NIH Needs ‘Honest Broker’ To Manage New COVID-19 Data Warehouse
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The health agency is looking for a vendor to act as a “neutral intermediary” to spur research without compromising patient privacy.
The National Institutes of Health is standing up a new research data sharing initiative around COVID-19 and needs an “honest broker” to manage the data warehouse and protect patient privacy.
NIH has stood up a number of efforts specifically to combat the COVID-19 pandemic, including a new program under the National Center for Advancing Translational Sciences called the National COVID Cohort Collaborative, or N3C.
“N3C is building a centralized national data resource that the research community can use to study COVID-19 and identify potential treatments as the pandemic continues to evolve,” according to a sources sought notice posted Wednesday to beta.SAM.gov. “Specifically, the N3C will enable the rapid collection and analysis of clinical, laboratory and diagnostic data from hospitals and health care plans. Collaborators will contribute and use COVID-19 clinical data to answer critical research questions to address the pandemic.”
To ensure the program does not run afoul of health data privacy rules, NIH “requires the services of an honest data broker for the NIH COVID-19 data warehouse to ensure the privacy and confidentiality of the clinical data it contains,” the notice states.
While NIH certainly is not interested in contracting with a dishonest vendor, “honest data broker” is an industry term used to define the work of clinical data middlemen at a time when health data remains extremely sensitive but is no longer managed by the patient.
“Prior to the age of big data, privacy was protected by individuals who maintained control over their own personal information,” researchers wrote in a paper published on PeerJ in 2015 entitled, “Establishing the role of honest broker: bridging the gap between protecting personal health data and clinical research efficiency,” cited by NIH’s National Center for Biotechnology Information.
“In other words, research subjects provided informed consent about (1) to whom, (2) how, (3) for what purpose, and (4) to what extent they would provide their personal information,” the paper continues. “However, in the current age of big data, ‘informed consent’ may no longer be a realistic and efficient method for protecting privacy.”
Instead, researchers can use the honest data brokers framework to anonymize patient data—including removing “direct and possible identifiers”—in order to further research without compromising patient privacy or requiring additional layers of consent.
“In other words, although identifiers were available when the data were collected or stored, these identifiers can be removed or unlinked from the clinical data for the intentional purpose of satisfying the consent waiver and protecting participant information before sharing data,” according to the report’s authors.
The N3C notice puts it another way: “The role of the honest broker is to stand as a neutral intermediary between the sources of clinical data for the warehouse and the warehouse itself to ensure the privacy and confidentiality of the data itself.”
The future vendor must have “extensive expertise as an honest data broker,” with specific experience enabling sharing of and collaboration around clinical and research data. The contractor must also be able to move fast, as NIH expects the honest broker services to be stood up “immediately.”
NIH is expecting a quick turnaround on this contract, with an anticipated period of performance from Aug. 1 through Dec. 31, 2020.
Responses to the RFI are due by 8 a.m. Aug. 3, and should include information on staff expertise; current capabilities; prior work of a similar nature; management and senior level experience; and “examples of prior contracts, grants or other arrangements whereby you provided honest data broker services involving clinical data.”
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