
An annual HIPAA risk analysis is necessary because it’s the foundation of an effective compliance program — and it’s required by law. Here’s why it matters:
- It’s a Legal Requirement
Under the HIPAA Security Rule (45 CFR §164.308(a)(1)(ii)(A)), covered entities and business associates must conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information (ePHI).
The Office for Civil Rights (OCR) repeatedly enforces this requirement, and failure to perform or update a risk analysis is one of the most common causes of HIPAA fines.
- Threats and Technology Change Constantly
Healthcare organizations face evolving cybersecurity threats. Ransomware, phishing, insider misuse, and software vulnerabilities.
An annual risk analysis ensures you’re identifying new threats and changes in your environment, such as:
- Updated systems or software
- New staff or vendors
- Relocated offices or added telehealth operations
- Cloud service or EHR changes
Without regular reviews, unnoticed gaps could leave patient data exposed.
- It Protects Against Fines and Breaches
Most OCR enforcement actions begin with the finding that the organization failed to conduct an updated risk analysis.
By performing one each year (and after significant changes), you demonstrate due diligence. This shows regulators, you are actively identifying, documenting, and mitigating risks. This can reduce penalties if a breach occurs and protects your organization’s reputation.
- It Drives Continuous Improvement
A risk analysis isn’t just about compliance — it’s a management tool. It helps you:
- Prioritize security investments
- Strengthen policies and procedures
- Train employees based on real vulnerabilities
- Build a strong compliance record
An annual HIPAA risk analysis keeps your organization compliant, secure, and prepared for evolving risks. It’s not a one-time task — it’s an ongoing process that proves your commitment to protecting patient data and maintaining trust.
If you need assistance with HIPAA Compliance, check out our HIPAA Keeper™. Our online compliance system has everything you need to get compliant and stay compliant. Your HIPAA Compliance Officer will have a HIPAA security analyst to guide and assist them every step of the way.

For more information or to speak to someone about HIPAA Compliance call us at 877.659.2467 or use the contact us form.