Security controls in an integrated Biobank to protect privacy in data sharing: rationale and study design

BMC Medical Informatics and Decision Making

Technical Advance

Masao Nagasaki¹  Hiroaki Hashizume¹  Yoshio Kawaguchi¹  Tomo Saito¹  Gen Tamiya¹  Takako Takai-Igarashi¹  Satoshi Nagaie¹  Soichi Ogishima¹  Hiroshi Tanaka¹  Kengo Kinoshita²  Masayuki Yamamoto³  Sachiko Nagase³  Naoko Minegishi³  Atsushi Hozawa³  Yoichi Suzuki³  Shinichi Kuriyama⁴  Shigeo Kure⁵  Naoki Nakamura⁵  Kichiya Suzuki⁵  Nobuo Yaegashi⁵  Fuji Nagami⁵ 

[1] Tohoku Medical Megabank Organization, Tohoku University, 2-1 Seiryo-machi, Aoba-ku, Sendai, Japan;Tohoku Medical Megabank Organization, Tohoku University, 2-1 Seiryo-machi, Aoba-ku, Sendai, Japan;Graduate School of Information Sciences, Tohoku University, Sendai, Japan;Tohoku Medical Megabank Organization, Tohoku University, 2-1 Seiryo-machi, Aoba-ku, Sendai, Japan;Graduate School of Medicine, Tohoku University, Sendai, Japan;Tohoku Medical Megabank Organization, Tohoku University, 2-1 Seiryo-machi, Aoba-ku, Sendai, Japan;Graduate School of Medicine, Tohoku University, Sendai, Japan;International Research Institute of Disaster Science, Tohoku University, Sendai, Japan;Tohoku Medical Megabank Organization, Tohoku University, 2-1 Seiryo-machi, Aoba-ku, Sendai, Japan;Graduate School of Medicine, Tohoku University, Sendai, Japan;Tohoku University Hospital, Tohoku University, Sendai, Japan;

关键词: Personalized healthcare;    Biobank;    Privacy violation risk;    Personal genome data;    Personal health data;    Data sharing policy;    Security policy;    Remote access;   

DOI  :  10.1186/s12911-017-0494-5

 received in 2016-09-07, accepted in 2017-06-27,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundWith the goal of realizing genome-based personalized healthcare, we have developed a biobank that integrates personal health, genome, and omics data along with biospecimens donated by volunteers of 150,000. Such a large-scale of data integration involves obvious risks of privacy violation. The research use of personal genome and health information is a topic of global discussion with regard to the protection of privacy while promoting scientific advancement. The present paper reports on our plans, current attempts, and accomplishments in addressing security problems involved in data sharing to ensure donor privacy while promoting scientific advancement.MethodsBiospecimens and data have been collected in prospective cohort studies with the comprehensive agreement. The sample size of 150,000 participants was required for multiple researches including genome-wide screening of gene by environment interactions, haplotype phasing, and parametric linkage analysis.ResultsWe established the TohokuMedicalMegabank (TMM) data sharing policy: a privacy protection rule that requires physical, personnel, and technological safeguards against privacy violation regarding the use and sharing of data. The proposed policy refers to that of NCBI and that of the Sanger Institute. The proposed policy classifies shared data according to the strength of re-identification risks. Local committees organized by TMM evaluate re-identification risk and assign a security category to a dataset. Every dataset is stored in an assigned segment of a supercomputer in accordance with its security category. A security manager should be designated to handle all security problems at individual data use locations. The proposed policy requires closed networks and IP-VPN remote connections.ConclusionThe mission of the biobank is to distribute biological resources most productively. This mission motivated us to collect biospecimens and health data and simultaneously analyze genome/omics data in-house. The biobank also has the mission of improving the quality and quantity of the contents of the biobank. This motivated us to request users to share the results of their research as feedback to the biobank. The TMM data sharing policy has tackled every security problem originating with the missions. We believe our current implementation to be the best way to protect privacy in data sharing.

【 授权许可】

CC BY   
© The Author(s). 2017