HIPAA Compliance: Guide for Health SaaS in Europe

Why a European SaaS Should Care About HIPAA

If your health SaaS targets US clients — hospitals, clinics, health insurers, or any organization handling US health data — you must be HIPAA compliant. As a SaaS provider with access to Protected Health Information (PHI), you're a "business associate."

What Is PHI?

Protected Health Information includes any individually identifiable health information: names, dates of birth, Social Security numbers, diagnoses, treatments, and any data that can identify a patient combined with health information. ePHI (electronic PHI) is the core focus for SaaS companies.

The 3 Fundamental HIPAA Rules

1. Privacy Rule

Defines who can access PHI and under what conditions. Requires the minimum necessary standard.

2. Security Rule

Mandates administrative, physical, and technical safeguards to protect ePHI: security policies, encryption, audit trails, access controls, authentication.

3. Breach Notification Rule

Mandatory notification to affected individuals within 60 days and to HHS for any PHI breach.

The Business Associate Agreement (BAA)

Before handling PHI, you must sign a BAA with each client defining your obligations for protecting PHI. Without a BAA, your client is in HIPAA violation.

HIPAA + GDPR: The Dual Constraint

As a European SaaS, you must manage both HIPAA and GDPR simultaneously. They have similar but not identical requirements — for example, GDPR requires 72-hour breach notification while HIPAA allows 60 days.

Practical Steps

1. Conduct a HIPAA-specific risk assessment for ePHI
2. Implement technical controls: AES-256 encryption, audit logs, MFA, RBAC
3. Write policies: security policy, incident response plan, access policy
4. Prepare your BAA template
5. Train your teams on HIPAA requirements (mandatory)
6. Document everything — HIPAA requires 6 years of compliance evidence

Compli.st centralizes your HIPAA compliance documentation and automates healthcare-specific security questionnaire responses.

Start your HIPAA compliance →