• Journal of the Korean Medical Association
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• v.61 no.12
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• pp.765-775
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• 2018

With growing interest in novel digital healthcare devices, such as artificial intelligence (AI) software for medical diagnosis and prediction, and their potential impacts on healthcare, discussions have taken place regarding the regulatory approval, coverage, and clinical implementation of these devices. Despite their potential, 'digital exceptionalism' (i.e., skipping the rigorous clinical validation of such digital tools) is creating significant concerns for patients and healthcare stakeholders. This white paper presents the positions of the Korean Society of Radiology, a leader in medical imaging and digital medicine, on the clinical validation, regulatory approval, coverage decisions, and clinical implementation of novel digital healthcare devices, especially AI software for medical diagnosis and prediction, and explains the scientific principles underlying those positions. Mere regulatory approval by the Food and Drug Administration of Korea, the United States, or other countries should be distinguished from coverage decisions and widespread clinical implementation, as regulatory approval only indicates that a digital tool is allowed for use in patients, not that the device is beneficial or recommended for patient care. Coverage or widespread clinical adoption of AI software tools should require a thorough clinical validation of safety, high accuracy proven by robust external validation, documented benefits for patient outcomes, and cost-effectiveness. The Korean Society of Radiology puts patients first when considering novel digital healthcare tools, and as an impartial professional organization that follows scientific principles and evidence, strives to provide correct information to the public, make reasonable policy suggestions, and build collaborative partnerships with industry and government for the good of our patients.

• Journal of Internet Computing and Services
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• v.22 no.6
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• pp.59-69
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• 2021

Malfunctions and failures linked to medical devices may result in significant damage for human being. Thus, in order to ensure that safety of medical device is achieved, it should be established and applied the international standard. It is required to integrate and customize activities at standards, owing to reference relationship between standards, especially, activities based safety analysis is too expensive. This paper proposes a integration process that integrate activities of development lifecycle and safety process. Additionally, we derived a guidance based on STPA for integration process. As a result, we can be performed systematically from early stage of the development and increased effectiveness of integration process by the guidance.

• Korean Journal of Radiology
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• v.22 no.3
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• pp.442-453
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• 2021

Artificial intelligence (AI) will likely affect various fields of medicine. This article aims to explain the fundamental principles of clinical validation, device approval, and insurance coverage decisions of AI algorithms for medical diagnosis and prediction. Discrimination accuracy of AI algorithms is often evaluated with the Dice similarity coefficient, sensitivity, specificity, and traditional or free-response receiver operating characteristic curves. Calibration accuracy should also be assessed, especially for algorithms that provide probabilities to users. As current AI algorithms have limited generalizability to real-world practice, clinical validation of AI should put it to proper external testing and assisting roles. External testing could adopt diagnostic case-control or diagnostic cohort designs. A diagnostic case-control study evaluates the technical validity/accuracy of AI while the latter tests the clinical validity/accuracy of AI in samples representing target patients in real-world clinical scenarios. Ultimate clinical validation of AI requires evaluations of its impact on patient outcomes, referred to as clinical utility, and for which randomized clinical trials are ideal. Device approval of AI is typically granted with proof of technical validity/accuracy and thus does not intend to directly indicate if AI is beneficial for patient care or if it improves patient outcomes. Neither can it categorically address the issue of limited generalizability of AI. After achieving device approval, it is up to medical professionals to determine if the approved AI algorithms are beneficial for real-world patient care. Insurance coverage decisions generally require a demonstration of clinical utility that the use of AI has improved patient outcomes.

• Journal of Digital Convergence
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• v.14 no.11
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• pp.283-288
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• 2016

This research is to study IoT based implementation of system and network for medical information processing. This paper's configuration environment consists of sensor node, gateway and server node as a basic IoT architecture. Medical terminal as a sensor node asks connect request to his server, and the server accepts the request if the medical device is already registered. Wearable medical device sends its collected sensing data to server, and server processes the received data for data visualization or saves them for usage in the future. This paper describes overall processes and their algorithms and suggests their software processing architecture.

• Korean Journal of Clinical Pharmacy
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• v.19 no.1
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• pp.65-68
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• 2009

Disposal infusion device is known to be useful for chemotherapy. Anti-cancer drug can be released by the force of carbon dioxide or balloon. In this study, we compared the$Anapa^{(R)}$ (LC0020) with B Company (LV2 ml) in terms of infusion rate and stability. Infusion rate was determined every six minute using software, MSI08IH. Stability of 5-fluorouracil was examined periodically using a High Performance Liquid Chromatography. Infusion rates of gas-derived $Anapa^{(R)}$ device were 2.29, 1.86, 1.98 ml/hr and those of balloon-derived B Company device were 1.71, 1.58, 1.37 ml/min. There were no significant differences in stability of 5-fluorouracil between $Anapa^{(R)}$ and B Company devices. In summary, gas-derived $Anapa^{(R)}$ device is thought to be comparable or superior to balloon-derived B Company device as far as infusion rate and stability are concerned. We expect that $Anapa^{(R)}$ as a home infusion device can be employed to improve a quality of life and compliance of cancer patients.

• Journal of Internet Computing and Services
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• v.19 no.6
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• pp.31-40
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• 2018

With the development of IT technology recently, medical information systems are being constructed in an integrated u-health environment through cloud services, IoT technologies, and mobile applications. These kinds of medical information systems should provide the medical staff with authorities to access patients' medical information for emergency status treatments or therapeutic purposes. Therefore, in the medical information systems, the reliable and prompt authentication processes are necessary to access the biometric information and the medical information of the patients in charge of the medical staff. However, medical information systems are accessing with simple and static user authentication mechanism using only medical ID / PWD in the present system environment. For this reason, in this paper, we suggest a dynamic situation authentication mechanism that provides transparency of medical information access including various authentication factors considering patient's emergency status condition and dynamic situation authentication system supporting it. Our dynamic Situation Authentication is a combination of user authentication and mobile device authentication, which includes various authentication factor attributes such as emergency status, role of medical staff, their working hours, and their working positions and so forth. We designed and implemented a dynamic situation authentication system including emergency status decision, dynamic situation authentication, and authentication support DB construction. Finally, in order to verify the serviceability of the suggested dynamic situation authentication system, the medical staffs download the mobile application from the medical information server to the medical staff's own mobile device together with the dynamic situation authentication process and the permission to access medical information to the patient and showed access to medical information.

• Journal of radiological science and technology
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• v.38 no.4
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• pp.389-394
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• 2015

There is a progressive development in the medical imaging technology, especially of descriptive capability for anatomical structure of human body thanks to advancement of information technology and medical devices. But however maintenance of correct posture is essential for the medical imaging checkup on the shoulder joint requiring rotation of the upper limb due to the complexity of human body. In the cases of MRI examination, long duration and fixed posture are critical, as failure to comply with them leads to minimal possibility of reproducibility only with the efforts of the examiner and will of the patient. Thus, this study aimed to develop an auxiliary device that enables rotation of the upper limb as well as fixing it at quantitative angles for medical imaging examination capable of providing diagnostic values. An auxiliary device has been developed based on the results of precedent studies, by designing a 3D model with the CATIA software, an engineering application, and producing it with the 3D printer. The printer is Objet350 Connex from Stratasys, and acrylonitrile- butadiene-styrene(ABS) is used as the material of the device. Dimensions are $120{\times}150{\times}190mm$, with the inner diameter of the handle being 125.9 mm. The auxiliary device has 4 components including the body (outside), handle (inside), fixture terminal and the connection part. The body and handle have the gap of 2.1 mm for smooth rotation, while the 360 degree of scales have been etched on the handle so that the angle required for observation may be recorded per patient for traceability and dual examination.

• Proceedings of the Korean Institute of Information and Commucation Sciences Conference
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• 2001.05a
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• pp.520-523
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• 2001

In this paper, a system that transmits ECG signals which get from hand baggage ECG is implemented by using Bluetooth technology. Bluetooth technology is a close range wireless communication used wireless frequency 2.4GHZ bandwidth. This technology consumes very small power and provides high reliability also self error correction with high speed frequency hopping. Because every device which uses Bluetooth protocol can communicate each other. These can connect between the system implemented and any devices such as mobile telephone with Bluetooth module, notebook, and the personal mobile device. Also, the paper proposes capability of transmission to the sever of hospital through each type of wireless communication device that acquired medical information signals in mobile medical machine. The system consists of hardware parts with Bluetooth module and host part, and software parts with bluetooth protocol stacks. The host precesses a connection with other device and transmits ECG signals with bluetooth frequency hopping sequence.

• Journal of the Korea Institute of Information and Communication Engineering
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• v.5 no.2
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• pp.297-301
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• 2001

In this paper, a system that transmits ECG signals which get from hand baggage ECG is implemented by using Bluetooth technology. Bluetooth technology is a close range wireless communication used wireless frequency 2.4GHz bandwidth. This technology consumes very small power and provides high reliability also self error correction with high speed frequency hopping. Because every device which uses Bluetooth protocol can communicate each other. These can connect between the system implemented and any devices such as mobile telephone with Bluetooth module, notebook, and the personal mobile device. Also, the paper proposes capability of transmission to the sever of hospital through each type of wireless communication device that acquired medical information signals in mobile medical machine. The system consists of hardware parts with Bluetooth module and host part, and software parts with blutooth protocol stacks. The host precesses a connection with other device and transmits ECG signals with bluetooth frequency hopping sequence.

• The Journal of Korean Obstetrics and Gynecology
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• v.29 no.3
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• pp.23-34
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• 2016

Objectives: The purpose of this study was to survey the status of clinical use of a pulse tonometric device (PTD).Methods: We searched domestic and international articles using the PTD from online medical databases including OASIS, RISS, DBpia and PubMed. We selected articles on clinical application of PTD but excluded articles on mechanical design or software programming for developing a new PTD. Finally we found 13 articles and classified the articles according to the disease of clinical study.Results: Out of the 13 articles, 5 were focused on the dysmenorrhea. Three articles were focused on the infertility, two article were focused on the post mastectomy. According to the results, the pulse energy has been widely used in research as the primary outcome.Conclusions: We found out that until now the researches on clinical application of PTD mainly had been performed for producing a variety of PTDs. This results of this study will be used as a useful information during perform a clinical study and clinics. We suggest that the standard operating procedure for PTD will be developed, and researches for development and its application of various new contents will be performed.