Category: HHS/OCR



$4 Million Judgment Awarded to Office for Civil Rights for HIPAA Violation

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A U.S. Department of Health and Human Services (HHS) Administrative Law Judge (ALJ) has ruled that the University of Texas MD Anderson Cancer Center violated the Health Insurance Portability and Accountability Act of 1996 (HIPAA) in its failure to encrypt its electronic devices and ordered MD Anderson to pay $4,348,000 in civil monetary penalties  to the Office for Civil Rights (OCR). This is the second summary judgment ordered in favor of the OCR in its history, and the fourth largest amount recovered by OCR for HIPAA violations.

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Involuntary Dissolution Does Not Absolve Business Associate of HIPAA Obligations

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A receiver appointed to liquidate the assets of Filefax, Inc. has agreed to pay $100,000 to the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) in a no-fault settlement regarding potential violations of the Health Insurance Portability and Accountability Act (HIPAA).

Filefax, an entity involuntarily dissolved by the Illinois Secretary of State in August 2017, previously provided services to HIPAA covered entities, including storage, maintenance, and delivery of medical records.  On February 10, 2015, OCR received an anonymous complaint alleging that an individual had transported medical records obtained from Filefax to a shredding and recycling facility to sell on February 6 and 9, 2015.  OCR investigated the matter and confirmed that an individual had left medical records that contained the protected health information (PHI) of approximately 2,150 patients at the shredding and recycling facility.  OCR’s investigation indicated that Filefax had either left the PHI in an unlocked truck in its parking lot or granted permission to an unauthorized person to remove the PHI from Filefax, and left the PHI unsecured outside of the Filefax facility.

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OCR Kick Starts 2018 with Severe $3.5 Million HIPAA Settlement and Corrective Action Plan

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Fresenius Medical Center North America (FMCNA) agreed to pay $3.5 million to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and adopt a two-year comprehensive corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA).

The no-fault resolution agreement states that FMCNA reported five separate incidents that occurred between February 23, 2012 and July 18, 2012 at five distinct FMCNA facilities (FMCNA Covered Entities).  FMCNA provides centralized corporate support to the FMCNA Covered Entities, including storing patient’s medical records, creating and disseminating HIPAA policies and procedures, and investigating the circumstances surrounding each breach reported to it by the FMCNA Covered Entities.

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Oncology Services Provider Reaches $2.3 Million Settlement with HHS for Data Breach

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21st Century Oncology, Inc. (21CO), a Florida-based oncology services provider, has agreed to pay $2.3 million in a no-fault resolution to the Department of Health and Human Services (HHS), Office for Civil Rights (OCR) to settle potential civil money penalties stemming from a 2015 cyberattack on its network SQL database.  The Federal Bureau of Investigation (FBI) was first to detect that an unauthorized third party illegally obtained patient information from 21CO in October 2015.  Upon further investigation by 21CO and OCR, it was determined that 21CO:

  • Impermissibly disclosed the protected health information (PHI), including names, social security numbers, and diagnoses, and treatments, of 2,213,597 of its patients.   
  • 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.   
  • Disclosed protected health information to  third party vendors, acting as its business associates, without obtaining satisfactory assurances in the form of a written business associate agreement.

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Recent OCR Action Provides HIPAA Guidance Related to Opioid Crisis and Privacy Rule in Research

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The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) recently released several new tools and guidance to ensure that patients and their family members can gain access to information needed to prevent and address opioid abuse and overdose, as well as mental health crises. The materials are focused on the Health Insurance Portability and Accountability Act (HIPAA) and also serve to fulfill certain clarification requirements on HIPAA and research under the 21st Century Cures Act (the “Cures Act”).  The Cures Act was passed by Congress in 2016 and requires, in part, that “health care providers, professionals, patients and their families, and others involved in mental [health] or substance use disorder treatment have adequate, accessible, and easily comprehensible resources relating to appropriate uses and disclosures of protected health information (PHI) under . . . [HIPAA].”

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A Bipartisan Effort to Focus on Healthcare Cybersecurity

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House Energy and Commerce Committee members Reps. Billy Long (R-Mo.) and Doris Matsui (D-Calif.) introduced the HHS Cybersecurity Modernization Act earlier this month in a bipartisan effort to address cybersecurity threats to the Department of Health and Human Services (HHS).  Representatives Long and Matsui have both described the bill, H.R. 4191, as a stepping-stone towards improving cybersecurity at HHS and the health care industry at large. However, the bill does not authorize any additional appropriations to do so.

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