의료분야 빅데이터 활용을 위한 규제 현황 고찰 및 개선방향 연구

= A Study on the Regulatory Status and Its Improvement for Utilization of Big Data in Medical Field

• 저자[authors] : 조한범
• 발행사항 : 서울 : 동국대학교, 2018
• 형태사항[Description] : 79 p. ; 26 cm
• 일반주기명[Note] : 지도교수: 조성구
• 학위논문사항[Dissertation] : 학위논문(석사)-- 동국대학교 : 의료기기산업학과  2018. 2
• DDC[DDC] : 610.28
• 발행국(발행지)[Country] : 서울
• 출판년[Publication Year] : 2018
• 주제어 : Privacy Act,regulatory status,big data in medical field,utilization,improvement,domestic and foreign regulations
• 소장기관[Holding] : 동국대학교 중앙도서관 (211020)

초록[abstracts]

With the development of science and technology, the era of the 4th industrial revolution is taking place. Stored data on online were gathered together as ‘big data’ through the 3rd industrial revolution, and now through the 4th industrial revolution, it is creating additional value by being fused with the service in various fields. Particularly, as trends shift from treatment to prevention, and as aging becomes an international issue, the use of big data in medical field is drawing attention.  Big data in medical field can make a great contribution to the development of new therapies, development of new drugs, and development of public health, but Korea’s Privacy Act has limitations in terms of utilization due to its strict protection level. Personal health information should not be thought of as unconditional protection but should be used as a research material for public interest. In this study, the differences between domestic and foreign regulations were investigated in order to study the direction of improvement in utilizing medical big data, and the problems of current domestic regulatory issues related to medical big data were examined.  After that, three approaches were proposed to maximize the utilization of medical big data and the optimal method was adopted. The first is to revise the Privacy Act in consideration of the current situation. The second is to use only the pseudonym processing technique among the current non-identification technologies when providing data for research purposes. The last one is to allow using personal information without the consent of information object by achieving permission from IRB(Institutional Review Board) or the Privacy Board, like the US HIPAA regulation. As a result of the feasibility study, a method of processing the medical data by the pseudonym processing technique when providing for research purpose was adopted. 
  In-depth interviews were conducted to obtain further opinions from experts and practitioners on the current regulations for the use of medical data for research purposes. In addition to the restriction of regulation, data standardization between medical institutions and the perception of people’s use of personal information are to be solved for the next tasks.