• 대한한의학회지
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• 제32권2호
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• pp.79-91
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• 2011

Objectives: The purpose was to study the market of traditional Korean medical devices and survey, list and number medical devices in traditional Korean medical clinics. Methods: we researched in three ways. 1. We investigated the list of devices regarded as traditional Korean medical devices in 'Report on production, export, and import of medical devices.' 2. We investigated the statistics of medical devices equipped in traditional Korean medical clinics through the website of the Health Insurance Review & Assessment Service. 3. We surveyed medical devices in traditional Korean medical clinics by mail. Results: 1. We could not directly investigate the market for traditional Korean medical devices because they were not categorized as such ('traditional Korean medical devices'). 2. The number of medical devices in traditional Korean medical clinics has increased alongside the increase of traditional Korean medical clinics. 3. Traditional Korean medical clinics hold over 64,962 medical devices and have below 50 percent of traditional Korean medical diagnosis devices. 4. Meridian function testing machines, pulse diagnosis devices, and yangdorak showed ranking of equipment-ratio equal to ranking of insurance fees. Conclusions: Traditional Korean medical device regulations should be enacted following definitive and concrete Korean traditional medical concepts by the Korean traditional medical society.

• 대한한의학회지
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• 제34권1호
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• pp.69-79
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• 2013

Objectives: The aim of this survey was to investigate utilization, intended use, problems with and demand for medical devices by surveying members of the traditional Korean medical society. Methods: We distributed questionnaires to 13,957 traditional Korean medical doctors via e-mail, and received replies from 1,225. The questionnaire consisted of 4 multiple-choice questions for survey respondent information, 8 multiple-choice questions about the status of medical devices utilizing, and a short answer question about the demand for medical devices. Results: Use of medical devices in traditional Korean medical clinics is common. Diagnostic medical devices are mainly used to assess the patient's condition and to establish a close rapport with clients. In case of therapeutic medical devices, they are usually used for secondary treatment. Issues with traditional Korean medical devices currently in use were ineligibility for national health insurance, low reliability, uncertain validity, and high price. In development of traditional Korean medical equipment, the need for diagnostic medical devices was greater than for therapeutic, and the need for the recording and analysis of medical image data and visualization of medical information was great. Conclusions: There is growing demand for facilitating the development and commercialization of traditional Korean medical devices. To satisfy this demand, research on evaluation indicators that reflect functional and structural clinical information and how to clinically assess the indicators should proceed.

• 대한예방한의학회지
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• 제28권1호
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• pp.31-42
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• 2024

Objective : In order to understand the changes in domestic approval regulations applicable to traditional Korean medical device companies, this article will explain the major amendments 「Regulation on Medical Device Approval Report Review, etc.」 from 2005 to the present on a year-by-year basis, and provide a counter plan to the recent changes in approval regulations. Methods : We analysed the changes in approval regulatory amendments related to the traditional Korean medical devices from 2005 to the present. Results : The Ministry of Food and Drug Safety is continuously improving medical device approval regulations to ensure the global competitiveness of domestic medical devices and contribute to the improvement of public health. Recent major approval regulatory amendments include the establishment of a review system for software medical devices and digital therapeutics, the recognition of real world evidence materials, the introduction of a biological evaluation of medical devices within a risk management process and a medical device approval licence renewal system. Conclusions : It is expected that the range of medical devices available to Korean medicine doctors will continue to expand in the future through the provision of non-face-to-face medical services and the development of advanced and new medical devices, as well as wearable medical devices and digital therapeutics. In order to increase the market entry potential of traditional Korean medical devices that incorporate advanced technologies such as digital technology and AI-based diagnosis and prediction technology, it is urgent that the government provide significant support to traditional Korean medical device companies to improve approval regulatory compliance.

• 동의생리병리학회지
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• 제28권4호
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• pp.430-439
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• 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.

• 한국한의학연구원논문집
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• 제11권1호
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• pp.119-125
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• 2005

We conduct a survey of actual condition of medical devices in korea traditional medicine on 157 oriental medicine doctors and 183 manufacturers. The 61% percent of doctors indicate the trouble in use of medical devices which is applied to korea traditional medicine. The manufacturers replied that devices have a problem with diagnosis(53%) and treatment(36%). To overcome these problems, it is necessary to develop devices based on the study of basic oriental medicine and the reliable clinical research. This study contributes the improvement of quality and the revision of rules on medical devices.

• 대한의사협회지
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• 제61권12호
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• pp.702-705
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• 2018

Advances in technology lead to advances in medical devices, and these advances have the positive effect of creating opportunities for beneficial developments in healthcare, such as innovating traditional healthcare processes or expanding opportunities for diagnosing and treating diseases. Nonetheless, device developers, suppliers, users, insurers, and patients all face the challenge of balancing patient safety and health effectiveness with a reasonable profit. In Korea, the New Health Technology Assessment system aims to introduce safe and effective health technology, but this is only effective for the entry of devices onto the healthcare market. This system is not enough for creating a healthy ecosystem in which high-quality technologies and devices survive in the market and naturally exit from the market if not successful. The nation must not lag in the rapid development of medical devices, but the concomitant requirement for patient safety is like two rabbits moving in different directions. There is not enough time to resolve each source of uncertainty for both developers and users. The early adoption of health technologies, including medical devices, offers new opportunities for treatment and diagnosis, but also poses unexpected health risks. Thus, we need to design a plan to generate scientific evidence related to medical devices after they introduced into practice. Additionally, regarding the use of individual medical devices, we believe that the creation of a healthy ecosystem for medical devices by implementing medical device surveillance culture is a way to manage the opportunities and risks of the early introduction of innovative medical devices.

• 의료법학
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• 제15권1호
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• pp.59-80
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• 2014

The Medical Affairs Law regulates that Medical Doctor and Korean Medical Doctor(KMD) can practice in the boundary of each licence. But there is no clear provision to explain what practice in the boundary of MD's permitted region and what is KMD's. Moreover practice over the boundary of licence could be punished as a violation of the Law. KMD's use of medical devices have been objects of legal conflicts in the field. Because there is no clear provision in the Law, judical precedents have played the role as practical and final regulations. In this study, analyses on some judical precedents could show some rationales whether an issued KMD's use of medical devices is in the boundary of license. The courts considered the theories based on the practice, the level of required specialty and education, and the probability of danger to a patient. The judical precedents should be reviewed more precisely in the respects that it is adaptable in "the written law system"and it is desirable to divide boundaries between MD's and KMD's.

• 대한한의진단학회지
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• 제16권3호
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• pp.23-32
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• 2012

Objectives: The objective of this study is to investigate and valuate currently provided database management systems (DBMS) of traditional Korean medical knowledge. Methods: We searched DBMS on the web and smart device application markets (Apple App Store and Google Play Store). Key words for searching were 'traditional medicine', 'acupuncture', 'moxibustion', 'herbal medicine', and '한의학'. We looked into each DBMS to find out its scopes and limits, and each was valuated according to its functionality, accessibility, and utility. Results: 186 DBMS of traditional Korean medical knowledge were investigated and 91% of them were applications for smart devices. Almost all DBMS provided acupuncture and herb information, and a small amount of DMBS provided prescription and research paper information. Functionality, accessibility, and utility valuation were performed by using scoring system from 0 to 2. Mean values of functionality, accessibility, and utility were 0.86, 1.29, and 1.09. Conclusions: On the whole, high accessibility and low functionality were found, and various data-calculating functions were not implemented. Further researches and developments about traditional Korean medical knowledge DBMS are necessary to provide correct traditional Korean medical information and to support the studies about Korean medicine.

• 한국인터넷방송통신학회논문지
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• 제17권5호
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• pp.137-142
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• 2017

인구의 고령화와 의료서비스 수요의 증가로 한의학의 이론을 기초로 한 의료기기 개발이 증가하고 있다. 개발한 의료기기의 임상적 유효성 확보를 위한 다양한 임상시험들이 수행되고 있으며, 이 과정에서 다양하게 수집되는 정보들의 체계적인 관리의 중요성이 증가하고 있다. 본 논문에서는 한의학의 대표적인 진단 방법인 맥진을 기기화 한 맥진기를 이용하여 임상시험을 진행하는데 있어 환자의 의학적 정보, 맥진기의 측정 정보들을 체계적으로 관리할 수 있는 데이터베이스를 설계하고 구축하였다. 구축된 데이터베이스는 임상시험에 대한 다양한 정보 및 측정된 정보의 질관리를 통해 기존 알고리즘 검증 또는 새로운 알고리즘 개발 시 효율적인 대응이 가능하고, 임상 데이터의 통제 측면에서도 여러 장점들을 가지고 있다. 본 연구의 결과는 이종의 맥진기나 다른 생체신호 측정기와의 정보 공유가 가능한 통합 데이터베이스 관리 시스템 구축을 위한 한의 의료기기 데이터 표준안 구성에 기여할 수 있을 것이다.

• 대한예방한의학회지
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• 제20권3호
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• pp.1-8
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• 2016

Objectives : There is a correlation between student's satisfaction of education and their occupation satisfaction. Therefore, Korean medical school students' satisfaction toward their education is important for their medical ability in Traditional Korean Medicine(TKM). The purpose of this study is to investigate TKM school students' satisfaction of education and their perceptions of TKM level. Methods : The questionnaire used in this study is consisted of questions about students' satisfaction and their perception toward issues about TKM. 168 cases were collected, and I analyzed 164 cases. Results : 43.9% of students think that the ratio of western medical courses to TKM courses in TKM school's curriculum is 'Proper'. 54.3% of students do not satisfy their curriculum. But, 51.2% of students would recommend high school students for entrance to TKM school. 77.9% of students think 'TKM doctor should use modern medical device'. 92.7% and 61.9% of students think 'Needed' toward 'Cooperation of western medicine and Korean medicine', and 'Medical unification' each. There are correlations ; (1)'recognition toward ratio of curriculum', (2)'satisfaction of curriculum', (3)'degree of recommendation to enter the TKM School', (4)'relation between TKM and Traditional Chinese Medicine(TCM) or Complementary and Alternative Medicine(CAM)'. Conclusions : Student's satisfaction of education is not quite high than satisfaction of TKM study itself. Most of respondents agreed usage of medical devices. The more they thought that they had curriculum for western medicine, the lesser they thought that medical unification was ont needed. Further studies are needed to assess satisfactions of students for their education with more accuracy results.