You’re "Compliant," But Are You Covered?

Introduction

If you're leading a thriving digital health company, chances are you've already checked the HIPAA compliance box.

You've got policies, BAAs, maybe even a few cybersecurity tools in place.

But here's the uncomfortable truth: compliance isn’t the same as security, and HIPAA compliance doesn’t mean HIPAA resilience.

Many companies I consult with believe they’re covered until a real-world breach or audit exposes a blind spot.

That’s where understanding the difference between a HIPAA Compliance Assessment and a Risk Assessment becomes critical.

Many companies use these terms interchangeably but they're not the same.

Both are required.

Both are different.

And if you’re doing one without the other, you’re not as secure or compliant as you think.

Let’s break it down.

What Is a HIPAA Compliance Assessment?

A HIPAA Compliance Assessment is a audit of your current compliance posture. It identifies where your organization falls short in meeting the HIPAA Security Rule, Privacy Rule, and Breach Notification Rule requirements.

Key Features of a Compliance Assessment:

• Focuses on complete policy and procedures;

• Focuses on other documentation (e.g., risk assessment) and alignment with HIPAA;

• Typically focused on documentation, policy, and procedure alignment;

• Collects and analyzes evidence to validate effectiveness of safeguards;

• Provides a roadmap to remediation tasks.

In short, a compliance assessment tells you, "Here’s what’s missing" and "Here's how you fix it" from a compliance standpoint.

Insight: If done right this should help your organization out with maturing or improving overtime. Assessment reports should never come back clean.

👉 If you're just getting started download our HIPAA Checklist.

What Is a HIPAA Risk Assessment?

A HIPAA Risk Assessment (also called a Security Risk Analysis or SRA) is a forward-looking evaluation that identifies and evaluates potential threats to the confidentiality, integrity, and availability of ePHI (electronic protected health information).

Key Features of a Risk Assessment:

• Focuses on how PHI could be compromised, not just what’s documented;

• Identifies risks internal and external;

• Evaluates vulnerabilities and impact;

• Prioritizes likelihood and severity;

• Required per HIPAA 45 CFR §164.308(a)(1)(ii)(A).

If a compliance assessment tells you what’s missing, a risk assessment tells you, "Here’s what could go wrong, and "How bad it would be."

Insight: This is not a one-and-done exercise. It must be conducted REGULARLY, especially when you introduce changes to your systems, infrastructure, or operations.

👉 Download for more details on HIPAA Risk Assessments.

HIPAA Requires Both, Here’s Why It Matters

Many digital health leaders fall into the trap of doing one and ignoring the other, usually opting for the cheaper, faster compliance assessment.

Or they think a HIPAA Risk Assessment is the same as a HIPAA Compliance Assessment.

But HIPAA mandates an ongoing risk management program, and the risk assessment is its foundation.

According to HHS, failure to conduct an accurate and thorough risk analysis is the #1 reason organizations are fined.

This has been going on for at least for the last 5 years!

Insight: Skipping the risk assessment is like locking your front door but leaving your windows wide open.

Why "Compliant" Isn’t the Same as "Secure

Here’s a wake-up call: You can be technically HIPAA compliant and still be dangerously exposed.

• You might have a BAA in place, but are you verifying your third-parties meet the requirements?

• You’ve got a data retention policy, but is data being disposed?

• Your providing security training, but are your developers trained on secure coding practices?

These nuances aren’t always caught in a compliance assessment, but they will show up in a risk assessment.

How to Tell If You Need a Compliance Assessment, Risk Assessment, or Both

You likely need a Compliance Assessment if:

• You’ve never done an assessment;

• You've been in business in over 12 months;

• You’ve recently onboarded new leadership or compliance tools.

You definitely need a Risk Assessment if:

• You’ve never done one;

• You're bringing on a new vendor;

• You've had a major change in a system or operations.

Insight: The most effective strategy is to perform both as part of an integrated HIPAA risk management program, then revisit them at least annually or whenever there’s a significant operational change.

Your Next Step: Don’t Guess, Assess

If you're building or scaling a digital health company with real risk exposure, you can't afford assumptions.

The "we're fine" mindset is exactly what hackers and auditors look for.

As a Fractional CISO, I work with digital health companies like yours to:

• Conduct HIPAA Compliance & Risk Assessments;

• Build security roadmaps tied to business objectives;

• Align compliance with product development.

Let’s make sure your compliance is a competitive advantage.

👉 Contact me to discuss a HIPAA assessment for your organization.