On Sept. 17, 2012, HHS announced its fourth HIPAA settlement of the year, reaching a resolution agreement with Massachusetts Eye and Ear Infirmary and Massachusetts Eye and Ear Associates, Inc. (collectively, “MEEI”) for $1.5 million and requiring a three-year corrective action plan with external monitoring. Also this week, HHS released an online security game, aimed at assisting small practices in training their employees on information security.
Some lessons to take from these announcements:
- Security for portable devices requires special attention. Don’t forget laptops, tablets, mobile phones, PDAs, and the like in both the risk analysis and the resulting policies, procedures, and processes.
- "Bring your own device" is a challenge for all organizations. Remember to include such devices in risk analyses and risk management.
- It is not just the breach, but what is revealed in the subsequent investigation. We have seen relatively minor breaches result in significant penalties because of allegedly inadequate underlying risk assessments or safeguards.
- Revisit—or perform—and document the risk analysis required under the Security Rule. The risk analysis is the heart of effective HIPAA security compliance, yet it often is forgotten.
- Document risk management determinations that result from the risk analysis.
- Training need not be limited to boring slide shows, and HHS has a variety of available resources to assist with compliance.
The resolution with MEEI is the second OCR financial settlement with a Harvard-affiliated teaching institution—OCR must not be a fan of the Crimson. The settlement relates to the February 2010 theft of an unencrypted laptop. A physician affiliated with MEEI was lecturing in South Korea when his personal laptop was stolen, containing protected health information of about 3,500 patients/research participants. Of note, the laptop allegedly was password protected and contained a “LoJack” tracking device that indicated that, after the theft, a new operating system was installed and software needed to access the PHI was not installed. When it was determined that the laptop could not be retrieved, its hard drive was remotely wiped. Accordingly, the risk from the breach seems very low.
What the HHS Office for Civil Rights (“OCR”) investigation revealed, however, is that MEEI allegedly did not have an adequate risk assessment or safeguards in place with respect to electronic PHI that is created, received, transmitted, or maintained on portable devices. As a result, OCR obtained a $1.5 million settlement, including a resolution agreement and a three-year corrective action plan with external monitoring (which represents a substantial additional cost to MEEI).
After the recent settlement with the Alaska Department of Health and Social Services, this is the second million-dollar-plus settlement in which a relatively minor breach that was reported to HHS led to allegations of an inadequate risk assessment and corresponding safeguards. In response to the MEEI settlement, covered entities (and business associates) may want to ask themselves: (1) what is the risk that an employee, contractor, or other authorized user will download PHI onto a personal mobile device and what controls can be put in place to manage this risk (e.g., policies, training, sanctions, audit log monitoring, and technical safeguards such as data loss prevention technology); and (2) has this question, and similarly detailed risk questions, been documented in an enterprise-wide risk analysis and risk management plan?
On the lighter side, HHS released an interactive, online security game to assist small practices with training their employees on information security. The game involves a virtual physician practice, which grows (new TV in the break room!) or loses patients and resources depending on whether you can guide its staff through a series of security questions. It is not a substitute for a robust security training program, but it certainly may be worth circulating among the workforce and encouraging its use. More importantly, it’s a good reminder that training need not be an entirely painful experience. Combined with other government resources, such as the NIST Security Checklist, the recently published audit protocol, and videos of state attorney general training sessions, there is a wealth of free resources to aid small providers with compliance efforts.