844-740-7100

    Colington Consulting

    Helping Organizations Achieve HIPAA Compliance™

    Contact Us

    Category: #CCHIPAA

    • Is a HIPAA Violation a Reportable Breach?

      Just because a member of an organization’s workforce violates HIPAA policies and procedures, it is not necessarily a breach reporting requirement. The significant determination is the extent to which any protected health information (PHI) may have been compromised based on breach rule guidance. So, before getting too technical regarding that determination, here are some cases to consider:

      1. An employee for a healthcare software company loses a computer containing the PHI of 2000 patients. Reportable breach?
      2. A hospital system is the victim of a ransomware attack. Reportable breach?

      A breach is generally an impermissible use or disclosure under the Privacy Rule that compromises the

      security or privacy of the PHI. An impermissible use or disclosure of PHI is presumed to be a breach unless the covered entity or business associate, as applicable, demonstrates that there is a low probability that the PHI has been compromised based on a risk assessment of at least the following factors:

      • The nature and extent of the PHI involved, including the types of identifiers and the likelihood of re-identification;
      • The unauthorized person who used the PHI or to whom the disclosure was made;
      • Whether the PHI was actually acquired or viewed; and
      • The extent to which the risk to the PHI has been mitigated.

      Going through this type of breach “risk assessment” can be challenging, especially in trying to determine if any PHI was acquired or viewed. To further complicate this process, the guidance does not specify what exactly a “low probability” is. So, this assessment process will take some work.

      Begin by using a decision tree and asking questions such as “Was the PHI disclosure to a person who reasonably would have not been able to retain that information?” and “Was the PHI secured by encryption?” The resulting series of yes or no responses will help to determine whether a breach notification is required.

      In most of these cases, the organization’s HIPAA Privacy and Security Officials should take the lead with this process. There may be a need to involve the organization’s healthcare and privacy attorney for advice. Experience and expertise with the process are clearly essential to helping determine probability.

      It is important to document the results, especially in those cases in which a determination was made that it was not a reportable breach. If, for some reason, any of the PHI was in fact compromised and a breach report was not made, demonstrating due diligence in the event an HHS Office for Civil Rights (OCR) investigation is necessary.

      Referencing the numbered case examples above:

      1. This would be a reportable breach if the PHI was not encrypted. However, if the PHI was encrypted, it could be an organizational HIPAA violation based on policies and procedures for mobile devices.
      2. This example is going to be a fact-specific determination. In 2016, OCR issued guidelines on the topic of ransomware attacks. If the PHI was encrypted, it may not be reportable. But any unsecured PHI will be a reportable breach. (See the full fact sheet.) In this case, the possibility exists that there may also be a HIPAA violation based on the cause of the attack and whether proper safeguards were followed by a workforce member or members.

      My advice is to make sure your organization’s HIPAA Sanction policies and procedures are clear for any violations, even for those cases that are not reportable. Ensure the organization has a comprehensive breach notification policy and accompanying procedures. Be familiar with the breach risk assessment process and be prepared should an impermissible use or disclosure occur.

      This blog was previously posted January 7, 2019

    • HIPAA Best Practices for Employee Termination

      On December 11, 2018, the HHS Office for Civil Rights (OCR) announced a settlement of $111,400 with Pagosa Springs Medical Center (PSMC) located in Colorado. The settlement was the outcome of a HIPAA enforcement action following the findings of an OCR investigation that was triggered by an allegation that a former employee of PSMC still had access to ePHI via a web scheduling client used by PSMC.

      According to OCR Director Roger Severino, “it’s common sense that former employees should immediately lose access to protected patient information upon their separation from employment.” 

      However, ensuring removal of access alone for the terminated employee would not have prevented PSMC as a Covered Entity (CE) from meeting other HIPAA requirements. OCR’s investigation revealed that PSMC did not have a Business Associate Agreement (BAA) in place with either the web-based scheduling calendar vendor, nor with the employee, thus ensuring the ePHI of 557 individuals were made vulnerable to attacks.

      Under a two-year Corrective Action Plan, PSMC must now update its security management and business associate agreement, as well as its policies and procedures, and must now re-train its employees and workers so that they are up to speed on these changes.

      The takeaway from this settlement agreement is that organizations that do not have or follow procedures to terminate information access privileges upon employee separation that results in a breach face possible HIPAA enforcement action by OCR. It is also important to make sure any process that records, shares, transmits, or modifies ePHI is thoroughly detailed in the BAA. Some CEs attempt to save money and time by establishing a work-around, which involves anonymizing ePHI while using web-based scheduling or communication apps without a BAA. However, such an undertaking is difficult to standardize in the long run. It is ultimately more cost-effective for CEs to take the time and resources to set up a BAA with relevant vendors, in order to avoid an investigation for failing to enforce HIPAA privacy and security mandates.

      Best Practice Lessons from this case:

      • The CE representative facilitating an employee’s termination must also have the ability and training to revoke and remove any previous access authorizations held by the employee. This must take place at the same time as when the notice of termination is provided.
      • CEs must complete BAAs with any vendor who provides the CE with the ability to record, modify, transmit, or share ePHI.
      • At the time of onboarding, all employees must be made aware that their employer requires them to give up all access and authorizations upon termination or voluntary departure from the company.
      • Training materials for employee onboarding should include privacy and security awareness related to:

      a) use of third-party services and applications;

      b) terms and conditions that trigger the creation of a BAA;

      c) assurances provided by Bas regarding policies and procedures to secure ePHI;

      c) security incident reporting; and

      d) password management.

      • Supervisors and other responsible officials must be trained to undertake oversight of employees’ uses and disclosures of PHI, including ePHI, in order to ensure compliance with HIPAA regulations.

      This blog was previously posted January 14, 2019

    • What Comes Up, Must Go Down: Regulatory Trends and HIPAA

      Enforcement of HIPAA mandates by the HHS Office for Civil Rights (OCR) are more aggressive than ever before, “totaling $28.7 million from enforcement actions” in 2018, an increase of 22% from the last record total of $23.5 million in 2016.  According to an OCR press release, 2018 saw that office establish “an all-time record year” in HIPAA enforcement activity, settling “10 cases” and being “granted summary judgment in a case before an Administrative Law Judge.” One of these 10 cases was the watershed HIPAA settlement with Anthem, Inc. for $16 million.

      OCR Settlements* and Judgement** for 2018

      Jan – FileFax*  –  $100,000

      Jan – Fresenius Medical Care* – $3,500,000

      Jun – MD Anderson** – $4,348,000

      Aug  – Boston Medical Center*  –  $100,000

      Sep – Brigham & Women’s Hospital* – $384,000

      Sep – Mass. General Hospital* – $515,000

      Sep – Advanced Care Hospitalists* – $500,000

      Oct – Allergy Associates of Hartford* – $125,000

      Oct – Anthem, Inc* – $16,000,000

      Nov – Pagosa Springs* – $111,400

      Dec – Cottage Health* – $3,000,000

      Total – Settlements & Judgement:  $28,683,400

      While the current administration did and continues to tout a posture of deregulation, the reality on the ground for organizations that must comply with HIPAA is that OCR has only strengthened its enforcement mechanisms, showing very little tolerance for security and privacy breaches arising from:

      • The mismanagement, or lack of proper storage, transmission, or disposal of patient PHI and ePHI.
      • An incomplete or missing Business Associate Agreement (BAA) made with any and all vendors who might be considered a Business Associates (BA) under HIPAA.
      • Cyberattacks via successful email phishing attempts targeting not just Covered Entity (CE) workers or employees, but also workers or employees of any vendor affiliated with the  CE.
      • Incompatible or insufficient risk analysis and risk management processes on the part of the CE.

      Out of these 11 instances of verified HIPAA violations,

      • 6 CEs were found to have mismanaged or improperly stored, transmitted, or disposed of patient PHI and ePHI (Fresenius Medical Care North America, FileFax, Inc., MD Anderson, Allergy Associates of Hartford, Pagosa Springs, and Cottage Health)
      • 3 CEs did not have a BAA in place to manage vendors who are considered to be BAs under HIPAA (Advanced Care Hospitalists, Pagosa Springs, and Cottage Health)  
      • 1 CE experienced an email phishing cyber-attack (Anthem, Inc.) 
      • 4 CEs made PHI or patient privacy vulnerable by exposing the same via TV shows, interviews, or recordings (Allergy Associates of Hartford, Boston Medical Center, Brigham and Women’s Hospital, and Massachusetts General Hospital)
      • 4 CEs lacked HIPAA-mandated risk assessment, risk analysis, risk notification, or risk management protocols (Cottage Health, MD Anderson, Advanced Care Hospitalists, and Fresenius Medical Care North America)

      From this analysis, it can be ascertained that CEs and BAs can avoid facing settlements and judgements due to violations of the HIPAA Privacy Rule and the HIPAA Security Rule by instituting the following “golden rules” and ensuring their staff are fully trained in the same:

      • Do have robust and comprehensive plan to assess, identify, report, respond, and manage all security or privacy risks.
      • Do ensure a signed and completed BAA is on file for all BAs
      • Do have highly specific protocols in place governing the collection, storage, transmission, and disposal of patient PHI and ePHI.

      Best practices include annual and periodic training for their workforce, conducting the required security risk assessment in an ongoing/periodic manner, and internally enforcing HIPAA policies and procedures to cover the organization’s security management processes.

      Organizations, large and small, must be aware of the aggressive posture of enforcement and record settlement amounts under OCR and this current administration. My advice for any organization is to conduct a thorough evaluation of the current HIPAA compliance in place. Make sure all the requirements are covered.  If a compliance program is not is place, consider outsourcing and let a consultant do the heavy lifting. Often times, a consultant can get the program in place much quicker than relying on the organization’s internal staff.

      This blog was previously posted February 12, 2019

    • How Do HIPAA Breach Reporting Requirements Affect State Reporting

      For those of us involved in the world of HIPAA compliance, we are certainly aware by now that the Breach Notification Rule requires Covered Entities (CE) and Business Associates (BA) to notify affected parties of any breach that has occurred to their protected health information. Those notification requirements and timelines are based on the “500 rule” of individuals affected, and there are different rules based on whether more or fewer than 500 were affected by the breach.

      But another important factor to consider, besides the Federal requirement, is what do State breach reporting laws require? This is a topic that has been getting a lot of attention lately.

      According to the National Conference of State Legislatures (NCSL), all 50 U.S. states and its territories have enacted laws that require both private and public entities to notify anyone who has been affected by a security breach of their personally identifiable information.

      The NCSL website explains that these laws specify exactly who must comply with the law, what constitutes “personal information,” what constitutes a breach, requirements for notice (e.g., timing or method of notice, who must be notified), and any exemptions that may apply.

      HIPAA Data Breach Reporting at the State Level

      At the State level, there exists a somewhat different landscape of potential pitfalls compared to the compromise of any of the 18 HIPAA Identifiers. Also, State reporting is not in lieu of the Federal reporting but in conjunction. Both Federal HIPAA and State breach reporting requirements must be adhered to.

      It is important to remember that State reporting timelines may be shorter than what is mandated by the HIPAA Breach Notification Rule.

      As an example, the State of California Civil Code states that for medical information, “Affected patients and the California Department of Health Services must be notified no later than 15 business days after the unauthorized access, use, or disclosure has been detected by the licensee.” There is an exception to delay the notification for law enforcement purposes in accordance with the Code.

      When Business Associates Are Breached

      Further complications to the breach notification requirements kick in when CEs engage the services of vendors that are designated BAs. We know about the requirement to execute Business Associate Agreements (BAA) when these vendors have accesses to a Covered Entity’s ePHI/PHI. What happens when CEs have hundreds of BAs and then some of those BAs have subcontractor BAs? How does an organization keep track of all the timelines in reporting? Oftentimes, this is done with a time-consuming manual review, causing organizations to spend excessive funds on complying – or, more commonly, not doing this exercise at all.

      Organizations commonly try and use ‘standard templates’ to standardize timelines, but reporting timeframes are often the center of agreement negotiations and are often changed.

      The 500 Rule

      According to the Breach Rule, if a breach affects 500 or more people, then the entity that is responsible for the breach must notify the Secretary of the applicable governmental entity as soon as possible, and no later than 60 days after the breach occurred.

      If the breach affects fewer than 500 people, however, then the responsible entity is only required to notify the Secretary annually, and no more than 60 days past the affected calendar year. Therefore, if a CE gives a BA 60 days to make the report but the breach affects 500 or more individuals, that CE will actually fail to meet the reporting deadline.

      Managing this process of timeline reporting is critical, especially with downstream BA vendors.

      “Understanding reporting time frames, both contractual and regulatory, is critical for healthcare organizations. But many compliance teams struggle to keep up with changing laws and the growth of their organizations as it relates to obligations to regulators and business partners,” says Jason Silverstein, COO, PHIflow. “Rather than depending on manual document review (which is expensive and time-consuming) to understand reporting timeframes, today’s leading compliance and privacy departments leverage innovative new technologies to automate many of the mundane tasks previously associated with antiquated compliance processes.”

      A summary of U.S. State Data Breach Notification Statutes per state provided by NCSL can be accessed here: http://www.ncsl.org/research/telecommunications-and-information-technology/security-breach-notification-laws.aspx

      Need Help with HIPAA Compliance?

      If you would like to discuss how Colington Consulting can help your organization meet these ever-changing governmental standards, call us at (800) 733-6379 today.

    • Not Worried About Your Patients? Worry About Your Bottom Line?

      We’re always talking about how not complying with HIPAA regulations badly affects patients. Their data is exposed to malicious entities. Their trust in your organization wanes. Even if you’re not worried about the moral implications or your public perception, the fact is you’re not off the hook for noncompliance. There are severe penalties for not following the rules. And that’s what we’ll be discussing in today’s article.

      A Breakdown of HIPAA Fines

      Penalties for HIPAA noncompliance are broken down into four categories of fines:

      1. Willful neglect with no corrective action taken.
      2. Willful neglect with corrective action taken.
      3. Reasonable cause for noncompliance.
      4. No knowledge of noncompliance.

      Each level of noncompliance comes with its own financial penalty for your company or organization. Let’s take a closer look at what each one means, and what its penalty is.

      Willful Neglect with No Corrective Action

      This is by far the most severe form of noncompliance, and therefore comes tagged with the harshest of government fines. From a legal standpoint, willful neglect is defined as a “conscious, intentional failure or reckless indifference.” If you work in the healthcare industry, there’s a good chance you’ve at least heard of HIPAA. We’ve reached a point where it is very difficult for organizations to claim ignorance of it. If it looks as though you haven’t even bothered to make the necessary changes, there’s a good chance you could be hit with this very serious charge. It comes with a nasty $50,000 minimum penalty for each violation, and can cost your organization up to a whopping $1,500,000 annually.

      Willful Neglect with Corrective Action

      If a company or organization is found guilty of willful neglect as defined above, resolving the noncompliance issue in a timely fashion will reduce the associated penalty. It’s still a hefty price that’s nothing to sneeze at however, and your best option of course is to comply with the regulations in the first place. After making the necessary changes, you could instead be hit with a $10,000 penalty for each violation, up to a maximum of $250,000 annually. The difference isn’t negligible at least, and is greatly preferable to ignoring the problem – both for your patients and for your company’s bottom line.

      Reasonable Cause

      The legal definition for reasonable cause in regard to HIPAA compliance is as follows:

      “An act or omission in which a covered entity or business associate knew, or by exercising reasonable diligence would have known, that the act or omission violated an administrative simplification provision, but in which the covered entity or business associate did not act with willful neglect.” While not as serious as “willful neglect,” it still comes with a heavy price tag of $1,000 for each violation and up to $100,000 annually.

      No Knowledge

      Noncompliance is to be considered “without knowledge” if the covered entity or individual did not know (and by exercising reasonable diligence would not have known) the action in question was a HIPAA violation. This is incredibly common, and is a huge culprit for many violations. This is why it is especially important to train your employees and make absolutely certain everyone knows and follows the regulations. Not rigorously training – and refreshing – your employees in HIPAA compliance can cost you $100 for every single violation, and up to $25,000 a year in damages. Teaching your staff the right way of doing things, taking the right precautions and putting processes in place will help you best to avoid these fines.

      Remember, there can be hefty fines for not following regulations. But most importantly, it’s important to protect the people you’re serving. Their lives are in your hands. Let us help you help them – and yourselves.  Give us a call today at 800-733-6379 for a free, no obligation, initial consultation. 

    • Protect Our Health by Protecting our Healthcare

      Our healthcare system, while far from perfect, is an absolute necessity for living. It would make sense then to be sure that it was well-protected.

      Unfortunately, this is often not the case. As we have seen over and over again, database breaches are more common in the healthcare industry than anywhere else. We’re not just experiencing a loss of data, but a loss of trust as well. How can people live their lives and stay safe from data theft at the same time?

      HIPAA Compliance

      It starts with a set of rules. Such a set has already been put together: The Health Insurance Portability and Accountability Act of 1996 (HIPAA). But rules are meaningless if no one is following them. According to the HIPAA journal, breaches in patient records during 2018 doubled to more than 13 million records. This is unacceptable – both from a patient standpoint and a legal one. And it’s only going to get worse as technology grows.

      Data Breaches and Technology

      Our healthcare technology has improved in leaps and bounds since the 1990’s. This is terrific. The average lifespan of Americans has also increased thanks to amazing breakthroughs and wearable devices like smart inhalers and insulin pens. Patients can have their glucose levels monitored from almost anywhere. We have remote MRI machines and smart beds. These are all helpful things. They greatly improve our quality of life.

      But what happens when all of these terrific inventions are used for ill purpose?

      Each of these devices works because they’re connected in some way shape or form to a database. Every patient uploads a massive amount of data about themselves whenever they’re used. Then, attackers breach these databases, access patients records, steal them and sell them on the dark web. In countries like the U.S., attackers from anywhere in the world can access expensive medical services, products, and drugs with the help of stolen medical records. The healthcare sector has proven to be extremely profitable for attackers, with a single record costing an average of $408.

      Data Breaches and Ransomware

      It’s not always about buying, selling, and manipulating patient data. Disturbingly often, it’s about holding hospitals hostage to fund criminals, political actors abroad and even terrorism. That might sound like an extremely bold declaration, but it’s an unfortunate and well-known truth. Ransomware attacks account for 85% of all the cyber-attacks on the healthcare sector. In one example which we mention in a previous article, Indiana-based healthcare system, Hancock Health, was hit by a ransomware attack that completely locked down all of their computers. In many instances, those computers were depended upon for keeping critical hospital systems running. They felt they had no choice but to pay the ransom in order to keep their patients safe. That attack had cost the company about $55,000 in Bitcoin.

      It was a risky move either way. Historically, only 19% of ransomware victims who pay the ransom actually get their files back. And the worst part is, that money goes to places that are in no way good.

      Our healthcare system is possibly the most important institution in our country. It definitely has its flaws, but it’s literally what keeps us alive. The absolute least we can do is follow the rules that were originally put in place to protect it. We’re here to help you make sense of those rules.  Call us today at 800-733-6379 to schedule a free, initial consultation.