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.
| Following a breach of unsecured protected health information, covered entities must provide notification of the breach to affected individuals, the Secretary, and, in certain circumstances, to the media. In addition, business associates must notify covered entities if a breach occurs at or by the business associate. Individual Notice Covered entities must notify affected individuals following the discovery of a breach of unsecured protected health information. Covered entities must provide this individual notice in written form by first-class mail, or alternatively, by e-mail if the affected individual has agreed to receive such notices electronically. If the covered entity has insufficient or out-of-date contact information for 10 or more individuals, the covered entity must provide substitute individual notice by either posting the notice on the home page of its web site for at least 90 days or by providing the notice in major print or broadcast media where the affected individuals ...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 |
| If a breach of unsecured protected health information occurs at or by a business associate, the business associate must notify the covered entity following the discovery of the breach. A business associate must provide notice to the covered entity without unreasonable delay and no later than 60 days from the discovery of the breach. To the extent possible, the business associate should provide the covered entity with the identification of each individual affected by the breach as well as any other available information required to be provided by the covered entity in its notification to affected individuals. ...read more |
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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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