Key Law and Policy Considerations for Clinical Bioinformaticians

This chapter describes five key areas in which clinical bioinformatics activities are regulated by law and policy. These are, namely, open-data requirements, consent practices, anonymization strategies, restrictions on cross-border data transfer, and prohibitions on genetic discrimination. The discussion draws on examples of norms that are currently in effect in North America, Europe, Asia, and Oceania in order to illustrate the ways in which positions on various specific questions can either mutually converge or deviate from one another around the globe. The tension that animates virtually all of the debates throughout this area, whether explicitly or through proxy issues, this chapter argues, is between the promotion of the interests of research participants—particularly in ensuring data privacy—on the one hand, and in establishing a landscape optimized to best promote medical research discoveries, on the other.