Administrative Requirements and Burden of Proof
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
sanctions against workforce members who do not comply with these
policies and procedures.
| 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 |
| 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 |
| In today's digital landscape, data breaches are an unfortunate reality that businesses of all sizes must contend with. A single security lapse can lead to significant financial losses, reputational damage, and legal headaches. While prevention is paramount, having a clear and well-defined data breach reporting procedure is crucial for minimizing the fallout when the inevitable happens. This article will guide you through the essential steps your business needs to take. Why a Solid Breach Reporting Procedure is Non-Negotiable Data breaches are not just a concern for large corporations; they affect small and medium-sized businesses (SMBs) just as much, if not more so. A robust reporting procedure serves multiple critical purposes: Compliance with Regulations: Various data privacy regulations, like GDPR, CCPA, and others, mandate specific reporting timelines and requirements. Failure to comply can result in hefty fines and legal action.Minimizing Damage: Swift and decisive action can significantly limit the scope ...read more |
| 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 |
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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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