• 대한물리의학회지
• /
• 제5권2호
• /
• pp.143-150
• /
• 2010

Purpose : In this study, by recognizes the legal constraints of a independent physical therapy clinic open, the other countries's law on physical therapist and the expected effect of independent clinic open, we suggest the need for independent clinic open in South Korea. Methods : To recognize the necessity and expected effect of independent physical therapy clinic open, by comparing the system and situation in South Korea with the countries joined in The World Confederation for Physical Therapy. Results : Effects of the independent physical therapy clinic open were following; 1. it could be guaranteed the option of the medical consumer 2. reduce the economic and time burden 3. provide a good quality medical service Conclusion : Independent physical therapy clinic open will provide a better therapeutic environment for consumer and contribute much to improving the benefit of welfare part of the nation. For provide a good quality to medical consumer, independent physical therapy clinic open and the amendment of related law and institutional device are positively necessary.

• 동의생리병리학회지
• /
• 제28권4호
• /
• pp.430-439
• /
• 2014

This study was performed to assess the perception and needs of the traditional Korean Medical Equipment (KME) in clinic. We conducted survey research among 15,550 traditional Korean medical doctors (KMD) responded to e-mail during 2 weeks. 899 participants the survey, consisting of questions regarding 'number of devices of the KME' and 'solution and improvement plan of the KME'. The participants were asked to choose their ranking of problems of the KME and also put a check mark in the column that the reasons for this choice. As results, final scores in priority ranking medical devices were derived in 7 categories. Physical therapy equipment and acupuncture treatment devices were included in high ranks. 42.8 % of the participants responded that the diagnostic medical devices seemed important in clinics and 67.4 % of the participants indicated that the therapeutic medical devices seemed to important in clinics. The identified problems of KME were 'low reproducibility and reliability of a diagnosis result (24.8%)' and 'uncertain validity of a diagnostic medical devices (20.5%)'. The improvement plan of the problems were 'to establish the law for using the medical devices (26.6%)' and 'evaluation of validity of the KME (26.2%)'. A survey of KMD revealed the condition of KME's number of devices and the solution plan for the problem of several KMEs. Understanding the needs of KMD could probably contribute to the research and development of KMEs in the future.

• 의료법학
• /
• 제24권1호
• /
• pp.131-155
• /
• 2023

의료법은 무면허 의료행위를 비의료인에 의한 의료행위와 의료인에 의한 면허외 행위로 나누어 놓았다. 종래에는 의료행위와 한방의료행위를 엄격히 구분하는 것이 일반적 태도였으나 대법원 2022. 12. 22. 선고 2016도21314 전원합의체 판결은 한의사의 면허외 행위 판단기준과 관련하여 새로운 방향성을 제시하였다. 본 논문에서는 대상 판결에서 제시된 새로운 판단기준을 구체적으로 분석하고 새로운 판단기준의 의의와 이원적 의료체계에 미칠 영향을 검토하였다. 대상 판결의 새로운 기준과 기존 판례의 종전 기준이 가진 차별성은 판단의 근거를 한방원리와의 연관성에서 찾지 않았다는 점에 있다. 한방원리와 서양의학적 원리를 배타적으로 구분하는 이분법적 사고에서 벗어나 의료행위의 중첩성과 가변성을 적극적으로 수용하였다는 점에서 진일보한 기준인 것이다.

• 의료법학
• /
• 제24권3호
• /
• pp.125-153
• /
• 2023

대법원 2022. 12. 22. 선고 2016도21314 전원합의체 판결은 한의사의 진단용 의료기기 사용이 면허된 것 이외의 의료행위에 해당하는지를 판단하는 새로운 기준을 제시하고, 이 기준에 따라 한의사의 초음파 사용을 무면허 의료행위가 아니라고 판단하였다. 대법원 2023. 8. 18. 선고 2016두51405 판결은 새로운 판단기준을 적용하여 뇌파계를 파킨슨병과 치매 진단에 사용한 행위가 한의사로서 면허된 것 이외의 의료행위에 해당하지 않는다고 판단한 첫 번째 사안이다. 대법원은 판례변경을 통해 의료기기 사용에 서양 의학적 지식과 기술이 필요하지 않아야 한다는 종전 기준을 폐기하였지만, 진단용 의료기기를 사용한 한의사의 서양 의학적 진단행위를 진단의 보조수단으로 볼 것인지는 불투명한 상태였다. 이에 대법원은 뇌파계를 활용하여 파킨슨병과 치매, 즉 서양 의학적 진단을 한 한의사의 행위를 면허된 것 이외의 의료행위가 아니라고 판단함으로써 진단의 보조수단이 가지는 의미를 명확히 정리하였다. 이외에도 대상 판결은 뇌파계의 개발, 제작 원리와 뇌파계 검사 결과의 자동 추출 및 자동 판독 여부 또한 판단기준에서 배제함으로써 한방의료행위의 의미가 수범자인 한의사의 관점에서 명확하고 엄격하게 해석되어야 한다는 죄형법정주의 관점을 더욱 투철하게 적용하고 진단용 의료기기가 한의학적 의료행위 원리와 관련 없음이 명백한 경우가 아닌 한 형사처벌 대상에서 제외됨을 분명히 하였다.

• 보건행정학회지
• /
• 제11권3호
• /
• pp.102-120
• /
• 2001

This paper examines the current situation and major impacts of e-business on healthcare industry: hospital, pharmaceutical, medical device and health-related internet sectors. Of the 137 samples collected with mail survey, the utilization rate of B2C e-commerce is 31.4% and B2B is 13.1%. And 74.5% of respondents remains the first development stage which represents the simple advertisement such as the one-way information offering. The key obstacle of expansion of health care e-commerce turns out to be the illogical and outdated medical-related law and institution. Finally, policy recommendations are proposed based on the evaluation of the current policy implemented by government.

• 보건행정학회지
• /
• 제8권1호
• /
• pp.203-230
• /
• 1998

This purposes of this study is to develope policies on the facilities for the elderly care in Korea. Methodology of this study adopts comparative analysis on the facilities for the elderly care in 6 countries which have experienced various problems on the elderly. These 6 countries are Japan, Sweden, America, Australian, England and Germany. Major issues for comparative analysis are the standard of care facilities, residence condition, finance of facilities establishment and expense, operating system, management, and the law and administrative structure about the facilities for the elderly care. The elderly people need various kinds of welfare services such as medical care facilities, nursing home facilities, home care facilities etc.. Thus the public policies for the aging population nations are compose of income maintenance program, health and medical care services and social welfare services. The policies of facilities for elderly care are very important since these policies include the characteristics of income maintenance, me\ulcorner미 care program and welfare program. This study willsupply basic data for the development of facilities for the elderly care in Korea, especially conceming the system and institutional device of the facilities.

• 의료법학
• /
• 제21권2호
• /
• pp.209-244
• /
• 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.

• 한국중재학회지:중재연구
• /
• 제27권2호
• /
• pp.83-105
• /
• 2017

In contemporary society interest in and consumption of beauty treatment are increasing, raising interest in health and beauty. However, beauty-related laws are becoming factors of hindrance of beauty development. Currently the Public Health Control Act plays a basic role in the beauty art business in Korea, However the contents are in discord with international laws and its definition is not clear. Therefore it is causing conflicts of different occupations and job associations which are similar to art business. Especially, because neither definitions nor policies on beauty care devices exist in the Public Health Control Act, beauty care devices using in foreign countries cannot be used in Korea due to classification as medical devices. Under this circumstance, therefore, beauty care device uses by beauty artists violate the law. The government has tried to solve these irrational regulations. Recently, the Small and Medium Business Administration announced 'the improvement plan of small business and young founders site regulation for public economy recovery' in a ministerial meeting on December 28, 2016. Regulations on policy preparation for skincare devices were inclusive in this announcement. It is the question whether the regulations will be executed or not. Even though beauty industrial competitiveness was presented in the 18th Presidential Council on National Competitiveness in 2009, it was not practiced. The proposal bills for beauty law improvement have been put forth several times since 2000 including an improvement plan for regulating beauty care devices. However, so far there have been no improvements. The damage on the regulation classifying beauty devices as medical devices is not only restricted to skincare. This develops beauty devices and the beauty industry which imports and exports beauty devices. When beauty devices are exported, complicated procedures are unavoidable and when beauty devices are imported, irrational problems like reregistration procedures and costs occur. The reason why an improvement plan has not gone into practice is the resistance of the dermatologists' association. Dermatologists tend to stand positively against harming public health by saying that beauty devices used by beauty artists cause people to suffer side effects. In contrast, anyone who has a licence to use beauty devices is able to use them in foreign countries. It is not only infringement of one's right as a beauty artist but also people's right to receive beauty care services. With this reason, Korean's current law under which beauty devices are ruled as medical devices should be revised with accordance to domestic surroundings. Therefore in order to advance and globalize the beauty industry, the support and cooperation of the Korean government and relevant associations is needed to legislate and revise the beauty devices laws. The relevant associations abandon regional self-centeredness and cooperate to define ranges, size and management of beauty devices for safe use. If no collaboration exists, an arbitration agency should be established to solve the problem.

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

• 한국진공학회:학술대회논문집
• /
• 한국진공학회 2015년도 제49회 하계 정기학술대회 초록집
• /
• pp.155.1-155.1
• /
• 2015

Nowadays, Plasma has been used in biological, medical such as wound healing, plant grow, killing cancer. When plasma generated, UV light and ROS(Reactive oxygen species), RNS(Reactive nitrogen species) can generated and those things effect to biological material. So we made simple plasma device using needle type of electrode and generated plasma. We used three kinds of gas and measured applied voltage and current. Also we observed optical emission spectrum. Using deuterium ramp, we can observed absorption spectrum and calculated radical density by lambert-beer's law. It is around ~1016cm3. And we can see the time-resolved absorption spectrum from monochromator, PMT(photo multiply tube), IV-converter, oscilloscope.