On March 21, 2025, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced a
settlement of
HIPAA security rule claims involving Health Fitness Corporation (Health Fitness). Health Fitness provides wellness plans to its clients across the country, and this settlement resolved a potential violation under the HIPAA Security Rule.
Health Fitness is subject to the HIPAA security rule by virtue of its status as a HIPAA business associate. The HIPAA security rule’s "risk analysis provision" requires a HIPAA business associate (or covered entity) 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.
The settlement marks the fifth enforcement action in OCR's Risk Analysis Initiative, and resolves OCR's investigation, which OCR initiated after receiving four reports from Health Fitness in 2018 and 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 for several years (until January 19, 2024), to determine the potential risks and vulnerabilities to the ePHI held by Health Fitness. It is particularly notable just how long ago (over 6 years) the initial breaches that led to this action occurred. A less to take away is that your work is not done when you report a breach. You need to continue to understand why the breach occurred and take (and document) steps to prevent that breach and others from occurring in the future.
Under the terms of the resolution agreement, Health Fitness agreed to implement a corrective action plan that OCR will monitor for two years and it 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.
It is never a bad time to renew your HIPAA risk assessment; there is a very useful tool that the HHS Assistant Secretary for Technology Policy (a/k/a HealthIT.gov) has created to help in that regard. In particular, OCR recommends that health care providers, health plans, health care clearinghouses, and business associates 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.
- Have 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.
- Incorporate lessons learned from incidents into the overall security management process.
- Provide training specific to your organization and its risks, and to individual job responsibilities on regular basis and reinforce workforce members' critical role in protecting privacy and security.
