California has officially enacted Senate Bill 53 (SB 53), the Transparency in Frontier Artificial Intelligence Act, marking a pivotal moment in U.S. technology regulation. Signed by Governor Gavin Newsom on September 29, SB 53 introduces the nation’s first comprehensive safety and transparency requirements for frontier AI developers — those building the most advanced and computationally intensive AI systems.

What does SB 53 require?

California’s AI safety law, SB 53, focuses on transparency and risk mitigation rather than liability, distinguishing it from last year’s vetoed SB 1047. Key provisions include

• Public safety frameworks: Large AI developers (annual revenue >$500M and training models at ≥10²⁶ FLOPs) must publish documented frameworks detailing how they incorporate national and international standards into their AI development processes.
• Catastrophic risk assessments: Companies must disclose assessments of risks that could lead to mass harm or $1B+ in damages, such as autonomous misuse or bioweapon development.
• Incident reporting: Critical safety incidents must be reported to California’s Office of Emergency Services (OES) within 15 days, and imminent threats within 24 hours.
• Whistleblower protections: Employees who raise safety concerns are shielded from retaliation, reinforcing accountability.
• Civil penalties: Noncompliance can result in fines up to $1 million per violation, enforceable by the state attorney general.

Why does this matter?

California’s move underscores a growing trend: state-level leadership in AI governance amid stalled federal action. SB 53 is widely viewed as a blueprint for future regulation, similar to how GDPR influenced global privacy standards. Analysts predict that transparency requirements will become a competitive differentiator, shaping procurement decisions and investor confidence.

How does HITRUST help with SB 53 compliance?

HITRUST is uniquely positioned to help organizations navigate SB 53’s requirements through its AI Security Assessment and Certification, which includes

• 44 harmonized AI controls mapped to NIST, ISO, OWASP, and the HITRUST CSF.
• Catastrophic risk mitigation strategies addressing model poisoning, prompt injection, and supply chain threats
• Incident response alignment with SB 53’s 15-day and 24-hour reporting windows
• Governance and transparency support for publishing safety frameworks and enabling whistleblower protections
• Independent assurance through HITRUST’s centralized QA and certification process

“As California leads the way in AI governance, HITRUST offers a certifiable path to compliance that balances innovation with accountability,” said Jeremy Huval, Chief Innovation Officer at HITRUST.

Will other states follow California’s AI law?

SB 53 signals a new era of AI accountability. Whether other states follow suit or Congress steps in with a federal standard, organizations that prioritize risk management and transparency today will be better positioned for tomorrow’s regulatory landscape.

Learn more about HITRUST’s AI Security Certification and how we can help your organization meet SB 53 requirements.

What is CMMC, and why is it challenging for contractors?

The Department of Defense’s (DoD) Cybersecurity Maturity Model Certification (CMMC) is now a prerequisite for doing business within the Defense Industrial Base. Unlike a simple checklist, CMMC is a maturity model with level-specific expectations tied to federal rulemaking and Defense Federal Acquisition Regulation Supplement (DFARS).

Contractors must implement the right controls at the right level, prove they work, and keep proving it over time. Common hurdles in this process include fragmented frameworks, audit fatigue, and the burden of producing credible, repeatable evidence. The good news is that the HITRUST CSF v11.6 and later includes mappings to CMMC Levels 1–3, enabling organizations to align their cybersecurity programs with federal mandates while leveraging a single integrated framework.

How does HITRUST make CMMC readiness simpler and stronger?

HITRUST translates CMMC requirements into a practical, defensible, and scalable assurance program. With the HITRUST framework mappings to CMMC Levels 1–3 and targeted reporting (including Level 1 Insights), organizations can “build once” and inherit rigor across mandates, reducing rework while improving audit confidence with prime contractors, assessors, and the DoD.

What’s the quick view: CMMC vs. HITRUST support?

 How do we map a practical path to CMMC using HITRUST?

• Confirm your target level. Anchor plans to determine whether you handle FCI (often Level 1) or CUI (typically Level 2; certain scenarios may require Level 3).
• Adopt HITRUST CSF mappings. Align policies and procedures to mapped controls to reduce interpretation risk and ensure complete, level-appropriate coverage.
• Leverage Level 1 Insights (if applicable). Use the CMMC Level 1 Insights Report to structure self-assessments and streamline accurate SPRS submissions.
• Plan validated assurance for higher levels. For Levels 2–3, use HITRUST’s validated assessments and evidence model to prepare for third-party or government-led audits.
• Operationalize continuous readiness. Centralize evidence, manage inheritance, and schedule periodic checks to avoid last-minute remediation cycles.

What benefits can contractors and suppliers expect?

• Efficiency: One integrated framework supports multiple outcomes — CMMC and beyond — reducing duplication and audit fatigue.
• Credibility: Evidence grounded in tested controls resonates with prime governmental contract holders, C3PAOs, and federal stakeholders.
• Scalability: Right-sized for SMBs yet robust enough for large integrators; inheritance and centralization keep costs predictable.
• Resilience: Continuous-readiness practices help you maintain compliance as contracts, environments, and threats evolve.

Why is now the right time to act?

With CMMC requirements maturing across solicitations and flow-down clauses reaching subcontractors, delays increase the risk to pipeline and partner trust. Adopting HITRUST now accelerates certification readiness and sets a durable foundation for ongoing assurance, so you’re prepared not only to earn certification, but to keep it.

How do we get started fast?

• Identify your CMMC level based on data sensitivity and planned opportunities.
• Activate HITRUST mappings to translate CMMC into implementable, testable controls.
• Use Level 1 Insights for efficient, defensible self-assessments and clean SPRS submissions.
• Schedule a validated assessment pathway for Levels 2–3 and establish a cadence for continuous evidence maintenance.

By Sean Dowling, VP & Head of HITRUST, vCISO and Federal Services at Accorian

For organizations pursuing HITRUST certification, the journey promises a structured path to compliance, risk reduction, and market credibility. Yet many underestimate what’s required to get there, and what it costs to do it wrong.

Poor planning in HITRUST adoption leads to ballooning timelines, budget overruns, and staff fatigue. But, when done strategically, the returns can be exceptional: according to Enterprise Strategy Group (ESG), organizations that properly implement HITRUST experience 464% ROI, with 63% increased operational efficiency and significantly reduced breach and compliance costs.

This article explores the hidden costs of poor HITRUST planning and how to avoid them through proper scope management, resourcing, and execution.

Where HITRUST projects go off track

Organizations often stumble into the same traps early in the HITRUST journey. The most common causes of budget and timeline overruns include the following.

Scope creep

When organizations fail to define clear technical and business boundaries, they include too many systems, processes, or geographies, leading to unnecessary complexity.

• Hidden costs: Increased number of controls, inflated assessment scope, and excessive evidence requirements.
• Pro tip: Start with a clearly defined scoping questionnaire and limit scope to the most critical systems (especially in first-time certifications).

Unrealistic timelines

Many teams underestimate the time needed for remediation, policy development, and evidence collection, especially across five HITRUST maturity levels (Policy, Process, Implemented, Measured, Managed).

• Hidden costs: Missed deadlines, overtime expenses, and failed validations requiring retesting.
• Pro tip: Include buffer time for control testing, policy revisions, and sample evidence validation. ESG reports show that HITRUST preparation can drop from 90 to 60 days with good planning.

Underestimating internal resource requirements

Without clear internal ownership, HITRUST projects may drain unallocated IT and compliance resources.

• Hidden costs: Productivity loss, staff burnout, and reduced engagement in both security and business operations.
• Pro tip: Assign a dedicated HITRUST project manager and allocate at least 15% FTE across 4–5 key stakeholders (e.g., IT, HR, Security, Compliance) to maintain momentum.

Cost categories often overlooked in HITRUST planning

What the ESG report reveals about the real economics of HITRUST

Operational efficiency gains

• 30% reduction in audit preparation time
• 63% increase in operational efficiency through reusable documentation and streamlined evidence management
• Eliminated redundant audits as HITRUST certification often replaces client-initiated audits

Risk avoidance

• Up to $9.77M in potential breach-related cost savings (based on Ponemon/IBM data)
• Reduction in cyber insurance premiums by 25% for organizations with HITRUST certifications
• Improved incident response and threat readiness, leading to measurable reductions in unplanned downtime costs — up to $9,000/minute

Revenue enablement

• Clients directly attribute up to 50% of revenue growth to HITRUST certification.
• Customers see accelerated RFP cycles and reduced procurement friction.
• Certification is increasingly required for vendor selection in healthcare and other regulated sectors.

How to build a realistic project plan

Step 1: Conduct an expanded gap assessment

Include control-by-control analysis tied to HITRUST CSF v11.5 (or your applicable version), validate maturity level coverage, and prioritize remediation actions by risk and effort.

Step 2: Define scope with surgical precision

Use HITRUST’s scoping worksheet and threat catalog to define the minimum viable scope — limiting unnecessary business units, cloud assets, or legacy systems.

Step 3: Develop a budget and timeline aligned to remediation reality

Factor in remediation lead time (especially for technical changes like MFA, FIPS encryption, etc.), and allow for 60–90 days of control operation before final assessment fieldwork.

Step 4: Use HITRUST for framework consolidation

ESG’s data reveals that HITRUST customers witness 80% overlap with HIPAA and 60% with PCI and SOC 2 while completing documentation. Take advantage of this to unify evidence collection.

Conclusion: A structured investment beats reactive spending

HITRUST certification, when approached strategically, offers undeniable value, from revenue growth to measurable risk reduction. But organizations must avoid the temptation to “audit their way to compliance.”

The ESG report affirms what experienced assessors already know: success requires structure, stakeholder alignment, and operational readiness. With a potential 464% ROI, HITRUST is not just a cost of doing business — it’s a business accelerator when done right.

HITRUST ROI snapshot