HITRUST (Health Information Trust Alliance) provides a comprehensive, certifiable security framework designed primarily for healthcare organizations and their business associates. Founded in 2007, HITRUST harmonizes over 60 regulations and standards into a unified control set, achieving a 99.41% breach-free rate among certified organizations.
Framework Structure
The HITRUST CSF (Common Security Framework) version 11.7.0 (December 2025) includes 14 control categories, 19 control domains, 49 control objectives, and 156 control references. The framework is built on ISO 27001 and integrates requirements from HIPAA, NIST, PCI DSS, GDPR, and dozens of other standards.
Assessment Types
HITRUST offers three assessment types in a traversable portfolio, allowing organizations to progress from basic to comprehensive certification.
e1 (Essentials, 1-year)
The e1 assessment covers 43 control statements focused on essential cybersecurity hygiene. It is designed for low-risk organizations and typically takes about 3 months. Certification is valid for one year with costs ranging from $20,000-$70,000 including assessor fees. The e1 maps to CISA Cyber Essentials and basic NIST 800-171 requirements.
i1 (Implemented, 1-year)
The i1 assessment covers 182 static control statements for moderate assurance. It is appropriate for organizations with broader cybersecurity requirements and takes 6-12 months. Certification is valid for one year with rapid recertification available. Costs range from $60,000-$200,000. The i1 maps to HIPAA Security Rule and NIST SP 800-171.
r2 (Risk-based, 2-year)
The r2 assessment is comprehensive with 200-2,000+ controls based on risk-based scoping using the PRISMA maturity model. It requires testing of at least 3 of 5 maturity levels and takes 9-24 months. Certification is valid for two years with an interim assessment required at year one. Costs range from $150,000 to over $1 million. The r2 provides the highest assurance level.
Who Needs HITRUST
HITRUST is widely adopted in healthcare. Over 80% of US hospitals and 85% of US health insurers use the framework. Healthcare covered entities, business associates, IT vendors, and pharmaceutical companies commonly pursue certification. Since 2015, major payers including Anthem, Humana, and UnitedHealth have mandated HITRUST for vendors.
Financial services and other industries increasingly adopt HITRUST for streamlined compliance across multiple frameworks.
Relationship to HIPAA
HITRUST CSF maps to HIPAA Security Rule requirements and provides certifiable evidence of compliance. However, HITRUST certification does not cover all HIPAA aspects such as OSHA requirements or CMS conditions of participation. HITRUST provides specific, prescriptive controls while HIPAA contains general requirements.
Relationship to SOC 2
HITRUST is a certifiable control framework while SOC 2 is an attestation reporting framework. There is approximately 88% overlap between HITRUST and SOC 2 Trust Services Criteria. Organizations can pursue combined SOC 2 + HITRUST assessments to leverage 80-90% work reuse.
Certification Process
The process begins with scoping through the MyCSF portal. A readiness assessment identifies gaps for remediation. After implementing required controls, an approved External Assessor conducts the validated assessment. HITRUST QA review takes 4-10 weeks before certification is issued.
Recent Updates
Version 11.7.0 (December 2025) optimized the e1 baseline to 43 requirements and added mappings for FedRAMP 20x, India DPDP Act, UK CAF, and APRA CPS 230. HITRUST launched AI Risk Management Assessment in August 2024 with 51 AI-specific controls aligned to ISO/IEC 23894 and NIST AI RMF. AI Security Certification became available in Q4 2024 as an add-on to existing assessments.
Cost Considerations
| Component | e1 | i1 | r2 |
|---|---|---|---|
| MyCSF Access | $3,000-$6,000 | $9,000-$15,000 | $15,000-$32,000 |
| Report Credit | ~$6,000 | ~$7,000 | $8,000-$9,000 |
| External Assessor | $15,000-$25,000 | $30,000-$60,000 | $50,000-$150,000+ |
| Total | $20,000-$70,000 | $60,000-$200,000 | $150,000-$1,000,000+ |
Organizations should budget for remediation efforts which can significantly exceed assessment costs depending on current security posture.