Agentic_AI_PWS_ Draft 2.0.docx

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7A20--Agentic AI (VA-25-00075915) (VA-25-00104844)
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36C10B26Q0115
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This is a Performance Work Statement (PWS) Version 2.0 for the Department of Veterans Affairs Veterans Health Administration National Center for Collaborative Healthcare Innovation, issued December 12, 2025, solicitation VA-25-00075915. The contract requires a contractor to provide, configure, and deploy a Commercial-Off-the-Shelf (COTS) cloud-based Agentic Artificial Intelligence system utilizing AI techniques and a Software as a Service (SaaS) delivery model within the VA Palo Alto Health Care System environment. The system must be deployed within 60 days of contract award and operate within a VA Authority to Operate (ATO) approved environment, with FedRAMP authorization required before live VA data use. The solution shall perform retrospective data and chart analysis on historical medical data, facilitate research grant discovery and proposal generation, and enable clinical study execution using an AI-enabled Studies platform. Key deliverables include deployment and configuration of analytics and grants platforms, comprehensive Data Security Plan, System Boundary Diagram, FedRAMP System Security Plan, Third-Party Assessment documentation, and implementation reports documenting successful completion of project tasks.

The contractor must provide access to Agent AI analytics for 20 investigators/clinicians at the facility, with 99% uptime guarantee and user onboarding and training completed within 30 days of module deployment, achieving at least 90% participant satisfaction. Additional requirements include at least one completed retrospective data analysis, one successful study recruitment using chart analysis, and integration of wearable devices (Apple Watch, Fitbit, CGM, Oura Ring) for up to 5 clinical studies with 95% successful integration within 45 days. The performance period is 12 months from award date. The contractor must comply with extensive federal security, privacy, and IT requirements including VA Critical Security Controls, Federal Identity Credential and Access Management (FICAM), IPv6 support, Zero Trust architecture, Health Insurance Portability and Accountability Act (HIPAA), and Section 508 accessibility standards. Personnel security requirements include background investigations per VA Handbook 0710, Privacy and HIPAA training completion, and contractor staff roster submission within 3 business days of award. Monthly progress reports, contractor project management plan, and incident response documentation are required deliverables.

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Agent AI

VA-26-00075915

PERFORMANCE WORK STATEMENT (PWS)

DEPARTMENT OF VETERANS AFFAIRS

Veterans Health Administration (VHA) National Center for Collaborative Healthcare Innovation (NCCHI)

Agentic Artificial Intelligence (AI)

Date: December 12, 2025

VA-25-00075915

PWS Version Number: 2.0

Contents

1.0BACKGROUND3
2.0APPLICABLE DOCUMENTS4
3.0SCOPE OF WORK7
4.0PERFORMANCE DETAILS8
4.1PERFORMANCE PERIOD8
4.2PLACE OF PERFORMANCE8
4.3TRAVEL9
5.0SPECIFIC TASKS AND DELIVERABLES9
5.1PROJECT MANAGEMENT9
5.1.1CONTRACTOR PROJECT MANAGEMENT PLAN9
5.1.2REPORTING REQUIREMENTS9
5.1.3PRIVACY & HIPAA TRAINING10
5.1.4TECHNICAL KICKOFF MEETING10
5.2AGENT AI IMPLEMENTATION10
5.2.1GRANT DISCOVERY AND PROPOSAL GENERATION12
5.2.2CLINICAL STUDY EXECUTION12
5.3ASSESSMENT, AUTHORIZATION AND CONTINUOUS MONITORING13
6.0GENERAL REQUIREMENTS14
6.1ENTERPRISE AND IT FRAMEWORK14
6.1.1VA TECHNICAL REFERENCE MODEL14
6.1.2ZERO TRUST – VA CRITICAL SECURITY CONTROLS14
6.1.3FEDERAL IDENTITY, CREDENTIAL, AND ACCESS MANAGEMENT (FICAM)15
6.1.4INTERNET PROTOCOL VERSION 6 (IPv6)16
6.1.5TRUSTED INTERNET CONNECTION (TIC)17
6.1.6STANDARD COMPUTER CONFIGURATION17
6.1.7VETERAN FOCUSED INTEGRATION PROCESS (VIP) AND PRODUCT LINE MANAGEMENT (PLM)17
6.1.8PROCESS ASSET LIBRARY (PAL)18
6.1.9AUTHORITATIVE DATA SOURCES18
6.1.10SOCIAL SECURITY NUMBER (SSN) REDUCTION19
6.2SECURITY AND PRIVACY REQUIREMENTS20
6.2.1POSITION/TASK RISK DESIGNATION LEVEL(S)20
6.2.2CONTRACTOR PERSONNEL SECURITY REQUIREMENTS21
6.3METHOD AND DISTRIBUTION OF DELIVERABLES22
6.4PERFORMANCE METRICS22
6.5FACILITY/RESOURCE PROVISIONS24
6.6GOVERNMENT FURNISHED PROPERTY24
6.7SHIPMENT OF HARDWARE OR EQUIPMENT24
ADDENDUM A – ADDITIONAL VA REQUIREMENTS, CONSOLIDATED25
ADDENDUM B – VA INFORMATION AND INFORMATION SYSTEM SECURITY/ PRIVACY LANGUAGE31

BACKGROUND

The Department of Veterans Affairs (VA), Veterans Health Administration (VHA), National Center for Collaborative Healthcare Innovation (NCCHI) is dedicated to advancing healthcare outcomes for Veterans through innovative technologies and practices. By fostering collaboration among healthcare professionals, researchers, technologists, and key stakeholders, the NCCHI aims to implement cutting-edge solutions to address Veterans' unique healthcare challenges.

As part of a commitment to advancing Veteran care through innovation, the Veterans Health Administration (VHA) is in the process of implementing Agentic Artificial Intelligence (AI), a cutting-edge artificial intelligence platform designed to transform complex medical data into actionable insights. By integrating AI-driven analytics into our clinical and operational workflows, we aim to enhance accuracy, personalize treatment plans, and optimize hospital efficiency while maintaining the highest standards of data security and compliance. This initiative reflects our mission to leverage technology for better outcomes, empowering our clinicians with intelligent tools to deliver faster, more precise, and cost-effective care.

Our strategy aligns with overarching federal guidance advocating for a competitive American AI marketplace, ensuring that government acquisitions not only benefit from cutting-edge solutions but also support interoperability and vendor diversity. We prioritize safeguarding taxpayer resources by closely monitoring AI performance and managing associated risks.

The project will engage cross-functional teams early in the acquisition process to address unique challenges presented by AI technologies. By doing so, we aim to streamline procurement procedures and optimize outcomes in alignment with the principles set forth in Office of Management and Budget Memorandum M-25-22—Driving Efficient Acquisition of Artificial Intelligence in Government.

Healthcare providers and health care systems will have a powerful tool to assist their work efficiently and effectively, enhancing workforce satisfaction, reducing stress/burnout and improving effectiveness and productivity for actual patient care. Patients will benefit from more clinician time spent with them instead of coding and from more accurate coding that can lead to better documentation of their health issues and potentially improved care.

The purpose of this project is to revolutionize patient care, operational efficiency, and medical research through the power of AI. By integrating Agentic AI, we aim to enhance diagnostic accuracy, accelerate treatment decisions, and predict patient risks—enabling earlier, more precise interventions. This AI-powered platform transforms complex, siloed data into actionable insights, reducing administrative burdens and empowering clinicians with real-time decision support. Beyond improving outcomes, Agentic AI drives cost-effective care by optimizing resource allocation, reducing readmissions, and streamlining clinical trials. As healthcare shifts towards value-based models, this technology positions the Veterans Health Administration at the forefront of innovation—delivering smarter, faster, and more personalized medicine while maintaining rigorous data security and compliance standards.

APPLICABLE DOCUMENTS

In the performance of the tasks associated with this Performance Work Statement, the Contractor shall comply with the following:

1. “Federal Information Security Modernization Act of 2014”

2. Federal Information Processing Standards (FIPS) Publication 140-3, “Security Requirements for Cryptographic Modules”, March 22, 2019

3. FIPS Pub 199. “Standards for Security Categorization of Federal Information and Information Systems,” February 2004

4. FIPS Pub 200, “Minimum Security Requirements for Federal Information and Information Systems,” March 2006

5. FIPS Pub 201-3, “Personal Identity Verification of Federal Employees and Contractors,” January 2022

6. 10 U.S.C. § 2224, "Defense Information Assurance Program", as amended

7. 5 U.S.C. § 552a, as amended, “The Privacy Act of 1974”

8. Public Law 109-461 (P.L. 109-461), Veterans Benefits, Health Care, and Information Technology Act of 2006, as amended, Title IX, Information Security Matters

9. 42 U.S.C. § 2000d “Title VI of the Civil Rights Act of 1964”, as amended

10. VA Directive 0710, “Personnel Security and Suitability Program,” June 4, 2010, https://www.va.gov/vapubs/index.cfm

11. VA Handbook 0710, “Personnel Security and Suitability Program,” May 2, 2016, https://www.va.gov/vapubs/index.cfm

12. VA Directive 6102, “Internet/Intranet Services,” August 5, 2019

13. 36 C.F.R. Part 1194 “Information and Communication Technology Standards and Guidelines,” as amended

14. Office of Management and Budget (OMB) Circular A-130, “Managing Federal Information as a Strategic Resource,” July 28, 2016

15. 32 C.F.R. Part 199, “Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)”, as amended

16. NIST SP 800-66 Rev. 2, “Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule: A Cybersecurity Resource Guide,” February 2024

17. 45 C.F.R Parts 160 and 164, Subparts A and E, the Standards for Privacy of Individually Identifiable Health Information (“Privacy Rule”); and 45 C.F.R. Parts 160 and 164, Subparts A and C, the Security Standard (“Security Rule”); as amended

18. Sections 504 and 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended

19. Homeland Security Presidential Directive (12) (HSPD-12), August 27, 2004

20. VA Directive 6500, “VA Cybersecurity Program,” February 24, 2021 (see VA NOTICE 24-18, dated September 27, 2024, “Update to VA Directive 6500 Cybersecurity Program”, and VA Notice 25-07, dated 3/18/25, “Amending VA Directive 6500 to incorporate M-24-15”)

21. VA Handbook 6500, “Risk Management Framework for VA Information Systems VA Information Security Program,” February 24, 2021 (see VA Notice 25-01, dated October 15, 2024, “Update to VA Handbook 6500 Risk Management Framework for VA Information Systems VA Information Security Program”, and VA Notice 25-06, dated 3/18/25, “Amending VA Directive 6500 to incorporate M-24-15”)

22. VA Handbook 6500.2, “Management of Breaches Involving Sensitive Personal Information (SPI),” June 30, 2023

23. VA Handbook 6500.6, “Contract Security,” March 12, 2010 (see VA Notice 24-12, dated April 22, 2024, “Update to VA Handbook 6500.6, Contract Security, Appendix C VA Information and Information System Security/Privacy Language For Inclusion Into Contracts, As Appropriate”)

24. VA Handbook 6500.8, “Information System Contingency Planning,” March 25, 2025

25. VA Handbook 6500.10, “Mobile Device Security Policy,” February 15, 2018

26. VA Handbook 6500.11, “VA Firewall Configuration,” August 22, 2017

27. OIT Process Asset Library (PAL), OIT Process Asset Library.

28. One-VA Technical Reference Model (TRM) (reference at https://www.va.gov/trm/TRMHomePage.aspx)

29. VA Directive 6508, “Implementation of Privacy Threshold Analysis and Privacy Impact Assessment,” October 15, 2014

30. VA Directive 6510, “VA Identity, Credential and Access Management,” September 3, 2024

31. VA Handbook 6510, “VA Identity, Credential and Access Management,” September 27, 2024

32. VA Directive and Handbook 6513, “Secure External Connections,” October 12, 2017

33. VA Directive 6300, “Records and Information Management,” September 21, 2018

34. VA Handbook, 6300.1, “Records Management Procedures,“ March 24, 2010

35. NIST SP 800-37 Rev 2, “Risk Management Framework for Information Systems and Organizations: A System Life Cycle Approach for Security and Privacy,” December 2018

36. NIST SP 800-53 Rev. 5, “Security and Privacy Controls for Federal Information Systems and Organizations,” September 23, 2020 (includes updates as of 12/10/2020)

37. VA Directive 0735, “Homeland Security Presidential Directive 12 (HSPD-12) Program,” October 26, 2015

38. VA Handbook 0735, “Homeland Security Presidential Directive 12 (HSPD-12) Program,” March 24, 2014

39. OMB Memorandum 05-24, “Implementation of Homeland Security Presidential Directive (HSPD) 12 – Policy for a Common Identification Standard for Federal Employees and Contractors,” August 5, 2005

40. OMB Memorandum M-19-17, “Enabling Mission Delivery Through Improved Identity, Credential, and Access Management,” May 21, 2019

41. OMB Memorandum, “Guidance for Homeland Security Presidential Directive (HSPD) 12 Implementation,” May 23, 2008

42. Federal Identity, Credential, and Access Management (FICAM) Architecture, June 30, 2023 (FICAM Architecture (idmanagement.gov))

43. NIST SP 800-116 Rev 1, “Guidelines for the Use of Personal Identity Verification (PIV) Credentials in Facility Access,“ June 2018

44. NIST SP 800-63-3, 800-63A, 800-63B, 800-63C, “Digital Identity Guidelines,” updated March 02, 2020

45. NIST SP 800-157, “Guidelines for Derived PIV Credentials,” December 2014

46. VA Memorandum, VAIQ #7100147, “Continued Implementation of Homeland Security Presidential Directive 12 (HSPD-12),” April 29, 2011 (reference https://www.voa.va.gov/documentlistpublic.aspx?NodeID=514)

47. IAM Identity Management Business Requirements Guidance document, May 2013, (reference Enterprise Architecture Section, PIV/IAM (reference https://www.voa.va.gov/documentlistpublic.aspx?NodeID=514)

48. VA Memorandum “Personal Identity Verification (PIV) Logical Access Policy Clarification,” July 17, 2019, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4896

49. Trusted Internet Connections (TIC) 3.0 Core Guidance Documents, https://www.cisa.gov/publication/tic-30-core-guidance-documents

50. OMB Memorandum M-19-26, “Update to the Trusted Internet Connections (TIC) Initiative,” September 12, 2019

51. OMB Memorandum M-08-23, “Securing the Federal Government’s Domain Name System Infrastructure,” August 22, 2008

52. Sections 524 and 525 of the Energy Independence and Security Act of 2007, (P.L. 110–140), December 19, 2007

53. Section 104 of the Energy Policy Act of 2005, (P.L. 109–58), August 8, 2005

54. Executive Order 13221, “Energy-Efficient Standby Power Devices,” August 2, 2001

55. VA Directive 0057, “VA Environmental Management Program,” October 25, 2022

56. Office of Information Security (OIS) VAIQ #7424808 Memorandum, “Remote Access,” January 15, 2014, https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28

57. Clinger-Cohen Act of 1996, 40 U.S.C. §11101 and §11103

58. “Veteran Focused Integration Process (VIP) Guide 4.0,” March 2021, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4371

59. VA Memorandum “Proper Use of Email and Other Messaging Services,” January 2, 2018, https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28

60. “Product Line Management Transformation Playbook” version 3.1, August 2023, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4946

61. NIST SP 500-267B Revision 1, “USGv6 Profile,” November 2020

62. OMB Memorandum M-21-07, “Completing the Transition to Internet Protocol Version 6 (IPv6),” November 19, 2020

63. Social Security Number (SSN) Fraud Prevention Act of 2017

64. Section 240 of the Consolidated Appropriations Act (CAA) 2018, March 23, 2018

65. C.F.R Title 15 Part 7, “Securing the Information and Communications Technology and Services (ICTS) Supply Chain”, as amended

66. Executive Order 14028, “Executive Order on Improving the Nation's Cybersecurity,” May 12, 2021, https://bidenwhitehouse.archives.gov/briefing-room/presidential-actions/2025/01/16/executive-order-on-strengthening-and-promoting-innovation-in-the-nations-cybersecurity/

67. OMB Memorandum M-22-09, “Moving the U.S. Government Toward Zero Trust Cybersecurity Principles”, January 26, 2022, https://www.whitehouse.gov/wp-content/uploads/2022/01/M-22-09.pdf.

68. NIST SP 800-52 Revision 2, “Guidelines for the Selection, Configuration, and Use of Transport Layer Security (TLS) Implementations

69. OMB M-22-18, “Enhancing the Security of the Software Supply Chain through Secure Software Development Practices,” September 14, 2022

70. OMB M-23-16, “Update to Memorandum M-22-18,” June 9, 2023

71. OMB M-21-31, “Improving the Federal Government’s Investigative and Remediation Capabilities Related to Cybersecurity Incidents,” August 27, 2021

72. NIST SP 800-88 Revision 1 “Guidelines for Media Sanitization,” December 2014

73. CISA Binding Operational Directive (BOD) 19-02: “Vulnerability Remediation Requirements of Internet-Accessible Systems,” April 29, 2019, BOD 19-02: Vulnerability Remediation Requirements for Internet-Accessible Systems | CISA

74. CISA BOD 22-01: “Reducing the Significant Risk of Known Exploited Vulnerabilities,” November 3, 2021, BOD 22-01: Reducing the Significant Risk of Known Exploited Vulnerabilities | CISA

75. CISA BOD 23-01: Improving Asset Visibility and Vulnerability Detection on Federal Networks.” Cybersecurity & Infrastructure Security Agency (CISA), BOD 23-01: Improving Asset Visibility and Vulnerability Detection on Federal Networks | CISA

76. VA Directive 6550, Pre-Procurement Assessment and Implementation of Medical Devices/Systems, June 03, 2019

77. VA Memorandum, “VA Security Controls,” January 17, 2025, https://www.voa.va.gov/DocumentView.aspx?DocumentID=5010

SCOPE OF WORK

This scope of this contract is to provide a Commercial-Off-the-Shelf (COTS), cloud-based Agentic AI system which utilizes AI techniques and technologies and a Software as a Service (SaaS) delivery model within the VA Palo Alto Health Care System (VAPAHCS) environment. The Agent AI system shall be capable of performing retrospective data/chart analysis on historical medical data, facilitating grant discovery and proposal generation, and executing clinical studies using the AI-enabled Studies platform. Key tasks involve deploying and configuring analytics and grants platforms, providing access to AI-powered tools, integrating wearable devices, and delivering comprehensive onboarding and training to investigators and clinicians. Performance targets include high accuracy and availability rates, timely onboarding and support, and satisfactory user experiences, ensuring efficient use of AI tools in research and clinical applications.

PERFORMANCE DETAILS

PERFORMANCE PERIOD

The Period of Performance (PoP) shall be 12 months from date of award.

Any work at the Government site shall not take place on Federal holidays or weekends unless directed by the Contracting Officer (CO).

There are 11 Federal holidays set by law (USC Title 5 Section 6103) that VA follows:

Under current definitions, five are set by date:

New Year's DayJanuary 1
JuneteenthJune 19
Independence DayJuly 4
Veterans DayNovember 11
Christmas DayDecember 25

If any of the above falls on a Saturday, then Friday shall be observed as a holiday. Similarly, if one falls on a Sunday, then Monday shall be observed as a holiday.

The other six are set by a day of the week and month:

Martin Luther King's BirthdayThird Monday in January
Washington's BirthdayThird Monday in February
Memorial DayLast Monday in May
Labor DayFirst Monday in September
Columbus DaySecond Monday in October
ThanksgivingFourth Thursday in November

PLACE OF PERFORMANCE

Tasks under this PWS shall be performed at Contractor facilities. The Contractor shall identify the Contractor’s place of performance in their proposal submission.

Work may be performed at remote locations with prior approval of the Program Manager (PM). The Contractor shall maintain onsite presence during normal Monday through Friday business hours. After-business-hours, emergency, and pre-approved scheduled work may be performed at remote locations with prior approval of the VA PM as stated in this PWS.

TRAVEL

The Government does not anticipate travel under this effort to perform the tasks associated with the effort.

SPECIFIC TASKS AND DELIVERABLES

The Contractor shall perform the following:

PROJECT MANAGEMENT

CONTRACTOR PROJECT MANAGEMENT PLAN

The Contractor shall deliver a Contractor Project Management Plan (CPMP) that lays out the Contractor’s approach, timeline, and tools to be used in execution of the contract. The CPMP should take the form of both a narrative and graphic format that displays the schedule, milestones, risks, and resource support. The CPMP shall also include how the Contractor shall coordinate and execute planned, routine, and ad hoc data collection reporting requests as identified within the PWS. The initial baseline CPMP shall be concurred upon and updated in accordance with Section B of the contract. The Contractor shall update and maintain the VA PM approved CPMP throughout the PoP.

Deliverable:

A. Contractor Project Management Plan

REPORTING REQUIREMENTS

The Contractor shall provide the Contracting Officer's Representative (COR) with Monthly Progress Reports in electronic form in Microsoft Word and Project formats. The report shall include detailed instructions/explanations for each required data element, to ensure that data is accurate and consistent. These reports shall reflect data as of the last day of the preceding Month.

The Monthly Progress Reports shall cover all work completed during the reporting period and work planned for the subsequent reporting period. The report shall also identify any problems that arose and a description of how the problems were resolved. If problems have not been completely resolved, the Contractor shall provide an explanation including their plan and timeframe for resolving the issue. The report shall also include an itemized list of all Information and Communication Technology (ICT) deliverables and their current Section 508 conformance status. The Contractor shall monitor performance against the CPMP and report any deviations. It is expected that the Contractor will keep in communication with VA accordingly so that issues that arise are transparent to both parties to prevent escalation of outstanding issues.

Deliverable:

A. Monthly Progress Report

PRIVACY & HIPAA TRAINING

The Contractor shall submit Talent Management System (TMS) training certificates of completion for VA Privacy and Information Security Awareness and Rules of Behavior Training and Health Insurance Portability and Accountability Act (HIPAA) training and provide signed copies of the Contractor Rules of Behavior in accordance with Section 9, Training, from Appendix C of the VA Handbook 6500.6, “Contract Security”.

Deliverables:

A. VA Privacy and Information Security Awareness and Rules of Behavior Training Certificate B. VA HIPAA certificate of completion

TECHNICAL KICKOFF MEETING

A technical kickoff meeting shall be held within 10 days after TO award. The Contractor shall coordinate the date and time of a virtual meeting with the Contracting Officer (CO), the VA PM, the Contract Specialist, and the Contracting Officer Representative (COR). The Contractor shall provide a draft agenda to the CO and VA PM at least five (5) calendar days prior to the meeting. Upon Government approval of the final agenda, the Contractor shall distribute to all meeting attendees. The Contractor shall prepare and distribute the meeting minutes of the kickoff meeting to the CO, COR, and all attendees within three (3) calendar days after the meeting. The Contractor shall obtain concurrence from the COR on the content of the meeting minutes prior to distribution of the document.

AGENT AI IMPLEMENTATION

The Contractor shall provide, configure and deploy a COTS cloud based Agent AI system which utilizes AI techniques and technologies and a SaaS delivery model within VAPAHCS's secure Amazon Web Services (AWS) Simple Storage Service (S3) bucket within 60 days of contract award. The Agent AI system shall be complaint with VA ATO requirements to include receiving the Federal Risk Authorization Management Program (FedRAMP) by date agreed upon with VA. See Section 5.3 of this PWS for additional detail regarding FedRAMP and VA Authority to Operate (ATO) requirements., Performance of this contract is contingent upon VA provision of an ATO, in which case the Contractor shall coordinate with VA to ensure compliance with all applicable security and operational directives. Specific platform functional requirements include:

- Operate within a VA ATO approved system.

- Operate on standard VA Government Furnished Equipment (GFE). This is defined as:

o Personal Computer (PC): Windows 10 x86_64 systems, 8GB Ram, 8th generation Intel i5 or equivalent, 120GB free storage, 100 mbps connection o Mobile: iPhone 11 or later, 80GB free storage, 100 mbps connection

- Mobile app shall have a version compatible with running on a PC over a hardwired connection. It is imperative that this functionality does not rely on the method of recording interactions to be uploaded at a later time once connectivity is restored; real- time processing capabilities are required.

The Agent AI system shall export Electronic Health Record (EHR) data in Parquet, Comma-Separated Values (CSV), or JavaScript Object Notation (JSON) file formats and provides 95% accuracy rate in converting and exporting EHR datas. Additionally, the Contractor shall customize the AI Agent to align with the specific workflows and use cases at VAPAHCS, including analytics, grant discovery, and clinical study execution features, detailed below. The Contractor shall complete the deployment within 60 days of project initiation.

The Agent AI shall provide research grant discovery, proposal generation and clinical study execution. The Contractor shall develop and provide a comprehensive Data Security Plan that verifies that the system adheres to VA’s cybersecurity policies and adherence to the Health Insurance Portability and Accountability Act (HIPAA) and other relevant regulations.

The platform shall support the following tasks with VAPAHCS investigators/clinicians, with documentation of successful completion via a summary report:

· Provide access to Agent AI analytics for 20 investigators/clinicians at VAPAHCS, including onboarding, training and customer support

· Document the completion of at least one (negotiable) retrospective data analysis using VHA data and Agent AI analytics, including feedback from end-users

· Document of at least one successful study recruitment using retrospective data/chart analysis with feedback from end-user

The Contractor shall migrate initial datasets into the AWS S3 bucket for testing purposes. This data sets shall reside within VHA using the provisioned S3 bucket for the pilot.

The Contractor shall ensure seamless access to the Agent AI analytics module for up to 20 VA investigators/clinicians, guaranteeing 99% uptime during the project duration. User onboarding and training shall be completed within 30 days of module deployment. The training shall be conducted virtually and shall include all aspects of the Analytics Module and access to an online user’s manual.

The Contractor shall deliver comprehensive onboarding and training sessions for the 20 investigators/clinicians involved in the pilot, ensuring at least 90% participant satisfaction and proficiency in using the Analytics Module within 15 days of training completion. Feedback from pilot users about the performance and usability of the AI agents shall be gathered on a monthly basis and included in the monthly report.

The Contractor shall provide an Agent AI Implementation Report. This report shall include details on the implementation, data set management, all customizations for VA systems effort, lessons learned and recommendations for future usage.

Deliverables:

A. Agent AI Implementation Report

GRANT DISCOVERY AND PROPOSAL GENERATION

The Analytic Agent shall enable the 20 VA investigators/clinicians to identify and apply for research funding opportunities using AI-powered tools, including a Specific Aims helper, reference manager, and writing assistants. These tools shall be operational with 95% accuracy in task assistance and fully integrated within 15 days of platform access. The tools shall create research profiles that accurately match relevant grants with a success rate of 90% and profiles shall be set up within 30 days.

The Contractor shall provide dedicated support throughout the grant discovery process, resolving support requests within 48 hours and maintaining a user satisfaction rate of 90% or higher. The AI Agent shall review a wide range of grant sources, including many that may not be known by the investigators, adding significant value. The Contractor shall elicit user feedback from eligible investigators. The Contractor shall provide a minimum of one Completed Grant Submission using this process.

Deliverable:

A. Completed Grant Submission

CLINICAL STUDY EXECUTION

The Agent AI shall enable VA users to conduct observational or interventional studies using the AI-enabled Studies platform for 5 studies. The platform shall maintain an availability of 99% and the Contractor shall ensure secure access within 30 days of study initiation. The Contractor shall integrate the Analytic Agent with desired wearable devices such as Apple Watch, Fitbit, CGM and Oura Ring, when applicable to the study). Integration across devices shall be 95% successful and completed within 45 days of initiation. The Contractor shall provide these wearable devices and seamlessly integrate the data into the research platform.

This capability is specific to the focus of the investigators conducting the clinical active trials. The Contractor shall identify active or upcoming VA trials with VA PM approval that have the potential to benefit from this tool. This tool shall be available to 5 investigators during the study period, who may overlap with or differ from the previous group of 20 users.

The Contractor shall provide support for both research and participant onboarding within 30 days of study initiation. The Contractor shall achieve a 90% satisfaction rate among onboarded participants and researchers. The Contractor shall create and provide a detailed Clinical Study Report detailing the objectives, execution and conclusions of the Study.

Deliverable:

A. Clinical Study Report

ASSESSMENT, AUTHORIZATION AND CONTINUOUS MONITORING

1. The information system solution selected by the Contractor shall comply with the Federal Information Security Management Act (FISMA).

2. The Contractor shall comply with FedRAMP requirements as mandated by Federal laws and policies, including making available any documentation, physical access, and logical access needed to support this requirement.

3. The Contractor shall, where applicable, assist with the VA ATO Process to help achieve agency authorization of the cloud service or migrated application.

4. The Contractor shall provide an Incident Response Plan (IRP) scenario within 14 days of award and complete Table-Top exercise within 21 days of award unless current VA IRP can be provided.

5. The Contractor shall provide a System Boundary Diagram that demonstrates implementation and any proposed VA interconnections including required ports and protocols at the time award.

6. The Contractor shall complete a FedRAMP System Security Plan (SSP) and supporting documentation at the time of award.

7. The Contractor shall complete a Third-Party Assessment Organization (3PAO) Security Assessment Plan (SAP) at the time of award.

8. The Contractor shall complete a 3PAO Security Assessment Report (SAR) at the time of award.

9. To the extent required to carry out the FedRAMP assessment and authorization process and FedRAMP continuous monitoring, to safeguard against threats and hazards to the security, integrity, and confidentiality of any non-public VA data collected and stored by the Contractor, the Contractor shall provide the VA access to the Contractor’s and Cloud Service Provider’s facilities, installations, technical capabilities, operations, documentation, records, and databases.

10. If new or unanticipated threats or hazards are discovered by either VA or the Contractor, or if existing safeguards have ceased to function, the discoverer shall immediately bring the situation to the attention of the other party in accordance with the security addendum B.

11. The Contractor shall not release any data without the written consent of VA. All requests for release must be submitted in writing to the COR/CO.

12. In order for live VA data to be used in this system, a FedRAMP Authorization and VA ATO will be required.

13. Identified gaps between required FedRAMP Security Control Baselines and Continuous Monitoring controls and the contractor’s implementation as documented in the Security Assessment Report shall be tracked by the Contractor for mitigation in a Plan of Action and Milestones (POA&M) document. Depending on the severity of the gaps, VA may require them to be remediated before a provisional or agency authorization is issued.

14. The Contractor shall maintain a security management continuous monitoring environment based upon the latest edition of the VA Cloud Computing Continuous Monitoring Process, FedRAMP Security Controls Baseline and FedRAMP Continuous Monitoring Strategy Plan.

15. The Contractor shall comply with all VA and FedRAMP privacy requirements.

16. VA may choose to cancel the Contract and terminate any outstanding orders if the Contractor has its ATO revoked and the deficiencies are greater than VA risk tolerance thresholds.

Deliverables:

A. System Boundary Diagram B. FedRAMP System Security Plan (SSP) and supporting documentation C. 3PAO Security Assessment Plan (SAP) D. 3PAO Security Assessment Report (SAR)

GENERAL REQUIREMENTS

ENTERPRISE AND IT FRAMEWORK

VA TECHNICAL REFERENCE MODEL

The Contractor shall comply with the VA OIT Technical Reference Model (VA TRM). Compliance with the VA TRM is achieved by using only technologies and standards that are listed as approved for use in the VA TRM. The Contractor shall provide all necessary information requested by VA to ensure TRM approval is obtained prior to use on VA’s network.

ZERO TRUST – VA CRITICAL SECURITY CONTROLS

VA has established minimum mandatory security requirements and requires that any network connected software system or service must meet the VA Critical Security Controls as outlined in the VA Memorandum, “VA Security Controls”, https://www.voa.va.gov/DocumentView.aspx?DocumentID=5010. VA Critical Security Controls identify the minimum mandatory requirements that must be implemented across all VA enterprise infrastructure, cloud computing environments, information systems, networks, and specialized devices (medical devices/systems, special-purpose systems, and research scientific computing devices) that process, store, and/or transmit VA data. Effective July 1, 2025, the Contractor shall implement these VA Critical Security Controls, within any network connected software system or service prior to being authorized for use in the VA. This functional requirement is not negotiable, and Plan of Action & Milestones (POAM) will not be accepted in the event these controls cannot be implemented for new systems. Critical Security Controls are intended to increase VA’s security posture and provide security and privacy risk visibility into the VA network and is not a new requirement. The Contractor’s failure to maintain these VA Critical Controls after implementation will result in VA discontinuing the use of the system.

FEDERAL IDENTITY, CREDENTIAL, AND ACCESS MANAGEMENT (FICAM)

The Contractor shall ensure Commercial Off-The-Shelf (COTS) product(s), software configuration and customization, and/or new software are Personal Identity Verification (PIV) card-enabled by accepting HSPD-12 PIV credentials using VA Enterprise Architecture (EA), and VA Identity and Access Management (IAM) approved Enterprise Technology Guidelines (ETG). The Contractor shall ensure all Contractor delivered applications and systems comply with the VA Identity, Credential, and Access Management policies and guidelines set forth in Executive Order 14028, VA Handbook 6510 VA Identity and Access Management, VA Handbook 0735 Homeland Security Presidential Directive 12 (HSPD-12) Program, CISA Binding Operational Directive 23-01, and align with the Federal Identity, Credential, and Access Management Roadmap and Implementation Guidance v2.0.

The Contractor shall ensure all Contractor delivered applications and systems provide user authentication services compliant with the National Institute of Standards and Technology (NIST) Special Publication (SP) 800-63-3, VA Handbook 6500, and VA IAM enterprise requirements for direct, assertion-based authentication, and/or trust based authentication, as determined by the ETGs. Direct authentication at a minimum must include Public Key Infrastructure (PKI) based authentication supportive of PIV card and/or Common Access Card (CAC), as determined by the business need.

The Contractor shall ensure all Contractor delivered applications and systems conform to the specific Identity and Access Management PIV requirements set forth in the Office of Management and Budget (OMB) Memoranda M-05-24, M-19-17, M-22-09, and NIST Federal Information Processing Standard (FIPS) 201-3. Contractor delivered applications and systems shall be on the FIPS 201 Approved Product List (APL). If the Contractor delivered application and system is not on the APL, the Contractor shall be responsible for taking the application and system through the FIPS 201 Evaluation Program.

The Contractor shall ensure all Contractor delivered applications and systems support:

1. Automated provisioning and are able to use enterprise provisioning service.

2. Interfacing with VA’s Master Person Index (MPI) to provision identity attributes, if the solution relies on VA user identities. MPI is the authoritative source for VA user identity data.

3. The VA defined unique identity (Secure Identifier [SEC ID] / Integrated Control Number [ICN]).

4. Multiple authenticators for a given identity and authenticators at every Authenticator Assurance Level (AAL) appropriate for the solution.

5. Identity proofing for each Identity Assurance Level (IAL) appropriate for the solution.

6. Federation for each Federation Assurance Level (FAL) appropriate for the solution, if applicable.

7. Two-factor authentication (2FA) through an applicable Technology Guideline as outlined in VA ETG.

8. A Security Assertion Markup Language (SAML) implementation if the solution relies on assertion-based authentication. Additional assertion implementations, besides the required SAML assertion, may be provided as long as they are compliant with NIST SP 800-63-3 guidelines.

9. Authentication/account binding based on trusted Hypertext Transfer Protocol (HTTP) headers if the solution relies on Trust based authentication.

10. Role Based Access Control.

11. Auditing and reporting capabilities.

12. Compliance with VIEWS 00155984, PIV Logical Access Policy Clarification https://www.voa.va.gov/DocumentView.aspx?DocumentID=4896.

The required Assurance Levels for this specific effort are Identity Assurance Level 3, Authenticator Assurance Level 3, and Federation Assurance Level 3.

INTERNET PROTOCOL VERSION 6 (IPv6)

The Contractor solution shall support IPv6-Only based upon the memo issued by the Office of Management and Budget (OMB) on November 19, 2020 (https://www.whitehouse.gov/wp-content/uploads/2020/11/M-21-07.pdf). Which defines IPv6-only as the state of an operational system or service when IPv4 protocol functions (addressing, packet forwarding) are not in use. The NIST USGv6 profile defines technical requirements for a product to be capable of operating in IPv6-Only environments. IPv6-Only technology, in accordance with the USGv6 Program (https://www.nist.gov/programs-projects/usgv6-program/usgv6-revision-1), NIST Special Publication (SP) 500-267B Revision 1 “USGv6 Profile” (https://doi.org/10.6028/NIST.SP.500-267Br1), and NIST SP 800-119 “Guidelines for the Secure Deployment of IPv6” (https://doi.org/10.6028/NIST.SP.800-119), compliance shall be included in all IT infrastructures, application designs, application development, operational systems and sub-systems, and their integration. In addition to the above requirements, all devices, applications, and systems shall support all applicable functionality on native IPv6-Only as well as dual stack (IPv6 / IPv4) connectivity without additional memory or other resources being provided by the Government, so that they can function in a mixed environment. All public/external facing servers and services (e.g., web, email, DNS, ISP services, etc.) shall support native IPv6-Only and dual stack (IPv6 / IPv4) users and all internal infrastructure and applications shall support using native IPv6-Only and dual stack (IPv6 / IPv4) for all functionality and operations.

TRUSTED INTERNET CONNECTION (TIC)

The Contractor solution shall meet the requirements outlined in Office of Management and Budget Memorandum M-19-26, “Update to the Trusted Internet Connections (TIC) Initiative“ (https://www.whitehouse.gov/wp-content/uploads/2019/09/M-19-26.pdf), VA Directive 6513 “Secure External Connections”, and shall comply with the TIC 3.0 Core Guidance Documents, including all Volumes and TIC Use Cases, found at the Cybersecurity & Infrastructure Security Agency (CISA) (https://www.cisa.gov/publication/tic-30-core-guidance-documents).

STANDARD COMPUTER CONFIGURATION

The Contractor IT end user solution that is developed for use on standard VA computers shall be compatible with and be supported on the standard VA operating system, Windows 10 (64bit) and Windows 11, Edge (Chromium based), and 365 Apps for enterprise. Applications delivered to VA and intended to be deployed to Windows 10 and or Windows 11 workstations shall be delivered as a signed .msi package with switches for silent and unattended installation and updates shall be delivered in signed .msp file formats for easy deployment using Microsoft Endpoint Configuration Manager (CM) VA’s current desktop application deployment tool. Signing of the software code shall be through a vendor provided certificate that is trusted by VA using a code signing authority such as Verizon/Cybertrust or Symantec/VeriSign. The Contractor shall also ensure and certify that their solution functions as expected when used from a standard VA computer, with non-admin, standard user rights that have been configured using the Defense Information Systems Agency (DISA) Secure Technical Implementation Guide (STIG) specific to the particular client operating system being used.

VETERAN FOCUSED INTEGRATION PROCESS (VIP) AND PRODUCT LINE MANAGEMENT (PLM)

The Contractor shall support VA efforts IAW the Veteran-Focused Integration Process (VIP) Guide and Product Line Management (PLM) Playbook. The major focus of VIP is on Enterprise Oversight, Governance, reporting, and establishing practices that focus on outcomes and continuously delivering sustainable IT capabilities to benefit the Veteran. PLM is a framework that focuses on delivering functional products that provide the highest priority work to customers while delivering simplified, reliable, and practical solutions to the business, medical staff, and our Veterans. The VIP Guide is a companion guide to the PLM Transformation Playbook and can be found at: https://www.voa.va.gov/DocumentView.aspx?DocumentID=4371 and the PLM Transformation Playbook can be found at https://www.voa.va.gov/DocumentView.aspx?DocumentID=4946. VIP and PLM are the authoritative processes that IT projects must follow to ensure development and delivery of IT products.

The VIP Guide provides guidance for transitioning from project-centric to product-centric delivery. The VIP guide applies to all OIT Office of Management and Budget (OMB) reportable products that are required to collect and report costs, schedules, risks, and other valuable information in VA PARS (whether products are procured or developed by VA) and any VA Information Technology project effort in Software Product Management (SPM) and Infrastructure Operations (IO), or their successors, that touch the VA network regardless of IT organizational alignment (whether it spends government funding from VA's Congressional IT Appropriation or any other appropriation).

The PLM Transformation Playbook details how OIT leadership expects Product Lines (PLs) to implement PLM, DevOps, and Lean-Agile principles, methods, practices, and techniques through levels of maturity. The PLM Transformation Playbook applies to all Information Technology (IT) products aligned to PLs in the Software Product Management, Infrastructure Operations and Product Engineering organizations within the OIT organization.

Others outside the referenced groups or organizations may use the VIP Guide and PLM Transformation Playbook for situational awareness as needed.

PROCESS ASSET LIBRARY (PAL)

The Contractor shall perform their duties consistent with the processes defined in the OIT Process Asset Library (PAL). The PAL includes a spectrum of OIT functions and activities, such as project management, operations, service delivery, communications, acquisition, and resource management. PAL serves as an authoritative and informative repository of searchable processes, activities or tasks, roles, artifacts, tools and applicable standards and guides to assist the OIT workforce, Government and Contractor personnel. OIT utilizes PAL processes to ensure compliance with policies and regulations and to meet VA quality standards. The PAL includes the contractor onboarding process consistent with Section 6.2.2 and can be found at process_CONB_ext.docx (live.com). The main PAL can be accessed at www.va.gov/process.

AUTHORITATIVE DATA SOURCES

The VA Enterprise Architecture Repository (VEAR) is one component within the overall EA that establishes the common framework for data taxonomy for describing the data architecture used to develop, operate, and maintain enterprise applications. The Contractor shall comply with the department’s Authoritative Data Source (ADS) requirement that VA systems, services, and processes throughout the enterprise shall access VA data solely through official VA ADSs where applicable, see below. The Information Classes which compose each ADS are located in the VEAR, in the Data & Information domain. The Contractor shall ensure that all delivered applications and system solutions support:

1. Interfacing with VA’s Master Person Index (MPI) (formerly the Master Veteran Index (MVI)) to provision identity attributes, if the solution relies on VA user identities. MPI is the authoritative source for VA user identity data.

2. Interfacing with Capital Asset Inventory (CAI) to conduct real property record management actions, if the solution relies on real property records data. CAI is the authoritative source for VA real property record management data.

3. Interfacing with electronic Contract Management System (eCMS) for access to contract, contract line item, purchase requisition, offering vendor, and solicitation information above the micro-purchase threshold, if the solution relies on procurement data. ECMS is the authoritative source for VA procurement actions data.

4. Interfacing with HRSmart Human Resources Information System to conduct personnel action processing, on-boarding, benefits management, and compensation management, if the solution relies on personnel data. HRSmart is the authoritative source for VA personnel information data.

5. Interfacing with VA Profile to access personal contact information, if the solution relies on VA Veteran personal contact information data. VA Profile is the authoritative source for VA Veteran Personal Contact Data.

6. Interfacing with VA/Department of Defense (DoD) Identity Repository (VADIR) for determining eligibility for VA benefits under Title 38, if the solution relies on qualifying active duty military service data. VADIR is the authoritative source for qualifying active duty military service in VA.

7. Interfacing with VA Systems Inventory (VASI) to access VA systems information, if the solution relies on VA system information. VASI is the authoritative source for VA Information Technology systems.

8. Interfacing with Enterprise Mission Assurance Support Service (eMASS) to access the Authority to Operate (ATO) status of all VA Information Systems. eMASS contains the official Authority to Operate (ATO) status of all VA Information Systems.

SOCIAL SECURITY NUMBER (SSN) REDUCTION

The Contractor solution shall support the Social Security Number (SSN) Fraud Prevention Act (FPA) of 2017 which prohibits the inclusion of SSNs on any document sent by mail. The Contractor support shall also be performed in accordance with Section 240 of the Consolidated Appropriations Act (CAA) 2018, enacted March 23, 2018, which mandates VA to discontinue using SSNs to identify individuals in all VA information systems as the Primary Identifier. The Contractor shall ensure that any new IT solution discontinues the use of SSN as the Primary Identifier to replace the SSN with the ICN in all VA information systems for all individuals. The Contractor shall ensure that all Contractor delivered applications and systems integrate with the VA MPI for identity traits to include the use of the ICN as the Primary Identifier. The Contractor solution may only use a Social Security Number to identify an individual in an information system if and only if the use of such number is required to obtain information VA requires from an information system that is not under the jurisdiction of VA.

SECURITY AND PRIVACY REQUIREMENTS

It has been determined that protected health information may be disclosed or accessed and a signed Business Associate Agreement (BAA) shall be required. The Contractor shall adhere to the requirements set forth within the BAA, referenced in Section D of the contract, and shall comply with VA Directive 6066.

POSITION/TASK RISK DESIGNATION LEVEL(S)

In accordance with VA Handbook 0710, Personnel Security and Suitability Program, the position sensitivity and the level of background investigation commensurate with the required level of access for the following tasks within the PWS are:

Position Sensitivity and Background Investigation Requirements by Task

Task Number
Tier1 / Low Risk
Tier 2 / Moderate Risk
Tier 4 / High Risk
5.1
☒
☐☐
5.2
☒☐☐
5.3
☒☐☐

The Tasks identified above and the resulting Position Sensitivity and Background Investigation requirements identify, in effect, the Background Investigation requirements for Contractor individuals, based upon the tasks the particular Contractor individual will be working. The submitted Contractor Staff Roster must indicate the required Background Investigation Level for each Contractor individual based upon the tasks the Contractor individual will be working, in accordance with their submitted proposal.

CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

Contractor Responsibilities:

1. The Contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain the appropriate Background Investigation, and are able to read, write, speak, and understand the English language.

Within 3 business days after award, the Contractor shall provide a roster of Contractor and Subcontractor employees to the COR to begin their background investigations in accordance with the PAL template artifact. The Contractor Staff Roster shall contain the Contractor’s Full Name, Date of Birth, Place of Birth, individual background investigation level requirement (based upon Section 6.2 Tasks), etc. The Contractor shall submit full Social Security Numbers either within the Contractor Staff Roster or under separate cover to the COR. The Contractor Staff Roster shall be updated and provided to VA within 1 day of any changes in employee status, training certification completion status, Background Investigation level status, additions/removal of employees, etc. throughout the Period of Performance. The Contractor Staff Roster shall remain a historical document indicating all past information and the Contractor shall indicate in the Comment field, employees no longer supporting this contract. The preferred method to send the Contractor Staff Roster or Social Security Number is by encrypted e-mail. If unable to send encrypted e-mail, other methods which comply with FIPS 140-2 (or its successor) are to encrypt the file, use a secure fax, or use a traceable mail service.

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