Breach Notification Requirements
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entity has insufficient or out-of-date contact information for 10 or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 likely reside. The covered entity
must include a toll-free phone number that remains active for at least
90 days where individuals can learn if their information was involved in
the breach. If the covered entity has insufficient or out-of-date
contact information for fewer than 10 individuals, the covered entity
may provide substitute notice by an alternative form of written notice,
by telephone, or other means.
These individual notifications must be provided without unreasonable
delay and in no case later than 60 days following the discovery of a
breach and must include, to the extent possible, a brief description of
the breach, a description of the types of information that were involved
in the breach, the steps affected individuals should take to protect
themselves from potential harm, a brief description of what the covered
entity is doing to investigate the breach, mitigate the harm, and
prevent further breaches, as well as contact information for the covered
entity (or business associate, as applicable).
With respect to a breach at or by a business associate, while the
covered entity is ultimately responsible for ensuring individuals are
notified, the covered entity may delegate the responsibility of
providing individual notices to the business associate. Covered
entities and business associates should consider which entity is in the
best position to provide notice to the individual, which may depend on
various circumstances, such as the functions the business associate
performs on behalf of the covered entity and which entity has the
relationship with the individual.
Media Notice
Covered entities that experience a breach affecting more than 500
residents of a State or jurisdiction are, in addition to notifying the
affected individuals, required to provide notice to prominent media
outlets serving the State or jurisdiction. Covered entities will likely
provide this notification in the form of a press release to appropriate
media outlets serving the affected area. Like individual notice, this
media notification must be provided without unreasonable delay and in no
case later than 60 days following the discovery of a breach and must
include the same information required for the individual notice.
Notice to the Secretary
In addition to notifying affected individuals and the media (where
appropriate), covered entities must notify the Secretary of breaches of
unsecured protected health information. Covered entities will notify the
Secretary by visiting the HHS web site and filling out and electronically submitting a breach report form.
If a breach affects 500 or more individuals, covered entities must
notify the Secretary without unreasonable delay and in no case later
than 60 days following a breach. If, however, a breach affects fewer
than 500 individuals, the covered entity may notify the Secretary of
such breaches on an annual basis. Reports of breaches affecting fewer
than 500 individuals are due to the Secretary no later than 60 days
after the end of the calendar year in which the breaches are discovered.
| 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 |
| 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 |
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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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