Unsecured Protected Health Information and Guidance
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.
| Notify individuals. If you quickly notify people that their personal information has been compromised, they can take steps to reduce the chance that their information will be misused. In deciding who to notify, and how, consider: state lawsthe nature of the compromisethe type of information takenthe likelihood of misusethe potential damage if the information is misused For example, thieves who have stolen names and Social Security numbers can use that information not only to sign up for new accounts in the victim’s name, but also to commit tax identity theft. People who are notified early can take steps to limit the damage. When notifying individuals, the FTC recommends you: Consult with your law enforcement contact about the timing of the notification so it doesn’t impede the investigation.Designate a point person within your organization for releasing information. Give the contact person the latest information about the breach, your response, and how ...read more |
| 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 |
| 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 |
| 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 |
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1/21/25 Healthcare Data Breaches and Their Devastating Impact
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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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