HITRUST

Name: Health Information Trust Alliance (HITRUST)

Type: Metaframework (framework of frameworks)

Authoritative Source:  Health Information Trust Alliance

Certification Available: Yes. HITRUST enables organizations to obtain a third-party certification against HITRUST controls.

Too Long / Didn’t Read (TL/DR): HITRUST is well known in the healthcare industry and is evolving into an industry-agnostic model. For organizations facing multi-jurisdictional or multi-sectoral requirements, HITRUST offers a proprietary framework that translates complexity into certifiable controls. Success under HITRUST is not measured by documents alone, but by the intersection of rigorously documented policy, operationalized process and verifiable control effectiveness.

Cost To Use HITRUST

There is a financial cost to use HITRUST, but pricing is not readily available on the HITRUST website. The annual cost to use HITRUST depends on several factors, including the type of assessment, size of the organization, number of in-scope systems and whether external consulting or advisory services are used. This includes licensing for the HITRUST MyCSF SaaS platform. 

Restrictions On Using HITRUST

Per the HITRUST CSF version 11.5 EULA, to download or use HITRUST, a “licensee” or “authorized user” must “be a HITRUST Qualified Organization or Qualified Individual, which includes organizations and/or individuals employing a function or activity involving the use or disclosure of individually identifiable health information or individually identifiable personal information, provided such organization and/or individual does not provide security products or services of any kind or nature. Federal, state, and/or local governmental organizations or employees acting in an official capacity are Authorized Users.”

HITRUST's EULA restricts common cybersecurity professionals from downloading or accessing its content, where it includes a "non-exclusive list of persons or entities that are not HITRUST Qualified Organizations and/or HITRUST Qualified Individuals and shall not be permitted to be a Licensee or Affiliate under any circumstance” that includes:

  • IT security service providers;
  • IT security product providers;
  • IT security consultants; and/or
  • IT security vendors and suppliers.

Origins of HITRUST

Founded in 2007, the Health Information Trust Alliance (HITRUST) was formed to address growing concerns over the fragmentation of healthcare cybersecurity and privacy mandates. Early efforts focused on translating HIPAA requirements into practical guidance. In 2009, the HITRUST Common Security Framework (CSF) debuted, consolidating HIPAA with risk-based controls drawn from industry standards. Over the 2010s, HITRUST CSF evolved through regular updates to reflect advances in compliance requirements, privacy laws and cybersecurity best practices. By the mid‑2020s, the framework evolved to become industry-agnostic, to be used outside healthcare (e.g., financial services, technology firms, manufacturing, etc.).

Purpose of HITRUST

HITRUST and its Common Security Framework (CSF) exist to provide a unifying force for organizations seeking demonstrable cybersecurity and privacy controls. While originally conceived in and for healthcare, HITRUST CSF has grown into an auditable, certifiable framework that can be used in nearly any industry. Central to its appeal is the way it harmonizes multiple compliance regimes into a single control set, while scaling according to risk and organizational size.

Integrated Control Set

HITRUST CSF is structured across 19 control domains, which incorporate integrated, risk-based requirements from over 60 authoritative standards and regulations (e.g., HIPAA, ISO 27001, NIST SP 800‑53/800‑171, PCI DSS and EU GDPR). This harmonization is designed to simplify compliance by reducing duplicate work and enabling broader coverage via a single framework.

HITRUST Certification Options

HITRUST offers three (3) assessment paths:

  • E1: A lighter, entry-level assessment for organizations building security practices.
    • Consists of 44 controls.
    • Annual, third-party validated assesment.
  • I1: An intermediate validated assessment
    • Consists of 182 controls.
    • Annual, third-party validated assesment.
  • R2: A full, risk-based assessment demonstrating maturity and operational effectiveness.
    • Tailored control set.
    • Bi-annual, third-party validated assesment.

Common Methods to Achieve and Maintain HITRUST Compliance

Achieving HITRUST certification, or aligning operationally with its controls, requires a structured sequence. A practical implementation roadmap typically includes:

  • Obtain Access To MyCSF. Organizations must obtain access to the MyCSF SaaS to use HITRUST.
  • Scoping and Readiness Assessment. Organizations must define asset and system boundaries, determine which control domains apply and perform a readiness assessment to identify gaps in documentation, policy, technical controls, or operational maturity.
  • Remediation and Policy Implementation. Identified gaps drive a remediation plan that includes:
    • Policy creation;
    • Process definition; and
    • Technical control deployment (e.g., access control, encryption, logging, incident response).
  • Validated Assessment. Engage a HITRUST-authorized assessor to perform the assessment using the official HITRUST Assessment Handbook and MyCSF platform.
  • Certification and Submission. Upon passing assessment criteria, the organization submits results to HITRUST for official certification.
  • Sustainment, Maintenance and Reassessment. Certification has a finite validity (no longer than two years), but maintaining compliance is ongoing. Organizations must continuously monitor controls, conduct periodic internal reviews, respond to emerging risk and prepare for subsequent reassessments.

The Indispensable Role of Documentation In HITRUST

Documentation is the backbone of any assurance framework, but it takes on elevated importance within HITRUST endeavors. The framework demands comprehensive evidence, not merely policy statements. Verified evidence supports operational control execution and effectiveness:

Policy & Procedure Documentation. Without policies and procedures in place, assessments yield limited scores and certification may fail. For each control in scope, HITRUST requires:

  • A documented policy attesting to the control’s requirement; and
  • An associated procedure describing how the control is operationalized, who is responsible and how it functions in practice.

Evidence of Implementation. Assessment typically includes review of:

  • Logs (access, change, incident);
  • Configuration records;
  • Training records;
  • Risk assessments;
  • Incident response testing and post-mortem; and
  • Vendor management documentation (e.g., TPRM practices).

Audit Trails and Change Management. Organizations must retain evidence reflecting changes in control implementation, updates following threats or incidents and results of internal audits that demonstrate a culture of continuous improvement and governance.