21st Century Oncology: 2,213,597 individuals, Mar 2016.

Failure to protect the health records of millions of persons costs entity millions of dollars 21st Century Oncology, Inc. (21CO) has agreed to pay $2.3 million in lieu of potential civil money penalties to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and adopt a comprehensive corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules. 21CO is a provider of cancer care services and radiation oncology. With their headquarters located in Fort Myers, Florida, 21CO operates and manages 179 treatment centers, including 143 centers located in 17 states and 36 centers located in seven countries in Latin America.

On two separate occasions in 2015, the Federal Bureau of Investigation (FBI) notified 21CO that patient information was illegally obtained by an unauthorized third party and produced 21CO patient files purchased by an FBI informant. As part of its internal investigation, 21CO determined that the attacker may have accessed 21CO's network SQL database as early as October 3, 2015, through the remote desktop protocol from an exchange server within 21CO's network. 21CO determined that 2,213,597 individuals were affected by the impermissible access to their names, social security numbers, physicians' names, diagnoses, treatment, and insurance information. OCR's subsequent investigation revealed that 21CO failed to conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of the electronic protected health information (ePHI); failed to implement security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level; failed to implement procedures to regularly review records of information system activity, such as audit logs, access reports, and security incident tracking reports; and disclosed protected health information (PHI) to third party vendors without a written business associate agreement.

"People need to trust that their private health information will remain exactly that; private," said OCR Director Roger Severino. "It's not just my hope that covered entities will learn from this example and proactively find and address their security risks, it's what the law requires."

In addition to a $2.3 million monetary settlement, a corrective action plan requires 21CO to complete a risk analysis and risk management plan, revise policies and procedures, educate its workforce on policies and procedures, provide all maintained business associate agreements to OCR, and submit an internal monitoring plan.

On May 25, 2017, 21CO filed for Chapter 11 bankruptcy protection in the United States Bankruptcy Court for the Southern District of New York. The settlement with OCR will resolve OCR's claims against 21CO and the corrective action plan will ensure that the reorganized entity emerges from bankruptcy with a strong HIPAA compliance program in place. The settlement with OCR was approved by the Bankruptcy Court on December 11, 2017.

The resolution agreement and corrective action plan may be found on the OCR website at http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/21CO/index.html.