The HIMSS Annual conference is an amazing event. It brings together many thought leaders in the healthcare industry and regulatory bodies once per year in a forum of knowledge transfer and demonstration that is totally unequaled.
RISC Management attended presentations by Leon Rodriguez, Director of the Office for Civil Rights of the Department of Health and Human Services, Susa
n McAndrew, deputy director for health information privacy, and David Holtzman, OCR’s health information privacy and enforcement specialist. The presentations included a significant amount of information related to the recently-released HIPAA Omnibus Rule, even though HIMSS presentations were submitted six months ago, long before the Omnibus Rule was published.


David Holtzman of the Office for Civil Rights discussed a number of the recent settlement agreements and enforcement actions against organizations, and the reasoning behind some of the significant fines and terms of the agreements. Some quotes worth noting for Covered Entities, Business Associates, and for “conduits” that have traditionally felt that they were not Business Associates are among the following. There were many more of great relevance during Holtzman’s engaging presentation:
Regarding the settlement agreement with Alaska’s DHSS, Holtzman said that the penalty resulted from, “…a systemic failure to implement a coordinated program.” In further detail regarding the Alaska DHSS settlement, the previous day Director Rodriguez indicated that the fine was such a significant amount because of the continued activities of the organization even after the breach was noticed, and that behavior was not modified immediately upon noticing that the breach had occurred. This clearly indicates the expectation of the OCR that an organization modify the behavior or condition that caused a breach as soon as possible after the breach has been identified, not months later when OCR is investigating.
Regarding the settlement with The Hospice of Northern Idaho, Holtzman stated that, “When OCR contacted The Hospice of Northern Idaho, there were no activities put into place regarding policies, procedures, or actions to address the Security Rule, and in 2011 and 2012 we could just not walk away from that.” This was a clear statement to the fact that OCR has an expectation from the industry at this point. That remaining ignorant of the requirements, or choosing to ignore them, is no longer acceptable. Further, Holtzman said, regarding the evident lack of Risk Analysis being performed across the industry, [that there is] “an expectation that every Covered Entity will have engaged in a Risk Analysis process.” The OCR simply will not accept the lack of a formal risk analysis at this point, as the presentation returned to again and again. Blue Cross Blue Shield (BCBS) of Tennessee was also commented on by Holtzman for failing to conduct a Risk Analysis after a change in their environment. This tells us that the expectation is there, as the original law indicated, that a Risk Analysis be conducted both periodically and whenever the environment and technology changes.
Please make sure your organization understands where it falls today with regards to legal standing, for example all of those “Conduit” organizations that have denied being Business Associates for years now, as well as where it’s risks and vulnerabilities are to PHI and ePHI. OCR’s recent job postings that both replace promoted members of the enforcement team, as well as increase the size of the enforcement team provide a clear indication of increased vigilance.
This information provided by RISC Management and Consulting, http://www.RISCsecurity.com
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