Breach Notification Rule: Guidance to Render Unsecured PHI Unusable, Unreadable, or Indecipherable to Unauthorized Individuals

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Per the HIPAA Breach Notification Rule, breaches of unsecured PHI must be reported to affected individuals, to HHS, and, in some instances, to the media.

The HIPAA Breach Notification Rule defines "unsecured protected health information as "protected health information that is not rendered unusable, unreadable, or indecipherable to unauthorized persons through the use of a technology or methodology specified by the Secretary in the guidance issued under section 13402(h)(2) of Public Law 111–5 (that is, Section 13402(h)(2) of the HITECH Act).

Section 13402 called for HHS to issue guidance specifying the technologies and methodologies that render protected health information unusable, unreadable, or indecipherable to unauthorized individuals

HHS has issued the guidance. It can be found here. 

Protected health information (PHI) is rendered unusable, unreadable, or indecipherable to unauthorized individuals (and is therefore "not unsecured") if one or more of the following applies:

1.    Electronic PHI has been encrypted as specified in the HIPAA Security Rule by “the use of an algorithmic process to transform data into a form in which there is a low probability of assigning meaning without use of a confidential process or key” (45 CFR 164.304 definition of encryption) and such confidential process or key that might enable decryption has not been breached.  To avoid a breach of the confidential process or key, these decryption tools should be stored on a device or at a location separate from the data they are used to encrypt or decrypt.  The encryption processes identified below have been tested by the National Institute of Standards and Technology (NIST) and judged to meet this standard.

• Valid encryption processes for data at rest are consistent with NIST Special Publication 800-111, Guide to Storage Encryption Technologies for End User Devices.
• Valid encryption processes for data in motion are those which comply, as appropriate, with NIST Special Publications 800-52, Guidelines for the Selection and Use of Transport Layer Security (TLS) Implementations; 800-77, Guide to IPsec VPNs; or others which are Federal Information Processing Standards (FIPS) 140-2 validated.

2.    The media on which the PHI is stored or recorded has been destroyed in one of the following ways:

• Paper, film, or other hard copy media have been shredded or destroyed such that the PHI cannot be read or otherwise cannot be reconstructed. Redaction is specifically excluded as a means of data destruction.
• Electronic media have been cleared, purged, or destroyed consistent with NIST Special Publication 800-88, Guidelines for Media Sanitization such that the PHI cannot be retrieved.