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

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Teladoc Reports $13.7B Loss for 2022, Just Two Years after Livongo Acquisition

Loss could indicate an industrywide slowdown in digital health adoption and suggests medical laboratories will want to continue developing a virtual care strategy

Only two years after Teladoc Health (NYSE:TDOC) completed acquisition of Livongo, a data-based health coaching company, the virtual healthcare provider reported a 2022 net loss of $13.7 billion, a company press release announced.

The loss, which has been described as “historic,” is “mostly from a write-off related to the plummeting value of its Livongo acquisition. … By comparison, in 2021 [just a year earlier], Teladoc posted a net loss of $429 million,” Fierce Healthcare reported.

However, during Teladoc’s fourth quarter earnings call, CEO Jason Gorevic said, “We are pleased with the strong fourth quarter and full-year operating results. Despite a challenging macro environment, we were able to expand our product offerings and enhance the level of care delivered across our integrated whole-person platform.” Teladoc Health’s 2022 revenue was $2,406,840 compared to $2,032,707 in 2021. That’s an 18% increase over last year’s revenue, according to the earnings report. Nevertheless, a month before the earnings call Teladoc laid off 300 non-clinician employees, Fierce Healthcare noted.

Jason Gorevic

“Teladoc Health has been at the forefront of the adoption curve, and we believe that our scale, breadth of product offering, and proven outcomes will enable us to maintain and expand our position in the market,” said Teladoc Health CEO Jason Gorevic during February’s earnings call. Clinical laboratory leaders may view the company’s $13B loss as indication that adoption in telehealth by physicians, healthcare providers, and patients of digital-based health services is not happening as swiftly has been predicted. (Photo copyright: The Business Journals.) 

Predictions in Telehealth Adoption Fall Short

Teladoc Health, based in Purchase, New York, acquired Livongo of Mountain View, California, in October 2020 for $18.5 billion. 

A news release at that time declared that the merger was “a transformational opportunity to improve the delivery, access, and experience of healthcare for consumers around the world.

“The highly complementary organizations,” the release stated, “will combine to create substantial value across the healthcare ecosystem, enabling clients everywhere to offer high quality, personalized, technology-enabled longitudinal care that improves outcomes and lowers costs across the full spectrum of health.”

The deal was hailed as advancing telemedicine and digital health services. As it turned out, though, the demand for those types of services fell far short of the Teladoc’s expectations. One way to interpret the cause of the multi-billion dollar write-down is that adoption of digital health services by physicians, healthcare providers, and consumers is not happening as fast as Teladoc projected.

It may also be that companies allocated too much money to deals during the COVID-19 pandemic, an unstable period of time for making major business decisions.

In fact, worldwide digital health funding fell 57% in 2022 after a high in 2021, according to a CB Insights State of Digital Health 2022 Report.

Teladoc to Reduce Costs while Pursuing Increased Adoption of Virtual Care

Gorevic told analysts during the earnings call that the company needs to reduce costs and reach a market that is “in the early innings.” Year-over-year growth of 6% to 11% is expected in 2023, he said.

“You should expect us to balance growth and margin with an increased focus on efficiency going forward. Part of that approach is rightsizing the cost structure to reflect the current growth rates of the business,” Gorevic said. “The more balanced approach does not mean that we will stop relentlessly pursing growth and increased adoption of virtual care across the industry. Virtual care’s role within the healthcare industry remains underpenetrated, and we will continue to invest to expand our leadership position,” he added.

Digital Health Investing Falls Off

However, citing digital health market data in the new CB Insights report, Becker’s Hospital Review(Becker’s) suggested the digital health bubble may have “popped,” and that funding by investors is falling fast from the “Golden Age” of 2021.  

The digital health category grew by 79% in 2021 to $57.2 billion, a record high, according to data cited by Becker’s. In the fourth quarter of 2021, there were 13 new digital health companies with valuations of at least $1 billion each. But by the end of 2022, digital health funding dropped to $3.4 billion. That’s “a five-year low,” Becker’s reported.

“The drop in funding in digital health companies I feel is a response to the volatility in healthcare where over 50% of hospitals and healthcare providers have posted losses for 2022 and a bleak outlook for 2023,” Darrell Bodnar, Chief Information Officer at North Country Healthcare in Lancaster, New Hampshire, told Becker’s.

And, in a statement about hospitals’ financial health, Fitch Ratings said providers in 2022 reported “weaker profitability and liquidity” as compared to 2021. For most providers, a “rapid financial recovery” is not expected, Fitch noted.

Labs Need Telehealth Strategies

All of this uncertainty in the telehealth/virtual care markets may ultimately benefit clinical laboratories and lab investors who delayed investing in technology that enables supporting physicians and patients using telemedicine visits. Still, it would be smart for medical laboratory leaders to develop a digital health strategy to meet consumer demand for lab testing services in tandem with virtual care visits with healthcare providers. 

—Donna Marie Pocius

Related Information:

Teladoc Health Reports Fourth Quarter and Full Year 2022 Results

Teladoc Sinks $13.7B Loss in 2022 Tied to Plummeting Value of Livongo Acquisition

Teladoc Health and Livongo Merge to Create New Standard in Global Healthcare Delivery, Access, and Experience

State of Digital Health 2022 Report

What is Digital Health?

Teladoc Health Reports $13B Loss in 2022

Early Not-for-Profit Hospital Medians Show Expected Deterioration, Will Worsen

Did the Digital Health Bubble Pop? CIOs Weight In

Cedars-Sinai Researchers Determine Smartphone App Can Assess Stool Form as Well as Gastroenterologists and Better than IBS Patients

Artificial intelligence performs BSS assessments with higher sensitivity and specificity than human diagnosticians

In a recent study conducted by scientists at Cedars-Sinai Medical Center in Los Angeles, researchers evaluated a smartphone application (app) that uses artificial intelligence (AI) to assess and characterize digital images of stool samples. The app, it turns out, matched the accuracy of participating gastroenterologists and exceeded the accuracy of study patients’ self-reports of stool specimens, according to a news release.

Though smartphone apps are technically not clinical laboratory tools, anatomic pathologists and medical laboratory scientists (MLSs) may be interested to learn how health information technology (HIT), machine learning, and smartphone apps are being used to assess different aspects of individuals’ health, independent of trained healthcare professionals.

The issue that the Cedars Sinai researchers were investigating is the accuracy of patient self-reporting. Because poop can be more complicated than meets the eye, when asked to describe their bowel movements patients often find it difficult to be specific. Thus, use of a smartphone app that enables patients to accurately assess their stools in cases where watching the function of their digestive tract is relevant to their diagnoses and treatment would be a boon to precision medicine treatments of gastroenterology diseases.

The scientists published their findings in the American Journal of Gastroenterology, titled, “A Smartphone Application Using Artificial Intelligence Is Superior to Subject Self-Reporting when Assessing Stool Form.”

Mark Pimentel, MD

“This app takes out the guesswork by using AI—not patient input—to process the images (of bowel movements) taken by the smartphone,” said gastroenterologist Mark Pimentel, MD (above), Executive Director of Cedars-Sinai’s Medically Associated Science and Technology (MAST) program and principal investigator of the study, in a news release. “The mobile app produced more accurate and complete descriptions of constipation, diarrhea, and normal stools than a patient could, and was comparable to specimen evaluations by well-trained gastroenterologists in the study.” (Photo copyright: Cedars-Sinai.)

Pros and Cons of Bristol Stool Scale

In their paper, the scientists discussed the Bristol Stool Scale (BSS), a traditional diagnostic tool for identifying stool forms into seven categories. The seven types of stool are:

  • Type 1: Separate hard lumps, like nuts (difficult to pass).
  • Type 2: Sausage-shaped, but lumpy.
  • Type 3: Like a sausage, but with cracks on its surface.
  • Type 4: Like a sausage or snake, smooth and soft (average stool).
  • Type 5: Soft blobs with clear cut edges.
  • Type 6: Fluffy pieces with ragged edges, a mushy stool (diarrhea).
  • Type 7: Watery, no solid pieces, entirely liquid (diarrhea). 

In an industry guidance report on irritable bowel syndrome (IBS)and associated drugs for treatment, the US Food and Drug Administration (FDA) said the BSS is “an appropriate instrument for capturing stool consistency in IBS.”

But even with the BSS, things can get murky for patients. Inaccurate self-reporting of stool forms by people with IBS and diarrhea can make proper diagnoses difficult.

“The problem is that whenever you have a patient reporting an outcome measure, it becomes subjective rather than objective. This can impact the placebo effect,” gastroenterologist Mark Pimentel, MD, Executive Director of Cedars-Sinai’s Medically Associated Science and Technology (MAST) program and principal investigator of the study, told Healio.

Thus, according to the researchers, AI algorithms can help with diagnosis by systematically doing the assessments for the patients, News Medical reported.

30,000 Stool Images Train New App

To conduct their study, the Cedars-Sinai researchers tested an AI smartphone app developed by Dieta Health. According to Health IT Analytics, employing AI trained on 30,000 annotated stool images, the app characterizes digital images of bowel movements using five parameters:

  • BSS,
  • Consistency,
  • Edge fuzziness,
  • Fragmentation, and
  • Volume.

“The app used AI to train the software to detect the consistency of the stool in the toilet based on the five parameters of stool form, We then compared that with doctors who know what they are looking at,” Pimentel told Healio.

AI Assessments Comparable to Doctors, Better than Patients

According to Health IT Analytics, the researchers found that:

  • AI assessed the stool comparable to gastroenterologists’ assessments on BSS, consistency, fragmentation, and edge fuzziness scores.
  • AI and gastroenterologists had moderate-to-good agreement on volume.
  • AI outperformed study participant self-reports based on the BSS with 95% accuracy, compared to patients’ 89% accuracy.

Additionally, the AI outperformed humans in specificity and sensitivity as well:

  • Specificity (ability to correctly report a negative result) was 27% higher.
  • Sensitivity (ability to correctly report a positive result) was 23% higher.

“A novel smartphone application can determine BSS and other visual stool characteristics with high accuracy compared with the two expert gastroenterologists. Moreover, trained AI was superior to subject self-reporting of BSS. AI assessments could provide more objective outcome measures for stool characterization in gastroenterology,” the Cedars-Sinai researchers wrote in their paper.

“In addition to improving a physician’s ability to assess their patients’ digestive health, this app could be advantageous for clinical trials by reducing the variability of stool outcome measures,” said gastroenterologist Ali Rezaie, MD, study co-author and Medical Director of Cedars-Sinai’s GI Motility Program in the news release.

The researchers plan to seek FDA review of the mobile app.

Opportunity for Clinical Laboratories

Anatomic pathologists and clinical laboratory leaders may want to reach out to referring gastroenterologists to find out how they can help to better serve gastro patients. As the Cedars-Sinai study suggests, AI smartphone apps can perform BSS assessments as good as or better than humans and may be useful tools in the pursuit of precision medicine treatments for patient suffering from painful gastrointestinal disorders.

—Donna Marie Pocius

Related Information:

Smartphone Application Using Artificial Intelligence is Superior to Subject Self-Reporting When Assessing Stool Form

Study: App More Accurate than Patient Evaluation of Stool Samples

Industry Guidance Report: Irritable Bowel Syndrome—Clinical Evaluation of Drugs

Artificial Intelligence-based Smartphone App for Characterizing Stool Form

AI Mobile App Improves on “Subjective” Patient-Reported Stool Assessment in IBS

Artificial Intelligence App Outperforms Patient-Reported Stool Assessments

Banner Health Introduces Virtual Waiting Rooms in 300 Medical Clinics Across Its Nationwide Healthcare System

As digital healthcare continues to gain acceptance and regulatory support, clinical laboratories will need to help patients provide biological samples for virtual doctor visits

Patterns are emerging in healthcare that will likely impact clinical laboratories now and into the future. Trends in telehealth and mobile health (mHealth) that were just beginning to develop before the COVID-19 pandemic have accelerated with the outbreak, and many are predicted to remain once the pandemic is over, reported Healthcare Business and Technology.

Now comes virtual waiting rooms to go along with virtual doctor’s visits. One example is Banner Health of Phoenix, Arizona. The non-profit has more than 50,000 employees in Ariz. and is the state’s largest employer. It operates 28 hospitals and multiple specialty clinics in six states, making it one of the largest health systems in the US as well.

Banner Health is working with LifeLink to deploy virtual waiting rooms in all of its 300 clinics.

What is a Virtual Waiting Room?

The Banner Health System includes 1,500 physicians who work in 300 clinics. More than one million patients in Arizona, California, Colorado, Nebraska, Nevada, and Wyoming are part of the system.

In the not too distant past, when patients visited Banner Health providers and received doctor’s orders for diagnostic tests, they then went to clinical laboratories or the lab’s patient service centers to provide a biological specimen for testing.

Now, because of COVID-19, patients at Banner Health clinics access virtual waiting rooms through a mobile device or computer. They check in virtually for video visits and may not visit a doctor’s office or medical facility at all. Instead, they engage their healthcare provider through a telehealth connection.

The introduction of the virtual waiting rooms is Banner Health’s response to the need for social distancing during the COVID-19 pandemic.

The virtual waiting rooms employ LifeLink chatbots, which interact with patients in a conversational way, and are available for both telehealth and in-person appointments. The chatbots can:

  • provide appointment reminders,
  • guide patients through completing necessary paperwork,
  • provide instructions on using telehealth technology,
  • check patients in for appointments, and
  • direct patients to an exam room for in-person doctor visits.

Banner Health used similar technology for patients visiting their emergency departments.

Jeff Johnson, JD, Vice President of Innovation Banner Health
“The traditional patient experience of walking into an office, filling out paper forms, reading instructions and then waiting for an exam room had to change. LifeLink chatbots have already helped hundreds of thousands of Banner patients navigate emergency room visits, so the concept of digitizing regular doctor appointment visits with a mobile, virtual waiting room chatbot assistant was a natural extension of the technology,” said Jeff Johnson, JD, Vice President of Innovation and Digital Business at Banner Health, in a press release. (Photo copyright: Healthcare IT News.)

Both Patients and Healthcare Providers Need to Adapt

“The COVID-19 pandemic requires an entirely different level of thinking when it comes to providing routine patient services,” said Greg Johnsen, CEO at LifeLink, in the Banner Health press release. “Like the changes we are seeing in retail, healthcare providers need to adapt, and the waiting room experience is one area that will need to change. We take great pride in knowing that LifeLink chatbots are providing peace of mind and convenience for patients that need to see their doctors.”

A significant innovation is that patients can easily engage with the chatbots through a “one-click authentication process and then interact through a standard web browser,” rather than requiring them to download and install a mobile device app, Healthcare IT News reported.

“One of the key benefits of this chatbot technology is the ease of use,” said Banner Health’s Jeff Johnson in the press release. “Interactions that use natural language eliminate the need for user training, and there are no apps or passwords required so it’s simple for patients to interact with us securely, on any device. We have seen high engagement rates as a result.”

One thing seems certain, as COVID-19 causes increased anxiety over social distancing, it is likely that virtual healthcare, telehealth, and digital pathology will continue to be developed in the medical industry.

This has implications for clinical laboratories, because if patients are being scheduled virtually, it is just a small additional step to have the doctor see them virtually via telehealth. In such circumstances, medical laboratories will need to have a way for the patient to provide a specimen for lab testing.

—Dava Stewart          

Related Information:

Banner Health Launches Virtual Waiting Rooms for Telehealth and In-Person Doctor Appointments

Banner Health Innovates with LifeLink Chatbots to Enable Virtual Waiting Rooms for Telehealth and In-Person Appointments

Health Care Isn’t Going Back to Normal After Pandemic

Chatbots are the Future of Healthcare. Here’s why.

Improving the Medicare Patient Experience with Conversational Mobile Technology — The Breakthrough at Banner Health

Mobile Chatbot Tech Improves ER Patient Experience at Banner Health

Essenlix Builds Mobile Technology Device That Performs CBC Tests Attached to a Smartphone

New advancements in mHealth, though encroaching on testing traditionally performed at clinical laboratories, offer opportunity to expand testing to remote locations

Mobile technology continues to impact clinical laboratories and anatomic pathology groups and is a major driver in precision medicine, as Dark Daily has reported. Most of the mobile-test development which incorporates smartphones as the testing device, however, has been for chemistry and immunoassay types of lab tests. Now, a new developer in Monmouth Junction, NJ, has created a Complete Blood Count (CBC) test that runs on devices attached to smartphones.

Such devices enable doctors to order test panels for patients in remote locations that also may lack resources, such as electricity.

The developer is Essenlix and it calls its new testing device iMOST (instant Mobile Self-Testing). According to the company’s website, which is mostly “Under Construction,” iMOST can provide “accurate blood and other healthcare testing in less than 60 seconds by a smartphone and matchbox-size-attachment, anywhere, anytime, and affordable to everyone.”

Stephen Chou, PhD, Professor of Electrical Engineering at Princeton University founded Essenlix, and told Business Insider that his company is developing something that will basically be “a mobile chemical biological lab in your hand.” (Photo copyright: Essenlix.)

The company description on the Longitude Prize website states that Essenlix “uses multidisciplinary approaches to develop a new innovative platform of simple, fast, ultrasensitive, bio/chemical sensing and imaging for life science, diagnostics, and personal health.

The Longitude Prize competition was established to promote the invention of “an affordable, accurate, fast and easy-to-use test for bacterial infections that will allow health professionals worldwide to administer the right antibiotics at the right time,” the website states.

The Essenlix iMOST mobile-testing device (above) connects to a smartphone (shown right) and enables clinical laboratory technicians to run tests in remote locations from samples taken at time the test. Though still in trials, iMOST, and other similar devices, promise to expand testing to outside of traditional medical laboratory locations and further promote precision medicine. (Photos copyright: Lydia Ramsey/Business Insider.)

Essenlix’s iMOST mobile testing system consists of:

  • a mobile application (app);
  • the device attachment, which goes over the phone’s camera; and,
  • a cartridge that holds a sample of blood.

So far, there have been two trials with a total of 92 participants, comparing traditional CBC testing with the Essenlix test. The results were within the FDA’s requirements for allowable error, prompting Chou to tell Business Insider, “Our error is clearly smaller than the FDA’s requirement, so the data is very, very good.”

Chou and his team are working toward FDA approval.

Other Testing Devices That Attached to Smartphones

Aydogan Ozcan, PhD, Professor of Electrical Engineering and Bioengineering at UCLA, and Mats Nilsson, PhD, Professor and Scientific Director of the Science for Life Laboratory at Stockholm University, have developed an attachment that they say can transform “a phone into a biomolecular analysis and diagnostics microscope,” according to The Pathologist. Dark Daily has published many e-briefings on Ozcan’s innovations over the years.

Their goal, the researchers said, was to create technology that can be used in low- and middle-income areas (LMICs), as well as in more advanced locations, such as Sweden. “I’ve been involved in other projects where we’ve looked at point-of-care diagnostic approaches,” he said, “and it seems to be very important that the devices [do not] rely on wired electricity or networks to serve not only LMICs, but also modern, developed environments. It’s often difficult to find an available power socket in Swedish hospitals.”

The molecular diagnostic tests that can be done with smartphone attachments—such as those developed by Ozcan and Nilsson—represent another way of using a smartphone in the healthcare arena, The Pathologist points out. Their invention combines the smartphone’s native camera, an app, optomechanical lasers, and an algorithm contained within the attachment to carry out fluorescence microscopy in the field.

Future of Mobile-Testing

An article appearing in the Financial Times describes some of the ways mobile technology is changing healthcare, including diagnostics that have traditionally been performed in the medical pathology laboratories.

“Doctors scan your body to look for irregularities, but they rely on pathologists in the lab to accurately diagnose any infection,” the article notes. “There, body fluids such as blood, urine, or spit are tested for lurking microbes or unexpected metabolites or chemicals wreaking havoc in your body. Now companies are miniaturizing these tests to create mobile pathology labs.”

Apple introduced the first iPhone in 2007. It’s doubtful anyone imagined the innovations in diagnostics and pathology that would soon follow. Thus, trying to predict what may be coming in coming decades—or even next year—would be futile. However, scientists and researchers themselves are indicating the direction development is headed.

Should Essenlix and other mobile-lab-test developers succeed in their efforts, it would represent yet another tectonic shift for medical pathology laboratories. Clinical laboratory managers and stakeholders should be ready, for the words of the ancient Greek philosopher Heraclitus have never been truer: “Change is the only constant in life.”

—Dava Stewart

Related Information:

Mobile Phone Microscopy

How Smartphones Are Transforming Healthcare

This Startup Wants to Make Blood Testing as Easy as Snapping a Photo with an iPhone

Is mHealth an Opportunity or Threat to Medical Laboratories and Pathology Groups?

New FDA Regulations of Clinical Decision-Support/Digital Health Applications and Medical Software Has Consequences for Medical Laboratories

UCLA Device Enables Diagnosis of Antimicrobial Resistance in Any Setting; Could Save Lives Lost to Antimicrobial Resistant Bacteria

Lab-on-a-Chip Diagnostics: When Will Clinical Laboratories See the Revolution?

Tiny, Simple-to-Use Lensless Microscope Might Soon Find a Place in Pathology

Cleveland Clinic Gives Patients Statewide 24/7 Access to Physicians through Smartphones, iPads, Tablets and Online: Will Telemedicine Also Involve Pathologists?

New service allows patients statewide to access urgent care via telephones and other devices as Cleveland Clinic positions itself to be a 24/7 provider of choice

Urgent care by telephone is the latest patient-centric and customer-friendly medical service to be offered by the Cleveland Clinic. It is also the first 24-hour online statewide healthcare service of its kind in Ohio, a milestone that has implications for pathologists and clinical laboratory executives because lab testing is often required in support of patients wanting access to urgent care, particularly after hours.

Express Care Online (formerly MyCare Online) is the Cleveland Clinic’s new telemedicine service. It enables patients to see a medical professional for urgent matters via computer or smartphone 24 hours a day/seven days a week, according to a Cleveland Clinic statement. (more…)

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