J and A Digital Phenotyping PRINT_Redacted.pdf

DEPARTMENT OF VETERANS AFFAIRS

Office of Procurement, Acquisition and Logistics (OPAL)

Strategic Acquisition Center (SAC) 5202 Presidents Ct, Suite 103

Frederick, MD 21703

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR

CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FEDERAL ACQUISITION

REGULATION (FAR) 13.5

(1) Identification of the agency and the contracting activity, and specific identification of the document as a "Justification for Other Than Full and Open Competition."

This Justification and Approval (J&A) for Other Than Full and Open Competition is executed by the Strategic Acquisition Center (SAC), on behalf of the Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Office of Healthcare Innovation and Learning.

(2) The nature and/or description of the action being approved, i.e., sole source under procedures for certain commercial items in accordance with

FAR 13.5.

This procurement is for Behavidence, Inc. located at 99 Wall Street Suite 4004, New York, New York 10005-4301 in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

The proposed sole source purchase from contractor Behavidence, Inc., a large business, of their product also named Behavidence. This also includes the associated evaluation of their products, that contain an evaluation of passive digital phenotyping of Veterans with informed consent. This is a new firm-fixed price contract, with one 12-month base year.

(3) A description of the supplies and/or services required, including the delivery schedule and/or the period of performance (inclusive of all option periods), and the estimated dollar value of the acquisition.

Behavidence, Inc. in partnership with the Veterans Integrated Services Network (VISN) 4 Mental Illness Research Education and Clinical Center( MIRECC) at the Crescenz VA Medical Center shall conduct a VA Institutional Review Board (IRB) approved research study. Behavidence, Inc. shall provide expertise in the development and refinement of the Behavidence mobile application, which continuously detects behavioral risk factors associated with Suicide and Post-traumatic stress disorder (PTSD) in Veterans. The application data will be supplied to the VA for validation. The VISN 4 MIRECC will assist in regulatory compliance, recruitment, and consent of subjects, sending and collection of the patient-reported outcomes, and data analysis.

Strategic Acquisition Center (SAC) 5202 Presidents Ct, Suite 103

Frederick, MD 21703

(4) The statutory authority permitting sole source.

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(x) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements ( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security

( ) Public Interest

(5) A statement demonstrating the unique qualifications of the proposed contractor or the nature of the action requiring use of the authority.

Behavidence, Inc., submitted a proposal to VHA Innovation Ecosystem’s Broad Agency Announcement (BAA). This BAA for Suicide Prevention is structured to allow for a competition cycle, which consists of submission of concept paper followed by an invitation-only full proposal, to select projects to be funded for an initial prototyping and testing phase and option period phase for subsequent field test/piloting.

Behavidence, Inc., and their proposal for providing a solution to aid suicide prevention went through all of the above processes and was selected as a solution to further develop and test. As such, considering no others like it have submitted a proposal and been accepted based on the above criteria, they are the only known Contractor and only solution to fit the VA’s need.

Furthermore, Behavidence, Inc. is uniquely qualified based on the following:

a. Behavidence, Inc is the only company offering their proprietary Behavidence, Inc.

mobile application.

b. Behavidence, Inc. has already begun work with the VA via prior IRB-approved work to start to develop the initial phenotypes that this work will build upon.

Therefore, selecting Behavidence, Inc. is in the best interest of the government to continue this work and prevent unnecessary duplication of efforts.

Strategic Acquisition Center (SAC) 5202 Presidents Ct, Suite 103

Based on information obtained from a search conducted on Dynamic Small Business utilizing NAICS 518210-computing infrastructure, data processing services, web hosting services, and related services, on March 25, 2025, the Government did not identify potential Service-Disabled Veteran Owned Small Business Vendors.

A search of Federal Procurement Data System (FPDS) resulted in 45 results; all were related to physical blood biology. No results were discovered for digital phenotyping, which is the requirement for this acquisition. Next, VetCert was queried using NAICS 518210 which returned 1,941 results. This requirement is part of a Broad Agency Agreement (BAA) that allows continuous vendors to submit new and innovative ideas and products to aid Veterans in the topic of suicide prevention. VetCert was queried using NAICS 518210 which returned 1,941 results. This requirement is part of a Broad Agency Agreement (BAA) that allows continuous vendors to submit new and innovated ideas and products to aid Veterans in the topic of suicide prevention. The NAICS code search on VetCert is broad and is not specific to this current requirement.

GSA E-library was also queried resulting in the same outcomes as mentioned above.

Although several vendors were returned, this is a specialized service being requested.

Dynamic Small Business Search was queried and again the same outcomes were reached. This is a broad NAICS code, and even adding the word “Suicide Prevention” did not return results that are specific to the requested requirement. On February 4, 2025, the Government identified a sole contractor through utilization of the BAA. The set of requirements of this acquisition entail a more complex interrelationship with VHA clinical practice, providers and patients. The requirement targets post- discharge patients using the existing Behavioral Health Lab (BHL) infrastructure with existing ATO and already developed integrations with VA Electronic Health Record to capture current mental health assessments, and apply Artificial Intelligence (AI) and Natural Language Programming (NPL) via risk detection algorithms monitoring Veterans who have consented to be part of the program via Multimedia Messaging Service (MMS) and digital postcards, enable early identification of emerging crises and timely intervention.

The sole contractor identified in the Dynamic Small Business search offers a SMS (short message service) text communications, which does not fulfill the needs of this requirement.

The Government has queried all government outlets as described above using the appropriate NAICS code and keyword search. Results returned do not meet the program office’s requirement.

No comparable results were discovered for digital phenotyping.

(9) Any other facts supporting the use of sole source.

Currently, no other comparable product exists on the open market.

Strategic Acquisition Center (SAC) 5202 Presidents Ct, Suite 103

10) Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

BAA concept paper submission is open to all. To date, over 100 concept papers regarding the topic of Suicide Prevention, have been submitted to the agency in response to the BAA. All have been reviewed, or are in process of being reviewed, on a rolling, monthly basis. All submissions are given equal, due consideration.

We will continue to perform market research, including attending trade shows and conferences, reaching out to known manufacturers in the field, and continue searching for patents and press releases to ensure that if other materials come to market meeting OHIL needs, future contacts will be open to competition.

(11) A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

For any subsequent acquisition, appropriate market research will be conducted to determine if sources capable of meeting the agencies needs have become available in the marketplace.

(12) Evidence that any supporting data that is the responsibility of technical or requirements personnel (e.g., verifying the Government’s minimum needs or requirements or other rationale for an exception to fair opportunity) and which form a basis for the justification have been certified as complete and accurate by the technical or requirements personnel.