Privacy & Information Security Law Blog

Last week, the Federal Trade Commission published a Notice of Proposed Rulemaking regarding notification for security breaches involving electronic health information. The FTC issued the proposal pursuant to certain health information technology provisions in the American Recovery and Reinvestment Act, signed into law on February 17th, 2009. The Commission's proposal includes a requirement that vendors of personal health records notify U.S. citizens and residents if their personal health information is subject to a security breach. In addition, vendors must notify the FTC no later than five business days following the discovery of a breach that affects 500 or more individuals, or, for breaches affecting fewer than 500 individuals, maintain a log to be submitted annually to the Commission.

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.

Provisions of the economic stimulus legislation (known as the American Recovery and Reinvestment Act (“ARRA”)), recently passed by the U.S. House of Representatives, require certain entities to notify affected individuals, government agencies and the media of breaches of “unsecured protected health information.” Additional provisions substantially revise regulations promulgated pursuant to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). While these provisions are specifically limited to the context of health data, they have ...

Two California medical privacy laws became effective on January 1, 2009.  The laws, A.B. 211 and S.B. 541, create new obligations for health care providers and facilities in California to protect against unlawful or unauthorized access to patient medical information.  In contrast, other medical privacy regulations, including the Privacy Rule promulgated under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), focus only on the unauthorized use or disclosure of protected health information.