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Legal and Regulatory Issues in Genetic Information Discrimination - Focusing on Overseas Regulatory Trends and Domestic Implications - (유전정보 차별금지의 법적문제 - 외국의 규율 동향과 그 시사점을 중심으로 -)

  • Yang, Ji Hyun;Kim, So Yoon
    • The Korean Society of Law and Medicine
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    • v.18 no.1
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    • pp.237-264
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    • 2017
  • With the onset of the Human Genome Project, social concerns about 'genetic information discrimination' have been raised, but the problem has not yet been highlighted in Korea. However, non-medical institutions' genetic testing which is related to disease prevention could be partially allowed under the revised "Bioethics and Safety Act" from June 30, 2016. In the case of one domestic insurance company, DTC genetic testing was provided for the new customer of cancer insurance as a complimentary service, which made the social changes related to the recognition of the genetic testing. At a time when precision medicine is becoming a new standard for medical care, discipline on genetic information discrimination has become a problem that can not be delayed anymore. Article 46 and 67 of the Bioethics Act stipulate the prohibition of discrimination on grounds of genetic information and penalties for its violation. However, these broad principles alone can not solve the problems in specific genetic information utilization areas such as insurance and employment. The United States, Canada, the United Kingdom, and Germany have different regulations that prohibit genetic information based discrimination. In the United States, Genetic Information Non-Discrimination Act takes a form that adds to the existing law about the prohibition of genetic information discrimination. In addition, the range of genetic information includes the results of genetic tests of individuals and their families, including "family history". Canada has recently enacted legislation in 2017, expanding coverage to general transactions of goods or services in addition to insurance and employment. The United Kingdom deals only with 'predictive genetic testing results of individuals'. In the case of insurance, the UK government and Association of British Insurers (ABI) agree to abide by a policy framework ('Concordat') for cooperation that provides that insurers' use of genetic information is transparent, fair and subject to regular reviews; and remain committed to the voluntary Moratorium on insurers' use of predictive genetic test results until 1 November 2019, and a review of the Concordat in 2016. In the case of employment, The ICO's 'Employment Practices Code (2011)' is used as a guideline. In Germany, Human Genetic Examination Act(Gesetz ${\ddot{u}}ber$ genetische Untersuchungen bei Menschen) stipulates a principle ban on the demand for genetic testing and the submission of results in employment and insurance. The evaluation of the effectiveness of regulatory framework, as well as the form and scope of the discipline is different from country to country. In light of this, it would be desirable for the issue of genetic information discrimination in Korea to be addressed based on the review of related regulations, the participation of experts, and the cooperation of stakeholders.

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Clinical Application of Dose Reconstruction Based on Full-Scope Monte Carlo Calculations: Composite Dose Reconstruction on a Deformed Phantom (몬테칼로 계산을 통한 흡수선량 재구성의 임상적 응용: 변형된 팬텀에서의 총제적 선량재구성)

  • Yeo, Inhwan;Xu, Qianyi;Chen, Yan;Jung, Jae Won;Kim, Jong Oh
    • Progress in Medical Physics
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    • v.25 no.3
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    • pp.139-142
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    • 2014
  • The purpose of this study was to develop a system of clinical application of reconstructed dose that includes dose reconstruction, reconstructed dose registration between fractions of treatment, and dose-volume-histogram generation and to demonstrate the system on a deformable prostate phantom. To achieve this purpose, a deformable prostate phantom was embedded into a 20 cm-deep and 40 cm-wide water phantom. The phantom was CT scanned and the anatomical models of prostate, seminal vesicles, and rectum were contoured. A coplanar 4-field intensity modulated radiation therapy (IMRT) plan was used for this study. Organ deformation was simulated by inserting a "transrectal" balloon containing 20 ml of water. A new CT scan was obtained and the deformed structures were contoured. Dose responses in phantoms and electronic portal imaging device (EPID) were calculated by using the XVMC Monte Carlo code. The IMRT plan was delivered to the two phantoms and integrated EPID images were respectively acquired. Dose reconstruction was performed on these images using the calculated responses. The deformed phantom was registered to the original phantom using an in-house developed software based on the Demons algorithm. The transfer matrix for each voxel was obtained and used to correlate the two sets of the reconstructed dose to generate a cumulative reconstructed dose on the original phantom. Forwardly calculated planning dose in the original phantom was compared to the cumulative reconstructed dose from EPID in the original phantom. The prescribed 200 cGy isodose lines showed little difference with respect to the "prostate" and "seminal vesicles", but appreciable difference (3%) was observed at the dose level greater than 210 cGy. In the rectum, the reconstructed dose showed lower volume coverage by a few percent than the plan dose in the dose range of 150 to 200 cGy. Through this study, the system of clinical application of reconstructed dose was successfully developed and demonstrated. The organ deformation simulated in this study resulted in small but observable dose changes in the target and critical structure.

Genetic Counseling in Korean Health Care System (한국 의료제도와 유전상담 서비스의 구축)

  • Kim, Hyon-J.
    • Journal of Genetic Medicine
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    • v.8 no.2
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    • pp.89-99
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    • 2011
  • Over the years Korean health care system has improved in delivery of quality care to the general population for many areas of the health problems. The system is now being recognized in the world as the most cost effective one. It is covered by the uniform national health insurance policy for which most people in Korea are mandatory policy holders. Genetic counseling service, however, which is well recognized as an integral part of clinical genetics service deals with diagnosis and management of genetic condition as well as genetic information presentation and family support, is yet to be delivered in comprehensive way for the patients and families in need. Two major obstacles in providing genetic counseling service in korean health care system are identified; One is the lack of recognition for the need for genetic counseling service as necessary service by the national health insurance. Genetic counseling consumes a significant time in delivery and the current very low-fee schedule for physician service makes it very difficult to provide meaningful service. Second is the critical shortage of qualified professionals in the field of medical genetics and genetic counseling who can provide the service of genetic counseling in clinical setting. However, recognition and understanding of the fact that the scope and role of genetic counseling is expanding in post genomic era of personalized medicine for delivery of quality health care, will lead to the efforts to overcome obstacles in providing genetic counseling service in korean health care system. Only concerted efforts from health care policy makers of government on clinical genetics service and genetic counseling for establishing adequate reimbursement coverage and professional communities for developing educational program and certification process for professional genetic counselors, are necessary for the delivery of much needed clinical genetic counseling service in Korea.