HIPAA Compliance Audits: What Healthcare Organizations Need to Know

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Guide to HIPAA compliance audits

If your organization handles protected health information—whether in paper form (PHI) or electronic format (ePHI)—you’re subject to the HIPAA Security, Privacy, and Breach Notification Rules. Maybe a client asked you to sign a business associate agreement (BAA), or you’re proactively tightening your security controls. Either way, the question remains: Are you really HIPAA compliant? And can you prove it?

Many HIPAA conversations I’ve had start the same way. The client says, “We’re HIPAA compliant—we passed an audit a few years ago.” Then I ask a simple follow-up: “Can you show me your most recent risk analysis?” The room usually goes quiet. Not because they’re hiding anything, but because they genuinely believed compliance was something you achieved once and then moved on from.

Whether you’re preparing for a prospective client review or reinforcing your existing program, there are a few proven paths to demonstrate HIPAA compliance. Here’s a practical breakdown.

Ways to Demonstrate HIPAA Compliance

There are several ways to demonstrate HIPAA compliance to your clients.

Self-Assessments: The Do-It-Yourself Route

Let’s get this out of the way—there’s no such thing as a formal “HIPAA certification.” You can conduct a self-audit based on the HIPAA Security Rule requirements. This involves reviewing your organization’s administrative, physical, and technical safeguards, identifying gaps, and remediating them internally. Self-audits can be helpful and cost-effective, but they carry limited weight with customers and regulators.

Independent Attestation: The AT-C 315 HIPAA Report

One of the more common and credible methods to demonstrate HIPAA compliance is through an attestation report conducted by an independent CPA firm, prepared under AT-C Section 315 of the AICPA’s attestation standards (formerly SSAE 18). This type of report provides assurance that your organization is in compliance with HIPAA’s auditable requirements.

We frequently issue AT-C 315 reports covering the HIPAA Security Rule and the Breach Notification Rule. Occasionally, engagements also include the Privacy Rule and relevant state regulations, depending on the client’s needs. These reports are typically Type I engagements, which evaluate compliance as of a specific point in time (rather than over a period, as with Type II). The result is a comprehensive, third-party assessment that can be shared with current or prospective clients.

What’s in An AT-C 315 HIPAA Report?

Our reports include the following:

  • Independent Auditor’s Opinion on HIPAA compliance
  • Entity’s Assertion of compliance
  • System Description, including organizational operations and ePHI environment
  • Control Activities documented by management
  • Tests of Controls and Results performed by the auditor
  • Mapping of HIPAA Requirements to Entity Controls, cross-referencing the Security and Breach Notification Rules

These elements provide clear, tangible evidence of HIPAA compliance that your stakeholders can understand and trust.

 

Do you need a HIPAA compliance audit?

Use Cases: Who Benefits From a HIPAA Audit?

HIPAA audits aren’t just for covered entities. Here’s who should consider obtaining a report:

  • Cloud and Managed Service Providers: If you’re storing or processing ePHI on behalf of healthcare organizations, you’re considered a business associate and are required to sign a BAA. A HIPAA attestation report helps validate your security posture.
  • Healthcare Providers and Payers: These organizations often use attestation reports to evaluate their own internal controls or vet key vendors. In some cases, they mandate independent HIPAA audits from their business associates as a risk management measure.
  • Technology Vendors in Healthcare: SaaS platforms, EHR systems, and data processors handling patient information often use HIPAA reports to streamline procurement and sales conversations.

Want Even More Assurance? Consider HITRUST

Some clients demand even stronger assurance—especially large payers, national providers, or insurers. That’s where the HITRUST certification process comes in.

HITRUST is built on the same underlying HIPAA requirements but expands into broader risk management and privacy frameworks. Linford & Co. is a Certified HITRUST Assessor and provides validated assessments for organizations seeking certification.

For a comparison of HITRUST vs. SOC 2 and a breakdown of how HITRUST fits into your compliance strategy, check out our recent posts.

 

HIPAA compliance audit FAQs

Frequently Asked Questions About HIPAA Compliance

Below are answers to some of the most common questions we hear from healthcare organizations navigating HIPAA compliance requirements.

What Is a HIPAA Compliance Audit?

A HIPAA compliance audit is a formal review to determine whether a covered entity or business associate complies with the HIPAA Rules, primarily:

Audits may be conducted by the Office for Civil Rights (OCR) within the U.S. Department of Health and Human Services (HHS), or indirectly through investigations following complaints or breaches.

Important clarification: Not every “HIPAA audit” is a government audit. Many organizations undergo internal audits, third-party readiness assessments, or gap analyses that are HIPAA-based but not performed by OCR.

What Are the HIPAA Compliance Requirements?

HIPAA does not prescribe a single checklist. Instead, it defines administrative, physical, and technical safeguards that must be implemented in a manner appropriate to your organization’s size, complexity, and risk profile. At a high level, requirements include:

  • Safeguarding electronic protected health information (ePHI)
  • Limiting use and disclosure of PHI
  • Implementing access controls and audit controls
  • Performing and documenting a HIPAA risk analysis
  • Training workforce members
  • Maintaining policies, procedures, and evidence of enforcement

From an auditor’s perspective, documentation and consistency matter just as much as intent.

What Triggers a HIPAA Audit?

HIPAA audits are most commonly triggered by events, not calendars. Typical triggers include:

  • A reported data or security breach
  • A patient complaint
  • A whistleblower allegation
  • Media attention or public reporting
  • Patterns identified by OCR through enforcement activity

In practice, many organizations encounter HIPAA scrutiny only after something has gone wrong.

Are HIPAA Audits Random?

Sometimes—but not in the way many people imagine. OCR has conducted periodic audit programs that include a degree of random selection. However, most HIPAA enforcement activity is reactive, driven by complaints or breaches. Random audits are relatively rare compared to investigations.

How Often Are HIPAA Audits Conducted?

There is no fixed audit cycle under HIPAA. Unlike financial audits or certifications, HIPAA does not require annual or recurring government audits. An organization could theoretically operate for years without OCR contact—until an incident occurs.

That said, from a risk perspective, organizations should treat HIPAA as an ongoing compliance obligation, not a one-time exercise. This is where terminology causes confusion.

  • HIPAA itself does not require periodic external audits
  • Many organizations choose to conduct annual or biennial internal or third-party assessments
  • Other frameworks (SOC 2, ISO 27001, HITRUST) may impose audit cycles, but those are separate from HIPAA

As an auditor, I typically recommend regular internal reviews even though they are not explicitly mandated.

How Do I Prepare for a HIPAA Audit?

Preparation is less about scrambling documents and more about operational discipline. Key preparation steps include:

  • Completing and documenting a HIPAA risk analysis
  • Maintaining written policies and procedures
  • Ensuring access controls are implemented and reviewed
  • Retaining evidence of workforce training
  • Validating incident response and breach notification processes
  • Being able to explain why controls are designed the way they are

Auditors are not just checking boxes—they are assessing whether controls are reasonable, implemented, and followed.

Does HIPAA Require Audit Logs?

Yes—with nuance. The HIPAA Security Rule requires audit controls that record and examine system activity involving ePHI. That typically means:

  • User access logs
  • System activity logs
  • Event tracking for sensitive systems

HIPAA does not mandate specific log formats, retention periods, or tools. However, the absence of meaningful logs is a common audit finding and is difficult to defend.

 

Final thoughts from an auditor on HIPAA compliance

Final Auditor’s Perspective

HIPAA compliance is less about perfection and more about reasonable, documented, and defensible practices. Most organizations that struggle in audits are not ignoring HIPAA—they are underestimating how much evidence and structure it requires.

If you treat HIPAA as a living risk-management process rather than a compliance checkbox, audits become far less intimidating—and far more predictable.

Next Steps for HIPAA Compliance

There’s no one-size-fits-all approach to HIPAA audits. Choose the level of assurance that matches your client’s expectations, industry risk, and budget. Whether it’s a self-assessment, an AT-C 315 audit, or a HITRUST certification, the goal is the same: to build trust through evidence-based compliance.

At Linford & Co., we deliver HIPAA audit engagements using a structured, phased approach designed to provide real value—not just a checklist. If you’re unsure where to start or want to talk through your audit options, get in touch with us.

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This article was originally published on 5/9/2018 and was updated on 1/21/2026.