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

4 Citations (Scopus)

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 - Jan 1 2017

Fingerprint

Information Dissemination
Access to Information
Confidentiality
National Institutes of Health (U.S.)
Research
Ecosystem
Pediatrics
Health

Keywords

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

ASJC Scopus subject areas

  • Genetics(clinical)

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

Sharing data under the 21st century cures act. / Majumder, Mary A.; Guerrini, Christi J.; Bollinger, Juli M.; Cook-Deegan, Robert; Mcguire, Amy L.

In: Genetics in Medicine, Vol. 19, No. 12, 01.01.2017, p. 1289-1294.

Research output: Contribution to journalReview article

Majumder, MA, Guerrini, CJ, Bollinger, JM, Cook-Deegan, R & Mcguire, AL 2017, 'Sharing data under the 21st century cures act' Genetics in Medicine, vol. 19, no. 12, pp. 1289-1294. https://doi.org/10.1038/gim.2017.59
Majumder MA, Guerrini CJ, Bollinger JM, Cook-Deegan R, Mcguire AL. Sharing data under the 21st century cures act. Genetics in Medicine. 2017 Jan 1;19(12):1289-1294. https://doi.org/10.1038/gim.2017.59
Majumder, Mary A. ; Guerrini, Christi J. ; Bollinger, Juli M. ; Cook-Deegan, Robert ; Mcguire, Amy L. / Sharing data under the 21st century cures act. In: Genetics in Medicine. 2017 ; Vol. 19, No. 12. pp. 1289-1294.
@article{71312bf8d0764731b5592aa6483b4b30,
title = "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. 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.",
keywords = "21st century cures act, Certificates of confidentiality, Data sharing, Hipaa, Privacy",
author = "Majumder, {Mary A.} and Guerrini, {Christi J.} and Bollinger, {Juli M.} and Robert Cook-Deegan and Mcguire, {Amy L.}",
year = "2017",
month = "1",
day = "1",
doi = "10.1038/gim.2017.59",
language = "English (US)",
volume = "19",
pages = "1289--1294",
journal = "Genetics in Medicine",
issn = "1098-3600",
publisher = "Lippincott Williams and Wilkins",
number = "12",

}

TY - JOUR

T1 - Sharing data under the 21st century cures act

AU - Majumder, Mary A.

AU - Guerrini, Christi J.

AU - Bollinger, Juli M.

AU - Cook-Deegan, Robert

AU - Mcguire, Amy L.

PY - 2017/1/1

Y1 - 2017/1/1

N2 - 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.

AB - 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.

KW - 21st century cures act

KW - Certificates of confidentiality

KW - Data sharing

KW - Hipaa

KW - Privacy

UR - http://www.scopus.com/inward/record.url?scp=85044357775&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85044357775&partnerID=8YFLogxK

U2 - 10.1038/gim.2017.59

DO - 10.1038/gim.2017.59

M3 - Review article

VL - 19

SP - 1289

EP - 1294

JO - Genetics in Medicine

JF - Genetics in Medicine

SN - 1098-3600

IS - 12

ER -