• Journal of Information Technology Services
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• v.22 no.4
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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.

• The Journal of Bigdata
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• v.8 no.1
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• pp.111-129
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• 2023

With the diffusion of digital innovation, the adoption of innovative medical technologies based on artificial intelligence is increasing in the medical field. This is driving the launch and adoption of AI-based SaMD(Software as a Medical Device), but there is a lack of research on the factors that influence the adoption of SaMD by medical institutions. The purpose of this study is to identify key factors that influence medical institutions' decisions to adopt AI-based SaMDs, and to analyze the weights and priorities of these factors. For this purpose, we conducted Delphi surveys based on the results of literature studies on technology acceptance models in healthcare industry, medical AI and SaMD, and developed a research model by combining HOTE(Human, Organization, Technology and Environment) framework and HABIO(Holistic Approach {Business, Information, Organizational}) framework. Based on the research model with 5 main criteria and 22 sub-criteria, we conducted an AHP(Analytical Hierarchy Process) analysis among the experts from domestic medical institutions and SaMD providers to empirically analyze SaMD adoption factors. The results of this study showed that the priority of the main criteria for determining the adoption of AI-based SaMD was in the order of technical factors, economic factors, human factors, organizational factors, and environmental factors. The priority of sub-criteria was in the order of reliability, cost reduction, medical staff's acceptance, safety, top management's support, security, and licensing & regulatory levels. Specifically, technical factors such as reliability, safety, and security were found to be the most important factors for SaMD adoption. In addition, the comparisons and analyses of the weights and priorities of each group showed that the weights and priorities of SaMD adoption factors varied by type of institution, type of medical institution, and type of job in the medical institution.

• Journal of Biomedical Engineering Research
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• v.42 no.6
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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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• v.14 no.11
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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.

• Journal of Biomedical Engineering Research
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• v.44 no.6
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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.

• Journal of the Korea Society of Computer and Information
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• v.19 no.10
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• pp.81-89
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• 2014

In this paper, we propose SA hash algorithm to avoid upload identical files and design server system using proposed SA hash algorithm. Client to want to upload file examines the value of SA hash and if the same file is found in server system client use the existing file without upload. SA hash algorithm which is able to examine the identical-file divides original file into blocks of n bits. Original file's mod i bit and output hash value's i bit is calculated with XOR operation. It is SA hash algorithm's main routine to repeat the calculation with XOR until the end of original file. Using SA hash algorithm which is more efficient than MD5, SHA-1 and SHA-2, we can design server system to avoid uploading identical file and save storage capacity and upload-time of server system.

• The Journal of Korean Physical Therapy
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• v.24 no.6
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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.

• Journal of the Korean Society of Physical Medicine
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• v.10 no.2
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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.

• Korean Journal of Veterinary Research
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• v.32 no.3
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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.

• Journal of Biomedical Engineering Research
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• v.44 no.4
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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.