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
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.
“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.
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.”
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.
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.
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.
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.”
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.
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:
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.
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.
This is important for clinical laboratory leaders to watch, because medical labs often interface with hospital EHRs to exchange vital patient data, a key component of complying with Medicare’s EHR incentive programs. If claims of interoperability are shown to be false, could labs engaged with those hospital systems under scrutiny be drawn into the DOJ’s investigations?
Violating the False Claims Act
In May, Coffey Health System (CHS), which includes Coffey County Hospital, a 25-bed critical access hospital located in Burlington, Kan., agreed to pay the US government a total of $250,000 to settle a claim that it violated the False Claims Act.
CHS’ former CIO filed the qui tam (aka, whistleblower) lawsuit, which allows individuals to sue on behalf of the government and share in monetary recovery. He alleged that CHS provided false information to the government about being in compliance with security standards to receive incentive payments under the EHR Incentive Program.
According to a DOJ press release, “the United States alleged that Coffey Health System falsely attested that it conducted and/or reviewed security risk analyses in accordance with requirements under a federal incentive program for the reporting periods of 2012 and 2013. The government contended that the hospital submitted false claims to the Medicare and Medicaid Programs pursuant the Electronic Health Records (EHR) Incentive Program.”
“Medicare and Medicaid beneficiaries expect that providers ensure the accuracy and security of their electronic health records,” said Stephen McAllister (above), United States Attorney for the District of Kansas, in the DOJ press release. “This office remains committed to protecting the federal health programs and to hold accountable those whose conduct results in improper payments.” (Photo copyright: US Department of Justice.)
The Recovery Act allocated $25 billion to incentivize healthcare professionals and facilities to adopt and demonstrate meaningful use (MU) of electronic health records by January 1, 2014. The federal Centers for Medicare and Medicaid Services (CMS) released the incentive funds when providers attested to accomplishing specific goals set by the program.
The website of the Office of the National Coordinator for Health Information Technology (ONC), HealthIt.gov, defines “meaningful use” as the use of digital medical and health records to:
Improve quality, safety, efficiency, and reduce
health disparities;
Engage patients and their families;
Improve care coordination and population and
public health; and
Maintain privacy and security of patient health
information.
The purpose of the HITECH Act was to address privacy and security concerns linked to electronic storage and transference of protected health information (PHI). HITECH encourages healthcare organizations to update their health records and record systems, and it offers financial incentives to institutions that are in compliance with the requirements of the program.
When eligible professionals or eligible hospitals attest to being in compliance with Medicare’s EHR incentive program requirements, they can file claims for federal funds, which are paid and audited by the Department of Health and Human Services (HHS) through Medicare and Medicaid.
Institutions receiving funds must demonstrate meaningful use
of EHR records or risk potential penalties, including the delay or cancellation
of future payments and full reimbursement of payments already received. In
addition, false statements submitted in filed documents are subject to criminal
laws and civil penalties at both the state and federal levels.
EHR Developers Under Scrutiny by DOJ
EHR vendors also have been investigated and ordered to make
restitutions by the DOJ.
In February, Greenway Health, a Tampa-based EHR developer, agree to pay $57.25 million to resolve allegations related to the False Claims Act. In this case, the government contended that Greenway obtained certification for its “Prime Suite” EHR even though the technology did not meet the requirements for meaningful use.
And EHR vendor eClinicalWorks paid the government $155 million to settle allegations under the False Claims Act. The government maintained that eClinicalWorks misrepresented the capabilities of their software and provided $392,000 in kickbacks to customers who promoted its product.
Legal cases such as these demonstrate that the DOJ will
pursue both vendors and healthcare organizations that misrepresent their
products or falsely attest to interoperability under the terms laid out by
Medicare’s EHR Incentive Program.
Clinical laboratory leaders and pathology groups should carefully
study these cases. This knowledge may be helpful when they are asked to create
and maintain interfaces to exchange patient data with client EHRs.
