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.



Covered entities and business associates must only provide the required notifications if the breach involved unsecured protected health information. Unsecured protected health information is protected health information that has not been rendered unusable, unreadable, or indecipherable to unauthorized persons through the use of a technology or methodology specified by the Secretary in guidance.  This guidance was first issued in April 2009 with a request for public comment. The guidance was reissued after consideration of public comment received and specifies encryption and destruction as the technologies and methodologies for rendering protected health information unusable, unreadable, or indecipherable to unauthorized individuals. Additionally, the guidance also applies to unsecured personal health record identifiable health information under the FTC regulations. Covered entities and business associates, as well as entities regulated by the FTC regulations, that secure information as specified by the guidance are relieved from providing notifications following the breach of such information. ...read more



In today's interconnected world, data breaches are an unfortunate reality. Whether it's a sophisticated cyberattack or a simple human error, the unauthorized access to sensitive information can have devastating consequences for individuals and organizations alike. While prevention is paramount, knowing how to respond effectively in the aftermath of a breach is equally critical. A key aspect of that response is data breach reporting. Why is Data Breach Reporting So Important? Data breach reporting is the process of notifying relevant authorities and affected parties about a security incident that has compromised personal or sensitive data. It's more than just an administrative formality; it's a legal obligation in many jurisdictions and has a profound impact on: Protecting Individuals: Prompt reporting allows affected individuals to take necessary steps to mitigate potential harm, such as changing passwords, monitoring their credit reports, and being vigilant against identity theft.Legal Compliance: Numerous laws and regulations, like ...read more



In today's interconnected world, data breaches are an unfortunate reality. Whether it's a sophisticated cyberattack or a simple human error, the unauthorized access to sensitive information can have devastating consequences for individuals and organizations alike. While prevention is paramount, knowing how to respond effectively in the aftermath of a breach is equally critical. A key aspect of that response is data breach reporting. Why is Data Breach Reporting So Important? Data breach reporting is the process of notifying relevant authorities and affected parties about a security incident that has compromised personal or sensitive data. It's more than just an administrative formality; it's a legal obligation in many jurisdictions and has a profound impact on: Protecting Individuals: Prompt reporting allows affected individuals to take necessary steps to mitigate potential harm, such as changing passwords, monitoring their credit reports, and being vigilant against identity theft.Legal Compliance: Numerous laws and regulations, like ...read more



Covered entities and business associates must only provide the required notifications if the breach involved unsecured protected health information. Unsecured protected health information is protected health information that has not been rendered unusable, unreadable, or indecipherable to unauthorized persons through the use of a technology or methodology specified by the Secretary in guidance.  This guidance was first issued in April 2009 with a request for public comment. The guidance was reissued after consideration of public comment received and specifies encryption and destruction as the technologies and methodologies for rendering protected health information unusable, unreadable, or indecipherable to unauthorized individuals. Additionally, the guidance also applies to unsecured personal health record identifiable health information under the FTC regulations. Covered entities and business associates, as well as entities regulated by the FTC regulations, that secure information as specified by the guidance are relieved from providing notifications following the breach of such information. ...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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