What is considered a breach?

Breach means the acquisition, access, use, or disclosure of PHI in a manner not permitted under the HIPAA rules which compromises the security or privacy of the PHI.

When is an unintentional disclosure not considered a breach?

Any unintentional acquisition, access, or use of PHI by a workforce member or person acting under the authority of a covered entity or a business associate, if such acquisition, access, or use was made in good faith and within the scope of authority and does not result in further use or disclosure in a manner not permitted.

Any inadvertent disclosure by a person who is authorized to access PHI at a covered entity or business associate to another person authorized to access protected health information at the same covered entity or business associate, or organized health care arrangement in which the covered entity participates, and the information received as a result of such disclosure is not further used or disclosed in a manner not permitted under the Privacy Rule.

A disclosure of protected health information where a covered entity or business associate has a good faith belief that an unauthorized person to whom the disclosure was made would not reasonably have been able to retain such information.

Can a healthcare provider demonstrate that a breach did not occur?

An acquisition, access, use, or disclosure of PHI in a manner not permitted is presumed to be a breach unless the provider or business associate demonstrates that there is a low probability that the PHI has been compromised based on a risk assessment of at least the following factors:

• The nature and extent of the protected health information involved, including the types of identifiers and the likelihood of re-identification;
• The unauthorized person who used the PHI or to whom the disclosure was made;
• Whether the protected health information was actually acquired or viewed; and
• The extent to which the risk to the PHI has been mitigated.

Reference

45 CFR § 164.402