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

Hosted by Robert Michel

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

Hosted by Robert Michel
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Elizabeth Holmes’ Partner, Billy Evans, is Creating an Artificial Intelligence Medical Testing Startup

NPR reports that the shamed Theranos founder/CEO is providing advice to Evans, but the startup denies that claim

Prison bars can’t block Elizabeth Holmes from finding her way back into the news spotlight. The disgraced founder and former CEO of Theranos is reportedly advising her partner Billy Evans on his new artificial intelligence (AI) diagnostic startup company, named Haemanthus after the blood lily.

According to sources who spoke with NPR, Evans’ new company Haemanthus, Inc. is developing a blood testing device and has patented a process that uses Raman spectroscopy, which, according to NPR, “has been shown to help diagnose ALS, also called Lou Gehrig’s disease, as well as some forms of cancer. It has also been used to discover improvised explosive devices on battlefields.”

Evans has already raised millions of dollars for the fledgling startup, NPR reported, adding that a source claimed finances for the company have come from “mostly friends, family, and other supporters so far.”

According to Newsweek, Evans’ goal is to raise $50 million toward the development of a “medical testing product.”

The company will “do medical tests using bodily fluids,” Newsweek reported, adding, “An image of the alleged device published by The New York Times is eerily similar to Theranos’ ‘Edison’ testing machine.”

Elizabeth Holmes is currently housed in a federal facility in Bryan, Texas. Sources told NPR that she has been “providing advice” to Billy Evans, her partner, on his new AI/medical testing company Haemanthus, which denied those claims stating on X that Holmes “has no role, now or future.” (Photo copyright: Wikimedia Commons.)

Haemanthus Denies Holmes’ Involvement

Holmes has reportedly been providing insight to Evans throughout her prison term, though her role with his budding company is unclear, NPR noted.

As previously reported by Dark Daily, Holmes is “barred from receiving payments from federal health programs for services or products, which significantly restricts her ability to work in the healthcare sector.”

Haemanthus denied Holmes’ involvement with the company, claiming that she “has no formal role” and that “Haemanthus is not Theranos 2.0,” Fortune reported.

Previous lengthy posts by Haemanthus on social media platform X fully denied any involvement with Holmes but have since been deleted. The company now uses their platform to curtly retort the significance of Holmes’ involvement, leaning on their advancements and high standards. “Skepticism is rational. We must clear a higher bar,” they said. “When The NY Times contacted us, we invited them to see our lab, tech, and team. They declined. The headline was already written. Our reality inconvenient.”

Further posts on X showcase Haemanthus’ desire to have the same groundbreaking prowess Holmes clung to throughout her Theranos venture. The company claims to have developed “the world’s first AI-native sensors for health,” adding, “Our technology captures thousands of biomarkers simultaneously.”

And the Holmes Saga Continues

Haemanthus is comprised of about a dozen people, including individuals who “worked with Evans at Luminar Technologies, which develops sensor technology for autonomous vehicles, according to the company’s patent and Delaware incorporation paperwork,” NPR reported.

Holmes is currently serving an 11-year federal prison sentence for her role in fraud involving Silicon Valley startup Theranos, which boasted clinical laboratory blood-test breakthroughs that turned out to be riddled with faulty equipment and fraudulent results.

Though whistleblowers brought Holmes scheme to the light, she has never admitted wrongdoing for her actions and continues to claim her innocence. In May, the Ninth Circuit of Appeals denied her request for a rehearing of her case.

—Kristin Althea O’Connor

AI in Clinical Laboratories Will Drive Business Forward for Diagnostic Leaders, Experts Say

At least a dozen sessions at the 2025 Executive War College explored artificial intelligence use in clinical labs

Although not explicitly stated, it was clear at the 2025 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management conference that artificial intelligence must be a path forward for labs to control costs in an unfavorable economic environment.

Even though the technology is largely unproven in clinical lab settings, the potential of artificial intelligence (AI) in labs is enough reason for laboratory leaders to explore it further.

“AI is allowing us to drive our business,” said Sam Terese, CEO and president at Alverno Laboratories, during a general session at the Executive War College. “It is really resonating that we need to use AI in the future.”

Clinical laboratory leaders should constantly ask themselves whether there is an AI solution to a problem, advised Sam Terese (above), CEO and president at Alverno Laboratories. Terese spoke at the 2025 Executive War College. (Photo copyright: LabX.)

‘Not a Lot of Trust’ in AI from Patients

Terese acknowledged that patients do not yet feel comfortable with the technology. “When you throw AI and healthcare together, from the public’s perspective, there’s not a lot of trust,” he said.

That said, Alverno is committed to increased use of AI in clinical labs in 2025, including for:

Terese urged laboratory owners and executives to not underestimate how quickly AI adoption could spread within the clinical lab industry. Digital pathology took half a century to evolve into its current state, but “AI took five years. The timeline is moving rapidly,” he observed.

Don’t Move Blindly Forward with AI, Experts Warn

At least a dozen sessions at this week’s Executive War College addressed an aspect of AI in labs.

One session explored the idea of AI offering predictive tools for anatomic pathologists. If clinical laboratory professionals focus too strongly on the risk of AI replacing human jobs, they will miss the technology’s potential to serve as an assistant, said Matthew Cecchini, MD, PhD, a pathologist at London Health Sciences Center and associate professor at Western University, Ontario, Canada. “I feel strongly that we need to engage with AI,” he noted.

Lab leaders must advise their staff to use AI with systems or processes that can tolerate mistakes because AI will get things wrong, Cecchini added.

“I treat AI like an eager intern where you have to check everything it does,” he said.

Presenter Ankit Ranjan, PhD, founder of AI company Sample Healthcare, agreed with that sentiment. He suggested that clinical laboratories should consider AI as a copilot until its algorithms can prove to lab staff that conclusions or predictions are accurate. The long game for AI in labs is not to cut a few staff from the budget but instead act as a revenue driver.

“Inserting AI into end-to-end processes is what really addresses problems,” Ranjan said.

Watch for much more coverage about the state of AI in clinical laboratories in upcoming issues of The Dark Report. If you’re not a subscriber, it’s a great time to take a free trial of our business intelligence briefings.

—Scott Wallask

Executive War College 2025: Clinical Laboratory Leaders to Explore Innovation, AI Disruption, and Paths Forward at Annual Gathering

30th edition of the conference returns to New Orleans this week, bringing together diagnostic lab executives and innovators

Medical laboratory leaders and executives, along with diagnostic innovators from across the country, are convening in New Orleans this week for the 30th annual Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management.

Given the political, regulatory, and financial upheaval occurring in the US, this year’s Executive War College gathering offers a timely opportunity for lab leaders to discuss important strategies and network with sellers.

Featuring 85 sessions across two days, attendees will delve into key topics such as revenue growth strategies, regulatory updates, AI integration, workforce development, and evolving payer dynamics.

With clinical laboratories playing an increasingly pivotal role in value-based care and patient outcomes, the 2025 conference agenda reflects a growing need for labs to operate not just as diagnostic services but as critical business units driving healthcare innovation.

Robert Michel (above), founder of the Executive War College and outgoing editor-in-chief of Dark Daily, will lead a closing session on Wednesday looking at common themes that emerged during the Executive War College. “It’s important that lab leaders take note of what they learned—whether it was during a session, networking reception, or chance meeting with a peer—before heading back to their organizations,” he said. (Photo copyright: LabX.)

Event Will Illustrate Paths Forward for Lab Industry

Robert Michel, founder of the Executive War College and outgoing editor-in-chief of Dark Daily, previously noted that smart laboratory leaders are viewing financial, staffing, and operational pressures as opportunities to move ahead.

“This path forward is informed by two longstanding precepts recognized by innovative managers,” Michel said. “One precept is ‘Change creates new winners and losers.’ The other precept is ‘Change creates opportunity.’ Savvy lab leaders recognize the powerful truths in each precept.”

The general sessions kick off Tuesday morning with a keynote address from Michel titled, “Healthcare at a Tipping Point: Why Lab Opportunities and Challenges in Coming Years Will Be Different than Those of the Past 30 Years.” The keynote will synthesize nationwide trends, setting the stage for two days of in-depth discussion.

Other general sessions on Tuesday will explore the continued move towards precision medicine, how to take innovative steps to improve lab operations, and ways to elevate the value of laboratory services.

Agenda Features More than One Dozen AI-Themed Sessions

Artificial intelligence (AI) will be another hot topic this year, particularly as labs grapple with how to harness a technology that just in the past year seems to have proliferated exponentially.

This year’s Executive War College will devote more than a dozen sessions to AI discussions, as experts from both the technology and pathology sectors dissect AI’s current capabilities, legal aspects, and financial implications.

Another major focus for 2025 is the regulatory environment. Several sessions will provide updates on the latest CLIA inspection deficiencies, where regulators stand on current concerns, and the future of laboratory developed test oversight given a federal court’s recent decision to vacate the Food and Drug Administration’s final rule on LDTs.

Wide Swath of Laboratory Influencers Expected

Nearly 1,000 attendees, speakers, and vendor representatives are expected at the Executive War College, including C-level executives, pathologists, lab directors, and business development leaders.

Watch Dark Daily this week for further updates from New Orleans, including coverage of the opening day’s general sessions and a wrap-up of what lab leaders learned during the event.

—Scott Wallask

States Pursue Legislation Limiting AI’s Growing Role in Payer Prior Authorization Denials and Claims Processing

This follows class action lawsuits in multiple states against insurance companies that deny millions of healthcare claims each year

Artificial intelligence (AI) has become ubiquitous in many aspects of healthcare. But perhaps its most controversial use is in the payer denial-of-claims process. Multiple states are pursuing legislation that would limit or outright ban AI’s use without physician involvement.

Clinical laboratories experience payment denials at both the prior authorization stage when a doctor orders a lab test as well as when the claim is submitted for reimbursement. And many labs perform tests for which they know they will not be paid just to maintain the client account relationships with doctors.

Now, several states are taking measures to protect patients from what some say is a dangerous trend to use AI algorithms only to review and deny medical claims for critical healthcare and clinical laboratory testing. This will be of interest to lab managers and those in charge of their lab’s revenue.

“Physicians and patients already face daunting challenges in navigating medical insurers’ bureaucratic administrative processes,” said Arizona Medical Association (ArMA) President Nadeem Kazi, MD, in a news release. “Taking physicians’ clinical experience out of these processes entirely is a misguided step,” he added.

In Arizona, the state’s House of Representatives passed Bill 2175 on February 20, which includes a ban on using AI to deny medical claims without physician involvement, NBC News reported.  

However, on March 13, the Arizona Senate’s Finance Committee altered the language in its version of the bill. In it, AI is not specifically mentioned.

Instead, the bill’s language now “requires a medical director or healthcare provider, before a healthcare insurer may deny a claim or issue a direct denial of a prior authorization, to individually review any denial that involves medical necessity or experimental status or that requires the use of medical judgment and prohibits the director or provider from relying solely on recommendations derived from any other source during the prior authorization denial or claim denial review.”

Presumably, “any other source” includes AI-driven software platforms used by payers for prior authorization denials and claims processing.

“While AI promises innovation for several areas of healthcare, the review and denial of medical insurance claims—some of which represent life-changing treatments and procedures—should be left to physicians who can make nuanced clinical judgments,” said Shelby Job, ArMA communications director, in a statement following that state’s passage of the House bill in February.

The bill is now being debated in the Arizona Senate. If the Senate passes its version, the two sides will need to reconcile their bills.

“Patients deserve healthcare delivered by humans with compassionate medical expertise, not pattern-based computer algorithms designed by insurance companies,” said ArMA President Nadeem Kazi, MD (above), in a news release. (Photo copyright: Arizona Medical Association.)

Multiple States Move to Limit Use of AI in Claims Denials

In an Arizona House of Representatives Committee on Commerce meeting, state Republican representative Julie Willoughby, who is also an ER nurse, said that “she hopes the bill will protect Arizonians from losing healthcare access due to AI interference,” NBC News reported following passage of the House bill.

“What we’re asking for in this is that any claims that are denied have a provider look them over for completeness to ensure that there isn’t anything that the AI algorithm may not have accounted for,” she said.

If signed into law, the bill will require a medical director at the insurance carrier in question to “individually review each claim or prior authorization before a healthcare insurer is able to deny a claim for that patient,” NBC News noted.

California passed similar legislation in September that would “ensure that a licensed physician supervises the use of AI decision-making tools when they are used to inform decisions to approve, modify, or deny requests by providers,” NBC News reported.

The author of the California bill, Democratic senator Josh Becker, JD, argued upon the bill’s passing that AI “should never replace the expertise and judgment of physicians,” adding, “An algorithm cannot fully understand a patient’s unique medical history or needs, and its misuse can lead to devastating consequences.”

And in Texas, a bill introduced by Republican senator Charles Schwertner, MD, states that AI “should not be used as the ‘sole basis of a decision to wholly or partly deny, delay, or modify healthcare services,’” NBC News reported.

In a statement, the Texas Coalition of Patients said the bill is “crucial in ensuring that life-altering healthcare decisions remain in the hands of medical professionals rather than Big Insurance’s automated systems.”

In all, 11 states have introduced legislation to “to push back on artificial intelligence use in reviewing medical claims,” according to NBC News.

In May 2023, The Dark Report explored payer claims denials, and it was acknowledged back then that automated systems were already reviewing claims.

And then there are the lawsuits. According to The Guardian, Cigna, Humana, and UnitedHealth all face class-action lawsuits concerning the use of AI to “deny lifesaving care.”

Can AI Coexist with Human-based Care?

Although at this time AI may not understand the nuanced complexities of healthcare claims, there seem to be plenty of uses for it in healthcare decision-making. It can analyze large sets of data for diagnosis, transcribe medical documents using automatic speech recognition, and streamline administrative tasks––all of which can help a workforce plagued by staff burnout and shortages, Los Angeles Pacific University noted.

And though its use in payer claims reviews and denials is being resisted, AI will likely continue to help doctors diagnose disease and make better treatment decisions. Nevertheless, clinical laboratory and pathology workers should be aware of how the tool is being used and keep an eye out for suspicious claims denials.                         

—Ashley Croce

Becker’s Health IT Releases Lists of Providers That Paid the Most for Their EHRs

New EHR installations may require new laboratory information system upgrades and interfaces

Electronic health record (EHR) systems continue to be one of the costliest investments healthcare providers can make. And the company that holds the largest portion of the EHR market is Epic, with anywhere from 36% to 44%, according to various published reports and research briefs.

Healthcare executives remorseful about the cost of their hospital’s EHR may take solace in Becker’s Health IT’s recent list of the “most expensive” Epic EHR installations. It is common for the largest projects to cross the $1 billion mark.

Clinical laboratory leaders tasked with interfacing their hospital’s laboratory information system (LIS) with their healthcare system’s EHR may find the following information useful. The investment in time begins months before the actual EHR implementation.

One example is Lake Charles Memorial Health System (LCMHS) Lake Charles, La. In a blog post, the health system reported that it took 18 months for its physicians, clinicians, and staff to prepare for the installation of their new Epic MyChart EHR.

“There are lots of things we wish our customers would do to make sure their system runs well. Making sure every user is trained, for example. Putting in upgrades quickly. Making sure that the hardware runs fast enough,” wrote Judy Faulkner, Epic founder and CEO, in an Epic blog post.

“The LCMHS staff and physicians have championed this project from the beginning, and I have them to thank for the success of this EMR transition and look forward to seeing the positive impacts as we settle into the operational changes and new experiences Epic brings Lake Charles Memorial Health System and those we serve,” said Devon Hyde (above), President and CEO of Lake Charles Memorial Health System, about the provider’s transition to a new Epic MyChart EHR. (Photo copyright: Lake Charles Memorial Health System.)

Top 10 Most Expensive Epic EHR Installs of 2024

While Becker’s noted that the following compilation is “not an exhaustive list,” here’s its list of the top 10 most expensive Epic EHR projects based on publicly available sources.

  1. Northwell Health, New Hyde Park, N.Y.:                                          $1.2 billion
  2. Trinity Health, Livonia, Mich.:                                                          $800 million
  3. AdventHealth, Altamonte Springs, Fla.:                                            $660 million
  4. Memorial Hermann Health System, Houston:                                   $500 million
  5. UAB Health System, Birmingham, Ala.:                                           $380 million
  6. Broward Health, Fort Lauderdale, Fla.:                                             $250 million
  7. Wellstar Health System, Marietta, Ga.:                                              $175 million
  8. Health First, Rockledge, Fla.:                                                             $160 million
  9. Sarasota Memorial Health Care System, Sarasota, Fla.:                    $160 million
  10. MultiCare Health System, Tacoma, Wash.:                                       $50 million

Largest Epic EHR Projects Ever

Beyond 2024, here are the “largest Epic EHR projects of all time,” Becker’s Health IT reported separately based on publicly available sources:

  1. Kaiser Permanente, Oakland, Calif:                                                   $4 billion
  2. Mayo Clinic, Rochester, Minn.:                                                         $1.5 billion
  3. Mass General Brigham, Somerville, Mass.:                                       $1.2 billion
  4. Northwell Health, New Hyde Park, N.Y.:                                          $1.2 billion
  5. NYC Health and Hospitals, New York, N.Y.:                                   $1 billion
  6. Sutter Health, Sacramento, Calif.:                                                      $1 billion
  7. New York-Presbyterian, New York, N.Y.:                                        $964 million
  8. Providence, Renton, Wash.:                                                               $800 million   
  9. Trinity Health, Livonia, Mich.:                                                          $800 million
  10. Duke University Health, Durham, N.C.:                                            $700 million
  11. UMass Memorial Health, Worcester, Mass.:                                     $700 million   

Training Key for New EHR: Report

According to a report by research firm KLAS titled, “EHR Implementations 2025: Investing in People to Avoid Pitfalls and Ensure Clinical Success,” in addition to the “tremendous financial undertaking,” healthcare organizations also face implementation challenges following EHR installations.

KLAS reported that among the healthcare leaders KLAS interviewed:

  • 27% had “an above-average EHR post-implementation” likely due to “providing technological foundation needed” at go-live, while,
  • 40% said implementation of the EHR “had significant misses” and,
  • 22% reported “average satisfaction with room for improvement.”

Providing staff with adequate training may smooth the way for new EHRs, according to the KLAS report. “Often, leaders wish they had invested in more training time and workflow-specific training in the context of patient care,” the authors wrote.

New EHR May Mean New LIS

Pathologists and clinical laboratory leaders may need to transition the laboratory information system (LIS) when the healthcare organization moves to a new EHR. At the very least, new interfaces will be required.

While a new EHR and LIS requires significant investments, they also provide opportunities for needed upgrades, competitive advantage, and security.           

—Donna Marie Pocius

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