Sharing Data under the 21st Century Cures Act

Abstract

On 13 December 2016, President Obama signed the 21st Century Cures Act (“the Act”) into law. Many of its provisions support the creation of an “Information Commons,” an ecosystem of separate but interconnected initiatives that facilitate open and responsible sharing of genomic and other data for research and clinical purposes. The Act also addresses potential barriers to data sharing. At the same time, the Act exacerbates or neglects several challenges, including increasing complexity by adding a new definition of “identifiable” and failing to address the financial sustainability of data sharing and the scope of commercialization. In sum, the Act is a positive step, yet there is still much work to be done before the goals of broad data sharing and utilization can be achieved.

Keywords: 21st Century Cures Act; Certificates of Confidentiality; Data Sharing; HIPAA; Privacy