- ClassificationCategoryData Protection & PrivacyDomainCybersecurityFramework FamilyHITRUST
- Regulatory ContextTypeControl FrameworkLegal InstrumentFrameworkSectorHealthcare SectorIndustryHealthcare & Life Sciences
- Region / PublisherRegionNorth AmericaRegion DetailUnited StatesPublisherHITRUST (HITRUST Services LLC)
- VersioningVersionHITRUST CSF v11.5.0 (current release: v11.9.0)Effective DateApril 14, 2025 (available in MyCSF)Issue DateApril 14, 2025 (HAA 2025-001); superseded by v11.9.0 on September 24, 2026
- AdoptionAdoption ModelCertificationImplementation ComplexityHigh
- Official ReferenceOpen Link in New TabSource
License included / downloadable: No
HITRUST Services LLC holds the copyright in the HITRUST CSF and offers it for download from the HITRUST Framework page. SmartSuite does not include or license the framework text. A HITRUST certification comes from an assessment through the HITRUST Assurance Program.
Framework text is licensed by its publisher and is included only where stated above.
- HITRUST CSF v11.5.0 is the April 2025 release of HITRUST's certifiable security and privacy control framework.
- It has since been superseded by v11.6.0 through v11.9.0 (September 24, 2026); the control structure described is unchanged.
- The core structure is ISO/IEC 27001 and 27002, incorporating more than 60 regulations, standards, and frameworks such as HIPAA, NIST SP 800-53, and the GDPR.
- Validated assessments come in three types: e1 and i1, valid one year, and r2, risk-based and tailored, valid two years.
- SmartSuite Compliance Management holds the tailored requirement set with an owner, evidence, and status for each requirement.
Overview
HITRUST CSF v11.5.0 is the April 2025 release of the HITRUST Common Security Framework, a certifiable security and privacy control framework that healthcare organizations, business associates, cloud providers and other regulated organizations use to give customers validated assurance. HITRUST made v11.5.0 available in MyCSF on 14 April 2025. It has since been superseded: v11.6.0 (22 August 2025), v11.7.0 (18 December 2025), v11.8.0 (8 May 2026) and v11.9.0 (24 September 2026) have followed, and the control structure described here is the same in the v11.9.0 Introduction.
HITRUST Services LLC develops and maintains the framework. It is a private framework, not a law. Its core structure is ISO/IEC 27001 and 27002, and it incorporates more than 60 other regulations, standards and frameworks, such as HIPAA, NIST SP 800-53 and the GDPR, mapping every requirement to its authoritative source (Introduction to the HITRUST CSF, v11.5.0).
Organizations tailor the requirement set to their risk, then complete a HITRUST validated assessment: e1 (foundational, valid 1 year), i1 (182 requirement statements, valid 1 year) or r2 (risk-based and tailored, valid 2 years). Assessments run through the MyCSF platform, and results can be shared with partners through the Results Distribution System.
Why does it matter?
HITRUST built the CSF so that one control set, mapped to many authoritative sources, supports one assessment that an organization can share with many parties. The Assurance Program gives organizations a common mechanism for communicating validated controls to business partners without redundant, overlapping and costly audits (Introduction, HITRUST Assurance Program).
Key benefits include:
- One control set, many sources
The CSF normalizes requirements from federal law such as HIPAA, federal agency guidance such as NIST, state law, international regulation such as the GDPR and industry frameworks such as PCI into one framework.
- Requirements scale to risk
Organizational, compliance and system risk factors decide which of three progressive implementation levels apply, so the requirement set fits the organization instead of being the same for everyone.
- Three assurance levels
e1 is a foundational 1-year assessment, i1 is a 1-year assessment with 182 requirement statements and r2 is a 2-year risk-based assessment. Work done for a lower level can be built upon for a higher one.
- A published version policy
Versions follow v[Major].[Minor].[Errata]. A minor release such as v11.5.0 changes requirement statements, authoritative sources, mappings or factors and is announced in an Assurance Advisory (HAA 2021-005).
- Segment-specific requirements
Additional implementation levels cover specific segments, such as cloud service providers, FedRAMP and EU GDPR, where those requirements apply.
How does it work?
The CSF has 14 control categories, 49 control objectives and 156 control specifications. The categories run from Information Security Management Program, Access Control and Risk Management to Communications and Operations Management, Information Security Incident Management, Business Continuity Management and Privacy Practices. Each control lists an objective, a reference, a specification, a risk factor type, topics, implementation requirements and a mapping to authoritative sources by level.
Implementation requirements come in three levels. Level 1 is the minimum baseline and each higher level adds requirements. The level that applies depends on organizational factors, such as the amount of sensitive information and geographic scope, compliance factors, such as PCI, FISMA or the GDPR, and system factors, such as Internet accessibility, third-party access and the number of users.
An organization scopes its systems in MyCSF, tailors the requirements and completes an e1, i1 or r2 assessment. The Assurance Program uses maturity-level scoring and risk ratings, and recognizes internal assessors and HITRUST Authorized External Assessor Organizations. HITRUST governs and manages the assurance process. Results can be distributed to partners through the Results Distribution System.
Key Elements
- Control categories and specifications
Fourteen categories hold 49 control objectives and 156 control specifications, built on the ISO/IEC 27001 and 27002 categories plus separate categories for the information security management program and risk management.
- Authoritative sources
Each requirement is mapped to the standard or regulation it comes from. More than 60 sources sit on top of the ISO/IEC 27001 and 27002 core, including HIPAA, NIST SP 800-53, the GDPR, PCI and COBIT.
- Risk factors and implementation levels
Organizational, compliance and system risk factors raise the level of requirement that applies. Segment-specific levels add requirements for areas such as cloud service providers.
- Assessment types
e1, i1 and r2 are the validated assessments. e1 and i1 are valid for 1 year, and r2 is valid for 2 years. r2 is the tailored assessment for organizations that must show compliance with sources such as HIPAA.
- MyCSF and the Results Distribution System
MyCSF is the software platform for assessments and corrective action plan management. The Results Distribution System is the API that distributes assessment results.
- What v11.5.0 changed
Released 14 April 2025, v11.5.0 consolidated more overlapping requirement statements, added nine mappings including ADHICS, Singapore's Cybersecurity Act 2018 and the NIS Directive, mapped COBIT 2019, and left the baseline r2 requirement statements unchanged from v11.4.0 (HAA 2025-001).
What does it cover?
The CSF applies to organizations in any sector that create, access, store or transmit sensitive information, and it is most associated with healthcare organizations, their business associates and cloud providers. Scope is set for each assessment by choosing the systems in scope and the risk factors that apply to them. A HITRUST assessment covers the scoped environment, not the whole organization.
What are its objectives?
The Introduction states what the CSF is meant to do.
Provide one common security and privacy framework, mapped to global authoritative sources.
Scale security and privacy requirements to organizational, compliance and system risk.
Offer certifiable, validated assurance through the e1, i1 and r2 assessments.
Reduce redundant requirements with each release by integrating and normalizing sources.
Let organizations share results with partners instead of repeating separate audits.
Framework in Context
The CSF is a private framework, not a regulation, and it is revised several times a year. v11.5.0 sits between v11.4.0 (6 December 2024) and v11.6.0 (22 August 2025). Later releases keep changing the authoritative sources: v11.9.0 refreshed the NIST SP 800-53 mapping to Rev. 5.2.0 and removed several sources, including NIST SP 800-53 r4 (HAA 2026-005). Check the HITRUST Framework page for the release that applies to a new assessment.
Common Framework Mappings
HITRUST maps each CSF requirement to authoritative sources, and HIPAA, ISO/IEC 27001 and 27002 and NIST SP 800-53 are among them. The list below also names frameworks that organizations commonly map alongside the CSF, and not every one is an authoritative source of it.
Mapped frameworks include:
CIS Controls v8.1
HIPAA
ISO 27001:2022
ISO 27002:2022
NIST CSF 2.0
NIST 800-53 Rev.5
PCI DSS 4.0.1
SOC 2
How SmartSuite Supports HITRUST CSF
SmartSuite provides the system for managing controls, evidence, mappings, assessments, and reporting.
Use Compliance Management to hold the requirement set you tailored in MyCSF, with an owner, evidence and status for each requirement, and Cyber & IT Risk for the risks and corrective actions an assessment turns up. HITRUST assessments and certifications are issued through the HITRUST Assurance Program, not through SmartSuite.
Scope and Requirement Set
Record each in-scope system with its organizational, compliance and system risk factors and the resulting requirement set by control category.
Control Evidence Library
Attach policies, configurations, logs and test results to each requirement statement, with an owner and a review date.
Assessment Type Tracker
Track e1, i1 and r2 assessments with their 1-year or 2-year validity, the assessor and the next due date.
Corrective Action Plans
Manage each gap as a corrective action with an owner, due date and closure evidence.
Version and Source Change Log
Record the CSF version in use, such as v11.5.0, and review each Assurance Advisory for added or removed authoritative sources.
Third-Party Assurance Register
Track vendors' HITRUST reports by assessment type and expiry date, with the requirements each vendor is responsible for.
Related frameworks

CIS Controls v8.1 is a prioritized set of 18 Controls and 153 Safeguards, in three Implementation Groups, with a new Govern function.

The HIPAA Omnibus Rule (78 FR 5566, 2013) made business associates directly liable, set the breach risk assessment and tiered penalties, and added GINA protections.

ISO/IEC 27001:2022 specifies requirements for an information security management system: Clauses 4 to 10, risk treatment, the Statement of Applicability and 93 Annex A controls.

ISO/IEC 27002:2022 is the reference set of 93 information security controls in four themes, with attributes and implementation guidance, that supports an ISO/IEC 27001 ISMS.

NIST CSF 2.0 (CSWP 29, February 26, 2024) is the voluntary cybersecurity framework with six Functions including Govern, 22 Categories, 106 Subcategories, Profiles and Tiers.

NIST SP 800-53 Rev. 5 is the NIST catalog of security and privacy controls in 20 families, mandatory for federal systems under OMB A-130 and FISMA; Release 5.2.0 issued August 27, 2025.
Frequently Asked Questions For HITRUST CSF v11.5.0 (Common Security Framework)
All three are HITRUST validated assessments. The e1 is a foundational assessment valid for 1 year, and the i1 is valid for 1 year with 182 requirement statements. The r2 is a risk-based, tailored assessment valid for 2 years, for organizations that must show compliance with sources such as HIPAA.
No. HITRUST released v11.5.0 on 14 April 2025 (HAA 2025-001). Later releases followed, and v11.9.0 was released on 24 September 2026 (HAA 2026-005). The 14-category structure is the same in the v11.5.0 and v11.9.0 Introductions.
It has 14 control categories, 49 control objectives and 156 control specifications. Each control has implementation requirements at three levels, and the level that applies depends on organizational, compliance and system risk factors. Requirements are mapped to authoritative sources such as ISO/IEC 27001 and 27002, HIPAA and NIST SP 800-53.
No. HIPAA is federal law for covered entities and business associates. The CSF is a private framework that maps HIPAA requirements as one of its authoritative sources, so one HITRUST assessment can cover requirements from several sources at once.
HITRUST consolidated more overlapping requirement statements and added mappings including ADHICS, Singapore's Cybersecurity Act 2018, the NIS Directive and GovRAMP Readiness. COBIT is now mapped as COBIT 2019, and the baseline r2 requirement statements did not change from v11.4.0 (HAA 2025-001).

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