Kogetsu Atsushi, Ogishima Soichi, Kato Kazuto
Department of Biomedical Ethics and Public Policy, Graduate School of Medicine, Osaka University, Suita, Japan.
Department of Bioclinical Informatics, Tohoku Medical Megabank Organization, Tohoku University, Sendai, Japan.
Front Genet. 2018 Jun 1;9:167. doi: 10.3389/fgene.2018.00167. eCollection 2018.
Genome and other data are already being used in areas including cancer and rare diseases. Data-sharing and secondary uses are likely to become much broader and far more extensive; thus, obtaining proper consent for these new uses of data is an important issue. Obtaining consent through online methods may be an option to overcome the problems associated with one-off, paper-based informed consent. When the process of obtaining consent takes place remotely, authentication must be assured. Patients may also choose to store some of their own information online, such as genetic information, and allow healthcare professionals to access this data. In this health information transfer and exchange process, it is vital that anyone accessing this information be correctly authenticated to protect patients' privacy. In this article, we first clarified that authentication has two roles: i.e., not only to prevent impersonation but also to prove intent, which is a vital step to ensure that medical research and health information exchange are conducted ethically. We then set out methods of authentication. As a result, we were able to make suggestions about the requirements for authentication and a possible method of authentication for these purposes. We considered problems of biometrics and recommended two-factor authentication without biometrics as a workable solution. However, three-factor authentication including biometrics seems likely to be used once biometrics become more common.
基因组和其他数据已在包括癌症和罕见病等领域得到应用。数据共享和二次使用可能会变得更加广泛；因此，就数据的这些新用途获得适当的同意是一个重要问题。通过在线方式获得同意可能是克服与一次性纸质知情同意相关问题的一种选择。当远程进行同意获取过程时，必须确保身份验证。患者也可能选择在网上存储他们自己的一些信息，如基因信息，并允许医疗保健专业人员访问这些数据。在这个健康信息传输和交换过程中，任何访问此信息的人都必须经过正确身份验证以保护患者隐私，这至关重要。在本文中，我们首先阐明身份验证有两个作用：即不仅要防止冒名顶替，还要证明意图，这是确保医学研究和健康信息交换符合道德规范的关键步骤。然后我们阐述了身份验证方法。结果，我们能够就身份验证的要求以及为此目的可能的身份验证方法提出建议。我们考虑了生物识别技术的问题，并推荐无生物识别技术的双因素身份验证作为可行的解决方案。然而，一旦生物识别技术变得更加普遍，包括生物识别技术的三因素身份验证似乎可能会被使用。
