• The Korean Society of Law and Medicine
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• v.21 no.2
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• pp.209-244
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• 2020

TMS and tDCS are non-invasive devices that treat the diseases of patients or individual users, and manage or improve their health by applying stimulation to a brain through magnetism and electricity. The effect and safety of these devices have proved to be valid in several diseases, but research in this area is still much going on. Despite increasing cases of their application, legislations directly regulating TMS and tDCS are hard to find. Legal regulation regarding TMS and tDCS in the United States, Germany and Japan reveals that while TMS has been approved as a medical device with a moderate risk, tDCS has not yet earned approval as a medical device. However, the recent FDA guidance, European MDR changes, recalls in the US, and relevant legal provisions of Germany and Japan, as well as recommendations from expert groups all show signs of tDCS growing closer to getting approved as a medical device. Of course, safety and efficacy of tDCS can still be regulated as a general product instead of as a medical device. Considering multiple potential impacts on a human brain, however, the need for independent regulation is urgent. South Korea also lacks legal provisions explicitly regulating TMS and tDCS, but they fall into the category of the grade 3 medical devices according to the notifications of the Korean Ministry of Food and Drug Safety. And safety and efficacy of TMS are to be evaluated in compliance with the US FDA guidance. But no specific guidelines exist for tDCS yet. Given that tDCS devices are used in some hospitals in reality, and also at home by individual buyers, such a regulatory gap must quickly be addressed. In a longer term, legal system needs to be in place capable of independently regulating non-invasive brain stimulating devices.

• 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.

• Korean Journal of Cognitive Science
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• v.33 no.1
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• pp.51-75
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• 2022

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation that is able to alter neuronal activity in particular brain regions. Many studies have researched how tDCS modulates neuronal activity and reorganizes neural networks. However it is difficult to conclude the effect of brain stimulation because the studies are heterogeneous with respect to the stimulation parameter as well as individual difference. It is not fully in agreement with the effects of brain stimulation. In particular few studies have researched the reason of variability of brain stimulation in response to time so far. The study investigated individual variability of brain stimulation based on circadian rhythm and chronotype. Participants were divided into two groups which are morning type and evening type. The experiment was conducted by Zoom meeting which is video meeting programs. Participants were sent experiment tool which are Muse(EEG device), tdcs device, cell phone and cell phone holder after manuals for experimental equipment were explained. Participants were required to make a phone in frount of a camera so that experimenter can monitor online EEG data. Two participants who was difficult to use experimental devices experimented in a laboratory setting where experimenter set up devices. For all participants the accuracy of 98% was achieved by SVM using leave one out cross validation in classification in the the effects of morning stimulation and the evening stimulation. For morning type, the accuracy of 92% and 96% was achieved in classification in the morning stimulation and the evening stimulation. For evening type, it was 94% accuracy in classification for the effect of brain stimulation in the morning and the evening. Feature importance was different both in classification in the morning stimulation and the evening stimulation for morning type and evening type. Results indicated that the effect of brain stimulation can be explained with brain state and trait. Our study results noted that the tDCS protocol for target state is manipulated by individual differences as well as target state.