• Title/Summary/Keyword: Healthcare Device

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Suggested Protocol for Efficient Medical Image Information Exchange in Korea: Breast MRI (효율적 의료영상정보교류를 위한 프로토콜 제안: 유방자기공명영상)

  • Park, Ji Hee;Choi, Seon-Hyeong;Kim, Sungjun;Yong, Hwan Seok;Woo, Hyunsik;Jin, Kwang Nam;Jeong, Woo Kyoung;Shin, Na-Young;Choi, Moon Hyung;Jung, Seung Eun
    • Journal of the Korean Society of Radiology
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    • v.79 no.5
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    • pp.254-258
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    • 2018
  • Purpose: Establishment of an appropriate protocol for breast magnetic resonance imaging (MRI) in the study of image quality standards to enhance the effectiveness of medical image information exchange, which is part of the construction and activation of clinical information exchange for healthcare informatization. Materials and Methods: The recommended protocols of breast and MRI scans were reviewed and the questionnaire was prepared by a responsible researcher. Then, a panel of 9 breast dedicated radiologists was set up in Korea. The expert panel conducted a total of three Delphi agreements to draw up a consensus on the breast MRI protocol. Results: The agreed breast MRI recommendation protocol is a 1.5 Tesla or higher device that acquires images with prone position using a breast dedicated coil and includes T2-weighted and pre-contrast T1-weighted images. Contrast enhancement images are acquired at least two times, and include 60-120 seconds between images and after 4 minutes. The contrast enhancement T1-weighted image should be less than 3 mm in thickness, less than 120 seconds in temporal resolution, and less than $1.5mm^2$ in-plane pixel resolution. Conclusion: The Delphi agreement of the domestic breast imaging specialist group has established the recommendation protocol of the effective breast MRI.

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.