Avoiding Increased Risks and Liabilities under the Just Released HITECH/HIPAA Rules
By Stephanie Cason
The Health Information Technology for Economic and Clinical Health (“HITECH”) Act, enacted on February 17, 2009, was designed to promote the widespread adoption and standardization of health information technology. It supports this goal by adding amendments designed to strengthen the privacy and security protections of health information established by HIPAA and contained provisions that substantially expanded the HIPAA Privacy, Security, and Enforcement Rules. The U.S. Department of Health and Human Services (“HHS”) published proposed regulations (the “Proposed Rule”) that will implement modifications to the HIPAA Privacy, Security, and Enforcement Rules under the HITECH Act. The Proposed Rule was issued on July 8, 2010, and published in the Federal Register on July 14, 2010 with a 60-day comment period.
The HITECH Act and the Proposed Rule create a variety of new obligations for covered entities (“CEs”) and business associates (“BAs”) with some of the most significant changes being the expanded duties as well as penalties to which on BAs are now subject. The HITECH Act required that HIPAA’s Security and Privacy Rules, as well as other aspects of HIPAA, be extended to BAs in much the same way as they apply to CEs; and a variety of changes in the Proposed Rule make it clear that the standards, requirements, and implementation specifications of HIPAA are applicable to BAs. Prior to the HITECH Act, HIPAA applied to BAs only indirectly by way of the BA’s contractual obligations to the CE. Additionally, the penalties for violations of the BA’s obligations were limited to damages that resulted from any contractual breach (unless the BA also happened to be a CE). The HITECH Act and the Proposed Rule expand both the application of certain HIPAA requirements and penalties to BAs.
Additionally, the Proposed Rule expands the definition of “business associate,” to include, most significantly, subcontractors of BAs or “downstream business associates” who create, receive, or transmit protected health information (“PHI”). Subcontractors who meet this criterion are now themselves considered BAs, and are therefore required to enter into business associate agreements and are subject to direct liability under the HIPAA rules. The Proposed Rule additionally clarifies that CEs are required to enter into business associate agreements with their BA, but not directly with subcontractors. Instead, it is now the responsibility of the BA who engages the subcontractor to enter into a BA agreement with that subcontractor. The subcontractor business associate agreement must comply with the same requirements as agreements between CEs and BAs.
The HITECH Act has also put more teeth in HIPAA enforcement efforts by increasing civil penalties for HIPAA violations and, in certain cases, requiring formal investigations and mandatory penalties. HHS issued the Interim Final Rule (“IFR”), revising HIPAA to incorporate provisions required by the HITECH Act that immediately took effect and the Proposed Rule makes a variety of changes to facilitate this new penalty scheme. The new penalty scheme establishes four categories of violations that reflect increasing levels of culpability and the corresponding tiers of civil money penalty amounts. The Proposed Rule clarifies that HHS will investigate complaints when a review of the facts indicates a potential violation is due to willful neglect. If a violation is found to have occurred due to willful neglect, a penalty will be imposed.
If a HIPAA violation occurs, procedures must be in place to adequately respond. Legal counsel should also be used to ensure appropriate compliance with any requirements of HIPAA. The best way to prevent liability under the new requirements is a showing of past compliance. In order to do this, entities should take steps before a violation occurs to prevent violations and ensure that compliance is adequately documented.
In sum, the new HIPAA obligations imposed under the HITECH Act and the Proposed Rule seek to strengthen the privacy and security of PHI and the and effectiveness of HIPAA, and in doing so they expand obligations and liabilities to a wider range of entities. The Proposed Rule provides CEs and BAs with 180 days after the effective date of issuance of the final regulations to come into compliance with most of the new requirements. However, the final regulations will not likely differ significantly from the Proposed Rule and entities should familiarize themselves with the new rules and begin to prepare now for changes.
About the Author
Stephanie A. Cason is an associate at Powers Pyle Sutter and Verville. Her practice focuses on healthcare and education law and public policy. She received her Juris Doctor, cum laude, from the University of Michigan Law School. During law school, she served as selection committee member, publication committee member and administrative manager for the Michigan Journal of Gender and Law. She was also the technology manager of the Organization of Public Interest Students. Ms. Cason also holds an undergraduate degree in Political Science from Reed College where her senior thesis analyzed the USA Patriot Act.
Ms. Cason’s prior experience includes serving as a law clerk in the Federal Public Defender Office, a law clerk for Judge Katherine Tennyson in Portland, Oregon, and internships with the American Civil Liberties Union and the Oregon Law Center.

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