What is HITRUST Compliance: Updated Guide For 2025

Posted in Healthcare Compliance

In highly regulated industries like healthcare, data security isn’t optional, it’s mandatory. With cyber threats on the rise, federal and state authorities now demand stricter compliance and vendor accountability. So, what is HITRUST? It’s a certifiable framework designed to help healthcare organizations manage risk, meet regulatory requirements, and safeguard sensitive health information.

HITRUST brings structure through its Common Security Framework (CSF), aligning multiple standards into one. It helps companies build trust, pass security reviews, and protect their reputation in a competitive market. This guide will walk you through everything you need to know about achieving HITRUST certification.

What is HITRUST?

What is HITRUST certification and why is it so widely recognized in healthcare and beyond? HITRUST stands for the Health Information Trust Alliance, established in 2007 to address growing concerns around information security, especially for sensitive healthcare data.

At its core is the HITRUST Common Security Framework (CSF), a certifiable, risk-based framework that consolidates requirements from over 50 global standards and regulations, including:

• HIPAA
• NIST
• ISO 27001
• PCI DSS
• GDPR

The HITRUST framework is organized into 19 control domains and 149 specifications, evaluated at one of three implementation levels based on organizational risk. This modular structure makes it adaptable for businesses of all sizes, from startups to enterprise systems..

Why HITRUST Compliance Matters in 2025

Cyber Threats are Escalating

Healthcare providers face an average of 2,110 cyberattack attempts per week, a 57% increase from last year. The growth of digital health products and services has widened the threat surface.

High Breach Impact

A single data breach can cause massive financial losses, regulatory penalties, and irreversible damage to reputation.

Vendor Scrutiny is Tightening

Healthcare payers and providers now require formal proof of compliance from third-party vendors.

HITRUST is a Unified Standard

It combines HIPAA, NIST, ISO, and GDPR into a single, certifiable framework for risk and compliance management.

Accelerates Enterprise Deals

Certification helps vendors pass security reviews faster, win contracts, and reduce delays in procurement, especially in high-growth sectors like telemedicine and digital health.

Baseline Expectation in 2025

HITRUST is now a minimum requirement for handling PHI, PII, or participating in data exchange, ensuring compliance across digital health ecosystems.

Continuous Risk Management

HITRUST provides tools for ongoing threat monitoring, control validation, and real-time improvements, which are essential for maintaining secure telehealth operations.

Strategic Market Advantage

HITRUST-certified vendors gain a competitive edge in a saturated healthcare technology market, including those delivering telemedicine services or enabling healthcare data exchange.

What is HITRUST Compliance and its Compliance Updates For 2025

The HITRUST CSF continues to evolve to address emerging threats and regulatory changes. The latest version, CSF v11.2, introduces several important updates:

Updated Control Mappings: 

The new version aligns with the latest NIST, ISO, and other industry standards, ensuring organizations remain compliant with evolving regulations.

Modular Assessment Options:

Organizations can now choose from three assessment types:

1. e1: A basic evaluation covering 44 essential controls, ideal for small organizations or those new to compliance.
2. i1: A best-practice assessment with over 180 controls, suitable for mid-sized organizations or as a stepping stone to r2 certification.
3. r2: A comprehensive, risk-based assessment with custom controls, designed for large enterprises with complex risk profiles.

Enhanced Automation and Continuous Monitoring:

The MyCSF platform offers improved automation, real-time monitoring, and simplified document management, making it easier to maintain compliance.

Cloud-Native and DevSecOps Support: 

The CSF includes guidance for cloud-native architectures and integrates with DevSecOps workflows, supporting modern software development and deployment practices.

For organizations providing digital health solutions, these updates provide a clear pathway to compliance. They also align with modern healthcare integration solutions and app development practices.

What Is HITRUST Eligibility? Who Can Get Certified in 2025?

HITRUST certification is not restricted to any specific industry or organization size. Any entity that handles PHI, PII, or other sensitive data can pursue certification. This includes:

• Hospitals, clinics, and health systems
• Digital health startups and telemedicine providers
• Health IT and SaaS platforms
• Life sciences and pharmaceutical ERP 
• Fintech and insurance firms
• Cloud service providers and managed service providers (MSPs)

The HITRUST framework is designed to be scalable. Whether you’re a small digital health startup or a global healthcare enterprise, HITRUST offers tailored assessment pathways (e1, i1, r2) to match your needs and resources.

What is HITRUST Qualification Criteria?

To qualify, organizations must have documented security policies, a well-structured IT environment, and the ability to collaborate with an external assessor. The HITRUST Certification process requires internal commitment and cross-functional collaboration, as the benefits, trust, risk reduction, and market access are significant.

For startups and medium-scale business enterprises, HITRUST certification can open doors to enterprise contracts and payer partnerships. It also lays the foundation for future compliance with frameworks like HIPAA, SOC 2, and ISO 27001. For more on digital health compliance, see Powerful HIPAA-Compliant Healthcare Solutions.

HITRUST vs. HIPAA, SOC 2, ISO 27001 – What’s the Difference?

Choosing the right compliance framework can be confusing. Here’s what HITRUST offers compared to HIPAA, SOC 2, and ISO 27001:

If you’re building healthcare apps or digital platforms, HITRUST certification can streamline onboarding with hospitals and payers. For more on compliance, SOC 2 Compliance: Everything You Need to Know.

Why Digital Health Products Must Adhere to HITRUST Compliance

Digital health platforms, apps, and SaaS solutions handle large volumes of protected health information (PHI), making them prime targets for cyberattacks. A single breach can cause reputational harm, legal exposure, and heavy regulatory penalties. HITRUST compliance offers a structured path to safeguard this sensitive data while aligning with healthcare regulations and industry expectations.

1. Required by Payers, Providers & Enterprise Clients

• HITRUST certification is now a baseline requirement for many hospitals, payers, and enterprise buyers.
• Vendors without it are often disqualified early in procurement processes.
• Especially for organizations offering Epic Integration or working with large hospital systems, certification is key to getting in the door.

2. Consolidates Regulatory Requirements

• HITRUST merges controls from HIPAA, NIST, ISO, GDPR, and more into a unified framework.
  
• This “assess once, report many” approach saves time and ensures broad regulatory alignment.
• It’s especially useful for companies offering Healthcare ERP Services, where compliance spans across clinical, financial, and operational systems.

3. Embeds Security into Your SDLC

• HITRUST integrates seamlessly with agile and DevOps workflows.
  
• It ensures secure development by requiring encryption, access controls, vulnerability management, and audit logging.
  
• Teams building APIs and digital tools for HL7 Integration Solutions can proactively address data exchange security at the development stage.

4. Boosts Market Trust & Competitive Advantage

• Certification signals that your product is secure and enterprise-ready.
• This builds trust with customers, investors, and partners, and can significantly shorten sales cycles.
• HITRUST compliance adds credibility to advanced platforms like Microsoft Dynamics 365 Healthcare, helping them scale safely in clinical environments.

5. Offers Scalable, Modular Compliance

• The HITRUST framework includes e1, i1, and r2 levels—ideal for organizations of all sizes.
• Startups can begin with a lightweight i1 assessment and scale up as they grow.
• Modular compliance reduces cost without compromising integrity.

6. Reduces Risk of Breaches & Penalties

• HITRUST-certified organizations tend to detect and respond to incidents more effectively.
• The framework emphasizes continuous monitoring and improvement, lowering the chance of regulatory fines.
• This is especially critical for companies offering healthcare data analytics services, where ongoing access to patient data demands high assurance.

What is HITRUST’s Certification Process? Step-by-Step Explained

The HITRUST certification process begins with a self-assessment, followed by a validated review to ensure compliance. Individuals can certify through training, while certified companies show strong data security and regulatory alignment.

To support this process, the MyCSF platform provides a structured and simplified way to manage HITRUST compliance. It helps organizations oversee controls, track documentation, and monitor timelines. MyCSF also enables gap assessments, corrective action management, and seamless sharing of HITRUST assessment information with stakeholders

Below is the step-by-step process for achieving HITRUST certification.

Readiness Assessment

Conduct an internal review to identify gaps in your current controls and policies. You can do this independently or with a HITRUST consulting partner.

Remediation

Address any deficiencies, update documentation, and harden systems to meet HITRUST requirements.

Validated Assessment

Engage a HITRUST-approved assessor to perform a thorough review of your security controls and evidence.

HITRUST Review

The HITRUST Alliance conducts a central audit to ensure all requirements are met and evidence is complete.

Certification

Once approved, your HITRUST certification is valid for two years, with interim maintenance and periodic updates required to maintain compliance.

For organizations new to compliance, they consider starting with the e1 or i1 HITRUST  assessment. These pathways provide a manageable entry point and prepare you for more advanced certifications as your security program matures.

HITRUST Certification Cost and Timeline

HITRUST certification is an investment in security and trust. Costs and timelines vary based on assessment type, organization size, and readiness:

Assessment Type	Cost	Works Best for
e1 Assessment	$10,000–$30,000	for small organizations with simple IT environments.
i1 Assessment	$40,000–$80,000	suitable for mid-sized organizations or those preparing for r2.
r2 Assessment	$100,000–$150,000+	for large enterprises with complex risk landscapes.

Timeline

Readiness:

1–3 months, depending on existing controls and documentation.

Assessment: 

3–6 months, including assessment, remediation, and review.

Key cost drivers include organization size, IT maturity, and documentation readiness. To save on costs, use HITRUST tools like MyCSF, choose the appropriate assessment type, and work with experienced advisors who understand the certification process.

HITRUST for Startups and Digital Health SMBs

HITRUST certification isn’t just for large enterprises. The e1 and i1 assessment paths are designed for agile startups and SMBs. Achieving certification helps startups build trust, accelerate sales, and improve their funding position.

Many payers and hospitals now require HITRUST certification from vendors. For startups, this can make a difference when closing enterprise deals and being left out of the procurement process. HITRUST Certification also sets a strong foundation for future compliance with HIPAA, SOC 2, and ISO 27001.

A HITRUST-certified telemedicine services provider that can onboard major hospital systems, win RFPs, and assure investors of its commitment to security.

HITRUST in Healthcare Software and App Development

Integrating HITRUST into your software development lifecycle is critical for healthcare app development companies. By building apps on HITRUST-ready cloud services like AWS, Azure, or GCP, you ensure your architecture supports required controls from day one.

Key areas to address include access controls, encryption, and audit logging. Partnering with development firms that understand HITRUST and security by design can help you avoid costly rework and ensure a smooth go-to-market launch.

The Future of HITRUST: What to Expect Beyond 2025

HITRUST is evolving to meet the demands of a digital, interconnected world. Its future is agile, automated, and globally recognized. Below are the upcoming upgrades that HITUST compliance will provide.

Real-Time, Continuous Compliance

Automation and CI/CD integration will enable organizations to maintain compliance in real time.

AI and Algorithmic Accountability

New controls will address AI transparency and ethical use of algorithms in healthcare, and advanced  AI Solutions in Healthcare can be developed.

Global Recognition

HITRUST is gaining traction in the EU and APAC, making it a valuable framework for organizations with international operations.

Expanded Modularity

Plug-and-play frameworks will make HITRUST more accessible for smaller organizations and startups.

Conclusion

HITRUST certification is more valuable than ever in 2025. It provides a unified, certifiable framework for managing risk, demonstrating compliance, and building trust with stakeholders. Whether you’re a startup, SaaS vendor, or enterprise, HITRUST helps you protect sensitive data, accelerate growth, and gain a competitive edge.

Security and trust are now non-negotiable. HITRUST certification signals your commitment to both. The first step is a readiness assessment evaluates your current controls, identifies gaps, and charts a path to certification.

Frequently Asked Questions

1. What does HITRUST stand for?

HITRUST stands for Health Information Trust Alliance.

2. What does HITRUST certified mean?

HITRUST Certification is a globally recognized certification of an organization’s compliance with the rigorous and comprehensive security and privacy requirements specified in the HITRUST CSF framework.

3. What is the difference between HIPAA and HITRUST?

HIPAA establishes the foundational requirements for protecting healthcare data. HITRUST builds on it and other authoritative sources to help organizations manage risk and compliance. 

4. What is the HITRUST framework?

The HITRUST framework (HITRUST CSF) helps organizations manage information security, privacy, and compliance requirements.

5. What is the purpose of the common agreement HITRUST?

The agreement aims to increase data access by supporting secure and appropriate sharing of electronic health information for current user needs.

6. Is HITRUST mandatory?

No, HITRUST is not mandated by the federal government, but it is a recommended certification.

7. Is HITRUST an audit?

Yes, A complete HITRUST audit includes dual assessments, a readiness assessment, and a validated assessment

8. How to verify HITRUST certification?

Organizations with HITRUST certifications can request that their certifications be verified with HITRUST and listed in a directory, which will be published on the Health 3rd Party Trust website (health3pt.org).

9. Is HITRUST internationally recognized?

Yes, HITRUST is a globally recognized framework.

10. What does CSF stand for in HITRUST?

Yes, CSF in HITRUST stands for Common Security Framework.

11. How does Folio3 Digital Health help customers achieve HITRUST compliance?

Folio3 Digital Health supports its customers in achieving HITRUST compliance by conducting comprehensive readiness assessments and gap analysis. Our team provides expert guidance and hands-on support for remediation, control implementation, and effective use of the MyCSF platform. We help clients meet stringent HITRUST CSF requirements, streamlining their path to certification and continuous security.

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