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.



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



Move quickly to secure your systems and fix vulnerabilities that may have caused the breach. The only thing worse than a data breach is multiple data breaches. Take steps so it doesn’t happen again. Secure physical areas potentially related to the breach. Lock them and change access codes, if needed. Ask your forensics experts and law enforcement when it is reasonable to resume regular operations.Mobilize your breach response team right away to prevent additional data loss. The exact steps to take depend on the nature of the breach and the structure of your business. Assemble a team of experts to conduct a comprehensive breach response. Depending on the size and nature of your company, they may include forensics, legal, information security, information technology, operations, human resources, communications, investor relations, and management. Identify a data forensics team. Consider hiring independent forensic investigators to help you determine the source and scope ...read more



Move quickly to secure your systems and fix vulnerabilities that may have caused the breach. The only thing worse than a data breach is multiple data breaches. Take steps so it doesn’t happen again. Secure physical areas potentially related to the breach. Lock them and change access codes, if needed. Ask your forensics experts and law enforcement when it is reasonable to resume regular operations.Mobilize your breach response team right away to prevent additional data loss. The exact steps to take depend on the nature of the breach and the structure of your business. Assemble a team of experts to conduct a comprehensive breach response. Depending on the size and nature of your company, they may include forensics, legal, information security, information technology, operations, human resources, communications, investor relations, and management. Identify a data forensics team. Consider hiring independent forensic investigators to help you determine the source and scope ...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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