The technical requirements, security controls, and documentation you need to build HIPAA-compliant healthcare software. No legal jargon—just actionable implementation steps.
Most HIPAA compliance guides are written by lawyers for lawyers. This one is different. We built healthcare SaaS products that passed HIPAA audits, and we learned what actually matters vs what's just compliance theater.
This checklist covers the technical safeguards, administrative requirements, and documentation you need to handle Protected Health Information (PHI). If you're building a healthcare SaaS platform, medical device software, or any product that touches patient data—this is your starting point.
Important:
This checklist is a technical implementation guide, not legal advice. Work with a HIPAA compliance attorney to ensure your specific use case meets all regulatory requirements.
Implement these technical controls to protect PHI from unauthorized access.
Policies, procedures, and training to ensure your team handles PHI correctly.
Controls for physical access to systems and data storage.
Policies and procedures you must document and maintain.
Want code examples, architecture diagrams, and a complete implementation timeline? We're preparing a comprehensive HIPAA implementation guide.
Includes: AWS/GCP setup scripts • Audit logging code samples • BAA templates • Risk assessment spreadsheet
HIPAA (Health Insurance Portability and Accountability Act) is a US federal law requiring healthcare organizations and their business associates to protect patient health information (PHI). Compliance involves technical safeguards (encryption, access controls), administrative safeguards (policies, training), and physical safeguards (secure facilities).
Yes, if your SaaS platform stores, processes, or transmits Protected Health Information (PHI). You're considered a Business Associate and must sign BAAs (Business Associate Agreements) with covered entities, implement technical safeguards, and undergo regular audits.
Key technical requirements include: encryption at-rest and in-transit (AES-256, TLS 1.2+), comprehensive audit logging of all PHI access, access controls with role-based permissions, automatic session timeouts, data backup and disaster recovery, and secure data transmission protocols.
For a new healthcare SaaS, implementing HIPAA compliance typically takes 8-12 weeks if built correctly from the start. This includes technical implementation, documentation, policies, and BAA preparation. Retrofitting compliance into an existing product takes longer (3-6 months).
A BAA is a legal contract between a covered entity (healthcare provider) and a business associate (your SaaS) that defines how PHI will be protected. It outlines responsibilities, breach notification procedures, audit rights, and liability. You cannot handle PHI without a signed BAA.
HIPAA violations can result in fines from $100 to $50,000 per violation (up to $1.5M per year for identical violations), criminal charges for willful neglect, loss of customers, and mandatory breach notifications to affected patients. Healthcare providers won't sign contracts without proof of compliance.
We've built healthcare SaaS products that passed HIPAA audits. We can implement compliance from day one or retrofit it into your existing platform in 8-12 weeks.