Understanding Risk in HIPAA: A Practical Guide for Security Teams

If your organization builds or manages software that handles protected health information (PHI), HIPAA compliance isn’t optional. But many developers and IT teams wrongly assume HIPAA is just about encryption, access control, or signing a Business Associate Agreement. In reality, HIPAA expects you to build a security program grounded in risk — not checklists.

What HIPAA Security Rule Really Requires

The HIPAA Security Rule mandates that covered entities and business associates implement “reasonable and appropriate” administrative, technical, and physical safeguards to protect ePHI. But it doesn’t define specific tools or configurations. Instead, it requires organizations to assess their own risks and implement controls that make sense for their environment.

That’s a classic example of risk-based security: start with a risk assessment, then choose controls based on impact and likelihood — not assumptions.

HIPAA References Risk Throughout

• §164.308(a)(1)(ii)(A): Requires a formal risk analysis of all systems that store or transmit ePHI
• §164.308(a)(1)(ii)(B): Requires a risk management process to reduce risks and vulnerabilities to a reasonable and appropriate level
• Documentation of both is required — and must be updated regularly

This directly aligns with NIST 800-30 for risk assessments and NIST 800-53 as a reference for appropriate safeguards.

Why Developers and Product Teams Should Care

If you’re writing code that interacts with PHI — or deploying infrastructure that stores it — you’re part of the compliance equation. Risk-based thinking needs to influence:

• Threat modeling and design reviews
• Access controls and audit logging
• Data retention and transmission policies
• Vendor risk evaluations (especially for APIs and hosting)

Common Questions

• What’s required in a HIPAA risk analysis?
• Do I need to use NIST 800 to comply with HIPAA?
• What makes a safeguard “reasonable and appropriate” under HIPAA?