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, 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



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



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



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

November 2025
SuMoTuWeThFrSa
1
2345678
9101112131415
16171819202122
23242526272829
30

Blog Home  

Newest Blog Entries
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

Blog Archives
November 2022 (11)
January 2025 (3)

Blog Labels
Data Breach Reporting (6)
Data Breach Notification (6)
Health Care Data (1)
ePHI Data (1)