AI Policy & Governance
Clear policies, data classification frameworks, and compliance guidelines that let your team use AI confidently while protecting sensitive data and meeting regulatory requirements.
Why Your Company Needs an AI Policy
The Risk of No Policy
A recent survey found that 68% of employees using AI at work have never disclosed it to their employer. In regulated industries, this creates serious risks:
- Confidential clinical data entered into consumer AI tools
- AI-generated regulatory content submitted without human review
- Intellectual property shared with AI platforms that train on user inputs
- No audit trail for AI-assisted decisions in GxP environments
- Inconsistent practices across departments creating compliance gaps
Our Approach
We develop policies that enable AI adoption rather than block it. The goal is clear guardrails that let employees use AI confidently, knowing exactly what they can and cannot do with different types of data and different AI tools.
Data Classification Framework
A 4-tier framework that maps directly to AI tool permissions, making it simple for employees to know what data can be used where.
Tier 1: Public
Information that is publicly available or intended for public disclosure.
AI Permission:
Any approved AI tool
Examples:
- Published research papers
- Press releases
- Public website content
- Industry news
Tier 2: Confidential
Internal business information not intended for public disclosure.
AI Permission:
Enterprise AI tools only
Examples:
- Internal presentations
- Meeting notes
- Draft communications
- General business plans
Tier 3: Restricted
Sensitive business information with limited access.
AI Permission:
Approved tools with restrictions
Examples:
- Financial data
- Competitive intelligence
- Unpublished research data
- Employee information
Tier 4: Sensitive / Regulated
Data subject to regulatory requirements or legal restrictions.
AI Permission:
No AI tool usage
Examples:
- Patient / PHI data
- GxP records
- Regulatory submissions
- Clinical trial data
Policy Deliverables
Complete, ready-to-implement policy documents tailored to your organization. Not recommendations -- actual documents you can approve and deploy.
Master AI Usage Policy
Comprehensive policy document covering approved tools, acceptable use, data handling requirements, review processes, and enforcement. Ready for your document management system.
Get startedData Classification Matrix
Complete mapping of your data types to the 4-tier classification framework with clear AI tool permissions for each tier. Includes decision tree for edge cases.
Get startedEmployee Guidelines
Plain-language quick reference guide for employees covering dos and do-nots, approved tools, data handling rules, and escalation procedures. Designed to be printed or posted on intranet.
Get startedDepartment-Specific Rules
Customized guidelines for each department (Clinical, Regulatory, Commercial, Finance, etc.) with role-specific examples and approved use cases relevant to their workflows.
Get startedTraining Materials
Slide deck, handouts, and assessment quiz for rolling out the AI policy to your organization. Can be delivered by your team or by IntuitionLabs trainers.
Workshop optionsReview Framework
Quarterly review schedule, update process, incident reporting template, and criteria for triggering policy updates. Keeps your policy current as AI evolves.
Ongoing supportCompliance Considerations
Our AI policy framework addresses the regulatory requirements most relevant to pharmaceutical and biotech companies.
21 CFR Part 11
Ensuring AI-assisted processes maintain electronic record integrity, audit trails, and electronic signature requirements. Defines when AI-generated content requires formal validation.
HIPAA
Strict prohibitions on entering protected health information (PHI) into AI tools. Guidelines for de-identification, business associate agreements with AI vendors, and breach notification protocols.
EU AI Act
Classification of AI systems by risk level, transparency requirements for AI-generated content, and documentation obligations for high-risk AI applications in healthcare and life sciences.
Frequently Asked Questions
Ready to Govern AI Responsibly?
Book a call to discuss your AI policy needs. We will help you create clear, practical governance that enables adoption while protecting your organization.
Schedule a Consultation