究) (A Study Concerning Health Needs in Rural Korea)

  • 이성관;김두희;정종학;정극수;박상빈;최정헌;홍순호;라진훈
    • Journal of Preventive Medicine and Public Health
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    • 제7권1호
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    • pp.29-94
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    • 1974
  • Today most developed countries provide modern medical care for most of the population. The rural area is the more neglected area in the medical and health field. In public health, the philosophy is that medical care for in maintenance of health is a basic right of man; it should not be discriminated against racial, environmental or financial situations. The deficiency of the medical care system, cultural bias, economic development, and ignorance of the residents about health care brought about the shortage of medical personnel and facilities on the rural areas. Moreover, medical students and physicians have been taught less about rural health care than about urban health care. Medical care, therefore, is insufficient in terms of health care personnel/and facilities in rural areas. Under such a situation, there is growing concern about the health problems among the rural population. The findings presented in this report are useful measures of the major health problems and even more important, as a guide to planning for improved medical care systems. It is hoped that findings from this study will be useful to those responsible for improving the delivery of health service for the rural population. Objectives: -to determine the health status of the residents in the rural areas. -to assess the rural population's needs in terms of health and medical care. -to make recommendations concerning improvement in the delivery of health and medical care for the rural population. Procedures: For the sampling design, the ideal would be to sample according to the proportion of the composition age-groups. As the health problems would be different by group, the sample was divided into 10 different age-groups. If the sample were allocated by proportion of composition of each age group, some age groups would be too small to estimate the health problem. The sample size of each age-group population was 100 people/age-groups. Personal interviews were conducted by specially trained medical students. The interviews dealt at length with current health status, medical care problems, utilization of medical services, medical cost paid for medical care and attitudes toward health. In addition, more information was gained from the public health field, including environmental sanitation, maternal and child health, family planning, tuberculosis control, and dental health. The sample Sample size was one fourth of total population: 1,438 The aged 10-14 years showed the largest number of 254 and the aged under one year was the smallest number of 81. Participation in examination Examination sessions usually were held in the morning every Tuesday, Wenesday, and Thursday for 3 hours at each session at the Namchun Health station. In general, the rate of participation in medical examination was low especially in ages between 10-19 years old. The highest rate of participation among are groups was the under one year age-group by 100 percent. The lowest use rate as low as 3% of those in the age-groups 10-19 years who are attending junior and senior high school in Taegu city so the time was not convenient for them to recieve examinations. Among the over 20 years old group, the rate of participation of female was higher than that of males. The results are as follows: A. Publie health problems Population: The number of pre-school age group who required child health was 724, among them infants numbered 96. Number of eligible women aged 15-44 years was 1,279, and women with husband who need maternal health numbered 700. The age-group of 65 years or older was 201 needed more health care and 65 of them had disabilities. (Table 2). Environmental sanitation: Seventy-nine percent of the residents relied upon well water as a primary source of dringking water. Ninety-three percent of the drinking water supply was rated as unfited quality for drinking. More than 90% of latrines were unhygienic, in structure design and sanitation (Table 15). Maternal and child health: Maternal health Average number of pregnancies of eligible women was 4 times. There was almost no pre- and post-natal care. Pregnancy wastage Still births was 33 per 1,000 live births. Spontaneous abortion was 156 per 1,000 live births. Induced abortion was 137 per 1,000 live births. Delivery condition More than 90 percent of deliveries were conducted at home. Attendants at last delivery were laymen by 76% and delivery without attendants was 14%. The rate of non-sterilized scissors as an instrument used to cut the umbilical cord was as high as 54% and of sickles was 14%. The rate of difficult delivery counted for 3%. Maternal death rate estimates about 35 per 10,000 live births. Child health Consultation rate for child health was almost non existant. In general, vaccination rate of children was low; vaccination rates for children aged 0-5 years with BCG and small pox were 34 and 28 percent respectively. The rate of vaccination with DPT and Polio were 23 and 25% respectively but the rate of the complete three injections were as low as 5 and 3% respectively. The number of dead children was 280 per 1,000 living children. Infants death rate was 45 per 1,000 live births (Table 16), Family planning: Approval rate of married women for family planning was as high as 86%. The rate of experiences of contraception in the past was 51%. The current rate of contraception was 37%. Willingness to use contraception in the future was as high as 86% (Table 17). Tuberculosis control: Number of registration patients at the health center currently was 25. The number indicates one eighth of estimate number of tuberculosis in the area. Number of discharged cases in the past accounted for 79 which showed 50% of active cases when discharged time. Rate of complete treatment among reasons of discharge in the past as low as 28%. There needs to be a follow up observation of the discharged cases (Table 18). Dental problems: More than 50% of the total population have at least one or more dental problems. (Table 19) B. Medical care problems Incidence rate: 1. In one month Incidence rate of medical care problems during one month was 19.6 percent. Among these health problems which required rest at home were 11.8 percent. The estimated number of patients in the total population is 1,206. The health problems reported most frequently in interviews during one month are: GI trouble, respiratory disease, neuralgia, skin disease, and communicable disease-in that order, The rate of health problems by age groups was highest in the 1-4 age group and in the 60 years or over age group, the lowest rate was the 10-14 year age group. In general, 0-29 year age group except the 1-4 year age group was low incidence rate. After 30 years old the rate of health problems increases gradually with aging. Eighty-three percent of health problems that occured during one month were solved by primary medical care procedures. Seventeen percent of health problems needed secondary care. Days rested at home because of illness during one month were 0.7 days per interviewee and 8days per patient and it accounts for 2,161 days for the total productive population in the area. (Table 20) 2. In a year The incidence rate of medical care problems during a year was 74.8%, among them health problems which required rest at home was 37 percent. Estimated number of patients in the total population during a year was 4,600. The health problems that occured most frequently among the interviewees during a year were: Cold (30%), GI trouble (18), respiratory disease (11), anemia (10), diarrhea (10), neuralgia (10), parasite disease (9), ENT (7), skin (7), headache (7), trauma (4), communicable disease (3), and circulatory disease (3) -in that order. The rate of health problems by age groups was highest in the infants group, thereafter the rate decreased gradually until the age 15-19 year age group which showed the lowest, and then the rate increased gradually with aging. Eighty-seven percent of health problems during a year were solved by primary medical care. Thirteen percent of them needed secondary medical care procedures. Days rested at home because of illness during a year were 16 days per interviewee and 44 days per patient and it accounted for 57,335 days lost among productive age group in the area (Table 21). Among those given medical examination, the conditions observed most frequently were respiratory disease, GI trouble, parasite disease, neuralgia, skin disease, trauma, tuberculosis, anemia, chronic obstructive lung disease, eye disorders-in that order (Table 22). The main health problems required secondary medical care are as fellows: (previous page). Utilization of medical care (treatment) The rate of treatment by various medical facilities for all health problems during one month was 73 percent. The rate of receiving of medical care of those who have health problems which required rest at home was 52% while the rate of those who have health problems which did not required rest was 61 percent (Table 23). The rate of receiving of medical care for all health problems during a year was 67 percent. The rate of receiving of medical care of those who have health problems which required rest at home was 82 percent while the rate of those who have health problems which did not required rest was as low as 53 percent (Table 24). Types of medical facilitied used were as follows: Hospital and clinics: 32-35% Herb clinics: 9-10% Drugstore: 53-58% Hospitalization Rate of hospitalization was 1.7% and the estimate number of hospitalizations among the total population during a year will be 107 persons (Table 25). Medical cost: Average medical cost per person during one month and a year were 171 and 2,800 won respectively. Average medical cost per patient during one month and a year were 1,109 and 3,740 won respectively. Average cost per household during a year was 15,800 won (Table 26, 27). Solution measures for health and medical care problems in rural area: A. Health problems which could be solved by paramedical workers such as nurses, midwives and aid nurses etc. are as follows: 1. Improvement of environmental sanitation 2. MCH except medical care problems 3. Family planning except surgical intervention 4. Tuberculosis control except diagnosis and prescription 5. Dental care except operational intervention 6. Health education for residents for improvement of utilization of medical facilities and early diagnosis etc. B. Medical care problems 1. Eighty-five percent of health problems could be solved by primary care procedures by general practitioners. 2. Fifteen percent of health problems need secondary medical procedures by a specialist. C. Medical cost Concidering the economic situation in rural area the amount of 2,062 won per residents during a year will be burdensome, so financial assistance is needed gorvernment to solve health and medical care problems for rural people.

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