Many companies want to adapt consumer wearables to monitor health conditions, including biomarkers tested by medical laboratories
Clinical laboratory managers know that wearable devices for monitoring biophysical functions or measuring biomarkers are becoming more complex and capable thanks to advances in miniaturization, informatics, software, and artificial intelligence machine learning that enable new functions to be developed and proved to be accurate.
In September, Fitbit (NYSE:FIT), took that a step further. The San Francisco-based maker of personal fitness technology, “received 510(k) clearance from the US Food and Drug Administration (FDA), as well as Conformité Européenne (CE marking) in the European Union, for its electrocardiogram (ECG) app to assess heart rhythm for atrial fibrillation (AFib),” according to a press release.
Helping Doctors ‘Stay Better Connected’ to Their Patients
“Helping people understand and manage their heart health has always been a priority for Fitbit, and our new ECG app is designed for those users who want to assess themselves in the moment and review the reading later with their doctor,” said Eric Friedman, Fitbit co-founder and Chief Technology Officer, in the press release.
Prior to submitting the device for approval to regulatory agencies, Fitbit conducted the clinical trial in regions throughout the US to evaluate the device’s ability to accurately detect AFib from normal sinus rhythm and generate ECG traces. The researchers proved that their algorithm was able to detect 98.7% of AFib cases (sensitivity) and was able to accurately identify normal sinus rhythms (specificity) in 100% of the cases.
Venkatesh Raman, MD, interventional cardiologist and Medical Director of the Cardiac Catheterization Lab at 609-bed MedStar Georgetown University Hospital, was Principal Investigator for the clinical study on Fitbit’s ECG app. “Physicians are often flying blind as to the day-to-day lives of our patients in between office visits. I’ve long believed in the potential for wearable devices to help us stay better connected, and use real-world, individual data to deliver more informed, personalized care,” he said in the press release.
“Given the toll that AFib continues to take on individuals and families around the world,” Raman continued, “I’m very enthusiastic about the potential of this tool to help people detect possible AFib—a clinically important rhythm abnormality—even after they leave the physician’s office.”
Fitbit ECG App Receives European CE Marking
In addition to receiving approval for the Fitbit ECG app in the US, the device also received CE marking (Conformité Européenne) for use in some European countries.
In October 2020, the app was made available to Fitbit Sense users in the US, Austria, Belgium, Czech Republic, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Poland, Portugal, Romania, Spain, Sweden, Switzerland, and the United Kingdom. The device also received approval for use in Hong Kong and India.
It is estimated that more than 33.5 million people globally have AFib, an irregular heart rhythm (arrhythmia) that can lead to stroke, blood clots, or heart failure. The American Heart Association estimates that at least 2.7 million Americans currently live with the condition. The most common symptoms experienced by those with the condition are:
Heart palpitations (rapid, fluttering, quivering or pounding),
Shortness of breath, and
Risk factors for AFib include advancing age, high blood pressure, obesity, diabetes, European ancestry, hyperthyroidism, chronic kidney disease, alcohol use, smoking, and known heart issues such as heart failure, ischemic heart disease, and enlargement of the chambers on the left side of the heart.
According to the Centers for Disease Control and Prevention (CDC), there are more than 454,000 hospitalizations annually in the US that list AFib as the primary diagnosis. In 2018, AFib was mentioned on 175,326 death certificates with the condition being the underlying cause of death in 25,845 of those cases.
The CDC reports that cases are increasing and projects that by 2030 12.1 million people in the US will have AFib. Many people are asymptomatic of the illness and do not know they have it, which can make AFib more difficult to diagnose.
“Early detection of AFib is critical, and I’m incredibly excited that we are making these innovations accessible to people around the world to help them improve their heart health, prevent more serious conditions, and potentially save lives,” Friedman said, in a statement.
Clinical laboratory managers should monitor these developments closely. Fitbit’s FDA clearance and CE Marking of its ECG app suggest this trend is accelerating.
Diamandis, who also founded Singularity University, a global learning and innovation community that uses exponential technologies to tackle worldwide challenges, according to its website, said, “We’re going to see Apple and Amazon and Google and all the data-driven companies that are in our homes right now become our healthcare providers.”
If this prediction becomes reality, it will bring significant changes in the traditional ways that consumers and patients have selected providers and access healthcare services. In turn, this will require all clinical laboratories and pathology groups to develop business strategies in response to these developments.
Amazon Arrives in Healthcare Markets
Several widely-publicized business initiatives by Amazon, Google, and Apple substantiate these predictions. According to an Amazon blog, healthcare insurers, providers, and pharmacy benefit managers are already operating HIPAA-eligible Amazon Alexa for:
Alexa also enables HIPAA-compliant blood glucose updates as part of the Livongo for Diabetes program. “Our members now have the ability to hear their last blood glucose check by simply asking Alexa,” said Jennifer Schneider, MD, President of Livongo, a digital health company, in a news release.
And Cigna’s “Answers By Cigna” Alexa “skill” gives members who install the option responses to 150 commonly asked health insurance questions, explained a Cigna news release.
The Apple Watch health app also enables people to access medical laboratory test results and vaccination records, and “sync up” information with some hospitals, Business Insider explained.
Virtual Care, a Payer Priority: Survey
Should healthcare providers feel threatened by the tech giants? Not necessarily. However, employers and payers surveyed by the National Business Group on Health (NBGH), an employer advocacy organization, said they want to see more virtual care solutions, a news release stated.
“One of the challenges employers face in managing their healthcare costs is that healthcare is delivered locally, and change is not scalable. It’s a market-by-market effort,” said Brian Marcotte, President and CEO of the NBGH, in the news release. “Employers are turning to market-specific solutions to drive meaningful changes in the healthcare delivery system.
“Virtual care solutions bring healthcare to the consumer
rather than the consumer to healthcare,” Marcotte continue. “They continue to
gain momentum as employers seek different ways to deliver cost effective,
quality healthcare while improving access and the consumer experience.”
“If you use Google in the United States to check symptoms,
you’ll get five-million to 11-million hits,” Schwab told The Dark Report.
“Clearly, there’s plenty of talk about symptom checkers, and if you go online
now, you’ll find 350 different electronic applications that will give you
medical advice—meaning you’ll get a diagnosis over the internet. These
applications are winding their way somewhere through the regulatory process.
“The FDA just released a report saying it plans to regulate
internet doctors, not telehealth doctors and not virtual doctors,” he
continued. “Instead, they’re going to regulate machines. This news is
significant because, today, within an hour of receiving emergency care, 45% of
Americans have googled their condition, so the cat is out of the bag as it
pertains to us going online for our medical care.”
Be Proactive, Not Reactive, Health Leaders Say
Healthcare leaders need to work on improving access to primary care, instead of becoming defensive or reactive to tech companies, several healthcare CEOs told Becker’s Hospital Review.
Clinical laboratory leaders are advised to keep an eye on
these virtual healthcare trends and be open to assisting doctors engaged in
telehealth services and online diagnostic activities.
Combining consumers’ health data, including clinical laboratory test results, to genetic data for predispositions to chronic diseases could be key to developing targeted drugs and precision medicine treatments
Genetic testing company 23andMe is beta testing a method for combining customers’ private health data—including clinical laboratory test results and prescription drug usage—with their genetic data to create the largest database of its kind.
Such information—stored securely but accessible to 23andMe for sale to pharmaceutical companies for drug research and to diagnostics developers—would place 23andMe in a market position even Apple Health cannot claim.
Additionally, given the importance of clinical lab test data—which makes up more than 70% of a patient’s medical records—it’s reasonable to assume that innovative medical laboratories might consider 23andMe’s move a competitive threat to their own efforts to capitalize on combining lab test results with patients’ medical histories, drug profiles, and demographic data.
23andMe plans to use third-party medical network Human API to collect and manage the data. Involvement in the beta test is voluntary and currently only some of the genetic company’s customers are being invited to participate, CNBC reported.
Apple Healthcare, 23andMe, and Predicting Disease
The announcement did not go unnoticed by Apple, which has its own stake in the health data market. Apple Healthcare’s product line includes:
Mobile device apps for using at point-of-care in hospitals;
iPhone apps that let customers store and share their medical and pharmaceutical histories and be in contact with providers;
ResearchKit, which lets researchers build specialized apps for their medical research;
CareKit, which lets developers build specialized monitoring apps for patients with chronic conditions; and
Apple Watch, which doubles as a medical device for heart monitoring.
What Apple does not have is genetic data, which is an issue.
An Apple Insider post notes, “As structured, 23andMe’s system has advantages over Apple’s system including not just genetic data, but insights into risks for chronic disease.”
This is significant. The ability to predict a person’s predisposition to specific chronic diseases, such as cancer, is at the heart of Precision Medicine. Should this capability become not only viable and reliable but affordable as well, 23andMe could have a sizeable advantage in that aspect of the health data market.
Genetic Test Results Combined with Clinical Laboratory
23andMe is hopeful that after people receive their genetic test
results, they will then elect to add their clinical laboratory results, medical
histories, and prescription drug information to their accounts as well. 23andMe
claims its goal is to provide customers with easy, integrated access to health
data that is typically scattered across multiple systems, and to assist with
“It’s a clever move,” Ruby Gadelrab, former Vice President of Commercial Marketing at 23andMe who now provides consulting services to health tech companies, told CNBC. “For consumers, health data is fragmented, and this is a step towards helping them aggregate more of it.”
CNBC also reported that Gadelrab said such a database
“might help 23andMe provide people with information about their risks for complex,
chronic ailments like diabetes, where it’s helpful for scientists to access a
data-set that incorporates information about individual health habits,
medications, family history and more.”
Of course, it bears saying that the revenue generated from cornering
the market on combined medical, pharmaceutical, and genetic data from upwards
of 10-million customers would be a sizable boon to the genetic test company.
CNBC reported that “the company confirmed that it’s a
beta program that will be gradually rolled out to all users but declined to
comment further on its plans. The service is still being piloted, said a person
familiar with the matter, and the product could change depending on how it’s
Will 23andMe Have to Take on Apple?
23andMe already earns a large portion of its revenue through
research collaborations with pharmaceutical companies, and it hopes to leverage
those collaborations to produce new drug therapies, CNBC reported.
This new venture, however, brings 23andMe into competition
with Apple on providing a centralized location from where consumers can access
and share their health data. But it also adds something that Apple does not
have—genetic data that can provide insight into consumers’ predispositions to
certain diseases, which also can aid in the development of precision medicine
treatments for those diseases.
Whether Apple Healthcare perceives 23andMe’s encroachment on
the health data market as a threat remains to be seen.
Nevertheless, this is another example of a prominent company
attempting to capitalize on marketable customer information. Adding medical information
to its collected genetic data could position 23andMe to generate significant
revenue by selling the merged data to pharmaceutical companies and diagnostics
developers, while also helping patients easily access and share their data with
It’s a smart move, and those clinical laboratory executives
developing ways to produce revenue from their lab organization’s patient lab test
data will want to watch closely as 23andMe navigates this new market.
Mobile, wearable, mHealth monitoring devices are a key element of many employer fitness programs and clinical laboratories can play an important role in their success
For years Dark Daily has encouraged clinical laboratories to get involved in corporate wellness programs as a way to support their local communities and increase revenues. Now, leveraging the popularity of mobile health (mHealth) wearable devices, UnitedHealthcare (UHC) has found a new way to incentivize employees participating in the insurer’s Motion walking program. UHC is offering free Apple Watches to employees willing to meet or exceed certain fitness goals.
This is the latest wrinkle in a well-established trend of incentivizing
beneficiaries to meet healthcare goals, such as stopping smoking, losing
weight, reducing cholesterol, and lowering blood pressure.
It’s an intriguing gamble by UHC and presents another opportunity for medical laboratories that are equipped to monitor and validate participants’ progress and physical conditions.
How to Get a Free Apple
Watch and FIT at the Same Time
CNBC reported that UHC’s Motion program participants number in the hundreds of thousands. And, according to a UHC news release, they can earn cash rewards up to $1,000 per year. The idea is that participants pay off the cost of their “free” Apple Watch one day at a time by achieving activity goals set in UHC’s FIT tracking method. Those goals include:
500 steps in seven minutes; six times a day, at least one hour apart;
3,000 steps in 30 minutes; and,
10,000 steps in one day.
Though hundreds of thousands of beneficiaries are eligible to participate in UHC’s Motion program through their employers, only 45% of those eligible have enrolled in Motion, Fox Business reported.
UHC hopes the offer of a free Apple Watch (which has
applications to track minutes of exercise, a heart rate monitor, and more) will
encourage people to sign up and then progress toward the Motion program’s FIT
As people meet these goals, they earn $4/day toward the cost
of the Apple Watch. Participants, who do not take enough steps in a six-month period
could be required to repay a percentage of the cost of the smartwatch.
Motion participants who already own an Apple Watch can still
earn up to $1,000 per year in cash rewards for achieving the FIT goals.
Impact of mHealth
Programs/Technology Not Clear
Chronic diseases, including diabetes and heart disease, annually cost the US healthcare system $190 billion and employers $126 billion in lost productivity, according to the Centers for Disease Control and Prevention (CDC).
However, some researchers say it’s too early for mHealth
wearables, medication apps, physician virtual engagement, and other digital tools
(many launched within the past five to seven years) to effect key indicators,
such as obesity, life expectancy, and smoking cessation.
“Some of the benefits of these new tools won’t be realized for a long time. It’s really hard to tease out the impact of digital health. Maybe we’re helping people, but we’re not detecting it,” James Murphy, MD, Associate Professor, University of California San Diego Health and radiation oncologist, told CNBC.
Nevertheless, it behooves medical laboratories to develop
procedures for analyzing and reporting data that could impact people who use
wearable mHealth devices to participate in employer wellness programs.
For example, labs could contact insurance companies with
information about biomarkers that provide views into an individual’s progress
toward personal health goals.
Data-driven recommendations from medical laboratories about
tests for chronic conditions such as heart disease and diabetes will likely be
welcomed by payers.
Consumers embrace wearable health-monitoring technology as developers find new ways to transfer collected health data directly into patient records
Traditionally, medical laboratories have been the gatekeepers for the lab test data of most patients. After all, it is regularly said that 70% or more of a patient’s permanent health record is made up of clinical laboratory test data. However, several market forces are at play that could eat away at the long-standing role of medical laboratories as the primary gatekeepers of patient test data.
Today, consumers increasingly want to use wearable devices that not only track their health and fitness, but are designed to also eventually stream self-monitored health data directly into clinical data repositories. As these wearable devices are cleared to use the same biomarkers involved in clinical laboratory tests to monitor the wearer’s health condition, then these devices will stream that data into the electronic health records (EHR) of patients with chronic diseases. (more…)