JA MD CLONE Platform - final to post.pdf

MD Clone Platform VA-24-00045345

JUSTIFICATION FOR AN EXCEPTION TO FAIR OPPORTUNITY

1. Contracting Activity: Department of Veterans Affairs (VA)

Office of Procurement, Acquisition, and Logistics Technology Acquisition Center 23 Christopher Way

Eatontown, New Jersey 07724

2. Description of Action: The proposed sole source action is for a firm-fixed price delivery order to be awarded under the National Aeronautics and Space Administration (NASA) Solutions for an Enterprise-Wide Procurement (SEWP) V to Thundercat Technology (Thundercat) for brand name MD Clone Platform which consists of MD Clone Platform XL, the integrated MD Clone User Portal and MD Clone Associated Business Services software licenses.

3. Description of the Supplies or Services: VA, Veterans Health Administration (VHA) requires the MD Clone Platform to be used with VA’s existing data warehouses to create synthetic data which maintains information privacy while simultaneously having computational clinical validity and maintaining meaningful clinical relationships throughout the created data sets. Synthetic data produced by the MD Clone Platform is statistically identical to data from real patients but is not possible to be associated with individual patients. The MD Clone Platform incorporates a self-service query platform or user portal that makes access to data far easier for non-traditional data analysis while maintaining full VA security compliance.

VHA requires the MDClone Platform, which includes MDClone Platform XL and MD Clone associated business services to meet White House Executive Orders (EO) and Office of Management and Budget (OMB) memos regarding the use of Artificial Intelligence (AL) in healthcare. The MD Clone Platform is already installed in the VA Enterprise Cloud and configured for use with VA data. This requirement also includes MDClone Synthetic Data Generation Platform software and support services for use of the software for events and collaborations. Use of the one system software license includes unlimited VHA user access. The period of performance shall be 12 months with four option periods. The total estimated value of the proposed action is $7,480,347.00, inclusive of all options.

4. Statutory Authority: The statutory authority permitting an exception to fair opportunity is Section 41 U.S.C. 4106(c)(2) as implemented by the Federal Acquisition Regulation (FAR) Subpart 16.505(b)(2)(i)(B), entitled “Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.”

5. Rationale Supporting Use of Authority Cited Above: The proposed source for this action is Thundercat Technology, 1925 Isaac Newton Square E, Suite 180, Reston, VA 20190. Based on market research as described in Section 8 of this document, it was determined that there is no competition available to procure the MD Clone Platform as Thundercat Technology is the sole reseller of the MD Clone Platform.

From a functionality standpoint, MD Clone is the only platform that offers an all-in-one analytics and data generation package. Furthermore, many platforms require advanced formatting and configuration work for key functionalities such as custom cohort and longitudinal data generation. In many cases, these tasks require working knowledge of programming languages such as Python, which will be an obstacle for Structured Query Language-oriented non-technical researchers. The use of something similar, CorGAN and FFgeneration software would require an additional 18-24 months of time delay for appropriate approvals, configuration of data, and integration of multiple tools, spinning up a new database does not meet current time requirements. The additional cost of the time of contract and government employees to complete the approvals, configuration, integration as well as training of employees on the new tool is estimated to be, at a minimum, $3M.

The data sets created with alternative software have to be manually curated. In addition, each data point is required to be traced back to its original data source and regression testing completed to prove the data set retains its clinical relevance and nearest neighbor analysis to confirm that the data set maintains privacy.

Data security has already been approved by VA Information Technology and Information System Security Officer for MD Clone’s Platform, resulting in full data that is accessible without delay. It takes multiple months to complete data security approvals once data access is approved following Institutional Review Board (IRB) or appropriate quality improvement project. As a result, the data sets become historical and unable to embrace changes in current data. The automated data set generation, which is available via MD Clone’s Platform, is critical to meeting White House EO and OMB memos regarding use of AI in healthcare.

Also, VHA requires the MD Clone Platform to provide VA a single process for the rapid generation of multiple synthetic data sets and the democratization of access for a larger diverse pool of research and clinical staff. No other brand name platform can provide this functionality.

Specifically, no other brand name platform is capable of integrating both a user query portal, rapid synthetic data generation, and automatic reports on the privacy and validity of data sets. There are many research organizations that provide data. However, the provided data is proprietary and secure, principally for data scientists, and access is limited. Synthetic data democratizes the data to non-clinical, non-researcher, non-data scientists, while maintaining the privacy and clinical utility of the data sets for the research and innovation community. The MD Clone Platform automated synthetic dataset generation and the user query portal allow for more users to unlock insights about emerging data concerns like the use of AI in Healthcare. Time is the critical factor.

The alternative software is fully manual, and inefficient for synthetic data set generation for meeting White House EO and OMB memos regarding use of AI in healthcare.

6. Efforts to Obtain Competition: Market research was conducted, details of which are in Section 8 of this justification. This effort did not yield any additional sources that can meet the Government's requirements. There is no competition anticipated for this acquisition. In accordance with FAR 16.505(a)(4)(iii)(A)(2), this justification will be provided with the solicitation to all appropriate NASA SEWP V holders. Furthermore, in accordance with FAR 5.301, 16.505(b)(2)(ii)(D), and 16.505(a)(4)(iii), the award notice for this action will be synopsized on the Contracting Opportunities Page and this justification will be made publicly available within 14 days of award.

7. Actions to Increase Competition: The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed.

8. Market Research: The Government’s technical experts conducted market research by reviewing other similar platforms. The other similar platforms reviewed were CorGAN and FFgeneration software. These products do not meet VA’s requirement as they require a manual mathematical regression be performed and curated by the data scientist. These other platforms cannot provide the required automated data set generation with fully curated and mathematically proven computational validity and meaningful clinical relationships accessible through a self-service user query portal.

Curated data sets take multi-months to develop making them historical and unable to incorporate current data and therefore would not produce the required results within the timeframe.

Based on reviews of these products, the Government’s technical experts determined that no other platform can meet the Government’s requirements as outlined in Section

5. Additionally, none of these other products can offer the single integration automated data set generation with mathematically proven privacy while simultaneously maintaining computational validity and meaningful clinical relationships. Based on all of these market research efforts, the Government’s technical experts have determined that only brand name MD Clone Platform can meet all of VA’s needs.

In addition, the Government representatives reached out to MD Clone on May 2, 2024, and confirmed that Thundercat is the sole source provider of the MD Clone Platform.

Furthermore, MD Clone confirmed the only way to purchase its products is via the NASA SEWP V contract vehicle to Thundercat. Therefore, there is no competition anticipated for this acquisition.

9. Other Facts: None.

10. Technical and Requirements Certification: I certify that the supporting data under my cognizance, which are included in this justification, are accurate and complete to the best of my knowledge and belief.

Amanda Purnell Date:

Director of Open Innovation Signature: ____________________________

11. Fair and Reasonable Cost Determination: I hereby determine that the anticipated price to the Government for this contract action will be fair and reasonable. Contracts awarded on NASA SEWP V have already been determined to be fair and reasonable.

Price analysis shall be conducted by comparing the sole source quote to the published list pricing for the required MD Clone Platform and to the Independent Government Cost Estimate.

Heather Utt Date: ________________________________

Procuring Contracting Officer Signature: ____________________________

12. Procuring Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Heather Utt Date: ________________________________

Procuring Contracting Officer Signature: ____________________________

Approval

In my role as procuring activity Advocate for Competition, based on the foregoing justification, I hereby approve the acquisition of MD Clone Platform on an other than fair opportunity basis pursuant to the authority cited in paragraph 4 above, subject to availability of funds, and provided that the property and services herein described have otherwise been authorized for acquisition.

Date: ____________ Signature: _________________________________ Jason Bullen Advocate for Competition Technology Acquisition Center

Office of Procurement Acquisition and Logistics