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 |
| 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 |
| 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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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
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