미국의 유전자 프라이버시 및 유전자 정보 이용과 관련된 법률 분석 및 맞춤의학에의 시사점

신승남 이화여자대학교 법학연구소 2009 法學論集 Vol.13 No.2

유전자 검사는 의료 및 약학 분야의 산업상 필요와 개인의 프라이버시 보호에 충돌되는 영역으로 알려져 있다. 이에 대하여 미국에서는 ADA, HIPAA, GINA 등 연방의회에서 다양한 법률을 제정하여 충돌되는 법익들의 균형점을 찾으려고 노력해왔다. 본 논문에서는 이러한 법률들의 실행과정에서의 문제점 및 미국 법원의 판례들을 살펴보고, 향후 한국에서 맞춤의학에의 적용과정에서의 시사점에 대하여 논의를 전개하였다. 유전자 정보의 수집 및 활용과 관련하여 유전자 정보를 고용과정에서 차별적으로 활용하는 것에 대하여 개인의 프라이버시 및 연방헌법상 평등권 보호를 위해 미국 연방법률들이 제정되었지만, 관련 산업분야의 산업상 필요성을 고려하여 규정한 많은 예외규정들이 오히려 연방법률들을 제정한 취지를 살리지 못하는 문제점들을 노출시키고 있다. 이러한 문제점들은 향후 우리나라에서 유사한 법률들을 제정하는 경우에 시사점이 될 것이다. The author reviews the kinds of American statutes and case law regarding the utilization and regulation of genetic information obtained for the purpose of applying for insurance coverage. Privacy Act, American Disability Act, Health Insurance Portability and Accountability Act, and Genetic Information Nondiscrimination Act are the main federal statutes designed to regulate the use of the genetic information. Those federal statutes have advantages of protecting against the potential misuse of the genetic information obtained from the individuals who applied for insurance coverage in a life insurance or disability insurance, or who used the genetic services. American common law and states law have insufficient protection measures against any possible abuse of the genetic information because those statutes and the common law use the fiduciary relationship as a basis of protecting the confidential information such as genetic information. However, if any third party not under the fiduciary relationship attempts to divulge such genetic information, then there are no appropriate remedies according to American states' statutes and the common law approach. Therefore, American federal laws were enacted to protect traditionally unprotected areas such as third party's misuse of the genetic information. Reviewing the implications of such federal laws designed to protect the genetic information, more thorough protective provisions are needed to included, since there are too many loopholes in protecting the owners of the genetic information. Any legislative activities for supporting the development of "personalized medicine" shall be waiting for enough discussion of the protection of the legitimate interests of the genetic information owners in terms of new legislation to protect the use of genetic information in Korea.

The Utilization and Limitation of Genetic Information in Insurance — Improvement Plan of China’s“Genetic Non-discrimination Act”

조평주 원광대학교 법학연구소 2022 의생명과학과 법 Vol.28 No.-

According to current Chinese law, insurance companies cannot use genetic information for medical, disease, disability, care and medical accident insurance. Nevertheless, this approach has not effectively solved the problem of “genetic discrimination” in China. Genetic information plays a vital role in insurance. The theory that genetic information can be used in insurance is based on risk classification and price equilibrium principle. Adverse selection can be avoided by dividing genetic information into different risk classes. This is an inevitable requirement of the insurer's right to know. For the consideration of social and public interests, commercial insurance should undertake a reasonable social relief function, but it is necessary to clarify the limitations of the social relief function of commercial insurance, and commercial insurance and social insurance cannot be equated. In terms of the characteristics of genetic information itself, there is no substantial difference between it and general medical information. Insurance covers uncertain risks, and with the progress of technology, the accuracy of genetic testing has also been improved. Therefore, theoretically speaking, it is not necessary to completely prohibit insurers from using genetic information in the insurance field. Therefore, in the future, China's legislation on genetic discrimination should be changed from completely prohibiting the use of genetic information by insurers to conditionally restricting the use of genetic information by insurers. First of all, the way to obtain genetic information by the insurer should be clarified, and the insurer should be prohibited from forcing the insured to carry out predictive genetic testing. The insurance applicant only must inform the specific genetic testing results. Secondly, it is necessary to set conditions for the insurer to use genetic information. The insurer can only use genetic information in personal insurance that meets a certain amount of money, and the use of genetic information must meet legal procedures and obtain the consent of the insured. In addition, it is also necessary to strengthen the regulation of the gene testing industry, formulate strict market access rules, and establish a gene consultant system to make up for the inferior position of the insured in the profession. Finally, improve the rescue of the insured, let professionals participate in the settlement of disputes, and increase the severity of punishment for the illegal use of genetic information by insurance companies.

개인 유전정보의 안정성 확보방안

윤영철 ( Young Cheol Yoon ) 한남대학교 과학기술법연구소 2010 과학기술법연구 Vol.16 No.2

The high technology in modern society like bio-technology or information technology requires more and more the use of personal genetic information not only in the field of research or medical service but also in the criminal procedure. In spite of the growing demand, so far there is no appropriate technical systems and legal rules which set up to control the use of the personal genetic information in various fields in a way to protect the personal information. Personal genetic information should be protected strictly, it is not only personal information but also information of family and community. Accesses and exposures of personal genetic information shold be restricted and managed in technical, systemic and legal category. Therefore, the effective and efficient protection of personal genetic information should depend on other preventive system and regulation. Namely, it can be protected effectively and efficiently by establishing technical security system, quality assurance system and control and direction system on the basis of self-regulation. These controls and managements for the protection of personal genetic information should be backed up by administration or administrative law which can rule the procedure of genetic test and the supervision of genetic information bank. Next, the regulation by criminal law as ultima ratio should protect the safety of personal genetic information.

증명책임 전환규정의 입법을 통한 개인의 유전자정보 보호방안

이세주 원광대학교 법학연구소 2011 의생명과학과 법 Vol.5 No.-

Personal genetic information contains that of blood relatives or family members of the person. If there is any release of personal genetic information, it also releases affiliated persons’ information too, which causes a huge extent of damage. While personal genetic information can be used for medical purposes, it is also vulnerable to the abuse for social discrimination. For example, an insurance company may refuse or require higher insurance charge to the insurance application of someone who has specific disease DNA, and a company may not employ or may fire them. As such, the release of personal genetic information has a large extent of damage, and is highly plausible to be used illegally, which requires special protection in the perspective of policy. However, the current legal system is not sufficient to protect genetic information, and thus, new legislation is required. In particular, it is highly required to mitigate or converse the burden of proof to make a claim for damages easy for the post-aid to those who are infringed. This study proposes to mitigate or converse the burden of proof by means of the legislation of presuming provisions under the law. Those who are infringed thanks to the release of personal genetic information shall make the genetic information preservation organization take legal responsibility, and the preservation organization shall pay special attention to the security or use of genetic information which, in turn, may reduce the infringement of personal genetic information.

증명책임 전환규정의 입법을 통한 개인의 유전자정보 보호방안

이세주 원광대학교 법학연구소 2011 의생명과학과 법 Vol.5 No.-

Personal genetic information contains that of blood relatives or family members of the person. If there is any release of personal genetic information, it also releases affiliated persons’ information too, which causes a huge extent of damage. While personal genetic information can be used for medical purposes, it is also vulnerable to the abuse for social discrimination. For example, an insurance company may refuse or require higher insurance charge to the insurance application of someone who has specific disease DNA, and a company may not employ or may fire them. As such, the release of personal genetic information has a large extent of damage, and is highly plausible to be used illegally, which requires special protection in the perspective of policy. However, the current legal system is not sufficient to protect genetic information, and thus, new legislation is required. In particular, it is highly required to mitigate or converse the burden of proof to make a claim for damages easy for the post-aid to those who are infringed. This study proposes to mitigate or converse the burden of proof by means of the legislation of presuming provisions under the law. Those who are infringed thanks to the release of personal genetic information shall make the genetic information preservation organization take legal responsibility, and the preservation organization shall pay special attention to the security or use of genetic information which, in turn, may reduce the infringement of personal genetic information.

헌법상 유전정보보호와 의사의 고지의무 : 미국의 사례를 중심으로

허전(Huh Jun),정덕영(Jeong Duck Young) 한국헌법학회 2009 憲法學硏究 Vol.15 No.2

인간은 부모로부터 유전정보를 계승하여 생명체로 태어나게 된다. 그러므로 가족구성원들은 유전정보를 공유하게 된다. 이러한 유전정보의 가족구성원간의 공유성은 유전자에 근거하는 가족적 연대를 공고히 할 수도 있지만 가족구성원간의 대립을 가져올 수도 있다. 자신에게 유전질환이 있는 것을 숨기고 싶어 하는 환자와 해당 환자의 유전정보를 알아내어 자기의 유전적 위험을 확인하고 싶어 하는 혈족의 이익이 충돌될 가능성이 있다. 이러한 가족구성원간의 대립은 히포크라테스 선서에 의한 비밀유지의 의무에 혼란을 줄 수 있다. 유전질환은 유전적 성질에 의해서 환자뿐만 아니라 혈족도 그러한 유전질환을 가지고 있을 가능성도 있다. 그러므로 유전의료를 담당하는 의사는 헌법상 환자의 프라이버시권을 보호하기 위해 비밀유지의무를 준수해야 하는지, 그렇지 않으면 유전적 위험에 처한 환자의 가족에게 유전정보를 고지해야 하는지에 대해 법적으로 해결하여야 할 문제이다. 환자의 유전정보에 대한 의사의 비밀보호의무가 법적으로 규정되어 있다. 하지만 의사는 환자의 유전질환을 가족에게 고지해야만 하는 예외가 존재한다. 즉, 가족에게 유전질환의 발생 가능성이 높고, 유전질환을 초기에 발견하면 치료가 가능하며, 고지한 경우와 고지하지 않은 경우를 비교형량하여 고지하지 않음으로써 발생하는 손해가 고지에 의해 발생하는 손해보다 더 큰 경우이다. 이러한 예외적인 사항은 미국의 판례에 의해 이미 도출되고 있다. 이 논문에서는 이러한 고지의무에 대해 미국의 판례와 입법례를 중심으로 살펴보려는 바, 이는 향후 우리나라에서도 나타날 수 있는 유전정보의 보호와 의사의 고지의무와의 충돌문제를 해결하는데 시사하는 바가 클 것이다. We are born with DNA which includes all the information about genetic inheritance. Therefore, family members share the same genetic information. DNA includes all the information about genetic inheritance. Sharing same genetic information may make family-relationship strong, but at the same time it may cause conflict among the family members. Because a patient wants to keep his genetic disease, but his family members want to check family genetic risk. In such a case, a doctor can be confused about confidentiality obligations by Hippocratic oath. There is high possibility that patient's family members have the same genetic disease which the patient has. Hence we should legally solve whether doctors should keep secret to protect the patient's privacy right, or has to notice patient's genetic information to patient's family members who have high risk of genetic disease. In principle, a doctor has confidentiality obligation. So, a doctor has to keep secret about the patient's disease. But there is an exception which a doctor has to notice patient's disease to patient family members. In other words, first there is high risk to occur genetic disease to patient's family members. Second, genetic disease can be cured if detected early. Third, damages caused by not notifying is bigger than damages caused by notifying. These exceptions are found on judicial precedents of America. Why we study the legislations and judicial precedents of America in relation to doctors' duty to notice is that it can give us many suggestions to solve the problems of “Genetic information protection and doctors' duty to notice” which may happen in Korea.

유전자검사의 법적 문제

정규원 ( Kyu Won Jung ) 법과사회이론학회 2003 법과 사회 Vol.24 No.-

유전체 시대의 유전정보 보호와 공유를 위한 개인정보 보호법제의 고찰

이원복 ( Won Bok Lee ) 법조협회 2018 法曹 Vol.67 No.3

생명의 비밀을 담고 있는 유전정보는 그 불변성, 가족 공유성, 고유 식별성, 표현형 예측성 때문에 다른 어떤 종류의 개인정보와도 다른 특수한 성질을 갖고 있고, 그로 인하여 특별히 보호할 필요가 있다. 유전정보를 보호하는 개인정보 보호법과 생명윤리 및 안전에 관한 법률도 이러한 유전정보의 특수성을 감안해서 일반적인 개인정보보다 더 두터운 특별한 보호를 하고 있다. 그러나 다른 한편으로 유전정보는 NGS라는 획기적인 염기서열 분석기술의 발전에 힘입어 생명과학 분야에서 새로운 연구와 기술 개발의 밑거름이 될 수 있다. 그리고 연구와 기술 개발이라는 측면에서는 우리나라의 유전정보 보호법제가 현실적으로 극복할 수 없는 제약으로 작용하고 있음도 분명하다. 그렇다면 다른 어떤 종류의 개인정보보다 보호의 필요성이 강하면서도 활용의 가능성도 넓게 열린 유전정보를 우리 개인정보 보호법제는 어떻게 다루어 나가야 할 것인가? 그 정책적인 해결책을 찾기 위해서는 무엇보다 우리 사회에서 유전정보의 정보주체 추적 가능성이 현실적으로 얼마나 되는지에 관한 학제적 연구가 이루어져야 할 것이고 그와 함께 유전정보의 익명성을 보호하는 암호화 기술 등의 개발도 병행되어야 할 것이다. 그리하여 유전정보의 익명성을 보호하는 기술이 유전정보의 정보주체 추적을 충분히 예방할 정도가 된다면 그러한 기술의 채용이 개인정보 보호법과 생명윤리 및 안전에 관한 법률 등에 반영이 되어야 할 것으로 보인다. Korea’s Bioethics and Biosafety Act of 2005 and the Personal Information Protection Act of 2011 govern the safeguarding of genetic privacy as well as the sharing of genetic data. These two pieces of legislation have long been criticized by the biomedical research community for their strict consent requirement for secondary use and third-party provision of genetic data, especially in light of the increasing availability of genomic data. More specifically, secondary use of the genetic information collected from a biospecimen is not allowed unless the prior consent specifically permits secondary use. Provision of genetic data to a third-party is allowed only in limited circumstances, and, even then, “personally identifiable information” must be removed. In the context of genomic data, removing “personally identifiable information” is seen as problematic, because more and more evidence points to the potential identifiability of genomic data. How do we solve this situation? As discussion has embarked at the legislature for relaxaing the privacy law, I argue that two points need to be considered for amending the genetic privacy law. First, domestic research needs to be done on the traceability of otherwise anonymous genomic information. Second, protection of genetic or genomic information will also need to rely on technology, such as cryptography, since obfuscation will diminish the value of genomic data. The lifetime invariability, hereditariness, personal uniqueness and association with phenotype are all special characteristics of genetic information not found in any other type of personal information that necessitate more work in these two areas. It is even more so considering the breakthrough in whole genome sequencing with next-generation sequencing.

한국의 유전적 정보 생산 구조

이정호(Yi Cheong-Ho) 한국과학기술학회 2005 과학기술학연구 Vol.5 No.1

한국에서 중요한 과학적 개념의 형성과 그 사회적 유통에 기여하는 것은 미국과 유럽, 그리고 일본에서 형성, 성숙, 정립된 후에 한국으로 유입되고 수용되는 과학 지식과 한국 사회가 근대화의 과정에 형성한 제도이다. 유전적 정보라는 개념도 이러한 맥락에서 예외일 수는 없다. 유전적 정보 개념은 고전적 유전학의 틀에서 이해되는 유전 또는 계승성의 개념에서 인간유전체연구사업의 와중에서 등장하여 성숙한 유전체학과 생물정보학에 의해 확대ㆍ심화된 것이다. 본 연구는 서구적 개념 및 지식 생산 구조를 모델로 하는 개념적, 과학지식적, 제도적 통합성을 기준으로 한국에서 유전적 정보의 생산 구조가 어떻게 형성되어 있는가에 대한 것이다. 한국에서 1980년대 중반에 나타났던 유전공학 담론은 한국에서 분자생물학의 발달은 촉진시켰지만, 생화학과-생화학교실과 같은 균형성이 없이 유전공학-유전학교실의 불균형성이 존재하게 되었다. 주로 의과대학의 (인간)유전학과 혹은 유전학교실의 수와 질에 있어서의 부족함 때문에 생명과학 전체에 미치는 영향력에서도 크게 성공하지 못했고, 통합적, 거시적 발전을 이루지 못한 것으로 보인다. 유전학의 발전적 재구성이라고 할 수 있는 유전체학은 한국에서는 유럽, 미국, 일본의 인간유전체연구사업의 발전 궤적의 ‘기초단계’ 혹은 ‘제 1기’ 형태에는 거의 인프라, 투자, 연구개발이 없었고, 기능유전체학과 단백체학을 중심으로 하는 ‘성숙단계’ 혹은 ‘제 2기’ 형태를 주축으로 하여 한국의 연구개발이 진행되고 있다. 유전체학과 같이 발달한 생물정보학에는 내적 구조에 이미 정보학과 연결되는 논리와 내용을 가지고 있는데, 한국에서는 정보기술(IT)의 아류 정도로 보는 편협하고 왜곡된 시각이 주도적인 가운데 시작된 것으로 보인다. 결과적으로 한국 생물정보학은 유전학 및 생명과학과의 통합적인 변에서는 결함을 노출하고 있다. 이러한 유전적 정보의 생산 구조가 가지는 문제점으로 인하여 한국에서 유전적 정보는 기초가 부실한 편이며 파편화된 유형으로 생산되어 나올 개연성을 가진다. 개념적, 제도적인 파편화의 사례는 개인식별의 유전학이 기존의 유전공학-유전학교실 체제로 흡수되지 못하고 의과대학 법의학교실에서 전문성과 연구실천을 확보한 것에서도 확인된다. 유전적 정보의 생산 구조에 영향을 미치는 환경은 한국의 생명공학과 시민사회운동으로 존재한다. The factors contributing to the formation of an important scientific concept in South Korea and its circulation in the society are the scientific knowledge that had been already formed, matured, and established in the U.S.A, Europe and Japan and has been introduced into Korea, and the institutions that have been formed during the recent modernization in South Korea. The concept of "genetic information" cannot be an exception in this context. The concept of genetic information is the one that has been extended and intensified by the genornics and bioinformatics formed and matured through the Human Genome Projects from the former concept of inheritance or heredity within the framework of classical and molecular genetics. The purpose of this study was to find out "how the production structure of genetic information in South Korea has been formed", under the perspective of the conceptual, epistemic, and institutional holisticity or integratedness in the concept and knowledge production structure idealized in Western advanced nations. The discourse of genetic engineering popular in the mid 1980's in South Korea has catalyzed the development of molecular biology. However, the institutional balance that had been established for the biochemistry departments in Natural Science College and Medical College was not formed between the genetic engineering and genetics departments in South Korea. Therefore, they were unable to achieve the more integrative and macro-level disciplinary impact on life sciences, largely due to institutional lack of the capable (human) genetics departments in some leading Korean colleges of Medicine. In genomics, the cutting-edge reprogramming and restructuring of the traditional genetics in the West, South Korea has not invested, even meagerly, in the infrastructure, fund, and research and development (R & D) for the Basic or First Phase of the research trajectory in the Human Genome Project. Without a minimal Basic Phase, the genomics research and development in Korea has been running more or less for the Advanced or Second Phase. Bioinformatics has started developing in Korea under a narrow perspective which regards it as a mere sub-discipline of information technology (IT). Having developed itself in parallel with genomics, bioinformatics contains its own unique logics and contents that can be both directly and indirectly connected to the information science and technology. As a result, bioinformatics reveals a defect in respect of being synergistically integrated into genetics and life sciences in Korea. Owing to the structural problem in the production, genetic information appears to be produced in a fragmented pattern in the Korean society since its fundamental base is weak and thin. A good example of the conceptual and institutional fragmentedness is that 'the genetics of individual identification' is not a normal integrated part of the Korean genetics, but a scientific practice exercised in the departments of legal medicine in a few Medical Colleges. And the environment contributing to the production structure of genetic information in South Korea today comprises "sangmyung gonghak"(or life engineering) discourse and non-governmental organization movement.

유전자감식의 제문제 ; 개인 유전정보의 형사사법적 이용의 문제점과 이에 대한 해결방안

윤영철 ( Young Cheol Yoon ) 한국형사정책학회 2006 刑事政策 Vol.18 No.2

The high technology in modern society like bio-technology or information technology requires more and more the use of individual genetic information not only in the field of research or medical service but also in the criminal procedure. In spite of the growing demand, so far there is no appropriate legal rules which set up to control the use of the individual genetic information in the criminal courts in a way to protect the personal information. As the criminal justice deals with the punishment which will seriously affect one`s basic benefit of the law, the use of the genetic information in a criminal court should be carefully controlled. On the other hand it is not imaginable and undesirable to totally prohibit it, for the use of genetic information apparently gives undeniable benefits to us. So it is the only choice left to us to make out technical and normative criterions in using the genetic information, the DNA Databank, etc., with them to fulfil the important, seemingly conflicting, values, for example the efficiency of criminal justice and the protection of the human rights of the suspects. At the same time the traditional principles of criminal procedure should also be taken into account. In this article several issues are pointed out and their solutions are suggested. At first, it recommends to set up concrete technical and normative criterions for the genetic identification which should secure at least reliability, propriety, fairness. Secondly, the strict reliability-criterions and permission-requisites of DNA evidence should be set up in order to find out the feasibility of it as evidence. Thirdly, in case of the DNA Databank, the technical and normative criterions for its reasonable operation should be set up and the procedural requisites for its transparent and fair operation should be regulated by law. And lastly, it suggest that there should be active public discussions to make more objective judgments on the social benefits and harms of high technology, the efficiency of the criminal justice, the protection of individual information, the usefulness and limits of genetic information in the criminal justice, etc.