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Propeller Health Gets $20M Investment

May 30, 2018
by David Raths
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Company will develop digital medicines for new therapeutic areas

Propeller Health, whose digital therapeutics platform is used to help reduce the cost of COPD and asthma care, announced a $20 million funding round led by Aptar Pharma, with participation from existing investors Safeguard Scientifics, Social Capital, Hikma, 3M Ventures and SR One.

Proceeds from the financing will support Madison, Wis.-based Propeller’s investment in its pipeline of digital therapeutics and additional connected devices for the treatment of chronic respiratory disease. Launched in 2010, Propeller, which was named an “Up and Comer” company by Healthcare Informatics in 2015, will also begin to develop digital medicines for new therapeutic areas.

The Propeller platform enables medical technology and pharmaceutical companies to conceptualize, develop and commercialize digital medicines. The company said its respiratory products have demonstrated significant increases in medication adherence  and health outcomes while delivering reductions in healthcare utilization, such as emergency room visits and hospitalizations.

“Since starting Propeller in 2010, we’ve built the most advanced digital medicine platform and therapeutic patient experiences to improve chronic respiratory disease,”

“Today marks a major step forward for our company,” said David Van Sickle, co-founder and CEO of Propeller Health, in a prepared statement. “With our industry-leading platform and in partnership with our growing Propeller Provider Network, we now have the foundation in place to bring the benefits of digital medicines to many new conditions.”

Propeller Health and Aptar Pharma separately announced a strategic partnership to work with leading pharmaceutical brands to co-develop and co-market digital medicines across therapeutic areas, leveraging Aptar’s  expertise in device development, packaging innovation and manufacturing.

Here is an example of how Propeller’s platform has been put to use: The city of Louisville, Ky., which has one of the highest asthma rates in the United States, completed in 2017 a community program called AIR Louisville that used smart connected inhalers.

The program leveraged Propeller Health’s FDA-cleared medication inhaler sensors that tracked when, where and how often Louisville residents experienced asthma symptoms. These data, along with Propeller Health's personalized asthma management system, helped patients to better manage their asthma symptoms, and aided city leaders in making smarter decisions about how to keep the air clean.

Over a two-year period, the program enrolled more than 1,147 participants, collected more than 570 patient years of data, 251,000 medication “puffs,” and more than 5.4 million environmental data points. The data were matched with environmental conditions including nitrogen dioxide, particulate matter, ozone, sulfur dioxide, pollen levels, temperature, humidity, and wind speed to identify the most significant triggers of asthma and COPD in the Louisville area.

Participants saw an 82 percent reduction in asthma rescue inhaler use, 29 percent improvement in the number of people gaining control of their asthma, twice the number of symptom-free days, and 14 percent increase in nights without symptoms.

 

 

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With Apple’s Launch of an ECG Device, Digital Health Leaders, Cardiologists See Possibilities, and Limitations

September 18, 2018
by Heather Landi, Associate Editor
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Tech giant Apple made a splash last Wednesday, September 12, when it unveiled its new Series 4 Apple Watch with advanced heart tracking capabilities, including an electrocardiogram (ECG) function, as well as fall detection capabilities.

The ECG sensor, and the software that supports it, received clearance from the U.S. Food and Drug Administration (FDA) on September 11. Apple’s development of an ECG app within the Apple Watch is notable as it signifies Apple’s intention of transitioning its smartwatch from just a consumer device to a medical device. What’s more, many healthcare industry leaders have noted that Apple’s efforts to get FDA clearance points to the scope of its investment in the digital health space.

During Apple’s annual fall product event in Cupertino, California last week, in announcing the new Series 4 Apple Watch, Jeff Williams, Apple’s chief operating officer, said it is the “first-ever ECG app offered directly to consumers.”

However, it is not the first over-the-counter ECG device to get FDA clearance. Mountain View, California-based AliveCor, an artificial intelligence company that develops personal electrocardiogram technology, received FDA clearance in November 2017 for its KardiaBand, a medical-grade device accessory for Apple Watch. According to the company, KardiaBand can record an ECG in 30 seconds and can detect abnormal heart rhythms. AliveCor also released machine-learning software called SmartRhythm, which continuously analyzes data from the watch’s built-in heart-rate sensor and accelerometer to spot unexpected patterns.

While KardiaBand is an add-on accessory to the Apple Watch, the new ECG app announced by Apple is built into a consumer product.

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According to Apple’s press release, the Apple Watch Series 4 enables customers to take an ECG reading right from the wrist using the new ECG app, which takes advantage of the electrodes built into the digital crown and new electrical heart rate sensor in the back crystal. With the app, users touch the digital crown and after 30 seconds, receive a heart rhythm classification.

The app can classify if the heart is beating in a normal pattern or whether there are signs of atrial fibrillation (AFib), a heart condition that could lead to major health complications, according to Apple. According to a STAT article, based on a review of a study of the new device that Apple submitted to the FDA, the heart monitoring app can accurately detect that a person has an irregular heart rhythm 99 percent of the time.

The heart sensor features and ECG app are a gamechanger for how consumers can track their health, says Daniel Kivatinos, chief operating officer and co-founder of Sunnyvale, Calif.-based DrChrono, an electronic health record (EHR) vendor. The company launched the first EHR platform for the iPad, iPhone and Apple Watch and is part of Apple’s Mobility Partner Program.

Many digital health and clinical leaders see Apple’s development of an ECG app built into a consumer device as a significant step on the journey towards the Internet of Things for healthcare, while also voicing a healthy dose of skepticism.

“We are inevitably on a course where there will be widespread deployment of a diverse array of devices that connect, communicate and collaborate for healthcare,” says Dave Levin, M.D., chief medical officer at Sansoro Health and former chief medical information officer (CMIO) for Cleveland Clinic. Levin also currently serves in a variety of leadership and advisory roles for healthcare IT companies, health systems and investors. “It’s an important step forward and full of promise in the long run, but likely to have many challenges and limitations in the near term,” he adds.

Sharing his thoughts on Apple’s ECG app, Sanket Dhruva, M.D., attending cardiologist at the San Francisco VA Health Care System and assistant professor of medicine, UCSF School of Medicine, says, “The detection of patients who have atrial fibrillation through the ECG feature of the Apple Watch is an important technological feat. We can expect an explosion of continuous data and more diagnoses of atrial fibrillation that would previously have been undetected.”

Joon Sup Lee, M.D., an interventional cardiologist and co-director of the UPMC Heart and Vascular Institute at the Pittsburgh-based UPMC Health System, notes that similar heart monitoring devices have been available, but have not been as integrated. “Obviously, this really changes the scenario given Apple’s size, market share and their overall power. It’s really the beginning, in the sense in that I think there will be many more monitoring abilities and services that will continuously come out to the technology market, but this represents a big step forward,” notes Lee, who also is the chief of the cardiology division of the University of Pittsburgh School of Medicine.

Lee adds, “Like most technological advances, it raises some very fascinating possibilities for the medical field, but a host of still unanswered questions.” From a healthcare provider perspective, the ECG app will generate a significant amount of data, Lee notes, “and exactly how good the software will be between distinguishing a worrisome rhythm, versus a false alarm, I think that remains to be answered. Obviously, Apple has a good idea of how accurate it is, but most of us haven’t seen it.” He adds, “[The ECG app] has the ability to both generate increased concern, but also it can catch potentially worrisome episodes that might have otherwise not been caught.”

Potential Limitations and Integration Challenges

One particular concern among cardiologists is whether use of the ECG app will lead to false positives or false negatives, and a potential increase in unnecessary healthcare utilization. On September 12, when Apple announced the ECG app, Ethan Weiss, M.D., a cardiologist with the University of California, San Francisco, tweeted in response: "I can’t figure out whether today is the best day in the history of cardiology or the worst."

Lee sees the potential for use of the ECG app to increase utilization of medical resources, in the short term. “It’s something that we should be aware of, that it may actually lead to increased utilization of medical resources from a societal standpoint and from an insurer and government payers’ standpoint, because it would detect things both real, and inevitably, there will be some false alarms.”

Dhurva notes that while the ECG app is a technological innovation, “the clinical implications are less certain.” “Currently, most people with atrial fibrillation are diagnosed through symptoms or heart rhythm monitors that are interpreted by cardiologists. Most of these people have risk factors for stroke and, therefore, are prescribed blood-thinning medications (aspirin or anticoagulants) to reduce their stroke risk. But with the Apple Watch, many people will diagnose themselves with brief periods of atrial fibrillation that they would not have otherwise noticed. We do not know if people with brief atrial fibrillation will benefit from these blood-thinning medications. It’s likely that the early detection will reduce stroke risk for some patients – which will be great. However, others may be placed on blood-thinners and suffer from bleeding risk to which they would not otherwise have been exposed.”

He also adds, “And I would not discount the stress and anxiety that people may feel from having an abnormal heart rhythm – even if it is not clinically significant—and being on blood thinners, which could lead them to curtail heart-healthy activities like vigorous exercise.”

Levin notes that, at least on paper, the detection capabilities of Apple’s ECG app are limited. “It is FDA cleared to identify normal heart rhythms or signs of AFib. Essentially the watch can tell the patient either ‘you are fine’ or ‘you should get this checked out for possible AFib.’ This may be useful but is also very limited. AFib can be benign or lethal. We don’t know the sensitivity and specificity of this device, but presumably they are not that great so there will be false negatives and false positives. The device does not address other important, common and lethal cardiac arrhythmias like ventricular fibrillation (VFib),” he says.

In addition, the ECG app platform is not currently linked to any EHR systems, and Levin notes that the lack of interoperability could be a major barrier to effective use.

According to Apple, the Series 4 Apple Watch offers a feature that enables consumers to export their heart monitoring data, in a PDF format, to their physicians. Kivatinos says this feature significantly changes the dialogue between providers and patients and enable doctors to gain valuable insights about their patients.

Levin has a more skeptical view: “This will be highly limiting. How will that PDF flow into the system of care in a timely and reliable manner? EHR’s are already overstuffed with PDFs which can be hard to find and are unstructured. Will this PDF be one more ‘needle’ in that ‘haystack’?”

As with other patient-generated data, Lee notes that healthcare provider organizations will need to develop new protocols to integrate the heart monitoring data into their EHRs. “If everybody with one of these suddenly starts sending PDFs to emergency rooms, that could cause a resource utilization issue.”

Beyond technical integrations, healthcare providers will need to have processes in place to make the heart monitoring data actionable, Levin notes. “Designing and deploying these kinds of devices is the easy part. Building the systems of care that can act upon the information they will supply will be much harder and essential if they are to have a significant impact on health.”

Taking in all of these factors, Levin says, “The combination of limited functionality, little interoperability, undefined sensitivity and specificity and lack of well-defined care process points to a rocky start and limited benefit.”

However, with the rapid pace of digital health innovation and growing use of consumer and clinical health devices, healthcare provider organizations are increasingly seeing the need to integrate patient-generated health data into clinical processes. According to Lee, future efforts will focus on "smarter" software and advanced solutions to not only collect all this data from consumers but also more efficiently cull through the data, pull out the most important and most useful medical data, and then incorporate it into the EHR.


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Apple Unveils Electrocardiogram App as Part of New Series 4 Apple Watch

September 12, 2018
by Heather Landi, Associate Editor
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In a move that signals Apple’s ongoing push into digital health, the technology company announced today during its annual fall product event in Cupertino, California that its new Series 4 Apple Watch includes an electrocardiogram function as well as fall detection capabilities.

In a press release issued today, Apple said the Apple Watch Series 4 with watchOS 5 brings “advanced activity and communications features, along with revolutionary health capabilities, including a new accelerometer and gyroscope, which are able to detect hard falls, and an electrical heart rate sensor that can take an electrocardiogram (ECG) using the new ECG app, which has been granted a De Novo classification by the FDA (U.S. Food and Drug Administration).”

According to Jeff Williams, Apple’s chief operating officer, it is the “first-ever ECG app offered directly to consumers.” The addition of the ECG app means Apple won’t have to rely on third-party medical devices if the heart rate sensor detects an irregular result.

According to the FDA’s website, the de novo classification option was developed as a regulatory pathway for novel, low-risk medical devices. “The De Novo process provides a pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.” De Novo classification is a risk-based classification process, the FDA states.

According to Apple’s press release, the Apple Watch Series 4 enables customers to take an ECG reading right from the wrist using the new ECG app, which takes advantage of the electrodes built into the Digital Crown and new electrical heart rate sensor in the back crystal. With the app, users touch the Digital Crown and after 30 seconds, receive a heart rhythm classification.

The app can classify if the heart is beating in a normal pattern or whether there are signs of Atrial Fibrillation (AFib), a heart condition that could lead to major health complications, according to Apple. “All recordings, their associated classifications and any noted symptoms are stored in the Health app in a PDF that can be shared with physicians,” the company stated.

CNBC reporter Christina Farr, tweeting live from the Apple event, noted that Williams said the app won’t catch “every instance” of AFib.

One particular concern among cardiologists is whether use of the ECG app will lead to false positives and a rise in the number of "worried well" consumers. Ethan Weiss, M.D., a cardiologist with the University of California, San Francisco, tweeted in response to the Apple ECG app announcement: "I can’t figure out whether today is the best day in the history of Cardiology or the worst."

According to the FDA’s letter of approval for the do novo classification of the ECG app, the ECG app “determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The ECG app is not recommended for users with other known arrhythmias.”

Also, in the letter it states, “The ECG app is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG app is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and not intended to replace traditional methods of diagnosis or treatment.” A FDA letter approving the photoplethysmograph analysis software as part of the Apple Watch noted that the feature "has not been tested for and is not intended for use in people under 22 years of age."

The ECG app builds on Apple’s previous work to incorporate heart rate tracking functions into the Apple Watch with a focus on detect arrhythmia and AFib. Last year, the company introduced its new Apple Watch Series 3 with enhanced health and fitness enhancements. The Apple Watch Series 3 included an updated Heart Rate app measuring heart rate during resting, workout, recovery and walking.

During last year’s event, the company also announced the Apple Heart Study, which uses data from Apple Watch to test if the heart rate sensors can detect cardiac arrhythmias, or abnormal heart rhythms, and possibly detect common heart conditions. Apple is currently working with Stanford Medicine on that research study in which the Apple Watch’s heart rate sensor is used to collect data on irregular heart rhythms and notify users who may be experiencing AFib. AFib, the leading cause of stroke, is responsible for approximately 130,000 deaths and 750,000 hospitalizations in the U.S. every year. Many people don’t experience symptoms, so AFib often goes undiagnosed.

According to Apple, the new Series 4 Apple Watch intermittently analyzes heart rhythms in the background and sends a notification if an irregular heart rhythm such as AFib is detected.  It can also alert the user if the heart rate exceeds or falls below a specified threshold.

The Apple Watch’s fall detection function utilizes a next-generation accelerometer and gyroscope, which measures up to 32 g-forces, along with custom algorithms to identify when hard falls occur, the company stated. “By analyzing wrist trajectory and impact acceleration, Apple Watch sends the user an alert after a fall, which can be dismissed or used to initiate a call to emergency services. If Apple Watch senses immobility for 60 seconds after the notification, it will automatically call emergency services and send a message along with location to emergency contacts,” the company said in a press release.

 

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Survey: 87 Percent of Consumers Have Adopted One Digital Health Tool

September 5, 2018
by Heather Landi, Associate Editor
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Digital health adoption continues to increase, with 87 percent of consumers saying they have adopted at least one digital health tool, compared to 80 percent in 2015, according to results from San Francisco-based Rock Health’s third national consumer survey on digital health adoption and sentiments.

Rock Health surveyed 4,000 U.S. adults to shed light on how consumers are engaging with technology-driven healthcare innovation. 2017 was the third year Rock Health deployed this survey, providing a three-year trend data for the first time.

Based on the survey data from 2015 to 2017, there is a clear upward trend of consumers taking control of their healthcare via the use of digital tools like telemedicine, wearables, and online provider reviews, according to Rock Health’s report on the survey data.

But the needle has not moved equally across every subgroup of the population—nor across every type of digital health solution, the report states. “The data tell us that some subgroups prefer traditional healthcare channels; that patient demographics influence readiness to pay out of pocket for expanded services; and that those with chronic conditions (often with the greatest potential to benefit from digital health) are selective in their uptake of digital health,” the report authors—Megan Zweig, Jen Shen and Lou Jug, wrote. “So while digital health solutions promise impactful, even life-altering outcomes for patients, consumers are still transitioning to testing out—and sustainably integrating—these solutions into their lives.”

Looking at adoption rates of various digital health solutions, adoption of online health information grew from 72 percent in 2016 to 79 percent in 2017 and adoption of online provider reviews grew to 58 percent in 2017 from 51 percent in 2016. However, only a quarter of consumers have adopted mobile tracking and the same percentage have adopted wearables.

Rock Health’s report on its third national consumer survey on digital health adoption and sentiments found that chronically ill seniors represent the greatest opportunity to improve health—though they are the least likely to use digital health tools. Digital health adoption is significantly higher among young, high-income adults compared to other consumer segments.

While aging adults have the second highest adoption of digital health technologies, the “worried well” segment—aged 18 to 35 with income greater than $75,000—is more likely to use digital tracking tools and wearables by a margin of more than 20 percentage points.

Not surprisingly, chronically ill seniors have the greatest demand for healthcare services—86 percent visited a doctor at least twice in the past year and 97 percent are managing at least one prescription. Yet they are the least likely to leverage digital health technologies, with extremely low rates of live video telemedicine use, digital health goal tracking, and wearable use.

The survey also found that respondents with a self-reported health condition are more likely to track health goals—though most do not use digital apps to do so. Those experiencing health challenges actively track their health, but digital solutions don’t consistently reach these high-need populations. For instance, respondents taking medication and those with high blood pressure are likelier than not to track a related health goal; but a minority of these groups use a digital solution to do so. Of those respondents tracking their blood pressure, only 11 percent do so with a digital app/journal.

However, respondents who self-identified as obese and who track diet or physical activity buck this trend. This subgroup has adopted digital tracking systems at a somewhat higher rate (29 percent use a digital app to track food/diet and 56 percent use a digital app to track physical exercise), compared to the average for all respondents, according to the report.

The Rock Health survey also found challenges to long-term growth for wearables. Among the 24 percent of respondents (974) that own a wearable device or smart watch, over a quarter (260) reported that they no longer use the wearable. As discontinued use threatens the lasting utility of wearables, innovators must offer sustained value to customers or face the fate of other expendable gadgets, the Rock Health researchers noted.

“Interestingly, the top two reasons for discontinued wearable use are contradictory: nearly 30 percent of users discontinued use after achieving their intended goal, while 20 percent stopped use because the wearable was ineffective in helping them achieve their goal,” the researchers wrote. Companies must figure out how to deliver long-term value to ensure sustainable customer engagement, even if users hit health goals along the way.

Fifty-eight percent of respondents have, at some point in their lifetime, searched for an online review of a healthcare provider, according to the report. This marks an increase from 50 percent in 2015, with the boost largely coming from increases in searches for pharmacies and hospitals. A significant group of respondents (ranging from 27 percent to 40 percent) report taking action based on provider online reviews.

Looking at data sharing and security, respondent willingness to share health data with an entity is correlated with confidence in that entity’s data security, the survey found.

Though most respondents are willing to share health data with their physician, there is a significant drop-off in willingness to share with other stakeholders. Fifty-eight percent of respondents are willing to share with health insurance companies and 52 percent with pharmacies.

Respondents’ willingness to share health data with an entity is nearly perfectly correlated with respondents’ confidence in the data security of that entity, the survey found. Of note, respondent confidence in data security of tech companies declined from 31 percent in 2016 to 24 percent in 2017, and the researchers note that may decline further if press about major data breaches continues.

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