On May 20, 2014, the Secretary of the Department of Health and Human Services (HHS) submitted the agency's Annual Report to Congress on Breaches of Unsecured Protected Health Information for Calendar Years 2011 and 2012 ("Breach Report"). This report provides valuable insight for healthcare entities regarding their data security and enforcement priorities.
Section 13402(i) of the Health Information Technology for Economic and Clinical Health Act (HITECH) requires the Secretary of Health and Human Services to prepare an annual report regarding the number and nature of breaches report to HHS, as well as the actions taken in response to those breaches.
By way of background, HITECH requires that both covered entities and business associates (as defined under HIPAA) provide notifications after a breach of unsecured protected health information (PHI). These required notifications include the affected individuals, HHS, and also media outlets in cases where the breach includes more than 500 residents of a state or jurisdiction. However, HHS has issued guidance explaining that encryption and destruction make PHI "unusable, unreadable, or indecipherable to unauthorized persons" and, thus, loss of such secured PHI does not trigger the breach notification requirements.
Healthcare providers accounted for the majority of breaches affecting 500 or more individuals in both 2011 and 2012 while business associates and health plans accounted for the remainder, as illustrated below.
Theft of PHI was the leading cause of a breach in both 2011 and 2012 followed by loss of PHI and unauthorized access/disclosures. In 2011, theft was the cause for 24% of the total number of individuals affected by a breach and loss accounted for 54% of individuals affected. This high affected rate due to loss was the result of single breach incident involving a business associate and loss of back-up tapes containing information on 4.9 million individuals. In 2012, the causes of breach returned to expected rates with 36% of individuals affected due to theft and 13% due to loss. The below tables outline the frequency of breach causes in 2011 and 2012 as well as the sources of the breached information in each year.
|Causes of Data Breach||2011||2012|
|Loss of PHI||17%||12%|
|Sources of Breach||2011||2012||Change|
|Other Portable Device||13%||9%||(4%)|
|Electronic Medical Records||2%||2%||0|
HITECH authorizes and requires HHS to conduct periodic audits of covered entities and business associates to ensure compliance with HIPAA rules. Unlike compliance reviews (which occur after a major breach) or compliance investigations, these audits are not triggered by an adverse event or incident. Instead, they are "based on application of a set selection criteria."
The Office for Civil Rights (OCR) (the office within HHS that is responsible for administering the Breach Notification Rules) implemented a pilot program of the audit process to assess the privacy and security compliance which was described in the Breach Report. The audit revealed that 31 out of 101 audited entities had at least one negative audit finding related to the Breach Notification Rule. Specifically, the audit examined the following four areas: (1) notification to individuals, (2) timeliness of notification, (3) methods of individual notification, and (4) burden of proof. All four areas had a similar number of deficiencies noted.
Implications and Recommendations for Healthcare Entities
Breaches involving 500 or more individuals accounted for less than 1% of reports filed with HHS, yet represent almost 98% of the individuals affected by a PHI breach. It is likely that OCR will continue investing significant resources into large scale PHI breaches due to the extensive impact of these breaches. Additionally, theft remains one of the top causes of PHI breaches and covered entities and business associates must take appropriate measures to ensure that any PHI stored or transported on portable electronic devices is properly safeguarded. Chronic vulnerabilities include:
Encryption: Even if a device is stolen or misplaced, the Breach Notification Rule will not apply if the data is properly encrypted. Thus, it is imperative that covered entities and business associates encrypt portable electronic devices (such as laptops) and all CDs or USB thumb drives.
Access Control: Healthcare entities must pay close attention to the physical access to and proper disposal of devices that contain PHI. Server rooms should be locked with limited access, and the physical access to buildings, floors, and offices should be secured to prevent theft of desktop computers containing PHI.
Disposal: Electronic devices need to be purged and the data securely erased (also known as "scrubbed") prior to the device being discarded, recycled, sold, or transferred to a third party, such as a leasing company. Such devices include computers, external storage media, and photocopiers.
Lastly, as explained in the Breach Report discussion of OCR's audit pilot program, covered entities most often explain noncompliance with the various aspects of the Breach Notification Rule by pleading unawareness of the requirements of the Rules. Covered entities and business associates should ensure that comprehensive privacy and security policies and procedures are developed and implemented to mitigate the risks of a breach and to effectively respond to a breach should one occur.