Privacy & Information Security Law Blog

David Holtzman, a health information privacy specialist at the Office for Civil Rights (“OCR”) within the Department of Health and Human Services (“HHS”), stated at a health privacy conference on May 11, 2010, that OCR has been “vigorously” enforcing the Security Rule, which was promulgated pursuant to the Health Insurance Portability and Accountability Act (“HIPAA”).  Prior to 2009, HHS divided civil enforcement responsibility for HIPAA between OCR, which enforced the HIPAA Privacy Rule, and the Centers for Medicare and Medicaid Services (“CMS”), which enforced the HIPAA Security Rule.  In July 2009, the Secretary of HHS delegated authority to enforce the HIPAA Security Rule to OCR to “facilitate improvements by eliminating duplication and increasing efficiency.”

We understand that yesterday Adam H. Greene (Office of the General Counsel, Civil Rights Division, U.S. Department of Health & Human Services), speaking at the ABA’s 11th Annual Conference on Emerging Issues in Healthcare Law, indicated that enforcement of the business associate provisions of the Health Information Technology for Economic and Clinical Health Act (the “HITECH Act”), which became effective on February 17, 2010, will be delayed until final rules addressing those provisions are published.  The HITECH Act’s business associate provisions require business associates to implement the information security safeguards specified by the HIPAA Security Rule, and comply with certain requirements of the HIPAA Privacy Rule.  Similarly, the HITECH Act requires covered entities to provide in their business associate agreements that all of the HITECH Act’s security requirements applicable to covered entities are also applicable to business associates.

The Department of Health and Human Services (“HHS”) released an interim final rule to incorporate the Health Information Technology for Economic and Clinical Health Act (“HITECH Act”) categories of violations and tiered civil penalty amounts.  The interim final rule is expected to be published in the Federal Register on October 30, 2009 and takes effect on November 30, 2009.  The rule applies to violations of the Health Insurance Portability and Accountability Act of 2003 (“HIPAA”) that occur on or after February 18, 2009.

The Department of Health and Human Services (“HHS”) has posted to its website a notification form that may be used to report breaches of unsecured protected health information to the agency.  Although some state agencies requiring notice of a breach employ a standard reporting form, the form issued by HHS has several unique features and requests more information than a typical breach reporting form.  Some interesting features of the form include:

• The form may be used to report both breaches affecting 500 or more individuals, as well as breaches affecting fewer than 500 ...

On August 17, the Federal Trade Commission ("FTC") issued a final rule ("FTC Final Rule") addressing security breaches of personal health records ("PHRs").  The FTC Final Rule applies to all breaches discovered on or after September 24, 2009, and to “foreign and domestic vendors of personal health records, PHR related entities, and third party service providers” that “maintain information of U.S. citizens or residents.”  The FTC Final Rule does not apply to covered entities or business associates as defined under regulations promulgated pursuant to the Health Insurance Portability and Accountability Act of 1996 ("HIPAA").  Full compliance is required by February 22, 2010.

In a move that portends increased enforcement of the Health Insurance Portability and Accountability Act (“HIPAA”) Privacy Rule, the Department of Health and Human Services (“HHS”) has created two new positions on its health information privacy enforcement team.  According to the job listings, the new Health Information Privacy Specialists at the HHS Office for Civil Rights (“OCR”) will be responsible for “reviewing, analyzing, implementing, promoting, or improving proposed or existing programs or policies needed to implement OCR’s authority for ensuring ...

On April 17, the U.S. Department of Health and Human Services ("HHS") issued proposed information security guidance, as required by the Health Information Technology for Economic and Clinical Health Act (the "HITECH Act") passed as part of American Recovery and Reinvestment Act of 2009 on February 17.  The HITECH Act requires covered entities and business associates, as well as vendors of personal health records, to provide notice of information security breaches affecting “unsecured protected health information” or “unsecured personal health record information,” respectively.  The HITECH Act further requires the Secretary of HHS to specify technologies and methodologies that would render protected health information ("PHI") unusable, unreadable, or indecipherable to unauthorized individuals.  If covered entities, business associates and vendors of personal health records apply the technologies and methodologies specified in the guidance to protected health information, they will not be required to provide notice to affected individuals, HHS or the media, as otherwise required by the HITECH Act, in the event the information is breached.

CVS Pharmacy (“CVS”), reportedly the largest retail pharmacy chain, has agreed to pay the Department of Health and Human Services (“HHS”) $2.25 million and submit a Corrective Action Plan (“CAP”) to HHS after an extensive nationwide investigation by the HHS Office of Civil Rights (“OCR”) and the Federal Trade Commission (“FTC”) which revealed that CVS employees disposed of protected health information (“PHI”) in violation of the Health Insurance Portability and Accountability Act’s (“HIPAA”) Privacy Rule.  In addition, CVS Caremark, the parent company of CVS, simultaneously entered into a Consent Order with the FTC to resolve claims that CVS had engaged in unfair or deceptive trade practices in violation of the FTC Act by failing to use reasonable and appropriate measures to prevent unauthorized access to PHI and by disseminating a false or misleading privacy notice about CVS’s protection of PHI.  In the Consent Order, the FTC specifically highlighted CVS’s failure to render PHI unreadable before disposal as well as its claim in its privacy notice that maintaining the privacy of its customers’ PHI was central to its operations as examples of unfair or deceptive trade practices.  The CVS settlement is noteworthy for two reasons: (1) it is the first joint enforcement action between OCR and the FTC and (2) although it is the second substantial monetary settlement for alleged HIPAA violations, the $2.25 million resolution amount dwarfs the first settlement for $100,000 between HHS and Providence Health in July 2008.