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Legal Issues in Protecting and Utilitizing Medical Data in United States - Focused on HIPAA/HITECH, 21st Century Cures Act, Common Law, Guidance - (미국의 보건의료데이터 보호 및 활용을 위한 주요 법적 쟁점 -미국 HIPAA/HITECH, 21세기 치료법, 공통규칙, 민간 가이드라인을 중심으로-)

  • Kim, Jae Sun
    • The Korean Society of Law and Medicine
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    • v.22 no.4
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    • pp.117-157
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    • 2021
  • This research reviewed the HIPAA/HITECH, 21st Century Cures Act, Common Law, and private Guidances from the perspectives in protecting and utilitizing the medical data, while implications were followed. First, the standards for protection and utilization are relatively clearly regulated through single law on personal medical information in the United States. The HIPAA has been introduced in 1996 as fundamental act on protection of medical data. Medical data was divided into personally identifiable information, non-identifying information, and limited dataset under HIPAA. Regulations on de-identification measures for medical information, objects for deletion of limited data sets, and agreement on prohibition of data re-identification were stipulated. Moreover, in the 21st Century Cures Act regulated mutual compatibility for data sharing, prohibition of data blocking, and strengthening of accessibility of data subjects. Common Law introduced comprehensive consent system and clearly stipulates procedures. Second, the regulatory system is relatively simplified and clearly stipulated in the United States. To be specific, the expert consensus and the safe harbor system were introduced as an anonymity measure for identifiable medical information, which clearly defines the process while increasing trust. Third, the protection of the rights of the data subject is specified, the duty of explanation is specified in detail, while the information right of the consumer (opt-out procedure) for identification information is specified. For instance, the HHS rule and FDA regulations recognize the comprehensive consent system for human research, but the consent procedure, method, and requirements are stipulated through the common rule. Fourth, in the case of the United States, a trust-based system is being used throughout the health and medical data legislation. To be specific, Limited Data Sets are allowed to use in condition to the researcher's agreement to prohibit re-identification, and de-identification or consent process is simplified under the system.

Study on the Painting of Gyeongwoo-gung Shrine (景祐宮圖) (국립문화재연구소 소장 '경우궁도(景祐宮圖)'에 관한 연구)

  • Kim, Kyung Mee
    • Korean Journal of Heritage: History & Science
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    • v.44 no.1
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    • pp.196-221
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    • 2011
  • The Royal Private Shrines or the Samyo(私廟), were dedicated to members of Choseon's royal family who could not be enshrined at the (official) Royal Ancestral Shrine, the Jongmyo(宗廟). The Samyo were constructed at the national level and were systematically managed as such. Because these private Shrines were dedicated to those who couldn't belong to the Jongmyo but were still very important, such as the ruling king's biological father or mother. The details of all royal constructions were included in the State Event Manuals, and with them, the two-dimensional layouts of the Samyo also. From the remaining "Hyunsa-gung Private Tomb Construction Layout Record(顯思宮別廟營建都監儀軌)" of 1824, which is the construction record of Gyeongwoo-gung Shrine(景祐宮) dedicated to Subin, the mother of King Sunjo(純祖), it became possible to investigate the so far unknown "The Painting of Gyeongwoo-gung Shrine", in terms of the year produced, materials used and other situational contexts. The investigation revealed that the "The Painting of Gyeongwoo-gung Shrine" is actually the "Hyunsa-gung Private Tomb Layout" produced by the Royal Construction Bureau. The bureau painted this to build Hyunsa-gung Private Shrine in a separately prepared site outside the court in 1824, according to the royal verdict to close down and move the temporary shrine inside the courtyard dedicated to Subin who had passed away in 1822. As the Construction Bureau must have also produced the Gyeongwoo-gung Shrine Layout, the painter(s) of this layout should exist among the official artists listed in the State Event Manual, but sadly, as their paintings have not survived to this day, we cannot compare their painting styles. The biggest stylistic character of the Painting of Gyeongwoo-gung Shrine is its perfect diagonal composition method and detailed and neat portrayalof the many palace buildings, just as seen in Donggwoldo(東闕圖, Painting of a panoramic view for Changdeokgung and Changgyeonggung Palaces). A well-perceiving architectural painting employs a specific point of view chosen to fit the purpose of the painting, or it can opt to the multi-viewpoint. Korean traditional architectural paintings in early ages utilized the diagonal composition method, the bird-eye viewpoint, or the multi-viewpoint. By the 18th century, detailed but also artistic architectural paintings utilizing the diagonal method are observed. In the early 19th century, the peak of such techniques is exhibited in Donggwoldo(Painting of a panoramic view for Changdeokgung and Changgyeonggung Palaces). From the perfect diagonal composition method employed and the details of the palace buildings numbering almost two hundreds, we can determine that the Painting of Gyeongwoo-gung Shrine also belongs to the same category of the highly technical architectural paintings as Donggwoldo(Painting of a panoramic view for Changdeokgung and Changgyeonggung Palaces). We can also confirm this hypothesis by comparing the painting techniques employed in these two paintings in detailthe way trees and houses are depicted, and the way ground texture is expressed, etc. The unique characteristic of the Painting of Gyeongwoo-gung Shrine is, however, that the area surrounding the central shrine building(正堂), the most important area of the shrine, is drawn using not the diagonal method but the bird-eye viewpoint with the buildings lying flat on both the left and right sides, just as seen in the "Buildings Below the Central Shrine(正堂以下諸處)" in the State Event Manual's Painting Method section. The same viewpoint method is discovered in some other concurrent paintings of common residential buildings, so it is not certain that this particular viewpoint had been a distinctive feature for shrine paintings in general. On the other hand, when the diagonalmethod pointing to the left direction is chosen, the top-left and bottom-right sections of the painting become inevitably empty. This has been the case for the Painting of Gyeongwoo-gung Shrine, but in contrast, Donggwoldo shows perfect screen composition with these empty margins filled up with different types of trees and other objects. Such difference is consistent with the different situational contexts of these two paintings: the Painting of Gyeongwoo-gung Shrine is a simple single-sheet painting, while Donggwoldo is a perfected work of painting book given an official title. Therefore, if Donggwoldo was produced to fulfill the role of depiction and documentation as well as the aesthetic purpose, contrastingly, the Painting of Gyeongwoo-gung Shrine only served the purpose of copying the circumstances of the architecture and projecting them onto the painting.

Legal Issues on the Collection and Utilization of Infectious Disease Data in the Infectious Disease Crisis (감염병 위기 상황에서 감염병 데이터의 수집 및 활용에 관한 법적 쟁점 -미국 감염병 데이터 수집 및 활용 절차를 참조 사례로 하여-)

  • Kim, Jae Sun
    • The Korean Society of Law and Medicine
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    • v.23 no.4
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    • pp.29-74
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    • 2022
  • As social disasters occur under the Disaster Management Act, which can damage the people's "life, body, and property" due to the rapid spread and spread of unexpected COVID-19 infectious diseases in 2020, information collected through inspection and reporting of infectious disease pathogens (Article 11), epidemiological investigation (Article 18), epidemiological investigation for vaccination (Article 29), artificial technology, and prevention policy Decision), (3) It was used as an important basis for decision-making in the context of an infectious disease crisis, such as promoting vaccination and understanding the current status of damage. In addition, medical policy decisions using infectious disease data contribute to quarantine policy decisions, information provision, drug development, and research technology development, and interest in the legal scope and limitations of using infectious disease data has increased worldwide. The use of infectious disease data can be classified for the purpose of spreading and blocking infectious diseases, prevention, management, and treatment of infectious diseases, and the use of information will be more widely made in the context of an infectious disease crisis. In particular, as the serious stage of the Disaster Management Act continues, the processing of personal identification information and sensitive information becomes an important issue. Information on "medical records, vaccination drugs, vaccination, underlying diseases, health rankings, long-term care recognition grades, pregnancy, etc." needs to be interpreted. In the case of "prevention, management, and treatment of infectious diseases", it is difficult to clearly define the concept of medical practicesThe types of actions are judged based on "legislative purposes, academic principles, expertise, and social norms," but the balance of legal interests should be based on the need for data use in quarantine policies and urgent judgment in public health crises. Specifically, the speed and degree of transmission of infectious diseases in a crisis, whether the purpose can be achieved without processing sensitive information, whether it unfairly violates the interests of third parties or information subjects, and the effectiveness of introducing quarantine policies through processing sensitive information can be used as major evaluation factors. On the other hand, the collection, provision, and use of infectious disease data for research purposes will be used through pseudonym processing under the Personal Information Protection Act, consent under the Bioethics Act and deliberation by the Institutional Bioethics Committee, and data provision deliberation committee. Therefore, the use of research purposes is recognized as long as procedural validity is secured as it is reviewed by the pseudonym processing and data review committee, the consent of the information subject, and the institutional bioethics review committee. However, the burden on research managers should be reduced by clarifying the pseudonymization or anonymization procedures, the introduction or consent procedures of the comprehensive consent system and the opt-out system should be clearly prepared, and the procedure for re-identifying or securing security that may arise from technological development should be clearly defined.