Tag: data sharing

Illustration of multicolored profiles. An overlay of strings of ones and zeroes is visible

Taking Data Sharing Seriously: Public Interest and Solidarity as Principles for an International Pandemic Treaty

The Petrie-Flom Center Staff Leave a comment

This post was originally published on the Verfassungsblog as part of our joint symposium on international pandemic lawmaking.

By Ciara Staunton and Deborah Mascalzoni

COVID-19 demonstrated the interconnectedness of the world and that our collective protection and well-being is contingent on our individual response. The importance of solidarity and acting in the public interest became key messages in public health, as too were these principles justified as the basis for data-sharing across borders. Accessing this data was critical and its timely access to this data was essential in research for the much-needed new vaccines.

Solidarity can be understood as the commitment to carry costs to assist others. In the same way that we were told to keep away from loved ones (the cost) to stop the spread of the virus (to assist others), individuals were encouraged to share their data with researchers and in turn researchers were encouraged to share their data with other researchers (the cost) to develop vaccines (to assist) for the global collective benefit (others). The response was remarkable. Data sharing became the default (the cost), vaccines were rapidly developed (to assist), but herein the solidarity pathway stopped. Access was (and still is) largely driven by national and private interests rather than the global collective benefit.

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Illustration of a man and a woman standing in front of a DNA helix

A Proposal for Localized Review to Safeguard Genetic Database Privacy

Robert Field Leave a comment

By Robert I. Field, Anthony W. Orlando, and Arnold J. Rosoff

Large genetic databases pose well-known privacy risks. Unauthorized disclosure of an individual’s data can lead to discrimination, public embarrassment, and unwanted revelation of family secrets. Data leaks are of increasing concern as technology for reidentifying anonymous genomes continues to advance.

Yet, with the exception of California and Virginia, state legislative attempts to protect data privacy, most recently in Florida, Oklahoma, and Wisconsin, have failed to garner widespread support. Political resistance is particularly stiff with respect to a private right of action. Therefore, we propose a federal regulatory approach, which we describe below.

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A data set that looks like America

Oliver Kim Leave a comment

By Oliver Kim

May marks the annual Asian American and Pacific Islander Heritage Month, which recognizes the history and contributions of this diverse population in the United States. Accounting for that diversity though is one of the challenges facing the Asian American-Pacific Islander (AAPI) community: for example, the Library of Congress commemorative website recognizes that AAPI is a “rather broad term” that can include

all of the Asian continent and the Pacific islands of Melanesia (New Guinea, New Caledonia, Vanuatu, Fiji and the Solomon Islands), Micronesia (Marianas, Guam, Wake Island, Palau, Marshall Islands, Kiribati, Nauru and the Federated States of Micronesia) and Polynesia (New Zealand, Hawaiian Islands, Rotuma, Midway Islands, Samoa, American Samoa, Tonga, Tuvalu, Cook Islands, French Polynesia and Easter Island).

Understanding that diversity has huge policy and political implications, particularly in health policy. Read More

Sharing Data for 21st Century Cures – Two Steps Forward…

Genetics in Medicine Leave a comment

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

The 21st Century Cures Act was passed with support from both sides of the aisle (imagine that!) and signed into law by then-President Obama late last year. This ambitious legislation drives action in areas as diverse as drug and device regulation and response to the opioid epidemic. It also tackles the issue of how to make data more broadly available for research use and clinical purposes. In our recently published GIM article, “Sharing data under the 21st Century Cures Act,” we examine the Act’s potential to facilitate data-sharing, in line with a recent position statement of the American College of Medical Genetics and Genomics. We highlight a number of provisions of the Act that either explicitly advance data-sharing or promote policy developments that have the potential to advance it. For example, Section 2014 of the Act authorizes the Director of National Institutes of Health to require award recipients to share data, and Section 4006 requires the Secretary of Health and Human Services to promote policies ensuring that patients have access to their electronic health information and are supported in sharing this information with others.

Just as relevant, the Act takes steps to reduce some major barriers to data sharing. An important feature of the Act, which has not been extensively publicized, is its incorporation of provisions from legislation originally proposed by Senators Elizabeth Warren and Mike Enzi to protect the identifiable, sensitive information of research subjects. Senator Warren, in particular, has been a vocal advocate of data sharing. Arguably, one of the biggest barriers to sharing is public concern about privacy. The relevant provisions address this concern chiefly via Certificates of Confidentiality. Among other things, the Act makes issuance of Certificates automatic for federally-funded research in which identifiable, sensitive information is collected and prohibits disclosure of identifiable, sensitive information by covered researchers, with only a few exceptions such as disclosure for purposes of other research. These protections became effective June 11, 2017. While NIH has signaled its awareness of the Act, it has not yet updated its Certificates of Confidentiality webpage. Read More