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.

HITRUST transforms cybersecurity in third-party risk management from a costly compliance burden into a scalable, defensible, and resilient business advantage. Organizations using the HITRUST validated assurance model report higher efficiency, lower operational costs, and dramatically improved risk posture — achieving measurable results that prove trust can be both strategic and profitable.

In our previous post, we explored what validated assurance is and how HITRUST operationalizes it. Now, let’s look at the outcomes, the tangible business impact of turning reactive vendor oversight into validated, proactive assurance.

How does HITRUST improve TPRM efficiency?

Traditional TPRM programs rely on repetitive, manual reviews that slow down procurement and exhaust risk teams. HITRUST replaces this fragmented approach with a standardized, reusable, and scalable model.

Efficiency gains include

• 3–5× higher vendor assessment throughput by standardizing methods and automating evidence reuse.
• Faster onboarding cycles, as pre-validated vendors can be approved in a fraction of the time.
• Streamlined collaboration across procurement, compliance, and security teams using consistent data and shared assurance results.

With the HITRUST validated assurance, every vendor review adds value, not administrative overhead.

How does HITRUST reduce TPRM operational costs?

Manual risk reviews consume valuable time, personnel, and budget. By eliminating redundant assessments and reusing validated certifications, organizations achieve up to 50% lower TPRM operational costs.

Key cost drivers reduced

• Labor hours spent managing questionnaires and evidence reviews.
• Redundant vendor assessments across departments.
• Inefficient coordination between buyers and vendors.

HITRUST consolidates assurance efforts into a single, defensible framework, reducing both cost and complexity while improving visibility.

How does HITRUST strengthen resilience and risk confidence?

Efficiency and cost savings are just the beginning. The true power of validated assurance lies in resilience. According to the HITRUST 2025 Trust Report, 99.41% of HITRUST-certified environments remained breach-free in 2024. That’s not a coincidence. It’s proof that verified, continuously updated controls lead to measurable protection.

Validated assurance improves resilience through

• Evidence-based security: Every certification is independently verified and quality-controlled.
• Continuous improvement: Threat-adaptive updates ensure controls evolve with emerging risks.
• Transparent results: Organizations gain clear visibility across vendor ecosystems to spot weaknesses before they become threats.

The outcome: fewer incidents, faster response times, and greater confidence across the supply chain.

How does HITRUST turn risk management into a strategic advantage?

Validated assurance doesn’t just prevent problems. It accelerates opportunity. By reducing friction between vendors and assessing organizations, HITRUST transforms third-party risk management into a business enabler.

With HITRUST validated assurance

• Vendors gain credibility through verified certifications recognized across industries.
• Organizations streamline procurement and strengthen compliance defensibility.
• Boards and regulators receive transparent, comparable, and auditable assurance data.

This shared trust ecosystem empowers organizations to move faster, innovate confidently, and demonstrate leadership in security and compliance.

What’s the bottom line?

HITRUST offers a proven model driving measurable business outcomes for cybersecurity in TPRM.

What was once a reactive process of vendor oversight has become a strategic pillar of resilience and growth, all made possible through HITRUST’s validated assurance ecosystem.

Learn more in our white paper

Explore how validated assurance delivers measurable efficiency, risk reduction, and resilience in our new white paper: Redefining Third-Party Risk Management with the HITRUST Validated Assurance

Discover how HITRUST empowers organizations to redefine vendor oversight, turning compliance burdens into breakthrough business results.

Validated assurance is the new standard for third-party trust, providing verified, benchmarked, and quality-controlled proof of security that replaces manual, self-attested processes. It enables organizations to assess, monitor, and trust vendors with confidence, reducing complexity while increasing transparency across the entire third-party ecosystem.

In our previous post, we explored why traditional third-party risk management (TPRM) models are breaking down, burdened by inefficiency, inconsistency, and incomplete assurance. Now, let’s understand the solution: validated assurance.

What is validated assurance — and why does it matter?

Validated assurance is a model that proves security and compliance, instead of just claiming it. It relies on independent verification, standardized frameworks, and centralized quality assurance to deliver consistent, defensible evidence of a vendor’s cybersecurity and privacy posture.

In short, validated assurance means you don’t have to take a vendor’s word for it. Their controls have been tested, verified, and approved against a trusted, recognized standard.

This approach solves a critical problem for both organizations evaluating vendors and vendors being assessed. It replaces unverified, inconsistent evidence with transparent, comparable results that everyone can trust.

How does validated assurance fix the gaps in traditional TPRM?

Traditional third-party risk management relies on subjective, manual, and often redundant processes. It creates friction among risk teams and vendors. Validated assurance replaces this with standardization, evidence, and scalability.

With validated assurance, organizations move from reactive oversight to proactive confidence, reducing both operational overhead and uncertainty.

How does HITRUST operationalize validated assurance?

HITRUST pioneered validated assurance by building it into every layer of its ecosystem.

• A unified framework

At the foundation is the HITRUST Framework, which harmonizes over 60 global regulations, standards, and best practices into one comprehensive control library. This ensures alignment across multiple requirements.

• Tiered assurance (e1, i1, r2)

Not all vendors require the same level of scrutiny. HITRUST’s tiered assessment model (e1,i1,r2) scales rigor to vendor criticality. This flexibility helps organizations evaluate vendors appropriately without sacrificing consistency.

• Centralized quality assurance

Every validated assessment undergoes a centralized QA review by HITRUST, ensuring each certification meets the same defensibility and quality standards, making the results uniformly reliable.

• Threat-adaptive updates

The HITRUST Framework evolves frequently to keep pace with emerging threats, vulnerabilities, and regulatory changes. This threat-adaptive model ensures that vendor assessments remain aligned with the latest risk environment.

• Automation and interoperability

Through integrations with platforms like ServiceNow via the HITRUST TPRM Services (formerly known as HITRUST Assessment XChange), validated assurance becomes scalable. Organizations can automate evidence reuse, monitor vendor status in real time, and streamline reporting.

• Standardized control set

With standardized controls, HITRUST enables organizations to develop efficiencies as they know exactly which controls were tested.

Who benefits from validated assurance?

Validated assurance is a win-win for both sides of the third-party risk equation.

Assessing organizations:

• Gain verified, comparable assurance across vendors.
• Reduce assessment time and resource strain.
• Build defensible confidence for boards, regulators, and auditors.

Vendors:

• Demonstrate security maturity once and reuse the certification multiple times.
• Reduce audit fatigue from repetitive questionnaires.
• Accelerate sales cycles with trusted, independently verified assurance.

In essence, validated assurance creates a shared ecosystem of trust, where proof replaces promises, and efficiency replaces redundancy.

What’s next?

The transition to validated assurance is more than an operational upgrade. It’s a strategic evolution.

Explore how validated assurance transforms third-party oversight into a measurable, defensible, and scalable model of trust in our new white paper: Redefining Third-Party Risk Management with the HITRUST Validated Assurance.