Risks and Legal Protections in the World of Big-Data

The development of large electronic data sets, whether from electronic health records, health registries, or large-scale gene-environment interaction studies, offer unparalleled, innovated opportunities to learn more about human health and disease. However, because these data may be used in unexpected ways without the knowledge or consent of individuals whose data are being used, they also raise critical concerns about protections of individuals against risks. Traditional approaches to protecting research participants and patients may not address new or heightened risks in the "bid data" area.