HHS Reports to Congress highlight HIPAA Compliance and Breach Activities
On June 11, 2014, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) issued two reports to Congress summarizing activities in calendar years 2011 and 2012. The Annual Report to Congress on Breaches of Unsecured Protected Health Information (the Breach Report) and the Annual Report to Congress on HIPAA Privacy, Security, and Breach Notification Rule Compliance (the Compliance Report) are mandated as part of the Health Information Technology for Economic and Clinical Health (HITECH) Act. The Breach Report and the Compliance Report demonstrate the continued attention of HHS on HIPAA issues and the importance of covered entities and business associates ensuring adherence to HIPAA.
The Breach Report provides an excellent overview of the HITECH Act requirements when there is a breach of unsecured protected health information (PHI) and the notice requirements. Following are several highlights from the Breach Report:
- In 2011, OCR received 236 reports of breaches involving 500 or more individuals, which affected over 11 million individuals;
- Healthcare providers accounted for 150 or 63% of the breaches involving 500 or more individuals in 2011, affecting almost four million individuals, and business associates accounted for 63 or 27% of the breaches involving 500 or more individuals in 2011, affecting more than seven million individuals;
- Paper (65 reports) and laptop computer (48 reports) were the two most common PHI locations in 2011 for breaches involving 500 or more individuals.
- In 2012, OCR received 222 reports of breaches involving 500 or more individuals, which affected over three million individuals;
- Healthcare providers accounted for 150 or 68% of the breaches involving 500 or more individuals in 2012, affecting over 1.5 million individuals, and business associates accounted for 55 or 25% of the breaches involving 500 or more individuals in 2012, affecting almost 1.4 million individuals;
- Laptop computers (60 reports) and paper (50 reports) were the two most common PHI locations in 2012 for breaches involving 500 or more individuals.
- OCR received almost 26,000 reports in 2011 of breaches involving less than 500 individuals, and more than 21,000 of these reports came from healthcare providers.
- OCR received more than 21,000 reports in 2012 of breaches involving less than 500 individuals, and almost 18,000 of these reports came from healthcare providers.
- Breaches in 2011 and 2012 are grouped into the following six (6) categories: theft; loss; unauthorized access/disclosure; improper disposal; hacking/IT incident; and, other.
- Theft accounted for 49% and 52% of the breach incidents in 2011 and 2012, respectively.
- The most common mitigation actions taken by covered entities who had a breach affecting 500 or more individuals included revising policies and procedures, improving physical security, training or retraining workforce members, providing free credit monitoring to customers and performing a new risk assessment.
OCR opened investigations into all of the breaches affecting 500 or more individuals that occurred in 2011 and 2012. In addition, OCR opened investigations into some of the breaches affecting fewer than 500 individuals.
The Compliance Report provides an excellent overview of OCR’s enforcement process and includes substantive enforcement data. Following are several highlights from the Compliance Report:
- From April 2003 through December 2012, OCR has received more than 77,000 complaints alleging HIPAA violations. As of December 31, 2012, over 70,000 (91%) of the complaints have been resolved, and, according to the Compliance Report, the majority of complaints received are resolved within one year of their receipt.
- In almost 43,000 of the reported cases through December, 2012, OCR determined that the complaint did not present an eligible case for enforcement under the HIPAA rules.
- OCR investigated more than 27,000 of these complaints and in almost 19,000 of these incidents, OCR required covered entities to take corrective action and/or provided technical assistance to covered entities to resolve areas of noncompliance.
The Compliance Report also provides an overview of the audits required of covered entities and business associates by the HITECH Act and HHS to ensure compliance with the HIPAA Privacy and Security Rules. These audits were divided into four categories of covered entities depending upon the type of entity and or size of entity. To date, 115 covered entities have been audited: 47 health plans, 61 health care providers, and seven health care clearinghouses.
The Breach Report and the Compliance Report demonstrate HHS’ and OCR’s commitment to ensuring HIPAA Privacy Rule and Security Rule Compliance. Covered entities: health plans, health care providers and health care clearinghouses, and business associates need to remain vigilant to ensure HIPAA compliance to try and prevent a breach or in the event the organization is audited. HIPAA compliance remains a focus of health care enforcement efforts and parties are well served to regularly review and update their HIPAA policies, perform a mock internal audit of their own HIPAA compliance, and be observant to ensure there are no breaches of PHI.
Saul Ewing attorneys have substantial experience in drafting and implementing HIPAA compliance plans, policies and procedures, negotiating and drafting business associate agreements and assisting clients in breach reporting. For more information on these matters, please contact Bruce Armon or Karilynn Bayus, or the attorney at the Firm with whom you are regularly in contact.