Per the notice below, the United States Office for Civil Rights (OCR) has taken action under the Health Insurance Portability and Accountability act of 1996 (HIPAA) for a wellness entity failing to conduct a HIPAA risk analysis.  OCR is increasing enforcement of the obligation to conduct HIPAA risk analyses.

HHS’ Office for Civil Rights Settles HIPAA Security Rule Investigation with Health Fitness Corporation

Settlement Marks the 5^th Enforcement Action in OCR’s Risk Analysis Initiative

The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a settlement with Health Fitness Corporation (Health Fitness), located in Illinois, that provides wellness plans to clients across the country, resolving a potential violation under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule.  OCR enforces the HIPAA Privacy, Security, and Breach Notification Rules, which set forth the requirements that covered entities (health plans, health care clearinghouses, and most health care providers), and business associates – such as Health Fitness – must follow to protect the privacy and security of protected health information (PHI).  The HIPAA Security Rule establishes national standards to protect and secure our health care system by requiring administrative, physical, and technical safeguards to ensure the confidentiality, integrity, availability, and security of electronic PHI (ePHI).  The “Risk Analysis provision” requires a regulated organization to conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI held by that organization.

“Conducting an accurate and thorough risk analysis is not only required but is also the first step to prevent or mitigate breaches of electronic protected health information,” said OCR Acting Director Anthony Archeval.  “Effective cybersecurity includes knowing who has access to electronic health information and ensuring that it is secure.”

The settlement marks the fifth enforcement action in OCR’s Risk Analysis Initiative.  This enforcement initiative was created to focus select investigations on compliance with the HIPAA Security Rule Risk Analysis provision, a key Security Rule requirement, and the foundation for effective cybersecurity and the protection of ePHI; to increase the number of completed Security Rule investigations involving potential violations of the Risk Analysis provision; and to highlight the critical need for organizations to prioritize compliance with this foundational HIPAA Security Rule requirement.  The settlement resolves OCR’s investigation of Health Fitness, which OCR initiated after receiving four reports from Health Fitness, over a three-month period (October 15, 2018, to January 25, 2019), of breaches of unsecured protected health information.  Health Fitness filed the breach reports on behalf of multiple covered entities as their business associate.  Health Fitness reported that beginning approximately in August 2015, ePHI became discoverable on the internet and was exposed to automated search devices (web crawlers) resulting from a software misconfiguration on the server housing the ePHI.  Health Fitness discovered the breach on June 27, 2018.  Health Fitness initially reported that approximately 4,304 individuals were affected and later estimated that the number of individuals affected may be lower.  OCR’s investigation determined that Health Fitness had failed to conduct an accurate and thorough risk analysis, until January 19, 2024, to determine the potential risks and vulnerabilities to the ePHI held by Health Fitness.  Under the terms of the resolution agreement, Health Fitness agreed to implement a corrective action plan that OCR will monitor for two years and paid $227,816 to OCR.  Under the corrective action plan, Health Fitness committed to take steps to ensure compliance with the HIPAA Security Rule and protect the security of ePHI, including:

• Annually reviewing and updating as necessary its risk analysis to determine the potential risks and vulnerabilities to the confidentiality, integrity, and availability of its ePHI;
• Developing and implementing a risk management plan to address and mitigate security risks and vulnerabilities identified in its risk analysis;
• Implementing a process for evaluating environmental and operational changes that affect the security of ePHI; and
• Developing, maintaining, and revising, as necessary, certain written policies and procedures to comply with the HIPAA Privacy, Security, and Breach Notification Rules.

The resolution agreement and corrective action plan may be found at:  https://www.hhs.gov/sites/default/files/health-fitness-ra-cap.pdf.  OCR recommends that health care providers, health plans, health care clearinghouses, and business associates that are covered by HIPAA take the following steps to mitigate or prevent cyber-threats:

• Review all vendor and contractor relationships to ensure business associate agreements are in place as appropriate and address breach/security incident obligations.
• Integrate risk analysis and risk management into business processes regularly.
• Ensure audit controls are in place to record and examine information system activity.
• Implement regular review of information system activity.
• Use mechanisms to authenticate information to ensure only authorized users are accessing ePHI.
• Encrypt ePHI to guard against unauthorized access to ePHI.
• Incorporate lessons learned from incidents into the overall security management process.
• Provide training specific to organization and job responsibilities and on regular basis and reinforce workforce members’ critical role in protecting privacy and security.
  

The HHS Breach Portal: Notice to the Secretary of HHS Breach of Unsecured Protected Health Information may be found at: https://ocrportal.hhs.gov/ocr/breach/breach_report.jsf.  OCR is committed to enforcing the HIPAA Rules that protect the privacy and security of peoples’ health information.  Guidance about the Privacy Rule, Security Rule, and Breach Notification Rules, and the Security Rule’s Risk Analysis requirement, can also be found on OCR’s website.  If you believe that your or another person’s health information privacy or civil rights have been violated, you can file a complaint with OCR at: https://www.hhs.gov/ocr/complaints/index.html.