Privacy is protected in biobank-based research in the U.S. primarily by Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the Federal Policy for Protection of Human Subjects (Common Rule). Neither rule, however, was created to function in the unique context of biobank research and therefore neither applies to all biobank based research. Not only is it challenging to determine when the HIPAA Privacy rule or the Common Rule apply, but these laws apply different standards to protect privacy. In addition, many other federal and state laws may be applicable to a particular biobank, researcher, or project. U.S. law also does not directly address international sharing of data or specimens outside of the EU - US Safe Harbor Agreement, which only applies to receipt of data by certain U.S. entities from EU countries, and is in the process of revision. Although new rules would help clarify privacy protections in biobanking.'Leviathan in the Commons: Biomedical Data and the State' by Jorge L. Contreras in Katherine Strandburg, Brett Frischmann and Michael Madison (eds) Governing Medical Knowledge Commons (Cambridge University Press, 2017 Forthcoming) analyzes
the role that the state has played with respect to the generation and management of large repositories of scientific data, situating it within the context of commons theory and the organization of common pool resources. Extending beyond the traditional “big science” conception of the state as creator/provisioner of large-scale scientific data pools, and the literature of state-based innovation incentives, this chapter identifies nine distinct but interdependent roles that the state has played in assembling and maintaining scientific data sets. It uses as a case study the U.S. federal government’s engagement with genomic research projects beginning with the Human Genome Project and encompassing a range of federally-funded, public-private and private sector projects. It then assesses the potential roles that the state may play in the formation and maintenance of new pools of biomedical data, namely data from clinical trials. The analytical framework described in this chapter offers a means by which state engagement with data-intensive research projects may be compared across agencies, fields and national borders. This framework may be used to assess the effectiveness of state engagement in such research programs and to configure state engagement in new data commons in a manner that can enhance the efficiency and effectiveness of data sharing arrangements and improve overall social welfare.'The Right to Try and the Future of the FDA in the Age of Personalized Medicine' (Mercatus Center, Working paper Series, 2016) by Adam D. Thierer asks
Do citizens have the right to determine their own courses of treatment and to use medicines and devices that they think could improve their health? And, to the extent regulators seek to restrict that freedom, what is the practicality and cost of doing so? These questions animate the debate over the so-called “right to try,” a growing movement to allow terminally ill individuals to experiment with alternative medical treatments, therapies, and devices that are tightly controlled by the Food and Drug Administration (FDA). This essay argues that such an expansion of the right-to-try notion may be happening already as technological innovation decentralizes and democratizes medical decisions. This expansion does not mean that all FDA regulation will fade away, but it will necessitate a move away from the agency’s command-and-control methods of the past and toward a new focus on patient empowerment through enhanced choice, improved risk education, and clearer consent mechanisms.