A11 RWD Data Sources RFI Posted 23Aug24.pdf

Advanced Research Projects Agency for Health (ARPA-H)

REQUEST FOR INFORMATION ON

Real World Data Sources for Health and Healthcare Research

RFI 75N992-24-RFI-102

THIS IS A REQUEST FOR INFORMATION ONLY. In accordance with Federal Acquisition Regulation (FAR) 15.201(e), responses to this RFI are not offers and cannot be accepted by the Government to form a binding contract. This RFI is issued solely for information and planning purposes and does not constitute a Request for Proposal (RFP). In accordance with FAR Part 10, the Government is conducting market research to determine the availability and adequacy of potential business sources in fulfilling its needs around real world healthcare data (See Section 3.0 for details). Proprietary information and trade secrets shall NOT be submitted in response to this RFI. The Government will not review any submittals with proprietary information or trade secrets.

The Government is not obligated to and will not reimburse the Contractor for any costs associated with preparing or submitting a response to this notice and submittals will not be returned to the sender.

This RFI is from the Advanced Research Projects Agency for Health (ARPA-H), 1301 K St NW, Washington DC, 20005

By submitting a response to this RFI, the vendor consents to that submission to be reviewed by Government personnel, Federally Funded Research and Development Center (FFRDC) employees, and Science and Engineering Technical Advisor (SETA) contractors supporting

ARPA-H.

1.0 SUMMARY

The Advanced Research Projects Agency for Health (ARPA-H) is a government agency which seeks to accelerate better health outcomes for everyone by supporting the development of high-impact solutions to society's most challenging health problems. In support of its mission, ARPA-H is conducting market research for potential procurements for real world healthcare data and related services. ARPA-H has a need for real world data (RWD) both to inform strategic direction, as well as on an ad-hoc basis in support of individual mission offices and their research and development programs.

Given the fragmented nature of available data sets, ARPA-H may have analytical needs surrounding the curation and integration of data sets. The Agency seeks technologies that can be used to link records for individuals using privacy preserving record linkage techniques (PPRL) across all data sets.

Additionally, ARPA-H is exploring potential models by which integrated data sets could be made available to the broader research community, complying with relevant privacy and ethics agreements while also lowering the barriers to access for the data. This RFI invites respondents to identify potential economic models, limitations, and potential restrictions in this topic area.

2.0 REQUEST FOR INFORMATION

1.1 The ARPA-H Information Technology and Data Innovation Office (ITDI) is conducting market research to determine if industry and academia have existing data sources and capabilities to meet the Agency’s strategic data needs, as well as the needs of ARPA-H research and development programs.

1.2 The Government will review and consider any product that is customarily available in the marketplace with or without modifications that industry deems capable, or potentially capable, of resolving the problem statement. This market research phase may include follow-up discussion activities to exchange details of potential solutions.

Additional helpful information includes possible candidate products, test data, and an estimated cost to deploy a ready solution.

3.0 STATEMENT OF NEED

Need Area 1: Real World Healthcare Data

To fulfill the mission of ARPA-H to accelerate better health outcomes for everyone, the agency wishes to establish a repository of RWD related to the health and healthcare of the United States population including but not limited to:

• Electronic Health Records (EHR)

• Public and private payer claims

• Prescription claims

• Diagnostic testing

• Social Determinants of Health (SDOH) o Socioeconomic factors, housing insecurity, financial insecurity, psychological pressures, discrimination etc.

• Geolocated environmental factors o Pollutants, Climate, Wastewater testing, Toxicology etc.

ARPA-H has a need to obtain data sets in support of strategic planning for the agency’s activities. Additionally, ARPA-H may have ad-hoc requirements for additional data sets in support of individual mission offices and programs. ARPA-H is exploring the feasibility of obtaining a diverse set of real world data sources, performing privacy preserving linkage of individuals across the data sets and making them available for use in the agency’s mission including conducting preliminary research to inform the design of programs, the general development of insights into health and healthcare from analysis of the data, direct support of research and development programs, and the assessment and evaluation of the effectiveness of ARPA-H programs in improving health outcomes. The agency is seeking to understand the market for these types of data, the capabilities and scope of data sources, the costs for access, and the constraints around the protection of privacy and ethical use of the data. The agency is seeking input from a variety of industry players including but not limited to healthcare providers, private payers, providers of Electronic Health Record platforms that have established secure enclaves for data, environmental health related data providers, and providers of data that represent social determinants of health such as financial and housing insecurity, education, socioeconomic and psychosocial factors

Need Area 2: Data Curation & Integration

In obtaining a significant amount of potentially disparate data, ARPA-H seeks solutions to ensure that data can be federated and integrated for maximum utility. Today, real world data is highly fragmented across healthcare providers, payers, federal agencies, data brokers and providers of healthcare related software such as Electronic Medical Records platforms. This fragmentation is a significant barrier to the ability of researchers to access data sets with the scale and diversity needed to conduct research with appropriate statistical power. Further, disparate data sets are not reliably linked to enable a full picture of an individual person to be understood. These issues result in extensive delays in the startup of new research, high costs to obtain data that is frequently duplicated across data brokers, and greatly varying processes for engaging in the legal agreements required to access the data. The fundamentally federated nature of these data sources also presents barriers to bringing disparate data sets together without significant risks to privacy and security of the data.

For these data to be broadly useful, they will need to be linked across individuals using appropriate privacy preserving record linkage (PPRL) techniques. The agency is seeking input from industry, academia and non-governmental organizations to understand current PPRL technologies and capabilities, the ability to link across disparate data sets, measures of fidelity of match and uncertainty.

The agency recognizes that bringing together diverse data sets from multiple sources is almost certain to require a federated approach and we are seeking input from industry and academia on current capabilities for federation whether they are modeled after the Trusted Research Environment (TRE) pattern, secure data access via Application Programming Interfaces (APIs), provisioning of cloud based databases under the data providers control with access provided to the agency, or more sophisticated methods such as performant homomorphic encryption and secure multi-party computation.

Need Area 3: Real World Data “Public Utility”

One potential goal for the agency is to make such a federated data resource available to the research community as a “public utility”. Doing so would require the development of innovative economic models that could support the availability of data for research while enabling data providers and data brokers to see a reasonable economic return on their investment in collecting and curating data sets. The agency is seeking industry input on the potential economic models that might support such a public utility model, enabling research by lowering barriers to data access while fairly compensating vendors for their investments. The agency is interested in models that establish a marketplace for the data resources that provides agility of access and enables the flow of funds from data consumers to data providers but is open to alternative models. The agency is interested in understanding current licensing and cost models, and how alternative models might be to the benefit of both data providers and data consumers. The agency is also interested in understanding potential limits on data usage as it pertains to privacy, intellectual property, and data rights concerns, as well as mitigation strategies addressing these concerns.

4.0 Capability Statement Questions & Requirements

ARPA-H requests capability statements from potential vendors addressing the need areas identified in section 3. This section includes specific information that should be included in responses (see section 5 for formatting details). While this section includes specific questions, ARPA-H welcomes additional feedback and information from respondees germane to the needs and problems identified in this RFI.

4.1 The response should include the following:

Need Area 1:

1. A brief description of capabilities to provide RWD sets responsive to the agency’s needs.

2. A detailed description of the data sets to include:

2.1. Descriptions of the original sources of the data without necessarily identifying specific providers

2.2. The characteristics of the data including descriptive statistics such as total number of individuals, breakdowns by gender, race and ethnicity, geography e.g. counts by ZIP3 codes, urban/suburban/rural categories, number and scope of variables, a high-level data dictionary if available

2.3. Frequency of update and delays associated with updates to the data

3. International data sets available by region (Europe, Asia, South Asia, Middle East, Central and South America, Africa) including countries covered and basic statistics if applicable.

4. Details of licensing and rough order of magnitude costs for procuring data sets covering:

4.1. All US States and Territories

4.2. International data sets by regions noted in 2.4 above

Need Area 2

5. Capabilities for privacy preserving record linkage including compatibility with PPRL methods from major industry players if applicable

6. Capabilities of methods for access e.g. APIs, cloud-based database, direct download etc.

particularly noting methods that could support federation of data sets

7. Capabilities of methods for supporting analysis or machine learning across federated data sets from multiple vendors

Need Area 3:

8. Descriptions of conceptual economic models that could enable a public utility for RWD.

9. Descriptions of concerns around intellectual property and data rights, and potential remedies for those concerns.

5.0 RESPONSE FORMAT

Vendors submitting a response to this RFI should include the following information in the order listed below. The page limit for responses to this RFI is 15 Pages.

1. Complete Business Name, including Unique Entity Identifier (UEI), Tax ID, CAGE Code, and GSA contract number (if applicable). If the vendor does not have a UEI, please indicate so in this section.

2. Contact Information (Respondent's name and title, address, telephone, e-mail).

3. Business Size and Classification (small, small-disadvantaged, SBA Certified 8(a), HUBZone, service-disabled veteran-owned, women-owned, other than small, etc.).

4. Capability statement that provides business details and describes technical competencies relative to the parameters identified in Section 4 above. Please respond to all questions, and format the response by need area.

Vendors are requested to submit their response to the RFI no later than 4:00pm EDT, August 23, 2024. Send responses to Acquisitions@ARPA-H.GOV.

Please note that the RFI is for informational purposes only and does not constitute a contract, commitment, or invitation to bid. The information provided by vendors will be used solely for ARPA-Hs’s internal evaluation and planning purposes. The Government will not reimburse the respondent for any cost associated with preparing or submitting a response to this RFI. All submissions to this RFI become Government property and will not be returned.

A submitted response to this RFI constitutes consent for the submission to be reviewed by Government personnel, Federally Funded Research and Development Center employees, and Science and Engineering Technical Advisor (SETA) support contractors.

Thank you for your interest in partnering with ARPA-H. We look forward to your valuable insights and recommendations.