• 한국IT서비스학회지
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• 제22권4호
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• pp.21-35
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• 2023

Software as Medical Devices (SaMD) is a growing category of medical devices that are composed of software to perform one or more medical purposes. SaMD is less likely to cause physical harm compared to conventional medical devices, particularly medical electrical equipments, and may be more vulnerable to privacy issues. This difference was acknowledged and resulted in introducing new regulation guidance specifically for cybersecurity of SaMD. It guides stakeholders of SaMD what to consider in what context in terms of cybersecurity. This study examines the current guidance of how cybersecurity is considered for SaMD by analyzing current medical device standards, then suggest which concept or details beyond current medical device standards may be applicable through analysis of international standards documents published for software in general.

• 한국빅데이터학회지
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• 제8권1호
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• pp.111-129
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• 2023

디지털 혁신의 확산에 따라 의료 분야에서도 인공지능을 기반으로 한 혁신의료기술의 채택이 활발해지고 있다. 이에 따라 인공지능 기반 소프트웨어형 의료기기인 SaMD(Software as a Medical Device)의 출시 및 도입도 촉진되고 있지만, 의료기관의 SaMD 도입 요인에 대한 연구는 미흡한 편이다. 본 연구의 목적은 '인공지능 기반 SaMD' 도입에 대한 의료기관의 의사결정에 영향을 미치는 중요한 요인들을 찾고, 이들 요인의 가중치와 우선순위를 분석하는 것이다. 이를 위해 의료계의 기술수용 모델, 의료 인공지능 및 SaMD 등에 관한 문헌연구 결과를 바탕으로 델파이 조사를 실시하였으며, HOTE(Human, Organization, Technology and Environment) 프레임워크와 HABIO(Holistic Approach {Business, Information, Organizational}) 프레임워크를 결합하여 연구 모형을 개발하였다. 5가지 주기준과 22개의 하부기준으로 구성된 연구 모형을 바탕으로 국내 의료기관과 SaMD 공급자의 전문가들을 대상으로 AHP(Analytic Hierarchy Process) 분석을 실시하여 SaMD 도입 요인을 실증적으로 분석하였다. 본 연구의 결과, 인공지능 기반의 SaMD 도입을 결정하는 주기준의 우선순위는 기술적 요인, 경제적 요인, 인적 요인, 조직적 요인, 환경적 요인의 순으로 나타났고, 하부기준의 우선순위는 신뢰성, 진료원가 절감, 의료진의 수용도, 안전성, 최고 경영자의 지원, 보안성, 인허가 및 규제 수준의 순이었다. 특히, 신뢰성, 안전성, 보안성 등의 기술적 요인이 SaMD 도입에 있어서 가장 중요한 것으로 나타났다. 또한, 각 집단별 가중치와 우선순위를 비교·분석한 결과, SaMD 도입 요인의 가중치와 우선순위는 기관의 유형, 의료기관의 유형 및 의료기관 보직의 유형에 따라 매우 다른 것으로 나타났다.

• 대한의용생체공학회:의공학회지
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• 제42권6호
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• pp.277-286
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• 2021

The global market size of AI based SaMD for medical image in 2023 will be anticipated to reach around 620 billion won (518 million dollars). In order for Korean manufacturers to efficiently obtain CE marking for marketing in the EU countries, the paper is to introduce the recommendation and suggestion of how to reclassify SaMD based on classification rules of MDR because, after introducing the Regulation EU 2017/745, classification rules are quite modified and newly added compared to the Directive 93/42/EEC. In addition, the paper is to provide several rules of MDR that may be applicable to decide the classification of SaMD. Lastly, the paper is to examine and demonstrate various secondary data supported by qualitative data because the paper focuses on the suggestion and recommendation with a public trust on the basis of various secondary data conducted by the analysis of field data. In conclusion, the paper found that the previous classification of SaMD followed by the rule of MDD should be reclassified based on the Regulation EU 2017/745. Therefore, the suggestion and recommendation are useful for Korean manufacturers to comprehend the classification of SaMD for marketing in the EU countries.

• KSII Transactions on Internet and Information Systems (TIIS)
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• 제14권11호
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• pp.4372-4394
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• 2020

The distribution of popular videos incurs a large amount of traffic at the base stations (BS) of networks. Device-to-multi-device (D2MD) communication has emerged an efficient radio access technology for offloading BS traffic in recent years. However, traditional studies have focused on synchronous user requests whereas asynchronous user requests are more common. Hence, offloading BS traffic in case of asynchronous user requests while considering their time-varying characteristics and the quality of experience (QoE) of video request users (VRUs) is a pressing problem. This paper uses social stability (SS) and video loading duration (VLD)-tolerant property to group VRUs and seed users (SUs) to offload BS traffic. We define the average amount of data transmission (AADT) to measure the network's capacity for offloading BS traffic. Based on this, we formulate a time-varying bipartite graph matching optimization problem. We decouple the problem into two subproblems which can be solved separately in terms of time and space. Then, we propose the socially aware D2MD user selection (SA-D2MD-S) algorithm based on finite horizon optimal stopping theory, and propose the SA-D2MD user matching (SA-D2MD-M) algorithm to solve the two subproblems. The results of simulations show that our algorithms outperform prevalent algorithms.

• 대한의용생체공학회:의공학회지
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• 제44권6호
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• pp.428-442
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• 2023

In this study, we have a goal to develop usability evaluation guidelines for heuristic-based artificial intelligence-based Software as a Medical Device (SaMD) in the medical field. We conducted a gap analysis between medical hardware (H/W) and non-medical software (S/W) based on ten heuristic principles. Through severity assessments, we identified 69 evaluation domains and 112 evaluation criteria aligned with the ten heuristic principles. Subsequently, we categorized each evaluation domain into five types, including user safety, data integrity, regulatory compliance, patient therapeutic effectiveness, and user convenience. We proposed usability evaluation guidelines that apply the newly derived heuristic-based Software as a Medical Device (SaMD) evaluation factors to the risk management process. In the discussion, we also have proposed the potential applications of the research findings and directions for future research. We have emphasized the importance of the judicious application of AI technology in the medical field and the evaluation of usability evaluation and offered valuable guidelines for various stakeholders, including medical device manufacturers, healthcare professionals, and regulatory authorities.

• 한국컴퓨터정보학회논문지
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• 제19권10호
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• pp.81-89
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• 2014

본 논문에서는 서버로의 중복파일을 업로드 방지를 위하여 SA 해쉬 알고리즘을 제안하고 이를 이용하여 서버 시스템을 설계한다. SA 해쉬 값으로 동일한 파일이 서버에 있는 지 검사하고 존재한다면 클라이언트에게 업로드를 받지 않고 기존 파일을 이용하는 방법으로 효율적인 시스템 설계를 할 수 있게 되는 것이다. 중복파일 검사를 할 수 있는 SA 해쉬 알고리즘은 출력하고자 하는 비트 수 n을 한 블록으로 하고 원본 파일을 블록 단위로 나누게 된다. 원본 파일의 mod i 비트와 출력 해쉬 값의 i 비트를 XOR 연산을 하게 된다. 이렇게 반복적으로 원본 파일 길이까지 XOR연산을 하는 것이 SA 해쉬 알고리즘의 메인 루틴이다. 기존 해쉬 함수인 MD5, SHA-1, SHA-2보다 중복파일 업로드 방지 서버 시스템에 적합한 해쉬 함수인 SA 해쉬 알고리즘을 통해 시간 및 서버 스토리지 용량의 절약을 도모할 수 있다.

• The Journal of Korean Physical Therapy
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• 제24권6호
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• pp.388-392
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• 2012

Purpose: Muscle imbalance between upper trapezius (UT) and serratus anterior (SA) during arm elevation is a factor causing shoulder dysfunction. However, there is no study to compare the muscle activities of the UT and middle deltoid (MD). The purpose of this study was to compare the muscle activities of the UT and MD between with and without elevation of shoulder girdle (ESG) during shoulder abduction. Methods: The subjects without (control group=9) or with (ESG group=8) participated in this study. The muscle activities of the UT and MD were measured using a electromyography during $90^{\circ}$ shoulder abducted position in both group. The data in middle of 3-second of the 5-second periods were used. The mean value of three trials was used in the data analysis. For each muscle, independent t-tests were performed to compare for group differences. Results: The muscle activity of UT was significantly greater in ESG group, compared to that of the control group (p<0.05). The muscle activity of MD was significantly smaller in ESG group, compared to that of the control group (p<0.05). Conclusion: These findings showed that low muscle activation of MD as well as SA may contribute to hyperactivity of UT during arm elevation.

• 대한물리의학회지
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• 제10권2호
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• pp.9-16
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• 2015

PURPOSE: The objective of this study was to identify the effects of shoulder abduction strength and EMG activities of the selected scapular and shoulder muscles during isometric shoulder abduction. METHODS: Thirty-four healthy young females were recruited for this study. Surface EMG equipment with inline force sensor was used to determine the shoulder abductor strength and the activity of the serratus anterior (SA), upper trapezius (UT), lower trapezius (LT), and middle deltoid (MD) during three shoe heel height conditions: (1) barefoot, (2) 3-cm shoe heel height, and (3) 7-cm shoe heel height. RESULTS: Isometric shoulder strength showed statistically significant difference among the conditions (p<0.05), and post-hoc test showed lower strength during the 7-cm condition ($49.98{\pm}17.56kg$) than during the barefoot ($44.97{\pm}20.15kg$) and 3-cm conditions ($36.59{\pm}17.07kg$). Furthermore, EMG activities of the SA, UT, and MD appeared to be statistically significantly different among the conditions, with lower values in the 7-cm condition compared to the barefoot condition (p<0.05). EMG ratios (MD/UT and SA/UT) were lower during the 7-cm condition than during the barefoot condition (p<0.05). CONCLUSION: These findings suggest that isometric shoulder abduction strength and EMG activities of scapular and shoulder muscles may be adversely changed with increasing shoe heel height.

• 대한수의학회지
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• 제32권3호
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• pp.369-376
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• 1992

This paper dealt with plasmid DNA profile in 98 Salmonella(S) isolated from pigs and cattle sources in Taegu, Gyeongbook and Gyeongnam during the period from 1984 to 1987. Also we were studied for restriction enzyme analysis of the plasmid DNA, and mouse infection, Sereny test and normal setum resistance test in guinea pig for S typhimurium and S enteritidis harbored or cured 60 megadalton(Md) plasmid and 36 Md plasmid, respectively. Of the 13 Salmonella isolated from cattle, 7 Salmonella harbored one or more plasmids and molecular sizes of the large plasmids were 60 Md for S typhimurium and 36 Md for S enteritidis. Of the 85 Salmonella isolated from pigs, 47 Salmonella were confirmed as being one or more plasmids, and all the S typimurium stains harbored 60 Md plasmid. In enzyme digestion with 8 types of restriction endonuclease for 60 Md plasmid DNA of S typhimurium, cleavage patterns were varied to enzymes, and the DNA was segmented into 4 to 15 fragments. In restriction enzyme analysis of 36 Md plasmid DNA obtained from four strains of S. enteritidis, the DNA showed the same cleavage patterns obtained with Eco RI, Hind III and Bam H I, and was segmented into 3 to 5 fragments. In virulence for mice by measuring the 50% lethal dose ($LD_{50}$), the $LD_{50}$ values obtained for 60 Md virulence-associated plasmid harbored strains of S typhimurium and 36 Md virulence-associated plasmid of S enteritidis were up to $10^4$-fold lower than the values obtained for the plasmid-cured strains of the same serotype. Only the plasmid harbored strains were resistant to the bactericidal activity of 90% guinea pig serum, and only they gave positive responses in sereny test. We suggested that their plasmid DNA might be associated with virulence for mice.

• 대한의용생체공학회:의공학회지
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• 제44권4호
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• pp.264-274
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• 2023

Purpose: The objective is to extract insights that can contribute to the formulation of harmonized international policies and support measures for innovative medical devices and management systems. This study aims to propose effective strategies for future medical device innovation and healthcare delivery. Results: It investigates technological advancements, regulatory approval systems, insurance policies, and successful commercialization cases in South Korea, the United States, and the European Union. In 2018, the FDA implemented insurance coverage for Software as a Medical Device (SaMD) and recognized insurance coverage for Digital Therapeutics (DTx). Germany is a country that ensures permanent reimbursement for healthcare applications since 2020, making it the first country to provide legal health insurance coverage for fostering a digital ecosystem. Conclusion: The findings of this research highlight the importance of cultivating a supportive regulatory and environmental framework to facilitate the adoption of innovative medical devices. Continuous support for research and development (R&D) efforts by companies, along with the validation of clinical effectiveness, is crucial.