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Filefax, Inc., a defunct Illinois medical records storage and management company, has been fined $100,000 for improperly handling medical data under an agreement with the court-appointed receiver managing the company’s assets on behalf of its creditors.  This settlement has implications for both service providers and their covered entity clients.  Fox Rothschild partners Elizabeth Litten and Michael Kline were quoted in an article by Marla Durben Hirsch entitled “Be prepared for HIPAA Issues if a business associate shuts down” in the August issue of Medical Practice Compliance Alert.

As the HHS press release stated, the consequences for HIPAA violations don’t stop when a business closes.  In this case, Filefax had been under investigation by state and federal authorities since 2015 for careless handling of medical records which had been abandoned at a shredding facility.   Medical Practice Compliance Alert notes:

This settlement shows that  a provider or business associate that has violated HIPAA can’t avoid the consequences by shutting down.  “OCR is saying that you’re still responsible if you close your doors.” Says attorney Elizabeth Litten with Fox Rothschild in Princeton, NJ.

But it also provides a cautionary tale for providers who work with business associates that go under because providers are ultimately responsible for their patients’ records.

The article suggests the following tips for a covered entity to reduce its risks when a business associate may be in shaky financial shape:

  1. Keep an inventory of your business associate relationships.
  2. Choose business associates carefully.
  3. Monitor your business associates’ compliance with HIPAA.
  4. Expect increased scrutiny if a business associate is already on the government’s radar.
  5. Watch for signs that the business associate may be running into financial trouble.
  6. Don’t sit idly if the business associate files for bankruptcy.

What should a covered entity do when it learns that a business associate may have violated its HIPAA responsibilities?  For starters, see our previous post entitled Ten Tips for Actions by a Covered Entity after a HIPAA Breach by a Business Associate.  And if that BA has ceased operations, be prepared to take control of the situation even if the BA may not have enough resources left to reimburse you for its mistakes. Remember, the buck always stops with the Covered Entity.

Harry S. Truman Library & Museum 2017

The recent criminal conviction of a Massachusetts physician provides a stark reminder that violating HIPAA can result in more than civil monetary penalties and the financial and reputational fall-out that results from a breach. In this case, perhaps the cover-up was worse than the crime, or maybe prosecutors decided that a conviction on other charges would have been harder to get. Either way, the case should alert covered entities and business associates to the fact that HIPAA violations can result in jail time and criminal fines.

The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) investigates complaints and may impose civil monetary penalties (CMPs) for violations of HIPAA.   The U.S. Department of Justice (DOJ) handles criminal investigations and penalties.  This may not provide much comfort, but a CMP will not be imposed if the HIPAA violation is determined to constitute a criminal offense.

OCR will refer matters to DOJ for criminal enforcement in some cases or will work cooperatively with DOJ where a DOJ investigation on other grounds reveals a potential HIPAA violation.  HHS reported that OCR had referred 688 cases to the DOJ for criminal investigation as of June 30, 2018.

The criminal enforcement of HIPAA was described in a Memorandum Opinion issued in 2005 jointly to HHS and the Senior Counsel to the Deputy Attorney General by Steven Bradbury, then-acting Assistant Attorney General of the Office of Legal Counsel within DOJ (the DOJ Memo). The DOJ Memo explains that HIPAA allows for criminal penalties only for violations that involve the disclosure of “unique health identifiers” or “individually identifiable health information” (IIHI) that are made “knowingly” and in violation of HIPAA.   Specifically, a person may be subject to criminal penalties if he or she knowingly (and in violation of HIPAA):  (i) uses or causes to be used a unique health identifier; (ii) obtains IIHI; or (iii) discloses IIHI to another person.  Criminal penalties range from misdemeanors to felonies.  The maximum criminal penalty (a fine of up to $250,000 and imprisonment of up to 10 years) can be imposed if one of these offenses is committed “with intent to sell, transfer, or use [IIHI] for commercial advantage, personal gain, or malicious harm.”  The DOJ Memo explains that “knowingly” refers to knowledge of the facts that constitute the offense, not knowledge of the law being violated (HIPAA).

The DOJ Memo emphasizes the fact that criminal penalties are reserved for limited and specific violations of HIPAA:  “Such punishment is reserved for violations involving `unique health identifiers’ and [IIHI]…  Thus, the statute reflects a heightened concern for violations that intrude upon the medical privacy of individuals.”  The DOJ Memo focuses on violations by covered entities. It notes that when a covered entity is not an individual, but is a corporate entity, the conduct of agents may be imputed to the entity when the agents act within the scope of employment, and the criminal liability of a corporate entity may be attributed to individuals in managerial roles.

DOJ might decide to seek a conviction for a violation of HIPAA when it believes such a conviction would be easier to get than a conviction for a violation of other federal laws governing health care providers (such as the anti-kickback statute).   After all, the DOJ Memo makes it clear that “knowing” refers to the conduct, not the state of the law.  However, it should be noted, as per the DOJ Memo, that the DOJ’s interpretation of “`knowingly’ does not dispense with the mens rea requirement of section 1320d-6 [HIPAA] and create a strict liability offense; satisfaction of the ‘knowing’ element will still require proof that the defendant knew the facts that constitute the offense.”

When a health care entity (like a large hospital system or health plan) has deep pockets, the OCR may decide to pursue very high civil monetary penalties and rely on the financial and reputational implications of the civil monetary penalties to act as a deterrence.  On the other hand, the DOJ may seek to deter behavior associated with a wider range of criminal activities by pursuing jail time for a HIPAA violation.

In the case of the Massachusetts physician, it is also likely that the DOJ pursued the criminal charge because she lied about her relationship with the third party to which she disclosed patient information. My law partner Charles DeMonaco, a white collar defense attorney and former DOJ prosecutor, agrees:

It is understandable why this doctor was indicted and convicted for these offenses.  She was accused of lying to the agents, which is always a major hurdle in a criminal case.  Even if an underlying crime cannot be established, a lie of a material fact to a government agent is a stand-alone false-statement felony.  It also establishes consciousness of guilt. The doctor could have asserted her Fifth Amendment privilege against self-incrimination to avoid talking to the government agents.  It is never a good thing for a doctor to speak with agents who are investigating the doctor’s conduct without counsel and without proper protection of limited use immunity being sought prior to the interview.  The government also proved that she accepted fees from the pharma company after providing the [IIHI] in violation of HIPAA.  Under these facts, it is not surprising that this case was brought as a criminal prosecution and that a guilty verdict was returned.

Everyone subject to HIPAA should be aware that a HIPAA violation involving disclosure or breach of IIHI may be the low-hanging fruit for criminal prosecutors originally focused on other violations of law.   In particular, covered entities should carefully evaluate arrangements with third parties that involve the sharing of IIHI with those parties for commercial/personal gain or commercial harm. If the sharing of IIHI is not permitted under HIPAA and commercial gain or harm is involved, these violations could result in the most severe level of criminal penalties, including significant jail time.

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)) .

Our partner Elizabeth Litten and I were quoted by our good friend Marla Durben Hirsch in her article in Medical Practice Compliance Alert entitled “6 Compliance Trends Likely to Affect Your Practices in 2016.” Full text can be found in the January 13, 2016, issue, but a synopsis is below.

For her article, Marla asked various health law professionals to make predictions on matters such as HIPAA enforcement, the involvement of federal agencies in privacy and data security, and actions related to the Office for Civil Rights (“OCR”) of the federal Department of Health and Human Services (“HHS”).

After the interview with Marla was published, I noted that each of Elizabeth’s and my predictions described below happened to touch on our anticipation of the expansion by HHS and other federal agencies of their scope and areas of healthcare privacy regulation and enforcement. I believe that this trend is not a coincidence in this Presidential election year, as such agencies endeavor to showcase their regulatory activities and enlarge their enforcement footprints in advance of possible changes in the regulatory environment under a new administration in 2017. If an agency can demonstrate effectiveness and success during 2016 in new areas, it can make a stronger case for funding human and other resources to continue its activities in 2017 and thereafter.

Our predictions that were quoted by Marla follow.

Kline Prediction: Privacy and data enforcement actions will receive more attention from federal agencies outside of the OCR.

In light of the amount of breaches that took place in 2015, the New Year will most likely see an increase of HIPAA enforcement. However, regulators outside of healthcare –such as the Department of Homeland Security, the Securities and Exchange Commission and the Federal Communications Commission — also try to extend their foothold into the healthcare compliance realm, much in a way that the Federal Trade Commission has.

Litten Prediction: The Department of Justice (DOJ) and the OCR will focus more on individual liability

In September of 2015, the DOJ announced through the Yates Memo, that they would be shifting their strategy to hold individuals to a higher level of accountability for an entity’s wrongdoing. The OCR has also mentioned that they will focus more on individuals who violate HIPAA. “They’re trying to put the fear in smaller entities. A small breach is as important as a big one,” says Litten.

Kline Prediction: OCR will examine business associate relationships.

The HIPAA permanent audit program, which has been delayed by the OCR, will be rolled out in 2016 and will scrutinize several business associates. In turn, all business associate relationships will receive increased attention.   According to Kline, “There will be more focus on how you selected and use a business associate and what due diligence you used. People also will be more careful about reviewing the content of business associate agreements and determining whether one between the parties is needed.”

We shall continue to observe whether the apparent trend of federal agencies to grow their reach into regulation of healthcare privacy continues as we approach the Presidential election.

Our partner Elizabeth Litten and I were once again quoted by our good friend Marla Durben Hirsch in her recent articles in Medical Practice Compliance Alert entitled “Misapplication of Internet Application Triggers $218,400 Settlement” and “Protect Patient Data on the Internet with These 6 Steps.”  The three of us together were able to come up with a number of ideas to assist physicians in improving the likelihood that protected health information (“PHI”) will be more secure. The full text can be found in the August 17, 2015 issue of Medical Practice Compliance Alert, but a synopsis of our input is included below.

Internet applications and files should be included in a physician practice’s HIPAA compliance plan, or a violation may result.  As an example, St. Elizabeth’s Medical Center (“SEMC”) in Brighton, MA recently settled several potential HIPAA violations for $218,400 with the Office of Civil Rights (“OCR”) of the Department of Health and Human Services (“HHS”).  One of the incidents involved SEMC’s use of an unauthorized internet-based document. The size of this settlement highlights the concerns of OCR about misuse by healthcare providers of internet-based document sharing or other applications.

Some steps to protect patient data on the internet include the following:

  1. Review the internet applications your practice uses. Litten says, “Take steps such as encryption to protect the data when it’s shared, transmitted and stored.”
  2. Ask the application’s manufacturer about its security safeguards. “If a manufacturer claims that (its application) is HIPAA protected, ask what that means,” Litten urges.
  3. Investigate all internal and external complaints and concerns. Kline says, “Expect the government to find out about PHI exposed on the Internet from a third party.”
  4. Keep track of the steps you take to identify and fix the problem. “You do better if you have a history that you endeavored to comply with HIPAA,” says Kline.
  5. Provide a mechanism by which employees can report concerns anonymously. Kline suggests, “You need a private place where people feel they’re not being watched.”
  6. Don’t allow staff to use unauthorized public networks. “Don’t open documents in, say, a Starbucks,” warns Litten.

In summary, in order for physicians to protect their practices, they must be certain that they understand HIPAA obligations with respect to privacy and security in the context of internet application usage.

As she had done in 2014, Marla Durben Hirsch interviewed my partner Elizabeth Litten and me for her annual Medical Practice Compliance Alert article on compliance trends for the New Year.  While the article, which was entitled “6 Compliance Trends That Will Affect Physician Practices in 2015,” was published in the January 5, 2015 issue of Medical Practice Compliance Alert, a synopsis of the article can be found here. As we have previously pointed out, we always enjoy our talks with Marla because she never fails to direct our thinking to new areas.   We look forward to the opportunity for further encounter sessions with her.

While the article discussed a diverse range of topics affecting physician practices, including accountable care organizations (ACOs) and telemedicine, this blog post will focus on HIPAA-related areas.

Even more HIPAA and related enforcement activities can be expected in 2015.

The article observed that providers will not see a reprieve in this area. Breaches of patient and consumer data continue to proliferate; the tremendous publicity that breaches outside of the HIPAA area have received, such as the hacking of Home Depot and Sony, will create more pressure on HHS’ Office for Civil Rights (OCR) to enforce HIPAA breaches.  The article quotes us as saying “It’s [A HIPAA privacy breach is] very personal to people when their health data is filched; it’s creepy.”  

The article also quotes Elizabeth, who warns that practices also should expect increased activity by the Federal Trade Commission in the area of healthcare data breaches through its enforcement of consumer protection laws and from the Food and Drug Administration’s protection of the integrity of medical devices, even though those federal agencies do not have the same comprehensive standards and clear regulations that OCR does to enforce HIPAA.

Additionally, there is likely to be more private litigation using HIPAA compliance as the standard of care, even though HIPAA itself does not give patients the right to sue for violations. The November 2014 ruling in the Connecticut Supreme Court discussed on this blog here and here recognized HIPAA’s requirements as a standard of care in a state breach of privacy lawsuit. Elizabeth and I observed that the Connecticut case will spawn copycat lawsuits using HIPAA the same way for state breaches of privacy, negligence and other causes of action.

Covered entities and business associates will refine their agreements, all as they come under more scrutiny.

Many practices and their business associates scrambled to sign business associate agreements (BAAs), often using model forms from OCR and professional societies, to ensure that they had them in place by the September 2013 effective date — and for those who needed only to update an existing BAA, September 2014. However, as discussed in the article, covered entities and business associates now are negotiating the language in BAAs and customizing them to their individual needs, such as choice of law and indemnification requirements.

One provision that may become more prevalent in newer BAAs would allow a business associate that deals with large amounts of data — such as a cloud electronic health records vendor — to use covered entity’s de-identified patient data for the business associates’ own uses. An industry is developing around the aggregation of data for purposes such as research or predicting patient outcomes, and some business associates are moving to capitalize on that data and use it or market it to others. According to Elizabeth, covered entities will need to determine whether they want to grant such business associates permission to use the data that way.

Business Associates Can Expect Audits by OCR in 2015.

The activities of business associates also will be under the microscope. The permanent HIPAA audit program, slated to begin in 2015, is expected to audit business associates as well as covered entities. Elizabeth observed that the use of subcontractors by business associates also will be examined more carefully, especially those who use off-shore subcontractors.

Again, to read more, click here and see the full article in the January 5, 2015 issue of Medical Care Compliance Alert.

The threats to health privacy in the face of the Ebola scare has not escaped the notice of the Office of Civil Rights (OCR).  As we reported last month, a great deal of information regarding the identity and condition of individuals who may have been exposed to or treated for Ebola has appeared in news reports. Ebola In The News – Is Too Much PHI Being Revealed And By Whom?  and Which Privacy Protections Apply? HIPAA, FERPA and Ebola.  On November 10, OCR issued a bulletin entitled HIPAA Privacy in Emergency Situations reminding covered entities and business associates that their obligations under HIPAA do not change during emergency situations such as the Ebola outbreak.

The bulletin notes that HIPAA balances the interests of patient privacy in a manner that ensures that appropriate uses and disclosures of the information still may be made when necessary to treat a patient, to protect the nation’s public health, and for other critical purposes.

Patient information can be shared for “treatment” purposes, and OCR notes  that “covered entities may disclose, without a patient’s authorization, protected health information [PHI] about the patient as necessary to treat the patient or to treat a different patient.” Further, treatment includes the coordination or management of health care, which may be critical when handling a communicable and dangerous infection such as Ebola.

OCR summarizes the disclosures which are permissible for public health purposes to agencies like the Centers for Disease Control and Prevention (CDC) or state or local health departments. “For example, a covered entity may disclose to the CDC protected health information on an ongoing basis as needed to report all prior and prospective cases of patients exposed to or suspected or confirmed to have Ebola virus disease.”

Other situations where disclosure is permissible include:

  • At the direction of a public health authority, to a foreign government agency that is acting in collaboration with the public health authority. (Highly relevant when coordinating information with government agencies in West Africa and other affected regions)
  • To persons at risk of contracting or spreading a disease or condition, but only if authorized under state or federal law.
  • To a patient’s family members, relatives, friends or others involved in the patient’s care.
  • When necessary to identify, locate, and communicate with family members, guardians, or anyone else responsible for the patient’s care, to notify them of the patient’s location, general condition, or death. OCR notes such disclosures may include police, the press, or the public at large. However, it is not a blanket authority to release PHI to the media unless there is a valid reason to do so. OCR also notes that verbal permission should be sought from the patient if possible.
  • To disaster relief organizations such s the Red Cross, but only for the coordination of contacting family members and others involved in the patient’s care.
  • To anyone else as necessary to prevent or lessen a serious and imminent threat to the health and safety of a person or the public – consistent with applicable law (such as state statutes, regulations, or case law) and the provider’s standards of ethical conduct.
  • Limited “directory” condition information may be released when a patient is identified by name. OCR warns: In general, except in the limited circumstances described elsewhere in this Bulletin, affirmative reporting to the media or the public at large about an identifiable patient, or the disclosure to the public or media of specific information about treatment of an identifiable patient, such as specific tests, test results or details of a patient’s illness, may not be done without the patient’s written authorization (or the written authorization of a personal representative who is a person legally authorized to make health care decisions for the patient).

Health care providers and their business associates are now clearly on notice that OCR will not look the other way if information relating to individuals potentially exposed to Ebola or similar diseases is disclosed without meeting a valid exception, no matter how persistently media outlets press for details.  Each covered entity and business associate should take the time to remind their personnel that the privacy rule remains in effect in emergencies.

 

 

Imagine you have completed your HIPAA risk assessment and implemented a robust privacy and security plan designed to meet each criteria of the Omnibus Rule.  You think that, should you suffer a data breach involving protected health information as defined under HIPAA (PHI), you can show the Secretary of the Department of Health and Human Services (HHS) and its Office of Civil Rights (OCR), as well as media reporters and others, that you exercised due diligence and should not be penalized. Your expenditure of time and money will help ensure your compliance with federal law.

Unfortunately, however, HHS is not the only sheriff in town when it comes to data breach enforcement.  The Federal Trade Commission (FTC) has been battling LabMD for the past few years in a case that gets more interesting as the filings and rulings mount (In the Matter of LabMD, Inc., Docket No. 9357 before the FTC).  LabMD’s CEO Michael Daugherty recently published a book on the dispute with a title analogizing the FTC to the devil, with the byline, “The Shocking Expose of the U.S. Government’s Surveillance and Overreach into Cybersecurity, Medicine, and Small Business.”  Daugherty issued a press release in late January attributing the shutdown of operations of LabMD primarily to the FTC’s actions.

Among many other reasons, this case  is interesting because ofthe dual jurisdiction of the FTC and HHS/OCR over breaches that involve individual health information.

On one hand, the HIPAA regulations detail a specific, fact-oriented process for determining whether an impermissible disclosure of PHI constitutes a breach under the law.  The pre-Omnibus Rule breach analysis involved consideration of whether the impermissible disclosure posed a “significant risk of financial, reputational, or other harm” to the individual whose PHI was disclosed.  The post-Omnibus Rule breach analysis presumes that an impermissible disclosure is a breach, unless a risk assessment that includes consideration of at least four specific factors demonstrates there was a “low probability” that the individual’s PHI was compromised.

In stark contrast to HIPAA, the FTC can bring an enforcement action based upon its decision that an entity’s data security practices are “unfair”, but it has not promulgated regulations or issued specific guidance as to how or when a determination of “unfairness” is made.  Instead, the FTC routinely alleges that entities’ data security practices are “unfair” because they are not “reasonable” – two vague words that leave entities guessing about how to become FTC compliant.

In 2013, LabMD filed a motion to have the FTC’s enforcement action dismissed.  LabMD argued, in part, that the FTC does not have the authoritiy to bring actions under the “unfairness” prong of Section 5 of the FTC Act.  LabMD further argued that there should only be one sheriff in town – not both HHS and the FTC.  Not surprisingly, in January 2014, the FTC denied the motion to dismiss, finding that HIPAA requirements are “largely consistent with the data security duties” of the FTC under the FTC Act.The opinion speaks of “data security duties” and “requirements” of the FTC Act, but these “duties” and “requirements” are not spelled out (much less even mentioned) in the FTC Act.  As a result, how can anyone arrive at the determination that the standards are consistent?  Instead, entities that suffer a data security incident must comply with the detailed analysis under HIPAA, as well as the absence of any clear guidance under the FTC Act.

In a March 10th ruling, the judge ruled that he would permit LabMD to depose an FTC designee regarding consumers harmed by LabMD’s allegedly inadequate security practices.  However, the judge also ruled that LabMD could not “inquire into why, or how, the factual bases of the allegations … justify the conclusion that [LabMD] violated the FTC Act.”  So while the LabMD case may eventually provide some guidance as to the factual circumstances involved in an FTC determination that data security practices are “unfair” and have caused, or are likely to cause, consumer harm, the legal reasoning behind the FTC’s determinations is likely to remain a mystery.

My partner Bill Maruca was quoted in Jeff Overley’s article “Historic HIPAA Fine Will Push Feds To Get Tougher” published in Law360 on Friday, February 20, 2014.   The article reports on the nearly $7 million fine imposed by the Puerto Rico Health Insurance Administration on a contractor, health plan Triple-S Salud Inc. (“Triple-S”).  Bill’s quote sums it up:  “This is a shocking fine, given the circumstances.”  The breach affected roughly 13,000 individuals eligible for both Medicare and Medicaid (“dual eligibles”), but what were the circumstances that made this fine so large as to be shocking to my esteemed colleague and other observers? 

Here’s my take.  First, the fine was imposed by Puerto Rico, not the Office of Civil Rights (“OCR”) within the Department of Health and Human Services (“HHS”), which is the federal agency generally associated with penalties for breaches involving protected health information (“PHI”), and is significantly higher than fines that have been reported by OCR as having been levied for breaches affecting many more individuals than the 13,000 affected here.  OCR has created training tools for state attorneys general and states that it “welcomes” collaborations with state attorneys general seeking to bring civil actions to enforce HIPAA, but no state has imposed such a large penalty for a HIPAA violation, either on its own or in collaboration with OCR. 

Second, the breach was not the result of a sophisticated hacking incident or careless laptop loss or theft capable of exposing thousands of individuals’ information in a single view.  Here, the breach resulted from Triple-S’s inclusion of individual Medicare health insurance claim numbers in plain sight on mailings addressed to the individuals.  This PHI would only have been viewed by those delivering or otherwise physically handling the mail addressed to the individuals, thereby subjecting the PHI to a relatively limited scope of potential viewers (presumably, the postal service and anyone retrieving a specific individual’s mail, with or without permission).    

Finally, while the disclosure of an individual’s Medicare health insurance claim number is a disclosure of PHI (and potentially might be used in an attempt to improperly claim health care benefits), it is not the type of PHI that most people are likely to consider sensitive and private.

More information about Triple-S and this incident (and perhaps past incidents involving HIPAA violations, such as the 2010 incident reported to HHS) is likely to surface in the coming weeks and months.

In the wake of the post-Omnibus Rule (the “Rule”) frenzy, it is necessary to consider some collateral effects that the Rule may have brought about with respect to compliance with HIPAA/HITECH.  The Office of Civil Rights (“OCR”) summaries of closed investigations (the “Summaries”) posted on the U.S. Department of Health and Human Services (“HHS”) list (the “HHS List”) of breaches of unsecured PHI affecting 500 or more individuals (“List Breaches”) has been a source of meaningful guidance as discussed in previous posts on this blog.  For example, the summary (the “Tennessee Summary”) for a State of Tennessee Sponsored Group Health Plan breach (the “Tennessee Breach”) continues to provide an excellent road map of pre-Omnibus Rule actions for covered entities (“CEs”) or business associates (“BAs”)  that suffer List Breaches or PHI breaches of any size.  

 

While the Tennessee Breach itself dealt with mishandling of paper PHI and not electronic health records, the Tennessee Summary does give direction for early intervention by affected CEs or BAs before HHS knocks on their door.  However, while there was excellent compliance in the aftermath of the Tennessee Breach, advice from pre-Rule Summaries cannot be used without carefully taking into account the new requirements respecting PHI breaches under the Rule.  As will be further discussed below, the most important new requirement in this regard is the necessity for a CE, BA or subcontractor to analyze the level of risk of compromise of the affected PHI.

 

The Tennessee Summary

 

The Tennessee Breach occurred on October 6, 2011 and involved approximately 1,770 enrollees with respect to names, addresses, birth dates and social security numbers.  According to the Tennessee Summary, an equipment operator at the state’s postal facility set the machine to insert four (4) pages per envelope instead of one (1) page per envelope, which caused the PHI of four individuals to be sent to one address per envelope.

 

The Tennessee Summary states that the CE did the following (with some parenthetical observations from the blog author):

 

1.         Retrained the equipment operator (suggesting that suspension and/or termination are not the only actions in appropriate cases with respect to dealing with employees involved with a PHI breach where rehabilitation is possible).

2.         Submitted a breach report to HHS (resulting in the posting on the HHS List).

3.         Provided notice to affected individuals.

4.         Notified the media.

5.         Created a toll-free number for information regarding the incident.

6.         Posted notice on the CE’s website.

7.         Modified policies to remove the social security number on templates for future mailings (a good policy whether paper or electronic PHI is involved).

8.         Offered identity theft protection to the affected individuals (a common decision for CEs and BAs based on the type of information that may have been compromised).

9.         Following the OCR investigation, reviewed its policies and procedures to ensure adequate safeguards are in place (with this disclosure in the Tennessee Summary, there is a suggestion that OCR continued to exercise some oversight or received reports after the investigation was finished).

 

The Tennessee Breach in Retrospect after the Omnibus Rule

 

There was no discussion in the Tennessee Summary of any analysis by the CE of the probable “risk of harm” from the Tennessee Breach under the proposed rule standards that prevailed prior to the Rule.  However, it is clear that, in the post-Rule period, a risk analysis of the probability that the PHI “has been compromised” would be necessary for the CE; failure to do such an analysis may be a violation in itself.   Under the Rule, there is a presumption that a breach of PHI has taken place unless there is a low probability that the PHI has been compromised.  The four factor analysis that would have been required of the CE in the Tennessee Breach case had it happened after the effectiveness of the Rule encompasses the following (with parenthetical comments):

 

(i)         Identifying the nature and extent of the PHI involved, including types of identifiers and risk of re-identification (i.e., names, addresses, birth dates and social security numbers);

 

(ii)        Identifying the unauthorized person(s) who impermissibly used the PHI or to whom the disclosure was made (in the case of the Tennessee Breach, subscribers to the health plan who were not individuals that had an obligation of their own to comply with HIPAA/HITECH);

 

(iii)       Determining whether the PHI was actually acquired or viewed or, alternatively, if only the opportunity existed for the PHI to be acquired or viewed (in the case of the Tennessee Breach, there is a likelihood that numerous recipients of the PHI or others without the right to view such PHI did in fact view it); and

 

(iv)       The extent to which risk to the PHI was mitigated (items 3, 4, 5, 6 and 8 above appear to be potential mitigating factors).

 

As stated in an earlier postings here and here, no Summary has been posted by OCR for any List Breach that occurred later than October 6, 2011. Additionally, no Summary has been posted by OCR for any List Breach involving a BA that occurred later than February 1, 2011.  While the Summaries continue to provide highly useful information for CEs, BAs and subcontractors relative to confronting PHI breaches, large and small, they must be analyzed with appropriate care and attention paid to changes brought about by the Rule.  It may be that a concern of OCR about potential confusion which could be created by publishing pre-Rule Summaries has prevented OCR from making recent postings of Summaries on the HHS List.