News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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IT Experts Demonstrate How AI and Computer Microphones Can Be Used to Figure Out Passwords and Break into Customer Accounts

Clinical laboratories and pathology groups should be on the alert to this new digital threat; telehealth sessions and video conferencing calls particularly vulnerable to acoustic AI attacks

Banks may be the first to get hit by a new form of hacking because of all the money they hold in deposit accounts, but experts say healthcare providers—including medical laboratories—are comparably lucrative targets because of the value of patient data. The point of this hacking spear is artificial intelligence (AI) with increased capabilities to penetrate digital defenses.

AI is developing rapidly. Are healthcare organizations keeping up? The hackers sure are. An article from GoBankingRates titled, “How Hackers Are Using AI to Steal Your Bank Account Password,” reveals startling new AI capabilities that could enable bad actors to compromise information technology (IT) security and steal from customers’ accounts.

Though the article covers how the AI could conduct cyberattacks on bank information, similar techniques can be employed to gain access to patients’ protected health information (PHI) and clinical laboratory databases as well, putting all healthcare consumers at risk.

The new AI cyberattack employs an acoustic Side Channel Attack (SCA). An SCA is an attack enabled by leakage of information from a physical computer system. The “acoustic” SCA listens to keystrokes through a computer’s microphone to guess a password with 95% accuracy.

That’s according to a UK study published in IEEE Xplore, a journal of the IEEE European Symposium on Security and Privacy Workshops, titled, “A Practical Deep Learning-Based Acoustic Side Channel Attack on Keyboards.”

“With recent developments in deep learning, the ubiquity of microphones and the rise in online services via personal devices, acoustic side channel attacks present a greater threat to keyboards than ever,” wrote UK study authors Joshua Harrison, MEng, Durham University; Ehsan Toreini, University of Surrey; and Maryam Mehrnezhad, PhD, University of London.

Hackers could be recording keystrokes during video conferencing calls as well, where an accuracy of 93% is achievable, the authors added.

This nefarious technological advance could spell trouble for healthcare security. Using acoustic SCA attacks, busy healthcare facilities, clinical laboratories, and telehealth appointments could all be potentially compromised.

“The ubiquity of keyboard acoustic emanations makes them not only a readily available attack vector, but also prompts victims to underestimate (and therefore not try to hide) their output,” wrote Joshua Harrison, MEng (above), and his team in their IEEE Xplore paper. “For example, when typing a password, people will regularly hide their screen but will do little to obfuscate their keyboard’s sound.” Since computer keyboards and microphones in healthcare settings like hospitals and clinical laboratories are completely ubiquitous, the risk that this AI technology will be used to invade and steal patients’ protected health information is high. (Photo copyright: CNBC.)

Why Do Hackers Target Healthcare?

Ransomware attacks in healthcare are costly and dangerous. According to InstaMed, a healthcare payments and billing company owned by J.P. Morgan, healthcare data breaches increased to 29.5% in 2021 costing over $9 million. And beyond the financial implications, these attacks put sensitive patient data at risk.

Healthcare can be seen as one of the most desirable markets for hackers seeking sensitive information. As InstaMed points out, credit card hacks are usually quickly figured out and stopped. However, “medical records can contain multiple pieces of personally identifiable information. Additionally, breaches that expose this type of data typically take longer to uncover and are harder for an organization to determine in magnitude.”

With AI advancing at such a high rate, healthcare organizations may be unable to adapt older network systems quickly—leaving them vulnerable.

“Legacy devices have been an issue for a while now,” Alexandra Murdoch, medical data analyst at GlobalData PLC, told Medical Device Network, “Usually big medical devices, such as imaging equipment or MRI machines are really expensive and so hospitals do not replace them often. So as a result, we have in the network these old devices that can’t really be updated, and because they can’t be updated, they can’t be protected.”

Vulnerabilities of Telehealth

In “Penn Medicine Study Shows Telemedicine Can Cut Employer Healthcare Costs by 25%,” Dark Daily reported a study conducted by the Perelman School of Medicine at the University of Pennsylvania (Penn Medicine) which suggested there could be significant financial advantages for hospitals that conduct telehealth visits. This, we projected, would be a boon to clinical laboratories that perform medical testing for telemedicine providers.

But telehealth, according to the UK researchers, may also be one way hackers get past safeguards and into critical hospital systems.

“When trained on keystrokes recorded using the video-conferencing software Zoom, an accuracy of 93% was achieved, a new best for the medium. Our results prove the practicality of these side channel attacks via off-the-shelf equipment and algorithms,” the UK researchers wrote in IEEE Xplore.

“[AI] has worrying implications for the medical industry, as more and more appointments go virtual, the implications of deepfakes is a bit concerning if you only interact with a doctor over a Teams or a Zoom call,” David Higgins, Senior Director at information security company CyberArk, told Medical Device Network.

Higgins elaborated on why healthcare is a highly targeted industry for hackers.

“For a credit card record, you are looking at a cost of one to two dollars, but for a medical record, you are talking much more information because the gain for the purposes of social engineering becomes very lucrative. It’s so much easier to launch a ransomware attack, you don’t even need to be a coder, you can just buy ransomware off of the dark web and use it.”

Steps Healthcare Organizations Should Take to Prevent Cyberattacks

Hackers will do whatever they can to get their hands on medical records because stealing them is so lucrative. And this may only be the beginning, Higgins noted.

“I don’t think we are going to see a slowdown in attacks. What we are starting to see is that techniques to make that initial intrusion are becoming more sophisticated and more targeted,” he told Medical Device Network. “Now with things like AI coming into the mix, it’s going to become much harder for the day-to-day individual to spot a malicious email. Generative AI is going to fuel more of that ransomware and sadly it’s going to make it easier for more people to get past that first intrusion stage.”

To combat these attacks patient data needs to be encrypted, devices updated, and medical staff well-trained to spot cyberattacks before they get out of hand. These SCA attacks on bank accounts could be easily transferable to attacks on healthcare organizations’ patient records.

Clinical laboratories, anatomic pathology groups, and other healthcare facilities would be wise to invest in cybersecurity, training for workers, and updated technology. The hackers are going to stay on top of the technology, healthcare leaders need to be one step ahead of them.

—Ashley Croce

Related Information:

How Hackers Are Using AI to Steal Your Bank Account Password

A Practical Deep Learning-Based Acoustic Side Channel Attack on Keyboards

AI Can Steal Passwords with 95% Accuracy by ‘Listening’ to Keystrokes, Alarming Study Finds

New ‘Deep Learning Attack’ Deciphers Laptop Keystrokes with 95% Accuracy

Can A.I. Steal Your Password? Study Finds 95% Accuracy by Listening to Keyboard Typing

Ransomware in Healthcare: What You Need to Know

Hospital 2040: How Healthcare Cybercrime is Predicted to Escalate

30 Crucial Cybersecurity Statistics (2023): Data, Trends and More

Penn Medicine Study Shows Telemedicine Can Cut Employer Healthcare Costs by 25%

University of Pennsylvania Researchers Use Cellulose to Produce Accurate Rapid COVID-19 Test Results Faster and Cheaper than Traditional PCR Tests

Researchers are working to create accurate rapid COVID-19 tests with lower costs and less waste than existing rapid clinical laboratory tests

University of Pennsylvania (UPenn) researchers have developed a biodegradable rapid COVID-19 test that raises the bar on traditional polymerase chain reaction (PCR) tests, which throughout the COVID-19 pandemic have been the gold standard for SARS-CoV-2 diagnostic testing.

Many clinical laboratory professionals are aware of the significant amount of waste going into landfills from spent COVID-19 rapid PCR tests that use biosensors to produce results. These biosensor systems “use printed circuit boards, or PCBs, the same materials used in computers. PCBs are difficult to recycle and slow to biodegrade, using large amounts of metal, plastic, and non-eco-friendly materials,” according to a Penn Engineering Today blog post.

UPenn’s new test does not use PCBs. Instead, its biosensor uses “bacterial cellulose (BC), an organic compound synthesized from several strains of bacteria,” the blog post noted.

“This new BC test is non-toxic, naturally biodegradable and both inexpensive and scalable to mass production, currently costing less than $4.00 per test to produce. Its cellulose fibers do not require the chemicals used to manufacture paper, and the test is almost entirely biodegradable,” the blog post continued.

The Penn engineers published their findings in the journal Cell Reports Physical Science titled, “A Bacterial Cellulose-Based and Low-Cost Electrochemical Biosensor for Ultrasensitive Detection of SARS-CoV-2.”

Cesar de la Fuente, PhD

“There is a need for biodegradable diagnostic testing,” said Cesar de la Fuente, PhD (above), Presidential Assistant Professor in the Psychiatry Department at the University of Pennsylvania’s Perelman School of Medicine. “We will be continuing to perfect this technology, which could hopefully help many people in the future, while also looking to expand it to other emerging pathogens in anticipation of future pandemics.” Clinical laboratories engaged in SARS-CoV-2 testing during the COVID-19 pandemic can attest to the massive amounts of waste generated by traditional PCR testing. (Photo copyright: University of Pennsylvania.)

Evolution of Improvement for SARS-CoV-2 Diagnostic Assays

Cesar de la Fuente, PhD, is Presidential Assistant Professor in the Psychiatry Department at the Perelman School of Medicine. His lab has been hard at work since the start of the pandemic to improve COVID-19 testing. The recent study was a collaboration between University of Pennsylvania’s de la Fuente Lab and William Reis de Araujo, Professor in Analytical Chemistry at the State University of Campinas (UNICAMP) in São Paulo, Brazil.

De Araujo leads the Portable Chemical Sensors Lab and has been pairing his electrochemistry expertise with de la Fuente’s lab for years, Penn Engineering Today noted.

The team wanted to combine the speed and cost-effectiveness of previous rapid tests with an eco-friendly biodegradable substrate material.

Bacterial cellulose (BC) was a great choice because it “naturally serves as a factory for the production of cellulose, a paper-like substance which can be used as the basis for biosensors,” Penn Engineering Today reported.

Additionally, BC has an excellent track record for a variety of uses, such as regenerative medicine, wound care, and point-of-care (POC) diagnostics, the blog post noted. UPenn’s test offers speed and accuracy without needing costly equipment making it desirable for clinical laboratories preparing to fight the next pandemic.

The test has shown to be capable of “correctly identifying multiple variants in under 10 minutes. This means that the tests won’t require ‘recalibration’ to accurately test for new variants,” Penn Engineering Today added.

Innovation Born from Inspiration

Though rapid tests are essential to help curb the spread of COVID-19, the negatives that come with these tests didn’t sit well with the UPenn team. This spurred them to strive for improvements.

PCR tests “are hampered by waste [metal, plastic, and the aforementioned PCBs]. They require significant time [results can take up to a day or more] as well as specialized equipment and labor, all of which increase costs,” Penn Engineering Today noted.

Additionally, “Sophistication of PCR tests makes them harder to tweak and therefore slower to respond to new variants,” the blog post concluded.

“There’s a tension between these two worlds of innovation and conservation,” de la Fuente told Penn Engineering Today. “When we create new technology, we have a responsibility to think through the consequences for the planet and to find ways to mitigate the environmental impact.” 

Need for Biodegradable Diagnostic Tests

“COVID-19 has led to over 6.8 million deaths worldwide and continues to affect millions of people, primarily in low-income countries and communities with low vaccination coverage,” the Cell Reports Physical Science paper noted.

“There is a need for biodegradable diagnostic testing,” de la Fuentes told Penn Engineering Today. “We will be continuing to perfect this technology, which could hopefully help many people in the future, while also looking to expand it to other emerging pathogens in anticipation of future pandemics.”

While UPenn’s test will require clinical trials and FDA approval before it can become available to clinical laboratories and for point-of-care testing, it promises a bright, eco-friendly future for rapid viral testing.

—Kristin Althea O’Connor

Related Information:

Penn Engineers Create Low-Cost, Eco-Friendly COVID Test

A Bacterial Cellulose-Based and Low-Cost Electrochemical Biosensor for Ultrasensitive Detection of SARS-CoV-2

Rapid COVID-19 Diagnostic Test Delivers Results within Four Minutes with 90% Accuracy

Penn Researchers Develop Faster, Biodegradable COVID-19 Tests

Penn Medicine Researchers Develop Fast, Accurate, Inexpensive COVID-19 Diagnostic Test Based on Electrochemical Technology

Penn Medicine Researchers Develop Fast, Accurate, Inexpensive COVID-19 Diagnostic Test Based on Electrochemical Technology

The rapid diagnostic test costs less than $5 per unit and can be adapted for other diseases, the developers say, which opens a slew of possibilities for clinical laboratories

Just as the SARS-CoV-2 coronavirus spurred deployment of new vaccine technology based on messenger RNA (mRNA), the COVID-19 pandemic also could prove to be a watershed for in vitro diagnostics (IVD) innovation in ways that benefit clinical laboratories.

In one notable example, researchers at the Perelman School of Medicine University of Pennsylvania (Penn Medicine) in Philadelphia have developed a biosensor that uses electrochemical impedance spectroscopy (EIS) to detect the presence of the COVID-19 coronavirus in biological samples.

A Penn Medicine news release noted that “The RAPID technology … transforms the binding event between the SARS-CoV-2 viral spike protein and its receptor in the human body, the protein ACE2 (which provides the entry point for the coronavirus to hook into and infect human cells), into an electrical signal that clinicians and technicians can detect. That signal allows the test to discriminate between infected and healthy human samples. The signal can be read through a desktop instrument or a smartphone.”

Though still in its early stages, the technique potentially offers dramatically lower costs and faster results than traditional RT-PCR (reverse transcription polymerase chain reaction) molecular tests. Moreover, the RAPID technology might be useful for identifying other types of biomarkers and could be the basis for diagnostic tests that help reduce the cost-per-test in medical laboratory testing while providing comparable sensitivity and specificity to existing methodologies.

Clinical trials began on January 5, 2021, and the Penn Medicine researchers say the IVD test technology can be applied to other infectious diseases, which, if proven accurate, would be a boon to clinical laboratory testing.

The Penn Medicine researchers published their study on May 9 in the journal Matter, titled, “Low-Cost Biosensor for Rapid Detection of SARS-CoV-2 at the Point of Care.”

Diagnostic Test Results in Four Minutes for Less than $5/Test

According to the news release, the RAPID 1.0 (Real-time Accurate Portable Impedimetric Detection prototype 1.0) biosensor test costs less than $5 and can deliver results in four minutes. The researchers reported overall accuracy of 87.1% on (139) nasal swab samples and 90% on (50) saliva samples.

The technology uses electrodes that can be mass-produced at low cost on commercially-available screen printers, the researchers said. Results can be read on electronic devices connected to a PC or smartphone.

RAPID 1.0 COVID-19 diagnostic test

RAPID 1.0 (above) is a low-cost COVID-19 diagnostic test developed at the César de la Fuente clinical laboratory at the Perelman School of Medicine University of Pennsylvania in Philadelphia. At less than $5/test, plus the ability to be adapted to other diseases, clinical laboratories performing disease screenings in rural or remote locations may have a new tool in the fight against infections.  (Photo copyright: University of Pennsylvania.)

Does Penn Medicine’s RAPID 1.0 Test Replace Traditional RT-PCR Testing?

In their published study, the Penn Medicine researchers cited the need for “fast, reliable, inexpensive, and scalable point-of-care diagnostics.”

RT-PCR tests, they said, “are limited by their requirement of a large laboratory space, high reagent costs, multistep sample preparation, and the potential for cross-contamination. Moreover, results usually take hours to days to become available.”

Researchers who have studied the SARS-CoV-2 coronavirus know that it uses a spike-like protein to bind to angiotensin-converting enzyme 2 (ACE2) receptors on the surfaces of human cells.

As described in Penn Medicine’s published study, the biosensor contains ACE2 and other biochemical agents anchored to an electrode. When the SARS-CoV-2 coronavirus attaches to the ACE2, the biosensor transforms the chemical reaction into an electrical signal that can be measured on a device known as a potentiostat.

The researchers tested their RAPID 1.0 technology with two commercially available potentiostat models:

The researchers initially developed the electrode as a printed circuit board, which is relatively expensive. To reduce costs, they constructed a version that uses filter paper as the main component. The researchers noted that one screen printer in a lab can produce 35,000 electrodes per day, including time needed to incorporate the chemical elements. “However, it must be noted that these steps can be fully automated into a production line for industrial purposes, drastically reducing time requirements,” they wrote.

The test can be performed at room temperature, they added, and total cost per unit is $4.67. Much of that—$4.50—is for functionalizing the ACE2 recognition agent. The cost for the bare electrode is just seven cents.

“The overall cost of RAPID may be further reduced through recombinant production of ACE2 and ACE2 variants,” the researchers said, adding that the RAPID 1.0 test can detect the SARS-CoV-2 coronavirus at low concentrations correlating to the earliest stages of the COVID-19 disease.

Cesar de la Fuente, PhD

The Penn Medicine research team was led by César de la Fuente, PhD (above), an Assistant Professor in Psychiatry, Microbiology, Chemical and Biomolecular Engineering and Bioengineering at the Perelman School of Medicine. “Prior to the pandemic, our lab was working on diagnostics for bacterial infections,” he said in the Penn Medicine news release. “But then, COVID-19 hit. We felt a responsibility to use our expertise to help—and the diagnostic space was ripe for improvements.” (Photo copyright: University of Pennsylvania.)

Testing Penn Medicine’s RAPID 1.0 Test

The researchers evaluated the technology in blinded tests with clinical samples from the Hospital of the University of Pennsylvania. The evaluation included 139 nasal swab samples, of which 109 were determined to be COVID-19 positive by RT-PCR tests and clinical assessments. Among these, the RAPID test successfully detected the SARS-CoV-2 coronavirus in 91 samples, for a sensitivity rate of 83.5%. One sample was from a patient diagnosed with the highly contagious SARS-CoV-2 Alpha variant B.1.1.7, which the test correctly identified as positive.

Among the 30 samples determined to be COVID negative, the RAPID test scored a specificity rate of 100%, meaning no false positives. Overall accuracy, including sensitivity and specificity, was 87.1%.

The researchers also analyzed 50 saliva samples: 13 COVID-positive and 37 COVID-negative. The test correctly identified all 13 positive samples but produced five false-positives among the 37 negative samples, for a specificity rate of 86.5%. The researchers speculated that this could be due to interactions between ACE2 and other biomolecules in the saliva but suggested that performance “will improve when using fresh saliva samples at the point-of-care.”

Are There Other Applications for the RAPID Test?

The Penn Medicine news release said the RAPID technology can be adapted to detect other viruses, including those that cause Influenza and sexually-transmitted diseases.

Robert Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report, said the test points to one silver lining in the COVID-19 pandemic. “Researchers around the world intensified their work to find ways to identify the SARS-CoV-2 virus that are faster, cheaper, and more accurate than the diagnostic technologies that existed at the time of the outbreak. In this regard, the COVID-19 pandemic may have accelerated the development and refinement of useful diagnostic technologies that will disrupt long-established methods of testing.”

Marcelo Der Torossian Torres, PhD, postdoctoral researcher at Penn Medicine and lead author of the study, said in the news release, “Quick and reliable tests like RAPID allow for high-frequency testing, which can help identify asymptomatic individuals who, once they learn they are infected, will stay home and decrease spread. 

“We envision this type of test being able to be used at high-populated locations such as schools, airports, stadiums, companies—or even in one’s own home,” he added.

Clinical laboratory managers may want to stay current on the development and possible commercialization of the RAPID 1.0 (Real-time Accurate Portable Impedimetric Detection prototype 1.0) biosensor test by the research team at Penn Medicine.

—Stephen Beale

Related Information

Low-Cost Biosensor for Rapid Detection of SARS-CoV-2 at the Point of Care

Rapid COVID-19 Diagnostic Test Delivers Results within Four Minutes with 90% Accuracy

UPenn Medical School Develops Low Cost COVID-19 Test Called RAPID

UPenn Working on Rapid COVID Test That Delivers Results Within Minutes

Rapid COVID-19 Test Developed at Penn Could Give On-the-Spot Results Quickly

One Step Closer to An At-Home, Rapid COVID-19 Test

Study Reveals Surprises in How Healthcare Consumers Respond to Wellness Programs and Incentives, Some of Which Utilize Clinical Laboratory Tests as Benchmarks

80% of US employers are using financial incentives in wellness programs, and Penn Medicine research suggests better incentive design is needed to get people to exercise

In recent years, there’s been plenty of headlines about wellness programs offered by employers and health insurers. Data show that such programs are cost-effective. But, until now, there were few studies about employees’ attitudes toward wellness programs. Because some of these wellness programs incorporate clinical laboratory testing, medical labs have a stake in their future.

The fact is that companies want healthier employees and they’re willing to pay for it. Experts say about 80% of US employers use financial incentives in worker wellness programs. And for each dollar a company spends on a wellness program, it saves about $3 in medical costs, according to an article the journal Health Affairs. (more…)

New Finding Has Major Implications for Genetic Testing as Researchers Learn that Greater Numbers of Humans Have Multiple Personal Genomes

New insights about personal genomes will give pathologists and clinical laboratory scientists different ways to use genetic tests in the screening, diagnosis, and treatment of disease

Here is a human genome curve ball for pathologists and clinical laboratory scientists engaged in genetic testing in their medical laboratories. New research indicates that a larger number of humans than was once believed may have more than one genome. This has implications for many medical and health issues.

Until recently, scientists assumed that, as a rule, each individual had a unique genome. Conditions such as mosaicism and chimerism were considered a rarity.

Greater Incidence of Multiple Genomes in a Single Individual (more…)

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