Plan offers members transparent pricing for medications and 24/7 virtual consults
Amazon is working to be price competitive in the healthcare products and services it provides. A recently launched plan offers Prime members fixed prices and affordable monthly rates for telehealth visits, treatment plans, and medication delivery for various types of health, beauty, and lifestyle care. Healthcare providers such as office-based physicians, clinical laboratories, and anatomic pathology groups, may once again be impacted by Amazon’s foray into medical care.
This is not the first time that Amazon (NASDAQ:AMZN) has waded into the medical pond. In 2022, the Seattle-based ecommerce company purchased One Medical (NASDAQ:ONEM) for $3.9B while at the same time launching Amazon Clinic (now known as Amazon One Medical Pay-per-visit), a virtual healthcare service, in an attempt to “reinvent” healthcare. Dark Daily covered these events in an ebrief at that time.
Since then, Amazon has offered pay-per-visit telehealth consultations to determine treatments for more than 30 common ailments such as pink eye (conjunctivitis), flu, and sinus conditions. Now, Amazon is adding “low, clear upfront pricing for a clinical visit, treatment plan, and fast, free medication delivery for Prime members for a range of common health, beauty, and lifestyle concerns, including anti-aging skincare treatment, men’s hair loss, erectile dysfunction, eyelash growth, and motion sickness,” according to an Amazon news release.
“We’re committed to giving customers convenient, affordable care options that put them in control of their health,” said Bergen Penhart, general manager for Amazon One Medical Pay-per-visit, in the news release. “This new offering makes it easy for Prime members to get expert clinical advice and prescribed treatments for common health, beauty, and lifestyle needs, all from the comfort of home.”
The platform supports both on-demand messaging and virtual video telehealth visits to address more than 30 common medical issues.
“This simple care experience was built to meet the needs of today’s customer. At Amazon, we’re working to reduce the burden on patients who’d like to move forward with care, but may be tired of navigating the hurdles of our healthcare system, waiting in a long line at the pharmacy, or worried about a surprise bill or medication cost,” said Harvard-trained lung specialist and chief medical officer for Amazon, Vin Gupta, MD (above). “We’re helping patients re-engage in care and spend time doing what they love instead.” These new medical initiatives from Amazon are meant to be convenient for patients, but have an impact on local healthcare providers, clinical laboratories, and pharmacies. (Photo copyright: Vin Gupta, MD.)
Convenience, Transparency, 24/7 Access to Healthcare
Telemedicine has seen a sharp rise in recent years, aided by necessity during the COVID-19 pandemic. Forbes reports that the percentage of hospitals offering telemedicine rose to 72% in 2021. Since so many Americans today use the Internet for everything from shopping for medications to interfacing with healthcare providers, it makes sense that Amazon, one of the world’s most successful online retailers, would want a cut of the action.
So what is the retail giant offering now that improves upon its previous healthcare services? It is promoting fixed prices and monthly payments with complete transparency. There are also no surprise bills for Amazon One Medical patients. Prime members can see the price for their telehealth consultation and prescription before deciding whether to go forward with the appointment and treatment.
In addition, Amazon One Medical patients can use a smartphone app (available on both Android and Apple iPhone) to review prices for treating five common health conditions and beauty treatments, as well as meeting virtually with a clinician 24/7 from anywhere in the world. In some areas Amazon even offers same-day or next-day medication deliveries.
“This simple, upfront pricing helps customers shop for their healthcare and make informed, confident decisions. Customers only pay for the cost of the consultation and medication (if prescribed). There are no additional fees, expenses, or subscriptions needed beyond Amazon Prime,” the news release states.
First Wrongful Death Lawsuit Filed against Amazon One Medical
However, the road to success in healthcare is not without its potholes. In “Amazon One Medical Call Centers Found Wanting in Washington Post Report,” we covered a 2024 Washington Post story on leaked documents that appeared to indicate Amazon’s One Medical primary care call center was not using trained, certified medical professionals to field patient phone calls and provide telehealth guidance.
This led to disappointment among Amazon One Medical patients, we reported.
According to The Washington Post, Amazon bought One Medical and hired workers for their call centers with “limited training and little to no medical experience.” This allegedly caused serious medical issues such as high blood pressure spikes and blood in stool to go unrecognized.
Caroline O’Donovan, the Washington Post reporter who broke the story, told PBS, “In the documents that were leaked to us, there’s a doctor who wrote a note saying, ‘I don’t think these call center people even realize that they’re triaging patients, which is not something that they’re qualified to do.’”
Amazon acknowledged that initial calls could have been handled more effectively, however the company insisted that no patients were harmed. In an email statement, Amazon spokesperson Dawn Brun said, “We take patients’ feedback seriously and the [Washington Post] story mischaracterizes the dedication we have to our patients and care teams.”
Nevertheless, Amazon One Medical now faces a lawsuit. The Daily Mail reported that Suzanne Tong of Oakland, Calif., is suing Amazon for negligence after her husband died following a video consultation during which he was told to “take an inhaler” for symptoms that included shortness of breath and blue feet.
“Hours later, the 45-year-old was rushed to the emergency department at the Alta Bates Summit Medical Center, where [according to court documents] he ‘collapsed in the waiting room and expired,’” The Daily Mail reported, adding, “The [court] filing claims that ‘to a reasonable degree of medical certainty,’ if Mr. Tong had received the ‘proper care, treatment and follow up’ at his appointment with Amazon One Medical on December 18, 2023, he would have survived.”
Amazon would not comment on the impending litigation citing patient privacy concerns, instead providing a statement to the press. In it, an Amazon One Medical spokesperson said, “While we are prohibited by law from discussing patient records, we refute claims that a change in the duration of visits or location of a virtual visit has impacted the care provided at Amazon One Medical,” the Los Angeles Times reported. “We care deeply about every patient we serve, and the quality and safety of our care are our highest priorities. We’re proud of our extensive quality and safety measures, and of the health outcomes we help our patients achieve. We take concerns about our care extremely seriously, and we’re committed to continuous improvement.”
According to The Daily Mail, this is the first wrongful death lawsuit brought against Amazon One Medical.
Warning to Clinical Labs, Pathology Groups
Stories like these raise questions as to whether the quality of care delivered by various telehealth services is being sacrificed for the sake of convenience and price transparency. Americans are increasingly living more online. Medical services moved online out of necessity, and many healthcare providers who stayed online have expanded their offerings due to customer demand.
Clinical laboratories and anatomic pathologists would be wise to stay informed on this growing trend. These business launches are a warning shot for lab managers and pathology groups to invest time and money becoming more patient/consumer friendly providers with websites that feature price transparency.
Requirement reflects increasing worldwide focus on preventing genetic disorders through clinical laboratory genetic testing
In a significant move, Abu Dhabi’s Department of Health has established a new policy that requires engaged couples to get genetic testing done along with clinical laboratory blood testing before walking down the aisle.
Abu Dhabi, the capital city of the United Arab Emirates (UAE), is following an established public health policy of testing soon-to-be-married couples for specific disease conditions. Now, however, instead of just infectious diseases, it is testing for specific genetic conditions as well.
This marks a first for Arab nations and also demonstrates a shift in the standard of care for those regions.
“Abu Dhabi continues to set a global standard in proactive healthcare, marking a significant paradigm shift from traditional and reactive healthcare to informed and holistic health planning and decisions,” said Asma Al Mannaei, DrPH, Director of Health Quality and Executive Director of the Research and Innovation Center at Abu Dhabi Department of Health (DOH), in a press release.
Clinical laboratory managers and pathologists in the US will note that the move in Abu Dhabi mirrors a similar trend in this country. A growing number of children’s hospitals are using genetic testing such as rWGS (Rapid Whole Genome Sequencing) as a pro-active screen for newborns where family history indicates the value of such testing.
It appears the use of genetic testing as a way of predicting risk for genetic disorders is growing in popularity across the globe.
“The integration of genetic testing as part of the premarital screening program is a proud milestone for Abu Dhabi. It positions the Emirate at the forefront of leading healthcare destinations globally, harnessing the power of genomics and latest technologies to promote informed decisions,” said Asma Al Mannaei, DrPH (above), executive director of the Research and Innovation Center at Abu Dhabi’s Department of Health, in a press release. “This step aims to prevent the transmission of genetic diseases to children and elevate early intervention through different phases including diagnostic, tailored genetic counselling, and introducing reproductive medicine solutions for couples.” (Photo copyright: Global Medical Tourism Summit.)
Why Screen for Genetic Disorders?
Pre-screening betrothed couples isn’t a new concept. The US previously required blood tests prior to marriage primarily to spot diseases such as Rubella (a.k.a., German Measles). The nationwide program was eliminated in 2019 for a variety of reasons including the fact that “the mandated blood tests worked to discourage marriage while doing little to actually identify people with disease or improve public health,” the Mises Institute noted at the time.
However, things are different in Middle East nations where consanguinity—when a couple shares a blood relative—is a common cultural norm. It’s not unusual in those regions for first cousins to marry and have children, which can lead to genetic complications.
“If a couple are consanguineous (related) their children have a higher chance of being affected by autosomal recessive genetic disorders. These only occur if a child has a mutation (change) in both copies of a particular gene pair,” according to Top Doctors.
This is where Abu Dhabi’s new genetic testing requirement comes in.
Making Informed Decisions for Future Families
Just like in the US, Abu Dhabians have been blood screening couples for infectious diseases for decades. Genetic testing as part of premarital screening was added at the end of 2024, a report from the Abu Dhabi Public Health Center (ADPHC) noted.
Screening is available at 22 primary healthcare centers throughout Abu Dhabi and the Al Dhafra and Al Ain regions.
“The comprehensive genetic testing list includes 570 genes that cover 840+ genetic disorders. It is important because it can help couples assess the risk of having children with genetic disorders and support them in making informed decisions about family planning,” the ADPHC stated in its report.
Dark Daily in the Middle East
It seems inevitable that in time genetic testing for engaged couples would eventually become a requirement.
Abu Dhabi’s DOH partnered with Abu Dhabi Public Health Center (ADPHC) to launch a pilot of the genetic testing program back in 2022. It screened more than 800 couples and found that 86% showing “genetic compatibility.” The other 14% received test results that required them to obtain more advanced family planning and intervention, the ADPHC reported.
As consanguinity is a common practice in many areas of the Middle East, other nations and Emirates may follow Abu Dhabi in requiring couples to undergo genetic testing. In the US, it would be prudent for clinical laboratories to watch growing trends as more couples opt for extra testing to provide best possible outcomes for their future families.
Clinical laboratories and anatomic pathology groups should prepare for a marked increase in orders for liver disease testing
New research from Virginia Commonwealth University’s Institute for Liver Disease and Metabolic Health in Richmond shows that four out of every 10 Americans has fatty liver disease of some type, according to a news release. Forty percent of Americans is an astonishing number! The study’s findings will almost certainly lead to clinical laboratories performing more testing in support of diagnosis, treatment decision making, and patient monitoring for liver disease than currently ordered by physicians.
Hepatologist Juan Pablo Arab, MD, director of alcohol sciences at Virginia Commonwealth University (VCU), led the team that conducted the research. He noted that the driving force behind the numbers is obesity and type two diabetes.
“By 2018, federal data showed that 42% of adults had some form of fatty liver disease—higher than prior estimates,” Arab’s team told Newsmax, adding that “Hispanic adults were at especially high risk … with nearly half (47%) affected.”
“This study highlights a significant health issue that affects a large portion of the US population, and it shows that certain groups are at a higher risk. We hope these findings will guide more targeted health interventions to reduce the burden of liver disease, especially in high-risk communities,” said Juan Pablo Arab, MD (above), hepatologist with VCU’s Institute for Liver Disease and Metabolic Health, director of alcohol sciences, and lead researcher in the VCU study, in a VCU news release. These insights can be expected to lead to guidelines calling for more clinical laboratory testing associated with the diagnosis of fatty liver disease. (Photo copyright: Virginia Commonwealth University.)
“Groups at greater risk for MASLD include men, adults older than 40, individuals with health insurance, those with higher body mass index, and people with other health issues like diabetes, high blood pressure, high triglycerides, and low levels of good cholesterol. Interestingly, the study found that black individuals had the lowest risk of developing MASLD compared with other groups,” the VCU news release notes.
Fatty liver disease can also be caused by excessive alcohol consumption (called alcohol-associated liver disease or ALD) or a combination of both metabolic dysfunction and moderate-to-high alcohol intake, which is called MetALD, Newsmax reported.
“Although MASLD was the most common type of liver disease found in this study, the researchers also uncovered substantial rates of MetALD and alcohol-associated liver disease. For MetALD, the study showed that men and individuals with a higher BMI [body mass index] were at a greater risk, and Asians were at lower risk. Surprisingly, the only factor that appeared to lower the risk of ALD was having health insurance, though the reasons for this are not clear,” according to the VCU news release.
On its website, Mayo Clinic notes that NAFLD is often symptomless, and that doctors typically depend on routine clinical laboratory blood test results to reach a diagnosis. Additional testing helps determine whether higher than normal liver enzymes are actually from fatty liver disease or some other condition.
Medical laboratories play a key role in facilitating the final diagnoses. According to Mayo Clinic, blood tests to identify liver disease include:
Medical imaging could also be required to reach a diagnosis, beginning with an abdominal ultrasound, Mayo Clinic added. Additionally, more precise tests may be ordered to determine the stiffness of the liver and likelihood of scarring or fibrosis. Those modalities include:
Labs will often perform these tests on the same patient multiple times as the patient’s lifestyle changes. A liver biopsy may also be required to determine severity of damage, Mayo Clinic added.
abdominal pain, spider-like blood vessels, yellowing of the skin and eyes (jaundice), itching, fluid buildup and swelling of the legs (edema) and abdomen (ascites), and mental confusion,” the ALF added.
As more healthcare providers focus their attention on diagnosing and treating this potentially deadly disease, clinical laboratories and anatomical pathology groups will likely see an uptick in tests ordered by doctors moving from initial diagnoses to more detailed testing and eventually to treatment follow ups.
Innovative in-office test, when integrated with UTI microbiology testing performed by clinical laboratories, could contribute to better patient outcomes
Treatments for certain bacterial infections are becoming less effective due to antimicrobial resistance (AMR). Now, after a 10-year-long worldwide competition, the first multi-million euro prize for an accurate, rapid, and cost effective clinical laboratory test for diagnosing and treating urinary tract infections (UTIs) went to Sysmex Corporation’s subsidiary Astrego. This milestone event could benefit tens of millions of people who suffer from UTIs annually.
Astrego, of Uppsala, Sweden, won the €8 million (US$8.19 million) Longitude Prize on AMR for its PA-100 AST System. The new diagnostic technology will “transform treatment of urinary tract infections and brings the power of clinical laboratory testing into a doctor’s office,” according to a news release from Challenges Works, the United Kingdom-based organization that organized and awarded the prize.
The Astrego system is, according to Challenge Works’ website, a “game-changing solution” in “a novel point-of-care diagnostic test that rapidly and accurately identifies the presence of a bacterial infection and the right antibiotic to prescribe.”
“We launched the Longitude Prize on AMR (in 2014) to create the urgent ‘pull’ needed to get innovators working on one of the biggest life-and-death challenges facing humanity. Hundreds of teams [that] competed with multiple solutions [are] now close to market thanks to the prize,” said Tris Dyson, Managing Director, Challenge Works, in a news release.
The new diagnostic technology “could herald a ‘sea change’ in antibiotic use” according to the judges of the competition, The Guardian reported.
“The PA-100 AST System (above) creates a future where patients can quickly and accurately get a diagnosis and the correct treatment when they visit the doctor,” said Sherry Taylor, MD, UK National Health Service, Temple Fortune Medical Group, London, in the Challenge Works news release. “Accurate, rapid diagnosis of bacterial infections that help doctors and health workers to manage and target antibiotics, will slow the development and spread of antibiotic resistant infections, improve healthcare and save potentially millions of lives,” she added. In-office point-of-care systems like the PA-100 may reduce the number of doctor orders for UTI tests to clinical laboratories while contributing to better patient outcomes. (Photo copyright: Sysmex.)
How the Test Works
In the UK, people are treated for UTIs more than any other infection. It takes about three days for doctors to receive the results from traditional microbiology testing. They then prescribe an antibiotic to treat the infection. But about half of “infection-causing bacteria are resistant to at least one antibiotic,” according to a news release from the Geneva, Switzerland-based NESTA Foundation which funded the Longitude Prize on AMR.
“It’s impossible to overstate how critical it is to address AMR [antimicrobial resistance]. By 2050, it is predicted to cause 10 million deaths a year—matching those caused by cancer—and cost $1 trillion in additional health costs,” the news release states.
UTI are more common in women and the reason for eight million healthcare appointments annually in the US, according to Medscape.
The PA-100 AST system makes it possible for patients to provide a small urine sample during their appointments with doctors, find out if they have a bacterial infection in 15 minutes, and receive the “right antibiotic to treat it within 45 minutes,” NESTA said. Sysmex describes the PA-100 AST as an “automated phenotypic analyzer, based on EUCAST standards,” that combines “phase-contrast microscopy and nanofluidics to make available antibiograms at point of care.” It enables healthcare providers to perform antimicrobial susceptibility testing (AST) in-office rather than sending out urine samples to microbiology laboratories.
The systems works as follows, according to the Sysmex website:
As a urine sample passes through the chip, “single bacterial cells are trapped in individual channels.”
Meanwhile, “larger cellular components” are filtered and kept out of the nanofluidic chip.
Contrast-phase microscopy enables real-time monitoring of cell growth. “Resistant bacteria keep a higher growth rate during incubation, while susceptible ones grow slowly or lyse.”
Expert computer software identifies that bacterial strain, delivers an “easy to interpret antibiogram after assay completion” and provides an “informed prescription decision” on which antibiotic is expected to fight the infection.
“The PA-100 AST System challenges bacteria present in a patient’s urine with microscopic quantities of antibiotics in tiny channels embedded in a cartridge the size of a smartphone,” said Mikael Olsson, CEO and co-founder of Sysmex Astrego, in The Microbiologist.
“We rapidly pinpoint whether a bacterial infection is present and identify which antibiotic will actually kill the bugs, guiding doctors only to prescribe antibiotics that will be effective,” he added.
Sysmex is conducting more studies in the UK and working with regulators in Europe for clearances, according to Olsson.
Older Antibiotics May Make Comeback
It’s possible that use of the PA-100 system to identify the best antibiotic to treat infections could lead to a resurgence in the use of previously retired antibiotics.
“Roughly 25-30% of patients have infections resistant to older first-line antibiotics which have been retired as a result; this means the remaining 70-75% of patients could still benefit from those older drugs,” Pathology in Practice reported, adding, “Since the PA-100 AST System identifies which specific antibiotic can treat an infection, it will likely allow retired antibiotics to be brought back into service because the test is able to demonstrate when an infection is susceptible to their effects.”
Many people could benefit from the older antibiotics, Challenge Works noted.
Revolutionizing Healthcare
The Sysmex Astrego’s PA-100 AST System is a significant development.
“Currently, I send the urine sample off for analysis, and it usually takes around three days to come back with results,” said Sherry Taylor, MD, UK National Health Service, Temple Fortune Medical Group, London, in the Challenge Works news release. “Having a bedside test that would enable rapid diagnosis through antibiotic susceptibility testing would revolutionize general practice and patient care. It’s all about using antibiotics only when necessary and appropriate.”
Each individual test costs about €25 (US$25.72), The Guardian reported, adding that ramped up production may lower the price.
The PA-100 AST System is the latest example of a diagnostic/therapeutic solution developed in Europe rather than the US, which is often slower to award regulatory clearance.
It also is another test that will be performed outside of traditional clinical laboratory settings, demonstrating the trend to move medical laboratory tests closer to patients.
Findings could lead to new clinical laboratory tests to screen for individuals with increased risk of blood transfusion complications
Pathologists and clinical laboratory scientists who understand the complexities of blood typing from one human to another will be interested to learn that a 50 year-old mystery has brought about an exciting new discovery—a new human blood group.
British and Israeli scientists led by the UK’s NHS Blood and Transplant (NHSBT) and the University of Bristol discovered the meaning behind a missing protein molecule found in a pregnant woman five decades ago. This anomaly has now been given its own blood group identification called MAL, according to a University of Bristol new release.
“Some people can lack this blood group due to the effect of illness, but the rare inherited form of the AnWj-negative phenotype has only been found in a handful of individuals—though due to this discovery it will now be easier to find others in the future,” the news release notes.
This is important because receiving mismatched blood can be fatal.
“AnWj is a high-prevalence red blood cell (RBC) antigen in the ISBT 901 series. Only nine reports of anti-AnWj have been published since it was first documented in 1972,” according to a 2012 article published by the American Association of Blood Banks, now known as the Association for the Advancement of Blood and Biotherapies (AABB).
For even the small proportion of the population with this new blood group, diagnosing its presence can have a major impact while preventing unwanted harm.
“The work was difficult because the genetic cases are very rare. We would not have achieved this without exome sequencing, as the gene we identified wasn’t an obvious candidate and little is known about Mal protein in red cells,” said Louise Tilley, PhD, Senior Research Scientist, IBGRL Red Cell Reference at NHS Blood and Transplant, in the news release.
“The genetic background of AnWj has been a mystery for more than 50 years, and one which I personally have been trying to resolve for almost 20 years of my career,” said Louise Tilley, PhD (above), Senior Research Scientist, IBGRL Red Cell Reference at NHS Blood and Transplant, in the news release. “It represents a huge achievement, and the culmination of a long term effort, to finally establish this new blood group system and be able to offer the best care to rare, but important, patients,” she added. Clinical laboratory scientists involved in blood banking will want to keep updated as further research into this new blood group is published. (Photo copyright: NHS Blood and Transplant.)
Unraveling the Mystery
In 1972, scientists were stumped by a pregnant woman with a blood sample that was “mysteriously missing a surface molecule found on all other known red blood cells at the time,” Science Alert reported. The AnWj antigen that was missing in that patient’s blood is present in 99.9% of human blood samples.
“Researchers found that the AnWj antigen is carried on the Mal protein. While illness can cause some people to lose the AnWj antigen, inherited cases of the AnWj-negative phenotype are extremely rare. Using whole exome sequencing on five genetically AnWj-negative individuals, researchers confirmed that, in these cases, the participants lacked the antigen due to homozygous deletions in the MAL gene,” an AABB news release stated.
The researchers named the group with the missing antigen the MAL blood group (short for Myelin and Lymphocyte Protein) which is where the antigen resides.
Genetic sequencing enabled the scientists to locate the gene when they “inserted the normal MAL gene into blood cells that were AnWj-negative. This effectively delivered the AnWj antigen to those cells,” Science Alert noted.
Mutated MAL genes result in the AnWj-negative blood type. The team discovered three patients with the blood type and no mutation, “Suggesting that sometimes blood disorders can also cause the antigen to be suppressed,” Science Alert added. The researchers also discovered that AnWj isn’t present in newborns but arrives sometime after they are born.
“Interestingly, all the AnWj-negative patients included in the study shared the same mutation. However, no other cell abnormalities or diseases were found to be associated with this mutation,” Science Alert said.
The discovery that “the Mal protein is responsible for binding AnWj antibodies” could lead to new clinical laboratory tests to screen for patients at risk from blood transfusions, AABB noted in its news release.
Facing the Challenge
Scientists had to overcome many challenges to uncover the details of this blood type. The complexity of the protein further hindered their efforts.
“MAL is a very small protein with some interesting properties which made it difficult to identify, and this meant we needed to pursue multiple lines of investigation to accumulate the proof we needed to establish this blood group system,” said Tim Satchwell, PhD, senior lecturer and cell biologist at the University of the West of England, in the University of Bristol news release.
“Resolving the genetic basis for AnWj has been one of our most challenging projects,” Nicole Thornton, head of IBGRL Red Cell Reference at NHSBT told the AABB. “There is so much work that goes into proving that a gene does actually encode a blood group antigen, but it is what we are passionate about, making these discoveries for the benefit of rare patients around the world.”
It’s hard to pinpoint how many individuals will benefit by testing for the blood group, Tilley told the BBC. Nevertheless, “the NHSBT is the last resort for about 400 patients across the world each year,” the BBC reported.
While more research needs to be done, the initial discovery is promising and may lead to new clinical laboratory tests to identify individuals who could be severely harmed should they receive the wrong blood type during a transfusion.
New guidelines come on the heels of recommendations covering post-market modifications to AI products, including those incorporated into systems used by clinical laboratories
Artificial intelligence (AI) is booming in healthcare, and as the technology finds its way into more medical devices and clinical laboratory diagnostic test technologies the US Food and Drug Administration (FDA) has stepped up its efforts to provide regulatory guidance for developers of these products. This guidance will have an impact on the development of new lab test technology that uses AI going forward.
In December, the FDA issued finalized recommendations for submitting information about planned modifications to AI-enabled healthcare products. Then, in January, the federal agency issued draft guidance that covers product management and marketing submission more broadly. It is seeking public comments on the latter document through April 7.
“The FDA has authorized more than 1,000 AI-enabled devices through established premarket pathways,” said Troy Tazbaz, director of the Digital Health Center of Excellence at the FDA’s Center for Devices and Radiological Health, in a press release announcing the draft guidance.
This guidance “would be the first to provide total product life cycle recommendations for AI-enabled devices, tying together all design, development, maintenance and documentation recommendations, if and when finalized,” Healthcare IT News reported.
“Today’s draft guidance brings together relevant information for developers, shares learnings from authorized AI-enabled devices, and provides a first point-of-reference for specific recommendations that apply to these devices, from the earliest stages of development through the device’s entire life cycle,” said Troy Tazbaz (above), director of the Digital Health Center of Excellence at the FDA Center for Devices and Radiological Health, in a press release. The new guidance will likely affect the development of new clinical laboratory diagnostic technologies that use AI. (Photo copyright: LinkedIn.)
Engaging with FDA
One key takeaway from the guidance is that manufacturers “should engage with the FDA early to ensure that the testing to support the marketing submission for an AI-enabled device reflects the agency’s total product lifecycle, risk-based approach,” states an analysis from consulting firm Orrick, Herrington and Sutcliffe LLP.
Another key point is transparency, Orrick noted. For example, manufacturers should be prepared to offer details about the inputs and outputs of their AI models and demonstrate “how AI helps achieve a device’s intended use.”
Manufacturers should also take steps to avoid bias in data collection for these models. For example, they should gather evidence to determine “whether a device benefits all relevant demographic groups similarly to help ensure that such devices are safe and effective for their intended use,” Orrick said.
New Framework for AI in Drug Development
On the same day that FDA announced the device guidelines, the agency also proposed a framework for regulating use of AI models in developing drugs and biologics.
“AI can be used in various ways to produce data or information regarding the safety, effectiveness, or quality of a drug or biological product,” the federal agency stated in a press release. “For example, AI approaches can be used to predict patient outcomes, improve understanding of predictors of disease progression and process, and analyze large datasets.”
The press release noted that this is the first time the agency has proposed guidance on use of AI in drug development.
These include “bias and reliability problems due to variability in the quality, size, and representativeness of training datasets; the black-box nature of AI models in their development and decision-making; the difficulty of ascertaining the accuracy of a model’s output; and the dangers of data drift and a model’s performance changing over time or across environments. Any of these factors, in FDA’s thinking, could negatively impact the reliability and relevancy of the data sponsors provide FDA.”
The FDA also plans to participate in direct testing of AI-enabled healthcare tools. In October, the FDA and the Department of Veterans Affairs (VA) announced that they will launch “a joint health AI lab to evaluate promising emerging technologies,” according to Nextgov/FCW.
Elnahal said the facility will allow federal agencies and private entities “to test applications of AI in a virtual lab environment.” The goal is to ensure that the tools are safe and effective while adhering to “trustworthy AI principles,” he said.
“It’s essentially a place where you get rapid but effective evaluation—from FDA’s standpoint and from VA’s standpoint—on a potential new application of generative AI to, number one, make sure it works,” he told Nextgov/FCW.
He added that the lab will be set up with safeguards to ensure that the technologies can be tested safely.
“As long as they go through the right security protocols, we’d essentially be inviting parties to test their technology with a fenced off set of VA data that doesn’t have any risk of contagion into our actual live systems, but it’s still informative and simulated,” he told Nextgov/FCW.
There has been an explosion in the use of AI, machine learning, deep learning, and natural language processing in clinical laboratory diagnostic technologies. This is equally true of anatomic pathology, where AI-powered image analysis solutions are coming to market. That two federal agencies are motivated to establish guidelines on working relationships for evaluating the development and use of AI in healthcare settings tells you where the industry is headed.
