• 의료법학
• /
• 제8권2호
• /
• pp.291-328
• /
• 2007

Under the present law, a medical corporation has the legalistic character of a noncommercial corporation and its commerciality is restricted by public service. In a recent precedent, however, a judgment has considered the service part in medical practice. The tendency of a precedent is that both commerciality of a medical institution and medical corporation are allowed to be pursued under fundamental order-observance. This change is found in china and india, which consider a medical service as national industry. In the case of ours, the now government demonstrate the industrialization or the market of medical service through promotion of commerciality of a medical corporation. This paper deal with the meaning of a medical corporation and the present condition of medical market under the present law and recommends a tendency of law policy through study of foreign's and our precedent for commerciality of medical advertisement and medical corporation.

• 문화기술의 융합
• /
• 제8권5호
• /
• pp.1-7
• /
• 2022

한국의 의료기기 산업은 1995년부터 시작된 G7 의료공학기술개발사업으로 본격적인 성장과 발전의 기틀을 마련하였으며 2020년 한국 의료기기 생산실적은 2001년에 비하여 8.52배, 수출 실적은 13.94배 성장하였다. 의료기기 국산화 개발 초기에 초음파 의료기기 등 전자 의료기기의 개발이 활발하였던 것과 비교하여 2020년에는 체외진단시약과 치과용 임플랜트의 생산 및 수출 실적이 상위권을 차지하고 있다. 그러나 한국 의료기기 시장에서 수입 의료기기가 차지하는 비중은 60-70%에서 큰 변화가 없는데 이는 한국의 의료기기 산업이 중저가 의료기기를 생산 수출하고, 기술집약적이고 자본집약적인 고가 의료기기는 주로 수입에 의존하고 있기 때문이다. 본 논문에서는 한국과 세계시장의 주요 의료기기 회사들의 생산 품목을 비교하여 한국 의료기기 산업의 세계 시장 진출에 대한 전략을 제시하고자 한다.

• Journal of Acupuncture Research
• /
• 제32권4호
• /
• pp.91-102
• /
• 2015

Objectives : The Oriental medical device industry is expected to continue to experience significant growth. It should increase its global market share rather than focusing on the domestic market. Countries around the world self-regulate their domestic market, so this study aims to aid in the development of a particular overseas market by introducing the U.S.(the largest market) medical device registration and approval process. Methods : For an understanding of the US medical device licensing process, we researched the relevant regulatory organization (FDA), the history, definition and classification of medical devices, the approval and 510(k) submission process related to substantial equivalence, IEC 60601-1 Edition 3, usability tests, and so on. Results : Medical devices in the United States are assigned to one of three regulatory classes: Class I, Class II and Class III, based on the level of control necessary to assure the safety and effectiveness of the device. If a company's device is classified as Class II and if it is not exempt, a 510k will be required for marketing. 1) A 510(k) is a premarket submission made to the FDA to demonstrate that the new device to be marketed is "substantially equivalent" to a legally marketed device (predicate device) 2) The IEC 60601-1 Edition 3 preparation process, which contains information related to usability, is expensive and time-consuming but a critical requirement. Conclusions : Although the U.S. market has high barriers to entry, access to this, large overseas market will encourage development of the Oriental medical device industry and commercial value enhancement is expected.

• 한국병원경영학회지
• /
• 제11권3호
• /
• pp.56-72
• /
• 2006

This study aims to deal with hospital staff's recognition on the opening of the medical services market, their attitude to the opening - agreement and disagreement, and their intention to use a foreign hospital or to consult its doctors again. It was conducted for 450 employees of one university hospital located in Gyeonggi Province, Korea with systemized questionnaires. The main results of this study are as follows: First, Medical technicians showed the highest level recognition on the opening of the medical services market. Second, The percentage of agreement to the opening was the highest for medical technicians and lowest for doctors while that of agreement was the highest for doctors and lowest for nurses. For residents, among doctors, the percentage of disagreement was the lower than that of agreement. Third, the intention to use a foreign hospital and to consult its doctor again was the lowest for medical engineers and the highest for doctors. Fourth, The most urgent task for local hospitals to accomplish in response to the opening was the improvement of the diagnosis and treatment technologies for nurses, and the improvement of the service provided by the hospital staff for the others. For doctors, in particular, the improvement of the diagnosis and treatment technologies was just the fourth urgent task. In conclusion, the result varies to the type of occupation. Apparent difference was found for doctors, in particular, that seem to be directly affected by the opening of medical services market. Local hospitals and doctors, therefore, should make efforts together to improve the diagnosis and treatment technologies. All the hospital employees of every type of occupation, meanwhile, need to prepare for the opening with medical service of improved quality.

• 간호행정학회지
• /
• 제6권1호
• /
• pp.147-159
• /
• 2000

This paper studied the factors that influence on RN staffing level in the 43 Specialized general hospitals. Market structure was analysed using the monopsony model. The degree of competition was estimated by Herfindal Index and market was defined as Great medical zone. As the result of the estimation, in the more competitive hospital market hospitals employed the higher level of RN staffing, so monopsony model was supported. Hospitals with above 1001bed employed more RN than hospitals with below 700bed did. Hospital type, hospital union and the number of medical doctor did not affect the level of RN staffing. There was positive correlation between the level of RN staffing and the number of nurse's aid. The structure of RN market in Specified general hospitals was proved monopsony market, it seems that government regulation will be needed to improve social efficiency and equity.

• 한국컴퓨터정보학회논문지
• /
• 제22권5호
• /
• pp.105-110
• /
• 2017

It is natural that the medical advertisement should be guaranteed as part of the basic commercial activities of medical institutions. However, the general public are non-specialist and they have less informed about medical care than medical specialists, and it is not easy to judge and select medical information. Also, if someone damaged by illegal medical advertising, it cannot be recovered to the original. In this regard, medical advertising has been legislated so that medical organizations can pre - screen the medical laws. However, In December 2015, after the Constitutional Court ruled unconstitutional preliminary censorship, it became virtually impossible to pre-screen. In recent years, illegal medical advertisement have been on the rise, and false and exaggerated medical advertising are increasing the damage to medical consumers. Therefore it is urgent to take countermeasures about this. Thus, this paper try to analyzes the characteristics of general commercial and other medical advertisements and looks for alternatives that can minimize the damage caused by illegal medical advertisements and institutional weaknesses by analyzing the regulatory trends in medical advertising.

• 무역상무연구
• /
• 제75권
• /
• pp.159-177
• /
• 2017

In this paper, we examined trends and regulations of the global medical equipment industry through literature search. The medical equipment industry is attracting attention as a new growth engine in the Fourth Industrial revolution. However, the medical device industry is a highly competitive field due to product diversity, short product life cycle and technological advances. In addition, Medical equipment are related to human health and safety. Therefore, it can only be exported if it is approved by national or international standards. Therefore, from the development stage of the product, the medical equipment should designate the country to be exported and develop a medical equipment that meets the requirements for licensing the medical equipment in the country. Therefore, In this paper, In this paper, we will present the practical considerations of the medical equipment exporting company by examining the global medical equipment market trends and the regulations related to medical equipment in major countries.

• 보건행정학회지
• /
• 제31권4호
• /
• pp.423-436
• /
• 2021

This article summarizes the structure of China's current social health insurance system and reviews the development status of China's private health insurance (PHI). China's medical security system is mainly composed of two parts: basic medical insurance (BMI) and PHI. Among them, the BMI provides reimbursement of basic medical expenses for the insured persons according to different proportions. PHI is a necessary supplement to the BMI and provides assistance to the insured persons in the event of illness or accident. By having PHI, people can obtain medical protection outside the coverage of BMI. In the development of PHI in China, the total medical cost is high and the insurance market size is large, but the proportion of PHI expenditure is low and the personal burden is high. Through this Chinese case, it will be helpful for mutual development between Korean PHI and national health insurance, for Korean insurance companies to enter the Chinese market, and for removing the medical burden on the people.

• 대한의용생체공학회:의공학회지
• /
• 제43권4호
• /
• pp.199-213
• /
• 2022

EN ISO 14971:2012 a risk management standard approved and applied as a European standard in 2012, will be adopted and applied as ISO 14971:2019 published in December 2019, ISO/TR 24971(Guidance) published in June 2020 from May 2022. After that, it is applied to IVDD surveillance and IVDR new and conversion, and the manufacturer is already preparing for application or is starting preparation for application. In addition, 98/78/EEC IVDD applied from 1998 will also be applied as REGULATION (EU) 2017/746 IVDR from May 2022. In particular, in IVDR, the requirements for post-marketing investigations such as Post Market Surveillance (PMS), Summary of safety and performance(SSP), Periodic Safety Update Report(PSUR) and Post Market Performance Follow Up(PMPF), which were not required in the existing IVDD, increased, and the contents were also specified. This study focused on ISO14971:2019 among these strengthened and newly applied regulations, and tried to present a detailed analysis and application plan of Post Market Surveillance (PMS) required by 2017/746 IVDR.

• 보험의학회지
• /
• 제30권2호
• /
• pp.8-11
• /
• 2011

Insurance medicine has been known to medical risk selection. The role of insurance medicine is sound maintenance of insurance system. So it's function is medical underwriting of life risks. However, emerging market has insufficient medical epidemiological research that is necessary for estimation of extra-risk and such market is usually lack of full understanding of life insurance among insurance customers. This problem makes difficult of performing the medical underwriting, as an original insurance medicine. Medical contributions at the stage of claims adjudication comparing the coverage provided in the product, with the information provided in the claims, based on medical records and the agreement between them. This is called medical verification. The insurance doctors can also use their medical knowledge to help the claims staff with informing claimants about the medical basis of claims decisions.