Build AI usage policies, risk frameworks, and evaluation metrics. Operationalize compliance for HIPAA, FINRA, FDA, and other regulated sectors.
Compliance, Risk, Legal, and IT leaders in regulated industries who need to deploy AI safely and maintain regulatory compliance. Essential for healthcare, finance, government, and manufacturing companies subject to HIPAA, FINRA, FDA, SEC, or other regulations.
Zero findings
Comprehensive documentation and controls for regulatory audits
60–80%
Lower AI risk exposure through systematic governance and evaluation
100%
All AI use cases covered by governance framework and policies
Validated
AI systems evaluated and approved before production deployment
Policies, procedures, and organizational structure for AI oversight
Systematic risk identification, scoring, and mitigation planning
Automated testing for accuracy, bias, safety, and compliance
Comprehensive logging of AI decisions, inputs, and outputs for compliance
HIPAA, FINRA, FDA, SEC, or other regulatory alignment documentation
Policies, procedures, and training for your team
Patient data protection, PHI handling, clinical decision support validation, and medical device AI compliance.
Focus: Data privacy, clinical validation, audit trails for patient care decisions
Trading algorithm oversight, customer data protection, KYC/AML compliance, and financial advice AI governance.
Focus: Algorithmic trading controls, customer data security, regulatory reporting
Quality control AI validation, production process oversight, documentation requirements, and traceability for regulated products.
Focus: Quality validation, process documentation, change control
Citizen data protection, procurement compliance, algorithmic transparency, and public sector AI ethics requirements.
Focus: Data sovereignty, transparency, public accountability
Inventory current AI use cases, identify regulatory requirements, assess risk exposure, and document existing controls. We interview stakeholders and review systems.
Create governance framework, policies, risk register, and evaluation protocols. We tailor frameworks to your industry and regulatory requirements.
Implement evaluation harnesses, audit trails, and monitoring. Train your team, establish approval workflows, and validate compliance.
4–8 weeks
Depending on scope, industry complexity, and number of use cases
12–20 hours
Total stakeholder time for interviews, reviews, and training
Timeline factors:
$15,000–$40,000
Initial framework setup + optional monthly retainer for ongoing governance
Governance frameworks improve risk management and compliance metrics across Universal Chart of Accounts processes:
Audit findings
Compliance violations
Risk exposure score
Policy coverage %
AI system approval time
Incident response time
Data breach risk
Regulatory penalty risk
AI accuracy rates
Bias detection scores
Audit trail completeness
Policy adoption rate
We deploy evaluation harnesses, audit logging, and monitoring tools that integrate with your existing AI systems and compliance infrastructure.
Risk: AI systems violate HIPAA, FINRA, FDA, or other regulations, leading to fines, legal action, or business restrictions.
Safeguard: Industry-specific compliance frameworks, regular audits, evaluation protocols that test for regulatory alignment, and documentation that demonstrates due diligence to regulators.
Risk: AI systems make biased decisions that discriminate against protected classes, leading to legal liability and reputational damage.
Safeguard: Bias testing frameworks, diverse training data validation, fairness metrics monitoring, and human oversight for high-stakes decisions.
Risk: Sensitive data exposed through AI systems, violating privacy regulations and causing customer trust issues.
Safeguard: Data encryption, access controls, audit logging, data minimization practices, and privacy impact assessments before AI deployment.
Risk: Policies created but not followed, leading to shadow AI deployment and compliance gaps.
Safeguard: Change management, training programs, approval workflows, monitoring for unauthorized AI use, and regular policy reviews with stakeholders.
Challenge: Deploying AI for clinical decision support but concerned about HIPAA compliance and medical liability. Auditors asking about AI governance.
Solution: Built HIPAA-aligned governance framework with PHI handling policies, clinical validation protocols, audit trails for patient care decisions, and bias testing for diagnostic AI systems.
Impact: Zero audit findings, approved AI deployment for 5 clinical use cases, reduced legal risk, improved patient safety through systematic validation.
Challenge: Using AI for customer service and fraud detection but need FINRA/SEC compliance. Teams deploying AI tools without oversight.
Solution: Created FINRA-aligned governance framework with algorithmic trading controls, customer data protection policies, KYC/AML compliance validation, and centralized approval workflows for all AI deployments.
Impact: 100% policy coverage, zero regulatory violations, faster AI approval process (2 weeks vs. 6 weeks), reduced risk exposure by 70%.
We have industry-specific frameworks that map to regulatory requirements. We review your specific regulations, identify AI-related compliance obligations, and design policies and controls that demonstrate due diligence. We also provide documentation templates that align with audit requirements.
We assess existing systems and bring them into the governance framework. This includes evaluating current systems for compliance gaps, documenting existing controls, and creating remediation plans where needed. We can also grandfather certain systems with appropriate risk mitigation.
Evaluation harnesses are automated testing frameworks that validate AI systems before deployment. They test for accuracy, bias, safety, and compliance using test datasets and defined metrics. We build custom harnesses for your specific use cases and integrate them into your CI/CD pipeline or approval workflows.
The retainer ($3–8K/month) includes: policy updates as regulations change, evaluation of new AI use cases, audit preparation support, quarterly risk assessments, training for new team members, and access to our compliance experts for questions. It ensures your governance framework stays current and effective.
With a well-designed framework, approval typically takes 1–2 weeks for standard use cases. Complex or high-risk use cases may take 3–4 weeks. The framework includes streamlined approval workflows, pre-approved templates for common use cases, and clear risk thresholds that determine approval level required.
Yes. Even non-regulated companies benefit from AI governance to manage risk, ensure quality, and scale AI responsibly. We can create lighter-weight frameworks focused on risk management, quality assurance, and ethical AI use rather than regulatory compliance.
The framework includes incident response procedures. We help you investigate, document, remediate, and learn from incidents. The audit trail and evaluation data help identify root causes. We also update policies and controls based on lessons learned to prevent similar incidents.
Book a 20-minute fit call to discuss your compliance requirements and see if our governance framework is right for your organization.
Last updated: November 2025