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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

International Team of Scientists Develop Smart Diaper That Alerts Parents When It Is Soiled and Needs to Be Changed

Not the first smart diaper to come along, but consumers seem unready for diapers that can flag urinary tract infections and other biomarkers usually tested by clinical laboratories

Will wonders never cease? For centuries, parents had only their own senses to determine when infants needed diaper changing. Today, however, caregivers can rely on “smart diapers” to send alerts when a diaper is soiled. Crying, smelly babies may no longer be the gold standard in diaper management. But are smart diapers practical?

Scientists at Penn State University in collaboration with scientists from the Hebei University of Technology and Tianjin Tianzhong Yimai Technology Development Company in China think so.

Funded by the National Institutes of Health (NIH) and the National Science Foundation (NSF), Penn State’s new smart diaper is based on a simple pencil-on-paper design that utilizes an electrode sensor array treated with a sodium chloride solution that detects dampness when urine is present.

The sensor array is “so cheap and simple” it “could clear the way for wearable, self-powered health monitors for use not only in ‘smart diapers’ but also to predict major health concerns like cardiac arrest and pneumonia,” a Penn State new release noted.

However, clinical laboratory managers following similar developments probably know that this is not the first scientific effort to develop a smart diaper that uses some type of sensor to detect a biomarker and issue an alert to the wearer or caregivers.

For example, nine years ago, In “New ‘Smart Diaper’ Tests Baby’s Urine for Urinary Tract Infections, Dehydration, and Kidney Problems—then Alerts Baby’s Doctor,” Dark Daily reported on a digital smart diaper invented by New York startup Pixie Scientific that constantly monitors a baby’s health to detect urinary tract infections, kidney problems, or dehydration before the health issue escalates. That smart diaper also uses a smartphone app to send data to the baby’s doctor.

In this latest research effort, the scientists published their findings in the journal Nano Letters, titled, “Pencil-on-Paper Humidity Sensor Treated with NaCl Solution for Health Monitoring and Skin Characterization.”

Huanyu "Larry" Cheng, PhD

“Our team has been focused on developing devices that can capture vital information for human health,” said Huanyu “Larry” Cheng, PhD (above), the James L. Henderson, Jr. Memorial Associate Professor of Engineering Science and Mechanics at Penn State in a news release. “The goal is early prediction for disease conditions and health situations, to spot problems before it is too late.” This is yet another example of how researchers are working to take more testing out of clinical laboratories and offer unique assays that can be used as wearables—whether as a diaper, a skin patch, or a smart watch. (Photo copyright: Penn State University.)

This Smart Diaper Is as Simple to Use as Paper and Pencil

The Penn State sensor array takes advantage of how paper naturally reacts to wetness and utilizes the graphite in pencil marking to interact with the water molecules and sodium chloride.

Once the water molecules are absorbed by the paper, the sodium chloride solution becomes ionized and electrons start to stream towards the graphite. This movement sets off the sensor, which is extremely sensitive to humidity. According to the study, the sensor can provide accurate readings over a wide range of humidity levels, from 5.6% to 90%.

“We wanted to develop something low-cost that people would understand how to make and use, and you can’t get more accessible than pencil and paper,” said Li Yang, PhD, a professor in the School of Artificial Intelligence at China’s Hebei University of Technology and one of the authors of the study, in the Penn State news release.

“You don’t need to have some piece of multi-million-dollar equipment for fabrication. You just need to be able to draw within the lines of a pre-drawn electrode on a treated piece of paper. It can be done simply and quickly.”

The diaper is connected to a tiny lithium battery. When the sensor recognizes an increase in humidity the battery powers transmission of the change to a smartphone via Bluetooth technology. This notification informs caregivers that it is time to change the diaper.

“That application was actually born out of personal experience,” explained Huanyu “Larry” Cheng, PhD, James L. Henderson, Jr. Memorial Associate Professor of Engineering Science and Mechanics at Penn State, one of the authors of the study and father to two young children. “There’s no easy way to know how wet is wet, and that information could be really valuable for parents. The sensor can provide data in the short-term, to alert for diaper changes, but also in the long-term, to show patterns that can inform parents about the overall health of their child.”

Do Consumers Want Smart Diapers?

Research into such wearable sensors has been gaining momentum in the scientific community as a novel way to detect and deal with several medical conditions. The Penn State team hopes that devices such as their smart diaper can be used in the future to alert caregivers about the overall health of their children and clients.

“Our team has been focused on developing devices that can capture vital information for human health,” Cheng said. “The goal is early prediction for disease conditions and health situations, to spot problems before it is too late.” 

Previous research teams have had similar smart diaper goals.

In “Researchers in Japan Have Developed a ‘Smart’ Diaper Equipped with a Self-powered Biosensor That Can Monitor Blood Glucose Levels in Adults,” we covered how a team of researchers at Tokyo University of Science (TUS) in Japan had developed a diaper that detects blood glucose levels in individuals living with diabetes, a debilitating illness.

However, these types of products have yet to gain significant popularity with consumers. Regardless, sales projections for smart diapers remain positive.

According to a MarketsandMarkets report, the smart diaper market, estimated to be $646 million (US) in 2021, is expected to surpass $1.5 billion by 2026. The demand for smart diapers, the report notes, is increasing due to:

  • Growing elderly populations,
  • Rising disposable incomes,
  • Increasing personal hygiene awareness,
  • Growing populations in emerging countries, and
  • Expanding preference for advanced technology when it comes to health.

So, it’s uncertain if consumers are now ready for a device in their baby’s diaper telling them it’s time for a change. Regardless, researchers will likely continue developing tools that combine new diagnostics with existing products to help people better understand and monitor their health and the health of their loved ones.

Meanwhile, clinical laboratory managers and pathologists can remain on the alert for future published studies and press releases announcing new wearable items containing sensors, such as smart diapers. The unanswered question is whether both consumers and healthcare professionals will consider these novel inventions useful devices in the care of young and old alike.

—JP Schlingman

Related Information:

Researchers Developed a “Smart Diaper” That Sends Notifications to Parents’ Phones

New Sensor Enables ‘Smart Diapers,’ Range of Other Health Monitors

Pencil-on-Paper Humidity Sensor Treated with NaCl Solution for Health Monitoring and Skin Characterization

Diaper Which Signals Time for Change by Chinese Team

New ‘Smart Diaper’ Tests Baby’s Urine for Urinary Tract Infections, Dehydration, and Kidney Problems—then Alerts Baby’s Doctor

Researchers in Japan Have Developed a ‘Smart’ Diaper Equipped with a Self-powered Biosensor That Can Monitor Blood Glucose Levels in Adults

Smart Diapers Market by End-Use (Babies, Adults), Technology (RFID Tags, Bluetooth Sensors), and Geography (North America, Asia Pacific, Europe, and Rest of World) (2022—2026)

The Smart Diaper is Coming. Who Actually Wants It?

With New Daily Monkeypox Cases Now in Single Digits, Can We Declare the Mission Accomplished?

Coordinating at-home testing for monkeypox may provide opportunities for clinical laboratories to add value for their physician clients

Microbiologists and clinical laboratory managers who oversee medical laboratory tests for monkeypox (aka, mpox) will be interested to learn that, according to the US Centers of Disease Control (CDC), cases per day have dropped into the single digits.

The United States led the world in cases during the 2022-2023 outbreak, according to the most recent CDC statistics. As of February 15, the US has reported 30,193 cases of monkeypox with 32 deaths.

Nevertheless, January 31 was the day that the US public health emergency involving monkeypox officially expired. Data from the World Health Organization shows the number of daily monkeypox cases in most countries around the world is declining, although numbers of cases are still increasing in some South American countries.

The global monkeypox outbreak appears to have slowed considerably, but are we out of the woods?

Jonathan Mermin, MD

“There were concerns that there would be ongoing transmission and that ongoing transmission would become endemic in the United States like other STIs: gonorrhea, chlamydia, syphilis. We have not seen that occur,” Jonathan Mermin, MD (above), Director of the National Center for HIV, Viral Hepatitis, STD, and TB Prevention at the CDC, told CNN.” We are now seeing three to four cases a day in the United States, and it continues to decline. And we see the possibility of getting to zero as real.” This decline in monkeypox test corresponds with a similar decline in COVID-19 clinical laboratory testing as well. (Photo Copyright: CDC.)

Untried Vaccine and At-home Testing for Monkeypox

When the monkeypox outbreak began in May of 2022, there were concerns about the US’ level of preparedness for dealing with a second pandemic while also battling COVID-19. But monkeypox was not entirely unknown to the scientific and medical communities.

Monkeypox first appeared in 1958 amongst a colony of monkeys being kept for research. The origin of the disease is not known. According to the CDC, the first reported human case of monkeypox was in 1970. Prior to the 2022 outbreak, most cases were found in central and western African countries. Cases outside of those areas could be traced back to travel from those specific countries.

When cases of monkeypox first appeared in the US, public health officials were concerned about the availability of testing, vaccines, and treatments. As CNN reported, though there was a new vaccine available, its effectiveness against monkeypox had never been tested on humans.

That treatment, known as TPOXX (Tecovirimat), was an antiviral drug approved by the FDA in 2018 to treat smallpox in adults and children, according to an FDA factsheet. The drug was difficult to obtain, and it took until August of 2022 for the federal government to declare monkeypox a public health emergency. That allowed it to deploy emergency funds towards fighting the outbreak.

The US government eventually set up a task force to address the outbreak led by Robert Fenton Jr. from the Federal Emergency Management Agency (FEMA), and Demetre Daskalakis, MD, Director of the CDC’s Division of HIV/AIDS Prevention (DHAP) in the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP).

The demographic found to be at the highest risk of monkeypox infection were men who have sex with other men. According to MedPage Today, “Daskalakis had both pandemic experience as former senior lead on equity in COVID-19 data and engagement for the New York City Department of Health and Mental Hygiene and an ‘in’ with the LGBTQ+ community from his work in HIV prevention and his transparency about being a gay man.”

When comparing monkeypox to HIV, Daskalakis said, “This one [monkeypox], you don’t have to change behaviors for generations; it’s for a few months. Once you build your force field of immunity with vaccines, people can make their own informed decisions about their risk.”

Opportunities for Clinical Laboratories

So, how should clinical laboratories respond if there’s another monkeypox flare up?

Daskalakis advocates for home testing. “People that are going to order home tests are going to be motivated to action in other ways. And so, thinking about HIV home testing, which was the grandparent of COVID-19 home testing, this really shows us how you reach people you’re not going to reach when you have lab-based, provider-only testing … When you look at the HIV home testing data from the CDC, 26% of the people that ordered a home test had never been tested before. That is way higher than what you would expect,” he told MedPage Today.

In “Healthcare Experts Say Consumers Are Ready for Self-Test Flu Kits, but Are Physicians and Clinical Laboratories Ready to Let That Cat Out of the Bag?Dark Daily explored similar opportunities for clinical laboratories to be instrumental in increasing consumers safety by helping patients accurately collect samples, administer tests, and understand test results.

We are not out of the woods in regard to monkeypox, vigilance is still required. But with existing harm reduction measures in the most vulnerable community, at-home testing and advancements in vaccines could help us keep our numbers as low as possible.

Ashley Croce

Related Information:

2022 (Mpox) Outbreak Cases and Data

About Mpox

Mpox Is Almost Gone in the US, Leaving Lessons and Mysteries In Its Wake

Mpox Is No Longer a Public Health Emergency in the US

2022-23 Mpox (Monkeypox) Outbreak: Global Trends

Where Did All the Monkeypox Go?

Healthcare Experts Say Consumers Are Ready for Self-Test Flu Kits, but Are Physicians and Clinical Laboratories Ready to Let That Cat Out of the Bag?

Healthcare Cyberattacks at Two Hospitals Prompt Tough Decisions as Their Clinical Laboratories Are Forced to Switch to Paper Documentation

Recent intrusions into the hospitals’ IT systems resulted in blocked medical records including medical laboratory data

Healthcare cyberattacks continue to be a threat that bring potentially costly business consequences for clinical laboratories. Just in the past month, two hospital systems had their health information technology (HIT) systems disrupted due to security incidents. In response, the hospitals’ medical laboratories were forced to switch from digital to paper documentation and, in at least one case, the organization reportedly had difficulty accessing electronic laboratory test results.

The incidents took place at 772-bed Tallahassee Memorial HealthCare (TMH) in Florida and 62-bed Atlantic General Hospital (AGH) in Berlin, Maryland.

At Tallahassee Memorial, an “IT security issue” on Feb. 2 resulted in the organization shutting down its IT systems for 13 days, including at its clinical laboratory. The hospital’s computer network went back online on Feb. 15, according to a news release.

At Atlantic General Hospital, according to an AGH news release, IT personnel discovered a ransomware attack on Jan. 29 that affected the hospital’s central computer system. As a result, the walk-in outpatient laboratory was closed until Feb. 14.

These recent cyberattacks underscore the importance for clinical laboratory leaders to have plans and procedures already in place prior to a disruption in access to critical patient data.

Ben Denkers

Healthcare cyberattacks can be a “complete blindside for a lot of organizations that think they have protections in place because they bought a product or they developed a policy,” said Ben Denkers (above), Chief Innovation Officer at CynergisTek, an Austin, Texas-based cybersecurity company, in an exclusive interview with The Dark Report. Since clinical laboratory test results make up about 80% of a patient’s medical records, disruption of a hospital’s IT network can be life threatening. (Photo copyright: The Dark Report.)

Laboratory Staff Unable to View Digital Diagnostic Results at Tallahassee Memorial

Though the exact nature of the incident at Tallahassee Memorial HealthCare has not been divulged, hospital officials did report the incident to law enforcement, which suggests a cyberattack had occurred.

Electronic laboratory test results were among the casualties of the IT difficulties at TMH. “Staff have been unable to access digital patient records and lab results because of the shutdown,” a source told CNN.

Attempts by Dark Daily to reach a medical laboratory manager for comment at TMH were unsuccessful. However, in a news release posted online shortly after the cyberattack, the health system advised staff members on dealing with the IT outages.

“Patients and families may notice the switch to paper documentation during registration, admission, or during their care, as our providers will be using paper forms, prescription pads, handwritten notes, or other similar paper methods where they may usually use an electronic process,” the news release stated. “We apologize for any delays this may create. We practice for situations like this, and we are prepared to provide safe, high-quality care to our patients during computer system downtimes.”

Atlantic General Hospital Reports Ransomware Incident to the FBI

At Atlantic General Hospital, the outpatient walk-in laboratory and outpatient imaging department both temporarily closed because of the ransomware attack.

Staff members throughout the hospital were “forced to manually check patients in and out of appointments and record all other information by hand instead of online,” Ocean City Today reported.

The hospital immediately informed the FBI of the ransomware incident and continues to work with an incident response team to determine whether criminals accessed any sensitive data. It was not clear whether the organization ultimately paid a ransom to unlock its systems.

The hospital’s medical laboratory director did not respond to an email from Dark Daily seeking further comment.

Healthcare Cyberattacks Attempt to Gain Access to Data

As we covered in “Ransomware Strikes Hospitals, Clinical Laboratories, and Medical Clinics without Warning and Is Now a Major Threat to all Healthcare Organizations,” healthcare organizations have increasingly been a target of cybercriminals and hackers who are after valuable patient data. For example, the healthcare and public health sector accounted for 25% of ransomware complaints as of October 2022, according to data from the FBI, as reported by the federal Cybersecurity and Infrastructure Security Agency.

Therefore, it is critical that clinical laboratory and hospital staff work with their IT counterparts to verify that technology and processes are in place to protect access to patient data.

In “Labs Must Audit Their Cybersecurity Measures,” Ben Denkers, who at that time was Chief Innovation Officer at CynergisTek, a cybersecurity firm based in Austin, Texas, told The Dark Report, “Testing, validating, and auditing whether measures are working as designed is a change of mentality for a lot of organizations.” (If you don’t subscribe to The Dark Report, try our free trial.)

An IT network attack is an attempt by a cybercriminal to gain unauthorized access to devices that contain and exchange data within an organization. Although this information may be on individual devices or on servers, network attacks are often only possible after a hacker enters a system through an endpoint, such as an individual’s email inbox.

“It’s important to understand that while the network server itself might have ultimately been the target, that doesn’t necessarily mean that it was compromised first,” Denkers told The Dark Report. “Phishing is a perfect example of a way an attacker could first gain access to a workstation, and then from there move laterally to a server.”

The final cost of a healthcare cyberattack often exceeds the ransom. Media coverage can lead to an organization’s diminished reputation within the community, and if protected health information (PHI) is accessed by the criminals, a hospital or health system may need to pay for identity theft monitoring for affected patients.

There also are regulatory repercussions that can be costly depending on the circumstances surrounding a cyberattack. For example, on Feb. 2, the US Department of Health and Human Services’ Office for Civil Rights announced a settlement with Banner Health Affiliated Covered Entities (Banner Health), a nonprofit health system headquartered in Phoenix, to resolve a data breach resulting from a hacking incident in 2016. That incident disclosed PHI for 2.81 million patients.

As part of the settlement, Banner Health paid a $1.25 million penalty and will carry out a corrective action plan to protect PHI in the future and resolve any alleged HIPAA violations, according to the HHS Office for Civil Rights.

This hefty penalty is a reminder to pathologists and clinical laboratory managers that—when it comes to cyberattacks—the classic adage “an ounce of prevention is worth a pound of cure” is appropriate advice.

—Scott Wallask

Related Information:

FBI Working with TMH to “Assess the Situation;” Computers Still Offline after Cyber Incident

TMH: Progress on IT Security Event Wednesday, Feb. 15, 2023

Tallahassee Memorial Managing IT Security Issue

CISA: Alert (AA22-294A)

Apparent Cyberattack Forces Florida Hospital System to Divert Some Emergency Patients to Other Facilities

Atlantic General Mum on Ransomware Event Details after System Are Restored

Atlantic General Hospital System Still Down Following Ransomware Attack

Atlantic General Hospital Fully Operational Following Cybersecurity Event

Nearly One Million Patient Records of Hospitals, Health Clinics, Medical Laboratories, and other Providers Stolen in Ransomware Attack on Medical Records Company

Australia’s NSW Health Chooses Epic for its Statewide Patient EHR

Five clinical laboratory information systems are part of the transition that will create a single statewide EMR for all New South Wales patients

In a massive project, Australia’s New South Wales Ministry of Health (NSW Health) has selected health information system developer Epic to unify its five pathology laboratory information management systems (LIMS), nine electronic medical record systems (EMR), and six patient administration systems (PAS) into a statewide single digital patient record (SDPR).

According to ITnews, providers in New South Wales currently use LIMS systems by Citadel Health and Integrated Software Solutions OMNI-Lab, EMR systems by Oracle Cerner and Orion Health, and patient administration systems from Oracle Cerner and DXC.

“The SDPR will consolidate geographically fragmented EMR, PAS, and LIMS systems to create a detailed lifelong patient record and deliver cost savings,” NSW Health said in a news release.

NSW Health is the largest public health system in Australia with more than 220 public hospitals, 16 Local Health Districts, and three Specialty Networks. NSW Health Pathology operates more than 60 pathology laboratories (clinical laboratories in the US) and has 150 patient service centers.

Andrew Montague

“While this initiative will provide untold benefits to all the patients of NSW, we are excited about its potential for improving the health outcomes of our regional patients,” said Andrew Montague (above), former Chief Executive, Central Coast Local Health District in a press release. “By enabling greater collaboration across all local health districts and specialty health networks, the Single Digital Patient Record will provide clinicians with even better tools to keep the patient at the center of everything we do.” This project is more market evidence of the trend to bring clinical laboratory test results from multiple lab sites into a single data repository. (Photo copyright: Coast Community News.)

Cloud-based Realtime Access to Patient Records

Australia has a population of about 26 million and New South Wales, a state on the east coast, is home to more than eight million people. Though the scale of healthcare in Australia is much smaller than in the US, this is still a major project to pull patient data together from all the NSW hospitals, physicians’ offices, and other healthcare providers such as clinical laboratories and pathology practices.

With the change, NSW clinicians will benefit from a cloud–based system offering up real-time access to patients’ medical records, NSW Health Pathology Chief Executive Tracey McCosker told ITnews.

“Patients and our busy staff will benefit from clinical insights gained from the capture of important new data. Our work in pathology is vital to the diagnostic process and developing a statewide laboratory information management system will ensure we provide the best possible services,” McCosker told ITnews.

The KLAS Research report, “US Hospital Market Share 2022,” states that Epic, located in Verona, Wisconsin, has the largest US electronic health record (EHR) market share, Healthgrades noted. According to KLAS:

NSW Health’s decision to engage Epic came after a process involving 350 clinicians, scientists, and technical experts, Zoran Bolevich, MD, Chief Executive of eHealth NSW and NSW Health’s Chief Information Officer, told ITnews.  

NSW Health’s Goal for Statewide Digital Patient Record

It was in December 2020 when NSW Health announced its plan to create the SDPR. 

“Our vision is to be able to provide a single, holistic, statewide view of every patient—and for that information to be readily accessible to anyone involved in the patient’s care,” Bolevich said in the news release.

The SDPR, according to NSW Health, will address the following:    

Challenges:

  • Current systems not connected statewide.
  • Inaccessible patient data.
  • Duplicative data collection.
  • Gaps in decision-making.

Goals:

  • Improve health outcomes.
  • Create patient centricity.
  • Leverage insights.

NSW’s government has already invested more than $106 million in the SDPR, Healthcare IT News reported.

Other Large EHR Rollouts

NSW Health is not the only large organization to take on such an ambitious project of creating a large-scale digital patient record. And not always to a successful conclusion.

The US Department of Veterans Affairs (VA)—also intent on EHR modernization—recently announced it is suspending roll-out of the Oracle Cerner EHR at VA centers until June 2023 to address technical issues affecting appointments, referrals, and test results.

Four VA centers in Washington, Oregon, and Ohio already went live with the system in 2022.

“We are delaying all future deployments of the new EHR while we fully assess performance and address every concern. Veterans and clinicians deserve a seamless, modernized health record system, and we will not rest until they get it,” said Deputy Secretary of Veterans Affairs Donald Remy, JD, in a news release.

For its part, Oracle Cerner wrote federal lawmakers noting the importance of continuing the project, which will move the VA away from its former VistA health information system. 

“Modernization requires change and some short-term pain for the long-term benefits of a modern technology infrastructure,” noted Oracle Cerner Executive Vice President Ken Glueck in the letter, Becker’s Health IT reported. “A modernization project of this scale and scope necessarily involves time to untangle the decades of customized processes established in support of VistA, which inevitably involves challenges.”

NSW Health’s goal is to build a single repository of health information—including lab test results from multiple clinical laboratory sites. When finished NSW Health expects that sharing patient data will contribute to producing better healthcare outcomes.

However, the VA’s experience—and several other similar attempts at large-scale electronic patient record installations—suggest the work ahead will not be easy. But for NSW Health, it may be worth the effort.   

—Donna Marie Pocius

Related Information:

NSW Health Taps Epic for Statewide, Single Digital Patient Record

Single Digital Patient Record Set to Deliver Vastly Improved Patient Experience

NSW Health to Partner with Epic in the Next Step Towards its Digital Healthcare System

US Hospital Market Share 2022: Strong Purchasing Energy across Large, Small, and Standalone Hospitals

EHR Market Share 2021: 10 Things to Know About Major Players Epic, Cerner, Meditech and Allscripts

Single Digital Patient Record (SDPR)

New South Wales Invests $106 Million in Single EMR System

Recent Separate Business Transactions by Fujifilm and GE Healthcare Suggest Bullish Outlook for Faster Adoption of Digital Pathology

Fujifilm acquired Inspirata’s Dynamyx digital pathology technology and business while GE Healthcare announced a partnership with Tribun Health in Europe

Clinical pathology laboratories, especially in the US, have been slow to adopt digital imaging systems. But recent industry deals suggest that the market may soon heat up, at least in the eyes of vendors. These collaborators may hope that, by integrating diagnostic data, the accuracy and productivity of anatomic pathologists will improve while also shortening the time to diagnosis.

In a December press release, Tokyo-based Fujifilm announced it acquired the global digital pathology business of Inspirata, including its Dynamyx digital pathology system. Inspirata is a Tampa-based cancer informatics company.

In the press release, Fujifilm stated that 85% of US healthcare organizations use analog systems for pathology. That compares with 86% in Europe and 90% in Asia, the company stated.

“Acquiring Inspirata’s digital pathology business allows Fujifilm to be an even stronger healthcare partner—bridging a technological gap between pathology, radiology, and oncology to facilitate a more collaborative approach to care delivery across the enterprise,” said Fujifilm CEO and president Teiichi Goto in the press release.

The press release cited data from Signify Research, a healthcare technology marketing data firm that is predicting the global market for digital pathology systems would double from $320 million in 2021 to $640 million by 2025.

Fujifilm previously had a deal with Inspirata to sell the Dynamyx system exclusively in the UK, Italy, Spain, Portugal, Belgium, the Netherlands, and Luxembourg, an August press release noted.

Henry Izawa

“A $320 million global industry in 2021 projected to reach $640 million by 2025, the rising number of cancer cases and the demonstrated benefits of digital pathology are fueling significant demand and market growth in the hospital and pharmaceutical industries,” said Henry Izawa (above), president and CEO, Fujifilm Healthcare Americas Corporation, in a press release. “These evolving clinical needs fuel Fujifilm’s investment and innovation in the digital revolution, and we look forward to introducing Dynamyx and its host of unique features and benefits to our Synapse customers and prospects as we strive to enable more efficient medical diagnosis and high-quality care.” (Photo copyright: LinkedIn.)

GE Healthcare Partners with Tribun Health

The Fujifilm acquisition followed an October 18 announcement of a collaboration between GE Healthcare and digital pathology company Tribun Health in Europe to provide an interface between the latter’s digital pathology software and GE Healthcare’s Edison Datalogue image-management system.

In announcing their new collaboration, GE Healthcare and Tribun Health said the integration of their systems—Edison Datalogue and the Tribun Health suite—would foster collaboration between pathologists and clinicians by providing a consolidated location for imaging records. This capability is especially important in oncology, they said.

“The oncology care pathway is one of the most complex with multiple steps involving a variety of specialists, complex tools, frequent decisions, and large data sets,” said GE Healthcare CEO of Enterprise Digital Solutions Nalinikanth Gollagunta in a GE press release. “With this digital pathology collaboration, we continue our journey towards simplifying the oncology care pathway with improved data management, the digitization of pathology, and streamlined data access.”

Tribun Health, based in Paris, France, offers a digital pathology platform that incorporates a camera system, artificial intelligence (AI)-based analysis, remote collaboration, and storage management, plus integration with third-party automation apps.

GE Healthcare claims that Edison Datalogue has the largest share of the Vendor Neutral Archive (VNA) market. That term refers to image archiving systems that use standard formats and interfaces instead of proprietary formats. They are an alternative to the more widely used Picture Archiving and Communications Systems (PACS) used in medical imaging.

The collaboration between the companies “is probably a strategic move to position GE as an integrator of imaging data and digital pathology data in oncology,” said Robert Michel Editor-in-Chief of Dark Daily and its sister publication The Dark Report.

GE’s History with Dynamyx

This is not GE Healthcare’s first foray into digital pathology. In fact, the company had a major hand in launching the very Dynamyx system that Fujifilm recently acquired.

Dynamyx was originally developed by digital pathology technology company Omnyx, LLC, which was a joint venture formed in 2008 between GE Healthcare and the University of Pittsburgh Medical Center (UPMC).

In “GE Healthcare Sells Omnyx to Inspirata,” The Dark Report interviewed Inspirata CEO Satish Sanan who at that time said the acquisition would allow his company to offer “a fully integrated, end-to-end digital pathology solution” in Canada and Europe. But GE Healthcare chose to end the partnership in 2016, citing regulatory uncertainty and variable global demand. Two years later, GE sold Omnyx to Inspirata.

GE Healthcare’s new collaboration with Tribun Health shows that the company “still recognizes the value of the pathology data in cancer diagnosis and wants to be in a position to manage that digital pathology data,” Michel said.

Fujifilm’s Plans

Fujifilm said it will incorporate Dynamyx into its Synapse Enterprise Imaging suite, which includes VNA, Radiology PACS, and Cardiology PACS. “Future releases of Dynamyx will also create opportunities for Fujifilm to support pharmaceutical and contract research organizations with toxicity testing data management for drug development,” the company stated in the press release.

US-based subsidiary Fujifilm Healthcare Americas Corporation will handle future development of the Dynamyx system. In the US, the system is currently cleared for the US Food and Drug Administration (FDA) for use with Leica’s Aperio AT2 DX scanner and Philips’ Ultra Fast Scanner.

With its recent moves into digital pathology, Fujifilm will be taking on major competitors including Philips, Danaher, and Roche, MedTech Dive reported.

Stephen Beale

Related Information:

Fujifilm Announces Asset Purchase Agreement with Inspirata, Inc. to Acquire the Company’s Digital Pathology Business

Fujifilm Agrees to Buy Inspirata’s Dynamyx in Challenge to Philips for Digital Pathology Market

GE Healthcare Announces Collaboration to Advance Digital Transformation of Pathology

Leica, Philips Come Out on Top in Digital Pathology Systems Market, KLAS Finds

GE Healthcare Sells Omnyx to Inspirata

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