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HIPAA vs SOC 2: Key Rules, Scope, and Compliance Steps

HIPAA vs SOC 2: Key Rules, Scope, and Compliance Steps

Your team already has a SOC 2 report in place. For a while, that covered what clients needed during security reviews. But now a healthcare client is asking about HIPAA. The team’s unsure why SOC 2 isn’t enough and what HIPAA adds that SOC 2 doesn’t.

This scenario comes up often when businesses start working with health data. The two frameworks sound similar but solve different problems. In this article, you’ll learn what HIPAA and SOC 2 each cover, how they compare, and when your business might need one (or both).

TL;DR
HIPAA is a legal requirement for protecting health data. SOC 2 is a voluntary audit that shows your systems and processes are secure
You need HIPAA if you handle PHI. You need SOC 2 when clients or partners ask for proof of controls. Many businesses end up needing both.
HIPAA has fixed rules defined by law. SOC 2 allows more flexibility in how you meet its requirements

Overview of SOC 2 and HIPAA

  SOC 2 stands for System and Organization Controls 2. It’s a framework used by businesses to show that their security and data handling practices meet a certain standard. You’ll see it most in software and cloud companies that work with other businesses.

The framework was developed by the American Institute of Certified Public Accountants (AICPA). It’s built around what are called Trust Services Criteria. These cover areas like security, confidentiality, and system availability. Each company decides what to include in scope. A third-party auditor checks the setup and issues a report.

HIPAA stands for the Health Insurance Portability and Accountability Act. It’s a federal law. It applies when a company handles protected health information like medical records or insurance data. This includes healthcare providers and any vendor they share data with.

HIPAA is enforced under the HITECH Act. The law includes two main sets of requirements: the Security Rule and the Privacy Rule. These rules are not optional.

SOC 2 and HIPAA both deal with sensitive data, but they apply in very different ways. One is voluntary. The other is not.

HIPAA vs SOC 2: Side-by-side comparison

Choosing between HIPAA and SOC 2 often comes down to what kind of data you handle and who you serve. Here’s a clear breakdown of how each framework approaches compliance:

CategorySOC 2HIPAA
ApplicabilityVoluntary, based on client or market expectationsMandatory for entities handling PHI
Framework OwnerAICPAU.S. Department of Health and Human Services (HHS)
Focus AreaSystem and data security controlsProtection of health data (PHI/ePHI)
Audit MethodIndependent CPA firm conducts Type I or Type II auditNo formal audit unless triggered by incident or complaint
Audit TriggerCompany-initiatedRegulator-initiated
Proof of ComplianceSOC 2 report (Type I or II)Documentation, policies, and breach logs
PenaltiesNo legal penalties; may affect deals or renewalsLegal and financial penalties; can include fines or jail
IndustriesSaaS, cloud, B2B tech, enterprise vendorsHealthcare, medtech, insurance, clinical platforms
ControlsRisk-based; mapped to Trust Services CriteriaDefined by HIPAA Security and Privacy Rules
Review FrequencyAnnually for most Type II reportsOngoing; based on internal review cycles and risk exposure
Use CaseSales enablement, client assurance, vendor risk reviewsRegulatory compliance for health data access and storage

Let’s now break down how each framework works in practice.

Key similarities

Both frameworks care about the same areas: access control, audit logs, encryption, risk reviews, policies, and staff training. They both require proof. It’s not enough to have a policy. You need evidence that it’s followed.

SOC 2 and HIPAA both expect vendors to be managed properly. If you share data, you’re responsible for how it’s protected—even if it lives in someone else’s system. They both want issues to be tracked. And they both expect a response when something breaks.

Key differences

SOC 2 allows interpretation. Companies decide how to meet the Trust Services Criteria based on their risk and operations. Controls are tailored to the environment. The final outcome is a formal report, issued after a third-party audit. This report shows how well the company’s systems hold up under scrutiny.

HIPAA sets specific requirements. It defines exactly what controls must be in place when handling protected health information. There’s no routine audit unless a breach or complaint triggers one. Oversight comes from the Department of Health and Human Services, and the consequences can include penalties or legal action.

The two frameworks focus on security, but they operate very differently—one through custom controls and client assurance, the other through regulation and enforcement.

Get SOC 2 and HIPAA compliant with ease

Compliance process for SOC 2 and HIPAA

SOC 2 follows an audit path. HIPAA runs on internal enforcement. That shapes how each one works.

Let’s take a closer look at both:

SOC 2 compliance process

Getting a SOC 2 report follows a clear sequence, but the details depend on your systems and scope. Here’s how the process typically plays out—from prep to final audit:

  • Define your scope: Start by choosing which Trust Services Criteria apply. Security is always included. Others (like Availability or Confidentiality) depend on your systems and what clients expect. Most businesses start with Security and add one or two more.
  • Run a readiness check: This step helps you see what’s missing. You look at your current controls, policies, and practices. Gaps stand out early here. Many companies bring in an advisor if it’s their first time through this.
  • Implement and document controls: Now you build out what’s needed. This might include access controls, logging, vulnerability scans, change management, or policy approvals. Every control must be in place and backed with evidence.
  • Schedule your audit: Once things are stable, a licensed CPA firm steps in. They review your controls and collect evidence. A Type I report checks what exists today. Type II looks at how well those controls hold up over time.
  • Complete the cycle: If the audit goes well, you get your SOC 2 report. That’s what clients expect during security reviews. Most companies repeat this annually.

HIPAA compliance process

HIPAA compliance isn’t a single checklist. It’s a set of actions that depend on your role, your data, and how your systems are set up. Here’s how most teams move through it—from identification to internal readiness:

  • Start with your role: Every organization falls into one of two categories: covered entity or business associate. If you’re a vendor handling patient data on someone else’s behalf, you’re a business associate, and HIPAA applies.
  • Map your PHI: Identify where protected health information lives and moves across your systems. That includes apps, databases, files, and cloud storage. You also need to document who has access and how.
  • Run a risk assessment: This step surfaces security gaps. You look for missing encryption, shared logins, weak policies, or anything else that puts PHI at risk. It also helps define what to fix first.
  • Apply required safeguards: HIPAA outlines three types: technical, administrative, and physical. These cover access control, backups, workstation security, breach response, and more. You must address all three areas.

Document policies and manage vendors: Teams need written procedures that explain how PHI is handled. These are tied to training and incident response. Any vendor with PHI access must have a signed Business Associate Agreement on file.

Can a business be HIPAA and SOC 2 compliant?

Yes, a business can be compliant with both HIPAA and SOC 2.

This usually happens in healthcare tech. A platform that stores patient data needs HIPAA. If that same platform sells into hospitals or large providers, those buyers often ask for a SOC 2 report as well.

Each framework covers a different angle. HIPAA checks if PHI is handled safely. SOC 2 shows whether your overall system and security program hold up under audit.

They overlap in some places—access control, risk reviews, vendor checks. But the requirements are different. One is tied to regulation. The other comes from client expectations.

If you’re in health tech and growing, dual compliance becomes hard to avoid. Most teams map controls once and then align them to both frameworks, which saves time and keeps the work from doubling.

Plenty of companies do this. What matters is how well your systems scale to handle it.

Get compliant in weeks, not months

SOC 2 vs. HIPAA: Which framework to choose and when?

Choosing between the SOC 2 and HIPAA frameworks depends on the type of data you manage and the clients you serve.

Pick SOC 2 if:

Your product handles sensitive business data and your clients expect proof of strong controls. This is common in SaaS, B2B tools, and cloud services. If sales cycles involve security reviews or procurement teams, they’ll likely ask for a SOC 2 report. Most teams go for Type II once they’ve set up their control environment.

Pick HIPAA if:

Your system stores or processes patient data. This includes PHI collected through forms, synced from EHR systems, or shared by a healthcare partner. HIPAA applies whether you’re the primary provider or a supporting vendor. The law doesn’t make room for exceptions once PHI is involved.

Some scenarios require both:

Because their clients care about both risk and regulation. A company selling into hospitals might need HIPAA to meet legal requirements, and SOC 2 to pass vendor risk assessments. In that case, it helps to map shared controls and build a common foundation. This approach makes ongoing audits easier to manage and reduces duplication across teams.

Speed up HIPAA and SOC 2 compliance with Sprinto

  Managing HIPAA and SOC 2 separately often means juggling two sets of controls, policies, and trackers. Sprinto replaces that with one system built to handle both frameworks in parallel.

It maps requirements across HIPAA and SOC 2 into a unified control set. Evidence is collected automatically (logs, policy acknowledgments, access records, system snapshots) and linked to the right requirement. No duplicate checklists. No switching between tools.

Controls like Business Associate Agreements, breach response protocols, and encryption policies live side by side. When something drifts (like a revoked permission or missed review), Sprinto logs it, flags the affected control, and keeps a record of what changed. If a control stops working as expected, it’s marked for review with all supporting details in place.

The result: audit prep turns into ongoing visibility. Whether the ask comes from a healthcare partner or an external auditor, teams can respond with exactly what’s needed—already in place.

Handling HIPAA and SOC 2 together used to mean running two separate checklists. What teams really need is one system that connects both—where you don’t repeat controls, and you’re not guessing which requirement maps to what.
Watch Sprinto in action and learn how the platform can simplify things.

Frequently asked questions

What is the difference between HIPAA and SOC 2?

HIPAA is mandatory for anyone handling protected health information. It comes with fixed rules (mostly written into law) and applies across healthcare. SOC 2, on the other hand, is something your team chooses to do. Usually because clients want to see how you secure systems. It’s based on the trust services criteria, but how you meet those controls is up to you. HIPAA is specific. SOC 2 is flexible. The overlap in the SOC 2 compliance vs HIPAA comparison causes confusion, but they exist for different reasons.

What are the consequences of not complying with HIPAA or SOC 2?

With HIPAA, you’re dealing with federal enforcement under the HITECH Act. If patient data leaks or even feels mishandled, you might get audited. If gaps are confirmed, penalties follow. SOC 2 doesn’t work that way. There’s no regulator. But if a client asks for your SOC 2 report and you don’t have one—or fail the audit—it slows deals or blocks them entirely. Neither hits right away, but both can cost you in different ways.

Do businesses need both HIPAA and SOC 2 compliance?

Yes, in many cases. Especially for platforms that collect PHI and sell into healthcare. HIPAA covers legal risk. SOC 2 handles trust. Together, they give you coverage across compliance and sales. Most teams don’t rebuild their controls twice—they map once and align both frameworks to the same system.

What is a Business Associate Agreement (BAA) and who needs one?

A BAA is required under HIPAA. It’s a contract between a healthcare provider and a vendor that has access to PHI. This might be a SaaS tool, a billing provider, or a managed services partner. The BAA shows both parties agree to follow HIPAA’s Security and Privacy Rule. Teams managing HIPAA and SOC 2 compliance often track these contracts alongside SOC 2 vendor controls.

Payal Wadhwa

Payal Wadhwa

Payal is your friendly neighborhood compliance whiz who is also ISC2 certified! She turns perplexing compliance lingo into actionable advice about keeping your digital business safe and savvy. When she isn’t saving virtual worlds, she’s penning down poetic musings or lighting up local open mics. Cyber savvy by day, poet by night!

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