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

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

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Damo Consulting Survey Predicts Future Health Network Spending Will Primarily be on Improving EHRs; Could be Positive Development for Medical Laboratories

Survey shows healthcare providers plan to wait for AI and digital health technologies to mature before making major investments in them

Clinical laboratories must develop strategies for connecting to their client doctors’ electronic health record (EHR) systems. Thus, a new survey that predicts most healthcare networks will continue to focus health information technology (HIT) spending on improving their EHRs—rather than investing in artificial intelligence (AI) and digital healthcare—provides valuable insights for medical laboratory managers and stakeholders tasked with implementing and maintaining interfaces to these systems.

According to Damo Consulting’s 2019 Healthcare IT Demand Survey, when it comes to spending money on information technology (IT), healthcare executives believe AI and digital healthcare technologies—though promising—need more development.

Damo’s report notes that 71% of healthcare providers surveyed expect their IT budgets to grow by 20% in 2019. However, much of that growth will be allocated to improving EHR functionality, Healthcare Purchasing News reported in its analysis of Damo survey data.

As healthcare executives plan upgrades to their EHRs, hospital-based medical laboratories will need to take steps to ensure interoperability, while avoiding disruption to lab workflow during transition.

The survey also noted that some providers that are considering investing in AI and digital health technology are struggling to understand the market, the news release states.

“Digital and AI are emerging as critical areas for technology spend among healthcare enterprises in 2019. However, healthcare executives are realistic about their technology needs versus their need to improve care delivery. They find the currently available digital health solutions in the market are not very mature,” explained Paddy Padmanabhan (above), Chief Executive Officer of Damo Consulting, in a news release. (Photo copyright: The Authors Guild.)

Providers More Positive Than Vendors on IT Spend

Damo Consulting is a Chicago-area based healthcare and digital advisory firm. In November 2018, Damo surveyed 64 healthcare executives (40 technology and service leaders, and 24 healthcare enterprise executives).  Interestingly, healthcare providers were more positive than the technology developers on IT spending plans, reported HITInfrastructure.com, which detailed the following survey findings:

  • 79% of healthcare executives anticipate high growth in IT spending in 2019, but only 60% of tech company representatives believe that is so.
  • 75% of healthcare executives and 80% of vendor representatives say change in healthcare IT makes buying decisions harder.
  • 71% of healthcare executives and 55% of vendors say federal government policies help IT spending.
  • 50% of healthcare executives associate immaturity with digital solution offerings.
  • 42% of healthcare providers say they lack resources to launch digital.  

“While information technology vendors are aggressively marketing ‘digital’ and ‘AI,’ healthcare executives note that the currently available solutions in these areas are not very mature. These executives are confused by the buzz around ‘AI’ and ‘digital,’ the changing landscape of who is playing what role, and the blurred lines of capabilities and competition,” noted Padmanabhan in the survey report.

The survey also notes that “Health systems are firmly committed to their EHR vendors. Despite the many shortcomings, EHR systems appear to be the primary choice for digital initiatives among health systems at this stage.”

Some Healthcare Providers Starting to Use AI

Even as EHRs receive the lion’s share of healthcare IT spends, some providers are devoting significant resources to AI-related projects and processes.

For example, clinical pathologists may be intrigued by work being conducted at Cleveland Clinic’s Center for Clinical Artificial Intelligence (CCAI), launched in March. The CCAI is using AI and machine learning in pathology, genetics, and cancer research, with the ultimate goal of improving patient outcomes, reported Becker’s Hospital Review.

“We’re not in it because AI is cool, but because we believe it can advance medical research and collaboration between medicine and industry—with a focus on the patient,” Aziz Nazha, MD, Clinical Hematology and Oncology Specialist and Director of the CCAI, stated in an article posted by the American Medical Association (AMA).

AI Predictions Lower Readmissions and Improve Outcomes

Cleveland Clinic’s CCAI reportedly has gathered data from 1.6 million patients, which it uses to predict length-of-stays and reduce inappropriate readmissions. “But a prediction itself is insufficient,” Nazha told the AMA. “If we can intervene, we can change the prognosis and make things better.”

The CCAI’s ultimate goal is to use predictive models to “develop a new generation of physician-data scientists and medical researchers.” Toward that end, Nazha notes how his team used AI to develop genomic biomarkers that identify whether a certain chemotherapy drug—azacitidine (aka, azacytidine and marketed as Vidaza)—will work for specific patients. This is a key goal of precision medicine

CCAI also created an AI prediction model that outperforms existing prognosis scoring systems for patients with Myelodysplastic syndromes (MDS), a form of cancer in bone marrow.

Partners HealthCare (founded by Brigham and Women’s Hospital and Massachusetts General Hospital) recently announced formation of the Center for Clinical Data Science to make AI and machine learning a standard tool for researchers and clinicians, according to a news release.

Meanwhile, at Johns Hopkins Hospital, AI applications track availability of beds and more. The Judy Reitz Capacity Command Center, built in collaboration with GE Healthcare Partners, is a 5,200 square feet center outfitted with AI apps and staff to transfer patients and help smooth coordination of services, according to a news release.

Forbes described the Reitz command center as a “cognitive hospital” and reports that it has essentially enabled Johns Hopkins to expand its capacity by 16 beds without undergoing bricks-and-mortar-style construction.

In short, medical laboratory leaders may want to interact with IT colleagues to ensure uninterrupted workflows as EHR functionality evolves. Furthermore, AI developments suggest opportunities for clinical laboratories to leverage patient data and assist in improving the diagnostic accuracy of providers in ways that improve patient care.

—Donna Marie Pocius

Related Information:

2019 Healthcare IT Demand Survey

Digital and AI are Top Priorities in 2019 as EHR Investments Continue to Dominate

Healthcare IT Spending Priorities Include Big Data Analytics, AI

Healthcare IT Demand Survey: Digital and AI are Top Priorities in 2019 as EHR Systems Continue to Dominate IT Spend

Cleveland Clinic Launches Clinical AI Center: 4 Things to Know

Cleveland Clinic Ready to Push AI Concepts to Clinical Practice

Cleveland Clinic Creating Center for AI in Healthcare

Partners HealthCare Embraces Democratization of AI to Accelerate Innovation in Medicine

Johns Hopkins Hospital Launches Capacity Command Center to Enhance Hospital Operations

The Hospital Will See You Now

Walgreens, CVS Add New Healthcare Services and Technology to Their Retail Locations; Is Medical Laboratory Testing Soon to Be Included?

Expanding healthcare services into communities is expected to increase orders for clinical laboratory tests, promote precision medicine, and lower overall costs

Clinical laboratories continue to adapt to servicing providers in non-traditional healthcare settings. These include freestanding urgent care centers as well as mini-clinics in retail locations. Dark Daily has covered this trend extensively in previous e-briefings.

To secure a share of this new market, national retailers, pharmacy chains, and grocery stores are increasing their health and medical service offerings and forging partnerships with other organizations, such as tech developers.

One such recent partnership involves Walgreens Boots Alliance Inc. (NYSE:WBA) and the Microsoft Corporation (NASDAQ:MSFT). In January, both parties announced a joint venture to develop new healthcare solutions that will improve patient outcomes while lowering cost through research and development, funding, and technology.

“Our strategic partnership with Microsoft demonstrates our strong commitment to creating integrated, next-generation, digitally-enabled healthcare delivery solutions for our customers, transforming our stores into modern neighborhood health destinations, and expanding customer offerings,” said Stefano Pessina, Executive Vice Chairman and Chief Executive Officer of Walgreens, in a Microsoft press release.

Through this partnership, Walgreens plans to provide personalized healthcare (aka, precision medicine) by connecting its customers to pertinent health information through digital devices and in-store expert advice. The goal is to proactively engage patients in their own care to improve medication adherence, reduce emergency room visits, decrease hospital readmissions, and provide customers with lifestyle management solutions.

In addition, the two companies will share each other’s market research and work with consumers, payers, providers, and pharmaceutical manufacturers to devise solutions that improve health outcomes while lowering costs.

“[Walgreens Boot Alliance] will work with Microsoft to harness the information that exists between payers and healthcare providers to leverage, in the interest of patients and with their consent, our extraordinary network of accessible and convenient locations to
deliver new innovations, greater value, and better health outcomes in healthcare systems across the world,” Pessina said in the press release.

As part of this partnership, Walgreens will move the majority of its IT infrastructure onto Microsoft Azure, a cloud computing and artificial intelligence (AI) platform. Walgreens also will provide Microsoft 365 to more than 380,000 employees and stores located throughout the world. Microsoft 365 is a business solution which bundles Windows 10 and Office 365 with advanced security features.

Other Walgreens Collaborations That Provide Healthcare at Retail Locations

Walgreens also announced several collaborations with other companies to become more competitive and secure their share of the healthcare market.  

Through its partnership with Chicago-based VillageMD, a national provider of primary care clinics, Walgreens will open five primary care clinics next to Walgreens stores in the Houston area. These clinics, called “Village Medical at Walgreens,” will offer customers comprehensive primary care services, pharmacists, nurses, and social workers.


“This collaboration with VillageMD demonstrates our ongoing commitment to create neighborhood health destinations that bring affordable healthcare services to customers and provide a differentiated patient experience to the communities we serve,” stated Patrick Carroll, MD (above), Chief Medical Officer, Clinical Programs and Alliances, Walgreens, in a Walgreens press release. “VillageMD has a strong track record nationally of improving outcomes and reducing the cost of healthcare through their transformative primary care model.” (Photo copyright: Walgreens.)

Another collaboration involves Verily Life Sciences, a research arm of Alphabet Inc. (NASDAQ:GOOG), Google’s parent company. The agreement is for multiple projects to improve health outcomes for patients with chronic illnesses. The two companies will be exploring the use of technology, such as sensors, and software to help prevent, manage, screen, and diagnose disease with the ultimate goal of deploying those technologies at Walgreens retail locations. 

“The continued rise in chronic diseases today can be costly to patients as well as to our healthcare system,” Pessina told Business Wire. “Working with Verily, we’ll look at how we can best support integrated and value-based care to meet our patients’ needs, as well as opportunities to address other chronic conditions over time.”

Service Agreements with LabCorp and Quest

In 2018, Walgreens announced a significant expansion of their collaboration with LabCorp, to increase the number of patient service center (PCS) locations within Walgreens stores. The two companies agreed to open at least 600 additional LabCorp-at-Walgreens facilities across the US over the next four years. At the time of the announcement, LabCorp operated 17 facilities at Walgreens in Florida, Colorado, North Carolina, and Illinois.

Along the same lines, Quest Diagnostics (NYSE:DGX) also has opened hundreds of patient-serviced centers within various food and drug retail stores throughout the US, which Dark Daily reported in 2017.

“Healthcare is too complicated, too big, and if I can say, a little too messy,” Pessina told Digital Commerce 360. “We cannot be helpful to our patients if we don’t team up with many, many different, practically all, the players in this industry.”

CVS HealthHubs Offer Blood Testing, Health Screenings, and Other Services

To remain competitive, CVS also is trying new ways to capitalize on the growing healthcare market.

In February, CVS announced the creation of three newly designed stores in the Houston area as pilot projects. These stores, called HealthHubs, will include expanded health clinics with medical laboratories for blood testing and health screenings. They’ll also feature dieticians, respiratory specialists, and dedicated space to assist customers with the management of some chronic health conditions, as well as wellness rooms for yoga classes and health seminars.

“We’re pleased and surprised pleasantly with the ecosystem of healthcare that we’ve created here and how approachable it is, how much people are interested in it, and there are certain things we can take to all stores,” Kevin Hourican, Executive Vice President, CVS Health and President, CVS Pharmacy, told Becker’s Hospital Review

With more retailers adding an ever-increasing number of healthcare services to their offerings, the number of medical laboratory tests available at those locations will likely also increase. Although this trend may boost competition for clinical laboratories, it could also benefit them by creating new opportunities to provide value-added services to their clients.

—JP Schlingman

Related Information:

Microsoft, Walgreens Team up to Develop New Healthcare Delivery Models

Walgreens Boots Alliance and Microsoft Establish Strategic Partnership to Transform Health Care Delivery

CVS Unveils HealthHub Store Design

Walgreens and VillageMD to Offer Primary Care Services in the Houston Area

Walgreens Boots Alliance and Verily Announce Strategic Partnership to Innovate on New Solutions to Improve Health Outcomes

Walgreens and LabCorp to Open at Least 600 LabCorp at Walgreens Patient Service Centers

Walgreens Works with Microsoft to Design Digital Health Corners in Stores

UnitedHealth Group’s MedExpress and Walgreens Boots Alliance Initiate Pilot Program to Put Urgent Care Centers in Walgreens Pharmacies

CVS Announces Plans to Add More Clinical Services to Its Minute Clinic Locations, Including Certain Medical Laboratory Tests

Researchers at Johns Hopkins University Use AI and Human Gut Bacteria to Predict Age of Microbiome Hosts

Clinical laboratories could soon have new tests for determining how fast a patient’s digestive system is aging as part of a precision medicine treatment protocol

When it comes to assessing human age and longevity, much research has focused on telomeres in recent years. Now clinical laboratory managers and pathologists will be interested to learn that provocative new research demonstrates that the human microbiome may also contain useful information about aging. Microbes that can be diagnostic biomarkers may be one result of this research.

From preventing weight loss to improving cancer treatments to stopping aging, human microbiome—especially gut bacteria—are at the heart of many near miraculous discoveries that have greatly impacted clinical pathology and diagnostics development. Dark Daily has reported on so many recent studies and new diagnostic tools involving human gut bacteria it’s a wonder there’s anything left to be discovered. Apparently, however, there is!

Using artificial intelligence (AI) and deep-learning algorithms, researchers at Insilico Medicine in Rockville, Md., have developed a method involving gut bacteria that they say can predict the age of most people to within a few years. Located at Johns Hopkins University, Insilico develops “artificial intelligence for drug discovery, biomarker development, and aging research” notes the company’s website.

According to a paper published on bioRxiv, an online biomedical publications archive operated by Cold Spring Harbor Laboratory, the Insilico scientists have “developed a method of predicting [the] biological age of the host based on the microbiological profiles of gut microbiota” as well an “approach [that] has allowed us to define two lists of 95 intestinal biomarkers of human aging.”


“This microbiome aging clock could be used as a baseline to test how fast or slow a person’s gut is aging and whether things like alcohol, antibiotics, probiotics, or diet have any effect on longevity,” Alex Zhavoronkov, PhD (above), one of the study’s authors and founder of Insilico Medicine, told Science. (Photo copyright: Insilico Medicine.)

Clinical Laboratories Might Be Able to Use AI and Gut Bacteria to Predict Age

To perform the study, the researchers collected 3,663 gut bacteria samples from 10 publicly available data sets containing age metadata and then analyzed the samples using a machine learning algorithm. The samples originated from 1,165 healthy individuals who were between the ages of 20 and 90. The individuals used for the study were from Austria, China, Denmark, France, Germany, Kazakhstan, Spain, Sweden, and the US.

The researchers divided the samples equally among three age groups:

  • 20 to 39 years old (young);
  • 40 to 59 years old (middle aged); and,
  • 60 to 90 years old (old).

The samples were then randomly separated into training and validation sets with 90% of the samples being used for training and the remaining 10% making up the validation set.

The scientists trained a deep neural network regressor to predict the age of the sample donors by looking at 95 different species of bacteria in the microbiome of the 90% training set. The algorithm was then asked to predict the ages of the remaining 10% of the donors by looking only at their gut bacteria.

They discovered that their computer program could accurately predict an individual’s age within four years based on their microbiome. They also were able to determine that 39 of the 95 species of bacteria examined were most beneficial in predicting a person’s age. 

In addition, the researchers found that certain bacteria in the gut increase with age, while other bacteria decrease as people age. For example, the bacterium Eubacterium hallii, which is associated with metabolism in the intestines, was found to increase with age. On the other hand, one of the most plentiful micro-organisms in the gut, Bacteroides vulgatus, which has been linked to ulcerative colitis, decreases with age.  

Understanding Microbiome’s Link to Disease

The human microbiome consists of trillions of cells including bacteria, viruses, and fungi, and its composition varies from individual to individual. Scientific research, like that being conducted at Insilico Medicine, expands our understanding of how gut bacteria affects human health and how diseases such as inflammatory bowel disease, arthritis, autism, and obesity, are linked to the microbiome.

This type of research could be used to determine how the microbiomes of people living with certain illnesses deviate from the norm, and possibly reveal unique and personalized ways to create healthier gut bacteria. It also could help researchers and physicians determine the best interventions, drugs, and treatments for individual patients dealing with diseases related to aging. Such advancements would be a boon to precision medicine.

“Age is such an important parameter in all kinds of diseases. Every second we change,” Zhavoronkov told Science. “You don’t need to wait until people die to conduct longevity experiments.”

Further research is needed to develop these findings into diagnostic tests acceptable for use in patient care. However, such tests could provide microbiologists and clinical laboratories with innovative tools and opportunities to help physicians diagnose patients and make optimal treatment decisions.

—JP Schlingman

Related Information:

This AI Can Tell Your Age by Analyzing Your Gut Microbiome

Human Microbiome Aging Clocks based on Deep Learning and Tandem of Permutation Feature Importance and Accumulated Local Effects

The Bacteria in Your Gut may Reveal Your True Age

Your Gut Microbiome Could Actually Reveal Your Age, Study Shows

University of Illinois Study Concludes Regular Physical Exercise Improves Human Microbiome; Might Be Useful Component of New Treatment Regimens for Cancer and Other Chronic Diseases

Attention Microbiologists and Medical Laboratory Scientists: New Research Suggests an Organism’s Microbiome Might Be a Factor in Longer, More Active Lives

FDA Approves Smartphone-based Urinalysis Test Kit for At-Home Use That Matches Quality of Clinical Laboratory Tests

Mobile technology continues to bring clinical-grade medical laboratory testing into patients’ homes, as more do-it-yourself kits receive FDA approval

Recently, the federal Food and Drug Administration (FDA) approved a smartphone-based at-home urine test that enables patients with chronic diseases, urinary tract infections, or high-risk pregnancies to monitor their health using a testing method that’s as easy as taking a smartphone selfie.

This latest breakthrough is another example of how technology is making it possible to move clinical laboratory testing closer to patients—in this instance into their homes. But it’s also taking away some of the urine testing being performed by medical laboratories.

The Dip.io urinalysis test system from Israeli-based Healthy.io received FDA 510(k) clearance for prescription home use. The test is for the semi-quantitative detection of glucose, specific gravity, blood, pH and protein, as well as the qualitative detection of nitrite. Special conditions also mandate in vitro diagnostic use only, according to the 501(k) Substantial Equivalence Determination Decision Summary.

In 2016, the Dip.io testing kit received CE marking, a certification mark that indicates health, safety, and environmental protection standards for products sold within the European Economic Area. And it has International Organization for Standardization (ISO) 13485 certification, making it commercially available in the European Union and the United Kingdom.

“We are incredibly proud of [achieving] this landmark ruling,” Healthy.io Founder and CEO Jonathan (Yonatan) Adiri (above) told MobiHealthNews. “It’s the highlight in a year that has seen us achieve so many of the key tasks we set out to achieve. With seven leading medical partners worldwide, including the UK National Healthcare System [sic] and a growing product portfolio, we’re set to meet 100,000 patients this year.” (Photo copyright: CNBC.)

Patients Can Take ‘Medical Selfies’

The kit is comprised of a:

  • Urine receptacle;
  • Single, individually wrapped Mission urinalysis reagent strip;
  • Color-board;
  • Smartphone app with backend cloud-based server; and,
  • User manual.

Combining a urine sample kit and testing strips with color recognition, computer vision, and artificial intelligence (AI) has enabled Healthy.io to offer patients the ability to take what it calls a “medical selfie.” The test kit achieved more than 99% usability across age groups from 18 to 80.

“The process for the user is very simple,” Adiri told VentureBeat. “We like to say ‘If you can text, you can test.’ The user simply opens the app and is walked through the process step by step—aided by our chatbot nurse named Emily.”

According to Adiri, “the user opens the kit, fills the cup, dips the stick, and, places it on our patented color-board. After waiting for 60 seconds (timed within the app) both the color-board and dipstick are scanned, similar to how a QR code is scanned. The image is normalized and data points are sent to our cloud, where they are classified into the correct clinical result.”

Adiri notes that one significant aspect of the Healthy.io device is it uses a standard urinalysis dipstick.

“It is important to first note that we haven’t tampered with the standard urine dipstick,” Adiri told VentureBeat. “It has been a tried and tested diagnostic tool for decades and is well established across many clinical pathways. We test for ketones, leukocytes, nitrites, glucose, protein, blood, specific gravity, bilirubin, urobilinogen, and pH. These indicators span a wide range of pathologies, from urinary tract infection to ketosis, kidney disease, health in pregnancy, and bladder cancer.”

The Healthy.io app integrates Dip.io (above) into the clinical process by automatically sending results to the patients’ electronic health records for physician review. The results may necessitate a follow-up clinical laboratory urine culture test to determine whether bacteria or other organisms are present in the urine. (Image copyright: Science and Enterprise.)

Adiri told VentureBeat that his company will be bringing an albumin-to-creatinine ratio (ACR) test to market as well. He says the test is “critical” for as many as 76 million Americans with diabetes, hypertension, and other medical issues who undergo urine testing looking for signs of chronic kidney disease. Healthy.io is also planning to release a skincare test.

“We see a leap forward in smartphone hardware that happens roughly every four years. Our urinalysis product would not have been possible five years ago because the image quality of smartphone cameras simply wasn’t good enough,” he noted.

Other Clinical Lab Grade Urine-testing Kits

Healthy.io received the FDA’s 510(k) approval on July 18, 2018. And as of February, 2019, the company has raised $18 million in venture capital funding, according to VentureBeat, which reports that 100,000 patients in Europe and Israel are already using Dip.io.

“We know that most patients with kidney disease and protein in their urine are untested and therefore go undiagnosed,” Josef Coresh, MD, PhD, professor of epidemiology, medicine, and biostatistics at Johns Hopkins Bloomberg School of Public Health, and head of Healthy.io’s clinical advisory board, told VentureBeat. “[This] technology—[which] directly [connects] patients at home with the medical system—is a gamechanger addressing a big need.”

According to mHealth Intelligence, Dip.io is reportedly one of the first Class II medical devices the FDA has approved for use with optical equipment designed by a third party, such as a smartphone.

But it’s not the only at-home clinical-grade urine testing kit in the market. California-based inui Health, formerly known as Scanadu, announced the launch of its own clinical-grade home urine analysis platform last year. Its FDA-approved kit includes a dippable paddle that measures five key biomarkers (protein, glucose, leukocytes, nitrites, and ketones) in urine and uses a smartphone app to provide results directly to patients within one minute. Results may be shared with providers via a HIPAA compliant system.

As more diagnostic tests become available for home-use, anatomic pathology and clinical laboratories should work closely with healthcare providers to ensure patients who use these new tools receive the proper interpretation guidance and follow-on diagnostic or monitoring tests they need.

The flood of new diagnostic technologies undergoing research and moving toward regulatory approval should motivate medical laboratory managers and clinical pathologists to rethink their lab’s business and clinical strategies. The goal would be to identify ways to offer these new diagnostic tools so that labs can deliver more value to physicians, patients, and payers—value for which clinical labs can be reimbursed under new payment models.

—Andrea Downing Peck

Related Information:

Healthy.io Gets FDA Nod for Smartphone Camera-based Home Urine Test

501(K) Substantial Equivalence Determination Decision Summary

Healthy.io Turns Your Smartphone into a Clinical-Grade Medical Testing Device

A Big Win for Digital Health: U.S. FDA Grants Landmark Class II Approval for Clinical Grade Smartphone Test—Healthy.io’s Dip.io Urinalysis

FDA Approves Smartphone-based mHealth Platform for Urinalysis Test

inui Health Announces the First Clinical Grade Diagnostics Test Accessible to Everyone, Anywhere in the World, from Their Smartphone

FDA Approves Smartphone Camera-based Dipstick Product

At-home, Smartphone-based Urine Testing Now a Clinical Reality

FDA Letter to Healthy.io Ltd.

Healthy.io Raises $18 Million for At-Home Urinalysis Tests

UnitedHealth Group to Launch Electronic Health Records Platform in 2019; Will It Guide Physicians to Preferred Clinical Laboratory Providers?

Leveraging the user base of its existing Rally mobile wellness platform, UnitedHealth Group plans to expand its new electronic health records system to 50 million benefited members and one million healthcare providers by the end of 2019 Before the end of 2019, UnitedHealth Group plans to introduce an electronic health records (EHR) system that it developed internally. It has a ready market for such a system because of its 50 million beneficiaries and one million providers. But this EHR may...
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