If you’re running or developing a SaaS product that could touch health-related data, you’ve probably searched “HIPAA compliance for SaaS” and ended up more confused than when you started.
You’re in good company.
HIPAA was never written with modern software in mind. But if your platform stores, processes, or transmits Protected Health Information (PHI), you can’t afford to ignore it.
This guide breaks HIPAA down into plain language—what really applies to SaaS companies, what you actually need to do, and the common pitfalls that trip teams up along the way.
When HIPAA Applies to SaaS
Not every SaaS company falls under HIPAA. But if your product handles PHI on
behalf of a Covered Entity (like a hospital, healthcare provider, or insurance company), you’re likely considered a Business Associate, and HIPAA applies to you.
HIPAA doesn’t care about your tech stack or programming language—if your system touches PHI, you’re responsible for protecting it.
Examples of PHI include:
- A patient’s name tied to health data
- Email addresses linked to appointment details
- IP addresses associated with medical record numbers
In the SaaS world, PHI can include:
- User-submitted health information
- Data stored in your databases
- Support tickets referencing health conditions
Bottom line: If data in your platform can be tied to a person and contains health-related details, it counts as PHI—and must be protected as such.
Key Components of HIPAA Compliance for SaaS
1. Protected Health Information (PHI)
Your team needs to understand exactly what PHI looks like and where it lives in your system. Label it clearly, and apply the right security controls—access limits, encryption, and monitoring.
2. Business Associate Agreements (BAAs)
If you’re a Business Associate, you must sign a BAA with every Covered Entity you serve—and with any subcontractors or cloud vendors who process PHI on your behalf.
Tip: Major providers like AWS, Azure, and GCP offer HIPAA-eligible services—but only after you sign their BAA.
3. Security Risk Assessment (SRA)
HIPAA mandates regular risk assessments to identify and address vulnerabilities. This goes beyond technical scans—it includes reviewing policies, training, and procedures too.
Use frameworks like NIST SP 800-30 to guide your assessment.
Policies You Actually Need (and Why)
HIPAA expects proof that your organization has thought through how to protect PHI. The following policies are essential:
✅ Information Security Policy – Defines your company’s overall approach to securing sensitive data.
✅ Access Control Policy – Specifies who can access PHI, how permissions are granted, and how they’re reviewed.
✅ Incident Response Plan – Details how you’ll detect, respond to, and report breaches.
✅ Data Retention & Disposal Policy – Explains how long PHI is stored and how it’s securely destroyed.
✅ Workforce Security Policy – Outlines how employees are onboarded, offboarded, and trained regarding PHI.
Pro Tip: These documents should match your real-world operations. Don’t rely on cookie-cutter templates—start with what you actually do, then document it clearly.
Common HIPAA Gaps in SaaS (and How to Fix Them)
Even diligent SaaS teams often miss the mark on a few critical points:
❌ Unsigned or outdated BAAs – A missing or unexecuted BAA means you’re not compliant, period.
❌ Overly broad access – If every engineer can access production databases, you have an exposure problem.
❌ Lack of audit logging – HIPAA requires you to log who accessed PHI, when, and what they did.
❌ No formal incident response plan – It’s not enough for your devs to “know what to do.” HIPAA requires a documented and tested plan.
❌ Unencrypted backups – Backups containing PHI must be encrypted both at rest and in transit—no exceptions.
❌ Assuming your cloud provider covers you – AWS, GCP, and Azure provide compliant infrastructure, but you’re still responsible for configuring and maintaining it properly.
Ready for a HIPAA Reality Check?
If you’re not sure where your SaaS platform stands, now’s the time to find out—before an auditor does.
Book a free HIPAA compliance review with our experts. We’ll help you identify risks, close gaps, and prepare your platform for confident, compliant growth.
Because when it comes to healthcare data, “we didn’t know” isn’t an excuse.
