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The new Apple Watch Series 4® is one of the more recent and sophisticated consumer health engagement tools. It includes a sensor that lets wearers take an electrocardiogram (ECG) reading and detect irregular heart rhythms. The U.S. Food & Drug Administration (FDA) recently approved these functions as Class II medical devices, which generally means that they have a high to moderate risk to the user. The FDA approval letters describe the Apple Watch Series 4 functions as intended for over-the-counter use and not to replace traditional methods of diagnosis or treatment.

Tech developers and HIPAA lawyers often mean different things when describing a health app or medical device as HIPAA compliant. For example, a health app developer will likely focus on infrastructure, whereas the lawyer will likely focus on implementation. When asked about HIPAA, the app developer might rely on International Organization for Standardization (ISO) certification to demonstrate its data privacy and security controls and highlight how the infrastructure supports HIPAA compliance. The HIPAA lawyer, on the other hand, will likely focus on how (and by whom) data is created, received, maintained and transmitted and must look to the HIPAA regulations and guidance documents issued by the U.S. Department of Health and Human Services (HHS) to determine when and whether the data is subject to HIPAA protection. ISO certification does not equate to HIPAA certification; in fact, there is no HIPAA compliance certification process, and it is often difficult from the outset to determine if and when HIPAA applies.

As discussed in this prior blog post, HHS’s guidance on various “Health App Scenarios” underscores that fact that health data collected by an app may be HIPAA-protected in some circumstances and not in others, depending on the relationship between an app developer and a covered entity or business associate. The consumer (or app user) is unlikely to understand exactly when or whether HIPAA applies, particularly if the consumer has no idea whether such a relationship exists.

Back to the Apple Watch Series 4, and the many other consumer-facing medical devices or health apps in already on the market or in development. When do the nuances of HIPAA applicability begin to impede the potential health benefits of the device or app? If I connect my Apple Watch to Bluetooth and create a pdf file to share my ECG data with my physician, it becomes protected heath information (PHI) upon my physician’s receipt of the data. It likely was not PHI before then (unless my health care provider told me to buy the watch and has process in place to collect the data from me).

Yet the value of getting real-time ECG data lies not in immediate user access, but in immediate physician/provider access. If my device can immediately communicate with my provider, without my having to take the interim step of moving the data into a separate file or otherwise capturing it, my physician can let me know if something is of medical concern. I may not want my health plan or doctor getting detailed information from my Fitbit® or knowing whether I ate dessert every night last week, but if I’m at risk of experiencing a medical emergency or if my plan or provider gives me an incentive to engage in healthy behavior, I may be willing to allow real-time or ongoing access to my information.

The problem, particularly when it comes to health apps and consumer health devices, is that HIPAA is tricky when it comes to non-linear information flow or information that changes over time. It can be confusing when information shifts from being HIPAA-protected or not, depending on who has received it. As consumers become more engaged and active in managing health conditions, it is important that they realize when or whether HIPAA applies and how their personal data could be used (or misused) by recipients. Findings from Deloitte’s 2018 consumer health care survey suggest that many consumers are interested in using apps to help diagnose and treat their conditions. For example, 29% were interested in using voice recognition software to identify depression or anxiety, but perhaps not all of the 29% would be interested in using the software if they were told their information would not be protected by HIPAA (unless and until received by their provider, or if the app developer was acting as a business associate at the time of collection).

Perhaps certain HIPAA definitions or provisions can be tweaked to better fit today’s health data world, but, in the meantime, health app users beware.

You may be surprised to learn that those “extra” benefits your company offers to its employees such as your employee assistance program (“EAP”) and wellness program likely are subject to the HIPAA privacy, security and breach notification rules (collectively, “HIPAA Rules”). Part 1 covers why most EAPs are subject to the HIPAA Rules. Part 2 will discuss wellness programs. In both cases, EAPs and wellness programs must comply with the HIPAA Rules to the extent that they are “group health plans” that provide medical care.

As background, the HIPAA Rules apply to “covered entities” and their “business associates.” Health plans and most healthcare providers are “covered entities.” Employers, in their capacity as employers, are not subject to the HIPAA Rules. However, the HIPAA Rules do apply to any “protected health information” (“PHI”) an employer/plan administrator holds on a health plan’s behalf when the employer designs or administers the plan.

Plan administrators and some EAP vendors may not consider EAPs to be group health plans because they do not think of EAPs as providing medical care. Most EAPs, however, do provide medical care. They are staffed by health care providers, such as licensed counselors, and assist employees who are struggling with family or personal problems that rise to the level of a medical condition, including substance abuse and mental health issues. In contrast, an EAP that provides only referrals on the basis of generally available public information, and that is not staffed by health care providers, such as counselors, does not provide medical care and is not subject to the HIPAA Rules.

A self-insured EAP that provides medical care is subject to the HIPAA Rules, and the employer that sponsors and administers the EAP remains responsible for compliance with the HIPAA Rules because it acts on behalf of the plan.   On the other hand, for an EAP that is fully-insured or embedded in a fully-insured policy, such as long-term disability coverage, the insurer will have the primary obligations for compliance with the HIPAA Rules for the EAP. The employer will not be responsible for overall compliance with the HIPAA Rules for an insured EAP even though it provides medical care, but only if the employer does not receive PHI from the insurer or only receives summary health information or enrollment/disenrollment information. Even then, the employer needs to ensure it doesn’t retaliate against a participant for exercising their rights under the HIPAA Rules or require waiver of rights under the HIPAA Rules with respect to the EAP.

An EAP that qualifies as an “excepted benefit” for purposes of HIPAA portability and the Affordable Care Act (as is most often the case because the EAP is offered at no cost, eligibility is not conditioned on participation in another plan (such as a major medical plan), benefits aren’t coordinated with another plan, and the EAP does not provide “significant benefits in the nature of medical care”) can be subject to the HIPAA Rules. In other words, just because you’ve determined that your EAP is a HIPAA excepted benefit doesn’t mean the EAP avoids the HIPAA Rules. Most EAPs are HIPAA excepted benefits, yet subject to full compliance with the HIPAA Rules.

Employers/plan administrators facing unexpected compliance obligations under the HIPAA Rules because of a self-insured EAP that provides medical care will need to enter into a HIPAA business associate agreement with the EAP vendor, amend the EAP plan document to include language required by the HIPAA Rules and develop and implement other compliance documents and policies and procedures under the HIPAA Rules. One option is to amend any existing compliance documents and policies and procedures under the HIPAA Rules for another self-insured group health plan to make them apply to the EAP as well. If the EAP is the plan administrator’s only group health plan for which it has compliance responsibility under the HIPAA Rules, the plan administrator should consult with legal counsel to develop and implement all necessary documentation for compliance with the HIPAA Rules.

Our partner Elizabeth Litten and I were recently featured again by our good friend Marla Durben Hirsch in her article in the April 2017 issue of Medical Practice Compliance Alert entitled “Business associates who farm out work create more risks for your patients’ PHI.” Full text can be found in the April, 2017 issue, but a synopsis is below.

In her article Marla cautioned, “Fully one-third of the settlements inked in 2016 with OCR [the Office of Civil Rights of the U.S. Department of Health and Human Services] dealt with breaches involving business associates.” She pointed out that the telecommuting practices of business associates (“BAs”) and their employees with respect to protected health information (“PHI”) create heightened risks for medical practices that are the covered entities (“CEs”) — CEs are ultimately responsible not only for their own HIPAA breaches but for HIPAA breaches of their BAs as well.

Kline observed, “Telecommuting is on the rise and this trend carries over to organizations that provide services to health care providers, such as billing and coding, telehealth providers, IT support and law firms.” Litten commented, “Most business associate agreements (BAAs) merely say that the business associate will protect the infor­mation but are not specific about how a business associate will do so, let alone how it will when PHI is off site.”

Litten and Kline added, “OCR’s sample business associate agreement is no dif­ferent, using general language that the business associate will use ‘appropriate safeguards’ and will ensure that its subcontractors do so too.”

Kline continued, “You have much less control over [these] people, who you don’t even know . . . . Moreover, frequently practices don’t even know that the business associate is allowing staff or subcontractors to take patient PHI off site. This is a collateral issue that can become the fulcrum of the relationship. And one loss can be a disaster.”

Some conclusions that can be drawn from Marla’s article include the following items which a CE should consider doing  when dealing with BAs:

  1. Select BAs with due care and with references where possible.
  2. Be certain that there is an effective BAA executed and in place with a BA before transmitting any PHI.
  3. Periodically review and update BAAs to ensure that they address changes in technology such as telecommuting, mobile device expansion and PHI use and maintenance practices.
  4. Ask questions of BAs to know where they and their employees use and maintain PHI, such as on laptops, personal mobile devices or network servers, and what encryption or other security practices are in place.
  5. Ask BAs what subcontractors (“SCs”) they may use and where the BAs and SCs are located (consider including a provision in BAAs that requires BAs and their SCs to be legally subject to the jurisdiction of HIPAA, so that HIPAA compliance by the CE and enforcement of the BAA can be more effective).
  6. Transmit PHI to the BA using appropriate security and privacy procedures, such as encryption.
  7. To the extent practicable, alert the BA in advance as to when and how transmission of PHI will take place.
  8. Obtain from each BAA a copy of its HIPAA policies and procedures.
  9. Maintain a readily accessible archive of all BAAs in effect to allow quick access and review when PHI issues arise.
  10. Have a HIPAA consultant available who can be contacted promptly to assist in addressing BA issues and provide education as to best practices.
  11. Document all actions taken to reduce risk from sharing PHI with BAs, including items 1 to 10 above.

Minimizing risk of PHI breaches by a CE requires exercising appropriate control over selection of, and contracting and ongoing interaction with, a BA. While there can be no assurance that such care will avoid HIPAA breaches for the CE, evidence of such responsible activity can reduce liability and penalties should violations occur.

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 Litten: Highlight 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.

 

My heart goes out to any family member trying desperately to get news about a loved one in the hours and days following an individual or widespread tragedy, irrespective of whether it was triggered by an act of nature, an act of terrorism, or any other violent, unanticipated, life-taking event. My mind, though, struggles with the idea that HIPAA could actually exacerbate and prolong a family member’s agony.

HIPAA is, generally speaking, intended to protect our privacy when it comes to health status, treatment, or payment and to facilitate appropriate access to our health information. But, as is typical with federal laws intersecting areas historically governed by State law, HIPAA defers to State law in some key respects.  For example, if a HIPAA provision is contrary to a similar provision of State law, it preempts State law unless the State law relates to the privacy of individually identifiable health information and is “more stringent” than the comparable HIPAA provision.  HIPAA also references “applicable law” in describing who can get information as a personal representative of an individual or act on behalf of a deceased individual.

So what does this mean in the context of family members seeking information about loved ones following the devastating Orlando, Florida night club shooting or following some other violent tragedy?

If a victim is hospitalized and a friend or family member is trying to get information about the victim, HIPAA permits the hospital to share information under the following circumstances:

*          A hospital may use protected health information (PHI) to notify or assist in the notification of a family member, personal representative or other person responsible for the patient’s care of the patient’s location, general condition or death

*          A hospital can use a facility directory to inform visitors and callers of a patient’s location and general condition

*          A hospital can release information as to the victim of a crime in response to law enforcement’s request for such information under certain circumstances, and law enforcement can notify the families

*          If the patient is competent, the patient can tell the hospital that it may release all information to their family and friends

*          If the patient is not competent to authorize release of information, a “personal representative” (a person authorized under State law to act on behalf of the patient to make health care decisions) can have all information necessary to make decisions.  That person can also authorize release of information to others

Sadly, the agony of loved ones seeking information about a patient may be prolonged if they are not viewed as family members or if State law does not recognize the loved one as a “personal representative”.  Sure, the federal Department of Health and Human Services (HHS) could amend the HIPAA regulations to deem certain individuals (for example, same-sex partners who are not legally married) to be personal representatives for purposes of access to PHI.  [Note: HHS treats legally married same-sex spouses as “family members” under HIPAA — see special topic publication available here.]

However, if the State law does not recognize these certain individuals as personal representatives, perhaps because the State law is “more stringent than” HIPAA in affording the patient greater privacy, HHS might also have to amend its HIPAA preemption regulations.

Hospitals and other health care professionals are constantly called upon to exercise discretion in dealing with requests for PHI from family members and loved ones of patients while complying with HIPAA.   HIPAA regulations may need to be modified or perhaps could be “waived” (as described yesterday’s Washington Post article) in some cases, but only when doing so furthers the fundamental HIPAA goals of privacy protection and facilitation of appropriate access.

Because of the enormity of the Orlando tragedy, some State legislatures may be expected to consider whether changes are necessary to promote information sharing in exigent circumstances while preserving the State’s interest in affording patients greater privacy protection than that afforded by HIPAA.

Daily struggles to protect personal data from hacking, phishing, theft and loss make it easy to forget that HIPAA is not just about privacy and security.  It also requires covered entities (CEs) to make an individual’s protected health information (PHI) accessible to the individual in all but a few, very limited circumstances.  Recent guidance published by the Department of Health and Human Services (HHS Guidance) emphasizes the need for covered entities to be able to respond to an individual who says “I want my PHI” in a way that complies with HIPAA and state law access requirements, even when these requirements seem confusing and contradictory.

HIPAA authorizations are, perhaps, one of the most commonly misunderstood and misused forms. The HHS Guidance helpfully reminds CEs that authorizations are not needed for a CE to share PHI for treatment, payment and health care operations, and, of course, a CE can share PHI with a business associate under a HIPAA-compliant business associate agreement.  But when an individual requests PHI, whether directly or through a third party, it’s critical that the CE understand whether it is an access request or a request for disclosure pursuant to a HIPAA-compliant authorization.

My law partner and fellow HIPAA enthusiast Beth Larkin comments on some of the difficulties a CE faces when responding to an individual’s access request, highlighting the need to distinguish between an access request and disclosure pursuant to an authorization:

The HHS guidance wants CEs to provide individuals “easy access” to their health information.  CEs still, however, have to deal with other HIPAA requirements, including verification of the identity of the requestor, securing the PHI from unauthorized access and determining breach if there is unauthorized access.  Also, it is not always clear whether a patient is exercising an access right or requesting PHI pursuant to an authorization.  The patient may not know the difference and just indicates he or she wants copies of records and may present either an access request or an authorization form.

The HHS Guidance explains that while a CE can require an individual to submit a written access request, it can’t do so in a manner that creates a barrier or would delay the individual’s access:

For example, a doctor may not require an individual: …  [t]o use a web portal for requesting access, as not all individuals will have ready access to the portal …

If a CE uses a written form for individuals to request access to records (and ensures the form is readily accessible in multiple ways), the CE should give individuals as much information as possible about each form.

For example, as illustrated in the chart included in the HHS Guidance, a HIPAA authorization permits, but does not require, a CE to disclose the PHI.  An access request requires the disclosure (and requires the CE to act on the request within 30 days).  In addition, HHS explains that fees charged by the CE are limited when the individual requests access, and not when PHI is requested pursuant to an authorization (though certain charges might be prohibited under HIPAA regulations proscribing the receipt of remuneration for the disclosure of PHI). Finally, HHS notes that PHI sent pursuant to an authorization must be sent securely, while an individual can request that PHI sent pursuant an access request can be sent through an unsecure medium (though the risks of such a choice should be communicated to the individual if feasible).  If the CE makes all of this information clear and encourages the individual to ask questions as to which form should be used, it seems reasonable for a CE to then be able to rely on the individual’s choice of form.

When a third party requests an individual’s PHI, though, it can be especially difficult for a CE to figure out whether an authorization form has been sent when an access request would have been appropriate. Here, HHS suggests the CE reach out to the individual:

Where it is unclear to a covered entity, based on the form of request sent by a third party, whether the request is an access request initiated by the individual or merely a HIPAA authorization by the individual to disclose PHI to a third party, the entity may clarify with the individual whether the request was a direction from the individual or a request from the third party.

In short, if a HIPAA authorization is really an individual’s misguided attempt to say “I want my PHI!”, the CE will need to make sure it follows the individual access right requirements in responding.

This week’s headlines read: “Scalia’s death probably linked to obesity, diabetes and coronary artery disease, physician says” and “Scalia suffered from many health problems”.   An article from a couple of weeks ago, immediately following reports of Justice Scalia’s February 13th death, reported that Scalia’s doctor said he had chronic cardiovascular disease.

These articles do not say whether the physician(s) who released Scalia’s health information did so in compliance with HIPAA, or whether any subsequent release of this information was HIPAA-compliant. The HIPAA regulations make it clear that the death of an individual does not mean the death of that individual’s right to have his or her individually identifiable health information protected under HIPAA (at least, not until the individual has been deceased for more than 50 years).

Justice Scalia’s status as a public figure, and the public’s general interest in the news of his death, also does not affect his HIPAA rights. As noted in Bill Maruca’s post about New York Giants’ defensive end Jason Pierre-Paul’s injuries last summer, there is no “public figure exception” to HIPAA.  Bill also accurately noted, in his blog about the Ebola cases treated in Texas in 2014, that there is no HIPAA exception for “newsworthy or unusually terrifying medical conditions.”

HIPAA permits a covered entity to disclose protected health information (PHI) to a coroner or medical examiner for the purpose of identifying a cause of death, but does not authorize  the coroner or medical examiner to further disclose the PHI. Because HIPAA also permits an executor, administrator, or other person who has authority to act on behalf of a deceased individual to act as the deceased person’s personal representative, such an authorized person might have provided a HIPAA-compliant authorization to Scalia’s health care providers to disclose Scalia’s PHI to third parties.  In addition, there are other ways in which PHI of someone who has died might be disclosed in compliance with HIPAA, but none of the articles I read provide the detail needed to see whether these circumstances existed.

The articles do, however, make it clear that the late Justice suffered an array of health issues that were not publicized prior to his death.

What would Justice Scalia have said, if, in fact, his PHI was disclosed improperly? His decisions involving the Fourth Amendment may provide some clues, but they are not precisely on point, and we cannot ask the Justice.  We can simply remind covered entities that HIPAA protections have an after-life —  and deserve (in fact, require) post-mortem respect.

 

A thoughtful reader responded to our last post, Debunking a Viral “Medical Hack” Meme,  which advised health plan subscribers to cite certain HIPAA compliance issues in efforts to overturn unfavorable insurance coverage decisions.

Jeff Knapp wrote:

This meme just popped up in my Facebook news feed this morning, and I was happy to see you addressed it so quickly. I too immediately noticed several flaws. In addition to the ones you noted here, there is certainly no right under HIPAA for an individual to speak with a covered entity’s privacy officer. While it’s true that a covered entity must designate a contact person or office, in my experience the contact person/office and the privacy officer are not the same. Typically, a privacy officer is dealing with higher-level issues than responding to requests for documents. I always enjoy reading your blog posts.

Mr. Knapp accurately notes that there is no right to contact a privacy officer, and in fact, HIPAA provides no private right of action for an individual whose protected health information was improperly accessed.  See Why Can’t I Sue Under HIPAA for a Breach of my Protected Health Information? What Can I Do?

Moreover, if the individual disputing a coverage decision is covered by a self-insured plan sponsored by his or her employer, the strategy advocated by the meme could easily backfire, notwithstanding any separation of insurance administration and human resources functions within an employer’s management structure, whether nominal or reasonable.

Since the early days of HIPAA, a steady trickle of misinterpretations, misunderstandings and half-truths have circulated informally both within the medical community and among the general public.  The prevalence of social media only amplifies the effect. For example, a meme currently making the rounds on Facebook suggests using HIPAA as a strategy for convincing a health insurer to reverse a coverage denial decision.  The post, entitled “Medical Hack,” began appearing this month.  While containing some accurate information, the post contains a number of flaws.

hipaa-medical-hack-insurance

It reads as follows:

So, your doctor ordered a medical test or treatment and your insurance company denied it. That is a typical cost saving method.

OK, here is what you do:

1. Call the insurance company and tell them you want to speak with the “HIPAA Compliance/Privacy Officer” (By federal law, they have to have one)

2. Then ask them for the NAMES and CREDENTIALS of every person accessing your record to make that decision of denial. By law you have a right to that information.

3. They will almost always reverse the decision very shortly rather than admit that the committee is made of low paid HS graduates, looking at “criteria words,” making the medical decision to deny your care. Even in the rare case it is made by medical personnel, it is unlikely it is made by a board certified doctor in that specialty and they DO NOT WANT YOU TO KNOW THIS!

4. Any refusal should be reported to the US Office of Civil Rights (OCR.gov) as a HIPAA violation.

As with any viral post, it is prudent to fact-check this advice with reliable sources such as Snopes.com.  Sure enough, Snopes has addressed the “hack” and classified it a mixture of true, false and undetermined information.   See http://www.snopes.com/hipaa-medical-hack-insurance-claim-denials/

To their credit, the fact-checkers at Snopes picked up on several flaws in the strategy suggested in the hack, particularly the fact that neither HIPAA nor the Affordable Care Act require insurers to base decisions to deny coverage of services or medications on the decision of a doctor, let alone a doctor that is board certified in the specialty under which that treatment fell.  (In fact, these issues are primarily regulated by state insurance laws.)   To that effect, Snopes notes:

… if insurance companies are entitled to deny coverage on a discretionary basis without the say-so of a doctor, there’s no reason a non-mandated process would be outlined through any plan resource or HHS guideline. Asking for such documentation would make as much sense as someone demanding a receipt for a donut you didn’t buy.

However, the most critical flaw in the suggested strategy is the fact that insurers and other covered entities are not required to account for all internal disclosures (and even many external disclosures for that matter), and disclosures for payment or health care operations purposes are specifically carved out of the accounting requirement in 45 C.F.R. 164.528(a).  Insurance clerks, regardless of their level of education, are likely to be utilizing patient records for payment and operations purposes when processing claims denials.

With regard to the requirement to designate a  “HIPAA Compliance/Privacy Officer,” the Snopes report stated “We were unable to locate any relevant portion of the act that specifically mandated what the meme claimed.”   In fact,  45 C.F.R. § 164.530 states:

(a)(1) Standard: Personnel designations.(i) A covered entity must designate a privacy official who is responsible for the development and implementation of the policies and procedures of the entity.

A better approach for health insurance subscribers facing denial of a treatment ordered by their physician is to follow the appeal mechanisms specified in their plans, and check their rights under applicable state law. For instance, Pennsylvania’s Act 68 includes certain standards for managed care plans and offers complaint and grievance procedures for individuals.

Lesson: Viral memes are often an unreliable source of legal advice.  I’m a major fan of Snopes.com, but sometimes even Snopes doesn’t get all the details.

Congratulations!  You have a HIPAA-compliant business associate (or subcontractor) agreement in place – now what? How can you implement the agreement without becoming a HIPAA guru?

There are many resources available that offer detailed guidance on risk analysis and implementation protocols (such as the Guide to Privacy and Security of Electronic Health Information published by the Office of the National Coordinator for Health Information Technology and numerous “Special Publications” issued by the National Institute of Standards and Technology (NIST)).

These are terrific resources and can keep a team of IT professionals and Privacy and Security Officers reading and scratching their heads for weeks, but here are a few simple and practical steps you can take to avoid the security incident that may result in a protected health information (PHI) breach.

  1. Make sure the covered entity knows which individual(s) is authorized to receive PHI at the business associate. If neither the services agreement nor the business associate agreement specifies the person to whom PHI is to be disclosed, make sure the name, title and contact information of any designated recipient is communicated to the covered entity in writing.
  2. Include a provision in the business associate agreement (or subcontractor agreement) or develop a process whereby the covered entity (or business associate) provides notice, when feasible, prior to transmitting PHI to the designated recipient. Particularly when the transmission of PHI is sporadic or infrequent, provision of advance notice helps heighten awareness of the parties’ HIPAA obligations with respect to particular data being transmitted.
  3. Establish an agreed-upon means of PHI transmission – for example, specify whether transmission will be made via encrypted email, portable device, hard copy, etc. – and document the chain of custody from covered entity to business associate and after receipt by business associate.
  4. Create a “vault” for PHI received by the business associate that is secured by access codes that are changed periodically and can be deactivated when personnel leave the employ of the business associate.
  5. Maintain a perpetual inventory of PHI repositories, delegating responsibility to the Security Officer to oversee or authorize repository access rights, review activity, and conduct regular audits.