Mistakes can occur should as if a a healthcare employee mistakenly sees the records of a patient, if a fax is shared with the incorrect recipient, an email including PHI is sent to the wrong person, or any other accidental disclosure of PHI has taken place, it is vital that the incident is made known to your Privacy Officer.
Your Privacy Officer will have to ascertain what actions need to be taken to minimize risk and lessen the potential for harm. The incident will need to be reviewed, a risk assessment may need to be carried out, and a report of the breach may need to be submitted to the Department of Health and Human Services’ Office for Civil Rights (OCR).
You should outline that a mistake too place and what exactly happened. You will need to outline which patient’s records were viewed or shared. The failure to submit a report on such a breach promptly can turn a simple error into a major violation incident, one that could lead to disciplinary action and potentially, penalties for your employer.
How Should Covered Bodies React to an Accidental HIPAA Violation?
Any accidental HIPAA violation must be respected and requires a risk assessment to see if PHI may have been exposed, the level of danger to individuals whose PHI has potentially been compromised, and the risk of more disclosures of PHI.
The risk assessment should ascertain:
- The extent of the breach
- The individual who viewed or acquired PHI
- The sort of information involved
- The patients potentially affected
- To whom information has been shared
- The possibility for re-disclosure of information
- Whether PHI was actually obtained or seen
- The extent to which risk has been limited
After the risk assessment, risk must be managed and minimized to an acceptable level. The HIPAA Breach Notification Rule (45 CFR §§ 164.400-414) also requires notifications to be sent out. Not all instance of PHI violations are reportable. There are three exceptions when there has been a HIPAA violation due to an error.
1) An unintentional acquisition, access, or use of PHI by a staff 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 broadcast to a member of staff by mistake. The data is accessed and viewed, but the mistake is realized and the fax is securely destroyed or the email is erased and no further disclosure occurs.
2) An inadvertent disclosure of PHI by an individual authorized to access PHI at a covered entity or business associate to another person authorized to access PHI at the covered body or business associate, or organized health care arrangement in which the covered entity operates in.
Example: Supplying the medical information of a patient to another person authorized to receive it, but a mistake is made and the information of a different patient is shared.
3) If the covered entity or business associate has a good faith belief that the unauthorized individual to whom the impermissible disclosure was made, would not have been able to retain the data.
Example: A physician shares X-rays films or a medical chart with a person not authorized to see the information, but realizes that a mistake has been made and retrieves the information before it is likely that any PHI has been seen and information retained.
In each instance, while breach notifications are not required, any employee that finds themselves in one of the above situations should still report the incident to their company Privacy Officer.
On all other occasions when there has been a breach of unsecured PHI, the incident must be made known to the OCR within 60 days of the identification of the breach and individuals impacted by the breach should be notified. HIPAA breach reporting requirements have been summarized here.
Unintentional HIPAA Violations Examples
Lost or stolen USB flash drives could be thought of by some to be examples of unintentional HIPAA violations as nobody intended for the USB flash drives to be lost or stolen. However, the loss or theft could have been reasonably predicted and potential breaches of ePHI avoided by encryption. The following examples of unintentional HIPAA violations were less predictable.
In May 2017, Olivia O’Leary (24) – a medical technician – claims to have been fired from her job at the Onslow Memorial Hospital in Jacksonville, NC, after commenting on a Facebook post. Her warning that the victim of an auto accident should have donned a seat belt was not seen by her employer as a reminder to always wear a seatbelt – O’Leary claims – but rather as a HIPAA violation.
In April 2016, the Raleigh Orthopedic Clinic in North Carolina was fined $750,000 for hiring an outside vendor to convert X-Ray films to digital form and then permitting the vendor to harvest the silver from the films. The clinic’s mistake was not having a Business Associate Agreement in place; and, as well as the fine, the clinic had to implement a Corrective Action Plan managed by the OCR.
In a further example of an unintentional HIPAA violation listed on the OCR’s website, staff were required to undergo HIPAA training when one member of staff spoke about HIV testing procedures with a patient in a waiting room – sharing the patient’s PHI to other patients in the waiting room. Following the OCR investigation, computer monitors were also repositioned to stop the accidental disclosure of PHI.
How Should Business Associates React Following an Accidental HIPAA Violation?
The proper response to an accidental HIPAA violation should be outlined in your business associate agreement.
HIPAA Rules require all accidental HIPAA breaches be reported to the covered body within 60 days of discovery, although the covered body should be alerted as soon as possible and notification should not be unnecessarily slowed down.
Business associates should supply their covered entity with as many details of the accidental HIPAA violation or breach as they can so that the covered entity can make a determination on the best course of action to implement.