Definition
The HIPAA Security Rule requires covered entities and business associates to protect the confidentiality, integrity, and availability of electronic protected health information.
In practice
- A team documents the data flow, owner, and evidence for this topic before deciding which control or process to improve.
Who this applies to
- Covered entities that create, receive, maintain, or transmit ePHI
- Business associates that handle ePHI for a covered entity
- Subcontractors that handle ePHI for a business associate
What the rule asks for
- Perform a thorough and accurate risk analysis of potential risks and vulnerabilities.
- Implement reasonable and appropriate administrative, physical, and technical safeguards.
- Maintain policies, procedures, and documentation that support the safeguards.
- Review and update security measures as the environment and risks change.
How teams put it into practice
- Maintain an inventory of systems, applications, users, vendors, and data flows involving ePHI.
- Use access controls, unique user identification, audit controls, and integrity protections appropriate to the risk.
- Test backup restoration and incident response instead of treating written plans as proof of readiness.
Common mistakes
- Calling a checklist a risk analysis without documenting threats, vulnerabilities, likelihood, and impact.
- Assuming encryption alone makes an environment compliant.
- Leaving access reviews, logging, and contingency testing as informal or undocumented activities.
Questions that come up
Does HIPAA require encryption?
The Security Rule treats encryption as an addressable implementation specification, which means the organization must assess whether and how to implement it and document the decision.
What are the three safeguard families?
Administrative safeguards, physical safeguards, and technical safeguards work together to protect ePHI.
References
- Security Rule guidance U.S. Department of Health & Human Services
- NIST SP 800-66 Rev. 2 National Institute of Standards and Technology