OCR ramps up HIPAA enforcement efforts
The Office for Civil Rights (OCR) stepped up HIPAA enforcement in a big way this year. The agency handed down more than $ 5 million in HIPAA settlement fines in one week in March, and in July reached a HIPAA violation settlement with Advocate Health Care in Illinois that carried a $ 5.55 million payment. OCR kicked off phase two of its HIPAA Audit Program and will likely complete desk audits of covered entities (CE) and business associates (BA) by the end of the year. Comprehensive on-site audits may occur early in 2017.
However, breaches continue to come at a relentless pace and questions have arisen about OCR’s handling of HIPAA violations, particularly repeat HIPAA offenders. And a truly permanent HIPAA audit program may not yet be in sight: OCR states that phase two audits will help the agency plan for a permanent audit program but doesn’t state when that might launch.
In a September 2015 report (https://oig.hhs.gov/oei/reports/oei-09-10-00510.pdf), the Office of Inspector General (OIG) said OCR?and the U.S. Department of Health and Human Services (HHS) as a whole?should strengthen its oversight of CEs and be proactive rather than reactive in its approach to HIPAA enforcement. The report found that in 26% of closed privacy cases, OCR did not have complete documentation of corrective actions taken by CEs. In addition, OCR’s case tracking system has significant limitations and makes it difficult for the agency’s staff to check if a CE under investigation has been the subject of previous investigations.
All of this may make some CEs and BAs feel that HIPAA compliance is merely optional, and that leads to a weaker privacy and security culture throughout the industry. Although OCR does take action to make its presence felt, it could do more, Frank Ruelas, MBA, principal of HIPAA College in Casa Grande, Arizona, says.
"I do believe that OCR is trying to let people know that it considers HIPAA compliance an important objective," he says. "With its guidance and ongoing alerts about the occasional enforcement actions here and there, I see OCR’s enforcement a small step above being a paper tiger in terms of how seriously people take it."
The waiting game
The OIG’s September 2015 report wasn’t the first time that agency has found fault with HHS and OCR’s methods, Kate Borten, CISSP, CISM, HCISSP, founder of The Marblehead Group in Marblehead, Massachusetts, says.
"OIG has published a number of reports over the years, identifying problems with HHS’ oversight and enforcement of these HIPAA rules," she says. "I know of no one in the profession who reads the OIG reports and disagrees."
But HHS and OCR have been slow to take action. More than five years passed between the end of phase one of the HIPAA Audit Program and the announcement of phase two, and OCR still has obligations it’s failed to fulfill. The agency’s slow pace may lead some to take it, and HIPAA, less seriously.
"Since the latest round of rule changes back in 2010, over six years ago, there are still outstanding rules and unmet commitments by HHS and OCR," Ruelas says. "In the end, it not only erodes credibility but also questions just how seriously is OCR taking its enforcement duties."
Another day, another fine
HHS and OCR regularly announce breach settlements, but 2016 saw a flurry of high-profile and costly settlements. OCR took the opportunity to make examples of a number of CEs and BAs in its statements, calling attention to the particular violations that tipped the settlements into the hundreds of thousands, or even millions, of dollars.
Although the settlements grab attention and headlines, it may be difficult to determine their positive impact. Some of the HIPAA violations in question date back years. Staff who worked at the organization, and may have been involved in the breach, are likely gone. Even administrators, executive leaders, and owners may change in that time. Some organizations may see OCR’s enforcement actions as too little, too late, Mac McMillan, FHIMSS, CISSM, cofounder and CEO of CynergisTek, Inc., in Austin, Texas, says.
"We all want the same thing: to see our industry do better," he says. "This is just more of the same old, same old. Same issues, different players."
A HIPAA settlement fine might be a crushing blow to a physician practice or small home health or physical therapy organization, but even the largest fines might not make an appreciable impact on larger organizations, McMillan says.
"To be really impactful, there will probably need to be more, they will need to happen closer to the actual event they’re related to, and possibly the fines will need to be bigger," he says. "The fines levied were really not substantial fiscally, and there was no accountability for those responsible for making security decisions, so they pay and move on."
Borten agrees that the long period of time between when a breach is reported and when OCR takes action lessens the impact. "The response or punishment must rapidly follow the event to have a significant impact on future behavior," she says.
Although some find California’s short breach notification timelines and black and white faxing rules burdensome, these measures have caused CEs and BAs to change their behavior and improved privacy and security, McMillan says.
Some CEs and BAs may be willing to take the chance they won’t be caught, Ruelas says. "I truly think that people see enforcement a lot like getting hit by lightning. However, if it does occur, it tends to be a game changer and does make for an interesting day."
But whether the change is meaningful or widespread may be difficult to determine, and any alteration to OCR’s HIPAA enforcement practices would likely be an improvement, he adds.
Learning from others’ mistakes
However, CEs and BAs can get something out of HIPAA settlements. Conscientious entities will fulfill the terms of the corrective action plan and even improve on it. And other CEs and BAs can take valuable lessons from OCR’s breach announcements. The agency often draws attention to specific issues that led to the breach, levies a pricey fine, and points out how the organization could have avoided the problem in the first place.
"HIPAA enforcement actions are important teaching tools," Borten says. "Workforce members can be asked if the same problem could arise in their organization, and how individuals can avoid the same fate."
Many privacy or security failures that lead to breaches are the result of human error and are still relevant regardless of when the breach occurred, she adds.
Although the security landscape has expanded beyond missing laptops and smartphones, Ruelas says there’s still a lot CEs and BAs can learn from these enforcement actions. Organizations may see ransomware, phishing, and privacy and security breaches on social media as the biggest threats?and rightly so. Yet many breaches still come down to 10-year-old HIPAA basics: misdirected faxes, incorrectly addressed emails, or handing the wrong documents to a patient.
While human error is still a concern, McMillan is most worried about the increasing number of breaches due to hacking, particularly the greater loss of data due to hacking and the effects such breaches have on the industry. "Human errors are still an issue, but the relative impact of those incidents compared to the impacts we see from hacking recently pales in comparison. Many of those attacks were the result of misconfigured or poor administration of systems resulting in serious outages and millions of lost records," McMillan says. "This is where OCR needs to focus attention."
The launch of phase two of the HIPAA Audit Program may promise some positive change. The audits are intended to help the agency improve HIPAA guidance and tools and pinpoint common problems and challenges CEs and BAs face. Desk audits of CEs began in July, with BAs scheduled to follow in the fall. However, it may take 90 days after submitting documents for CEs to receive a draft audit report. Until then, it will be difficult to predict what OCR’s response to the audits might be.
The audit reports will not be made public, although OCR representatives indicated they will likely be available through a Freedom of Information Act request. Sharing some data might help CEs and BAs.
"I do think that if audit results can somehow be summarized and shared, just by their detailed nature, the audits can be wonderful sources of information for the HIPAA community," Ruelas says.
It took three years for the agency to update the audit protocols to reflect changes made by the HIPAA omnibus rule, he adds. It’s too soon to tell how long it might take the agency to revise or refocus its guidance based on the results of the phase two audits, but it would no doubt be beneficial for all CEs and BAs to see results sooner rather than later.
Establishing a permanent audit program is one of OCR’s responsibilities under HIPAA, and the agency’s failure to develop one has drawn criticism from the industry and from other regulatory agencies such as the OIG. OCR agreed with the OIG’s latest call for a permanent audit program. Phase two is an encouraging step in that direction, but still not quite enough.
"It has been very vocal on its commitment to establishing an effective and permanent auditing program," Ruelas says. "Let’s see if it really is going to walk the talk."