AI Use Compliance and Risk Attch 5.pdf

PDF 120 KB Posted

Attached to
Clinical Trial Management System for TB Clinical Research
Solicitation number
2026-Q-97423
Issued by

About this file

This is a template for an Artificial Intelligence (AI) Use Compliance and Risk Management Plan intended for federal contractors who plan to use, may use, or propose to use AI in contract performance when the primary deliverable is not AI system development or delivery. The document requires contractors to disclose and document all AI tool usage, including the tool name, developer/vendor, AI classification (generative AI, agentic AI, classical/predictive machine learning, computer vision, natural language processing, or reinforcement learning), and whether usage is required or optional for contract performance.

The template mandates contractors to provide comprehensive details regarding AI system hosting environments (contractor environment, commercial SaaS, FedRAMP-authorized cloud, CDC/HHS environment, or local/offline), data handling practices, and whether government information will be processed, stored, or used for model training. Contractors must identify the types of data involved (public information, government nonpublic information, personally identifiable information, protected health information, procurement-sensitive information, or proprietary/business confidential information), data retention periods, and sharing practices with third parties. The plan requires documentation of safeguards including human review and verification procedures, monitoring mechanisms (accuracy/performance, data leakage signals, abuse/misuse, prompt injection, unauthorized access), and incident response protocols. Contractors must affirm that AI will not be used without Contracting Officer approval, that all planned or potential AI use has been disclosed, that government information will not be entered into unapproved tools, and that government data will not be used to train or improve AI models unless expressly authorized. The contractor must maintain and update the plan throughout contract performance and notify the Contracting Officer and Contracting Officer's Representative of any changes, expansions, or new AI use, while preventing unlawful discriminatory use and maintaining compliance with applicable privacy, security, data rights, records, civil rights, and AI requirements.

View the file

Other files

File Type Posted
Questions_Answers Worksheet.xlsx XLSX spreadsheet
Letter of Supply Template Attachment 3.docx DOCX document
Attachment 1 SOW crosswalk.docx DOCX document
VPAT Report- Attachment 6.docx DOCX document
SOL-75D30126Q79181 DB.pdf PDF
Pricing Schedule Attachment 2-.xlsx XLSX spreadsheet
RFP-CLINICAL TRIAL MANAGEMENT SYSTEM-FE.pdf PDF
CTMS questions Attachment 4_.pdf PDF

On GovTribe

Work with this file

  • Download the original file
  • Contacts named in this file
  • Similar government files
  • Ask GovTribe AI about this file

Text version

Attachment (if Applicable, disregard if not applicable)

Artificial Intelligence (AI) Use Compliance and Risk Management Plan

Purpose: Use this when a contractor plans to use, may use, or later proposes to use AI in contract performance, but the primary deliverable is not the development or delivery of an AI system.

1. Background

Name of AI tool/system:

Contractor using the AI:

Subcontractor or service provider, if any:

Contract task/function supported:

Describe how AI will be used in contract performance:

Is AI use required to perform the work, or optional?

Required

Optional

Unknown

AI classification:

Generative AI

Agentic AI

Classical/Predictive Machine Learning

Computer Vision

Natural Language Processing

Reinforcement Learning

Other: [Insert]

Is this use limited to contractor internal operations?

Yes

No

Will the AI touch Government information, systems, identities, networks, or operations?

Unknown

Was the AI system procured to support this particular contract per requirements in the

Statement of Work?

2. Who owns and supports this use?

Contractor AI owner:

Contractor technical support contact:

Contractor privacy/security contact:

CDC/HHS program office using or receiving outputs:

Expected users:

Contractor staff only

CDC/HHS staff

Public users

Beneficiaries, patients, applicants, regulated entities, or other external parties

Other: [Insert]

3. Tool background

Tool or product name:

[Insert]

Developer/vendor:

[Insert]

Is the AI technology open-source, proprietary, Government-furnished, or other?

☐ Open-source

☐ Proprietary/commercial

☐ Government-furnished

☐ Contractor-developed

☐ Subcontractor-provided

☐ Other: [Insert]

If the system uses an LLM or foundation model, what is the primary model?

[Insert]

Who provides the LLM/foundation model?

[Insert]

What model options are available?

[Insert]

Does it require an API key?

☐ Yes

☐ No

☐ Unknown

Attach or link, if available:

☐ Model card

☐ System card

☐ Data card

☐ Vendor security documentation

☐ Evaluation summary

☐ Terms of service

☐ Privacy/data retention policy

☐ Audit-log documentation

4. Where is it hosted and authorized?

Hosting environment:

☐ Contractor environment

☐ Commercial SaaS

☐ FedRAMP-authorized cloud

☐ CDC/HHS environment

☐ Local/offline environment

☐ Other: [Insert]

Where is the system hosted?

[Insert country/region/cloud/provider]

Is the product directly FedRAMP authorized or available through a FedRAMP-authorized instance?

☐ Yes

☐ No

☐ Not applicable

☐ Unknown

If no, is it undergoing FedRAMP authorization?

☐ Yes

☐ No

☐ Unknown

5. What data will be used?

Will the AI process, store, transmit, summarize, analyze, or generate Government information?

Unknown

Types of data involved:

Public information

Government nonpublic information

PII

PHI

Procurement-sensitive information

Proprietary/business confidential information

☐ Other: [Insert]

What information will be entered into the AI tool?

[Insert]

What outputs will the AI generate?

[Insert]

Will prompts, uploads, outputs, logs, or user interactions be stored?

☐ Yes

☐ No

☐ Unknown

Retention period:

[Insert]

Will Government data, prompts, outputs, or logs be used to train, fine-tune, improve, or benchmark any model?

Yes

No

Unknown

Will any data, prompts, outputs, or logs be shared with other users, tenants, vendors, subcontractors, or third parties?

Yes

No

Unknown

Explain storage, use, retention, deletion, and sharing:

6. Is this high-impact?

Could the AI output materially affect an individual’s or organization’s rights, benefits, services, health, safety, access, eligibility, enforcement status, or other significant interests?

Yes

No

Unknown

Could CDC/HHS personnel rely on the AI output as a principal basis for a decision or action?

Yes

No

Unknown

Is the AI used only for internal drafting, summarization, or administrative support with human review before use?

High-impact rationale:

7. What safeguards are in place?

How will contractor personnel verify AI outputs before relying on them?

What human review is required before AI-generated content is submitted to CDC/HHS?

How will the contractor prevent unauthorized disclosure of Government information?

How will the contractor prevent misuse, unauthorized use, or corruption of the AI system?

How will the contractor protect privacy, civil rights, and civil liberties?

What internal policies govern this AI use?

8. Monitoring and misuse protection

What is monitored?

Accuracy/performance

Performance degradation or drift

Data leakage signals

Abuse/misuse

Prompt injection

Unauthorized access

Other: [Insert]

Does CDC/HHS have access to monitoring information, audit logs, or summary reports?

Upon request

Not applicable

How are issues detected, escalated, and corrected?

When will CDC/HHS be informed?

What is the standard operating procedure for incidents or unacceptable outputs?

9. Required contractor affirmation

The contractor affirms that:

AI will not be used unless approved by the Contracting Officer.

The contractor has disclosed all planned or potential AI use.

The contractor will not enter Government information into unapproved AI tools.

The contractor will not use Government data to train, fine-tune, or improve an AI model unless expressly authorized.

The contractor will maintain and update this AI Use Card throughout contract performance.

The contractor will notify the Contracting Officer and COR before changed, expanded, or new AI use.

The contractor will prevent unlawful discriminatory use or outputs.

The contractor will comply with applicable privacy, security, data rights, records, civil rights, and AI requirements.

File details come from the government source that posted it. Updated .