ISO/IEC 42001 and the HITRUST AI Security Assessment and Certification address AI risk from fundamentally different angles. While ISO/IEC 42001 defines how organizations govern AI, HITRUST provides assurance that AI security controls are implemented and tested, producing evidence-based confidence in the security of deployed AI systems.

Why organizations must focus on AI security now?

AI adoption has accelerated faster than most security and risk programs can adapt. AI risk no longer stops at the enterprise perimeter. It now lives inside the software, platforms, and services organizations buy and rely on every day.

Vendors are racing to introduce AI features and back-office efficiencies, often faster than security teams can assess them. For third-party risk management (TPRM) teams, this creates a critical question: How do we know a vendor’s AI platform is secure?

That question drives direct comparisons between ISO/IEC 42001 and the HITRUST AI Security Assessment and Certification.

What problem does ISO/IEC 42001 solve?

ISO/IEC 42001 demonstrates that an organization has implemented an AI governance and management structure. It shows that policies exist, responsibilities are defined, and AI-related activities are overseen through a formal management system.

For vendor risk programs, this can signal

• Governance maturity
• Executive oversight of AI
• Commitment to responsible AI practices

ISO/IEC 42001 certification is based on whether the AI management system meets the standard’s requirements, but audits are typically risk-based and sample evidence rather than testing every possible control in depth. As a result, some listed controls may never be tested, even in certified environments.

In the market, ISO/IEC 42001 certifications may be issued by either accredited certification bodies (preferred) or non-accredited bodies. Accreditation improves consistency and trust, but buyers may not always be able to easily distinguish the rigor behind different certificates. This creates a market where assurance rigor varies significantly. TPRM teams cannot easily distinguish high-quality audits from low-quality ones.

Overall, ISO/IEC 42001 is not primarily designed as a technical security validation of a deployed AI system; it validates the organization’s AI management systems and governance processes, with security addressed through management-system controls rather than deep system testing. It answers how AI is managed — not how AI is protected.

What problem does HITRUST AI Security Certification solve?

The HITRUST AI Security Assessment and Certification addresses a different and increasingly urgent problem: proving that deployed AI systems are secure.

HITRUST focuses on

• AI-specific security risks in real systems
• Prescriptive controls mapped to threats and tailored to AI deployment scenarios
• Independent testing, centralized quality assurance, and certification

Rather than evaluating governance maturity, HITRUST validates whether security controls are implemented, tested, and effective in operational AI environments. Every applicable HITRUST AI security control must be implemented and tested for certification. There is no selective control adoption or selective testing. This delivers defensible, evidence-based AI security assurance.

How do ISO/IEC 42001 and HITRUST AI compare?

Why governance alone doesn’t reduce AI security risk

Governance maturity does not equal security assurance.

Two organizations may both hold ISO/IEC 42001 certifications while operating AI systems with vastly different security postures. Because the standard is principle-based, security depth depends heavily on interpretation and implementation.

For TPRM teams, this creates

• Inconsistent evidence across vendors
• Heavy reliance on narrative explanations
• Increased effort to interpret and normalize risk

When AI is embedded in third-party products, this lack of standardization leaves material security risk unmeasured.

How HITRUST delivers measurable AI security assurance

HITRUST AI Security Certification was developed through extensive industry collaboration to address this exact gap. It enables scalable trust across vendor ecosystems by providing

• 44 harmonized, AI-specific security controls
• Prescriptive controls mapped to NIST publications, ISO/IEC standards, and OWASP guidance 
• Regular updates to address emerging AI threats
• Explicit mapping between threats and required controls
• Standardized reporting suitable for executives, regulators, and TPRM teams

The outcome is proof that AI systems are protected.

Is ISO/IEC 42001 or HITRUST AI the right choice?

For most organizations, the answer is not one or the other. It is understanding their distinct roles.

• ISO/IEC 42001 helps organizations govern AI responsibly.
• HITRUST AI Security Certification helps organizations prove AI systems are secure.

When AI is operational, customer-facing, or embedded in third-party products, governance alone is not enough.

In our upcoming blog, we’ll explore why this creates a critical blind spot in third-party risk management and why validated AI security assurance is becoming essential for managing AI risk at scale.