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HIPAA Compliance for SaaS Startups

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Tailored for SaaS and your role.

RN
Expertly reviewed by Raphael NCertified

Head of Compliance StrategyCPA, CISA, ISO 27001 Lead Auditor

Last Verified

January 11, 2026

Our Editorial Process →

Strategic Priorities for SaaS Leaders

RN

Raphael N

CPACISAISO 27001 Lead Auditor

Head of Compliance Strategy

Raphael leads go-to-market compliance strategy for high-growth SaaS and AI teams. With over a decade of experience across Big Four firms and fintech startups, he specializes in translating complex SOC 2 requirements into automated, engineering-friendly workflows.

Editorial Standards & Methodology

All RiscLens content is researched, written, and reviewed by compliance professionals with real-world audit experience. We maintain strict editorial independence and never accept payment for coverage or rankings.

Audit readiness checklist

  • Define scope and evidence owners for HIPAA Compliance
  • Map controls to your SaaS workflows
  • Confirm evidence cadence and review approvals
  • Document exceptions and compensating controls
  • Validate auditor expectations before kickoff

Evidence to prepare

  • Policy ownership records
  • Control testing results
  • Risk assessments
  • Monitoring evidence

Frequently Asked Questions

When does a SaaS company need HIPAA compliance?

HIPAA applies when you handle PHI as a Business Associate for covered entities (healthcare providers, insurers). This includes storing, processing, or transmitting PHI through your platform.

What makes a SaaS platform HIPAA-compliant?

Key elements include encryption (transit/rest), access controls, audit logging, BAA execution capability, breach procedures, and workforce training. Architecture must support PHI isolation.

Can we use standard cloud infrastructure for HIPAA?

Yes, major cloud providers (AWS, Azure, GCP) offer HIPAA-eligible services with BAAs. You're responsible for proper configuration, access controls, and application-level security.

About RiscLens

Our mission is to provide transparency and clarity to early-stage technology companies navigating the complexities of SOC 2 (System and Organization Controls 2) compliance.

Who we serve

Built specifically for early-stage and growing technology companies—SaaS, fintech, and healthcare tech—preparing for their first SOC 2 audit or responding to enterprise customer requirements.

What we provide

Clarity before commitment. We help teams understand realistic cost ranges, timeline expectations, and common gaps before they engage auditors or expensive compliance vendors.

Our Boundaries

We do not provide legal advice, audit services, or certifications. Our assessments support internal planning—they are not a substitute for professional compliance guidance.

Technical Definition

SOC 2 (System and Organization Controls 2) is a voluntary compliance standard for service organizations, developed by the AICPA, which specifies how organizations should manage customer data based on the Trust Services Criteria: security, availability, processing integrity, confidentiality, and privacy.