• The Journal of the Korean dental association
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• v.57 no.6
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• pp.316-324
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• 2019

The new medical technology assessment system has a basic goal of protecting the public's health rights and promoting the development of the new medical technology with safe and effective medical technology that has been scientifically proven. The purpose of this study is to contribute to the activation of the new medical technology evaluation system by analyzing the application cases of the dental field after the implementation of the new medical technology evaluation system and proposing an efficient approach to approach the new medical technology evaluation system. The number of related literature and medical technology evaluation results are not significant in dental applications, the number of cases and the length of follow-up period of the relevant medical technology adopted as the new medical technology was far higher. As the speed of medical technology development increases, medical technology is expected to develop in the dental field as well. To introduce the medical technology to the clinical site, access to the correct direction of evidence is required to collect and objectify data at the medical site in order to prepare a literary basis for the medical technology.

• Korean Journal of Acupuncture
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• v.29 no.2
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• pp.315-326
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• 2012

Objectives : The new health technology assessment system was introduced in April 2007. The purpose of new health technology assessment is assessing safety and efficacy in deciding a behavior of new health technology according to the Health Insurance Act. This study aims to understand the present status of new health technologies of Korean medicine. Methods : This research introduces new health technologies and their present status, and searches for a development direction for the new health technology of Korean medicine in the future. Results : Thirty seven cases(3%) of Korean medicine doctors who utilized new health technologies application were found. In the status about new health technologies application by technologies assortment, diagnostic test techniques were used more often than treatment skills. New medical technology that included korean medicine doctor as actual user was only one item, i.e. HCV antibody test. Conclusions : In order for the new health technology of korean medicine to settle down well, continuous interest and efforts of both government and medical community are necessary.

• Journal of Society of Preventive Korean Medicine
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• v.21 no.3
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• pp.75-85
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• 2017

Objectives : The new health technology assessment (nHTA) involves evaluating the safety and efficacy of the new health technology under the Medical Services Act by the New Health Technology Assessment Project Division from 2007. The purpose of this study is to understand the status of applications and recent trends of the results, and suggest strategies for the development of new health technologies in Korean Medicine. Methods : We investigated and analyzed the results of evaluation of new health technology of whole conventional medical and the list of new health technologies in Korean Medicine provided by the New Health Technology Assessment Project Division from 2007 to 2016. Results : The number of applications for new health technology of Korean medicine was low as 41 items in the whole number of 2,013 items. The evaluation method of new health technologies in both, the whole medical and Korean medicine fields was the same, but the tendency in results was very different. Most of the new health technology items in Korean medicine were classified as existing technology (20 items), early stage technology (7 items), and Only 2 items were evaluated as research stage technology. Conclusions : In order to develop new health technology in the Korean medical field, we have made suggestions about the health technology assessment systems, R&D infrastructures, and corporation with conventional medicines.

• The Korean Journal of Health Service Management
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• v.7 no.3
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• pp.203-212
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• 2013

Medical devices separated by a committee of the International Electrotechnical Commission IEC TC (Technical Committee) 62 medical electrical equipment being promoted by the International standards. Actually, a lot of standards were existed, but many national and international standards for medical devices were lacking in practical standards that can be applied to their development. Most international standards were focused in electrical and mechanical safety of medical devices. Therefore, there were few practical standards which contain essential performance evaluation. Although medical device regulations do not enforce a fixed lifecycle model, activities are presented in a sequential manner, thus hinting at a waterfall process. Meanwhile, for a decade or more, software teams have benefitted from agile development methods. Several medical device manufacturers have adopted agile practices while keeping development in compliance with regulations, but conflicts arise and decisions have to be taken in favor of agility or formality. However, if there are new practical standards of medical devices, it must be possible to promote the medical devices industry in their nation. To do this, there is a need to develop a new standard could apply to the international market through the analysis of the medical device related technology. Consequently, new standards such as NP (New proposal) or NWIP (New Work Item Proposal) should be developed through international standardization of medical device technology.

• Health Policy and Management
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• v.28 no.3
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• pp.272-279
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• 2018

Since the introduction of new health technology assessment in 2007, benefit coverage process of health insurance related to new health technology has become an upgraded system through the evidence-based decisions. As a result of enforcing this system for 10 years, however, there have been several rising concerns. It needs to support the insufficient evidence of medical technologies, introduce reassessment system for post management of market entry technologies, and improve evaluation methods and process. In addition, there is the possibility of emerging an unheard-of medical technology, fused various categories like artificial intelligence, robot, information technology, physics and life science in the fourth industrial revolution. Now, new updated system introduced to improve new technology assessment, such as 'limited health technology assessment system,' 'system for postponement of new health technology assessment,' 'one-stop service system,' and 'integrated operation of approval for medical devices and new health technology assessment.' Therefore it needs to prepare the improvement plan for new health technology assessment to be established more advanced system, and we have to resolve concerns by communication with various healthcare experts and patients now and for ever.

• Korean Journal of Acupuncture
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• v.29 no.2
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• pp.327-342
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• 2012

Objectives : Nowadays, the assessment of new health technologies is gaining interest as an important issue for the safety of national health in the rapidly changing medical environment. The aim of this study is to understand how ignorant the korean medicine doctors are of new health technologies. Methods : The authors conducted a survey on the status of the ignorance of new health technologies in Korean medical doctors by e-mail. Results : Korean medical doctors' ignorance of new health technologies proved serious. The awareness of the law, however, was reached to some degree. The respondents answered that the present items of Korean Medicine listed in the medical care expenses by national health insurance system are too deficient to treat their patients effectively. Conclusions : It is strongly needed to try for more active registration of Korean medical new health technologies.

• IE interfaces
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• v.21 no.2
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• pp.209-220
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• 2008

Recently, innovative medical services are fast emerging, which include customized medical services based on bio-informatics, composition of cure and well-being exploiting ubiquitous technology, hospital supply chain management using RFID, and so forth. However, conventional approaches for new service development hardly give us systematic model to analyze and produce creative medical services. Because most of them are static and concentrate on microscopic tools or techniques. Thus, it is highly desirable to suggest an integrative framework to organize the whole transformation process from technology to medical service. The objective of this study is to propose a medical service engineering model based on the dynamic innovation theory. The proposed model contains objectives of service system, strategies of hospital, stages, activities required to deal with medical service life cycle, which incorporates the acquisition of new technology, transformation to the product, penetration into market, and adoption of consumers. In addition, the usefulness and applicability of the newly proposed model are provided using catholic medical center example.

• Journal of Society of Preventive Korean Medicine
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• v.17 no.2
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• pp.89-103
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• 2013

Objectives: This study was aimed to contribute to the establishment of base for the development of new health technology in Korean Medicine. Methods: Survey was performed with 200 samples obtained through stratified sampling from the list of members of Association of Korean Medicine. Results: For the question about the recognition of new health technology, 54.0% answered 'yes' and 45.0% answered 'no', For the question about whether using the therapy not listed in the medical care of national health insurance, 43.5% answered 'use', Conclusion: Doctors of Korean Medicine seem to want the enlargement of new health technology in the Korean Medicine.

• Progress in Medical Physics
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• v.31 no.3
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• pp.124-134
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• 2020

Here we review the evolutionary history of radiation therapy technology through the festschrift of articles in celebration of the 30th anniversary of Korean Society of Medical Physics (KSMP). Radiation therapy technology used in clinical practice has evolved over a long period of time. Various areas of science, such as medical physics, mechanical engineering, and computer engineering, have contributed to the continual development of new devices and techniques. The scope of this review was restricted to two areas; i.e., output energy production and functional development, because it is not possible to include all development processes of this technology due to space limitations. The former includes the technological transition process from the initial technique applied to the first model to the latest technique currently used in a variety of machines. The latter has had a direct effect on treatment outcomes and safety, which changed the paradigm of radiation therapy, leading to new guidelines on dose prescriptions, innovation of dose verification tools, new measurement methods and calculation systems for radiation doses, changes in the criteria for errors, and medical law changes in all countries. Various complex developments are covered in this review. To the best of our knowledge, there have been few reviews on this topic and we consider it very meaningful to provide a review in the festschrift in celebration of the 30th anniversary of the KSMP.

• The Journal of the Convergence on Culture Technology
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• v.8 no.5
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• pp.29-37
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• 2022

MDR, a new European medical device regulation newly enacted in 2017, requires that medical device products that have received CE conformity certification through MDD be re-certified by May 2024 in line with the new CE MDR regulation. The new MDR requires more stringent medical device clinical evaluation and clinical investigation than the previous MDD required, and also require the submission of documented post-marketing surveillance data. Korean medical device makers also need to meet the new MDR requirements and obtain conformity certification, but the industry is still confused because they do not understand the new regulations thoroughly. In this study, medical device regulations in Korea, the United States, and Europe are compared, and the European MDR is further compared with the previous European Medical Device Directive MDD to help understand the requirements of the new European Medical Device Act.