Special Notice: Request For Information DIGITAL HEALTH .

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Special Notice: Request for InformationDIGITAL HEALTH SOLUTIONS FOR COVID-19RFI Number: HHS-NIH-NCI-RFI-COVID19-01Contracting Office AddressDepartment of Health and Human Services, National Institutes of Health (NIH), National CancerInstitute (NCI), Office of Acquisitions, Rockville, MDThis is a Request for Information (RFI) for market research. This is NOT a solicitation forproposals or quotations. The purpose of this RFI is to obtain knowledge and information forproject planning purposes.Virtual Meeting for Industry EngagementNCI and NIBIB will host an interchange meeting to give industry an opportunity to communicatewith acquisition personnel and program staff. The virtual meeting will be held on Friday, May29, 2020 from 2:00-3:00 PM EDT. All interested organizations are highly encouraged toattend this meeting and seek clarification about any of the information discussed below beforesubmitting a response. The virtual meeting will be held via WebEx. See Attachment 1 forWebEx information.Written questions about this notice may be submitted electronically via email toDigital Health COVID [email protected] by 5:00 PM EDT on May 27, 2020.PurposeThe National Institute of Biomedical Imaging and Bioengineering (NIBIB) and the NationalCancer Institute (NCI) of the National Institutes of Health (NIH) require services to developdigital health solutions to address the COVID-19 pandemic and enable new research into usingdigital health technologies to advance the public health response. The digital health solutions willfacilitate approaches that leverage multiple data sources, privacy-preserving technologies, andcomputational tools for managing population health and individuals’ lives during the COVID-19pandemic. Such management could include, for example, assessing the readiness of individualsto return to work, calculating the risk of possible SARS-CoV-2 infection, identifying and tracingcontacts of COVID-19 cases, monitoring the health status of infected individuals, or linkingindividuals to clinical trials of therapies or preventative interventions for COVID-19. Particularfocus includes digital health solutions for traditionally underrepresented populations as well asthose with diminished access to healthcare resources.This effort will employ a hub-and-spoke technology implementation model, in which eachsupported digital health solution (the spokes) will be encouraged to share deidentified data andother digital assets it generates with an NIH-supported central data hub. The data hub willprovide researchers a single access point to deidentified data, algorithms, and other capabilitiesPage 1 of 6

generated by the various digital health solutions. Standards that enhance interoperability willenable unambiguous linking of digital resources among the spokes of the hub. This will enableresearchers, for example, to apply a risk classification algorithm developed in one spoke toindividuals’ health data that was collected by other spokes. The purpose of this notice is to obtaininformation for the “spokes of the hub”; not the hub itself.BackgroundIn the midst of the COVID-19 pandemic, there is an urgent need to protect individuals fromcoronavirus exposure while allowing society to return to normal function as quickly as possible.At present, we have only the blunt tools of social distancing and quarantine to contain theepidemic. Being able to precisely deploy containment efforts only where needed may allowlarger segments of the population to return to less restricted living and reduce the risk ofrecurrence of devastating local outbreaks.Novel digital health solutions have the potential to improve care, understanding of healthoutcomes, and risk factors related to the COVID-19 pandemic. This is especially important inunderserved populations, which are disproportionately affected by COVID-19 and often havelimited access to healthcare services. This is also important in its potential to broaden thegeographic understanding of factors related to exposure, spread, and containment.The collection of large digital health datasets has potential privacy implications, so there is anequally urgent widespread interest in providing adequate privacy protections that enable theutilization of personal health data without unduly compromising civil liberties. Anecdotalevidence supports the notion that privacy concerns work against broad adoption of newtechnological data-collection solutions, so it is important to address these concerns transparently,while also balancing them against the need to interrupt the COVID-19 pandemic and facilitatesociety returning to normal.Finally, there is a need for a high-quality COVID-19 research data set that can allow academic,public health, and translational researchers to make discoveries that might otherwise not bepossible from individual, siloed data. Enabling new research into digital health technologies andthe data generated by those technologies has the potential to advance the public health responseand facilitate underlying approaches that could improve future epidemic and pandemic planning.Given the breadth and specialization of digital technologies that might be brought to bear on theCOVID-19 pandemic, it is likely that there are research questions that can only be answered byintegrating and analyzing data generated by multiple different technologies and solutions.Project Requirements & ObjectivesInterested organizations are asked to describe their solution that addresses one or more ofthe following project objectives:Page 2 of 6

A technological solution (such as a smartphone application, commercial wearabletechnology, computational modeling algorithm, or novel approach to data analysis and/oraggregation) that has one or more of the following abilities: tracing user contact with individuals diagnosed with or suspected of havingcontracted COVID-19; rapidly integrating commercial COVID-19 diagnostic test results, patient-reportedsymptoms, wearable sensor data, electronic health records, and/or other diversedata sources with central or decentralized databases; determining likelihood of user having undiagnosed COVID-19; determining risk to user of contracting COVID-19; determining information that individuals, employers, government agencies, andothers can use to evaluate risk of allowing individuals to return to normal work,travel, and public life activities; determining information that healthcare providers can use to follow patients athome and intervene when/if physiological decompensation occurs; matching individuals to clinical trials for COVID-19; ascertaining patterns of movement that influence exposure, spread, andcontainment of COVID-19; providing strong privacy protections to allow integration, analysis, and federationof existing datasets for the purpose of COVID-19-related research; otherwise contributing to limiting the spread of COVID-19, improving the care ofCOVID-19 patients, or enhancing the safety of workplaces, modes of travel, orpublic spaces with regard to COVID-19. Direct access to relevant information to the intended target audience via a high-qualityuser interface. A plan for iterative updates to the solution in order to take advantage of additionalactionable data, computational tools, and/or science as it becomes available. The offerorshould specify how it will monitor the data, tools, and science that is relevant to itssolution, a high-level overview of the process by which it will integrate relevant findingsinto its solution, and any potential advances it sees in its solution as a result of suchupdates. For solutions that collect user data, a set of privacy protections that exist as close to theuser as possible. Individuals (e.g., users of smartphone applications) should be givenevery available opportunity to know how their data is being used, to opt-in to datacollection, and to provide specific assent at any point in which the use of their data willexpand. If personally identifiable information (PII) or protected health information (PHI) iscollected and stored (e.g., on a device, in a platform), a plan for securing and protectingthat information according to privacy laws and regulations. The offeror should describecapabilities to de-identify data for subsequent sharing for research purposes. A pilot to validate the performance, usability, user adoption, and reliability of thesolution, to begin immediately upon completion of a minimal viable version of thesolution. The pilot should include a scaled approach involving populations of increasingsize. The offeror will provide a set of performance metrics it will use to evaluate thefeasibility, utility, and adoption of its approach.Page 3 of 6

A means to transmit data and other digital assets derived from use of the technology intoan NIH-supported data hub for research purposes. The offeror should provide details forsharing both de-identified data as well as data that can be unambiguously linked to othersources in the NIH-supported data hub, such as data generated by other solutions. Planfor possible models for data linkage should describe approaches to be pursued, such as atrusted broker model or privacy-preserving data linkage models. The plan should addresshow data standards, best practices, and documentation will be leveraged to enhance datafindability, accessibility, interoperability and reuse. A plan for how a public roll-out of the solution could be accomplished following thevalidation pilot phase, while incorporating modifications and additional considerationsthat arise during the validation phase. If implementation of the solution will be in conjunction with public health authorities,employers, health care providers, or other partners, a description of the partnership withthe relevant partner. For solutions that might require regulatory oversight, e.g. in the area of clinical decisionsupport, a plan for contact with appropriate U.S. regulatory bodies (e.g. FDA in the formof pre-submission meetings and/or breakthrough device designation), as early invalidation phase as possible. A plan to address any public reporting requirements and other applicable regulations tothe methods proposed.Information SoughtNCI seeks to obtain knowledge and information for project planning from organizations that areinterested in and capable of performing the work described herein. Based on the informationprovided in this notice, organizations may submit a capability statement, which is encouraged tocover the following points:(1) A description of your organization’s solution to address the stated project objective(s)(2) A list of prospective personnel and affiliated organizations/institutions who wouldpotentially be involved with a brief summary of their relevant experience;(3) a summary of successful adoption of similar technologies or other relevant pastperformance or experience that would assist with demonstrating capability to successfullydeliver the proposed solution;(4) A high-level, rough order of magnitude cost and time estimate for your solution, usingthe following phasing milestones:a. Delivering a digital health technology customized for addressing the COVID-19pandemic, while also enabling new research that leverages the data and otherdigital assets generated by the technology. The technology would be able to berapidly deployed within 4 to 8 weeks of the start of a contract for pilot validation.b. Perform an initial pilot study to assess the performance, usability, and reliabilityof the technology for achieving its intended purpose.c. Share de-identified data and other digital assets derived from use of thetechnology for research purposes.Page 4 of 6

d. Deliver a report that includes assessment of the outcomes of this first phase,including the feasibility and utility of the approach for achieving its intendedpurpose, and recommendations for potential movement into a subsequent phase(5) Address whether the organization would consider it feasible to enter into a fixed pricecontract based on achievement of milestones for this type of project.Anticipated NAICS code for this acquisition is 541715, Research and Development in thePhysical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology), whichhas a size standard of 1,000 employees.Information Submission Instructions:1. Page Limitations: A tailored submission is required in response to this RFI.General brochures will not be reviewed. Interested organizations are asked to statethe objective(s) from the Technical Scope section that their solution addresses. Thepage limitation for this RFI is 10 pages.2. Cover Page: Provide a cover page with the business concern’s name, Small BusinessAdministration size standard(s), point of contact and contact information (email andphone), organization’s address, and DUNS number (if available).3. Delivery Point: All information sent in response to this Request for Informationnotice must be submitted electronically (via email) toDigital Health COVID [email protected] in Microsoft Word or Adobe PortableDocument Format (PDF). The subject line must specify HHS-NIH-NCI-RFICOVID19-01.4. Response Date: Electronically submitted responses are due no later than 5:00 PM(Eastern Daylight Time) on June 5, 2020.DISCLAIMER AND IMPORTANT NOTES: This notice does not obligate the Governmentto award a contract or otherwise pay for the information provided in response. The Governmentreserves the right to use information provided by respondents for any purpose deemed necessaryand legally appropriate. Respondents are advised that the Government is under no obligation toacknowledge receipt of the information received or provide feedback to respondents with respectto any information submitted. The Government, at their sole discretion, may contact interestedparties that respond to this inquiry to conduct additional exchange of information and/or marketresearch. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, shouldsuch a requirement material