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entity has insufficient or out-of-date contact information for 10 or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 If the covered entity has insufficient or out-of-date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.
| Move quickly to secure your systems and fix vulnerabilities that may have caused the breach. The only thing worse than a data breach is multiple data breaches. Take steps so it doesn’t happen again. Secure physical areas potentially related to the breach. Lock them and change access codes, if needed. Ask your forensics experts and law enforcement when it is reasonable to resume regular operations.Mobilize your breach response team right away to prevent additional data loss. The exact steps to take depend on the nature of the breach and the structure of your business. Assemble a team of experts to conduct a comprehensive breach response. Depending on the size and nature of your company, they may include forensics, legal, information security, information technology, operations, human resources, communications, investor relations, and management. Identify a data forensics team. Consider hiring independent forensic investigators to help you determine the source and scope ...read more |
| 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. ...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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1/21/25 Healthcare Data Breaches and Their Devastating Impact
1/21/25 Your Essential Guide to Data Breach Reporting Procedures
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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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