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 an unparalleled, innovative 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 “big data” era. My research colleagues and I conducted legal research to elucidate the web of legal protections afforded research participants in genomic research, including laws governing human subjects research, privacy, consent, discrimination, and use of research participants’ genetic information. It has revealed substantial regulatory activity and variation across the 50 states that may fill known gaps in federal protections. For example, some states go further than the Genetic Nondiscrimination Act (GINA) by extending genetic antidiscrimination statutes to life and disability insurers or to employers with less than 15 employees. In addition, states explicitly provide remedies, such as statutory damages, attorneys’ fees, and costs that can facilitate enforcement of legal rights not afforded in federal laws. This research has broader implications for data use in other research or in health care settings. In this paper, I suggest how this research can inform approaches to data privacy law in the United States and beyond to provide appropriate protections as health systems and scientists seek to harness the promise of big data while respecting individuals’ interests in their data.