As she has done in January for several years, our good friend Marla Durben Hirsch quoted my partner Elizabeth Litten and me in Medical Practice Compliance Alert in her article entitled “MIPS, OSHA, other compliance trends likely to affect you in 2017.” For her article, Marla asked various health law professionals to make predictions on diverse healthcare matters including HIPAA and enforcement activities. Full text can be found in the January 2017 issue, but excerpts are included below.

Marla also wrote a companion article in the January 2017 issue evaluating the results of predictions she published for 2016. The 2016 predictions appeared to be quite accurate in most respects. However, with the new Trump Administration, we are now embarking on very uncertain territory in multiple aspects of healthcare regulation and enforcement. Nevertheless, with some trepidation, below are some predictions for 2017 by Elizabeth and me taken from Marla’s article.

  1. The Federal Trade Commission’s encroachment into privacy and security will come into question. Litten said, “The new administration, intent on reducing the federal government’s size and interference with businesses, may want to curb this expansion of authority and activity. Other agencies’ wings may be clipped.” Kline added, “However, the other agencies may try to push back because they have bulked up to handle this increased enforcement.”
  2. Telemedicine will run into compliance issues. As telemedicine becomes more common, more legal problems will occur. “For instance, the privacy and the security of the information stored and transmitted will be questioned,” says Litten. “There will also be heightened concern of how clinicians who engage in telemedicine are being regulated,” adds Kline.
  3. The risks relating to the Internet of things will increase. “The proliferation of cyberattacks from hacking, ransomware and denial of service schemes will not abate in 2017, especially with the increase of devices that access the Internet, known as the ‘Internet of things,’ warns Kline. “More devices than ever will be networked, but providers may not protect them as well as they do other electronics and may not even realize that some of them —such as newer HVAC systems, ‘smart’ televisions or security cameras that can be controlled remotely — are also on the Internet and thus vulnerable,” adds Litten. “Those more vulnerable items will then be used to infiltrate providers’ other systems,” Kline observes.
  4. More free enterprise may create opportunities for providers. “For example, there may not be as much of a commitment to examine mergers,” says Kline. “The government may allow more gathering and selling of data in favor of business interests over privacy and security concerns,” says Litten.

The ambitious and multi-faceted foray by the Trump Administration into the world of healthcare among its many initiatives will make 2017 an interesting and controversial year. Predictions are always uncertain, but 2017 brings new and daunting risks to the prognosticators.  Nonetheless, when we look back at 2017, perhaps we may be saying, “The more things change, the more they stay the same.”

It was nearly three years ago that I first blogged about the Federal Trade Commission’s “Wild West” data breach enforcement action brought against now-defunct medical testing company LabMD.   Back then, I was simply astounded that a federal agency (the FTC) with seemingly broad and vague standards pertaining generally to “unfair” practices of a business entity would belligerently gallop onto the scene and allege non-compliance by a company specifically subject by statute to regulation by another federal agency. The other agency, the U.S. Department of Health and Human Services (HHS), has adopted comprehensive regulations containing extremely detailed standards pertaining to data security practices of certain persons and entities holding certain types of data.

The FTC Act governs business practices, in general, and has no implementing regulations, whereas HIPAA specifically governs Covered Entities and Business Associates and their Uses and Disclosures of Protected Health Information (or “PHI”) (capitalized terms that are all specifically defined by regulation). The HIPAA rulemaking process has resulted in hundreds of pages of agency interpretation published within the last 10-15 years, and HHS continuously posts guidance documents and compliance tools on its website. Perhaps I was naively submerged in my health care world, but I had no idea back then that a Covered Entity or Business Associate could have HIPAA-compliant data security practices that could be found to violate the FTC Act and result in a legal battle that would last the better part of a decade.

I’ve spent decades analyzing regulations that specifically pertain to the health care industry, so the realization that the FTC was throwing its regulation-less lasso around the necks of unsuspecting health care companies was both unsettling and disorienting. As I followed the developments in the FTC’s case against LabMD over the past few years (see additional blogs here, here, here and here), I felt like I was moving from the Wild West into Westworld, as the FTC’s arguments (and facts coming to light during the administrative hearings) became more and more surreal.

Finally, though, reality and reason have arrived on the scene as the LabMD saga plays out in the U.S. Court of Appeals for the 11th Circuit. The 11th Circuit issued a temporary stay of the FTC’s Final Order (which reversed the highly-unusual decision against the FTC by the Administrative Law Judge presiding over the administrative action) against LabMD.

The Court summarized the facts as developed in the voluminous record, portraying LabMD as having simply held its ground against the appalling, extortion-like tactics of the company that infiltrated LabMD’s data system. It was that company, Tiversa, that convinced the FTC to pursue LabMD in the first place. According to the Court, Tiversa’s CEO told one of its employees to make sure LabMD was “at the top of the list” of company names turned over to the FTC in the hopes that FTC investigations would pressure the companies into buying Tiversa’s services. As explained by the Court :

In 2008, Tiversa … a data security company, notified LabMD that it had a copy of the [allegedly breached data] file. Tiversa employed forensic analysts to search peer-to-peer networks specifically for files that were likely to contain sensitive personal information in an effort to “monetize” those files through targeted sales of Tiversa’s data security services to companies it was able to infiltrate. Tiversa tried to get LabMD’s business this way. Tiversa repeatedly asked LabMD to buy its breach detection services, and falsely claimed that copies of the 1718 file were being searched for and downloaded on peer-to-peer networks.”

As if the facts behind the FTC’s action weren’t shocking enough, the FTC’s Final Order imposed bizarrely stringent and comprehensive data security measures against LabMD, a now-defunct company, even though its only remaining data resides on an unplugged, disconnected computer stored in a locked room.

The Court, though, stayed the Final Order, finding even though the FTC’s interpretation of the FTC Act is entitled to deference,

LabMD … made a strong showing that the FTC’s factual findings and legal interpretations may not be reasonable… [unlike the FTC,] we do not read the word “likely” to include something that has a low likelihood. We do not believe an interpretation [like the FTC’s] that does this is reasonable.”

I was still happily reveling in the refreshingly simple logic of the Court’s words when I read the brief filed in the 11th Circuit by LabMD counsel Douglas Meal and Michelle Visser of Ropes & Gray LLP. Finally, the legal rationale for and clear articulation of the unease I felt nearly three years ago:   Congress (through HIPAA) granted HHS the authority to regulate the data security practices of medical companies like LabMD using and disclosing PHI, and the FTC’s assertion of authority over such companies is “repugnant” to Congress’s grant to HHS.

Continuation of discussion of 11th Circuit case and filings by amicus curiae in support of LabMD to be posted as Part 2.

U.S. Representative Tim Murphy (R-PA) has been a vocal advocate for mental health reform for a number of years.  Part of his crusade is driven by his concern that the HIPAA privacy rule “routinely interferes with the timely and continuous flow of health information between health care providers, patients, and families, thereby impeding patient care, and in some cases, public safety.”  Congressman Murphy’s efforts have resulted in the inclusion in the recently-passed 21st Century Cures Act of a provision entitled “Compassionate Communications on HIPAA” targeted at improving understanding of what mental health information can be shared with family members and caregivers.

The 21st Century Cures Act streamlines the drug approval process, authorizes $4.8 billion in new health research funding, including $1.8 billion for Vice President Joe Biden’s “cancer moonshot” and $1.6 billion for brain diseases such as Alzheimer’s, and provides grants to combat the opioid epidemic.

Of most interest to readers of this blog, the Act also calls for the Department of Health and Human Services (HHS) to clarify the situations in which HIPAA permits health care professionals to communicate with caregivers of adults with a serious mental illness to facilitate treatment.  By December 13, 2017, the Secretary of HHS is required to issue guidance  regarding when such disclosures would require the patient’s consent; when the patient must be given an opportunity to object; when disclosures may be made based on the exercise of professional judgment regarding whether the patient would object when consent may not be obtained due to incapacity or emergency; and when disclosures may be made in the best interest of the patient when the patient is not present or is incapacitated.   HHS is directed to address communications to family members or other individuals involved in the care of the patient, including facilitating treatment and medication adherence.  Guidance is also required regarding communications when a patient presents a serious and imminent threat of harm to self or others.  HHS is directed to develop model training materials for healthcare providers, patients and their families.

The law incorporates the Substance Abuse and Mental Health Administration’s definition of the term “serious mental illness” as “a diagnosable mental, behavioral, or emotional disorder that results in serious functional impairment and substantially interferes with or limits one or more major life activities.”

Importantly, the law neither changes existing regulatory exceptions under HIPAA nor directs HHS to modify them.  Instead, it calls for further explanation of existing rules that are often poorly understood by providers, patients and caregivers alike or may actually be used inappropriately to thwart the flow of meaningful and helpful information leading to barriers to effective communication that would benefit patients and improve mental health outcomes.

An existing public safety exception permits a covered entity to use or disclose PHI if the covered entity, in good faith, believes the use or disclosure is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public; and the disclosure is made to a person or persons reasonably able to prevent or lessen the threat, including the target of the threat.

The existing exception for caregivers permits disclosures to a family member, other relatives, or a close personal friend of the individual, or any other person identified by the individual, but only regarding PHI that is directly relevant to such person’s involvement with the individual’s health care or payment for care.

PHI may also be disclosed when the patient is present and provides consent, does not object to a disclosure of PHI to another individual accompanying them when given the opportunity to object, or where the covered entity reasonably infers from the circumstances, based on the exercise of professional judgment, that the patient does not object to the disclosure.

Other existing exceptions address emergency situations as well as cases where the patient is incapacitated, and permit disclosure of only the PHI that is directly relevant to the other person’s involvement with the patient’s care or payment.

The new law falls short of Rep. Murphy’s previous legislative proposals.  In 2015, Murphy introduced a bill entitled the Helping Families In Mental Health Crisis Act. which he said would “allow the doctor or mental health professional to provide the diagnosis, treatment plans, appointment scheduling, and prescription information to the family member and known caregiver for a patient with a serious mental illness. This change would apply for those who can benefit from care yet are unable to follow through on their own self-directed care.”   This bill was passed by the House by a wide margin but was not enacted.

While the new law does not expand HIPAA exceptions, it does make it more likely that those exceptions already on the books will be more clearly understood and implemented in cases involving serious mental illness.

It may not come as a surprise that Congressman Tom Price, MD (R-GA), a vocal critic of the Affordable Care Act who introduced legislation to replace it last spring, was selected to serve as Secretary of the U.S. Department of Health and Human Services (HHS) in the Trump administration. What may come as a bit of a surprise is how Price’s proposed replacement bill appears to favor transparency over individual privacy when it comes to certain health care claim information.

Section 601 of the “Empowering Patients First” bill (Bill) would require a health insurance issuer to send a report including specific claim information to a health plan, plan sponsor or plan administrator upon request (Report). The Bill would require the Report to include all information available to the health insurance issuer that is responsive to the request including … protected health information [PHI] … .”

Since a “plan sponsor” includes an employer (in the case of an employee benefit plan established or maintained by the employer), the Bill would entitle an employer to receive certain PHI of employees and employees’ dependents, as long as the employer first certifies to the health insurance issuer that its plan documents comply with HIPAA and that the employer, as plan sponsor, will safeguard the PHI and limit its use and disclosure to plan administrative functions.

The Report would include claim information that would not necessarily be PHI (such as aggregate paid claims experience by month and the total amount of claims pending as of the date of the report), but could also include:

“A separate description and individual claims report for any individual whose total paid claims exceed $15,000 during the 12-month period preceding the date of the report, including the following information related to the claims for that individual –

(i) a unique identifying number, characteristic or code for the individual;

(ii) the amounts paid;

(iii) the dates of service; and

(iv) applicable procedure and diagnosis codes.”

After reviewing the Report and within 10 days of its receipt, the plan, plan sponsor, or plan administrator would be permitted to make a written request for additional information concerning these individuals. If requested, the health insurance issuer must provide additional information on “the prognosis or recovery if available and, for individuals in active case management, the most recent case management information, including any future expected costs and treatment plan, that relate to the claims for that individual.”

Price transparency has been studied as a potentially effective way to lower health care costs, and employers are often in a difficult position when it comes to understanding what they pay, as plan sponsors, to provide health insurance coverage to employees and their families.   Laws and tools that increase the transparency of health care costs are desperately needed, and the Empowering Patients First bill valiantly attempts to create a mechanism whereby plan sponsors can identify and plan for certain health care costs. On the other hand, in requiring the disclosure of procedure and diagnosis codes to employers, and in permitting employers to obtain follow-up “case management” information, the bill seems to miss the HIPAA concept of “minimum necessary”. Even if an employer certifies that any PHI it receives will be used only for plan administration functions, employees might be concerned that details regarding their medical condition and treatments might affect employment decisions unfairly and in ways prohibited by HIPAA.

If Dr. Price steps up to lead HHS in the coming Trump administration, let’s hope he takes another look at this Section from the perspective of HHS as the enforcer of HIPAA privacy protections.

Last week, I blogged about a recent U.S. Department of Health and Human Services Office of Civil Rights (OCR) announcement on its push to investigate smaller breaches (those involving fewer than 500 individuals).   The week before that, my partner and fellow blogger Michael Kline wrote about OCR’s guidance on responding to cybersecurity incidents.  Today, TechRepublic Staff Writer Alison DeNisco addresses how a small or medium sized business (MSB) can deal with the heightened threat of OCR investigations or lawsuits emanating from a security breach.  Alison’s piece, “Security breaches:  How small businesses can avoid a HIPAA lawsuit”, is must-read for MSBs struggling to understand and prioritize their cybersecurity needs.

Michael and I spoke with Alison about the recent OCR pronouncements, and she pulled several of our comments together to create a list of tips for an SMB to consider to minimize HIPAA security breach headaches. The following 6 tips are excerpted from the full article:

  1. Hire a credible consultant to help you approach the issue, and how you would respond in the event of a breach. [In other words, perform your own security risk assessment, or, if impractical, hire an expert to perform one.]
  2. Document that you have policies and procedures in place to fight cyber crime. “If you didn’t document it, it didn’t happen,” Kline said.
  3. Stay informed of cybersecurity news in your industry, or join an association. Be aware of what other companies in your space are doing to protect themselves.
  4. Update your security settings on a regular basis, perhaps every time you add new employees or change systems, or on an annual basis.
  5. Present annually to your company board on where the company is in terms of cybersecurity protection, and where it needs to be to remain as safe as possible in the future.
  6. If you’re an IT consultant working with a healthcare organization, be clear with your client what you need to access and when, Litten said. “A client that has protected health information in its software should carefully delineate who has access to that software,” she added.

The article also quotes Ebba Blitz, CEO of Alertsec, who offers an equally important tip for the SMB dealing with employees’ use of mobile devices that contain or are used to transmit PHI:

You need a good plan for mitigating BYOD,” Blitz said. She further recommends asking employees to document their devices, so businesses can keep track of them and install security tools.

In summary, confronting ever-growing and evolving challenges of cybersecurity for SMBs is dependent upon serious planning, development and implementation of current policies and procedures, documentation of cybersecurity measures taken and entity-wide commitment to the efforts.

What you might have thought was not a big breach (or a big deal in terms of HIPAA compliance), might end up being a big headache for covered entities and business associates. In fact, it’s probably a good idea to try to find out what “smaller” breaches your competitors are reporting (admittedly not an easy task, since the “Wall of Shame” only details breaches affecting the protected health information (PHI) of 500 or more individuals).

Subscribers to the U.S. Department of Health and Human Services Office of Civil Rights (OCR) listserv received an announcement a couple of weeks ago that OCR would begin to “More Widely Investigate Breaches Affecting Fewer than 500 Individuals”. The announcement states that the OCR Regional Offices investigate all reported breaches involving PHI of 500 or more individuals and, “as resources permit”, investigate breaches involving fewer than 500.  Then the announcement warns that Regional Offices will increase efforts “to identify and obtain corrective action to address entity and systemic noncompliance” related to these “under-500” breaches.

Regional Offices will still focus these investigations on the size of the breach (so perhaps an isolated breach affecting only one or two individuals will not raise red flags), but now they will also focus on small breaches that involve the following factors:

*          Theft or improper disposal of unencrypted PHI;

*          Breaches that involve unwanted intrusions to IT systems (for example, by hacking);

*          The amount, nature and sensitivity of the PHI involved; and

*          Instances where numerous breach reports from a particular covered entity or business associate raise similar concerns

If any of these factors are involved in the breach, the reporting entity should not assume that, because the PHI of fewer than 500 individuals was compromised in a single incident, OCR is not going to pay attention. Instead, whenever any of these factors relate to the breach being reported, the covered entity (or business associate involved with the breach) should double or triple its efforts to understand how the breach occurred and to prevent its recurrence.  In other words, don’t wait for the OCR to contact you – promptly take action to address the incident and to try to prevent it from happening again.

So if an employee’s smart phone is stolen and it includes the PHI of a handful of individuals, that’s one thing. But if you don’t have or quickly adopt a mobile device policy following the incident and, worse yet, another employee’s smart phone or laptop is lost or stolen (and contains unencrypted PHI, even if it only contains that of a small handful of individuals), you may be more likely to be prioritized for investigation and face potential monetary penalties, in addition to costly reporting and compliance requirements.

This list of factors really should come as no surprise to covered entities and business associates, given the links included in the announcement to recent, well-publicized OCR settlements of cases involving smaller breaches.  But OCR’s comment near the very end of the announcement, seemingly made almost in passing, is enough to send chills down the spines of HIPAA compliance officers, if not induce full-blown headaches:

Regions may also consider the lack of breach reports affecting fewer than 500 individuals when comparing a specific covered entity or business associate to like-situated covered entities and business associates.”

In other words, if the hospital across town is regularly reporting hacking incidents involving fewer than 500 individuals, but your hospital only reported one or two such incidents in the past reporting period, your “small breach” may be the next Regional Office target for investigation. It will be the covered entity’s (or business associate’s) problem to figure out what their competitors and colleagues are reporting to OCR by way of the “fewer than 500” notice link.

In a recent Guidance, the Office of Civil Rights of the U.S. Department of Health and Human Services (“OCR”) appears to have attempted to reverse an impression that its emphasis is more on privacy of protected health information (“PHI”) than on security of PHI. Its July 2016 article draws attention to the need by covered entities and business associates for equal attention to PHI security.

Relative to this OCR initiative, our partner Elizabeth Litten and I were recently featured again by our good friend Marla Durben Hirsch in her article in the August 29, 2016 issue of Environment of Care Leader entitled “OCR: Providers need to assess cybersecurity response.” Full text can be found in the August 29, 2016 issue, but a synopsis is below.

Litten and Kline observed that the Guidance provided less specificity than prior guidance releases in the HIPAA area and seemed to be  more geared to large providers and managed healthcare systems. Nonetheless, Litten observed, “The bar [for PHI security] is higher than what some providers thought, especially if you read this with the [contemporaneous OCR] guidance on ransomware. So you may need [to take more steps] to protect your software.” Kline added, “OCR is going to say that if we tell you to do this and you don’t, tough on you.”

Some of the tips provided by Litten and Kline in the article include the following:

  1. Litten: Protect your electronic patient information if you haven’t done so already, taking into account your particular resources and limitations. “You don’t need a forensic analyst on staff, but you may want the contact information of one in your address book. If you’re not sure how to proceed or even where to start, you may need to hire a consultant to help you.”
  2. Kline: Develop policies and procedures to address cybersecurity. “The fact that you’ve done something constructive and documented that you’ve tried to comply, you’re so much better off [if you get audited by OCR].”
  3. Kline and Litten: Review your cybersecurity response policies, plans and procedures annually.
  4. Litten: Ask your electronic health record and other health IT vendors about the cybersecurity capabilities of their systems. “You want to make use of tools you have or at least know what you don’t have.”
  5. Kline: Understand that OCR considers a cybersecurity incident, not just a breach and not just ransomware, a reportable breach that must be put through the four-part risk analysis to determine whether that presumption can be refuted. “It’s not just [clear] breaches that need a HIPAA risk analysis.”
  6. Kline and Litten: Document all of your plans, policies and pro­cedures your facility has to respond to a cybersecurity incident and what you have done if you have been subject to one.
  7. Litten: Use free or easily available resources when you can. For instance, OCR has tools on its website, such as a sample risk analysis to determine vulnerabilities of electronic patient data. Your local medical societies may also offer tools, webinars and training.
  8. Litten: Make sure that your business associates also have cybersecurity protections in place. “The [G]uidance specifies that business associates as well as covered entities need to have this capability. Because it’s the covered entity that’s ultimately responsible for protecting its patient data and for reporting security breaches, it falls to the entity to ensure that the business associate complies.” So you need to ask business associates what their cybersecurity response plans entail and make sure that they’re adequate, include the fact that they have such a plan in the representa­tions and warranties of your business associate agreement, require swift reporting to you of any cybersecurity incidents suffered by a business associate and make sure that business associates limit access to your patients’ data. “You don’t want seepage of patient protected health information.”

In light of the clear concerns of OCR that covered entities and business associates, both large and small, pay sufficient attention to security of PHI, current compliance efforts should evidence relevant concrete policies and procedures that cover not only privacy but also security. Documentation of such efforts should specifically address current issues such as ransomware and risk analysis to demonstrate that the covered entity or business associate is staying current on areas deemed to be of high risk by OCR.

HIPAA turns 20 today.   A lot has changed in the two decades since its enactment.  When HIPAA was signed into law by President Bill Clinton on August 21, 1996, DVDs had just come out in Japan, most people used personal computers solely for word processing, the internet domain myspace.com had just come online, Apple stock was at a ten-year low, and Microsoft Windows CE 1.0 would soon be released (in November of 1996 as a portable operating system solution).  In December of 1996, Microsoft’s Office 97 was published in CD ROM and also available on a set of 45 3 ½ inch floppy disks.  The internet did not exist in many countries, and The New York Times took the bold step of starting its own website.  Google was also born in 1996, but few people had heard of it outside of Stanford University. Pokémon hit the market for the first time, but it wasn’t a game played on cell phones.  Even texting was a rarity:

“Most early GSM mobile phone handsets did not support the ability to send SMS text messages, and Nokia was the only handset manufacturer whose total GSM phone line in 1993 supported user-sending of SMS text messages. According to Matti Makkonen, the inventor of SMS text messages, Nokia 2010, which was released in January 1994, was the first mobile phone to support composing SMSes easily … Initial growth was slow, with customers in 1995 sending on average only 0.4 messages per GSM customer per month.” [https://en.wikipedia.org/wiki/Short_Message_Service]

According to Wikipedia, the first secure data kidnapping attack was invented by experts at Columbia University and was presented at an IEEE Privacy and Security conference in 1996.   Fast forward 20 years to the first six months of 2016, and ransomware attacks of hospitals made headlines after a hospital in Hollywood, California paid $17,000 in ransom (reportedly in bitcoins, another digital invention never considered in 1996).

The Department of Health and Human Services (HHS) released a “FACT SHEET: Ransomware and HIPAA” in July of 2016, reporting a 300% increase in ransomware attacks reported in the first 6 months of 2016 as compared with those reported in all of 2015.  It’s hard to imagine that, back in 1996 (or even in 2000 or 2003, when the Privacy Rule and Security Rule, respectively, were first promulgated) HIPAA compliance would require staving off and responding to cybersecurity attacks involving data “kidnapping”.

Over the years, this blog site has addressed many issues that were not a gleam in the eyes of the federal and state governments, healthcare organizations, insurers, patients and many other stakeholders in 1996.  Ten of these issues featured in the last two years on this blog and their links and posting dates are noted below.

  • Is Your Facility a PokéStop? (A what?) – July 20, 2016
  • HIPAA audits – April 10, 2016
  • Health Information Mobile Apps – March 31, 2016
  • The Federal Trade Commission becomes one of several competing new sheriffs in town for regulating healthcare privacy and security – January 11, 2016
  • Stolen laptops as constant sources of HIPAA privacy breaches – September 3, 2015
  • Dumpster diving as a common source of HIPAA breaches respecting paper records – July 31,  2015
  • Federal and state governments become victims of HIPAA breaches even with high levels of security – June 26, 2015
  • Countless cases of alleged theft and other crimes involving PHI or other HIPAA breaches by employees, including physicians – March 24, 2015
  • Numerous lawsuits by State Attorneys General to enforce HIPAA and state health information privacy laws – December 17, 2014
  • The “Wall of Shame” features many highly respected and well-known hospitals, universities, insurers, Fortune 500 companies and numerous other lesser-known victims – July 30, 2014

It can be expected that many more unanticipated and challenging issues will confront HIPAA in the future as the dizzying advance of technology surges onward, matched only by the boundless ingenuity of hackers and others seeking to profit from illegal activities relating to PHI.

The aftermath of the Orlando nightclub tragedy has led to much discussion about ways that healthcare providers can and should deal with compliance with health information privacy requirements in the face of disasters that injure or sicken many individuals in a limited time frame. One aspect is the pressure to treat patients while simultaneously fulfilling the need to supply current and relevant information to family, friends and the media about patient status without breaching HIPAA by improperly disclosing protected health information (PHI).

Our partner Elizabeth Litten has already posted a prior blog entry on some HIPAA issues that surfaced in the Orlando disaster. She and I were recently featured again by our good friend Marla Durben Hirsch in her article in the August, 2016 issue of Medical Practice Compliance Alert entitled “After Orlando: Keep family, friends informed without violating HIPAA.” Full text can be found in the August, 2016 issue, but a synopsis is below.

Some of the tips provided by Litten and Kline in the article include the following:

  1. Kline: Review and update your practice’s disaster/emergency plan. “[Orlando] was such a disaster, and [there was an appearance created that] the hospital didn’t approach it with calmness and a professional approach.”
  2. Litten: One of the easily forgotten parts of HIPAA is that a covered entity can exercise professional discretion. “It’s best if the patient can agree [to the disclosure]. But if the patient can’t give consent, the provider has ways to provide information and exercise that discretion.” Kline added, “So there’s no need for a HIPAA waiver; the rule anticipates such situa­tions.”
  3. Litten: Make sure that the practice’s desig­nated spokesperson is knowledgeable about HIPAA. “This includes what can and can’t be divulged to friends, family members and the media.
  4. Litten: Educate clinicians on professional discretion. “Remember when disclosing information to view it through the eyes of the patient. If you reasonably believe that a patient would want the information communicated, it’s OK. The professional is acting as proxy for a patient who can’t speak.” 
  5. Kline: Share contact information so staff can quickly get guidance from the practice’s compliance officer, especially during emer­gency situations. “For instance, a clinician being bombarded in the emergency department may have a question regarding whether she can tell a patient’s relative that the patient has been treated and released (she can).”
  6. Kline: Add this information to your practice’s HIPAA compliance program. “If you have policies and procedures on this, docu­ment that training occurred, and [if it] can show you attempted to comply with HIPAA, a court would be very hard pressed to find liability if a patient later claims invasion of privacy.” 
  7. Kline: Don’t discriminate. “So clinicians exercis­ing their professional discretion in informing friends and family members need to be gender neutral and objective.”
  8. Kline and Litten: Train administrative staff about HIPAA. “Not only should medical staff know the rules, but so should other staff members such as front desk staff, managers and billing personnel. It’s pretty bad when the head of a hospital is so uninformed about HIPAA that he provides misinformation to the mayor.”
  9. Kline and LittenHighlight the limitations of the disclosure. “You can’t go overboard and reveal more than is allowed. For instance, a provider can tell a friend or family member about an incapacitated patient’s location, general condition or death. But that doesn’t mean that he can divulge that the lab tests indicate the patient has hepatitis. HIPAA also requires that a disclosure be made only of information that’s ‘minimally necessary.'”

Planning ahead by healthcare providers can help them comply with HIPAA if a disaster situation occurs to keep family and friends informed as to patient status, while contemporaneously carrying out their most important tasks: saving lives, alleviating pain and providing quality care to victims. This approach, however, combined with a good helping of common sense and professionalism, is not confined to disasters – it should be the practice of providers for non-emergent situations as well.

 

Are strangers wandering around your health care facility with their noses buried in their smartphones? And if so, what should you do about it? They’re playing Pokémon GO, a location-based augmented reality mobile game that was released for iOS and Android devices on July 6, 2016. Its popularity exceeded all expectations (my kids are probably playing it right now).

The game’s objective requires players to search in real-world locations for icons that appear on a GPS-like virtual map. The icons may represent PokéStops where players may find and capture Pokémon (“pocket monster” characters) that appear on the player’s phone superimposed over images of the real-world location when in augmented reality (AR) mode, and “Gyms” where they can virtually battle other players. Niantic, Inc., a Google spinoff, developed the game and based its PokéStops and Gyms on user-contributed locations (“portals”) from its previous augmented reality game, Ingress. These sites include businesses, parks, public buildings, museums, churches, private homes, and yes, even hospitals.

When players encounter Pokémon, they can take screen shots using their phone’s camera, which in AR mode will also capture whatever is in the background at the time. Naturally, this is giving hospitals and other healthcare facilities some concerns about safety, privacy, and maintaining a peaceful healing environment.  Indeed, in extreme cases of “invasion by Pokémon GO players,” the law of tort or criminal trespass could possibly be invoked by a health care facility in many jurisdictions. Simply stated, the action of trespass can be maintained against anyone who interferes with the right of ownership or possession of land, whether the invasion is by a person or by something that a person has set in motion. However, such an action would undoubtedly create a media sensation and must be carefully considered before undertaking it

The game has already made headlines for contributing to incidents where deeply-absorbed players have been injured by following their phones into the path of danger. The Advisory Board reports that the game has directed players near a hospital’s helipad Amid ‘Pokémon Go’ craze, hospitals say game players could jeopardize patient safety. Healthcare Business and Technology reports “The sheer amount of unauthorized visitors has raised safety concerns about everything from security issues to increased germ exposure that heightens patients’ risk of infections.” Pokemon Go causes problems for hospitals: How to respond.

Ban it? Embrace it?

Accordingly, some hospitals have asked players to avoid their campuses or banned the game outright. Others have forbidden their staffs from playing the game while on site, according to Healthcare IT News. The game appeals to a surprisingly wide age group since many adults have fond memories of playing the original Nintendo game in the mid-1990’s.

For HIPAA purposes, the use of smartphone cameras in the game can be problematic. At a recent meeting of the Healthcare Council of Western Pennsylvania, compliance officers reported that they had discovered PokéStops in their facility near patient care areas where records were potentially visible. Hospitals certainly do not want to encourage or permit individuals to wander their halls who are not there to obtain care or visit patients they know.

Many hospitals have policies on use of cameras or camera phones on campus, and those policies should be reviewed and recirculated to staff as well as communicated to patients and visitors in light of the popularity of the game.

Some children’s hospitals, however, are big fans of the game and its ability to motivate hospitalized kids to be more physically active and socially interactive. USA Today reports:

In the past, young patients at C.S. Mott Children’s Hospital in Ann Arbor, Mich., shuffled down the hallways without speaking to each other, but now it’s not uncommon to see them stop and talk near a Pokémon Go hotspot.

Advocate Children’s hospital in Oak Lawn/Park Ridge, IL tweeted a photo of a young patient playing the game with the caption “Luke’s mom says @Pokemon Go has been a lifesaver to get him out of his hospital room and moving around!” We hope they had Luke’s mom’s permission for the tweet. Toronto’s Sunnybrook Hospital tweeted : “We love that #PokemonGO encourages exercise! Remember: stay alert & safe. Can’t catch ’em all from a hospital bed.” Of course HIPAA is not an issue in Canada, but there is Ontario’s Personal Health Information Protection Act (PHIPA). And a meme is circulating featuring an anime-style nurse which reads “

Hey Pokémon Go players. Have extra lures? Then drive to your nearest Children’s Hospital and drop the lure there. There are plenty of kids who would love to go out and collect Pokémon, but they are stuck in bed, so this will help them.”

(Lures are markers players can collect and distribute within the game that help attract Pokémon).

Wipe yourself off the map?

Hospitals are not the only unwilling hosts of PokéStops and Gyms. The Holocaust Museum and Arlington National Cemetery are among locations that are included in the game’s map. As a result of objections, Niantic has set up a link to a form on its web site through which you can request removal of a PokéStop or Gym. It is not clear how long it will take for the company to remove an unwelcome site.

It’s common these days for technology to outpace policy, but it’s a good idea to understand this sudden craze and decide how to approach it in your organization.