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 (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.

Interestingly, the guidance specifies only two methods for securing PHI in a manner that would avoid the application of the HITECH Act’s breach notification provisions. First, the guidance provides that PHI will be deemed unusable, unreadable or indecipherable if it has been encrypted, provided the encryption key has not also been breached. In this regard, HHS has followed the lead of more than 45 state breach notification laws that likewise provide “safe harbors” for encrypted information. HHS does, however, specify that encryption must comply with the HIPAA Security Rule’s provisions and further provides two specific examples of encryption that have been deemed to meet this standard: (1) for data at rest, encryption consistent with National Institute of Standards and Technology Special (NIST) Publication 800-111 and; (2) for data in transit, encryption that complies with Federal Information Processing Standard 140-2.

Second, the guidance provides that PHI will be deemed unusable, unreadable or indecipherable if media on which it is stored or recorded has been destroyed by one of the following methods: (1) paper, film or other hard copy media have been shredded or destroyed such that PHI cannot be read or reconstructed; and (2) electronic media have been cleared, purged or destroyed consistent with NIST Special Publication 800-88 such that PHI cannot be retrieved.

The guidance is clear that its recitation of information safeguards, though a proposal pending public comment, is intended to be exhaustive. The guidance, developed jointly by the Office for Civil Rights, Office of the National Coordinator for Health Information Technology, and Centers for Medicare and Medicaid Services, acknowledges that use of the technologies and methodologies described therein are not required but, if used, “create the functional equivalent of a safe harbor” with respect to the breach notification provision contained in the HITECH Act. The guidance also notes that any other applicable requirements, such as mitigation requirements contained in the Privacy Rule and state breach notification laws, must be followed to the extent applicable, regardless of adherence to the guidance.

As above, this information security guidance relates to two sets of forthcoming breach notification regulations. The first, applicable to covered entities and business associates, will be issued by HHS and the second, applicable to vendors of personal health records and certain other non-HIPAA covered entities, was issued by the Federal Trade Commission in proposed form on April 16.

Public comments on the HHS information security guidance are due by May 21, 2009. HHS has specifically signaled interest in receiving comments regarding whether limited data sets of PHI should be considered, by definition, to render PHI unusable, unreadable or indecipherable such that the HITECH Act’s breach notification provisions would not apply.

In addition to the guidance, HHS also issued a request for information soliciting public comment on the breach notification provisions of the HITECH Act to inform its future rulemaking and its annual updates to the guidance. The guidance is available here and both the guidance and the request for information are available here.