Definition of Breach
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; and
- The 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 use or disclosure without performing a risk assessment to
determine the probability that the protected health information has been
compromised.
There are three exceptions to the definition of “breach.” The first
exception applies to the unintentional acquisition, access, or use of
protected health information by a workforce member or person acting
under the authority of a covered entity or business associate, if such
acquisition, access, or use was made in good faith and within the scope
of authority. The second exception applies to the inadvertent disclosure
of protected health information by a person authorized to access
protected health information at a covered entity or business associate
to another person authorized to access protected health information at
the covered entity or business associate, or organized health care
arrangement in which the covered entity participates. In both cases, the
information cannot be further used or disclosed in a manner not
permitted by the Privacy Rule. The final exception applies if the
covered entity or business associate has a good faith belief that the
unauthorized person to whom the impermissible disclosure was made, would
not have been able to retain the information.
| 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 |
| 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 |
| 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 |
| The HIPAA Breach Notification Rule, 45 CFR §§ 164.400-414, requires HIPAA covered entities and their business associates to provide notification following a breach of unsecured protected health information. Similar breach notification provisions implemented and enforced by the Federal Trade Commission (FTC), apply to vendors of personal health records and their third party service providers, pursuant to section 13407 of the HITECH Act. ...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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