• 보건의료기술평가
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• 제6권2호
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• pp.95-99
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• 2018

As technologies develop, the digital health sector is gradually expanding. Internationally, the global summit for Digital Health named Global Digital Health Partnership (GDHP) was launched in 2018. Many countries are participating in GDHP and share their policy experiences on digital health and find the ways to cooperate with participating countries (13 countries, including South Korea, and Hong Kong). This article reviewed the international trends in digital health policy environment and evidence assessment focusing on GDHP activities, and derived implications for health technology assessment of digital health. Consequently, to assess the intervention effects of digital health is very complex and the assessment should be considered multidimensional aspects (social, clinical, and technical). In addition the patient experience should be assessed qualitatively. Health technology assessment (HTA) should assess the effect of digital health policies to changes in health care systems resulting from the application of advanced technologies related to the 4th Industrial Revolution. Digital health is also related to new HTA, HTA of existing technologies, and R&D on the promising health technology. Therefore, it is necessary to review the trends of the technology's management policy consistently through the HTA of digital health.

• 보건행정학회지
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• 제28권3호
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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.

• 보건행정학회지
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• 제28권3호
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• pp.263-271
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• 2018

Health technology assessment (HTA) is defined as multidisciplinary policy analysis to look into the medical, economic, social, and ethical implications of the development, distribution, and use of health technology. Following the recent changes in the social environment, there are increasing needs to improve Korea's healthcare environment by, inter alia, assessing health technologies in an organized, timely manner in accordance with the government's strategies to ensure that citizens' medical expenses are kept at a stable level. Dedicated to HTA and research, the National Evidence-based Healthcare Collaborating Agency (NECA) analyzes and provides grounds on the clinical safety, efficacy, and economic feasibility of health technologies. HTA offers the most suitable grounds for decision making not only by healthcare professionals but also by policy makers and citizens as seen in a case in 2009 where research revealed that glucosamine lacked preventive and treatment effects for osteoarthritis and glucosamine was subsequently excluded from the National Health Insurance's benefit list to stop the insurance scheme from suffering financial losses and citizens from paying unnecessary medical expenses. For the development of HTA in Korea, the NECA will continue exerting itself to accomplish its mission of providing policy support by health technology reassessment, promoting the establishment and use of big data and HTA platforms for public interest, and developing a new value-based HTA system.

• 대한예방한의학회지
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• 제21권3호
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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.

• 보건의료기술평가
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• 제6권2호
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• pp.81-87
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• 2018

With the recent change of healthcare environment including rapid technological development, evidences are more and more important and necessary to support relevant policies in health technology assessment to provide safe and effective health services, utilizing medical resources efficiently. Despite of the emphasis on the importance of real world data and real world evidence in health care research, current infrastructure supporting clinical research is considerably weak due to absence of legal and institutional basis. However, in accordance with the Article 26 of the Health and Medical Technology Promotion Act, there is a limited legal apparatus that can be used only in public data with other dataset for the purpose of healthcare technology assessment at the National Evidence-based Collaborating Agency. Although the use of linked data from various sources was often required in the field of clinical research, it was not yet working well due to insufficient environmental conditions. In order to support the decision-making of medical practice and health care policies, data-linking platform for clinical research is needed. If the legal system that can link up to the data of the private institutions without violating the significant value such as the protection of private informations is established, it will be a decisive foundation reinforcing the researches and policy making processes for the improvement of the national health care system.

• 대한한의학회지
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• 제40권3호
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• pp.59-75
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• 2019

Objectives: The purpose of this study is to examine the current status of Korean medicine health technology assessment and explore realistic plans to activate it. Methods: We investigated all the applications for new health technology assessment related to Korean medicine from 2007 to 2016. The several expert meetings were held to draw out the barriers and improvement strategies of the new health technology assessment of Korean medicine field. Results: There were 31 cases in total except for duplications or reapplies falling into 3 main types. First, 19 of them were to try to enter a medical market and be covered by National Health Insurance. Eight cases were to apply western medicine technology as new health technology in Korean medicine area. The rest was 4 cases, which were totally not appropriate for the purpose of new health technology assessment system. According to the expert opinion, the obstacles of activation in new health technology assessment of Korean medicine were application of unstandardized technology, lack of understanding and experience, lack of clinical trial supporting system for Korean medicine, lack of committee members within the nHTA(new Health Technology Assessment) review board, ambiguous definition of medical practice and sharp conflict between western medicine and Korean medicine. Conclusions: Several suggestions were derived. First of all, to activate Korean medicine in the nHTA system, the existing system should be used sufficiently, and multifaceted efforts are needed to upgrade the system, if necessary. Also, self-help efforts, Korean medicine clinical trial supporting system and increasing R&D investment, establishing extra-committee for Korean medicine in nHTA could be needed. Finally, long-term strategy for improving collaboration between Korean medicine and western medicine should be considered.

• 보건의료기술평가
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• 제6권2호
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• pp.156-161
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• 2018

Objectives: To evaluate results and workloads of the horizon scanning of the emerging health technology since 2014 to 2016. Methods: In order to analyze the results of the emerging health technology, we identified the number of research procedure between 2014 and 2016. The sixteen findings were calculated annual workload by person, and categorized by medical phase, classification of disease, and healthcare technology. Results: An average of 5.67 personnel were involved over three years, assessment of each emerging healthcare technology was performed for each person of identifying 54 cases, filtering 2.4 cases, prioritizing 0.9 cases were performed. According to the mapping by healthcare technologies, nine medical devices (56.3%), six drugs (37.5%), and one material of the medical treatment (6.3%) were assessed. Among sixteen findings, fifteen cases were health technologies for treatment and only one case for diagnosis. Conclusion: Future plans of the horizon scanning of the emerging health technology is required appropriate manpower in charge each target number of assessment. And a legal basis should be provided for policy reflection rate. Furthermore, an evaluation criteria and procedures should be transparent to avoid a conflict of interest.

• 보건행정학회지
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• 제30권2호
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• pp.164-177
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• 2020

This study aims to compare the experience of selected countries in operating separate payment system for new healthcare technology and to find implications for price setting in Korea. We analyzed the related reports, papers, laws, regulations, and related agencies' online materials from five selected countries including the United States, Japan, Taiwan, Germany, and France. Each country has its own additional payment system for new technologies: transitional pass-through payment and new technology ambulatory payment classification for outpatient care and new technology add-on payment for inpatient care (USA), an extra payment for materials with new functions or new treatment (C1, C2; Japan), an additional payment system for new special treatment materials (Taiwan), a short-term extra funding for new diagnosis and treatment (NUB; Germany), and list of additional payments for new medical devices (France). The technology should be proven safe and effective in order to get approval for an additional payment. The price is determined by considering the actual cost of providing the technology and the cost of existing similar technologies listed in the benefits package. The revision cycle of the additional payment is 1 to 4 years. The cost or usage is monitored during that period and then integrated into the existing fee schedule or removed from the list. We conclude that it is important to set the explicit criteria to select services eligible for additional payment, to collect and analyze data to assess eligibility and to set the payment, to monitor the usage or cost, and to make follow-up measures in price setting for new health technologies in Korea.

• 보건의료산업학회지
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• 제7권4호
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• pp.273-288
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• 2013

This paper is a general review contextualizing the state of the domestic health technology assessment. The aim of the paper is to present an overview of health technology assessment in Korea based on examining clinical efficacy as well as cost-benefit analysis, and to suggest the issue of appraisal based on social value. We have included a discussion of a major case study of the technology appraisal process of NICE (the National Institute for Clinical Excellence) in the UK. The review of the existing process of NICE shows that the appraisal both gives interest in health technology a sense of value perspective and raises methodological issues in terms of reliability. Details of the appraisal process and several guidelines for best practice have emerged. Suggestions are listed and their role in assessing is explained as a conclusion.

• 대한한의학회지
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• 제38권1호
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• pp.21-33
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• 2017

Objectives: The purpose of this study is to present the needs for New Health Technology in Korean medicine field and suggest the strategy to raise the application and selection rate. Methods: In this study, we reviewed the application status of New Health Technology application from April 27, 2007 to June 30, 2016. And we analyzed the assessment methods, procedures, and failure factors through the two Research stage technologies reports in Korean medicine field. Results: In Korean medicine field, the application status of New Health Technology is very small as 2% of the whole applications. Moreover, 62.9% of the applied technology were either an existing technology or an early technology, so did not enter the assessment process. Two technologies categorized as Research stage technology also had failed to adopt New Health Technology because they were lacking evidences or need more research to prove effectiveness. Conclusions: In order to develop New Health Technology in Korean medicine, more efforts should be made to activate research that can prove the safety and effectiveness of medical technology, and to create a quantitative or qualitative basis for the results of the research. Also, it is necessary to increase researchers' awareness of New Health Technology. And the strategy to positively utilize the "Limited Approval" to promote clinical studies.