Threats to PHI are coming fast and furious. Although many organizations are ready to take HIPAA compliance seriously, it requires sustained attention and resources for organizations to protect PHI. That can't happen if privacy and security officers aren't being heard by the board and senior leaders.
In July, OCR announced it reached a HIPAA breach settlement with Oregon Health and Science University (OHSU), an academic health center. In its statement on the settlement, the agency drew attention to the vital role hospital executives and senior leaders play in HIPAA compliance. OHSU did complete risk analyses and identify vulnerabilities, including those that caused the two massive breaches named in the settlement, but no action was taken to mitigate these vulnerabilities. Without support from the top, OHSU's security risks remained unaddressed until it was too late. Failure to address these risks came with a $2.7 million price tag, a strict three-year corrective action plan, and the kind of bad press that's difficult to put a positive spin on.
Privacy and security officers need executive support, but obtaining it may be a challenge. Alliances with key staff and an understanding of the concerns senior leaders face can be a win for privacy and security in the boardroom.
Growing threats to PHI, particularly ransomware, have drawn attention to privacy and security this year. Senior leaders and members of the board may be feeling the pressure to change the way their organizations operate and step up security measures.
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 monetary 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 been raised 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 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."
Q: Can I leave a patient a voicemail about an MRI procedure, including the time and date? What should I do if someone else at the patient's home answers the phone? How much info can I leave with the other person, and how can I verify that person's identity and relation to the patient?
Q: If my medical waste includes PHI, do I need a BAA with our waste management vendor?
A: Yes. For example, clinics and hospitals contracting with bio-waste disposal vendors that dispose of IV bags execute a BAA with the bio-waste disposal vendors. It's no different than the requirement to execute a BAA with a document shredding vendor. If the vendor will come in contact with PHI, a BAA is in order.
Editor's note: Apgar is president of Apgar & Associates, LLC, in Portland, Oregon. He is also a BOH editorial advisory board member. This information does not constitute legal advice. Consult legal counsel for answers to specific privacy and security questions. Opinions expressed are that of the author and do not represent HCPro or ACDIS. Email your HIPAA questions to Associate Editor Nicole Votta at nvotta@hcpro.com.
Hackers and malware are routine threats for most healthcare organizations, but this year saw criminals add a devastating tool to their arsenal: ransomware.
Although the dramatic increase in ransomware attacks against healthcare organizations is largely a recent phenomenon, ransomware itself is not new. According to the FBI, it's been around for several years, but the agency began to see an uptick in ransomware attacks in 2015, particularly against organizations. Early this year, the Department of Defense specifically warned healthcare organizations that they are a top target for ransomware. As ransomware continued to grab headlines and lawmakers called for official action, HHS released ransomware response and prevention guidance for healthcare organizations (www.aha.org/content/16/160620cybersecransomware.pdf).
State and federal lawmakers took notice as well. At a March 22 joint hearing of the House of Representatives subcommittees on Information Technology and Health Care, Benefits, and Administrative Rules, some lawmakers suggested HIPAA should be modified to specifically require covered entities and business associates to report ransomware attacks.
Security officers must act now to protect their organizations, and in turn, organizations must be prepared to invest in security and carefully follow related policies. The price for failing to do so could be high.