As described above, the Precision Medicine Initiative needs a large amount of data sharing associated with genetic information of individuals. Of course such initiative needs more rigorous privacy protection beyond the traditional way of data protection. Patient participants have been more and more involved in this initiative in terms of the design as well as the appearance in the webpages. Whatever you achieve with their participation, it should be based on traditional ethical obligations to protect the right of privacy derived from the respect to human dignity. The US Health Insurance Portability and Accountability Act (HIPAA) [51] of 1996 and the Privacy Rule [52] of 2000 stipulated the definition of protected health information (PHI) and how it could be “de-identified” (by removing some individual identifiable information) to be exempted from the regulations. The 2012 report of President’s Commission on ethics of whole-genome sequencing [10] reflected that items defined as de-identification in HIPAA regulation may not be actually enough for anonymity purposes. In such case, one option is to redefine more sophisticated ways of de-identification of the genome-sequenced data by means of information technology. Another option would be to obtain informed consent of study subjects to use their “de-identified” data, which may not be in complete anonymity. While both options may be needed in certain circumstances, more rigorous data security infrastructure is required. Additionally, some mechanisms may be needed where only a “qualified” investigator can access such information.

In case of brain imaging, there are additional issues. One issue is that MRI brain imaging data may be reconstructed to such image of face, which enable subject’s acquaintances to identify whose image it is. Development of a technology to “deface” brain MRI data has been discussed, but there would be some cases, in which such procedures are not practical. In such a case, the abovementioned informed consent comes to be required. Another issue is arising, regarding studies of Alzheimer’s disease, in which brain imaging is associated with pathological autopsy analysis. This type of studies not only need the “informed consent” of a subject for imaging examination but also “advance directive” of this subject during living time for future autopsy analysis, which has a nature of “broad consent” (without complete information of future studies). Furthermore, and upon the death of this subject, “legal permission (or authorization)” for autopsy by a family member of a deceased is required by law. Similarly, a “surrogate consent” by a family member may be needed to perform association studies and enable to compare brain images with tissue pathological analysis.

When you take a strategy of patient involvement, expanding awareness, and empowerment to them, you need further efforts to assure their “right to know” and “right not to know.” The right to know means patients’ right to control, including access to, their own information. This right is derived from fundamental privacy right, a part of a personal right, a corollary of human dignity. A recent discussion on this issue goes beyond the traditional issue of informed consent at the time of inclusion of a study subject. The Declaration of Helsinki [53], international ethical principles for medical research involving human subjects by the World Medical Association, recommends to provide the research subject with an option of being informed about the study results. Also, the European Union’s Clinical Trial Regulation [54], implemented in 2016, requires the investigators to provide participants with an identifier number of clinical trial registration by which the ongoing trial information and trial results are open to public. In addition to the study’s information or outcome, there is an issue of “incidental findings.” For example, during the process of brain imaging for neuro-imaging study, the researcher may find a brain tumor as an unintended or incidental finding [55]. In this case the ethical question is: does this neuroscientist has the obligation to provide care for this brain tumor? A priori, the immediate perception is that the investigator’s ethical obligation is to deal with such incidental finding properly. Logically, if the neuroscientist does not have the expertise to provide proper treatment for the brain tumor, he or she should advise this patient to consult with an oncologist. There may be other cases in which an investigator could provide care for a disease revealed as incidental findings (e.g., comorbidity diseases), which is called “ancillary care” [56]. The issue is particularly problematic in the case of epidemiological studies in developing country, where ancillary care may not be available in the ordinary practice [57]. To what extent the investigator has to provide care, or who should pay for this additional medical expenditure, depends on how the study’s protocol was designed and the nature of the particular situation. At the very least, the researchers are obliged to define at the time of protocol development how this kind of incidental findings should be managed, including who should pay for what.