Security & Compliance Checklist: SOC 2, HIPAA, GDPR for LLM Gateways

As organizations increasingly rely on Large Language Models (LLMs) to power their applications, the need for robust security and compliance frameworks has never been more critical. Whether you're handling sensitive customer data, processing healthcare information, or serving users in the European Union, your LLM gateway must meet stringent regulatory requirements.

At Requesty, we've seen firsthand how compliance challenges can slow down AI adoption. That's why we've built security and compliance features directly into our platform, helping over 15,000 developers route their LLM traffic securely while maintaining regulatory compliance.

This comprehensive guide breaks down the essential security and compliance requirements for LLM gateways, focusing on three critical frameworks: SOC 2, HIPAA, and GDPR. We'll provide actionable checklists and show you how to implement these standards effectively.

Why Compliance Matters for LLM Gateways

LLM gateways sit at a critical junction in your infrastructure, processing potentially sensitive data including:

  • Personal identifiable information (PII)

  • Protected health information (PHI)

  • Proprietary business data

  • Customer conversations and queries

With 83-85% of enterprise buyers now requiring SOC 2 compliance as a vendor prerequisite, and regulatory penalties reaching millions of dollars, compliance isn't just about avoiding fines—it's about enabling business growth and maintaining customer trust.

Modern LLM gateways like Requesty's unified platform must balance the need for powerful AI capabilities with stringent security requirements. This means implementing robust access controls, encryption, monitoring, and incident response capabilities while maintaining the flexibility to route between 160+ models.

Understanding the Big Three: SOC 2, HIPAA, and GDPR

Before diving into specific checklists, let's understand what each framework requires and when it applies to your LLM gateway.

SOC 2: The Enterprise Standard

SOC 2 (System and Organization Controls 2) has become the de facto standard for SaaS and cloud service providers. It evaluates how organizations manage customer data based on five Trust Services Criteria:

  • Security (mandatory): Protection against unauthorized access

  • Availability: System uptime and reliability

  • Processing Integrity: Accurate and complete processing

  • Confidentiality: Protection of confidential information

  • Privacy: Personal information handling

For LLM gateways, SOC 2 Type 2 certification (which assesses operational effectiveness over 6-12 months) demonstrates to enterprise customers that you have mature security controls in place. This is particularly important when using enterprise features like SSO integration and user spend limits.

HIPAA: Healthcare's Gold Standard

The Health Insurance Portability and Accountability Act (HIPAA) applies to any organization handling protected health information (PHI). This includes:

  • Healthcare providers using LLMs for patient interactions

  • Health tech companies processing medical data

  • Any LLM gateway that might receive PHI in prompts or responses

HIPAA requires three types of safeguards:

  • Administrative: Policies, training, and risk assessments

  • Physical: Facility and device security

  • Technical: Access controls, encryption, and audit logs

Non-compliance can result in fines up to $1.5 million per violation, making HIPAA compliance essential for healthcare applications.

GDPR: Global Privacy Protection

The General Data Protection Regulation (GDPR) applies to any organization processing data of EU residents, regardless of where the company is located. Key requirements include:

  • Lawful basis for data processing

  • Strong data subject rights (access, erasure, portability)

  • Data minimization and purpose limitation

  • Breach notification within 72 hours

  • Privacy by design and default

With penalties up to €20 million or 4% of global turnover, GDPR compliance is crucial for any LLM gateway with international users.

The Complete Security & Compliance Checklist

Here's your comprehensive checklist for achieving compliance across all three frameworks:

Core Security Controls (All Frameworks)

Access Management

  • Implement role-based access controls (RBAC) for all systems

  • Enforce multi-factor authentication (MFA) for admin access

  • Use API key rotation and management policies

  • Maintain principle of least privilege

Encryption

  • Encrypt all data at rest using AES-256 or stronger

  • Use TLS 1.2+ for all data in transit

  • Implement end-to-end encryption for sensitive data flows

  • Manage encryption keys securely with rotation policies

Monitoring and Logging

  • Deploy comprehensive audit logging for all access and changes

  • Implement real-time security monitoring (SIEM)

  • Set up anomaly detection for unusual patterns

  • Maintain logs for required retention periods (varies by framework)

Incident Response

  • Document incident response procedures

  • Establish clear escalation paths

  • Test response plans quarterly

  • Maintain breach notification procedures for each framework

Using Requesty's security features, you can implement many of these controls automatically, including guardrails for prompt injection protection and comprehensive audit logging across all 160+ supported models.

SOC 2 Specific Requirements

Security (Mandatory)

  • Vulnerability assessments and penetration testing (annually minimum)

  • Security awareness training for all employees

  • Vendor risk management program

  • Change management procedures

Availability

  • Disaster recovery and business continuity plans

  • Uptime monitoring and SLAs

  • Redundancy and failover capabilities

  • Capacity planning and monitoring

Requesty's routing optimizations provide built-in failover and load balancing, ensuring high availability even when individual model providers experience outages.

Processing Integrity

  • Input validation for all prompts

  • Output validation for model responses

  • Error handling and logging procedures

  • Data quality controls

Confidentiality

  • Data classification and labeling

  • Confidentiality agreements with employees and vendors

  • Access reviews (quarterly minimum)

  • Secure data disposal procedures

Privacy

  • Privacy policy and notices

  • Consent management systems

  • Data retention and deletion policies

  • Privacy impact assessments

HIPAA Specific Requirements

Administrative Safeguards

  • Designate a HIPAA Security Officer

  • Conduct annual risk assessments

  • Develop workforce training programs

  • Execute Business Associate Agreements (BAAs) with all vendors

  • Implement sanction policies for violations

Physical Safeguards

  • Facility access controls and visitor logs

  • Workstation security policies

  • Device and media controls

  • Equipment disposal procedures

Technical Safeguards

  • Unique user identification for each person

  • Automatic logoff after inactivity

  • Encryption of all ePHI

  • Audit controls tracking all PHI access

  • Integrity controls preventing unauthorized changes

  • Transmission security for all PHI in transit

When handling healthcare data, Requesty's guardrails can automatically detect and redact PHI, ensuring compliance while maintaining functionality.

GDPR Specific Requirements

Lawful Basis and Transparency

  • Document lawful basis for each processing activity

  • Provide clear, accessible privacy notices

  • Maintain records of processing activities

  • Implement privacy by design principles

Data Subject Rights

  • Access request procedures (respond within 30 days)

  • Rectification capabilities

  • Erasure mechanisms ("right to be forgotten")

  • Data portability in machine-readable format

  • Objection and restriction procedures

Data Protection

  • Data minimization practices

  • Purpose limitation controls

  • Storage limitation policies

  • Accuracy maintenance procedures

Accountability

  • Data Protection Impact Assessments (DPIAs)

  • Data Processing Agreements with all processors

  • Breach notification procedures (72-hour deadline)

  • DPO appointment (if required)

Implementation Strategy for LLM Gateways

Successfully implementing these compliance frameworks requires a strategic approach:

Phase 1: Assessment and Scoping (Weeks 1-2)

1. Identify Applicable Frameworks

  • Determine which regulations apply based on your data types and geography

  • Consider customer requirements and contractual obligations

  • Plan for future expansion and requirements

2. Define Scope

  • Map all systems processing sensitive data

  • Identify data flows through your LLM gateway

  • Document all third-party integrations and vendors

3. Gap Analysis

  • Compare current controls against requirements

  • Prioritize high-risk gaps

  • Estimate resources needed for remediation

Phase 2: Control Implementation (Weeks 3-8)

1. Technical Controls

  • Deploy encryption for data at rest and in transit

  • Implement access controls and MFA

  • Set up monitoring and logging infrastructure

  • Configure Requesty's security features including guardrails

2. Administrative Controls

  • Develop required policies and procedures

  • Create training programs

  • Establish incident response procedures

  • Execute necessary agreements (BAAs, DPAs)

3. Physical Controls

  • Secure facility access

  • Implement device controls

  • Establish media handling procedures

Phase 3: Automation and Optimization (Weeks 9-12)

Modern compliance platforms can automate up to 75% of compliance tasks. Consider:

  • Automated evidence collection

  • Continuous control monitoring

  • Policy template libraries

  • Integrated risk assessments

  • Automated audit preparation

Requesty's enterprise features include built-in compliance tools like user budgets, SSO integration, and comprehensive analytics that simplify audit preparation.

Phase 4: Audit and Certification (Ongoing)

1. Internal Audits

  • Conduct quarterly self-assessments

  • Test incident response procedures

  • Review and update policies

  • Monitor control effectiveness

2. External Audits

  • Select qualified auditors

  • Prepare evidence packages

  • Remediate findings promptly

  • Maintain continuous compliance

Leveraging Technology for Compliance

Modern LLM gateways need sophisticated tools to maintain compliance while delivering high performance. Here's how technology can help:

Automated Compliance Monitoring

  • Real-time control monitoring

  • Automated evidence collection

  • Compliance dashboards and reporting

  • Integration with existing security tools

Requesty's platform provides comprehensive logging and monitoring across all API calls, making audit trails automatic and compliance reporting straightforward.

Smart Data Handling

  • Automatic PII/PHI detection and redaction

  • Dynamic data classification

  • Consent management integration

  • Automated retention and deletion

Our guardrails feature can automatically detect and handle sensitive data according to your compliance requirements.

Intelligent Routing for Compliance

  • Route sensitive data to compliant models only

  • Implement geographic restrictions

  • Enforce data residency requirements

  • Apply model-specific security policies

With Requesty's smart routing, you can automatically route requests based on compliance requirements, ensuring healthcare data only goes to HIPAA-compliant models or EU data stays within GDPR-compliant infrastructure.

The Cost of Non-Compliance

Understanding the risks helps justify compliance investments:

Financial Impact

  • HIPAA fines: Up to $1.5 million per violation

  • GDPR penalties: Up to €20 million or 4% of global turnover

  • Increased insurance premiums: Up to 58% higher for non-compliant organizations

  • Lost business: 83% of enterprise RFPs require SOC 2

Operational Impact

  • Breach remediation costs averaging $4.45 million

  • Business disruption during investigations

  • Increased audit and legal costs

  • Resource diversion from growth initiatives

Reputational Impact

  • Customer churn increases by 7% post-breach

  • Negative media coverage

  • Loss of competitive advantage

  • Difficulty attracting top talent

Best Practices for Continuous Compliance

Compliance isn't a one-time achievement—it requires ongoing attention:

1. Regular Reviews

  • Quarterly control assessments

  • Annual risk assessments

  • Policy updates as regulations change

  • Vendor compliance reviews

2. Employee Training

  • Initial security awareness training

  • Annual refreshers

  • Role-specific training

  • Incident response drills

3. Technology Updates

  • Security patch management

  • Regular vulnerability scanning

  • Encryption algorithm updates

  • Access control reviews

4. Documentation

  • Maintain current policies

  • Document all changes

  • Keep audit trails complete

  • Update risk registers

5. Vendor Management

  • Regular vendor assessments

  • Updated agreements

  • Compliance attestations

  • Incident notification procedures

Getting Started with Compliant LLM Routing

Implementing comprehensive compliance across SOC 2, HIPAA, and GDPR can seem overwhelming, but the right approach and tools make it manageable. Here's your action plan:

1. Assess Your Requirements

  • Identify which frameworks apply to your use case

  • Understand your data types and flows

  • Define your compliance timeline

2. Choose the Right Platform

  • Select an LLM gateway with built-in compliance features

  • Ensure the platform supports your required frameworks

  • Verify the vendor's own compliance certifications

3. Implement Controls Systematically

  • Start with high-risk areas

  • Use automation where possible

  • Document everything

  • Test regularly

4. Monitor and Improve

  • Set up continuous monitoring

  • Regular internal assessments

  • Stay updated on regulatory changes

  • Learn from incidents and near-misses

Requesty simplifies this journey by providing a unified LLM gateway with enterprise-grade security features, comprehensive audit logging, and built-in guardrails. Our platform helps you maintain compliance while accessing 160+ models through a single, secure API.

Conclusion

Security and compliance for LLM gateways isn't just about checking boxes—it's about building trust with your users and enabling sustainable growth. By implementing the controls outlined in this guide, you'll not only meet regulatory requirements but also build a more secure, reliable platform.

The convergence of SOC 2, HIPAA, and GDPR requirements around core security controls means that a unified approach to compliance is both possible and efficient. With the right tools and processes, you can maintain continuous compliance while focusing on delivering value through AI.

Ready to build a compliant LLM gateway? Start with Requesty and get access to 160+ models with built-in security features, comprehensive logging, and enterprise-grade compliance tools. Our platform helps you save up to 80% on costs while maintaining the highest security standards.

For more information on implementing specific compliance features, check out our security documentation or explore our enterprise features designed for organizations with strict compliance requirements.