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.



Following a breach of unsecured protected health information, covered entities must provide notification of the breach to affected individuals, the Secretary, and, in certain circumstances, to the media. In addition, business associates must notify covered entities if a breach occurs at or by the business associate. Individual Notice Covered entities must notify affected individuals following the discovery of a breach of unsecured protected health information. Covered entities must provide this individual notice in written form by first-class mail, or alternatively, by e-mail if the affected individual has agreed to receive such notices electronically. If the covered entity has insufficient or out-of-date contact information for 10 or more individuals, the covered entity must provide substitute individual notice by either posting the notice on the home page of its web site for at least 90 days or by providing the notice in major print or broadcast media where the affected individuals ...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



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



Think about service providers. If service providers were involved, examine what personal information they can access and decide if you need to change their access privileges. Also, ensure your service providers are taking the necessary steps to make sure another breach does not occur. If your service providers say they have remedied vulnerabilities, verify that they really fixed things.  Check your network segmentation. When you set up your network, you likely segmented it so that a breach on one server or in one site could not lead to a breach on another server or site. Work with your forensics experts to analyze whether your segmentation plan was effective in containing the breach. If you need to make any changes, do so now.  Work with your forensics experts. Find out if measures such as encryption were enabled when the breach happened. Analyze backup or preserved data. Review logs to determine ...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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