While HIPAA’s recently enhanced penalty provisions and newly enacted security breach notification 
requirements have each received a significant amount of attention, the connection between them and its significant implications for employers and health care providers subject to HIPAA have not. Most significantly, because of the enhanced penalties, it is critical that covered entities conduct a careful and documented risk assessment before deciding not to provide notice of a security incident.
HIPAA’s recently promulgated security breach notification regulations require notice only if (a) there has been access to, or acquisition, use or disclosure of, protected health information (PHI) in violation of the HIPAA Privacy Rule; and (b) that violation “poses a significant risk of financial, reputational or other harm” to the subjects of the PHI. In the preamble to the security breach regulations, the U.S. Department of Health and Human Services (HHS) takes the position that a covered entity “will need to perform a risk assessment” to determine whether the second element of the notification standard has been satisfied. Besides identifying four factors that covered entities might consider in conducting this risk assessment, HHS provides no other guidance on how to assess risk. HHS does emphasize, however, that “[c]overed entities and business associates must document their risk assessments, so their they can demonstrate, if necessary, that no breach notification was required.” In other words, covered entities should expect that if HHS ever challenges a decision not to provide notice of a security breach, HHS’ first request will be for production of the covered entity’s risk assessment that decision.
The decision whether to provide notice of a security breach could be momentous for a covered entity. Under HIPAA’s security breach notification regulations, if the incident involves more than five hundred individuals in the same state, the covered entity would be required to report the breach to HHS, which will post the report on its Web site and notify “prominent media outlets,” which may choose to publicize the breach. As a result, notification of even a relatively small breach could expose the covered entity to class action litigation, damaging media coverage, and collateral damage to patient or employee relationships, in addition to the cost of providing notice and incident response services to affected individuals. Given these potential adverse consequences, a covered entity often will have an overriding interest in finding that a HIPAA violation did not create a material risk of harm and, therefore, does not require notification.
However, HIPAA’s enhanced penalties substantially increase the potential exposure to a covered entity that decides not to provide notification without first conducting and documenting a credible assessment of the risk to individuals arising from the security incident. Under the new penalty scheme, HHS must impose a penalty upon finding that a covered entity’s HIPAA violation resulted from “willful neglect.” “Willful neglect” means “conscious, intentional failure or reckless indifference to the obligation to comply with the regulation that is the target of the complaint." HHS likely would find that failing to notify individuals of a security breach without conducting a risk assessment or basing a decision on a superficial risk assessment constitutes “willful neglect.”
A finding by HHS of “willful neglect” would trigger exposure to substantial penalties. In that case, the penalty would ranger from a minimum of $10,000 per violation to a maximum of $50,000 per violation if the violation (i.e., the failure to notify affected individuals of the security breach) is corrected within 30 days of notice from HHS, and a minimum of $50,000 per violation and a maximum of $1.5 million per violation if the violation is left uncorrected. Moreover, HIPAA’s amended enforcement provisions, and recently proposed regulations construing those amendments, provide HHS with substantial discretion in determining what constitutes a violation. If HHS were to determine, in the context of a security breach, that each person who did not timely receive a notice is one violation, or that one violation is each day that notice to affected individuals was improperly delayed, the potential penalties could run into the millions of dollars. While to date, HHS has not imposed a single civil monetary penalty, the agency’s statutory authority to impose multi-million dollar penalties provides it with substantial leverage in negotiating settlements with alleged violators of HIPAA. HHS recently demonstrated its new-found muscle when it announced, on July 27, 2010, a $1 million settlement with a covered entity that allegedly did not properly dispose of PHI.
By contrast, a covered entity that conducts a credible risk assessment in good faith likely would have no exposure for any penalties. The recently proposed revisions to HIPAA’s Enforcement Rule bar HHS from imposing a penalty if the covered entity demonstrates that the violation did not result from willful neglect and was promptly corrected after the covered entity knew, or should have known, of the violation. This means that if a covered entity based a decision not to provide notice on a credible risk assessment, it likely would have no exposure for a civil monetary penalty, even if HHS were to disagree with the entity’s decision. Thus, HHS would have no leverage to extract a monetary settlement — as long as the covered entity provided notice to affected individuals promptly after being informed of HHS’ disagreement with the results of the covered entity’s risk assessment.
Because security incidents typically are investigated and evaluated under substantial time pressure, covered entities should consider obtaining, and familiarizing themselves with, a risk assessment tool before they are confronted with a security incident. One example of such a risk assessment tool is a software application called RADAR (Risk Assessment, Documentation and Reporting) recently released by ID Experts, a firm specializing in comprehensive data breach solutions for healthcare. More information about RADAR is available here.
This entry was written by Philip L. Gordon.
Photo credit: Randy Plett
On August 4, we posted about uncertainty created by the U.S. Department of Health and Human Services' (HHS) decision to withdraw its interim final regulations addressing security breach notification for breaches that involve protected health information (PHI) subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Since that time, HHS updated its website to state that, "[u]ntil such time as a new final rule is issued, the Interim Final Rule that became effective on September 23, 2009, remains in effect." This means that the harm standard embodied in the Interim Final Rule is still in effect and that, until further notice, employers and providers must conduct the risk assessment discussed in our July 30 blog post. 
The U.S. Department of Health and Human Services (HHS) published on July 14, 2010, a voluminous Notice of Proposed Rulemaking (NPRM), containing dozens of proposed amendments to three sets of Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulations: the Privacy Rule; the Security Rule; and the Enforcement Rule. The proposed amendments are directed principally at implementing the Health Information Technology for Economic and Clinical Health Act (HITECH Act), which amended HIPAA and wen into effect on February 17, 2010. A careful review of the NPRM for its impact on employers who sponsor HIPAA-covered plans reveals that, if the proposed changes were adopted, employers would be required to revise their business associate agreements, their HIPAA notice of privacy practices, and their policies for responding to access requests. The NPRM also provides employers with a roadmap for avoiding civil monetary penalties. To learn more about the NPRM and its implications for employers, please continue reading Littler's ASAP, 
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