보건의료 학술연구를 위한 공공데이터의 이차 활용 법제개선에 관한 연구 : 생체‧의료정보와 유전체정보를 중심으로
Public Data, Secondary Use, Privacy, Bio·Medical Information, Genomics Data
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초록
공공기관이 수집‧처리하던 디지털화된 개인정보는 전자정부 촉진정책으로 인해 그 관리 측면에서 획기적인 효율성을 갖게 되었다. 공공데이터는 정보통신기술의 발전에 따라 원래의 수집목적 외로 이차 활용의 요구가 증가하고, 활용분야는 더욱 광범위해지는 추세이다. 보건의료분야에서는 국민건강보험공단이나 건강보험심사평가원등에서 수집된 정보를 공중보건사업의 수행이나 정책연구를 위한 이차 활용한지도 상당한 시간이 지났다. 최근에는 대규모의 유전체 분석정보, 임상정보, 의료기기를 통해 얻을 수 있는 정보까지 함께 재조합하여 신약개발, 질병예방, 희귀난치성 질환 치료 등 보건의료관련 공공데이터의 이차 활용 영역은 확대되었다. 정부는 각 공공기관 간 데이터베이스를 공유하고, 수집목적 외로 활용할 수 있도록 법률을 개선하였다. 그리고 학술연구뿐 만아니라 산업과 비즈니스 등 다양한 목적을 위해서도 이차 활용할 수 있도록 공공데이터의 제공과 이용활성화를 지원하는 방향으로 제도를 마련하고 있다. 다른 법률에 특별 규정이 있는 경우에는 개인정보를 목적 외로 사용하는 이차 활용을 가능하도록 하고 있고, 정보주체의 동의 없이 사용해야 하는 경우는 익명화 처리를 하여 활용할 수 있도록 함에도 불구하고 여전히 학술연구를 위한 이차 활용은 활발하지 못한 실정이다. 아직까지 개인정보보호법이 이차 활용의 걸림돌이 된다는 평가는 이차 활용을 하는 주체가 누구인가, 어떤 목적으로 이차 활용하는가에 따라 정보주체의 프라이버시가 침해될 수 있다는 우려에 기인한다. 본 연구는 보건의료 학술연구 목적의 이차 활용을 위한 공공데이터의 공유 및 이용과 관련된 법률을 고찰하여 개인정보 보호의 한계를 살피고, 정보프라이버시 보호와 공공데이터의 이차 활용의 조화를 위하여 절차적 요건으로서 규범변화의 방향을 제언한다.
Abstract
The aim of this study is to suggest how to strike a balance between the benefits of secondary use of public data and rights of self-determination for other purposes that within frameworks of personal data protection laws. Particularly, the research sought to find common ground between private rights and public interest by specifying privacy issues which could be threatened by secondary use of sensitive information such as bio or medical information. Each public agency uses aggregated databases which enable extraction of new meanings and utilization of individual dataset. While not new, these issues play increasingly critical and complex roles given that the Information and Communication Technology Revolution has created a dilemma regarding individual privacy. The nature of the utilization of public data from the database by various public agencies causes them to hold and collect personal information beyond the primary purposes in common databases as secondary use of personal information, incurring serious cases of legal violation of information usage. Essentially all bio or medical information in public agencies are sensitive and require protection in varying degrees. Theoretically, only limited processing of such information is allowed, and no special laws can exempt consent. In other words, priority is given to a subject's right of self-determination. The idea concerning privacy and public interest is embedded within a complementary ‘using vs. protecting’ concept that is not trusted by the owner(s) of the data. There is clearly a need to consider whether the Government is balancing this critically important relationship between data subjects and personal information and whether the current approach is fit for its purpose. The current special law in place exempts written consent upon approval of Institutional Bioethics Committee, thereby allowing researchers to utilize data for secondary use without consenting process. Nonetheless, in such case of exemption, the principle of proportionality should be met by allowing a subject to practice his or her right of self-determination. As the secondary use of personal information is randomly scattered in the database of the public and collected beyond primary purposes, the minimized use of personal information protected by common law is likely to be violated with the absent clarity in the norms of secondary usage of personal information. Laws to protect personal information protect the interests of the people by requiring consent at every step of information process. Secondary use, however, does not require consent according to a special law that exempts such condition. The problem is exacerbated when every public agency adheres to different special laws that reflect the objectives of each agency. Restricting the right of self-determination on sensitive information such as bio or medical information must notify subjects the purposes in which their information will serve and how the information is being processed. Whether purpose is justifiable for the sake of public is directly related to the roles of Data Protection Authorities which deliberates the process of secondary use. In the new phase of the secondary use of public information, this study attempts to balance between public interest and private rights as well as ‘using’ and ‘protecting’ through the review procedures to ensure the data subject’s rights including the broad consent to entrust personal data processing in case of substitution.
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