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Security, Privacy and Information Governance

Category: HHS



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.

In addition to the fine, 21CO agreed to enter into a two-year corrective action plan (CAP) with HHS-OCR whereby 21CO agrees to:

  • Appoint a compliance officer.
  • Complete a risk analysis and risk management plan.
  • Revise and adopt policies and procedures.
  • Provide HHS with an accounting and copies of its business associate agreements.
  • Conduct internal and external monitoring.
  • Create an internal reporting mechanism for workforce members to report violations of 21CO’s policies and procedures.
  • Submit to HHS an annual report for the duration of the CAP that summarizes its compliance with the aforementioned requirements.

This resolution and corrective action plan is the first OCR-HIPAA compliance enforcement action since May 2017.   It underscores the importance of having a robust HIPAA compliance program that properly assesses vulnerabilities and mitigates them to a reasonable and appropriate level.  The settlement was approved by the United States Bankruptcy Court for the Southern District of New York on December 11, 2017. 21CO has 136 centers located across 17 states and 36 centers in seven Latin American countries and had petitioned for bankruptcy on May 25, 2017,

The OCR settlement comes on the heels of two other major settlements for 21CO.  On March 8, 2016, 21CO entered into a settlement agreement with the U.S. Department of Justice (DOJ) for $34.7 million over a billing fraud case, and most recently settled with the DOJ on December 12, 2017 for $26 million to settle  False Claims Act allegations.   

If you have questions about HIPAA compliance or health care fraud and abuse matters, please feel free to contact any member of Drinker Biddle’s Health Care Team.

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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Investigation Continues After Massive Data Breach at Henry Ford Health System

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An unknown hacker gained access to 18,470 patients’ personal health information via employee emails at Detroit-based Henry Ford Health System (HFHS).

According to the press release, HFHS first learned of the incident on October 3, 2017, after becoming aware that the email credentials of a group of employees were compromised.  Even though the emails were name and password protected by encryption, they remained vulnerable to such illegal access.  The email accounts contained patient health information, including:

  • Patient name
  • Date of birth
  • Medical record number
  • Provider’s name
  • Date of service
  • Department’s name
  • Location
  • Medical condition
  • Health insurer

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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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Latest OCR Reminder Regarding Mobile Device Security and PHI

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With the ever-increasing use of mobile devices in the workplace that create, receive, maintain, and transmit electronic protected health information (ePHI), the Department of Health and Human Services (HHS), Office for Civil Rights (OCR)’s latest Cybersecurity Newsletter issued an important reminder of the importance of mitigating the risks surrounding the use of mobile devices.

Mobile devices pose unique security risks because of their portability, small physical size, and capacity to store vast amounts of data. Both the Federal Trade Commission (FTC) and OCR frequently remind all organizations, but especially those entities that process ePHI, of the importance of protecting data on mobile devices.

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OCR’s Guidance on HIPAA-Permissible Information Sharing During Patient Opioid Crisis

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In response to President Trump’s call to action on opioids, acting Department of Health and Human Services (HHS) Secretary Eric D. Hargan declared the opioid crisis a national public health emergency on October 26, 2017.  The next day, HHS-Office for Civil Rights (OCR) released new guidance on when and how health care providers can share a patient’s health information with the patient’s family and close friends during certain crisis situations, such as opioid overdoses, without violating the Health Insurance Portability and Accountability Act (HIPAA) privacy regulations.

HIPAA prohibits health care providers from sharing protected health information about patients who have capacity to make their own health care decisions and object to information sharing, unless there is a serious and imminent threat of harm or safety.  However, health care professionals may disclose some health information without a patient’s permission under certain circumstances, including:

  • Sharing health information with family, close friends, or any other person identified by the patient, and involved in caring for the patient if the provider determines that doing so is in the incapacitated or unconscious patient’s best interests and the information is directly related to the family or friend’s involvement in the patient’s health care or payment for care. The provider may use professional judgment and experience with common practice to make reasonable inferences of the patient’s best interest.
  • Informing persons in a position to prevent or lessen a serious or imminent threat to the patient’s health or safety.

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