The Office of Civil Rights of the U.S. Department of Health and Human Services (“HHS”) has published its first round of annual reports to Congress under the HITECH (Health Information Technology for Economic and Clinical Health) Act of 2009 to Congress. The first report concerns HHS’s HIPAA (Health Insurance Portability and Accountability Act of 1996) enforcement activity for 2009 and 2010 and the second report focuses on reported or recorded data breaches occurring in 2009 and 2010.  

The HITECH Act contains multiple breach notification requirements for HIPAA-covered entities and their business associates. Covered entities and business associates that create unreadable or indecipherable protected health information, however, are exempt from such requirements. Covered entities must notify individuals and the Secretary of HHS of any breach of unsecured protected health information within 60 days following the discovery of the breach. For breaches involving more than 500 residents of a state, a covered entity must also notify the media in addition to the individuals and the Secretary of HHS. Business associates of covered entities under HIPAA must notify the covered entity of any breach of unsecured protected health information so the covered entity can notify affected individuals. 

As reported by HHS, between September 23, 2009 and December 31, 2010, the HHS Office of Civil Rights received 45 reports of breaches affecting 500 individuals or more in 2009 and 207 reports in 2010, resulting in notification of 7.8 million affected individuals. 

The general causes of breaches of unsecured protected health information included, first and foremost, theft.  27 of the 45 large 2009 incidents involved theft and 17 of those incidents occurred on the premises of a covered entity or its business associates. Likewise, 99 of the 207 incidents in 2010 involved theft, primarily of electronic or paper records, affecting some 2,979,121 people. Types of theft noted by HHS included theft of back-up tapes transported by a vendor of a medical facility, of laptops or desk-top computers at covered entity sites, and of smart phones or flash drives. Other causes of breaches generally involved loss of electronic media or paper records containing protected health information, unauthorized access to, use of or disclosure of protected health information, human error, and improper disposal. Notably, loss of portable electronic devices is a major factor in the loss of electronic media.

With respect to complaints and compliance with HIPAA’s Privacy Rule, HHS reports that from April 14, 2003, the date HIPAA-covered entities were to comply with the Privacy Rule, through December 31, 2010, it received 57,375 complaints and resolved 91% of them.   Through the same time period, HHS investigated 19,161 complaints, achieved corrective action in 66% of them and found no violation in 34%. 

HHS further reports that between April 20, 2005, and December 31, 2010, it investigated 289 complaints of the 803 it received related to HIPAA’s Security Rule, resolving 77% of them and finding no violation in 48%. 

The compliance issues related to the Privacy Rule most investigated included impermissible uses and disclosures of protected health information, lack of safeguards, and denial of individual access. HHS Security Rule investigations focused on a covered entity’s failures to demonstrate adequate policies and procedures to address response or reporting of security incidents, security training, access controls and workstation security.  

The two HHS reports to Congress show a marked improvement in compliance with HIPAA’s Privacy Rule. However, the reports also highlight a continuing vulnerability for covered entities that rely on electronic devices and employee accountability for elements of their privacy and security compliance programs under HIPAA (as we have touched on in previous posts). As noted by HHS, remedial actions for violations include revising policies and procedures; improving physical security; training or retraining workforce members; adopting encryption technologies; changing passwords; performing new risk assessments; and revising business associate agreements to specify required confidentiality protections. The HHS reports remind covered entities and their business associates to review and place appropriate limits on employee access to protected health information and incorporate HHS’s remedial measures into their best practices.