HITRUST Certification for Healthcare Software Companies
HITRUST certification gives healthcare software companies a widely recognized way to prove their security program meets the expectations of health systems, payers, and other enterprise buyers. The HITRUST CSF harmonizes HIPAA, NIST, ISO, and other frameworks into one assessable standard, with e1, i1, and r2 assessment levels that scale with risk. This guide explains how the assessments differ, what readiness involves, and how cloud inheritance reduces the effort. Custom Healthcare Solutions builds the software controls and evidence HITRUST assessors look for. Let's plan your path to certification.
What HITRUST Certification Means for Software Vendors
HITRUST is an organization that maintains the HITRUST CSF, a controls framework designed for healthcare and other regulated industries. Certification requires an assessment by an authorized external assessor firm, followed by HITRUST's own quality review. Many large healthcare organizations ask vendors for HITRUST certification because it maps to multiple regulations at once and includes centralized quality assurance. Our healthcare compliance and security page explains how we approach these frameworks.
One Framework, Many Regulations
The HITRUST CSF maps requirements from HIPAA, NIST, ISO 27001, PCI DSS, and other sources into a single control set. One assessment can answer questions buyers would otherwise ask separately for each framework.
External Assessor Plus HITRUST Review
An authorized external assessor tests your controls, then HITRUST reviews the work before issuing certification. That two-layer review is part of why buyers trust HITRUST results over self-attestations and questionnaires.
Why Healthcare Buyers Request It
Large health systems and payers manage hundreds of vendors. A HITRUST certification lets them rely on a standardized, quality-controlled assessment instead of reviewing each vendor's security program from scratch themselves.
Not a HIPAA Requirement
HIPAA doesn't require HITRUST. Certification demonstrates a mature security program aligned with HIPAA, but your organization is still responsible for complying with HIPAA itself, including the Privacy and Breach Notification Rules.
HITRUST e1, i1, and r2 Assessments Compared
HITRUST offers three main validated assessment levels, and choosing the right one depends on your risk profile and what your customers require. The e1 covers foundational cybersecurity practices, the i1 addresses a broader set of leading practices, and the r2 is a risk-based assessment tailored to your organization. Higher levels take more time and effort but carry more weight with large healthcare buyers. Confirm current requirements with HITRUST, as they evolve.
e1: Essentials, One-Year
The e1 validates a focused set of foundational cybersecurity controls. It suits early-stage companies and lower-risk vendors, and it's often the fastest route to a HITRUST certification that customers recognize.
i1: Implemented, One-Year
The i1 covers a larger set of leading security practices with a fixed control set. It suits vendors with moderate risk and customers wanting more assurance than an e1 provides.
r2: Risk-Based, Two-Year
The r2 is the most comprehensive assessment, with controls tailored to your risk factors, systems, and regulatory scope. It's valid for two years with an interim assessment and is often required by large enterprises.
Choosing the Right Level
Ask key customers which level they accept. Many vendors start with e1 or i1 to unblock deals, then move to r2 when larger contracts or higher-risk data require it.
Preparing Your Software for a HITRUST Assessment
HITRUST readiness usually takes several months, because controls must be both implemented and operating with evidence before the validated assessment. For software companies, many required controls live in the application and its infrastructure, so engineering work is often the longest part of readiness. Building those controls into the product also makes future assessments easier, since evidence can be generated automatically rather than assembled manually by your team each assessment cycle.
Scoping the Assessment
Define which systems, locations, and data are in scope. Tight, accurate scoping reduces effort, while scope that's too broad adds controls and evidence requirements that don't reflect your real risk.
Readiness Assessment and Gap Remediation
A readiness assessment in HITRUST's MyCSF platform identifies gaps against required controls. Remediation covers technical controls, written policies, and procedures, each with evidence showing implementation and ongoing operation over time.
Controls Built Into the Application
Access management, audit logging, encryption, vulnerability management, and change control are implemented in the software and infrastructure, generating evidence automatically for assessors instead of relying on screenshots and spreadsheets assembled manually.
Policies, Procedures, and Evidence
HITRUST evaluates whether controls are documented, implemented, and in some assessments, measured and managed. Written policies and procedures must match how your team actually operates day to day, not an idealized version.
Reducing HITRUST Effort Through Inheritance
HITRUST's Shared Responsibility and Inheritance Program lets you inherit controls from HITRUST-certified service providers, such as major cloud platforms, rather than testing them yourself. For cloud-hosted healthcare software, inheritance can significantly reduce the number of controls you must evidence directly. Timelines still depend on your maturity, but many first certifications take six to twelve months or more. Our HITRUST readiness pricing page explains how we scope this work.
Inheriting From Cloud Providers
Major cloud providers offer inheritable controls for physical security, infrastructure, and some platform services. You inherit only what applies to the services you use and must still configure them correctly.
Shared Responsibility in Practice
Some controls are fully inherited, some are shared, and some remain entirely yours, such as application access management and secure development. A clear responsibility matrix prevents gaps and duplicate work.
Architecture Choices That Simplify Certification
Using managed, HITRUST-inheritable services, centralized logging, and infrastructure as code reduces the number of custom controls you must evidence. Architecture decisions made early can shorten readiness considerably later in the process.
Maintaining Certification
Certification requires ongoing control operation, interim assessments for r2, and renewal. Automated evidence collection and scheduled reviews keep your program ready, so each cycle builds on the last instead of restarting.
Frequently Asked Questions About HITRUST Certification
What is HITRUST certification?
HITRUST certification confirms that an organization's security controls meet the HITRUST CSF, a framework that harmonizes HIPAA, NIST, ISO, and other standards. An authorized external assessor tests the controls, and HITRUST performs a quality review before issuing certification. Healthcare buyers often request it to evaluate vendor security.
Is HITRUST required for HIPAA compliance?
No. HIPAA doesn't require HITRUST or any certification. HITRUST demonstrates a mature, independently validated security program aligned with HIPAA and other frameworks, which many healthcare customers value. Your organization remains responsible for meeting HIPAA's Privacy, Security, and Breach Notification Rule requirements directly, regardless of certification status.
What is the difference between HITRUST e1, i1, and r2?
The e1 validates foundational cybersecurity controls and is valid for one year. The i1 covers a broader fixed set of leading practices, also for one year. The r2 is a risk-based, tailored assessment valid for two years with an interim review, and is the most comprehensive and demanding.
How long does HITRUST certification take?
It depends on your maturity and the assessment level. An e1 can be achieved relatively quickly by a well-prepared company, while an r2 often takes six to twelve months or more, including readiness, remediation, validated assessment, and HITRUST's quality review. Inheritance from cloud providers can shorten the process.
Should we get SOC 2 or HITRUST first?
Ask your target customers. Many healthcare software companies start with SOC 2 for healthcare software because it's widely accepted across industries, then add HITRUST when health systems or payers require it. Because the frameworks overlap, controls built for one substantially support the other, reducing the effort of adding the second later.
Build the Controls HITRUST Assessors Look For
Plan your HITRUST path with our team, explore our healthcare software development services, or visit the Custom Healthcare Solutions homepage.