• Journal of Biomedical Engineering Research
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• v.44 no.1
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• pp.73-79
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• 2023

The purpose of this study is to derive medical devices with different management systems through comparison of domestic and overseas medical device product classification systems and to propose management conversion measures for the products. The definitions of medical devices were compared and the scope of medical devices defined by each country was confirmed through surveys of the Medical Device Act, Federal Food, Drug & Cosmetics Act (FD&C) in the U.S., and Medical Device Regulations (MDR) in Europe. Using the Ministry of Food and Drug Safety's regulations on medical device products and grades, 21 CFR part 860-892 and product code classification files in U.S., and EMDN in Europe as basic data to compare medical device products and derive medical devices with different management systems. As a result of comparing the definition and product classification systems of medical devices in Korea, the U.S. and Europe, medical device accessories, prosthetic limbs and aids among assistive devices for persons with disabilities, drugs, quasi-drugs and industrial products that are not managed by medical devices in Korea are managed as medical devices in the U.S. and Europe. This study aims to improve public health by securing systematic product safety management and essential performance under medical device regulations. Management within a single medical device system will increase the efficiency of licensing work of domestic medical device manufacturers and related organizations. It is also expected to help advance the system according to the international harmony of the item classification system and enhance smooth import and export competitiveness.

• Tuberculosis and Respiratory Diseases
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• v.73 no.1
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• pp.48-55
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• 2012

Background: The epidemiology of tuberculosis (TB) has been assessed based on the data of the analysis of TB patients notified to the surveillance system in Korea. However, the national status of TB is not validated through this surveillance system. The objective is to determine the epidemiology of TB and to understand the accurate status of TB patients treated in private institutions. Methods: Medical records of 53,579 patients who had been diagnosed with TB in 2008 were analyzed. Results: Among 53,579 patients, the number of sputum smear positive cases was 15,639(29.2%) and the number of new cases was 39,191 (73.1%). The drug resistance rate of new cases was 5.3%, while the rate stood at 13.3% for TB patients with treatment history. The number of multi-drug resistant TB (MDR-TB) patients was 2,472 (4.6%), which consists of 2.9% of new cases and 9.3% of TB patients with prior treatment history. The number of extensively drug-resistant TB patients was 749 (1.4%), consisting of 1.1% of new cases and 2.2% of TB patients with prior treatment history. In terms of treatment outcomes, 66.4% of all TB patients, 70.5% of new cases, 64.4% of relapse cases, and 46.8% of MDR-TB cases were cured or completed. It was inferred that in 2008, the total number of TB patients reached 70,767, 145.6 per 100,000 people (95% confidence interval, 145.5~145.7). Conclusion: We conclude that the medical records review of the Health Insurance Review and Assessment Service (HIRA) data can be very effective in promoting the understanding of the current status of TB in private institutions.

• Journal of Information Management
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• v.36 no.1
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• pp.57-75
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• 2005

The Industrial Metadata Registry(IMR) for standardizing industrial information metadata was implemented and four drafts of metadata sets were developed based on the ISO/IEC 11179. The IMR consists of four individual metadata registries characterized by subject category. Accordingly, the system includes the integrated administration module, and the divisions administration module. The users of the system are divided into committee members and general users. The system has been developed with Oracle 9i and Java JSP over Linux operating system. The system will support the procedure for data sharing and exchanging among users and organizations and improve the availability and manageability of data and provide the standardization of data across the industry.

• The Journal of Korean Institute of Communications and Information Sciences
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• v.30 no.8B
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• pp.549-561
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• 2005

As Internet and network technologies have been developed, e-commerces are getting more complex and more various. This paper, for meta-data and data exchange between heterogeneous database systems, uses XML schema proposed in W3C, and XML schema can present meta-data and data of relational database system as XML document format which is structural. It supports various primitive data formats, so that it uses the structure which reflects adequately data formats which relational database system offered. However, current e-commerces use heterogeneous platforms, so difficulties that is mutual interchange and management exist. For the solution for these problems, a standard ontology which defines relations of product classifications and the standard of property expression and the location ontology which offers e-commerce's information about products are constructed. Applying these ontology information to search system, by offering information which customers need efficient search is performed. Combining these ontologies and product classification category information, called XMDR, this XMDR is introduced into product search system, so this paper proposes to construct ontology server method for efficient search.

• The KIPS Transactions:PartD
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• v.10D no.2
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• pp.233-246
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• 2003

The mediator-based system integrates heterogeneous information systems with the flexible manner. But it does not give much attention on the query optimization issues, especially for the query reusing. The other thing is that it does not use standardized metadata for schema matching. To improve this two issues, we propose mediator-based Distributed Information Integration System (DIIS) which uses query caching regarding performance and uses ISO/IEC 11179 metadata registry in terms of standardization. The DIIS is designed to provide decision-making support, which logically integrates the distributed heterogeneous business information systems based on the Web environment. We designed the system in the aspect of three-layer expression formula architecture using the layered pattern to improve the system reusability and to facilitate the system maintenance. The functionality and flow of core components of three-layer architecture are expressed in terms of process line diagrams and assembly line diagrams of Eriksson Penker Extension Model (EPEM), a methodology of an extension of UML. For the implementation, Supply Chain Management (SCM) domain is used. And we used the Web-based environment for user interface. The DIIS supports functions of query caching and query reusability through Query Function Manager (QFM) and Query Function Repository (QFR) such that it enhances the query processing speed and query reusability by caching the frequently used queries and optimizing the query cost. The DIIS solves the diverse heterogeneity problems by mapping MetaData Registry (MDR) based on ISO/IEC 11179 and Schema Repository (SCR).