HIPAA breach

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This blog recently discussed tips for a covered entity (CE) in dealing with a HIPAA business associate (BA). Now, even though you have adopted all of the tips and more, in this dangerous and ever more complex data security world, one of your BAs suffers a breach and it becomes your responsibility as the victim CE to respond. What should you do?

Our partner Elizabeth Litten and I discussed aspects of this issue with our good friend Marla Durben Hirsch who included some of our discussion in her article in the June 2017 issue of Medical Practice Compliance Alert entitled “6 ways practices can reduce the risk of delegating breach-notification duties.” Full text of the article can be found in the June, 2017 issue, but a number of the items included below are drawn from the article.

  1. Locate the most recent Business Associate Agreement (BAA) with the BA who experienced the breach, and see what it says about the post-breach obligations of the CE and the BA. Two important threshold issues are whether the BA complied with the time period for reporting breaches to the CE contained in the BAA and the remaining time, if any, available to the CE for complying with any reporting requirements under HIPAA and state law, remediation and limitation of loss requirements, and notification requirements to affected individuals (collectively, the Requirements).
  2. Determine promptly what are the time deadlines for notification to insurance carriers if cybersecurity or general liability insurance may be available to the BA and/or the CE for payment of expenses of the breach and its remediation.
  3. Spell out any circumstances where the BA will handle the consequences of a breach that occurred on its watch, and the scope of its responsibilities vs. that of the CE. These can range from delegating to the BA the entire range of Requirements to assumption by the CE of complying with the Requirements with payment by the BA of the costs thereof.
  4.  Make sure that the required reporting and notification Requirements are sent on CE stationery or, if such Requirements are being delegated to the BA (especially where the breach affected a number of different CEs), the notifications make it clear that the breach was attributable to the acts of the BA and not the CE. As CE, insist that the final wording of the required reporting and notification documents be subject to your approval.
  5.  Ensure that your staff is familiar with the circumstances of the breach so that they will be able to answer questions from affected individuals and the media intelligently. It may be advisable to designate a single trained and articulate person to be referred all inquiries, so that the responses are uniform, accurate and clear.
  6.  Assess whether the BA handled the breach adequately and whether you want to retain your relationship with the BA. Did the BA comply with HIPAA and the BAA in the post-breach period? Did the BA cooperate with the CE? What is the likelihood of a repeat breach by the BA? Is the CE assuming the risk of potential repeat HIPAA breaches if the BA relationship is continued?
  7. If you determine as CE that you will continue your relationship with the breaching BA, consider whether the BAA with the BA requires changes based upon the experience of the breach and its aftermath.
  8. As CE, consider modifying, updating and/or strengthening all of your BAAs as a result of your experience.
  9. As CE, you may require improving and/or changing your cybersecurity insurance coverage as a result of experience with the breach.
  10.  As CE, document all activities and decisions respecting HIPAA made in the post-breach period to defend your actions as reasonable and to provide concrete planning steps for future HIPAA compliance.

While all the precautions in the universe by a CE cannot eliminate a HIPAA breach by a BA, a CE that is victimized by such a HIPAA breach can do many things to reduce its liability and image damage and strengthen its own HIPAA compliance and risk avoidance efforts for the future by adopting the steps described above.

Post Contributed by Matthew J. Redding.

On April 26, 2017, Memorial Hermann Health System (“MHHS”) agreed to pay the U.S. Department of Health and Human Services (“HHS”) $2.4 million to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule.

The underlying incident occurred in September of 2015, when a patient presented a falsified Texas driver’s license to MHHS’ staff upon appearing for the patient’s scheduled appointment. MHHS’ staff contacted law enforcement to verify the patient’s identification, and law enforcement thereafter came to the facility and arrested the patient. The incident drew some national attention from immigration activist groups.  Our partner Bill Maruca posted a blog in September 2015 that discussed the event.

It is important to note that the disclosure to law enforcement was not a contributing factor to the alleged HIPAA violation. In fact, a covered entity is permitted under HIPAA to disclose protected health information (“PHI”) to the limited extent necessary to report a crime occurring on its premises to law enforcement (see 45 CFR 164.512(f)(5)). However, in the MHHS case, the potential HIPAA violation occurred when MHHS issued press releases to several media outlets, addressed activist groups and state officials, and published a statement on its website following the incident, identifying the patient by name on each occasion.

The MHHS facility was a gynecology clinic, and its disclosure of a patient’s name associated with the facility constituted PHI. Therefore, the release of the patient’s name without the patient’s authorization was an impermissible disclosure of PHI under HIPAA.

The OCR alleged that, in addition to the impermissible disclosure of PHI, MHHS failed to document the sanctions imposed on its workforce members responsible for the impermissible disclosures.

6 Takeaways:

Covered entities, such as hospitals, physician practices, and other health care entities, should be cautious in publicizing any event involving its patients so to avoid impermissibly disclosing PHI. Further, public disclosure could open the door to liability under state statutes and common law (e.g., patient’s right of privacy, freedom from defamation, and contractual rights). Here are a few takeaways from the MHHS HIPAA settlement:

  1. PHI must remain protected. The disclosure of PHI to law enforcement, or the presence of health information in the public domain generally, does not relieve the covered entity of its obligations under HIPAA. Instead, covered entities have a continuing obligation to protect and maintain the privacy and security of PHI in their possession and control, and to use and disclose only such information as is permitted under HIPAA.
  2. Avoid inadvertently publishing PHI. PHI is not limited to health information that identifies a patient by his/her name, SSN, address or date of birth. In addition, it includes any other health information that could be used to identify the patient in conjunction with information publicly available. We’ve seen other instances where health care entities inadvertently publish PHI in violation of HIPAA, leading to significant fines (see NY Med: $2.2 Million settlement).
  3. Review your HIPAA policies and procedures with respect to your workforce’s publications and disclosures to the media. To the extent not done so already:
    1. Develop a policy prohibiting your general workforce from commenting to the media on patient events.
    2. Develop a policy with respect to monitoring statements published on your website to avoid publishing any PHI.
    3. Designate a workforce member with a sufficient HIPAA background (nudge, nudge, HIPAA Privacy Officer) to handle media inquiries and provide the workforce with contact information of such member.
  4. Review your HIPAA policies and procedures with respect to law enforcement events.
    1.  For events not likely to compromise the health and safety of others, encourage your workforce to handle such events as discreetly as possible, involving only those members of the workforce who have a need to know.
    2. Train your workforce to identify the situations where disclosure of a patient’s PHI to law enforcement is permissible and those situations where the patient’s authorization must be obtained before disclosing his/her PHI to law enforcement.
  5. Don’t forget to timely notify the affected individuals. If an impermissible disclosure of PHI occurs, do not let the publicizing of such disclosure cause you to forget your breach notification obligations. Failing to timely notify the affected individual could result in additional penalties (see Presence Health: $475,000 settlement). The breach notification clock starts ticking upon the covered entity’s discovery (as defined under HIPAA) of the impermissible disclosure.
  6. Document your responses to impermissible disclosures of PHI and your compliance with HIPAA. HIPAA places the burden on the covered entity to maintain sufficient documentation necessary to prove that it fulfilled all of its administrative obligations under HIPAA (see 78 FR 5566 at 5641). Therefore, once you discover an impermissible disclosure, document how your entity responds, including, without limitation, the breach analysis, proof that the patient notices were timely sent, sanctions imposed upon the responsible workforce members, actions taken to prevent similar impermissible disclosures, etc. Don’t forget, the covered entity is required to maintain such documentation for at least 6 years (see 45 C.F.R. 164.414 and 164.530(j)) .

This blog series has been following breaches of Protected Health Information (“PHI”) that have been reported on the U.S. Department of Health and Human Services (“HHS”) ever-lengthening parade list (the “HHS List”) of breaches of unsecured PHI affecting 500 or more individuals (the “List Breaches”).  As reported in a previous blog post in this series, as of August 14, 2013 (and today), there were postings of 646 List Breaches.

Several prior posts in this series here and here addressed the extent to which such List Breaches are being reported by covered entities (“CEs”) as having been attributable to events involving business associates (“BAs”).

As of August 20, 2013, 146 of the total of 646 List Breaches (22.6%) reportedly involved BAs of the reporting CEs.  This is remarkably consistent with the percentage of 22.3% (83 of the total of 372 List Breaches) as of December 2, 2011, reportedly involving BAs of the reporting CEs.

Further analysis of the HHS List as of August 20, 2013, reveals the following:

• 3 of the 6 List Breaches (50%) that affected 1,000,000 or more individuals reportedly involved BAs of the reporting CEs.

• 16 of the 43 List Breaches (37.2%) that affected between 30,000 and 999,999 individuals reportedly involved BAs of the reporting CEs.

• 21 of the 80 List Breaches (26.3%) that affected between 10,000 and 29,999 individuals reportedly involved BAs of the reporting CEs.

• 106 of the 517 List Breaches (20.5%) that affected between 500 and 9,999 individuals reportedly involved BAs of the reporting CEs.

While the foregoing review is only a snapshot of the HHS List as of a given date, it would indicate that, as the size of a List Breach increases, it is more likely that involvement of a BA will be reported. However, the overwhelming proportion of List Breaches (79.5%) on the HHS List, which affected fewer than 10,000 individuals, have reported no involvement of a BA.

More data will be required before the impact of BA involvement in smaller and larger List Breaches becomes clearer. However, there are indications that the larger the List Breach that is reported by a CE, the greater the likelihood that it will involve an alleged BA.  It is therefore incumbent upon any CE at a minimum to

(i) choose its BAs with care,

(ii) enter into effective business associate agreements with terms appropriate for the specific risks that may be present, and

(iii) continue to monitor the total performance of BAs, including both delivery of services and HIPAA compliance.