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Clinical Laboratories and Pathology Groups

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Ransomware Strikes Hospitals, Clinical Laboratories, and Medical Clinics without Warning and Is Now a Major Threat to all Healthcare Organizations

Across the nation, healthcare attorneys and others report that ransomware attacks are happening weekly, and that once providers’ data systems are encrypted, they have few options to regain control of their information systems

Ransomware is now the single biggest threat to your hospital, clinical laboratory, and anatomic pathology group’s ability to operate a viable business. Few practice administrators and managers are fully aware of this threat. And yet, many still have not taken even basic steps to protect their organizations from ransomware attacks.

Encryption attacks that shut down a hospital or lab’s information services come without warning, rendering the provider unable to access electronic healthcare records (EHRs), to schedule appointments, or conduct most other normal business activities.

Further, negotiating with the ransomware attackers to obtain a de-encryption key can take weeks. During that time, the hospital or lab cannot access its essential information systems and that disrupts or even stops patient care.

Think this cannot happen to your hospital or lab? Think again.

Just this spring, Scripps Health of San Diego was hit with a ransomware attack. Key information systems were encrypted, and it did not take patients long to notice that they could not email their physicians, access their medical records, or see their test results.

The ransomware attack became the headline story on the San Diego nightly news. Scripps would only admit that many essential information systems had been encrypted and that the organization was using paper to conduct business.

The ransomware attack on Colonial Pipeline of Houston, which took place one week after the Scripps Health attack, also became global news. Colonial Pipeline supplies gasoline and similar fuels to 14 states—from Georgia in the South to New York and New Jersey in the North. Dark Daily readers living along the Atlantic Coast personally experienced the shortage of gasoline in their communities because of the ransomware attack on Colonial Pipeline.

No Ransom Payment, No De-encryption Key

Ransomware is probably the single biggest threat to every hospital and every clinical lab in this country. But few healthcare organizations are taking the essential steps needed to make their information systems more resistant to an encryption attack. Even fewer hospitals and labs have policies or procedures in place that outline how management should react when an encryption attack is first discovered. Yet these attacks are hitting medical providers every week across the US.

Dark Daily surveyed several major law firms that have sizeable healthcare practices. Each firm stated it is contacted weekly by one or more hospitals, labs, and medical clinics that have had their digital systems encrypted, followed by a demand for ransom. The healthcare providers were told by the hackers that if they did not pay the ransom, they would not receive the de-encryption key required to bring their software, apps, and digital systems back into service.

“This is the biggest story in healthcare, yet it gets little attention,” stated Robert L. Michel, Editor-in-Chief of Dark Daily’s sister publication The Dark Report. “The reason why you don’t read more news stories about ransomware attacks on hospitals and labs is simple. If it becomes known that a hospital or a lab paid ransom to obtain the de-encryption key needed to restore access to its information systems, that encourages other hackers to attack the organization as well, since the hackers know the organization will pay the ransom. They figure if the provider paid the ransom once, the same provider will likely pay it again.”

Payment of Ransom Does Not Guarantee Restoration of Critical Systems

As bad as a ransomware attack on a hospital, lab, or a medical clinic can be—it can get worse. “Experts involved in helping hospitals and labs respond to a ransomware attack say there is no guarantee the de-encryption key provided by the hackers after payment of ransom will restore access to the encrypted systems,” Michel noted. “We hear reports of hospitals and labs that spent more on their efforts to bring the encrypted systems back online and functioning than they did on the actual ransom.”

To help laboratory managers, CIOs, IT directors, safety and compliance officers, and anatomic pathology laboratory managers and administrators better understand the legal issues triggered by—and your obligation in response to—a ransomware attack, Dark Daily is conducting “Ransomware Protection and Response for Clinical Labs, Hospitals, and Pathology Groups: Effective Steps for Protecting Your LIS, EHR, and Other IT from an Encryption Attack,” on Thursday, August 19, 2021, from 1-2:30 pm Eastern.

This is a must-attend webinar—not only for you—but for everyone in your hospital, health system, or clinical laboratory who will be working to prevent ransomware attacks, or who is involved in restoring digital services following such an attack.

Two experts who are contacted each week by multiple hospitals, labs, and medical clinics that were attacked, had their digital systems encrypted, and received a ransom demand for hundreds of thousands—even millions—of dollars from hackers, will be sharing their knowledge and experience in the legal implications of—and the recovery from—ransomware attacks.

Emily Johnson and Paul Caron

The panelists (above) are:

Johnson and Caron will cover best practices designed to provide crucial training and decision-making skills for handling a ransomware attack on hospital and health system clinical laboratories and anatomic pathology practices. These best practices include:

  • Legal issues triggered by a ransomware attack: What to do when an incident is a breach and when it is not.
  • Your obligations in response to a ransomware attack: HIPAA privacy and other regulatory rules, contractual arrangements (e.g., reference labs), and crisis communication to patients and other stakeholders.
  • Responding to and negotiating with ransomware perpetrators—including the expected “etiquette” in dealing with cybercriminals—and collaborating with consultants who are experienced in how to deal with ransomware demands.
  • And much more.

The roundtable discussion will help you understand how a security incident can occur with or without a breach of protected health information (PHI). Johnson and Caron also will discuss how knowing what to do in each scenario is essential to reducing collateral damage to both patients and your organization, and how to educate your hospital, lab and the broader medical community to address—both proactively and in response—the surging risk of ransomware attacks.

Act now to guarantee your place at this critical webinar. Click HERE to register, or copy and paste the URL https://info.darkdaily.com/ransomware-protection-response-for-clinical-labs-hospitals-and-pathology-groups into your browser.

And because so many healthcare administrators, physicians, and pathologists are working remotely, Dark Daily has arranged special group rates for hospitals, practices, and physicians that would like their essential leaders to participate in this important webinar and roundtable discussion on protecting against—and recovering from—ransomware attacks.

Inquire at info@darkreport.com or call 512-264-7103.

—Michael McBride

Related Information

Ransomware Protection and Response for Clinical Labs, Hospitals, and Pathology Groups

Scripps CEO Says Cyberattack Was Result of Ransomware

Colonial Pipeline Ransomware Attack

Ransomware Attacks on Scripps Health, Universal, and Utah Pathology Services Show Hospitals and Health Systems Are Increasingly in the Crosshairs

Recent attacks illustrate how costly a security breach can be and why clinical laboratories and pathology groups must work to protect their information systems from ransomware attacks

Recent ransomware attacks on Scripps Health, Universal Health Services, and Utah Pathology Services clearly illuminate the vulnerabilities within the healthcare industry to being targeted. These attacks left patients’ protected health information (PHI) exposed and the healthcare organizations open to federal scrutiny and possibly fines or other punitive actions.

Therefore, it is crucial clinical laboratories and pathology groups have a cybersecurity strategy in place for dealing with ransomware attacks. Running security drills may need to be part of that strategy. Managers and employees should undergo specific training and vendors must be vetted carefully. Without such a strategy, the question is not if an attack will happen, but rather when an attack will succeed.

Ransomware Attackers are Getting Better

“Ransomware is increasing in sophistication; it’s increasing in prevalence. The purveyors of ransomware are generally reinvesting the fees that they collect from the entities they extort to acquire more capabilities,” Beau Woods, Senior Advisor at the federal Cybersecurity and Infrastructure Security Agency (CISA), told The San Diego Tribune.

“They’re getting better, they’re getting more frequent, particularly during the pandemic where we’ve opened up more connectivity to allow more remote work,” he added.

The Scripps Health attack is notable for several reasons, with one being the length of the outage it caused. The attack was first detected on May 1 of this year. It took four weeks before Scripps could restore most of its network and get its Epic EHR back online, Health IT Security reported.

However, the ransomware attack on Universal Health Services (NYSE:UHS) may be the biggest attack so far. It took place on September 27, 2020, and caused a three-week outage. The company told The San Diego Tribune the incident had a $67 million impact on operations.

According to HIPAA Journal, “The phone system was taken out of action, and without access to computers and electronic health records, employees had to resort to pen and paper to record patient information. In the early hours after the attack occurred, the health system diverted ambulances to alternative facilities and some elective procedures were either postponed or diverted to competitors. Patients reported delays receiving test results while UHS recovered from the attack.”

At Utah Pathology Services, an employee e-mail hack resulted in the potential exposure of patient data. The malicious actors attempted to divert funds intended for a physician but failed to do so. However, the information of 112,000 patients was accessible to the hacker during the attempt.

“The compromised data varied by patient but could include names, contact information, insurance details such as ID and group numbers, medical and health information like internal records numbers and clinical and diagnostic information, and some Social Security numbers,” Health IT Security reported.

Bryan-S.-Ware-and-Christopher-Krebs

“We are seeing adversaries that are targeting our pharmaceutical companies, pharmaceutical research, laboratory companies, testing and really even out into the future manufacturing of the vaccine systems,” Bryan S. Ware (above left) Assistant Director for Cybersecurity for the Department of Homeland Security’s (DHS) Cybersecurity and Infrastructure Security Agency (CISA) told CyberScoop. CISA Director Christopher Krebs (above right) added, “At the onset of the COVID-19 pandemic, we recognized just how vital the healthcare sector was to the response and we established Project Taken to bring to bear the government’s particular set of skills to protect those organizations.” (Photo copyrights: CyberScoop/Business Insider.)

Value of Patient Data on the Dark Web is Increasing

In the case of the Utah Pathology Services attack, the hackers were specifically after money. However, according to cybersecurity company SecureLink, patient records are “the new prize” for hackers. Healthcare data carries a value of its own on the digital black market. In fact, healthcare data is more valuable than credit card or banking data.

“Healthcare data is valuable on the black market because it often contains all of an individual’s personally identifiable information, as opposed to a single marker that may be found in a financial breach,” SecureLink wrote in a blog post.

In “Here’s How Much Your Personal Information Is Selling for on the Dark Web,” credit rating agency Experian estimated a stolen medical record could sell for between $1 and $1,000, while a Social Security number alone is worth about a dollar.

A 2018 Trustwave Global Security Report estimated that a healthcare record is worth about $250. Trustwave, however, estimated the value of a banking record at less than $5. That strongly suggests health records are increasing in value.

And even after a healthcare entity has regained control of its IT infrastructure, the hacker still has possession of the stolen patient information. It may take weeks or years for the hacker to sell that information, meaning the breach represents a continuing threat to the healthcare organization and its patients.

Clinical Laboratories Must Prepare for an Attack

Simply understanding the threat is not enough. Clinical laboratory and pathology group managers must have robust plans in place for both protecting patient information and for dealing with a security breach should one occur.

According to a Health IT Security report, “The ransomware attack that struck all 400 UHS care sites and caused three weeks of EHR downtime in September, cost the health system $67 million in recovery costs and lost revenue.”

The report added, “Security researchers have long-recommended the need for providers to shift into a proactive security model, like zero trust. Recent reports show successful cyberattacks on healthcare providers doubled in the last year, with at least 560 providers falling victim to ransomware.”

In “Three Federal Agencies Warn Healthcare Providers of Pending Ransomware Attacks; Clinical Laboratories Advised to Assess Their Cyberdefenses,” Dark Daily reported on an FBI, federal Department of Health and Human Services (HHS), and federal Cybersecurity and Infrastructure Security Agency (CISA) joint advisory (AA20-302A) that warned US hospitals, clinical laboratories, and other healthcare providers to prepare for impending ransomware attacks in 2020.

To deal with the ransomware attacks, we wrote, “CISA, FBI, and HHS advise against paying ransoms. ‘Payment does not guarantee files will be recovered,’ the advisory states. ‘It may also embolden adversaries to target additional organizations, encourage other criminal actors to engage in the distribution of ransomware, and/or fund illicit activities.’ The federal agencies advise organizations to take preventive measures and adopt plans for coping with attacks.

“The advisory suggests:

  • Training programs for employees, including raising awareness about ransomware and phishing scams. Organizations should ‘ensure that employees know who to contact when they see suspicious activity or when they believe they have been a victim of a cyberattack.’
  • Regular backups of data and software. These should be ‘maintained offline or in separated networks as many ransomware variants attempt to find and delete any accessible backups.’ Personnel should also test the backups.
  • Continuity plans in case information systems are not accessible. For example, organizations should maintain ‘hard copies of digital information that would be required for critical patient healthcare.’”

Given the enormous amounts of money hackers can earn from selling protected health information on the Dark Web, it is a near certainty these attacks will continue. Clinical laboratory and anatomic pathology group managers would be well advised to plan for the inevitability that their health system will be targeted.

—Dava Stewart

Related Information:

It’s Not Just Scripps. Ransomware Has Become Rampant During Pandemic

Scripps Health Network Still Down, 2 Weeks After Cyberattack

Universal Health Services Ransomware Attack Cost $67 Million in 2020

112K Patients Impacted by Utah Pathology Services Email Hack

Healthcare Data: The New Prize for Hackers

Here’s How Much Your Personal Information Is Selling for on the Dark Web

Trustwave Global Security Report

UHS Ransomware Attack Cost $67M in Lost Revenue, Recovery Efforts

CISA Turns to Security Experts with Street Cred to Protect Health Sector

Three Federal Agencies Warn Healthcare Providers of Pending Ransomware Attacks; Clinical Laboratories Advised to Assess Their Cyberdefenses

UK’s NHS Will Use Amazon Alexa to Deliver Official Health Advice to Patients in the United Kingdom

Since Alexa is now programed to be compliant with HIPAA privacy rules, it’s likely similar voice assistance technologies will soon become available in US healthcare as well

Shortages of physicians and other types of caregivers—including histopathologists and pathology laboratory workers—in the United Kingdom (UK) has the UK’s National Health Service (NHS) seeking alternate ways to get patients needed health and medical information. This has prompted a partnership with Amazon to use the Alexa virtual assistant to answer patients healthcare inquiries.

Here in the United States, pathologists and clinical laboratory executives should take the time to understand this development. The fact that the NHS is willing to use a device like Alexa to help it maintain access to services expected by patients in the United Kingdom shows how rapidly the concept of “virtual clinical care” is moving to become mainstream.

If the NHS can make it work in a health system serving 66-million people, it can be expected that health insurers, hospitals, and physicians in the United States will follow that example and deploy similar virtual health services to their patients.

For these reasons, all clinical laboratories and anatomic pathology groups will want to develop a strategy as to how their organizations will interact with virtual health services and how their labs will want to deploy similar virtual patient information services.

Critical Shortages in Healthcare Services

While virtual assistants have been answering commonly-asked health questions by mining popular responses on the Internet for some time, this new agreement allows Alexa to provide government-endorsed medical advice drawn from the NHS website.

By doing this, the NHS hopes to reduce the burden on healthcare workers by making it easier for UK patients to access health information and receive answers to commonly-asked health questions directly from their homes, GeekWire reported. 

“The public needs to be able to get reliable information about their health easily and in ways they actually use. By working closely with Amazon and other tech companies, big and small, we can ensure that the millions of users looking for health information every day can get simple, validated advice at the touch of a button or voice command,” Matthew Gould, CEO of NHSX, a division of the NHS that focuses on digital initiatives, told GeekWire

The Verge reported that when the British government officially announced the partnership in a July press release, the sample questions that Alexa could answer included:

  • Alexa, how do I treat a migraine?
  • Alexa, what are the symptoms of the flu?
  • Alexa, what are the symptoms of chickenpox?

“We want to empower every patient to take better control of their healthcare and technology like this is a great example of how people can access reliable, world-leading NHS advice from the comfort of their home, reducing the pressure on our hardworking GPs (General Practitioners) and pharmacists,” said Matt Hancock, Secretary of State for Health and Social Care, in the press release.

MD Connect notes that the NHS provides healthcare services free of charge to more than 66-million individuals residing in the UK. With 1.2 million employees, the NHS is the largest employer in Europe, according to The Economist. That article also stated that the biggest problem facing the NHS is a staff shortage, citing research conducted by three independent organizations:

Their findings indicate “that NHS hospitals, mental-health providers, and community services have 100,000 vacancies, and that there are another 110,000 gaps in adult social care. If things stay on their current trajectory, the think-tanks predict that there will be 250,000 NHS vacancies in a decade,” The Economist reported.

UK’s Matt Hancock, Secretary of State for Health and Social Care (above), defends the NHS’ partnership with Amazon Alexa, saying millions already use the smart speaker for medical advice and it’s important the health service uses the “best of modern technology.” Click here to watch the video. (Video and caption copyright: Sky News.)

“This idea is certainly interesting and it has the potential to help some patients work out what kind of care they need before considering whether to seek face-to-face medical help, especially for minor ailments that rarely need a GP appointment, such as coughs and colds that can be safely treated at home,” Professor Helen Stokes-Lampard, Chairman at the Royal College of General Practitioners, and Chair of the Board Of Directors/Trustees at National Academy of Social Prescribing, told Sky News.

“However,” she continued, “it is vital that independent research is done to ensure that the advice given is safe, otherwise it could prevent people seeking proper medical help and create even more pressure on our overstretched GP service.”

Amazon has assured consumers that all data obtained by Alexa through the NHS partnership will be encrypted to ensure privacy and security, MD Connect notes. Amazon also promised that the personal information will not be shared or sold to third parties.

Alexa Now HIPAA Compliant in the US

This new agreement with the UK follows the announcement in April of a new Alexa Skills Kit that “enables select Covered Entities and their Business Associates, subject to the US Health Insurance Portability and Accountability Act of 1996 (HIPAA), to build Alexa skills that transmit and receive protected health information (PHI) as part of an invite-only program. Six new Alexa healthcare skills from industry-leading healthcare providers, payors, pharmacy benefit managers, and digital health coaching companies are now operating in our HIPAA-eligible environment.”

Developers of voice assistance technologies can freely use these Alexa skills, which are “designed to help customers manage a variety of healthcare needs at home simply using voice—whether it’s booking a medical appointment, accessing hospital post-discharge instructions, checking on the status of a prescription delivery, and more,” an Amazon Developer Alexa blog states.

The blog lists the HIPAA-compliant Alexa skills as:

  • Express Scripts: Members can check the status of a home delivery prescription and can request Alexa notifications when their prescription orders are shipped.
  • Cigna Health Today by Cigna (NYSE:CI): Eligible employees with one of Cigna’s large national accounts can now manage their health improvement goals and increase opportunities for earning personalized wellness incentives.
  • My Children’s Enhanced Recovery After Surgery (ERAS) (by Boston Children’s Hospital: Parents and caregivers of children in the ERAS program can provide their care teams updates on recovery progress and receive information regarding their post-op appointments.
  • Swedish Health Connect by Providence St. Joseph Health, a healthcare system with 51 hospitals across seven states and 829 clinics: Customers can find an urgent care center near them and schedule a same-day appointment.
  • Atrium Health, a healthcare system with more than 40 hospitals and 900 care locations throughout North and South Carolina and Georgia: Customers in North and South Carolina can find an urgent care location near them and schedule a same-day appointment.
  • Livongo, a digital health company that creates new and different experiences for people with chronic conditions: Members can query their last blood sugar reading, blood sugar measurement trends, and receive insights and Health Nudges that are personalized to them.

HIPAA Journal notes: “This is not the first time that Alexa skills have been developed, but a stumbling block has been the requirements of HIPAA Privacy Rules, which limit the use of voice technology with protected health information. Now, thanks to HIPAA compliant data transfers, the voice assistant can be used by a select group of healthcare organizations to communicate PHI without violating the HIPAA Privacy Rule.”

Steady increases associated with the costs of medical care combined with a shortage of healthcare professionals on both continents are driving trends that motivate government health programs and providers to experiment with non-traditional ways to interact with patients.

New digital and Artificial Intelligence (AI) tools like Alexa may continue to emerge as methods for providing care—including clinical laboratory and pathology advice—to healthcare consumers.

—JP Schlingman

Related Information:

“Alexa, How Do I Treat a Migraine?” Amazon and NHS Unveil Partnership

Amazon’s Alexa Will Deliver NHS Medical Advice in the UK

NHS Health Information Available Through Amazon’s Alexa

UK’s National Health Service Taps Amazon’s Alexa to Field Common Medical Questions

What Happens When Amazon Alexa Gives Health Advice?

Alexa, Where Are the Legal Limits on What Amazon Can Do with My Health Data?

Amazon Alexa Offering NHS Health Advice

A Shortage of Staff Is the Biggest Problem Facing the NHS

Need Quick Medical Advice in Britain? Ask Alexa

Alexa Blogs: Introducing New Alexa Healthcare Skills

Amazon Announces 6 New HIPAA Compliant Alexa Skills

Amazon Alexa Is Now HIPAA-Compliant: Tech Giant Says Health Data Can Now Be Accessed Securely

Can Artificial Intelligence Diagnose Skin Cancers More Accurately than Anatomic Pathologists? Heidelberg University Researchers Say “Yes”

Apple Updates Its Mobile Health Apps, While Microsoft Shifts Its Focus to Artificial Intelligence. Both Will Transform Healthcare, But Which Will Impact Clinical Laboratories the Most?

As Primary Care Providers and Health Insurers Embrace Telehealth, How Will Clinical Laboratories Provide Medical Lab Testing Services?

VA Engages Private Sector Companies in Major Telehealth Initiative to Bring Critical Healthcare Services to Thousands of Veterans Living in Remote Areas

17 Former Employees Accuse Orig3n of Clinical Laboratory Test Inaccuracies, Contamination, and Fabricated Test Results

This is not the first time genetic-testing company Orig3n has been scrutinized by state and federal investigators over its business practices

It’s not often that multiple employees of a clinical laboratory company go public with criticism about the quality of their lab company’s tests. But that is what is happening at Orig3n. Problems at the Boston-based genetic testing company were the subject of an investigative report published by Bloomberg Businessweek (Bloomberg).

In September, Bloomberg reported that 17 former Orig3n employees said the company’s Deoxyribonucleic acid (DNA) tests sometimes failed to deliver the intended results or were often contaminated or inaccurate. The individuals had been employed by the company as managers, lab technicians, software engineers, marketers, and salespeople between 2015 and 2018.

The former employees claimed that Orig3n “habitually cut corners, tampered with or fabricated results, and failed to meet basic scientific standards,” Bloomberg reported. The individuals also stated that advice intended to be personalized to individual consumers’ genetic profiles was often just generic information or advice that had no scientific basis.

According to Bloomberg, the individuals also alleged that Orig3n’s lab was careless in its handling of genetic samples in several ways, including:

  • Multiple samples being labeled with the same barcode;
  • DNA and blood samples for stem cell bank misplaced or mixed up;
  • No controls to ensure accuracy;
  • Handling methods that could lead to contamination; and
  • Fabricating results when a test outcome was unclear.

The former employees also stated that “Orig3n ran tests without proper authorization in its lab at the 49ers’ stadium, and that managers regularly compelled them to write positive reviews of Orig3n’s tests on Amazon.com and Google to offset waves of negative feedback,” Bloomberg reported.

“Accurate science didn’t seem to be a priority. Marketing was the priority,” said a former lab technician who spoke with Bloomberg on the condition of anonymity. Orig3n denied the accusations in a statement, describing them as “grossly inaccurate,” and claimed the former employees were simply disgruntled.

“In some cases, former employees are former employees for a reason,” Orig3n Chief Executive Officer Robin Smith told Bloomberg. “We’ve found after employees are gone that they have not done things appropriately.”

Jessica Stoll, MS, CGC (above), a certified genetic counselor and Associate Director of the Gastrointestinal Cancer Risk and Prevention Clinic at the University of Chicago Medicine, told NBC, “The majority of genetic testing is still a gray area and there’s always the possibility of uncertain results. I don’t find them particularly useful, and in some cases I can actually find them harmful.” (Photo copyright: Cancer Wellness Center.)

Is it Dog or Human DNA?

In 2018, NBC Chicago (NBC) conducted an investigation into various consumer DNA testing kits. NBC sent DNA samples to several different testing companies. This included non-human samples, which NBC’s investigators had obtained from a female Labrador Retriever.

With the exception of Orig3n, all of companies identified the DNA as non-human and did not process the kits. Orig3n did, however, process the canine DNA. It then returned a seven-page analysis that suggested the subject of the sample “would probably be great for quick movements like boxing and basketball, and that she has the cardiac output for long endurance bike rides or runs,” NBC reported.

This would be funny if it weren’t so concerning.

Following reports that it had processed dog DNA, Orig3n stated it had made changes and improvements to the company’s testing methodologies. Smith also stated Orig3n’s lab protocols had been improved as well.

“Sometimes we look at the accuracy of things and go, ‘Man, that’s not working,’” Smith told Bloomberg. “Our approach and our philosophy is [sic] to constantly improve the products.” 

Serious Accusations of Clinical Laboratory Malfeasance

Founded in 2014 with the intent of creating the world’s largest stem cell bank, by 2016, Boston-based Orig3n had refocused its attention on the burgeoning field of direct-to-consumer DNA testing. On its website, Orig3n sells several DNA-testing kits with varying costs.

Orig3n’s attempt to offer free genetic tests to large numbers of people at a professional sporting event in the fall of 2017 may be what caught the attention of federal investigators and led to a deeper investigation. Dark Daily previously covered this controversy, which centered around Orig3n’s plan to distribute free genetic testing kits to fans at a Baltimore Ravens football game.

In that situation, state and federal healthcare regulators blocked the giveaway over concerns about protected health information (PHI). Now, Orig3n is being accused of questionable business practices by 17 of its former employees. 

The former employees’ statements that the company’s genetic testing lab did not follow appropriate test protocols—and that it allegedly mishandled specimens and even reported false test results—are serious allegation of malfeasance and warrants an investigation.

Pathologists and clinical laboratory managers know that patient harm can potentially result from inaccurate genetic test results if used for clinical purposes. Dark Daily will continue to follow the investigation into Orig3n.

—JP Schlingman

Related Information:

DNA Company Tampered with Results, Former Employees Say

Home DNA Kits: What Do They Tell You?

Orig3n Holds Inaugural Ravens DNA Day on September 17 at M and T Bank Stadium to Kick Off the Season

Orig3n Partners with San Francisco 49ers to Reward Fans for Contributions to Advancing the Future of Medicine through Genetics and Regenerative Medicine Research

State and Federal Agencies Throw Yellow Flag Delaying Free Genetic Tests at NFL Games in Baltimore—Are Clinical Laboratories on Notice about Free Testing?

HHS Announces Culpability Limits for HIPAA Violations, Drops Annual Fines Owed by Providers

Clinical laboratories need to understand how their patients’ protected health information is being used and secured by vendors to avert data breaches and HHS penalties

Most readers of The Dark Report, the sister publication to the Dark Daily, are aware that more than 24-million clinical laboratory patients had their protected health information (PHI) stolen during several recent data breaches involving multiple medical laboratory companies.

The first public statements made by clinical lab companies about breaches of protected health information were issued in June. Collectively, the following three lab companies announced that the data of more than 20 million patients was compromised:

In the eight weeks that followed, additional medical laboratory companies publicly disclosed breaches of their patient data, including:

What all these clinical lab companies had in common was that they had contracted with American Medical Collection Agency (AMCA) to process lab test claims. AMCA is where the data breaches originated.

Under the rules established by the federal Health Insurance Portability and Accountability Act (HIPAA) of 1996, responsibility for the security of patient PHI falls to covered entities and business associates. This includes healthcare providers, health plans, and healthcare clearinghouses, such as AMCA. For clinical laboratories, this also includes vendors who receive patients’ PHI to complete their service contracts.

Until recently, any violation of HIPAA could draw down enormous fines—called Civil Money Penalties (CMPs)—by the US Department of Health and Human Services (HHS). Fines could reach $1.5 million annually across four categories, or tiers, of violations, depending on HHS’ determination as to the “level of culpability” of the violator. Those categories and min/max fines include:

  • No Knowledge, $100-$50,000 fine, $1.5 mil annual limit.
  • Reasonable Cause, $1,000-$50,000 fine, $1.5 mil annual limit.
  • Willful Neglect-Corrected, $10,000-$50,000, $1.5 annual limit.
  • Willful Neglect-Not Corrected, $50,000-$50,000, $1.5 annual limit.

Earlier this year, HHS released a “Notification of Enforcement Discretion Regarding HIPAA Civil Money Penalties.” In it, HHS revised its interpretation of the law and reduced CMPs, while more clearly defining how provider culpability ties to the ultimate amount of the fines:

  • No Knowledge, $100-$50,000 fine, $25,000 annual limit.
  • Reasonable Cause, $1,000-$50,000 fine, $100,000 annual limit.
  • Willful Neglect-Corrected, $10,000-$50,000, $250,000 annual limit.
  • Willful Neglect-Not Corrected, $50,000-$50,000, $1.5 annual limit

In the notice, HHS stated, “the Department recognized that section 13410(d) contained apparently inconsistent language (i.e., its reference to two penalty tiers ‘for each violation,’ each of which provided a penalty amount ‘for all such violations’ of an identical requirement or prohibition in a calendar year). To resolve this inconsistency, with the exception of violations due to willful neglect that are not timely corrected, the [interim final rule] adopted a range of penalty amounts between the minimum given in one tier and the maximum given in the second tier for each violation and adopted the amount of $1.5 million as the limit for all violations of an identical provision of the HIPAA rules in a calendar year.”

Modern Healthcare reports that “organizations that have taken measures to meet HIPAA’s requirements will face a much smaller maximum penalty than those who are found neglectful.”

Thus, the new HHS guidelines will be of interest to clinical laboratories, which must ensure the privacy of patients’ PHI, including being keenly aware of how vendor business associates are handling their patients’ data.

In an exclusive interview with The Dark Report, James Giszczak (above), Data Privacy and Cybersecurity Attorney and Chair of the Litigation Department at McDonald Hopkins, said two important steps clinical laboratories must take include, “ensuring that your vendor has appropriate insurance policies in place that cover PHI breaches, and confirming that vendors comply with laws governing the protection of patients’ information.” To do that, he says, every lab needs to ensure that all critical provisions are covered in each contract it has with each vendor. (Photo copyright: Institute of Continuing Legal Education.)

Did HHS Go Too Far?

Some experts, however, wonder if HHS went too far in reducing annual penalties providers may owe. Could lower annual CMP caps cause organizations to relax strict PHI policies? Some privacy authorities urge caution and raise concern about how incentives may be perceived by providers and others.

“HHS is adopting a much lower annual cap for all violations except those due to willful neglect, which means significantly lower penalties for large breaches and for ongoing persistent violations of the rules,” Deven McGraw, Chief Regulatory Officer at Citizen Corporation and former Deputy Director Health Information Privacy for HHS’ Office for Civil Rights, told FierceHealthcare.

“Arguably,” she continued, “the incentive to fix these persistent failures is much less because the potential fines for failing to do so will not be very large. Same is true for large breaches—if you breach 10 records, at a minimum penalty of $1,000 for a breach due to reasonable cause, your fine would be $100,000, which is the annual cap.”

New Annual Limits Recognize ‘Unintentional’ Violations

But not all experts agree. Prior to HHS’ announcement, minimum to maximum penalty violations were the same as noted in the tiers above. The annual limits ($1.5 million), however, were the same for each of the four tiers.

Matthew Fisher, Partner at Mirick O’Connell and Chair of the Worcester, Mass. firm’s health law group, says the new penalty structure “is arguably good in terms of aligning potential penalties with the level of culpability.”

“If a violation was clearly unintentional and without knowledge, why should a potentially massive fine follow? While the discretion existed, the interpretation will now be binding and remove the potential uncertainty,” he told FierceHealthcare.

Advice for Clinical Laboratories

Labs are advised to develop appropriate procedures to safeguard their patients’ PHI under federal and state laws. And this includes knowing how vendors handle PHI. 

“Every lab should be proactive and do a review to understand each vendor’s policies, procedures, training, and response in the event of a breach,” James Giszczak, Data Privacy and Cybersecurity Attorney and Chair of the Litigation Department at McDonald Hopkins in Bloomfield Hills, Mich., told The Dark Report (TDR).

“By being prepared, clinical laboratories can save themselves many headaches,” he said. “Ultimately, these proactive steps may help laboratories save time, money, and costly bad publicity.”

Following that advice, along with understanding the new HHS notice, will help medical laboratory managers ensure the privacy and security of their client’s PHI.

—Donna Marie Pocius

Related Information:

HHS Implements HIPAA Fine Caps Based on Level of Culpability

Notification of Enforcement Discretion Regarding HIPAA Civil Money Penalties

HHS Moves to Reduce HIPAA Fines Lowering the Cap More Than $M for Some Violations

HHS to Cap HIPAA Fines Based on “Culpability”

Labs Should Heed Lessons from Huge Data Breach

Late-Breaking Lab News: Add Eight More Laboratories to the List of Lab Companies Whose Patient Data Were Breached

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