The Connecticut Supreme Court handed down a decision in the case of Byrne v. Avery Center for Obstetrics and Gynecology, P.C., — A.3d —-, 2014 WL 5507439 (2014) that

[a]ssuming, without deciding, that Connecticut’s common law recognizes a negligence cause of action arising from health care providers’ breaches of patient privacy in the context of complying with subpoenas, we agree with the plaintiff and conclude that such an action is not preempted by HIPAA and, further, that the HIPAA regulations may well inform the applicable standard of care in certain circumstances.

Interestingly, the decision is dated November 11, 2014, the federal holiday of Veterans Day, but was available on Westlaw on November 7, 2014.  The Court’s decision was rendered 20 months after the date that the case was argued on March 12, 2013.

The decision adds the Connecticut Supreme Court to a growing list of courts that have found that HIPAA’s lack of a private right of action does not necessarily foreclose action under state statutory and common law.  The Byrne case, however, has added significance, as it appears to be the first decision by the highest court of a state that says that state statutory and judicial causes of action for negligence, including invasion of privacy and infliction of emotional distress, are not necessarily preempted by HIPAA.  Moreover, it recognized that HIPAA may be the appropriate standard of care to determine whether negligence is present.

The Byrne case has important implications for HIPAA matters beyond the rights of individuals to sue under state tort law, using HIPAA regulations as the standard of care.  For example, in the area of business associate agreements (“BAAs”) and subcontractor agreements (“SCAs”), as was discussed in a posting in October 2013 on this blog relating to indemnification provisions,

there should be a negation of potential third party beneficiary rights under the BAA or SCA. For example, HIPAA specifically excludes individual private rights of action for a breach of HIPAA – a [p]arty does not want to run a risk of creating unintentionally a separate contractual private right of action in favor of a third party under a[n indemnification] [p]rovision.

A party should, therefore, endeavor to limit the number of persons that may assert a direct right to sue for indemnification resulting from a breach of a BAA.  Failing to limit the number of persons that may assert a direct right to sue for indemnification resulting from a breach of a BAA or SCA can be costly indeed, especially if the number of states that follow the Byrne case principles increases.

Efforts to use HIPAA regulations as standards for causes of action under state law can be expected to rise as a result of the Byrne decision.  Covered entities, business associates and subcontractors should consider acquiring sufficient cybersecurity insurance with expanded coverage and limits.

The number of large breaches of Protected Health Information (PHI) under HIPAA that have been reported on the so-called “Wall of Shame” (the HHS List) maintained by the U.S. Department of Health and Human Services has jumped by 239 to 885 in less than a year.    The most common breach type is “theft” in this ever-lengthening parade on the HHS List of PHI breaches affecting 500 or more individuals (the List Breaches). Previous blog posts in this series including those discussed here and here discussed the volume of List Breaches that occurred in earlier periods.

It took nearly 3½ years between the inception of the HHS List on March 4, 2010 and August 13, 2013, to reach 646 postings, for an annualized average of approximately 189 postings per twelve-month period. In less than twelve months from August 13, 2013 to July 29, 2014, 239 more marchers have joined the parade on the HHS List.

A total of 430 or almost one-half (48.6%) of the total of 885 List Breaches reported the breach type to involve “theft” of all kinds, including laptops, other portable electronic devices, desktop computers, network servers, paper records and others. If the approximately 73 additional List Breaches that have reported the breach type as a “loss” of various types (excluding as a loss item any List Breach that also reported theft as a breach type) is added to the 430 theft events, the total for the two categories swells to approximately 503 or 56.8% of the 885 posted List Breaches. Combining the two categories appears to make some sense, as it is likely that a number of the List Breaches categorized as a “loss” event may have involved some criminal aspects.

Even more significant may be the fact that approximately 272 (30.7%) of the List Breaches reflected the cause or partial cause of the breach to be “theft” or “loss” respecting laptops or other portable electronic devices (collectively, Portable Devices). Theft or loss of Portable Devices thus constituted 54.1% of the approximately 503 List Breaches that reported theft or loss as the breach type.

As has been emphasized in the past, it may have become more a question of when a covered entity (CE), business associate (BA) or subcontractor (SC) will suffer a PHI security breach and how severe the breach will be, rather than if it will ever suffer a breach. The geometric increase in Portable Devices that can create, receive, maintain and transmit PHI requires CEs, BAs and SCs to perform adequate risk assessments and establish effective policies and procedures respecting employer-supplied and personally-owned Portable Devices.

Does your business associate agreement (BAA) reflect your business deal, or is it a bare bones HIPAA compliance document?

Now is the time to check. The HIPAA “Omnibus Rule” published in January of 2013 gave covered entities, business associates, and subcontractors until September 22, 2014 to make their business associate agreements (BAAs) compliant, so use the next few weeks to make sure your BAA complies with the law and reflects your business deal.

skeleton
Copyright: clairev / 123RF Stock Photo

HHS published a bare bones sample BAA when the Omnibus Rule came out, and a number of posts to this blog provide tips that can be used in reviewing and updating your BAA.

But don’t forget that a good BAA supports and is supported by the underlying services contract between the parties, and should be the meat on the bones of the BAA and the brain behind it. A perfectly HIPAA-compliant BAA will crumble into dust if it’s not written to reflect and support the services contract and underlying business deal. Here are two key questions to ask to make sure the business deal and BAA are working in synch:

Question 1: Who are the parties to the BAA?

  • What are the roles of the parties under HIPAA? Check definitions and what is being performed by one party “on behalf of” the other.
  • If the business associate is really a subcontractor (because the covered entity is really a business associate or subcontractor itself), does the BAA (or subcontractor agreement (SA)) recognize and describe the privacy and security obligations imposed by the BAA above it? Has such BAA or subcontractor actually reviewed the BAA or SA above it?
  • If both parties are covered entities, does the BAA clearly describe when the business associate is acting as such, and not as its own covered entity?
  • Will the covered entity ever act as a business associate in relation to the other party?

Question 2: What is the business reason for or purpose of the use and/or disclosure of protected health information (PHI)?

  • What is the reason PHI is being created, received, maintained or transmitted on behalf of the covered entity, business associate or subcontractor?
  • Do the parties have reciprocal obligations to abide by privacy and security standards, such as minimum necessary standards?
  • Will the business associate (or subcontractor) have any claim to own, de-identify, aggregate, modify or keep data derived from the PHI that is the subject of the BAA (for example, will the business associate’s activities with respect to the PHI under the BAA produce other data or data sets not subject to or contemplated by the services contract)?

The bottom line? Before the summer fades (and certainly before September 22nd), make sure your BAA meets the Omnibus Rule requirements, but also make sure it reflects and supports your business deal. The bare bones BAA may not be what you want or need.

Michael J. Coco writes:

If you have ever bought or sold a business, or you have experience with the process, you are aware of the due diligence efforts and multiple agreements required to close the deal. Transactions involving the sale or purchase of health care related business, such as a medical practice, often take the form of asset purchases, set in motion by executing an asset purchase agreement (“APA”). The APA can be a voluminous document written by the purchaser to protect the purchaser. APAs have been known to cover every conceivable circumstance that may reflect negatively on the purchaser after the acquisition. APAs have been known to cover everything from the seller’s violation of a local ordinance to more serious violations, including violations of federal law. With a novelette of protective provisions, a well-written APA seems to cover everything. But like all legal documents, a typical APA needs to keep up with evolving law and, in the case of health care, the law evolves quickly.

Major and fairly recent changes in healthcare law include the clear requirement under applicable HIPAA provisions for covered entities to have business associate agreements in place and for business associates to have subcontractor agreements in place. Breach notification rules and penalties have also been created or refined under HIPAA. The typical APA requires the seller to represent that it has not violated any law, and often expands this representation to its employees. However, few APAs discuss potential HIPAA breaches by employees, or breaches by business associates. More importantly, there may be no specific representation that the seller has in place all of the appropriate business associate agreements.

Although a good due diligence review should evaluate business associate agreements, the purchaser should consider adding specific business associate agreement and breach representations, along with the corresponding indemnification provisions. Buyers should request copies of all business associate agreements currently in place, as well as any subcontractor agreements. In addition, the buyer should ask a seller to disclose any circumstance in which it discovered a potential breach, but determined the breach was not reportable based on an internal risk assessment conducted by the seller. Because the buyer is ordinarily acquiring the good will of the medical practice as an essential element, a past breach by the seller or the seller’s business associate could seriously reduce the value of the buyer’s investment. For this reason, buyers should consider adding specific breach and business associate representations to their APAs.

[Michael Coco handles a range of corporate matters, focusing his practice primarily in the area of health law. As a former ER staff nurse and chemist, Michael has in-depth insight into such topics as FDA approval of medical devices as well as hospital compliance with federal and state laws and regulations, including privacy and security of health information and professional standards.]

A party (Party) to a HIPAA Business Associate Agreement (BAA) or Subcontractor Agreement (SCA), whether a covered entity (CE), business associate (BA) or  subcontractor (SC), may struggle with the question as to whether to agree to, demand, request, submit to, negotiate or permit, an indemnification provision (Provision) respecting the counterparty (Counterparty) under a BAA or SCA.  On January 25, 2013, the U.S. Department of Health and Human Services  published “Sample Business Associate Agreement Provisions,” which were silent on the matter of indemnification.  Nonetheless, inclusion of Provisions is often a major question for Parties to BAAs and SCAs.

There are a number of common themes that, at a minimum, may determine in a specific case for a Party whether the BAA or SCA should include such a Provision.  Because a breach of HIPAA, especially in the areas of privacy and security, can result in enormous financial liability, humiliating publicity and large monetary penalties, appropriate care should be given regarding such Provisions. In addition to the items listed below, the relative bargaining power of the Parties may be a significant factor in this matter.  Below are ten items for consideration.

1.         A CE or BAA may assert that it has a “standard form” of BAA that includes a Provision running solely for such Party’s benefit.  The Counterparty may legitimately push back and demand that such Provision be removed, or at least that the BAA be revised to include a reciprocal Provision for its benefit.  (A Party may also ask its Counterparty whether the Counterparty has ever previously executed a BAA or SCA that does not contain such a Provision.)

2.         Before a Party agrees to any Provision whereby it is indemnifying the Counterparty, it should find out from its own liability insurance carrier whether such a Provision is permitted under such Party’s insurance policy or if agreeing to such a Provision will have any adverse impact on its insurance coverage.

3.         If a Provision is to be included (and perhaps as a general rule), there should be a negation of potential third party beneficiary rights under the BAA or SCA.  For example, HIPAA specifically excludes individual private rights of action for a breach of HIPAA – a Party does not want to run a risk of creating unintentionally a separate contractual private right of action in favor of a third party under a Provision.

4.         A Party should endeavor to limit its own maximum dollar amount exposure for indemnification.  For this reason alone, a Provision should be viewed as not standard.

5.         A Party should endeavor to limit the time period for indemnification under the Provision.

6.         If the BAA or SCA includes a Provision, a Party may desire to limit its monetary liability for any and all breaches under the BAA or SCA solely to the indemnification obligations under the Provision.

7.         A Party should consider expressly limiting its monetary liability under the Provisions to events directly and proximately caused by a material breach of the BAA and only to the extent that the material breach of such Party caused damages to the Counterparty.

8.         Where a BA or SC is a lawyer or law firm that is counsel (or another licensed person who has professional and ethical obligations) to a Counterparty, consider whether there are professional responsibilities of attorneys (or such other licensed person) respecting the negotiation of the Provision, including notifying the Counterparty that it should consider retaining separate counsel to advise it on the Provision (and other terms).

9.         If a regulatory authority exacts a monetary penalty from a Party in connection with a HIPAA breach or such Party is found to have been involved in a HIPAA breach, the right to indemnification of such Party by the Counterparty under a Provision may be limited or not enforceable at all as a matter of public policy.

10.       If a Provision is to be included, attention should be given to its impact on corollary matters, such as limitation on recovery of consequential, special, punitive and other damages and attorneys’ fees and legal expenses.

In light of the above and other potential considerations, careful thought should be given as to whether or not a Provision is appropriate in a specific case and merits what could become a serious and potentially irresolvable stumbling block to the underlying business relationship.  In extreme cases, the matter of indemnification and its complexities and consequences could even result in termination of the business relationship between the Parties.

Unless the Department of Health and Human Services (HHS) makes another last-minute, litigation-inspired decision to delay the September 23, 2013 compliance date, we’re well into the 10-day countdown for compliance with most of the Omnibus Rule requirements.  Here’s “TIP THREE” —

TIP THREE:

Covered Entities and Business Associates:  make sure you know where your Protected Health Information (PHI) sits, and make sure you have a Business Associate Agreement (BAA) with whoever houses it. 

Does your vendor create, receive, maintain, or transmit protected health information (PHI) on your behalf?  If so, it’s very likely they are a Business Associate even if they aren’t expected to actually access the PHI.  The Omnibus Rule added language to the definition of Business Associate to make it clear that it includes a person who, on behalf of a Covered Entity, provides “data transmission services with respect to a covered entity and that requires access on a routine basis” to the PHI. 

In the preamble to the Omnibus Rule, HHS describes what it means for a data transmission service to have “access on a routine basis” to PHI and distinguishes such a vendor from a “mere conduit” (which is not a Business Associate).  HHS says that the determination of whether the vendor is a “mere conduit” is “fact specific” and meant to apply narrowly to services like the U.S. Postal Service or United Parcel Service and their “electronic equivalents, such as internet service providers… .”  HHS explains that a “mere conduit” does not access PHI “other than on a random or infrequent basis as necessary to provide the transportation service or as required by law.”  On the other hand, an entity that maintains PHI on behalf of the Covered Entity is a Business Associate and not a conduit, “even if the entity does not actually view” the PHI. 

My tip?  If you are a Covered Entity or Business Associate and use a vendor to store electronic or hard copy health information on your behalf in the cloud, on a server, or anywhere else, make sure you have a BAA or Subcontractor Agreement, respectively, in place even if you don’t expect the vendor to access the PHI on a “routine basis.”

In January 2011 this blog series discussed here and here that the University of Rochester Medical Center (“URMC” or the “Medical Center”) became a marcher twice in 2010 in the parade of large Protected Health Information (“PHI”) security breaches.  The U.S. Department of Health and Human Services (“HHS”) publishes a list (the “HHS List”), which posts large breaches of unsecured PHI incidents affecting 500 or more individuals.  The HHS List now reveals that URMC reported a third large security breach that occurred on February 15, 2013 (the “2013 Breach”). The HHS List reveals that 537 individuals were affected by a URMC loss of an “other portable electronic device.”  There are several interesting aspects about the 2013 Breach.

First, this blog series earlier observed that URMC apparently determined that it was not necessary or appropriate to publish its PHI breaches in 2010 in the URMC Newsroom or elsewhere on the URMC website.  Our later post reported a reader’s comment that the second breach of URMC in 2010 could be located with some effort on the general University of Rochester website.  In contrast, however, the 2013 Breach was prominently published by URMC on May 3, 2013 in the URMC Newsroom and can be found in the 2013 archives.

Apparently a URMC resident physician misplaced a USB computer flash drive that carried PHI and which was used to transport information used to study and continuously improve surgical results. The information was copied from other files and, therefore, the Medical Center believes its loss will not affect follow-up care for any patients.  Additionally, the URMC posting observed that “after an exhaustive but unproductive search, hospital leaders believe that the drive likely was destroyed in the laundry.”

According to the URMC posting,

The flash drive included the patients’ names, gender, age, date of birth, weight, telephone number, medical record    number (a number internal to URMC), orthopaedic physician’s name, date of service, diagnosis, diagnostic study, procedure, and complications, if any. No address, social security number or insurance information of any patient was included.

It is refreshing that URMC has given the public notice of the 2013 Breach on its website.  Significantly, URMC also disclosed its development of new policies for the use of smart phones, iPads and other mobile devices to safeguard protected health information. In addition, URMC is retraining users of its PHI and encouraging its physicians and staff to access sensitive patient information using its secure network rather than via portable devices.

One puzzling aspect of URMC’s actions is that its notifications to affected individuals and the posting by the Medical Center did not occur until the week of April 28, 2013. This is clearly past the date required by HHS.  HHS requires that notifications be made “without unreasonable delay and in no case later than 60 days following the discovery of a breach.”  Sixty days after the breach discovery on February 15, 2013 would have been April 16, 2013.

It is clear that the proliferation of mobile devices has geometrically expanded the potential for lost or improperly accessed PHI.  Even the most carefully planned and communicated policies cannot assure the protection of PHI from inappropriate compromise, whether intentional or accidental.  Moreover, the continual advancement of technology in this area at lightning speed often renders policies obsolete almost as soon as they are finalized and disseminated.  In the long run, it may make the question of the potential for a PHI breach for a covered entity, business associate or subcontractor more of a matter of “when” and “how” rather than “if.”

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.

 

The September 23, 2013 deadline for updating Business Associate Agreements is extended for one year under the Omnibus Rule for covered entities who have compliant Business Associate Agreements in place by Friday, January 25, 2013. This also applies to agreements between Business Associates and their subcontractors.

Covered Entities and Business Associates (as well as Business Associates and their subcontractors) may continue to rely on those agreements for up to one year beyond the compliance date of the modifications, regardless of whether the contract meets the applicable contract requirements in the Omnibus Rule. This includes existing written agreements between business associates and subcontractors under which such subcontractors agree to the same restrictions and conditions that apply to the business associate. Such contracts are deemed to be compliant with the modifications to the Rules until either the covered entity or business associate has renewed or modified the contract following the compliance date of the modifications, or until September 23, 2014 (one year after the compliance date), whichever is sooner. "Evergreen" contracts which automatically renew also qualify for the extension.

Covered Entities (providers, health plans/insurers, and clearinghouses) should verify that they have current signed business associate agreements in place no later than this Friday in order to be grandfathered for an extra year.

Business Associates who have delegated functions to subcontractors involving PHI need to make sure they have signed written agreements in place that meet the standards of the existing rule under which the subcontractors agree to follow HIPAA.   This is where there may be more gaps, since many Business Associates may have been unaware of their obligations to assure compliance by their subcontractors.

 

Even grandfathered Business Associate Agreements and subcontractor agreements should be reviewed to see if the contracted party (business associate or subcontractor) is acting as an agent of the Covered Entity or Business Associate.  If it is, the date on which a breach is discovered (or should have been discovered) is imputed up contractual chain and could mean that the Covered Entity is responsible for reporting breaches it knows nothing about. 

If you need help determining whether you qualify for grandfathering, please contact your Fox Rothschild attorney immediately

By Elizabeth Litten and Michael Kline

Many Covered Entities (CE) and Business Associates (BA) (and now, Subcontractors (SC) as well) are using a variety of approaches to limit exposure to liability and the potentially dire consequences associated with security breaches of Protected Health Information (“PHI”).  Recently, we have noticed “PHI Warnings” in email and facsimile transmissions, by which CE, BA, or SC warn unintended recipients not to transmit or re-send PHI to third parties.  Such PHI Warnings are being routinely used by hospitals, providers, health insurers, law firms and others that create, receive, maintain, or transmit PHI.  Such PHI Warnings should be used and worded with caution, however.

For example, instructions such as the following sample may be found at the bottom of a CE’s email transmission:

 

Email Confidentiality Notice:  The information contained in this transmission is privileged and confidential and/or protected health information (PHI) and may be subject to protection under the law, including the Health Insurance Portability and Accountability Act of 1996, as amended (HIPAA).  This transmission is intended for the sole use of the individual or entity to whom it is addressed.  If you are not the intended recipient, you are notified that any use, dissemination, distribution, printing  or copying of this transmission is strictly prohibited and may subject you to criminal or civil penalties.  If you have received this transmission in error, please contact the sender immediately by replying to this email and deleting this email and any attachments from any computer.

 

Unfortunately, if an unintended (or unprepared) recipient of such PHI reads this message and follows the sender’s instruction by “replying” to the email, such recipient could be unintentionally perpetuating or re-publishing the breach.  Particularly in a case where the original email was sent to a number of recipients, a “reply” could easily become a “reply to all” and have the effect of re-sending (and announcing) PHI to new unintended third parties. Such a result could make it much more difficult for the original sender to ascertain the total scope of the security breach in its subsequent remediation and compliance efforts.

 

Moreover, such PHI Warnings should only be used in the context of overall HIPAA/HITECH policies and procedures of the sender.  For example, if the unintended recipient were a BA or SC of the sender, the attempt to comply with the sender’s instructions could actually conflict with, and result in a breach of, the parties’ Business Associate Agreement (“BAA”).

 

The following sample avoids the problem described above by providing an alternative  method of notifying the original sender but perhaps may still be “too little, too late,” as a serious PHI security breach may have already occurred:

 

This email and its attachments may contain privileged and confidential information and/or protected health information (PHI) intended solely for the use of ______________ and the recipient(s) named above.  If you are not the recipient, or the employee or agent responsible for delivering this message to the intended recipient, you are hereby notified that any review, dissemination, distribution, printing or copying of this email message and/or any attachments is strictly prohibited.  If you have received this transmission in error, please notify the sender immediately at 800-xxx-xxxx and permanently delete this email and any attachments.

 

Finally, if PHI is sent to a recipient prior to the parties’ execution of a compliant BAA and implementation of policies and procedures to protect PHI properly, a PHI Warning is unlikely to mitigate the liability of the sender (or recipient) for a security breach under HIPAA/HITECH.