New findings from the accumulation of human gene sequence data and associated personal clinical data and medical information (hereinafter simply referred to as "genetic information") are indispensable for medical innovation. To elucidate the mechanism of an unknown disease, it is important to share and analyze a large amount of genetic information. Conversely, it is important to guarantee a monopoly (i.e., control) of specific information by a specific person to provide an incentive for investment in research and development of new medical products, such as new drugs. Maintaining an appropriate balance between sharing and safeguarding genetic information is an issue common to all, regardless of nationality. Since 2008, the use of next-generation sequencers has spread, drastically reducing the cost and time required for gene sequencing . More and more genetic tests are being performed worldwide and the accumulation of genetic information has accelerated in various countries. This collection of genetic information ranges from biobanks, where public or private research institutes store biological samples (e.g., blood or human tissue) collected from patients or healthy individuals for research purposes, to direct-to-consumer genetic diagnostic services provided by private companies. Because genetic testing requires only a small biological sample, some of these samples are transported across borders to be analyzed and collected as gene sequence data in other countries. Factors influencing the cross-border transfer of genetic information can be divided into the following two aspects: practical factors and institutional factors. Unless restricted by law, as in China, genetic information will flow from one country to another where it is much easier to handle, collect, or utilize in general. Genetic information for medical innovation can be stored in each country or across borders, although this is intricately affected by various factors. Considering these situations, the purpose of this study is to identify policy issues and recommend possible solutions related to domestic and cross-border sharing and the control of genetic information for medical innovation, given the recent rapid accumulation of genetic information and cross-border transfers. Specifically, this study will compare institutional and practical aspects of genetic information accumulation infrastructure in Japan and the U.S. to understand the characteristics and differences between these two countries, and explore the factors associated with the cross-border transfer of genetic information. Findings of the study will contribute to future efforts related to policy making for the medical industry, national security, and international cooperation. To achieve these objectives, this study consists of the following three parts: (1) a comparative study of Japanese and U.S. policies and legislation affecting the sharing and control of genetic information, (2) a field survey of the collection and utilization status of genetic information in both countries, and (3) an analysis of the influential factors on the domestic and cross-border collection status.