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The majority of HIPAA covered entities, business associates, and healthcare employees take great care to ensure HIPAA Rules are followed, but what happens when there is accidental HIPAA violation? How should healthcare employees, covered entities, and business associates respond?
How Should Employees Report an Accidental HIPAA Violation?
Accidents happen. If a healthcare employee accidentally views the records of a patient, if a fax is sent to an incorrect recipient, an email containing PHI is sent to the wrong person, or any other accidental disclosure of PHI has occurred, it is essential that the incident is reported to your Privacy Officer.
Your Privacy Officer will need to determine what actions need to be taken to mitigate risk and reduce the potential for harm. The incident will need to be investigated, a risk assessment may need to be performed, and a report of the breach may need to be sent to the Department of Health and Human Services’ Office for Civil Rights (OCR).
You should explain that a mistake was made and what has happened. You will need to explain which patient’s records were viewed or disclosed. The failure to report such a breach promptly can turn a simple error into a major incident, one that could result in disciplinary action and potentially, penalties for your employer.
How Should Covered Entities Respond to an Accidental HIPAA Violation?
Any accidental HIPAA violation must be treated seriously and warrants a risk assessment to determine the probability of PHI having been compromised, the level of risk to individuals whose PHI has potentially been compromised, and the risk of further disclosures of PHI.
The risk assessment should determine:
- The nature of the breach
- The person who viewed or acquired PHI
- The types of information involved
- The patients potentially impacted
- To whom information has been disclosed
- The potential for re-disclosure of information
- Whether PHI was actually acquired or viewed
- The extent to which risk has been mitigated
Following the risk assessment, risk must be managed and reduced to an appropriate and acceptable level. The HIPAA Breach Notification Rule (45 CFR §§ 164.400-414) also requires notifications to be issued. Not all breaches of PHI are reportable. There are three exceptions when there has been an accidental HIPAA violation.
1) An unintentional acquisition, access, or use of PHI by a workforce member or person acting under the authority of a covered entity or business associate, if such acquisition, access, or use was made in good faith and within the scope of authority.
Example: A fax or email is sent to a member of staff in error. The information is accessed and viewed, but the mistake is realized and the fax is securely destroyed or the email is deleted and no further disclosure is made.
2) An inadvertent disclosure of PHI by a person authorized to access PHI at a covered entity or business associate to another person authorized to access PHI at the covered entity or business associate, or organized health care arrangement in which the covered entity participates.
Example: Providing the medical information of a patient to another individual authorized to receive it, but a mistake is made and the information of a different patient is disclosed.
3) If the covered entity or business associate has a good faith belief that the unauthorized person to whom the impermissible disclosure was made, would not have been able to retain the information.
Example: A physician gives X-rays films or a medical chart to a person not authorized to view the information, but realizes that a mistake has been made and retrieves the information before it is likely that any PHI has been read and information retained.
In each case, while breach notifications are not required, any member of staff that finds themselves in one of the above situations should still report the incident to their Privacy Officer.
In all other cases when there has been a breach of unsecured PHI, the incident must be reported to OCR within 60 days of the discovery of the breach and individuals impacted by the breach should be notified. HIPAA breach reporting requirements have been summarized here.
How Should Business Associates Respond to an Accidental HIPAA Violation?
The correct response to an accidental HIPAA violation should be detailed in your business associate agreement.
HIPAA Rules require all accidental HIPAA violations and data breaches to be reported to the covered entity within 60 days of discovery, although the covered entity should be notified as soon as possible and notification should not be unnecessarily delayed.
Business associates should provide their covered entity with as many details of the accidental HIPAA violation or breach as possible to allow the covered entity to make a determination on the best course of action to take.