Authentication of Patients and Participants in Health Information Exchange and Consent for Medical Research: A Key Step for Privacy Protection, Respect for Autonomy, and Trustworthiness.

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.