Securing Patient Data in Plain English: Understanding HITRUST Compliance

Patient health records are under fire.

Healthcare data breaches surged 68% to a record high in 2021. Over 30 million sensitive patient records were exposed, shining new light on the urgent need for rock-solid healthcare data security.

Yet complex regulations like HIPAA have healthcare security leaders tangled in red tape trying to lock down sensitive health information. Requirements managed separately turn compliance into a convoluted, never-ending process.

This is where HITRUST comes in…

HITRUST condenses healthcare‘s complex regulatory framework into a single, unified approach for managing data protections, risk, and compliance.

By achieving HITRUST certification, organizations can simplify compliance while advancing cyber defenses for safeguarding sensitive patient data.

Intriguing…but still confusing, right?

In this beginner‘s guide, I‘ll explain HITRUST compliance plainly, walking through:

  • Simple definition of HITRUST compliance
  • Key reasons healthcare organizations pursue certification
  • How HITRUST incorporates other major regulations
  • Step-by-step overview of the certification process
  • Common certification challenges to consider
  • Real healthcare examples of HITRUST in action

Let‘s break down this critical healthcare security framework in plain English!

What Exactly is "HITRUST Compliance"?

A Brief Definition

HITRUST develops and maintains the HITRUST CSF, a comprehensive set of information security controls and practices pulled from major regulations and standards across the healthcare industry.

When an organization meets all requirements within the HITRUST CSF framework, they achieve HITRUST compliance.

Similar to ISO or NIST certification, HITRUST compliance signals an organization has implemented a broad baseline of security safeguards tailored specifically to healthcare.

But what‘s the point?

Certification brings a number of important benefits:

  • Condenses compliance scope: Rather than managing dozens of complex regulations separately, HITRUST folds requirements into a single framework. This greatly simplifies compliance efforts.

  • Advances data protections: HITRUST incorporates hundreds of prescriptive security controls designed specifically to safeguard sensitive patient health information (PHI).

  • Enhances risk management: HITRUST requirements emphasize continuously identifying and remediating vulnerabilities before they are exploited in cyber attacks.

  • Demonstrates security commitment: Much like SOC 2 or ISO 27001 certification, achieving HITRUST compliance signals an organization has invested in implementing stringent healthcare security practices and controls.

In today‘s escalating threat landscape, HITRUST certification equips healthcare organizations with institutional-grade security while streamlining compliance with seminal healthcare privacy laws.

Why HITRUST Matters: Key Driver for Healthcare Organizations

While compliance plays a role, healthcare security teams pursue HITRUST certification primarily to safeguard sensitive patient data.

2021 saw breaches within healthcare sectors soar, exposing diagnostics records, treatment histories, SSNs, financial data, and other sensitive patient health information.

Healthcare data breach statistics for 2021

With nearly 30 million healthcare records breached last year alone, it‘s no surprise healthcare CISOs are urgently seeking ways to lock down PHI.

Beyond just checking boxes for HIPAA and other seminal regulations, key reasons healthcare organizations pursue HITRUST include:

Unifying compliance complexity: Most healthcare entities must comply with dozens of laws and standards from HIPAA to ISO to NIST. HITRUST harmonizing these requirements under a single framework greatly reduces compliance scope and effort.

Advancing technical safeguards: The HITRUST CSF catalogues prescriptive technical controls tailored to securing healthcare environments. Required safeguards like endpoint data loss prevention, network segmentation, and encrypted data communications strengthen data protection.

Enhancing administrative safeguards: HITRUST incorporates both technology controls and administrative policies like improved third-party risk management, data classification, SOC 2 audits, and incident response planning.

Proactive threat awareness: HITRUST requirements emphasize continuous processes for identifying security gaps, monitoring for threats, containing impacts of exploitation. Rather than waiting for incidents, HITRUST pushes healthcare organizations to proactively get ahead of risks.

Demonstrable PHI security to patients: In an era of healthcare consumerism, HITRUST certification allows providers to showcase investments in institutional-grade controls for securing patient medical records.

For forward-thinking healthcare CISOs and security leaders, HITRUST adoption offers both cyber risk reduction and reputational benefits.

HITRUST Incorporates Other Major Healthcare Standards

A primary value driver of HITRUST is its ability to centralize requirements from major healthcare regulations and security standards:


The HITRUST CSF fully incorporates every existing safeguard from the HIPAA Security Rule. This enables healthcare organizations to address foundational HIPAA compliance through the HITRUST framework.

ISO 27701 / 27001

As an information security management system standard, HITRUST reinforces many of the technical, physical, and administrative controls put forth within ISO 27001. The inclusion of ISO 27701 specifically covers healthcare privacy controls.

NIST SP 800-53

Originally designed for U.S. federal information systems, NIST guidelines are now seen as seminal standards in healthcare as well. HITRUST directly maps CSF controls to those within NIST special publication 800-53.


While focused on payment card security, HITRUST reinforces core data protection mechanisms from PCI DSS including strong access controls and cryptography.


Europe‘s strict privacy law is also relevant for multinational healthcare providers. While not tailored specifically for GDPR, HITRUST does support key requirements around regulated health data use, processing, and subject privacy rights.

This consolidation of seminal healthcare regulations and overall information security standards makes HITRUST compliance especially efficient for covered entities.

Step-By-Step: The Process of Achieving HITRUST Certification

While some may think of HITRUST like a simple audit checklist, certification requires a structured, months-long process under the watch of accredited professionals.

Here is an overview of key steps in the journey toward HITRUST compliance:

Step 1: Download the latest HITRUST CSF framework

Interested organizations must first obtain the current HITRUST CSF version for use as the baseline review standard. HITRUST issues major updates to the framework every 1-2 years.

Step 2: Determine assessment scope

With help from HITRUST consulting partners, organizations determine the boundaries of what‘s included in the compliance review such as environments, systems, processes and business units. More expansive scopes demand longer assessments.

Step 3: Perform a readiness assessment

Through either self-assessment or formal gap analysis, organizations benchmark existing policies, systems, and controls against requirements in the HITRUST CSF. This surfaces areas needing improvement prior to true certification pursuit.

Step 4: Remediate identified gaps

Based on the readiness assessment, organizations launch projects to implement missing controls or enhance processes to close gaps relative to HITRUST standards. This "remediation" phase commonly requires months of concerted effort for larger healthcare entities.

Step 5: Schedule the formal certification assessment

With remediation complete, organizations contract credentialed, HITRUST-authorized third party assessors to perform the official on-site certification analysis.

Overview of the HITRUST CSF Certification Process

HITRUST certification process overview (Source: HITRUST Alliance)

Step 6: Complete comprehensive control analysis

During the 1-2 week assessment, auditors review systems, examine evidence, interview personnel and draft the final assessment report. Common analysis areas include data encryption, access controls, third-party oversight, incident response and dozens of other HITRUST control requirements.

Step 7: Achieve certified status!

Following HITRUST quality assurance activities and a 90-day final review period, organizations are officially awarded HITRUST certified status. This signals compliant implementation of healthcare‘s leading risk management framework.

Maintaining certified status does require full re-assessments every 24 months. Like any effective compliance program, HITRUST is about the journey rather than the destination!

Common Challenges with HITRUST Adoption

While beneficial, attaining and retaining HITRUST compliance introduces challenges to consider upfront:

Significant time requirements

Even fast-moving organizations should plan for 6-12 months from project kickoff to final certification. Developing hundreds of process documents, implementing dozens of technical controls, scheduling external auditors, and completing the quality assurance gauntlet takes considerable time even for security teams familiar with HITRUST.

Consulting and auditing costs

Large healthcare entities often spend upwards of $100,000+ in auditing and consulting fees alone during their first-time pursuit of HITRUST certification. Full IT project costs can range even higher factoring internal resourcing needs for security engineering, compliance, and IT infrastructure teams.

Complex control requirements

With nearly 200 prescriptive safeguards spanning policies, procedures, and technologies, unraveling every HITRUST requirement presents learning curves even for seasoned security veterans. Mapping relevant controls and strengthening vulnerabilities demands methodical effort and expert partners.

Continuous compliance needs

New threats and evolving regulations result in HITRUST issuing updated CSF requirements every 1-2 years. Renewing compliance through refreshed assessments every 24 months demands security team attention and resources in perpetuity.

Like other advanced compliance standards, attaining and showcasing ongoing HITRUST certification does require substantial effort. But the risk reduction and reputational benefits this new "seal of approval" brings for health data protection makes the investment worthwhile for most covered healthcare institutions.

HITRUST in Action: Real-World Healthcare Use Cases

Still struggling to grasp what HITRUST compliance looks like in actual healthcare environments?

A few examples showcase how different organizations have leveraged certification:

Large Hospital Systems

A regional hospital system comprising dozens of hospitals and hundreds of outpatient clinics relied on HITRUST to standardize and strengthen controls for safeguarding patient health data across their care continuum. Combining gap assessment, vendor risk management, endpoint encryption and other key projects, the 18-month HITRUST journey better secured PHI while earning an esteemed certification badge that resonates with safety-focused healthcare consumers.

Multinational Biopharma Companies

Complex biopharma and medical device developers manage huge volumes of sensitive trial data with human subject personal identifiers as well as proprietary intellectual property. HITRUST provided a turnkey approach these firms used to reinforce broad data governance while demonstrating rigorous PHI controls to research partners. Compliance supports data sharing and compliance across global drug development ecosystems.

Healthcare Cloud Services

Modern healthcare delivery involves major use of cloud services for records, diagnostics, research, billing and more. AWS, Microsoft, Google and other hyperscale cloud providers have undertaken their own HITRUST CSF certifications allowing healthcare clients to trust stringent controls are in place for their sensitive data in the cloud. SaaS health platforms like Epic EHR systems are also pursuing authorized HITRUST compliance.

Across healthcare delivery, drug development, cloud services and other market segments, HITRUST adoption continues accelerating as the foremost industry seal of approval for vigilant healthcare data security.

In Closing: HITRUST Demystified

If you feel baffled by HITRUST complexity:

In simple terms, HITRUST certification enables healthcare organizations to:

  • Consolidate and simplify compliance with healthcare privacy laws
  • Systematically implement hundreds of security controls tailored to protect sensitive patient health records
  • Continuously monitor risk and get ahead of emerging threats putting data at risk

Yes – attaining and showcasing ongoing HITRUST compliance presents cost, time and skill hurdles.

But as healthcare business leaders and IT teams remain under fire to lock down sensitive personal data, adopting healthcare‘s most comprehensive security framework is today‘s gold standard for risk reduction.

To explore your organization‘s options for advancing healthcare data protections with HITRUST or complementary controls, connect with our team below. My security experts are here to guide you towards the controls fitting your unique risk profile.