
Whether the PHI was actually acquired, accessed, used, or disclosed. The unauthorized person who used the PHI or to whom the disclosure was made. The nature and extent of the PHI involved, including the types of HIPAA identifiers and the likelihood of re-identification. The risk assessment has to take into account the following factors: It is also the case that a use or disclosure not permitted by the Privacy Rule is considered a breach of HIPAA unless the Covered Entity or Business Associate can demonstrate by way of a risk assessment that there is a low probability the security or privacy of PHI has been compromised. These are when a workforce member or person acting under the authority of a Covered Entity or Business Associate accesses PHI unintentionally or discloses PHI inadvertently “in good faith”, and the unauthorized use or disclosure of PHI does not result in a further use or disclosure not permitted by the Privacy Rule. There are exceptions to what is considered a breach of HIPAA. Exceptions to the Breach Notification Requirements The notification to the Covered Entity must include the information necessary for the Covered Entity to comply with the Breach Notification Rule. When a breach of HIPAA is identified by a Business Associate, they are required to notify the Covered Entity for whom they are providing a service within sixty days. In breaches involving more than 500 individuals, Covered Entities are also required to notify prominent media outlets serving the location.īusiness Associates are also required to comply with the Breach Notification Rule. The Department of Health and Human Services (HSS) also has to be notified within sixty days of breaches involving more than 500 individuals or, if the breach involves fewer than 500 individuals, at the end of the calendar year. The notification must include a description of the breach, the nature of information that was acquired, accessed, used, or disclosed, and advice about what steps individuals should take to protect themselves from potential loss or harm.
When a breach of HIPAA is identified, Covered Entities must notify affected individuals within sixty days.
The text of HIPAA is very clear about what is considered a breach of HIPAA – § 164.402 of the Breach Notification Rule defining a breach as “the acquisition, access, use, or disclosure of protected health information in a manner not permitted under subpart E of this part which compromises the security or privacy of the protected health information.” Covered Entities that fail to comply with the Breach Notification Rule – or fail to do so in a timely manner – can be issued substantial penalties. It is important to know what is considered a breach of HIPAA because Covered Entities are required to report breaches of HIPAA to affected individuals and the Department of Health and Human Services under the Breach Notification Rule.