Are annual HIPAA risk assessments necessary?

Computer security

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.

About Suze Shaffer

Suze Shaffer is the owner and president of Aris Medical Solutions. She specializes in HIPAA compliance, risk management, and cyber security. She believes that by educating her clients in understanding why and what needs to be done to protect their practice they have a better outcome.

Suze has been instrumental in helping clients nationwide with risk management, implementing privacy and security rule policies and procedures, and ultimately protecting patient data. She includes state and federal regulatory requirements to ensure clients are protected in all areas.

She has spoken at numerous conferences and functions. She continues to educate organizations how to minimize the risks of data breaches. HIPAA compliance is not an option, it is mandatory for every organization that comes in contact with protected health information to have reasonable and appropriate security measures in place. Unfortunately, most organizations don’t realize they are not compliant until they suffer a data breach or they are faced with an audit or investigation.

Did you know that the Office for Civil Rights (OCR) is the agency that investigates data breaches? Have you seen the heavy fines that have been imposed for non-compliance?

All 50 states now have their own set of privacy laws and the State's Attorney General may also investigate privacy violations!

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