Definition of Breach
A breach is, generally, an impermissible use or disclosure under the
Privacy Rule that compromises the security or privacy of the protected
health information. An impermissible use or disclosure of protected
health information is presumed to be a breach unless the covered entity
or business associate, as applicable, demonstrates that there is a low
probability that the protected health information 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 protected health information 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 protected health information has been mitigated.
Covered entities and business associates, where applicable, have
discretion to provide the required breach notifications following an
impermissible use or disclosure without performing a risk assessment to
determine the probability that the protected health information has been
compromised.
There are three exceptions to the definition of “breach.” The first
exception applies to the unintentional acquisition, access, or use of
protected health information by a workforce member or person acting
under the authority of a covered entity or business associate, if such
acquisition, access, or use was made in good faith and within the scope
of authority. The second exception applies to the inadvertent disclosure
of protected health information by a person authorized to access
protected health information at a covered entity or business associate
to another person authorized to access protected health information at
the covered entity or business associate, or organized health care
arrangement in which the covered entity participates. In both cases, the
information cannot be further used or disclosed in a manner not
permitted by the Privacy Rule. The final exception applies if the
covered entity or business associate has a good faith belief that the
unauthorized person to whom the impermissible disclosure was made, would
not have been able to retain the information.
| Protected health information (PHI) is rendered unusable, unreadable, or indecipherable to unauthorized individuals if one or more of the following applies: 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 ...read more |
| Covered entities and business associates, as applicable, have the burden of demonstrating that all required notifications have been provided or that a use or disclosure of unsecured protected health information did not constitute a breach. Thus, with respect to an impermissible use or disclosure, a covered entity (or business associate) should maintain documentation that all required notifications were made, or, alternatively, documentation to demonstrate that notification was not required: (1) its risk assessment demonstrating a low probability that the protected health information has been compromised by the impermissible use or disclosure; or (2) the application of any other exceptions to the definition of “breach.” Covered entities are also required to comply with certain administrative requirements with respect to breach notification. For example, covered entities must have in place written policies and procedures regarding breach notification, must train employees on these policies and procedures, and must develop and apply appropriate ...read more |
| When your business experiences a data breach, notify law enforcement, other affected businesses, and affected individuals. Determine your legal requirements. All states, the District of Columbia, Puerto Rico, and the Virgin Islands have enacted legislation requiring notification of security breaches involving personal information. In addition, depending on the types of information involved in the breach, there may be other laws or regulations that apply to your situation. Check state and federal laws or regulations for any specific requirements for your business. Notify law enforcement. Call your local police department immediately. Report your situation and the potential risk for identity theft. The sooner law enforcement learns about the theft, the more effective they can be. If your local police aren’t familiar with investigating information compromises, contact the local office of the FBI or the U.S. Secret Service. For incidents involving mail theft, contact the U.S. Postal Inspection Service. Did the ...read more |
| Notify individuals. If you quickly notify people that their personal information has been compromised, they can take steps to reduce the chance that their information will be misused. In deciding who to notify, and how, consider: state lawsthe nature of the compromisethe type of information takenthe likelihood of misusethe potential damage if the information is misused For example, thieves who have stolen names and Social Security numbers can use that information not only to sign up for new accounts in the victim’s name, but also to commit tax identity theft. People who are notified early can take steps to limit the damage. When notifying individuals, the FTC recommends you: Consult with your law enforcement contact about the timing of the notification so it doesn’t impede the investigation.Designate a point person within your organization for releasing information. Give the contact person the latest information about the breach, your response, and how ...read more |
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1/21/25 Healthcare Data Breaches and Their Devastating Impact
1/21/25 Your Essential Guide to Data Breach Reporting Procedures
1/21/25 Understanding Your Obligations in Data Breach Reporting
11/16/22 Administrative Requirements and Burden of Proof
11/16/22 Notification by a Business Associat
11/16/22 Breach Notification Requirements
11/16/22 Unsecured Protected Health Information and Guidance
11/16/22 Guidance to Render Unsecured Protected Health Information Unusable, Unreadable, or Indecipherable to Unauthorized Individuals
11/16/22 Definition of Breach
11/16/22 Breach Notification Rule
11/16/22 Notify Individuals
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