In our most recent post, the Top 5 Common HIPAA Mistakes to Avoid in 2018, we noted that the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) has recently published guidance on disclosing protected health information (PHI) related to overdose victims. OCR published this and other guidance within the last two months in response to the Opioid Crisis gripping the nation and confusion regarding when and to whom PHI of patient’s suffering from addiction or mental illness may be disclosed.

Pills and capsules on white backgroundTo make the guidance easily accessible to patients and health care professionals, OCR published two webpages, one dedicated to patients and their family members and the other dedicated to professionals.

  • Patients and their family members can find easy-to-read commentary addressing the disclosure of PHI in situations of overdose, incapacity or other mental health issues here.
  • Physicians and other health care professionals can find similar fact sheets tailored to their roles as covered entities here.
  • OCR also recently issued a two-page document summarizing its guidance on when health care professionals may disclose PHI related to opioid abuse and incapacity [accessible here].

The main points from this guidance include:

  1. If a patient has the capacity to make decisions regarding his or her health care, a health care professional may not generally share any PHI with family, friends or others involved in the patient’s care (or payment for care), unless the patient consents to such disclosure.  However, a health care professional may disclose PHI if there is a serious and imminent threat of harm to the patient’s health and the provider in good faith believes that the individual to whom the information is disclosed would be reasonably able (or in a position) to prevent or lessen such threat. According to OCR, in the context of opioid abuse, this rule allows a physician to disclose information about the patient’s opioid abuse to any individual to whom the physician in good faith believes could reasonably prevent or lessen the harm that could be caused by the patient’s continued opioid abuse following discharge.
  2. If the patient is incapacitated or unconscious, HIPAA allows health care professionals to disclose certain PHI to family and close friends without a patient’s permission where (i) the individuals are involved in the care of the patient, (ii) the health care professional determines that disclosing the information is in the best interests of the patient, and (iii) the PHI shared is directly related to the family or friend’s involvement in the patient’s health care (or payment for such health care). As an example, OCR clarified that a physician may, in his or her professional judgment, share PHI regarding an opioid overdose and related medical information with the parents of someone who is incapacitated due to an overdose.
  3. OCR also addressed the difficult situation where a patient is severely intoxicated or unconscious, but may regain sufficient capacity to make health care decisions several hours after arriving in the emergency room.   In such situations, HIPAA would allow a physician or nurse to share PHI related to the patient’s overdose and medical condition with the patient’s family or close personal friends while the patient is incapacitated, so long as the nurse or doctor believes that it is in the patient’s best interest to do so and the information shared with the family member or friend is related to the individual’s involvement in the patient’s health care.

OCR published similar guidance, available at the above websites, regarding the disclosure of PHI related to the mental health of a patient.  Included in that guidance is clarification that HIPAA does not prohibit treating physicians from sharing PHI of a patient with a mental illness or substance use disorder for treatment purposes, except in the case of psychotherapy notes.

However, it is important to understand that OCR’s guidance on these issues does not supersede state laws or other federal laws or rules of medical ethics that would apply to disclosure of a patient’s PHI, including the federal confidentiality regulations [located at 42 CFR Part 2] pertaining to patient records maintained in connection with certain federally-assisted substance use disorder treatment programs.  The “Part 2” regulations (as well as state patient confidentiality laws that are more restrictive than HIPAA) could prohibit some or all of the disclosures which OCR has now clarified are permitted under HIPAA.

If you have a question regarding how this new guidance may affect your practice, please contact a knowledgeable attorney.

Post Contributed by Matthew J. Redding.

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

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

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

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

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

6 Takeaways:

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

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

A patient requests a copy of her medical record, and the hospital charges the per-page amount permitted under state law. Does this violate HIPAA? It may.

In the spring of 2016, the Office of Civil Rights (OCR) within the U.S. Department of Health and Human Services, the agency that enforces HIPAA, issued a new guidance document on individuals’ right to access their health information under HIPAA (“Access Guidance”).   The Access Guidance reminds covered entities that state laws that provide individuals with a greater right of access (for example, where the state law requires that access be given within a shorter time frame than that required by HIPAA, or allows individuals a free copy of medical records) preempt HIPAA, but state laws that are contrary to HIPAA’s access rights (such as where the state law prohibits disclosure to an individual of certain health information, like test reports) are preempted by HIPAA.

For New Jersey physicians, for example, this means they may not automatically charge $1.00 per page or $100.00 for the a copy of the entire medical record, whatever is less, despite the fact that the New Jersey Board of Medical Examiners (“BME”) expressly permits these charges.  In fact, according to the Access Guidance, physicians should not charge “per page” fees at all unless they maintain medical records in paper form only.  New Jersey physicians also may not charge the “administrative fee” of the lesser of $10.00 or 10% of the cost of reproducing x-rays and other documents that cannot be reproduced by ordinary copying machines.  Instead, a New Jersey physician may charge only the lesser of the charges permitted by the BME or those permitted under HIPAA, as described below.

HIPAA limits the amount that covered entities may charge a patient (or third party) requesting access to medical records to only a “reasonable, cost-based fee to provide the individual (or the individual’s personal representative) with a copy” of the record.  Only the following may be charged:   

(1) the reasonable cost of labor for creating and delivering the electronic or paper copy in the form and format requested or agreed upon by the individual, but not costs associated with reviewing the request, searching for or retrieving the records, and segregating or “otherwise preparing” the record for copying;  

(2) the cost of supplies for creating the paper copy (e.g., paper, toner) or electronic media (e.g., CD or USB drive) if the individual requests the records in portable electronic media; and  

(3) actual postage costs, when the individual requests mailing. 

The fee may also include the reasonable cost of labor to prepare an explanation or summary of the record, but only if the individual, in advance, chooses to receive and explanation or summary AND agrees to the fee to be charged for the explanation or the summary.   

A provider may calculate its actual labor costs each time an individual requests access, or may develop a schedule of costs for labor based on the average (and HIPAA-permitted types of) labor costs incurred in fulfilling standard types of access requests.  However, a provider is NOT permitted to charge an average labor cost as a per-page fee unless the medical record is: (1) maintained in paper form; and (2) the individual requests a paper copy or asks that the paper record be scanned into an electronic format.  Thus, under HIPAA, a per-page fee is not permitted for medical records that are maintained electronically.  As stated in the Access Guidance, “OCR does not consider per page fees for copies of … [protected health information] maintained electronically to be reasonable” for purposes of complying with the HIPAA rules.   

A provider may also decide to charge a flat fee of up to $6.50 (inclusive of labor, supplies, and any applicable postage) for requests for electronic copies of medical records maintained electronically.    OCR explains that the $6.50 is not a maximum, simply an alternative that may be used if the provider does not want to go through the process of calculating actual or average allowable costs for requests for electronic copies. 

OCR has identified compliance with “individual access rights” as one of seven areas of focus in the HIPAA audits of covered entities and business associates currently underway, signaling its concern that physicians and other covered entities may be violating HIPAA in this respect.  All covered entities should, therefore, calculate what HIPAA permits them to charge when copies of medical records are requested by an individual (or someone acting at the direction of or as a personal representative of an individual), compare that amount to the applicable state law charge limits, and make sure that only the lesser of the two amounts is charged.


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.

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.

We blogged on this back in early May, but compliance with individuals’ rights to access their PHI under HIPAA is even more critical now that OCR has announced that its current HIPAA audits will focus on an audited Covered Entity’s documentation and process related to these access rights.

In an email sent to listserv participants on July 12, 2016 from OCR-SECURITY-LIST@LIST.NIH.GOV, the U.S. Department of Health and Human Services (HHS) included the following list of areas of focus for the desk audits:

Requirements Selected for Desk Audit Review
Privacy Rule
Notice of Privacy Practices & Content Requirements  [§164.520(a)(1) & (b)(1)]
Provision of Notice – Electronic Notice   [§164.520(c)(3)]
Right to Access  [§164.524(a)(1), (b)(1), (b)(2), (c)(2), (c)(3), (c)(4), (d)(1), (d)(3)]
Breach Notification Rule
Timeliness of Notification  [§164.404(b)]
Content of Notification  [§164.404(c)(1)]
Security Rule
Security Management Process —  Risk Analysis  [§164.308(a)(1)(ii)(A)]
Security Management Process — Risk Management  [§164.308(a)(1)(ii)(B)]

As discussed in our prior post, HHS issued guidance regarding individuals’ rights to access PHI earlier this year. Here is a link to this PHI access guidance:  Individuals’ Right under HIPAA to Access their Health Information |

The HHS access guidance stresses that Covered Entities should provide individuals with “easy access” to their PHI and cannot impose “unreasonable measures” on the individuals with respect to this right to access. The HHS access guidance provides important information regarding the different rules that apply when an individual provides a signed authorization for release of their PHI versus when an individual is really making a request for access to his or her PHI.

If an individual is asking for the PHI to be provided to him or her, this is really a request for access even if the individual is providing a signed authorization for release of the PHI.

If the individual is asking the PHI to be directed to a third party, this can be either a situation when a signed authorization is needed or can be an access request, depending on who is really originating the request (the individual or the third party). A Covered Entity cannot require an individual to provide a signed authorization to make an access request.  A Covered Entity can require that the access request be in writing and can require use of a form as long as it does not impose undue burden on the individual’s right to access.

The HHS access guidance also indicates that if an individual requests that his or her PHI be provided by email, the Covered Entity is required to do so and further, if the individual requests in writing that the PHI be provided by unsecure, unencrypted email, the Covered Entity is required to do so after notifying the individual in writing of the risks of this method of transmission. (This notice can be included on the access request form.)

As a result of the HHS access guidance, a Covered Entity may need to review and amend its HIPAA Privacy Policies and Procedures governing individual rights with respect to access to PHI, the form it uses for individual access requests, and its employee training protocols to be sure employees aren’t requiring a patient  (or member, in the case of a health plan Covered Entity) to sign an authorization form when the patient is requesting access to PHI.

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.

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

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

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

Our predictions that were quoted by Marla follow.

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

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

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

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

Kline Prediction: OCR will examine business associate relationships.

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

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

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

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

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

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

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

We know by now that protected health information (PHI) and other personal information is vulnerable to hackers.  Last week, the Washington Times reported that the Department of Health and Human Services (HHS), the agency responsible for HIPAA enforcement, had suffered security breaches at the hands of hackers in at least five separate divisions over the past three years.  The article focused on a House Committee on Energy and Commerce report that described the breaches as having been relatively unsophisticated and the responsible security officials as having been unable to provide clear information regarding the security incidents.

We know it’s not a question of “if” sensitive information maintained electronically will be compromised by a hacking or other type of cyber security incident, but “when” — regardless of who maintains it — and how destructive an incident it will be. Even HHS and its operating divisions, which include both the Office of Civil Rights (OCR), charged with protecting PHI privacy and security, and the Food and Drug Administration (FDA), the country’s principal consumer protection and health agency, are vulnerable.

Just one day before its coverage of the House Committee report on the cyber security vulnerabilities that exist within the very government agencies charged with protecting us, the Washington Times reported on an even more alarming cyber security risk: the vulnerability of common medical devices, such as x-ray machines and infusion pumps, to hacks that could compromise not just the privacy and security of our health information, but our actual physical health.

This report brought to mind a recent report on the ability of hackers to remotely access the control systems of automobiles.  While the thought of losing control of my car while driving is terrifying, the realization that medical devices are vulnerable to hackers while being used to diagnose or treat patients is particularly creepy.  The two situations may present equally dangerous scenarios, but hacking into a medical device is like hacking into one’s physical being.

So while it’s one thing to have PHI or other sensitive information compromised by a hacking incident, it’s much more alarming to think that one’s health status, itself, could be compromised by a hacker.