On Friday, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced the fifth enforcement action under its Risk Analysis Initiative. In this case, OCR reached a settlement with Health Fitness Corporation (Health Fitness), a wellness vendor providing services to employer-sponsored group health plans.
This announcement is interesting for several reasons. It furthers the OCR’s Risk Analysis Initiative. The enforcement action is a reminder to business associates about HIPAA compliance. The development also points to a significant development under ERISA for plan fiduciaries and service providers to their plans.
The OCR Risk Analysis Initiative
Anyone who takes a look at prior OCR enforcement actions will notice several trends. One of those trends relates to enforcement actions following a data breach. In those cases, the OCR frequently alleges the target of the action failed to satisfy the risk analysis standard under the Security Rule. This standard is fundamental – it involves assessing the threats and vulnerabilities to electronic protected health information (ePHI), a process that helps to shape the covered entity or business associate’s approach to the other standards, and goes beyond a simply gap analysis.
“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.”
For those wondering how committed the OCR is to its enforcement initiatives, you need not look further than its Right to Access Initiative. On March 6, 2025, the agency announced its 53rd enforcement action. According to that announcement, it involved a $200,000 civil monetary penalty imposed against a public academic health center and research university for violating an individual’s right to timely access her medical records through a personal representative.
The DOL Cybersecurity Rule
Businesses that sponsor a group health plan or other ERISA employee benefit plans might want to review the OCR’s announcement and resolution agreement concerning Health Fitness a little more carefully. In 2024, the DOL’s Employee Benefits Security Administration (EBSA) issued Compliance Assistance Release No. 2024-01. That release makes clear that the fiduciary obligation to assess the cybersecurity of plan service providers applies to all ERISA-covered employee benefit plans, including wellness programs for group health plans.
OCR commenced it investigation of Health Fitness after receiving four reports from Health Fitness, over a three-month period (October 15, 2018, to January 25, 2019), of breaches of PHI. According to the OCR, “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.” Despite these breaches, according to the OCR, Health Fitness had failed to conduct an accurate and thorough risk analysis, until January 19, 2024.
For Health Fitness, it agreed to implement a corrective action plan that OCR will monitor for two years and paid $227,816 to OCR. For ERISA plan fiduciaries, an important question is what they need to do to assess the cybersecurity of plan service providers like Health Fitness during the procurement process and beyond.
We provide some thoughts in our earlier article and want to emphasize that plan fiduciaries need to be involved in the process. Cybersecurity is often a risk left to the IT department. However, doing so may leave even the most ardent IT professional ill equipped or insufficiently informed about the threats and vulnerabilities of the particular service provider. When it come to ERISA plans, this means properly assessing the threats and vulnerabilities as they relate to the aspects of plan administration being handled by the service provider.
Third-party plan service providers and plan fiduciaries should begin taking reasonable and prudent steps to implement safeguards that will adequately protect plan data. EBSA’s guidance should help the responsible parties get there, along with the plan fiduciaries and plan sponsors’ trusted counsel and other advisors.