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.
| Protected health information (PHI) is rendered unusable, unreadable, or indecipherable to unauthorized individuals if one or more of the following applies: Electronic PHI has been encrypted as specified in the HIPAA Security Rule by “the use of an algorithmic process to transform data into a form in which there is a low probability of assigning meaning without use of a confidential process or key” (45 CFR 164.304 definition of encryption) and such confidential process or key that might enable decryption has not been breached. To avoid a breach of the confidential process or key, these decryption tools should be stored on a device or at a location separate from the data they are used to encrypt or decrypt. The encryption processes identified below have been tested by the National Institute of Standards and Technology (NIST) and judged to meet this standard. Valid encryption processes for data at rest are ...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 |
| 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 |
| 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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