Administrative Requirements and Burden of Proof

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 sanctions against workforce members who do not comply with these policies and procedures.



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; andThe 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 ...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



If a breach of unsecured protected health information occurs at or by a business associate, the business associate must notify the covered entity following the discovery of the breach.  A business associate must provide notice to the covered entity without unreasonable delay and no later than 60 days from the discovery of the breach.  To the extent possible, the business associate should provide the covered entity with the identification of each individual affected by the breach as well as any other available information required to be provided by the covered entity in its notification to affected individuals. ...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

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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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