• Annual Conference of KIPS
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• 2019.05a
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• pp.375-378
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• 2019

최근 딥러닝과 머신러닝 기법이 소프트웨어의 성능 향상에 도움이 되는 것이 입증됨에 따라, 의료 영상 진단 보조 소프트웨어를 개발하기 위한 시도가 활발해 지고 있다. 그 중 캡슐내시경은 소장 소화기관을 관찰할 수 있는 초소형 의료기기로, 기존의 내시경 검사와 다르게 이물감이 느껴지지 않고 의료보험 적용으로 최근 들어 널리 이용되고 있다. 일반적으로 캡슐 내시경은 8 시간 동안 소화기간을 촬영하며, 한 번의 검사 결과로 생성된 동영상 데이터 셋은 수 만장의 이미지를 포함하기 때문에, 방대한 양의 이미지들을 효율적으로 관리하기 위한 체계가 필요하다. 특히, 방대한 양의 캡슐내시경 이미지를 학습하는 경우, 수 만장의 이미지 속에서 유의미한 특징(촬영정보, 의사소견, 환자정보, 병변의 위치 및 크기 등)을 추출해내야 하므로 학습 데이터 레이블링을 위한 정보를 정확히 추출해야 하는 작업이 요구된다. 따라서 본 논문에서는 캡슐내시경 영상을 학습할 때, 학습 데이터 레이블 정보를 체계적으로 구축할 수 있게 하는 레이블 정보 추출 기법을 제안하고자 한다. 제안하는 기법은 병원에서 14년간 수집된 총 340명의 캡슐내시경 데이터(약 1,700 만장의 이미지)를 토대로 영상데이터를 구조적으로 분석하여 유의미한 정보를 추출하고 노이즈 데이터를 제거한 뒤, 빅데이터 저장소에 적재할 수 있음을 보였다.

• Journal of Applied Reliability
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• v.16 no.3
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• pp.216-223
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• 2016

Purpose: This paper suggests the procedure to enhance the reliability of the software of the medical device that is to cure, treat, diagnose, and prevent a disease or an abnormal health conditions. Methods: After test requirements are classified by the software requirements specification for safety and backgrounds, reliability assessment methods are suggested. Results: Verification and validation for function and safety can be performed whether the medical device software are implemented as intended. Conclusion: Procedure on the static analysis, unit test, integration test, and system test are provided for the medical device software.

• 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.

• KIPS Transactions on Computer and Communication Systems
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• v.12 no.9
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• pp.283-290
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• 2023

With the recent steady development of IoT technology, it is widely used in medical systems and smart TV watches. 66% of software development is developed through language C, which is vulnerable to memory attacks, and acts as a threat to IoT devices using language C. A stack-smashing overflow attack inserts a value larger than the user-defined buffer size, overwriting the area where the return address is stored, preventing the program from operating normally. IoT devices with low memory capacity are vulnerable to stack smashing overflow attacks. In addition, if the existing vaccine program is applied as it is, the IoT device will not operate normally. In order to defend against stack smashing overflow attacks on IoT devices, we used canaries among several detection methods to set conditions with random values, checksum, and DSLR (random storage locations), respectively. Two canaries were placed within the buffer, one in front of the return address, which is the end of the buffer, and the other was stored in a random location in-buffer. This makes it difficult for an attacker to guess the location of a canary stored in a fixed location by storing the canary in a random location because it is easy for an attacker to predict its location. After executing the detection program, after a stack smashing overflow attack occurs, if each condition is satisfied, the program is terminated. The set conditions were combined to create a number of eight cases and tested. Through this, it was found that it is more efficient to use a detection method using DSLR than a detection method using multiple conditions for IoT devices.

• 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.

• Proceedings of the Korean Society of Computer Information Conference
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• 2022.07a
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• pp.223-224
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• 2022

본 논문에서는 축형 척추관절염으로 발전할 수 있는 천장관절염 환자들을 진단하기 위해 장골의 관심영역을 자동 생성할 수 있는 세그멘테이션 방법을 제안한다. 다양한 MRI 기기로부터 얻은 천장관절염 환자의 영상에서 장골의 GT(Ground Truth)를 생성하였으며, 대장 용종 검출을 위한 세그멘테이션 모델인 PraNet과 지역 특징 간의 표현 능력을 활용할 수 있는 Position Attention Module을 사용하여 유의미한 성능 향상을 보여주었다.

• Journal of Biomedical Engineering Research
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• v.44 no.6
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• pp.363-376
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• 2023

According to the COVID-19, development of various medical software based on IoT(Internet of Things) was accelerated. Especially, interest in a central software system that can remotely monitor and control ventilators is increasing to solve problems related to the continuous increase in severe COVID-19 patients. Since medical device software is closely related to human life, this study aims to develop central monitoring system that can remotely monitor and control multiple ventilators in compliance with medical device software development standards and to verify performance of system. In addition, to ensure the safety and reliability of this central monitoring system, this study also specifies risk management requirements that can identify hazardous situations and evaluate potential hazards and confirms the implementation of cybersecurity to protect against potential cyber threats, which can have serious consequences for patient safety. As a result, we obtained medical device software manufacturing certificates from MFDS(Ministry of Food and Drug Safety) through technical documents about performance verification, risk management and cybersecurity application.The purpose of this study is to conduct a usability assessment to ensure that ergonomic design has been applied so that the ventilator central monitoring system can improve user satisfaction, efficiency, and safety. The rapid spread of COVID-19, which began in 2019, caused significant damage global medical system. In this situation, the need for a system to monitor multiple patients with ventilators was highlighted as a solution for various problems. Since medical device software is closely related to human life, ensuring their safety and satisfaction is important before their actual deployment in the field. In this study, a total of 21 participants consisting of respiratory staffs conducted usability test according to the use scenarios in the simulated use environment. Nine use scenarios were conducted to derive an average task success rate and opinions on user interface were collected through five-point Likert scale satisfaction evaluation and questionnaire. Participants conducted a total of nine use scenario tasks with an average success rate of 93% and five-point Likert scale satisfaction survey showed a high satisfaction result of 4.7 points on average. Users evaluated that the device would be useful for effectively managing multiple patients with ventilators. However, improvements are required for interfaces associated with task that do not exceed the threshold for task success rate. In addition, even medical devices with sufficient safety and efficiency cannot guarantee absolute safety, so it is suggested to continuously evaluate user feedback even after introducing them to the actual site.

• The Korean Society of Law and Medicine
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• v.23 no.1
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• pp.81-119
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• 2022

Medical device market is strongly related with health care market. Public regulation in medical device market tends to be more lenient than health care market. In this market, competition law, administrative law and intellectual property law are intertwined, and thereby a variety of legal issues could be developed. Recently, dominant undertaking's abuse case was dealt with KFTC(Korea Fair Trade Commission) and Seoul High Court. The issues were whether dominant undertaking discriminated trading partners and this discrimination was anticompetitive. In this case, Seoul High Court revoked the KFTC's decision, holding that the undertaking did not harm competition, though it has dominant power in the relevant medical device market. This decision would be a meaningful precedent, not only that there have been small numbers of dominance abuse cases in Korea, but also that this case happened in medical device market. This case dealt with various issues like market definition, market power, alleged abuse and its anticompetitive effect. The court held that medical device markets are distinguished from medical device repairing market. However, the court did not clarify that medical device repairing market is a single branded market only for repairing the plaintiff's medical devices. Second, plaintiff's dominance is based on the lock-in effect, which means that hospitals could not switch devices like CT or MRI from plaintiff to other competitors. This could be supplemented from the fact that medical devices are expensive and the using period are significantly long. However market definition based on single branded market theory could be applied in rare and exceptional cases. Therefore the general application of single branded market theory might result in overestimate of market power. This type of abuse pattern requires improper condition contrary to resonable trade practice. KFTC asserted free charge for plaintiff's copy right. However, it is not clear whether the cases for free charge are general or not. Even if so, the intention and motive of providers for free charge should be proved. The main issue of anticompetitive effect was whether plaintiff raised rival's cost. Competitor's cost was increased due to plaintiff's copy right and its license fee. However the charge for license could be within the scope of fair and legal exercise of copy right. If competitors are excluded due to legal exercise of copy right or efficiency, the exclusionary abuse could not be proved.

• Journal of Internet Computing and Services
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• v.16 no.1
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• pp.47-55
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• 2015

Recently, the environment of a hospital information system is a trend to combine various SMART technologies. Accordingly, various smart devices, such as a smart phone, Tablet PC is utilized in the medical information system. Also, these environments consist of various applications executing on heterogeneous sensors, devices, systems and networks. In these hospital information system environment, applying a security service by traditional access control method cause a problems. Most of the existing security system uses the access control list structure. It is only permitted access defined by an access control matrix such as client name, service object method name. The major problem with the static approach cannot quickly adapt to changed situations. Hence, we needs to new security mechanisms which provides more flexible and can be easily adapted to various environments with very different security requirements. In addition, for addressing the changing of service medical treatment of the patient, the researching is needed. In this paper, we suggest a dynamic approach to medical information systems in smart mobile environments. We focus on how to access medical information systems according to dynamic access control methods based on the existence of the hospital's information system environments. The physical environments consist of a mobile x-ray imaging devices, dedicated mobile/general smart devices, PACS, EMR server and authorization server. The software environment was developed based on the .Net Framework for synchronization and monitoring services based on mobile X-ray imaging equipment Windows7 OS. And dedicated a smart device application, we implemented a dynamic access services through JSP and Java SDK is based on the Android OS. PACS and mobile X-ray image devices in hospital, medical information between the dedicated smart devices are based on the DICOM medical image standard information. In addition, EMR information is based on H7. In order to providing dynamic access control service, we classify the context of the patients according to conditions of bio-information such as oxygen saturation, heart rate, BP and body temperature etc. It shows event trace diagrams which divided into two parts like general situation, emergency situation. And, we designed the dynamic approach of the medical care information by authentication method. The authentication Information are contained ID/PWD, the roles, position and working hours, emergency certification codes for emergency patients. General situations of dynamic access control method may have access to medical information by the value of the authentication information. In the case of an emergency, was to have access to medical information by an emergency code, without the authentication information. And, we constructed the medical information integration database scheme that is consist medical information, patient, medical staff and medical image information according to medical information standards.y Finally, we show the usefulness of the dynamic access application service based on the smart devices for execution results of the proposed system according to patient contexts such as general and emergency situation. Especially, the proposed systems are providing effective medical information services with smart devices in emergency situation by dynamic access control methods. As results, we expect the proposed systems to be useful for u-hospital information systems and services.

• Proceedings of the Korean Institute of Information and Commucation Sciences Conference
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• 2021.05a
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• pp.323-325
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• 2021

With the recent revitalization of virtual reality and game industries, digital therapeutics for medical purposes are emerging. Digital therapeutics refer to sports-based therapeutics such as virtual reality contents and games that are effective in preventing, managing, and treating diseases, not drugs. Through this study, we plan and develop contents for healing and brain enhancement using virtual reality technology as a therapeutic digital therapy. Through this, it can help to improve the brain of children who are dependent on electronic devices in the digital age and rarely use their brains.