CONTROL NUMBER VA-26-00034718

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

1. Contracting Activity: Department of Veterans Affairs (VA) Office of Procurement, Acquisition, and Logistics

Technology Acquisition Center 23 Christopher Way, NJ 07724

2. Description of Action: This proposed action is for a firm-fixed-price contract issued under a sole source basis to Firely USA Inc, 228 East 45th Street, Suite 9E New York, NY 10017, to provide a graphical user interface for the creation, validation, documentation, and publication of Fast Healthcare Interoperability Resources (FHIR) specifications. The Department of Veterans Affairs, Veterans Health Administration (VHA), Digital Health Office, Office of Clinical Informatics, Knowledge-Based Systems (KBS) directorate, Director of Standards & Interoperability (S&I) requires a sole source action for procurement of brand name Firely Simplifier, Software-as-a-Service (SaaS) subscription licenses for the Firely Simplifier platform, including associated maintenance, updates, and vendor-provided training.

3. Description of Supplies or Services: The VA requirement is for a SaaS-based FHIR specification development platform that provides integrated capabilities for collaborative authoring, standards conformance validation, version control, documentation generation, and publication of FHIR Implementation Guides (IGs) used by VA programs and external trading partners. Specifically, VA requires the SaaS tool to include the following capabilities: 1) Authoring and maintaining FHIR Application Programming Interface (API) Implementation Guides and companion specifications; 2) Validation of FHIR artifacts against Health Level Seven (HL7) standards and profiles; 3) Integrated management of Structure Definitions, Value Sets, Code Systems, Capability Statements, test cases, and example resources; 4) Generation and publication of human-readable and machine-consumable specifications; 5) Enterprise collaboration, reuse, and lifecycle management of FHIR specifications. The proposed sole source action is to procure SaaS subscription licenses for the Firely Simplifier platform, including associated maintenance, updates, and vendor-provided training. The products to be acquired include Simplifier Enterprise Plus with Single Sign-On, Forge Seats, Projects, and Simplifier Maintenance. The tool will be used by the VHA KBS S&I team, contractors, and VA programs to author, test, validate, manage, and publish HL7® FHIR® API IGs and companion specifications.

VA requires an integrated, web-based SaaS environment that enables collaborative FHIR standards development and ensures conformance with HL7 FHIR and related national interoperability standards. The required platform replaces the use of spreadsheets, text editors, and unsupported open-source tools, improving productivity and reducing rework and delays in standards development.

Firely Simplifier Tool VA-26-00034718

The period of performance includes one (1) 12-month base period with four (4) 12-month option periods. The total estimated value of the proposed acquisition, inclusive of all options, is .

4. Statutory Authority: The statutory authority permitting other than full and open competition is 41 U.S.C. 3304(a)(1) as implemented by the FAR Overhaul 6.103-1 entitled, �Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.�

5. Rationale Supporting Use of Authority Cited Above: Innovation in Health Information Technology (Health IT) within VA must be founded on nationally recognized, open standards that support true semantic and structural interoperability across the continuum of care. This includes support for telehealth, mobile health applications, care coordination, analytics, population health, research, and Veteran engagement. VHA has developed extensive clinical decision support capabilities within its Electronic Health Record;

however, these capabilities are historically implemented using non-standard, non-shareable formats that are tightly coupled to legacy technologies, limiting interoperability both within and outside VA.

Achieving VA�s interoperability objectives requires the use of open standards, specifically HL7® FHIR®, that enable seamless data exchange, standardized clinical workflows, effective clinical decision support, and continuity of care across VA and community provider organizations. These standards must also support the authoring, testing, validation, and publication of FHIR IGs that are consumable by both federal and commercial healthcare systems. Market research determined that there is only one (1) commercially available, professionally managed toolset capable of meeting these requirements in an enterprise, production-grade environment.

FHIR implementation is technically complex and requires specialized tooling.

The HL7 IG Publisher is frequently updated without notice, which can cause validation failures and significantly delay development timelines. Authoring and maintaining FHIR IGs requires managing numerous interdependent artifacts, including Structure Definitions, Value Sets, Code Systems, Capability Statements, test cases, example resources, and overarching implementation guidance. Without an integrated toolset, these activities require manual file editing, spreadsheets, and text documents, increasing risk, reducing quality, and impeding timely delivery.

Firely�s Simplifier is a web-based, collaborative platform purpose-built for the creation, validation, documentation, and publication of FHIR specifications. It replaces manual and fragmented authoring methods with an integrated environment that significantly improves productivity, ensures conformance standards, and enables reuse of validated FHIR data models from national and international healthcare organizations. Simplifier directly supports VA�s S&I mission by enabling the development of high-quality, standards-based APIs that promote interoperability, clinical safety, and seamless care transitions for Veterans.

There are currently no viable alternatives to Firely�s Simplifier platform that provides equivalent enterprise-level functionality, professional support, and lifecycle management for complex FHIR standards development. As an open standard, HL7 FHIR itself, Firely is consensus-based and not a federal product; however, VA�s ability to apply, constrain, and operationalize these standards at scale requires a professionally managed toolset. Without Firely�s Simplifier, VA would be unable to effectively distribute authoritative standards guidance across the enterprise, resulting in inconsistent implementations, reduced interoperability with federal and commercial partners, and increased risk to patient safety.

As a result, Firely possesses unique qualifications and specialized expertise that are not otherwise available in the marketplace. Use of the cited authority is necessary to ensure continuity of standards development, alignment with national interoperability mandates, and the successful execution of VA�s Health IT modernization objectives in support of Veteran care.

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. The ordering activity will make publicly available the justification along with the solicitation in accordance with FAR Overhaul 6.103-1(d).

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 completed.

8. Market research was conducted to determine whether a commercially available, supported SaaS tool exists that meets VA�s requirements for authoring, validating, managing, and publishing HL7® FHIR® API IGs and associated companion specifications. The VA requirement is for a SaaS-based FHIR specification development platform that provides integrated capabilities for collaborative authoring, standards conformance validation, version control, documentation generation, and publication of FHIR IGs used by VA programs and external trading partners.

As of July 2025, the S&I team evaluated commercially available and open-source FHIR tooling used across government and industry. Open-source options, including the HL7 IG Publisher and Lantana Consulting Group�s Trifolia on FHIR, were reviewed. The HL7 IG Publisher is an unsupported tool intended for technical experimentation and is frequently updated without notice, causing validation failures and schedule delays. Trifolia on FHIR has been discontinued and is no longer maintained or supported. These tools lack the required enterprise SaaS capabilities, professional support, training, and lifecycle management required to support VA�s production-level standards development.

Market research determined that no other commercial SaaS platforms are currently available that provide a fully supported, professionally managed toolset capable of meeting VA�s requirements. The FHIR specification development market currently includes only one (1) commercial vendor offering an enterprise SaaS platform with integrated tooling, validation, collaboration, and support, Firely Simplifier.

Internet market research was conducted in July 2025, and additional outreach was made to the HL7 community to identify alternative commercial vendors. No additional qualified sources were identified. Firely Simplifier has been commercially available since 2012 and is used globally by public and private-sector healthcare organizations to develop and maintain FHIR standards.

Additional market research was conducted through direct correspondence with Ms. Michelle Beck, Senior Vice President of Firely, on January 8, 2026. Ms. Beck confirmed that Firely USA, Inc. is the exclusive provider of the Simplifier SaaS platform, including maintenance, updates, and training, and has no authorized resellers.

Based on the results of market research, Firely Simplifier is the only commercially available, supported SaaS tool capable of meeting VA�s requirements for enterprise FHIR specification development. Accordingly, this requirement will be issued on a sole-source basis to Firely USA, Inc.

9. Other Facts: N/A

Technical/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.

Fair and Reasonable Cost Determination

I hereby determine that the anticipated price to the Government for this contract action will be fair and reasonable in accordance with FAR 15.404-1(b), via (2) comparison of the proposed prices to historical prices paid, whether by the Government or other than the Government, for the same or similar items and (5) comparison of proposed prices with independent Government cost estimates.

Contracting Officer Certification/Approval

I certify that this justification is accurate and complete to the best of my knowledge and belief. This contract action exceeds the simplified acquisition threshold, but does not exceed $900,000, therefore, the certification required by FAR 6.104-2 serves as the Contracting Officer�s approval.