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김진경(Kim, Jinkyung),한우석(Han, Woo Sok) 한양법학회 2009 漢陽法學 Vol.28 No.-
In response to the Health Insurance Portability and Accountability Act of 1996, the U.S. Department of Health and Human Services issued the Privacy Rule in 2003. Since the Privacy Rule allows for the use and disclose of ‘protected health information (PHI)’ under certain circumstances, we reviewed when and how PHI could be disclosed and, to that end, how the individual right is protected under the Privacy Rule. The Privacy Rule permits the use and disclose of PHI with individual’s authorization. However, health services research which usually deal with population-level data would be impracticable if millions of individual authorizations are required. Thus, in addition to the individual’s authorization, the Privacy Rule further allows for the following ways to use and disclose PHI for research purposes: 1) obtain waiver or alteration of the authorization requirement by and IRB or Privacy Board, 2) use de-identified data set, and 3) use limited data set under data use agreement. The Privacy Rule also grants individuals rights, including access to their protected health information, the right to amend, and the right to an accounting of the disclosures of their information. To this end, the Privacy Rule protects the privacy of individual health information, while at the same time allows researchers to have access to the individual health information necessary to conduct the research. The review of federal individual information protections in the U.S. provides insights on establishing appropriate laws and regulations in Korea on individual privacy protection and the use and disclose of personal information for public interest.
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의료정보 이용 및 공개에 관한 법적기준 -미국 프라이버시 규칙과 피험자보호 규칙의 검토-
김진경,한우석 한양법학회 2009 漢陽法學 Vol.28 No.-
In response to the Health Insurance Portability and Accountability Act of 1996, the U.S. Department of Health and Human Services issued the Privacy Rule in 2003. Since the Privacy Rule allows for the use and disclose of ‘protected health information (PHI)’ under certain circumstances, we reviewed when and how PHI could be disclosed and, to that end, how the individual right is protected under the Privacy Rule. The Privacy Rule permits the use and disclose of PHI with individual’s authorization. However, health services research which usually deal with population-level data would be impracticable if millions of individual authorizations are required. Thus, in addition to the individual’s authorization, the Privacy Rule further allows for the following ways to use and disclose PHI for research purposes: 1) obtain waiver or alteration of the authorization requirement by and IRB or Privacy Board, 2) use de-identified data set, and 3) use limited data set under data use agreement. The Privacy Rule also grants individuals rights, including access to their protected health information, the right to amend, and the right to an accounting of the disclosures of their information. To this end, the Privacy Rule protects the privacy of individual health information, while at the same time allows researchers to have access to the individual health information necessary to conduct the research. The review of federal individual information protections in the U.S. provides insights on establishing appropriate laws and regulations in Korea on individual privacy protection and the use and disclose of personal information for public interest.
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