• Title/Summary/Keyword: Medical device law

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Development of Age Classification Deep Learning Algorithm Using Korean Speech (한국어 음성을 이용한 연령 분류 딥러닝 알고리즘 기술 개발)

  • So, Soonwon;You, Sung Min;Kim, Joo Young;An, Hyun Jun;Cho, Baek Hwan;Yook, Sunhyun;Kim, In Young
    • Journal of Biomedical Engineering Research
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    • v.39 no.2
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    • pp.63-68
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    • 2018
  • In modern society, speech recognition technology is emerging as an important technology for identification in electronic commerce, forensics, law enforcement, and other systems. In this study, we aim to develop an age classification algorithm for extracting only MFCC(Mel Frequency Cepstral Coefficient) expressing the characteristics of speech in Korean and applying it to deep learning technology. The algorithm for extracting the 13th order MFCC from Korean data and constructing a data set, and using the artificial intelligence algorithm, deep artificial neural network, to classify males in their 20s, 30s, and 50s, and females in their 20s, 40s, and 50s. finally, our model confirmed the classification accuracy of 78.6% and 71.9% for males and females, respectively.

Invasive Brain Stimulation and Legal Regulation: with a special focus on Deep Brain Stimulation (침습적 뇌자극기술과 법적 규제 - 뇌심부자극술(Deep Brain Stimulation)을 중심으로 -)

  • Choi, Min-Young
    • The Korean Society of Law and Medicine
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    • v.23 no.2
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    • pp.119-139
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    • 2022
  • Brain stimulation technology that administers electrical and magnetic stimulation to a brain has shown a significant level of possibility for treating a wide range of various neurological and psychiatric disorders. Depending on its nature, the technology is defined either as invasive or non-invasive, and deep brain stimulation (DBS) is one of the most well-known invasive brain stimulation technologies. Currently categorized as grade 4 medical device in accordance with Guideline On Medical Devices And Their Grades, a Notification of Ministry of Food and Drug Safety (MFDS), the DBS has been used as a stable treatment for several diseases. At the same time, the DBS technology has recently achieved substantial advancement, encouraging active discussions for its use from various perspectives. On the contrary, debates over legal regulation related to the use of DBS has relatively been smaller in numbers. In this context, this article aims to 1) introduce the DBS technology and its safety in setting out the tone; 2) touch upon major legal issues that would potentially rise from its use for four different purposes of treatment, clinical study, areas of non-standard treatment where no other methods are available, and enhancement; and finally 3) highlight disputes concerning common emerging issues observed in the aforementioned four purposes from the viewpoint of legal responsibility and liability of using the DBS, which are benefit-risk assessment, physicians' duty of information, patients' capacity to consent, control for device, and insurance coverage.

Neurotechnologies and civil law issues (뇌신경과학 연구 및 기술에 대한 민사법적 대응)

  • SooJeong Kim
    • The Korean Society of Law and Medicine
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    • v.24 no.2
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    • pp.147-196
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    • 2023
  • Advances in brain science have made it possible to stimulate the brain to treat brain disorder or to connect directly between the neuron activity and an external devices. Non-invasive neurotechnologies already exist, but invasive neurotechnologies can provide more precise stimulation or measure brainwaves more precisely. Nowadays deep brain stimulation (DBS) is recognized as an accepted treatment for Parkinson's disease and essential tremor. In addition DBS has shown a certain positive effect in patients with Alzheimer's disease and depression. Brain-computer interfaces (BCI) are in the clinical stage but help patients in vegetative state can communicate or support rehabilitation for nerve-damaged people. The issue is that the people who need these invasive neurotechnologies are those whose capacity to consent is impaired or who are unable to communicate due to disease or nerve damage, while DBS and BCI operations are highly invasive and require informed consent of patients. Especially in areas where neurotechnology is still in clinical trials, the risks are greater and the benefits are uncertain, so more explanation should be provided to let patients make an informed decision. If the patient is under guardianship, the guardian is able to substitute for the patient's consent, if necessary with the authorization of court. If the patient is not under guardianship and the patient's capacity to consent is impaired or he is unable to express the consent, korean healthcare institution tend to rely on the patient's near relative guardian(de facto guardian) to give consent. But the concept of a de facto guardian is not provided by our civil law system. In the long run, it would be more appropriate to provide that a patient's spouse or next of kin may be authorized to give consent for the patient, if he or she is neither under guardianship nor appointed enduring power of attorney. If the patient was not properly informed of the risks involved in the neurosurgery, he or she may be entitled to compensation of intangible damages. If there is a causal relation between the malpractice and the side effects, the patient may also be able to recover damages for those side effects. In addition, both BCI and DBS involve the implantation of electrodes or microchips in the brain, which are controlled by an external devices. Since implantable medical devices are subject to product liability laws, the patient may be able to sue the manufacturer for damages if the defect caused the adverse effects. Recently, Korea's medical device regulation mandated liability insurance system for implantable medical devices to strengthen consumer protection.

Study on the Improvement of Relevant Legislative System for Activating Research Equipment Industry (연구장비산업 활성화를 위한 관련 법제 개선방안에 대한 연구)

  • Baek, Woonil;Han, Gapun
    • The Journal of Society for e-Business Studies
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    • v.25 no.2
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    • pp.127-146
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    • 2020
  • Overseas advanced countries are aware of the importance of research equipment and are providing a lot of policy support to revitalize the research equipment industry. However, Korea does not have any law to support policies or related projects to revitalize the research equipment industry. Therefore, there is an urgent need for legislation to support policies and projects for revitalizing research equipment industry. It is considered necessary to establish a separate special law for revitalizing the research equipment industry so that it can gain competitiveness in the global market of the research equipment industry. As we have seen, the necessary articles in the relevant laws should be specified so that various promotion policies can be developed to foster the research equipment industry. In order to promote the development of research equipment industry, there are three essential items to be specified in the law. First is research and development support, second is infrastructure development, and third is business incubation. The following contents should be included in each contents. First of all, "research and development support" includes research and envelopment project promotion and support policy items, research equipment development trends and investment trends, joint research between industry, academia, And research and development support for fusion, hybrid and commercialization. Next, the items to be included in "infrastructure development" should include the establishment of research equipment clusters, related support items, training of professional manpower, and research equipment development base area and institutions. Finally, the items that should be included in "business incubation." include support matters for the development of excellent companies (priority purchase system, etc.), matters related to technology transfer and marketing, matters concerning the protection of intellectual property, And matters for promoting overseas expansion.

Study on the Modeling Technique for Prediction about Pressure Drop of an Intravenous Lung Assist Device (혈관 내 폐 보조장치의 압력손실 예측을 위한 모델링기법에 관한 연구)

  • 김기범;권대규;정경락
    • Journal of Biomedical Engineering Research
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    • v.24 no.4
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    • pp.293-299
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    • 2003
  • In this paper, the correlation of Pressure drop about the Newtonian and non-Newtonian fluid was investigated experimentally for vibrating intravascular lung assist device (VIVLAD) and we determined correlation equation to make a prediction about Pressure drop for designing VIVLAD. Design conditions to predict the pressure drop of the modules were studied through an experimental modeling before inserting the artificial lung assist device into as venous. Experiments were performed by distilled water, glycerol/water mixed solution(40% glycerol) of Newtonian fluids. and the bovine blood of non-Newtonian fluids. These fluids were flowed outside and parallel of hollow fiber membranes. Also we measured pressure drop according to the number of the fiber membranes which ware inserted into the inside diameter of shell of 3 cm, and developed the prediction equations by curve fitting method based on correlation between the experimental pressure drop and the frontal area or the packing density of device. The result showed that the Pressure drop and the friction factor of the water/glycerol mixed solution were similar to that of bovine blood. It was showed that the water/glycerol mixed solution (40% glycerol) could be used for measuring the pressure drop and the friction factor instead of the bovine blood. Also, we could estimate the prediction equation of pressure drop and friction factor as the function of Packing density at the number of hollow fibers. We obtained the reliance of the prediction equations because the pressure drop and the friction factor measured from the experiments were similar to that from the prediction equation. These results may be used to further usefulness for the design of VIVLAD.

A Study on the Emoticon Extraction based on Facial Expression Recognition using Deep Learning Technique (딥 러닝 기술 이용한 얼굴 표정 인식에 따른 이모티콘 추출 연구)

  • Jeong, Bong-Jae;Zhang, Fan
    • Korean Journal of Artificial Intelligence
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    • v.5 no.2
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    • pp.43-53
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    • 2017
  • In this paper, the pattern of extracting the same expression is proposed by using the Android intelligent device to identify the facial expression. The understanding and expression of expression are very important to human computer interaction, and the technology to identify human expressions is very popular. Instead of searching for the emoticons that users often use, you can identify facial expressions with acamera, which is a useful technique that can be used now. This thesis puts forward the technology of the third data is available on the website of the set, use the content to improve the infrastructure of the facial expression recognition accuracy, in order to improve the synthesis of neural network algorithm, making the facial expression recognition model, the user's facial expressions and similar e xpressions, reached 66%.It doesn't need to search for emoticons. If you use the camera to recognize the expression, itwill appear emoticons immediately. So this service is the emoticons used when people send messages to others, and it can feel a lot of convenience. In countless emoticons, there is no need to find emoticons, which is an increasing trend in deep learning. So we need to use more suitable algorithm for expression recognition, and then improve accuracy.

Design of a Tracking & Recall Management System for Implantable Devices (이식형 의료기기의 추적 및 회수 관리를 위한 통합전산관리시스템 설계)

  • Park, Soon-Mahn;Yoo, Sun-Kook
    • Journal of the Institute of Electronics Engineers of Korea SC
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    • v.48 no.5
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    • pp.74-80
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    • 2011
  • Medical implant devices are one of the targets of the US's Food & Drug Administration (FDA) for tracking in case of a serious adverse event since they are directly connected to the lives of patients. The US law stipulates that the public health agency shall order implantable device makers to track their product down to the patient level if a serious adverse event has occurred or defects have been discovered; in reality, however, the agency can pass on the responsibility for tracking or recalling faulty devices to the manufacturers or use mass media. This article proposes an efficient tracking and recall management system and examines four main virtual scenarios based on such. This research seeks to suggest a system that enables FDA to perform accurate and prompt tracking and recall management for patients' enhanced safety.

Verification of Extended Source-To-Imager Distance (SID) Correction for Portal Dosimetry

  • Son, Jaeman;Kim, Jung-in;Park, Jong Min;Choi, Chang Heon
    • Progress in Medical Physics
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    • v.29 no.4
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    • pp.137-142
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    • 2018
  • This study aimed to evaluate and verify a process for correcting the extended source-to-imager distance (SID) in portal dosimetry (PD). In this study, eight treatment plans (four volumetric modulated arc therapy and four intensity-modulated radiation therapy plans) at different treatment sites and beam energies were selected for measurement. A Varian PD system with portal dose image prediction (PDIP) was used for the measurement and verification. To verify the integrity of the plan, independent measurements were performed with the MapCHECK device. The predicted and measured fluence were evaluated using the gamma passing rate. The output ratio was defined as the ratio of the absolute dose of the reference SID (100 cm) to that of each SID (120 cm or 140 cm). The measured fluence for each SID was absolutely and relatively compared. The average SID output ratios were 0.687 and 0.518 for 120 SID and 140 SID, respectively; the ratio showed less than 1% agreement with the calculation obtained by using the inverse square law. The resolution of the acquired EPIDs were 0.336, 0.280, and 0.240 for 100, 120, and 140 SID, respectively. The gamma passing rates with PD and MapCHECK exceeded 98% for all treatment plans and SIDs. When autoalignment was performed in PD, the X-offset showed no change, and the Y-offset decreased with increasing SID. The PD-generated PDIP can be used for extended SID without additional correction.

3-D Hetero-Integration Technologies for Multifunctional Convergence Systems

  • Lee, Kang-Wook
    • Journal of the Microelectronics and Packaging Society
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    • v.22 no.2
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    • pp.11-19
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    • 2015
  • Since CMOS device scaling has stalled, three-dimensional (3-D) integration allows extending Moore's law to ever high density, higher functionality, higher performance, and more diversed materials and devices to be integrated with lower cost. 3-D integration has many benefits such as increased multi-functionality, increased performance, increased data bandwidth, reduced power, small form factor, reduced packaging volume, because it vertically stacks multiple materials, technologies, and functional components such as processor, memory, sensors, logic, analog, and power ICs into one stacked chip. Anticipated applications start with memory, handheld devices, and high-performance computers and especially extend to multifunctional convengence systems such as cloud networking for internet of things, exascale computing for big data server, electrical vehicle system for future automotive, radioactivity safety system, energy harvesting system and, wireless implantable medical system by flexible heterogeneous integrations involving CMOS, MEMS, sensors and photonic circuits. However, heterogeneous integration of different functional devices has many technical challenges owing to various types of size, thickness, and substrate of different functional devices, because they were fabricated by different technologies. This paper describes new 3-D heterogeneous integration technologies of chip self-assembling stacking and 3-D heterogeneous opto-electronics integration, backside TSV fabrication developed by Tohoku University for multifunctional convergence systems. The paper introduce a high speed sensing, highly parallel processing image sensor system comprising a 3-D stacked image sensor with extremely fast signal sensing and processing speed and a 3-D stacked microprocessor with a self-test and self-repair function for autonomous driving assist fabricated by 3-D heterogeneous integration technologies.

Problems of the Radiation Safety Management System and Legal Improvement Plans in the Department of Radiological Science: Focusing on the survey of the head of the Department of Radiological Science (방사선(학)과 방사선 안전관리제도의 문제점과 법적 개선방안: 전국 방사선(학)과장 설문조사를 중심으로)

  • Hyun-Jung, Lee;Chang-Gyu, Kim;Man-Seok, Han;Cheol-Ha, Baek
    • Journal of the Korean Society of Radiology
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    • v.16 no.7
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    • pp.815-824
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    • 2022
  • The current radiation safety management system is also applied to radiation practices at universities. The application of the law raised concerns about poor radiation practice education and hindering the development of radiology. Accordingly, the Korean Radiology Professors Association needed to grasp the reality of the management system for radiation practice education at each university and the current radiation safety management system in the department of Radiological science. So, a survey was conducted on heads of radiological science departments across the country. Through the survey, it was found that the current application of the Nuclear Safety Act to radiation safety management in the department of Radiological science is excessively restrictive and not very effective. In addition, radiology practice education for the purpose of training health and medical professionals should be controlled by the Ministry of Health and Welfare and the Korea Centers for Disease Control, but there is a problem of being supervised by the Nuclear Safety and Security Commission. Therefore, in this study, as a legal improvement plan to solve this problem, first, a plan according to a partial amendment to the Higher Education Act, second, a plan to be supervised by the Ministry of Health and Welfare through the amendment of article 37 of the Medical Service Act, third, article 20-2 of the Enforcement Decree of the Medical Service Technologists Act was newly inserted to propose three measures to be supervised by the Ministry of Health and Welfare.