Sharing data under the 21st century cures act

Mary A. Majumder, Christi J. Guerrini, Juli M. Bollinger, Robert Cook-Deegan, Amy L. Mcguire

    Research output: Contribution to journalReview article

    7 Scopus citations

    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. For example, the Act supports the National Institutes of Health in mandating data sharing, provides funding and guidance for the large national cohort program now known as All of Us, expresses congressional support for a global pediatric study network, and strengthens patient access to health information. The Act also addresses potential barriers to data sharing. For example, it makes the issuance of certificates of confidentiality automatic for federally funded research involving "identifiable, sensitive" information and strengthens the associated protections. At the same time, the Act exacerbates or neglects several challenges, for example, 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.

    Original languageEnglish (US)
    Pages (from-to)1289-1294
    Number of pages6
    JournalGenetics in Medicine
    Volume19
    Issue number12
    DOIs
    StatePublished - 2017

    Keywords

    • 21st century cures act
    • Certificates of confidentiality
    • Data sharing
    • Hipaa
    • Privacy

    ASJC Scopus subject areas

    • Genetics(clinical)

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  • Cite this

    Majumder, M. A., Guerrini, C. J., Bollinger, J. M., Cook-Deegan, R., & Mcguire, A. L. (2017). Sharing data under the 21st century cures act. Genetics in Medicine, 19(12), 1289-1294. https://doi.org/10.1038/gim.2017.59