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Choose Your Business Associates Wisely: An $80K Mistake

January 8, 2025

As we ring in the new year, it’s important to remember that Business Associates (BAs) are just as responsible for protecting patient health data as their Covered Entity counterparts. 

A major misstep by a BA was highlighted recently on a federal level, and the first fine of 2025 was imposed. 

Elgon, a Massachusetts-based medical record and billing support company for Covered Entities, was levied a $80,000 fine due to numerous violations of the Security Rule, which were exposed by the fallout of a ransomware attack. 

As a proposed update to the Security Rule is currently open for public comment and may take effect in the spring, it is crucial for Covered Entities to select Business Associates (BAs) who prioritize compliance. BAs are just as responsible for ensuring that Protected Health Information (PHI) is kept secure.

 

What Happened? 

Elgon was the victim of a ransomware attack on March 25, 2023. Unfortunately, the BA didn’t realize the intrusion of its firewalls for over a week until a ransom note was discovered. Elgon then reported the breach, which affected over 30,000 patients of a Covered Entity. Thousands of social security numbers, addresses, and other personally identifiable information were leaked from the attack. 

When Elgon was investigated, it was uncovered that the organization failed to recognize its risks in a Security Risk Analysis (SRA). The SRA is at the foundation of a successful practice or business, giving an organization a benchmark on how it handles PHI and how it can improve. This fine is also the second enforcement of the OCR’s Risk Analysis Initiative, highlighting the importance of completing and maintaining this assessment. 

 

How to Protect Your Organization

Covered Entities and Business Associates need to uphold their commitment to protecting patient data. This recent fine is a stark reminder of what can happen when the proper procedures are not followed, exposing the personal information of thousands of patients. 

To avoid and mitigate situations like this, Covered Entities must carefully choose the right BA to work with, ensuring they also understand the importance of protecting patient data.  For BAs, having the proper safeguards in place is vital, earning trust from Covered Entities that you can keep their patients’ PHI safe. 

A key document that establishes the liability of both parties is the Business Associate Agreement (BAA). The BAA is a written document required when working with Business Associates and vice versa. This signed agreement ensures both parties know their responsibilities when handling patient data. Proposed updates to the Security Rule expand on this, with BAs potentially having to verify they are enforcing the proper safeguards on a yearly basis, certified by a compliance expert. 

Overall, this fine sets the tone for a new year of significant changes and enforcement by the OCR. Covered Entities and Business Associates must both understand their critical role in protecting patients. 

To learn more about how you can become HIPAA compliant, schedule a consultation with our team of experts today. 

 

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$700K HIPAA Settlement: What the Ambry Genetics Phishing Breach Teaches Every Practice

September 21, 2026 Penelope Schweitzer No comments yet

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August 5, 2026 The latest HIPAA fine is another clear reminder that ransomware attacks are, unfortunately, here to stay in the healthcare industry. A settlement involving the OSF Healthcare System was recently announced by the Office for Civil Rights (OCR). As an enterprise healthcare provider in the midwest, the organization serves 174 locations, including 16 hospitals – a prime target for a ransomware attack.    So, what happened?  In April 2021, OSF discovered that they joined the unlucky club of ransomware victims when a malicious actor deployed Nephilim, a ransomware strain made to target larger organizations. Once the ransomware infected OSF systems, the hacker demanded payment or patient Protected Health Information (PHI) would be leaked online. In this attack, sensitive information like financial account information, driver’s license numbers, medical record numbers, and more, were all exposed. Over 53,000 patient records were exposed in this attack.  When ransomware attacks in healthcare have soared 278% in recent years, it’s more of a when then an if your organization doesn’t have the right safeguards in place.  While the breach was discovered in April, OSF healthcare reported the breach to the OCR in October. The OCR took it from there, digging into what precautions (or lack thereof) let this happen.  What did the OCR discover? If you’ve read any of our other fine breakdowns, you already know where this is going: another missing Security Risk Analysis (SRA).  The SRA is a required document every HIPAA-regulated entity (ie: every practice and their Business Associates that handle patient information) needs to complete. The SRA is a thorough review of the physical, technical, and administrative safeguards in place to prevent PHI ending up in the wrong hands. While the OCR didn’t specify exactly how the ransomware got into OSF’s system, a technical safeguard vulnerability was very likely the entry point. A proactive SRA could have flagged that gap before it turned into a major breach. In addition to missing this required documentation, OSF also took too long to report the breach to the OCR and notify affected patients. This is a direct violation of the Breach Notification Rule, which requires organizations to notify patients within 60 days of a discovered breach. Moreover, since the breach impacted more than 500 patients, OSF was also required to report this breach to the OCR within 2 months as well. Time is of the essence in every component of a breach, from securing systems to ensuring affected parties are aware to protect themselves and an over five month delay was unacceptable in the eyes of the OCR.    What was the result?  OSF’s settlement tops the list as the largest fine of the year, coming in at $552,250, plus government monitoring for the next two years.  It’s very important to note that this breach occurred in 2021, meaning that over five years were spent from the initial breach, to investigations, to the public press releases. Also, the average cost of a healthcare breach is over 7 million dollars –  from implementing secure systems, notifying patients, legal fees, and more. The Takeaway While the settlement payment and Corrective Action Plan (CAP) are just the cherries on top, this experience was a tremendous cost of time, money, and resources, highlighting the importance of making sure everything is secure before a situation occurs.  So, when was the last time you looked at your SRA? It’s time to seriously analyze your current compliance posture. Ransomware groups don’t check whether you’re a small dental office or a 16-hospital health system before they attack, they check whether the door was left open. Time and again, OCR’s findings come back to the same root cause: organizations can’t secure what they haven’t even identified as a problem. Looking to review your current compliance standings? Meet with our team of experts for a complimentary educational consultation. 

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