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Parks: Fitness still the leading use case for smartwatches

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Despite all the convenience features of modern smartwatches, for users it’s still all about fitness, according to recently released data from Parks Associates. 

The research firm says that tracking steps is the most popular smartwatch use case, with 60 percent of the United States’ 13.3 million smartwatch users reporting that they track their steps with their device.

According to Senior Director of Research Harry Wang, this desire for fitness tracking, as well as heart rate monitoring, is driving a healthy interest in smartwatches generally.

“Purchase intentions for smart watches have nearly doubled since the third quarter of 2015, and the device has a high NPS (net promoter score), which bodes well for future adoption,” Wang said in a statement. “The smart watch industry learned that it has to continue to innovate to sustain consumer purchase interest, and health and fitness functions are high among their investment priorities. In the US, while companies are still experimenting with form factors, features, battery life, and pricing, the healthcare industry has shown a strong interest in leveraging wearables for patient engagement.”

Beyond the realm of fitness, consumers are also using connected health devices, but there’s a lot of room for additional adoption there. The most common connected medical device for consumers is the blood pressure cuff, Parks found, followed by pulse oximeters.

To illustrate adoption of connected health devices, Parks used the example of patients with diabetes. While 78 percent own a glucometer, only 28 percent check it daily. And while 76 percent of people with diabetes own smartphones, only 24 percent use an app to manage their diabetes.

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Digital health news briefs for 2/28/27: Fate of Samsung's Simband, Tetris could help prevent PTSD

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Whatever happened to Samsung's Simband? Fast Company has a deep dive today on the story behind Samsung's Simband wearable and SAMI platform, which were announced in a big way back in 2014 but aren't yet available commercially. The article tells the story of how Samsung rushed the program to launch in an effort to pre-empt the Apple Watch, then largely backed off the project once it became clear the Apple Watch wouldn't be the health device most people expected. That's only part of the story, which also includes some drama between Samsung's different business units and an update on the fate of the project: it's still underway in some capacity, but it's safe to say it's not as high as it once was on the company's priority list.

Evolent Health mulls merger. Evolent Health, a healthcare technology company that helps health systems transition to value-based care, is reportedly considering a merger with the Advisory Board, a health research and consulting business that currently has a 6 percent stake in Evolent. Reuters reported the news. Evolent actually launched in 2011 as a collaboration between the Advisory Board and UPMC Health Plan.

Old-school games for health. A new study published today in the journal Molecular Psychology suggests the game Tetris, an old arcade and computer game in which players manipulate falling blocks, could help prevent post-traumatic stress syndrome. In a study with 71 volunteers, people who had just been in a traumatic car accident were either asked to play Tetris for 20 minutes while visualizing the crash or assigned to a control group that performed a less visually-intensive task. The intervention group reported significantly fewer intrusive memories of the event in a one-week follow-up. After a month, however, the effects were no longer detectable.

New Fitbit hits the shelves. The new Fitbit Alta HR, announced at the beginning of this month, was officially made available yesterday. With the Fitbit Alta HR, the wearables company has added the PurePulse heart rate tracking technology from devices like the Fitbit Charge HR to the slimmer fashion-forward Fitbit Alta. The new version of Alta also adds additional features for sleep tracking.
 

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Adidas releases beta version of All Day, an app to track all aspects of wellness

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Consistency and dedication may the hallmarks of success for fitness, but that doesn’t mean the apps to support exercise or diet need to be narrow in their focus. Operating on the idea that consumers want flexibility in how they pursue their health goals, Adidas has released a new app that offers a wide variety of content and tracking for multiple aspects of health.   

All Day, which is now available in limited beta release on both iOS and Android, offers customizable workouts, meal plans, mindfulness exercises and sleep tracking, and pairs with Apple Health Kit and Google Fit to handle all that data. To create the app, Adidas partnered with fitness company EXOS, the American College of Sports Medicine and Verily to develop content, and rather than taking a hard line on being a serious workout app, All Day aims to guide users through various aspects of health and wellness. The initial release is targeted at women, Sport Techie reports.

“Adidas All Day will initially focus on the female athlete who seeks variety and likes to try new things to challenge and inspire herself to be better every day. With an experience powered by rich scientific insight, the app makes fit living more approachable while still keeping it fun” Stacey Burr, vice president and general manager of Adidas Digital Sports, said in a statement.

Ideally, the app is designed to be used, well, all day – a videoof the current iteration features a woman doing just that by starting the day with app-prompted workouts and meals, taking time out for meditation in the afternoon, and a few more exercises and consultations before setting the app to track her sleep.

This is a much broader-reaching move than the company’s earlier actions to be a bigger player in connected fitness. The nearly 70-year-old German sportswear company previously showed its digital health intentions with the miCoach app (they opened the API to developers in 2014), and got even deeper into the game with the purchase of Runtastic in 2015. But those were more geared towards athletes or just working out rather than the holistic approach to wellness All Day represents.

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Owlet announces second-gen Smart Sock, Connected Care platform

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Utah-based Owlet Baby Care, maker of smart socks for infant health monitoring, has announced the second generation of its device as well as a new connected care platform that will roll out with the Owlet Smart Sock 2. 

“From day one, our mission at Owlet has been to revolutionize the way we care for our infants, and that starts with understanding their overall health,” Owlet CEO and cofounder Kurt Workman said in a statement. “The launch of the new Owlet Smart Sock 2, with its unparalleled insights through the Connected Care platform, is getting us even closer to that goal. We’re now helping parents take a more proactive approach to their baby’s health by giving them a more complete picture. This is part of our mission to empower parents with the right information at the right time. We believe that each baby has a right to have Mom and Dad there when they need them, and the first step is to empower parents with that information so that they can act.”

Like the original Owlet Smart Sock, the Smart Sock 2 tracks an infant's heart rate, skin temperature, blood oxygenation and sleep data. But the new sock boasts a number of incremental but important improvements over the original: An improved Bluetooth radio means it now works if the sock is up to 100 feet away from the base station; it's been redesigned to fit more securely on a baby's foot and to be harder for the infant to kick off; and it can be worn on either foot, allowing parents to alternate it if necessary. In addition, the sensor placement on the app is more accurate and the sock fits more intuitively, the company said in a statement.

The new Connected Care platform currently gives parents access to more historical trend data than they previously could access and more detailed tracking around when alarms occured. They can also do some basic trend analysis, looking at averages and rates for different metrics. But Owlet has much bigger plans for the future of the platform –  plans that take them further into the medical realm.

"Owlet's vision is that with the Connected Care platform, parents and medical professionals may one day be able to identify patterns and trends in an infant's vitals leading to early illness detection, as well as underlying health issues," the company writes in its press release. "These may include sleep irregularities, RSV, pneumonia, bronchiolitis, chronic lung disorders (CLDI) and Congenital Heart Defects (CHD)."

Owlet has been among the most high-profile startups in the smart infant monitoring space, with more than $25 million in funding, including some grant-related funding from the National Institutes of Health. The company has a medical director and has conducted some validation studies on its technology, but doesn't yet have FDA clearance.

While connected infant companies like Owlet tout their devices as providing peace of mind for parents, an editorial published in the Journal of the American Medical Association this year suggested that the devices have shown no evidence of a medical benefit -- and they might actually be harmful by causing parents undue alarm. 

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S Health relaunches as Samsung Health, adds telemedicine integration and more

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As it launched its Galaxy S8 and S8+ phones, Samsung also quietly announced the re-invention of its S Health app as "Samsung Health". The added features were rumored back in January. Samsung Health includes the tracking and social features that were in S Health previously, but adds a slew of new features and a new user interface.

The app is at least part of the somewhat mysterious partnership American Well and Samsung announced at HIMSS. Samsung's most-touted feature, called "Ask an Expert", allows users to connect, via video, to a board-certified doctor. The cost per visit is $59 without insurance, the same price American Well charges, and the app also includes realtime insurance verification.

It seems clear from both American Well's previous comments and yesterday's Samsung press release that Ask an Expert will tap into American Well's Exchange feature to allow users to see a variety of doctors at institutions that use American Well. The release states that "AAE’s network contains more than 1,200 board certified licensed physicians with an average of 10-15 years of clinical experience".

"This isn’t telemedicine, this is a connected healthcare ecosystem,” American Well CEO and President Dr. Roy Schoenberg told MobiHealthNews at HIMSS. “And we’ve been building up so that is bigger than anything we have done, and what Samsung is saying is, ‘I’m not going to build healthcare on my product, I’m going to tap into that ecosystem and open the door through technology that touches a lot of people.'”

In addition to the telemedicine features, Samsung Health includes access to lifestyle, food, and fitness trackers; a step leaderboard to compete with friends; a "Discover" feature for health content (which, if rumors from January are true, could come from WebMD); integration with connected health devices; and rewards for signing up with Ask an Expert or Health Insights, a feature that adds analytics and coaching to Samsung's health trackers.

The app will be available on all devices that run Android 4.4 and higher, though some older devices and devices in certain countries may not have access to all features.

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VivaLnk launches Fever Scout, the FDA-cleared thermometer patch

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Santa Clara, California-based VivaLnk is officially selling Fever Scout, its FDA-cleared, smartphone-connected wearable thermometer patch for children. The soft, peel-and-stick patch is now available for $59.99 in-store at Best Buy locations across the country as well as online at Amazon, Target and the company’s own website. 

The flexible, adhesive Fever Scout patch is designed to be worn under an infant or child’s arm (but can also be used for adults, the company told MobiHealthNews), and it continuously monitors temperature and sends results via Bluetooth to a parent’s smartphone. The patch, which is reusable and works with replacement adhesives, has a range of a 131 feet and a rechargeable battery than can be used for a week straight before needing to be charged.

“We put a lot of thought into this as far as the low power design and the connectivity,” VivaLnk CEO and cofounder Jiang Li told MobiHealthNews. “It’s easy for parents and children, it can be worn when they are sleeping, it feels more like a sticker than a medical device. And it passed the chew test.”

Originally announced at CES 2015, Fever Scout was slated for an earlier release but delayed their launch a few times in order to stay in accordance with a change in FDA guidelines mid-2015. The company received clearance of the device in January of this year.

While it’s mainly intended for children, Li said Fever Scout could also be used to remotely monitor other patients, such as those who are elderly, post-operative or dealing with a complex condition like cancer.  With the ease of use and the company’s trademarked eSkin technology, Li said they are looking at many next generation uses for the patch as well as exploring partnerships with hospitals and healthcare systems to build an entire remote monitoring system.

“We are examining ways we could incorporate more functionality in the patch, adding sensors for other vital signs or EKG monitoring,” Li said. “Eventually, we want to create an entire platform to work with an entire kit of our sensor technology. “

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Heather Mack
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Garmin's latest tracker takes aim at stress, "fitness age"

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Wearables are at something of a crossroads right now. While companies might have previously differentiated new generations of wearables with new sensors and sleeker designs, now consumers are looking for something more: wearables that don’t just track their life, but help them improve it.

Garmin’s newest device, the vívosmart 3 activity tracker announced today, boasts a number of new features toward that end.

“Health conscious customers are becoming more interested in the meaning behind their activity stats,” Dan Bartel, Garmin vice president of worldwide sales, said in a statement. “As in, I like seeing the data, but how does it correlate to my overall wellbeing? With its new fitness and wellness monitoring tools that tell you things like fitness age and stress level, the vívosmart 3 is able to provide users with those answers, and that is a game changer for the activity tracker industry.”

The three new things that vívofit 3 tracks are VO2 max, fitness age, and stress. VO2 Max and fitness age are related metrics that show users whether their fitness level overall is poor or superior, and what age correlates to their fitness. These are levels that users can change by working out.

Stress (which wearables expert Dan Ledger believes is one of the biggest market opportunities in the space) is calculated via heart rate variability. And here the actionability piece comes in: a breathing exercise right on the device is accessible if a user’s stress level is too high. And a longterm stress timeline, available in the Garmin connect app, helps users put their stress levels with the rest of their lives. 

Of course, the $139.99 device also tracks all the things fitness tracker users expect: steps, heart rate, floors climbed, calories, distance and sleep. It also tracks activity intensity, and can be set up to forward push notifications from certain smartphones. It’s water-resistant with a 5-day battery life.

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The Qualcomm Tricorder X Prize has its winner, but work on tricorders will continue

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After more than five years of designing, building, and testing versatile, portable consumer medical devices, the $10 million Qualcomm Tricorder X Prize has announced a winner. Final Frontier Medical Devices, a small team led by engineer-turned ER doctor Basil Harris and his brother George (also an engineer) won the top prize of $2.6 million. Runner-up Dynamical Biomarkers Group will walk away with $1 million. 

Walk away may not be the right word, however — the X Prize foundation also announced the ways it will continue to support these teams and the other five finalists in bringing their tricorder devices to market, even though the competition is officially over. The balance of the $10 million (minus $1 million given out as milestone prizes over the course of the competition) will go to funding these initiatives.

“We’ve won already,” Basil Harris told MobiHealthNews in an interview earlier this week, before the winner was announced. “This is a win across the board. No matter what the final announcement is, we feel like for my team this has been incredible.”

“Every team that was able to get into the top seven that came out with a device are winners,” DBG team leader Chung-Kang Peng added.

A long road

Qualcomm and X Prize launched the prize at CES in 2012, licensing the word tricorder from CBS — the term originated as a handheld scanning device, most memorably a medical scanner, on Star Trek. Teams were challenged to build a real-life version of the tricorder, a device weighing five pounds or less that could continuously monitor five vital signs, diagnose 13 disease states, and be used not just by a medical professional but by anyone.

“It’s like when they thought up the competition they said ‘It’s not hard enough to make a tricorder. Let’s make a tricorder and take Bones McCoy out of the equation too,’” Harris joked.

Tricorder X Prize Director Grant Campany said that all X Prizes, starting with the Ansari X Prize for Suborbital Spaceflight that launched in 1996, aim to nudge the market forward in areas where it might not move or might not move fast enough on its own.

“We focus on what we consider to be bottlenecks or market failures,” he said. “One of the most profound market failures facing mankind today is that hundreds of millions of people are without modern healthcare. And the opportunity [to fix that failure] is technology. … If X Prize didn’t step in, where would money come from to support R&D and testing for devices that have never been developed before? Given the relevant risk, this is where X Prize sees its sweet spot. How can an incentivized competition really tip the curve and really provide the impetus for development from people around the world — not just geographically limited but make it a truly global operation where we can attract the best minds and the best talents to this particular problem.”

The original call for submissions attracted more than 300 pre-registrations. By late 2013, when the X Prize announced the teams for the first time, there were 34. The diversity of the teams was impressive — from Silicon Valley startups to large public companies to garage operations, there was really no common thread. They came from all over the world. There were college teams (one of which made it to the semifinals) and even a high school team. 

By the end of 2014, the 34 teams were winnowed down to 10 semifinalists, which eventually became seven after two teams merged and two dropped out (one by choice and one because its prototype was tragically held up in customs). These 10 built prototypes and had to demonstrate their accuracy in clinical tests. 

At the end of last year, only DBG and Final Frontier remained to move on to the final phase, where the devices were left alone in a room with consumer testers, to see if they were sufficiently user friendly.

The final two

Final Frontier Medical Devices and Dynamical Biomarkers Group couldn’t be more different. The Washington Post called the end of the competition “A Basil and Goliath Story”: Harris’s team consisted (at least originally) of seven people working nights and weekends with next to no budget, whereas Peng had 50 doctors, scientists and programmers and the backing of HTC and the Taiwanese government.

At the end of the day, though, the teams produced devices that are similar in many ways. Both DBG and Final Frontier ended up with modular devices that include a touchscreen (a smartphone for DBG and a tablet for Final Frontier’s device, called DxtER) and a number of different sensors. And both teams had the same learning curve about the importance of the user experience aspect.

“We came at the problem a little bit differently I think than most of the other teams that entered the competition in that I came at it from the AI perspective of ‘What do I do in the ER to make a diagnosis?’,” Harris said. “…I think we did it in the reverse direction of most teams that may have started with the cool sensors and then built the AI afterward. I think you need both components, but we’re a small team, so we started with what we knew. I think that sums us up from a design perspective.”

Peng agreed, saying that sometimes it was difficult to get the UI and clinical parts of the team on the same page.

“We initially naively thought it was purely a technology problem,” he said. “We developed algorithms for image analysis, for signal analysis. Like Basil said it’s a completely different approach. At the end, we reached pretty much the same conclusion. The clinical AI needed to help you do the screening, diagnosis, prescreening — those are actually more important.”

Harris says his small, close knit team was actually an advantage, as it allowed them to quickly pivot and discard ideas that weren’t working.

“When you’re developing into the unknown like this, we went down many blind passageways and dead ends and you just learn from those mistakes and you regroup,” he said. “You need to decide when to cut off a certain path and go down a new one if it’s not giving you the results that you need.”

Campany also echoed the importance of the direct-to-consumer piece, which gives the tricorder a distinctly different role to play in healthcare than simply an advanced medical sensor.

“I think what really separates these devices from anything else out there is they have been objectively evaluated under strict conditions with the intended user being the consumer,” he said. “I know there’s a lot of companies that claim they are the tricorder, but I challenge any of them to stand up to the rigor or the complexity these devices have been challenged to design. We talk about 13 medical conditions, continuously monitoring five vital signs and intended to be used by a consumer. These are very different criteria than anything else we’ve seen and quite frankly we think these teams are at least 18 months ahead of anything else being developed around the world.”

What’s next?

Now that the contest is complete, the market’s push has been delivered. The question is, will it be enough to keep it rolling?

“I think what we’ve seen now is we have a real demonstration of technology, deployed in an objective environment, and there’s validation there,” Campany said. “When we consider what opportunities that opens up for us, now that there’s data, people will be incentivized to not only collaborate with these teams but also to fund them. We’ve gone beyond the valley of death now and we’re looking at how we can now accelerate the development of these technologies to reach the masses. That’s really what this is all about.”

But that doesn’t mean Qualcomm and the X Prize Foundation won’t give the teams some help. 

“This Qualcomm Tricorder X Prize generated a critical mass of diverse and qualified teams, enabling nearly five years of experimentation and iterations, that ultimately resulted in an extraordinary outcome,” Marcus Shingles, CEO of the X Prize Foundation, said in a statement. “We could not be more pleased with the quality of innovation and performance of the teams who competed, particularly with teams Final Frontier and Dynamical Biomarkers Group. Although this X Prize competition phase has ended, X Prize, Qualcomm Foundation, and a network of strategic partners are committed and excited to now be entering a new phase which will support these teams in their attempt to scale impact and the continued evolution of the tricorder device through a series of new post-competition initiatives.”

In addition to the winner, the X Prize announced tonight that the Qualcomm foundation will put $3.8 million towards the “promotion of the digital health ecosystem, including the continuation of consumer testing, guidance for the Qualcomm Tricorder XPRIZE teams, and support for further development of tricorder devices,” the foundation explained in a statement. “Specifically, the Foundation has requested a proposal for a $2.5 million grant to the University of California, San Diego, including the Altman Clinical and Translational Research Institute. The balance of the commitment will be distributed to other organizations.”

The Roddenberry Foundation, established by the son of Star Trek creator Gene Roddenberry, pledged an additional $1.6 million toward the goal of getting tricorder devices into hospitals and communities.

Over the course of the competition, the FDA has worked with the X Prize Foundation to provide a dedicated help desk for participants. The FDA will continue to support the finalists and semifinalists as they move their devices toward the market. 

“We formed a relationship with the FDA, the CDRH, a little over three years ago,” Campany said. “The FDA formed this FDA help desk which enabled 18 volunteers to interact with the teams. And now that relationship becomes even more critical as these devices are basically honed for commercialization and receiving the appropriate guidance from the FDA on what they need to do from a clinical standpoint to actually get to market. We think we have a tremendous asset there with the FDA and I think the teams and everyone else who will be using this resource will receive a lot of value from it.”

The X Prize will also produce a feature-length documentary and a traveling exhibit to raise public awareness of the technology, and will work with retailers to secure distribution channels for the finished devices.

What’s next for the teams is more work, but with a loosening of some of the constraints of competition. The teams are now free to work together and learn from each other, something both finalists have considered.

“We’re not stopping,” Harris, whose team has incorporated under the name Basil Leaf Technologies, said. “We’re pushing ahead. It’s not something where we can take this demo product and start marketing it. This is health-related serious business with making diagnoses. We’ve started the process of getting each of the individual components approved through the FDA and that involves clinical testing. The competition was very rigorous and modeled after a clinical trial, but it was still a competition and the FDA wants more data. At my hospital, we’ve started a clinical test with our first novel sensor and we’re going to march through each of the sensors until we can build up the whole kit.”

DBG is working on a second generation device that, freed of the X Prize’s weight limit, will be able to diagnose 50 diseases, not just 13.

“We actually have a plan to deploy this system in rural villages in China,” Peng said. “We’re in discussion with the Chinese government right now.”

Much like Gene Roddenberry’s bright vision of the future on Star Trek, Harris has his own dream of how his device, or ones like it, will be used.

“My dream in the future is to be in the ER and have a patient come in and say ‘I have this tricorder’ and maybe CK’s team made it or one of the other teams made it, it doesn’t matter,” he said. “This is a technology that’s coming down the pipe. I want to be able to believe that information and go to the next step. … That’s where we’re going to start to see an improved efficiency in the healthcare system and improved access to quality care across the board.”

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Samsung and WellDoc partner to offer direct-to-consumer version of diabetes management app

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Baltimore, Maryland-based WellDoc, which makes a digital platform for chronic disease management, is teaming up with consumer electronics giant Samsung to offer an integrated tool for people living with diabetes.

BlueStarC will be available directly to consumers under Samsung’s newly launched mobile health app Samsung Health (formerly known as S Health). The diabetes management app is the third incarnation of WellDoc’s mobile tool that analyzes patient-entered diabetes data to compare past trends, offer near-real-time feedback and create personalized condition management plans and progress reports users can share with family and healthcare professionals.

The new app, which is the most distinctly lifestyle-focused of all three BlueStar apps, marks WellDoc’s biggest step into the consumer tech space to date. The company also offers a prescription-only version of the app called BlueStarRX, and in January received FDA clearance for the non-prescription version. That move allowed WellDoc to offer the product through more channels, and the BlueStarC version expands opportunities even further, as it falls under the FDA’s category of enforced discretion and is considered low-risk. All versions analyze diabetes data entered by the patient and compare past trends to create personalized management plans, but the non-prescription and BlueStar C versions do not feature the insulin calculator of BlueStarRX.

“This is something we’ve been working towards for awhile,” WellDoc CEO Kevin McRaith told MobiHealthNews. “The key was to make the user experience as simplified and valuable as possible. By integrating with Samsung Health, that really enables us to scale, and we are really excited for the partnership.”

The alliance comes at a time when both companies are taking big steps towards expanding their reach.  As an investor, partner and distribution channel provider for WellDoc, Samsung offers a lot to the digital health company. But it’s also a significant move for Samsung, which is increasingly taking its entrée into healthcare more seriously.

“Our enhanced partnership with WellDoc gives us an opportunity to serve global consumers, who we believe are ready to embrace the combined health innovations that our companies plan to offer,” Suntae Jung, vice president of R&D for Samsung’s Mobile Communications team, said in a statement.

Just a few weeks before the FDA clearance of the non-prescription BlueStar app, WellDoc received FDA clearance for the wireless integration of BlueStar with Johnson and Johnson subsidiary LifeScan’s blood glucose monitoring system. Using blood glucose data from OneTouch, BlueStar’s platform identifies trends and patterns, sending information to the user’s healthcare team while offering the user individualized feedback in real time. It also offers virtual coaching based on their specific care plan, and the whole system works with the OneTouch Reveal mobile app. WellDoc also announced a partnership with the American Association of Diabetes Educators (AADE), a professional membership organization of over 14,000 educators. With that partnership, the BlueStar system began incorporating AADE’s educational content into the platform. 

Similarly, Samsung has been taken pains to insert itself more firmly into the digital health industry. In February, the company announced a somewhat mysterious collaboration with telemedicine provider American Well. Details are still murky, but the integration intends to leverage American Well’s enterprise telehealth service called the Exchange, which the company launched last year. The Exchange allows payers and providers who use white-labeled American Well telehealth services to offer their care to one another, allowing the end user to access healthcare from brands they are already know and trust.

The WellDoc partnership isn’t quite as secretive, but McRaith said more details about the integration with Samsung Health – in the form of more partnerships with health plans, payers and wearables – will emerge over the next few months.

“Within Samsung and WellDoc, we’re exploring all the ways we can create that user experience to get the right value, however each user wants to connect with the platform,” McRaith said. 

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Fitbit CEO talks smartwatch, corporate wellness on Q1 earnings call

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Fitbit is showing signs of rebounding after a weak Q4 that saw layoffs and restructuring for the wearable company. In its Q4 earnings call, the company reported a net loss per share of 15 cents, compared to a projected loss of 18 percent. 

“Twenty-seventeen marks a 10-year anniversary for the company,” CEO James Park said on the company’s earnings call. “We have accomplished much over this period of time. We have a large, growing base at more than 50 million registered device users, we have a broad global distribution footprint of more than 55,000 retailers, and we remain a global leader in wearables.”

Over the quarter, Fitbit sold three million devices for a revenue of $299 million. That’s due in part to the launch of its newest product, the Fitbit Alta HR, and the new sleep and social features that debuted with it. 

But going forward Fitbit will need to do more than just iterate on its wrist-worn trackers. On the call, Park articulated two distinct pathways for the company: it’s still-forthcoming smartwatch offering and its employee wellness business.

The call didn’t offer much news on the smartwatch product, other than that it’s on track for launch and that the price range won’t deviate from Fitbit’s existing range for products — between $59 and $300.

“Overall we are optimistic about the smartwatch category, and a lot of that optimism is driven by what we feel is going to be our own unique perspective when we launch our product,” Park said. “And that’s going to be a focus on health and fitness, but with the right general purpose functionality; long battery life coupled with an amazing interactive experience; and one of the largest, most effective fitness social networks. So I think all those things working together makes us pretty excited about the launch in our entry in this smartwatch category.”

Fitbit’s corporate wellness business is currently in use by more than 1,300 companies, Park said, but it only makes up about 10 percent of the company’s revenue. By reorganizing the business around distinct consumer and enterprise needs, Fitbit hopes to grow those numbers.

“Employee wellbeing, which includes not only physical health, but also social connectedness is increasingly becoming critical to overall corporate business strategy,” Park said. “Wearables and connected health and fitness devices play directly into this trend and employers are increasingly taking notice and subsidizing these options.”

Ultimately, Park believes that the consumer and enterprise businesses will reinforce each other.

“We believe these two groups are connected in virtuous circle where a large installed network and focused health and fitness brand make us the partner of choice for enterprise customers and health ecosystem players and, in turn, enable us to sell more devices to consumers who want to be part of the same network as their family, friends and colleagues,” he said.

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Teenage inventors show off prototype for cancer-detecting bra

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Higia Technologies, a Mexican biosensors company headed by 18-year-old Julian Rios Cantu, has unveiled a prototype version of a bra called Eva, which founders say can detect breast cancer. Eva, a thick-strapped item that looks like a sports bra, is equipped with sensors to map the surface of the breast and surrounding areas along with texture, color and temperature.

Since cancerous tumors bring increased blood flow to the skin that can change the temperatures, Eva was designed to be worn an hour to 90 minutes per week to track any changes over time. Through regular tracking and logging in an app, Eva could be used to alert the wearer of any changes and prompt them to visit their doctor.

Eva still hasn’t been tested, but the idea is promising enough that Higia Technologies have attracted funding, winning the top prize of $20,000 at the Global Student Entrepreneur Awards competition develop the idea.

"We know that tumors often have an abnormal system of blood vessels, but we also know that increased blood flow isn't necessarily a reliable marker of cancer,” Cancer Research UK’s Anna Perman told BBC News."At present, there is no evidence to show whether this bra is a reliable way to detect tumours, and it's certainly not a good idea for women to use technology that hasn't been tested in good-quality scientific trials.

Another company has been working on a similar breast cancer diagnosic wearable is Cyrcadia Health, a Reno, Nevada-based organization formerly known as First Warnings Systems which made some headlines back in 2012. Cyrcadia has quite a head start on Higia -- its product, the iTBra, has already secured FDA 510(k) Class II approval and completed some US clinical trials. The company announced last month that it would launch its product in Asia.

"One of our objectives has been to launch Cyrcadia's early breast cancer monitoring technology in Asia, where breast cancer is accelerating at twice the pace of the rest of the world," CEO Rob Royea explained in a statement. "With a much higher breast density population, virtually no nationalized screening initiatives, and the average age for breast cancer incident rate being approximately 20 years earlier than for those women in Europe and the U.S., a wearable technology such as Cyrcadia's is addressing a clear and urgent need in Asia. There is great interest by several global insurance providers to partner with Cyrcadia Health in delivering our wearable monitoring to Asia expected by late 2017."

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Study on Ava's fertility-tracking wearable shows correlation between resting pulse rate and onset of fertility

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It may not seem like a big change, but an extra two beats per minute in resting pulse rate could mean the difference between getting pregnant or not. This clue into fertility windows have led researchers at the University of Zurich to suggest the wearable fertility trackers from San Francisco and Zurich-based Ava could be a value tool for couples looking to conceive.

The study, published in the journal Scientific Reports (part of Nature Publishing Group), represents a new validation point for the Ava bracelet, which uses sensors to record nine physiological factors that correspond to a rise in hormones that indicate the onset of ovulation. While previous research – conducted shortly after the company’s launch in July 2016showed the Ava bracelet detecting an average of 5.3 fertile days per cycle with 89 percent accuracy, this trial gives a strong case that a resting pulse rate can be used to identify the window of fertility in near-real time.

“What many women and their partners don’t realize is that a woman can only get pregnant five days before ovulation and the day of ovulation itself,” lead researcher Dr. Brigitte Leeners said in a statement. “In our research, we found that resting pulse rate usually is lowest during menstruation but rises significantly five days before ovulation and again after ovulation. Ava is the first technology that uses temperature, resting pulse rate, and other parameters, including heart rate variability, sleep and bioimpedance, to provide a convenient and accurate at-home method to identify the beginning of the fertile window.”

The results come from two separate prospective observational trials that tracked 274 ovulatory cycles from 91 women, who wore the Ava bracelet and tested their ovulation day with a urine test. Researchers found resting pulse rates increase an average of two beats per minute at the beginning of the fertile window compared to the menstrual phase.

“These findings indicate that pulse rate (measured during sleep) is a promising parameter for FABMs,” the researchers wrote in the article. “And PR monitoring using wearable PPG sensors could be used as a conveniently measured parameter within a modern multi-parameter fertility awareness-based method.”

Ava, which raised $9.7 million in November 2016 to develop out their product and run trials, has also added new pregnancy-monitoring features to their companion mobile app for Ava users who conceive. The pregnancy features, available starting June 1, provide week-by-week, detailed explanations of the myriad changes to the mother and baby’s development over time, including sleep quality, weight and resting pulse rate.

“With more than 50 confirmed pregnancies to date among Ava users, we wanted to add features enabling them to continue monitoring their sleep and physiological stress throughout pregnancy,” Ava CEO and cofounder Lea von Bidder said in a statement. “Ava’s vision is to accompany women through all different life stages and this is a major step for us in reaching that vision. ”

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To get deeper into healthcare ecosystem, Fitbit blends enterprise and digital health sectors into one

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Fitbit’s activity-tracking wearables may be a common features of many corporate wellness programs – their products are currently in use by over 1,300 companies – but all those step challenges and healthy lifestyle motivators aimed at lowering healthcare costs still only make up about 10 percent of the company’s revenue. So, in order to best position their enterprise strategy, Fitbit is merging their group health and digital health business arms together.

At Fitbit’s Captivate event in San Francisco this week, the company officially announced a move they had alluded to during their recent first quarter earnings call: Fitbit Group Health and Fitbit Digital Health will now function as a singular entity called Fitbit Health Solutions. 

“We are integrating because of increasing traction in the healthcare space,” said Amy McDonough, who previously served as the vice president of Group Health and will now hold the position of senior vice president of Fitbit Health Solutuons. “Our charge as Fitbit Health Solutions is to take on a more significant role in helping not only employers, but also health plans, and health systems address the ongoing challenges of health engagement, prevention and care management.”

What that means, McDonough told MobiHealthNews, is Fitbit will take what they have learned from their eight years of experience in the employer space and, rather than reinvent new ways of approaching health plan and health system clients, carry over best enterprise practices that are infused with their growing understanding of digital health integration.

“There were already a lot of synergies there, and we realized we could be better organized around the business if we were working as one,” McDonough said. “We’re not dividing and conquering, but we’re finding ways to be better together.”

Adam Pellegrini, who was appointed Fitbit’s vice president of Digital Health in August, will serve as general manager of Fitbit Health Solutions. Before Fitbit, Pellegrini worked as Walgreens Boots Alliance’s vice president of digital health and was responsible for transforming how the pharmacy retailer approached omni-channel digital healthcare.

“When we talk about health solutions – and I’ve spent many years in the corporate wellness space, going back to analog pedometers  – there are a lot of ways it has changed,” Pellegrini said. “But what we see today is a lot of energizing of the wellness space and the impact that wearables have had.”

Pellegrini pointed to Fitbit’s expanding presence in research– it has been part of over 250 studies to date – and said it was a good reason to believe that Fitbit will play an increasing role in healthcare.

“What are the possibilities in this space as we go forward?” he said. “I want to hear what people are looking for, and we know there is a lot to learn as we go beyond walking programs.”

At the outset, Fitbit Health Solutions wants to be a one-stop shop for new enterprise clients.

“Looking into healthcare, we see a lot of opportunities to partner, and we want to be easy to do business with,” McDonough said. “We want to have a single point of content, and all opportunities across a continuum for health plans, employers and health systems. We want to be able to hit all markets at once.”
 
While it’s too early to say exactly how Fitbit Health Solutions will move forward in the coming months, McDonough said a potential example could be similar to what they have done with UnitedHealthcare, when they began offering a customized integration with the payer’s wellness program, Motion.

“This will also make it easier for clients and consumers to access data, and for organizations to measure their ROI,” McDonough said. “There’s no one-size-fits-all, of course, but we can develop ways to offer an integrated platform that can be used by employers. If there is going to be one person interacting with the system, it didn’t make sense for clients to have to divide their attention between two different services.”

As Fitbit has existing business clients to support, McDonough said the transition to Fitbit Health Solutions will be “an evolution, not a revolution.”

“We really have to think about how to take advantage of things that are working with our health organization partners like UnitedHealthcare. We want to figure out how to provide the same level of data and integration we have with enterprise systems into the healthcare ecosystem. The market is still very much in its infancy; this revolution of healthcare bringing in technology.”

As Fitbit CEO James Park said during the first quarter earnings call, the consumer and enterprise business may very well reinforce one another.

“Employee wellbeing, which includes not only physical health, but also social connectedness is increasingly becoming critical to overall corporate business strategy,” he said. “Wearables and connected health and fitness devices play directly into this trend and employers are increasingly taking notice and subsidizing these options.”What’s more, Park said, they could help keep the consumer device sales going.“We believe these two groups are connected in virtuous circle where a large installed network and focused health and fitness brand make us the partner of choice for enterprise customers and health ecosystem players and, in turn, enable us to sell more devices to consumers who want to be part of the same network as their family, friends and colleagues,” he said. 

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Simple Habit raises $2.5 million for freemium meditation app

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San Francisco-based meditation app Simple Habit has raised $2.5 million in a new round of funding that includes investors New Enterprise Associates (NEA), Fabrice Grinda's FJ Labs, Foundation Capital and the founders of Dropbox and Gusto. This is the first round of funding for the company, whose app launched on the iOS App Store in April 2016.

CEO Yunha Kim, who went from being an investment banker to being an entrepreneur and CEO (of lockscreen app Locket, which was acquired by Wish), knows something about work stress. She created Simple Habit, the story goes, to deal with her own stress but saw potential to bring the benefits of meditation to others.

"We aim to help millions of people throughout the world live more mindfully," Kim said in a statement. "This new round of financing will allow us to expand our team in San Francisco."

The app offers more than a thousand guided meditations from famous mindfulness and meditation teachers. Users can also search for meditations aimed at particular symptoms like insomnia, or aimed at particular life situations like a hard day at work. Meditations are as short as five minutes long, and the app encourages users to complete one a day. The latest update enables premium users to download meditations for offline access (during a plane ride, for example), a new search feature, and even an alarm clock feature that can wake the user up with a gentle morning meditation. The app is free, but users can pay for premium access and in-app purchases. 

"Simple Habit was crafted from a personal need that applies to all of us," Rick Yang, a partner at NEA, said in a statement. "The benefits of mindfulness and meditation are clear, and Yunha and the team have built a beautiful product and experience that makes it accessible to everybody."

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Apple's new AI acquisition has some healthcare experience

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Lattice, the "dark data" startup Apple snapped up earlier this week, may well have aspirations in the healthcare space. 

Apple acquired the company a few weeks ago according to Tech Crunch, which says a source put the deal at $200 million. Lattice is working on using artificial intelligence to turn "dark data", which is unstructured, largely unusable data generated through digital interactions, into structured, usable data.

Obviously Apple is working on a number of different initiatives, and the company has declined to comment on its plans for the acquisition. But there is reason to think that Lattice might be taken up as part of Apple's many healthcare efforts. That's because Lattice grew out of a Stanford research project called DeepDive. In fact, cofounder Christopher Ré won a MacArthur Genius Grant to pursue the project.

Although it was arguably most famous for its applications in fighting human trafficking, DeepDive had at least two applications in the medical space, according to a Stanford website about the project.

One application is focused on a problem that a number of healthcare AI efforts are tackling: sifting through the huge and growing volume of medical literature. Specifically, the project is focused on scanning the medical literature for genes, diseases, and phenotypes and infering their relationships in order to augment OMIM, a human-curated database of genetic disorders.

The other application is in the field of pharmacogenomics and even precision medicine, using DeepDive to "extract relations between genes, diseases, and drugs in order to predict novel pharmacological relationships."

Apple wouldn't be the first tech company to buy an AI company and set it to work on healthcare. Google bought AI startup DeepMind in 2014 and has ended up focusing most of that company's energies in the healthcare space. 

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Apple and Nokia settle suit, return Withings products to Apple Stores, and hint at future digital health collaboration

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Withings products are back on Apple Store shelves following the settlement of a patent lawsuit between Apple and Withings parent company Nokia. The announcement comes with a suggestion that the two companies could be working together on a digital health project now that their relationship is restored.

"This is a meaningful agreement between Nokia and Apple," Maria Varsellona, chief legal officer at Nokia, said in a statement. "It moves our relationship with Apple from being adversaries in court to business partners working for the benefit of our customers."

In December, Nokia filed a number of complaints against Apple in Germany and the United States alleging that Apple products infringe on Nokia patents ranging from software, display, chips and more. The suit called back a 2011 settlement in which Apple purportedly agreed to a license covering some Nokia Technology patents, but subsequently declined Nokia’s offers to license other patents that are used in Apple products.

Apple responded by pulling products from Withings (which Nokia had acquired six months prior) from its stores. While it couldn't be confirmed at the time that the removal was a response to the litigation, Nokia's announcement of the settlement -- and of the restocking of Withings products -- seems to confirm that it was. As we reported at the time, Apple made a similar move in the past against Fitbit.

The settlement details aren't being disclosed, but it includes Apple licensing some Nokia patents and making an up-front payment to the company as well. 

The most interesting part of Nokia's announcement is the company's assertion that "Apple and Nokia are exploring future collaboration in digital health initiatives". We've reached out to Apple and Nokia for details on this future collaboration and will update if we hear more.

But the suggestion is interesting, as Apple has seemed lately to get more and more bold about its under-the-radar digital health efforts. Apple CEO Tim Cook has recently been spotted wearing, and talking about, a prototype wristworn glucometer. The company is also apparently working on an app for Parkinson's diagnosis and two potentially FDA-cleared cardiac devices.

Jeff Williams, Apple's chief operating officer, said in a statement that Apple "look[s] forward to expanding our business relationship with Nokia". 

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Warby Parker soft-launches eye exam app for customers

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Online eye glasses retailer Warby Parker has launched a new app to offer online eye exams to users. While a number of companies offer ocular telehealth in various forms to users in regulatory-friendly states, and some of those companies also sell contact lenses, Warby Parker would be the first glasses retailer to venture into the space.

The FDA-registered app, called Prescription Check, is currently being offered for free to users in California, Florida, New York, and Virginia. It's also only available for those who currently own Warby Parker glasses. The company plans to expand to additional states in the future, but also may not continue to offer the app free of charge.

Like most other smartphone eye exams from companies like Opternative and Simple Contacts, Prescription Check doesn't replace a comprehensive eye exam; it merely measures refractive error. Users are still encouraged to get their eyes checked regularly for things like cataracts or glaucoma. The vision test takes about 20 minutes and requires 12 feet of space, and it requires that users have both a smartphone and a computer.

And, like other existing smartphone eye tests, it appears that Warby Parker won't offer users a new prescription via the app if their prescription has changed. A doctor will review the test results and, if the user's prescription hasn't changed, will renew their prescription. If it has, the doctor will recommend a comprehensive eye exam. Either way, they'll respond within 24 hours.

Warby Parker started working on this service about two years ago, when smartphone eye exams were an even more nascent space than they are now. Now they are introducing it into a world where ocular telemedicine is a bit of a hot topic in the legislative world.

Similar companies have faced their own regulatory challenges, including in South Carolina where a law was passed outlawing smartphone-based eye exams, with the state legislature actually overriding the governor's veto to get the law through. That law is currently the subject of a lawsuit from Opternative. On the other hand, the state of Virginia recently passed a proactive law that protects ocular telemedicine services, a measure that was supported by Opternative, Simple Contacts, and a number of other companies in the burgeoning space.

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Two studies show the use of consumer wearables is increasing in clinical research, but limitations in accuracy still exist

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The proliferation and ever-increasing sophistication of wearable activity trackers makes clear that we have come a long way from analog pedometers and clunky heart rate monitors, but new research suggests those metrics may be the only ones modern wearables can accurately track.

Stanford researchers took a hard look at seven different consumer wearables with a group of 60 volunteers, who wore the devices while walking or running on treadmills or riding a stationary bike. At the same time, their heart was also measured with the gold standard of electrocardiograph. Additionally, metabolic rate was estimated with an instrument for measuring the oxygen and carbon dioxide in breath.

According to the results of the study, published in the Journal of Personalized Medicine, all the devices were pretty spot-on with heart rate. Of the Apple Watch, Fitbit Surge, Basis Peak, Microsoft Band, Mio Alpha 2, PulseOn and the Samsung Gear S2, six had an error of less than 5 percent with heart rate. Some were more accurate than others, and were affected by things like the user’s weight or skin tone.

Once it got to caloric burn, however, none of the devices fared well. The most accurate device was off by an average of 27 percent (Fitbit Surge), and the worst was off by almost 93 percent (PulseOn).

“The heart rate measurements performed far better than we expected,” lead study author Euan Ashley told Stanford News. “But the energy expenditure measures were way off the mark. The magnitude of just how bad they were surprised me.”

Even though consumer devices aren't held to the same standards as medical grade devices, Ashley noted, people are still using them to base life decisions on the data provided. But, to the devices' credit, the researchers conceded it's tough to create algorithms strong enough to predict caloric expenditure for individuals. 

"My take on this is it's very hard to train an algorithm that would be accurate across a wide variety of people because energy expenditure is variable based on someone's fitness level, height and weight, etc," gradute researcher Anna Shceherbina told Stanford News.

Measuring caloric burn is a tough one, and no one device on the market seems to have cracked the code yet. That hasn't stopped everyday people and researchers from using them, however. Just a few weeks ago, researchers at the University of California Davis tapped Healbe, makers of the GoBe 2 Smart Life Band fitness tracker, to validate its caloric intake and expenditure capabilities. 

But even with the energy expenditure limitations, researchers are increasingly turning to consumer wearables in clinical studies. This is especially true for Fitbit, which has been part of more than 350 publications. The Fitabase Research Librarycompiled by Fitbit’s data-crunching and research facilitation partner Fitabase, puts every single research study or trial that used Fitbit in one place. A recent analysis in the Journal of the Federation of American Societies for Experimental Biology (FASEB) found Fitbit devices were the most common consumer physical activity monitors in published work, accounting for 83 percent of clinical trials using consumer devices, and 95 percent of NIH-funded research. The most common primary outcome measure is physical activity, and most conditions studied were mental and brain related. Oddly, body weight-related conditions were not the first. 

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In-Depth: What Texas's landmark telemedicine legislation means for the industry and the nation

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In the State of Texas, a major piece of telemedicine legislation is sitting on Governor Greg Abbott’s desk. Known as Senate Bill 1107 and House Bill 2697, the bill abolishes the requirement that patient-physician relationships be established with an in-person visit before telemedicine can be used.

Texas is the final state of 50 to abolish this requirement, so the bill's passage will allow national direct-to-consumer telemedicine companies like Teladoc, American Well, Doctor on Demand, and MD Live to extend their video-based operations nationwide. Technically, there are still limitations in Arkansas and Idaho, as those states still have restrictions on phone call-only telemedicine.

As well as opening up this market and bringing telemedicine services to a large, geographically distributed population that could greatly benefit from them, this bill also signals the end of a more than two-year legal battle between Teladoc and the Texas Medical Board that culminated in what might have been a landmark antitrust case.

As we wait for Governor Abbott to sign the bill (and according to multiple sources, the signing is all but a foregone conclusion), MobiHealthNews is diving deep into the history of this bill, how it came to be, and what its passing means for Texas, telemedicine, and the nation.

History: A medical board rule and legal battles

In some ways, Texas is an unlikely last state to welcome telemedicine. As a large state with a geographically distributed population and a lot of rural poverty, it’s a prime candidate for the benefits of telemedicine.

“Texas has 35 counties that don’t have a single family physician in them,” Teladoc CEO Jason Gorevic told MobiHealthNews. “They rank 46th in the country in terms of primary care physicians per capita at a time when the state’s population is growing faster than any other state. So the access issues are particularly acute.”

Teladoc, which is based in Dallas, began operating in the state in 2005. But around 2010 the Texas Medical Board began restricting the practice of telemedicine, especially telemedicine by video, through a prescribing rule revision that required physicians to establish their patient relationship with an in-person visit.

This is where there are two different versions of the story. Teladoc and MDLive, which have operated continuously in Texas with their phone-only services, maintain that medical board rules have always permitted phone calls, even when they restricted the use of video telemedicine. The Medical Board, conversely, has maintained that this is essentially a loophole created by a drafting error and that the intent of the rule is clear: to forbid all telemedicine without an establishing in-person visit.

When Teladoc continued to use telemedicine by phone, the Texas Medical Board sent them a public letter telling asking them to stop, then issued an emergency rule clearing up any ambiguity between phone and video visits. Teladoc sued over the rule, saying that the interpretation of the law in the letter constituted a rule in and of itelf and that the making of that rule didn’t follow the proper procedures for rulemaking.

To make a long story short, that lawsuit beget a much bigger lawsuit in April 2015, one which might have gone all the way up to the Supreme Court. Teladoc sued the medical board under antitrust laws, saying that as a group of practicing physicians with a financial interest in the restriction of telemedicine, the medical board couldn’t pass rules designed to muscle out its competition.

“Unfortunately we had to go to bat for our clients’ right to avail themselves of our services,” Gorevic said. “But it was worth the effort, and we see that as our responsibility as a leader in the space. We never ceased operating in the state and in fact we were reluctant to go to court, but ultimately the reason we went to court was to protect our right to continue to operate and the right of our clients to operate our services. … We stepped up and took a stand and we didn’t see any of our competitors doing the same thing.”

That lawsuit dragged on for two years with a number of twists and turns and cost Teladoc $7 million in a single quarter, according to a public earnings call. Indications were looking positive for the company (the FTC, the federal government’s primary antitrust actor, even filed a friend-of-the-court brief on Teladoc’s behalf), but ultimately the two sides realized they would rather reach a compromise than take the case any further up the ladder. Last fall they requested a stay in the case and a settlement seemed likely to follow.

Gorevic confirmed to MobiHealthNews that if Abbott signs the bill, it will essentially end the long legal battle.

“We expect that the legislation, if signed by the governor, will end the lawsuit,” he said. “It will obviate the need for the lawsuit.”

Coming together at the table

Legislative attempts to end the lawsuit and meet a compromise on telemedicine began back in 2015. LaToya Thomas, director of the State Policy Resource Center for the American Telemedicine Association, told MobiHealthNews that there was a strong sense that legal guidance was the only way to not only end that conflict, but to prevent similar conflicts in the future.

“Texas’s case is a unique one in which the state legislator needed to get involved not only because of what was happening with the medical board but the implication of what could happen with other boards,” she said, adding that a grassroots effort stopped the state’s counseling board from passing a similar rule.

Nora Belcher, the director of the Texas eHealth Alliance, said that early attempts to create compromise legislation were too disjointed to make it through the legislature.

“After last session, what I heard from legislative leadership was ‘Y’all get in a room and work it out’,” she said. “A bunch of the bills from last session were all aimed at resolving the Teladoc lawsuit in different ways. But because there were so many and they were so different they couldn’t get any traction.”

So Belcher, along with Teladoc, the medical board, and a number of other stakeholders including hospitals and nurse practitioners, did just that. They started meeting a full year before the legislative session to draft a single bill everyone could be happy with.

“You’ve got to tip your hat to the Texas eHealth Alliance,” Thomas said. “The folks they were able to get to the table were a multi-stakeholder group of hospitals, solo providers, and telemedicine providers. They had an insightful leader in Nora Belcher and they had someone they could trust.”

As it turned out, the providers didn’t want too much: they wanted the assurance of a robust standard of care, no changes to the licensure arrangement, and some clarifications about reimbursements, particularly that health plans wouldn’t be expected to pay for phone calls or faxes. The legislature wanted a bill that wouldn’t be a “vendor bill” — that would protect all telemedicine providers equally. The law addresses all these issues.

Gorevic thinks what ultimately led to the state and the companies being able to work together was just the changing perception of telehealth between 2010 and today.

“Frequently regulators protect the status quo in the states of change,” he said. “I think that was the case here and – as is frequently the case – the more you can demonstrate the value and put in place measures to ensure equality, the more the status quo starts to change; it starts to adapt to innovation. Having been the leader in the market we were able to be part of that. Over time people started to understand telehealth was not a novelty, but a real solution to real problems in the healthcare system and could bring tremendous value to people in Texas.”

The law even contains some novel forward-looking provisions, such as redefining store and forward technology to include cloud infrastructure. As we noted in our initial coverage however, the bill also makes Texas the 20th state to ban telemedical abortions, an aspect of the law that could well see legal challenge going forward.

Ultimately, the legislature itself wasn’t the holdup: the bill passed unanimously in both the House and the Senate. 

Other Texas telemedicine legislation

SB 1107 wasn’t the only telemedicine bill to make it through the 185th legislative session in Texas, though it was what Belcher and her team referred to as “the big bill”.

One bill, SB 1633, would allow more telepharmacy technology to be used in Texas in areas where they don’t have pharmacies. Another, HB 1697, would establish a grant program for teleNICU services for premature infants. A third, SB 922, would ensure Medicaid reimbursement for the use of telemedicine in schools.

All but SB 1633 are on their way to the governor as well, and the telepharmacy bill is currently in reconciliation between the House and Senate.

“It’s a shockingly good year for us,” Belcher said. “We had 17 bills last year and the only two that passed. Really this year if we get three of these four, these are huge not just structural wins, but symbolic wins that say ‘Let’s have these big conversations.’ It’s new, it’s different, it’s scary. We’re passed that as a state and that’s exciting.”

Telemedicine in Texas is open for business

Despite the current regulatory state of affairs, all four of the top direct-to-consumer telemedicine companies have some existing presence in Texas they’re building on. Teladoc and MDLive have been operating phone-only services, per their interpretation of the existing rule. American Well has been in Texas via its relationships with hospitals, which can currently use telemedicine for follow-up visits with no legal issues. The prescribing rule also has a longstanding mental health exception, so Doctor on Demand has been offering telemental health services in the state.

But following the passage of the bill into law, all four companies will be able to operate video visits not just in Texas, but all across the country. 

“Obviously we are the last state to completely authorize video direct-to-consumer telemedicine. That’s a big deal for the companies because they can now have a 50-state strategy,” Belcher said. 

American Well CEO Roy Schoenberg was careful to highlight American Well’s decision to stay out of Texas, despite that the company does offer phone calls.

“For us probably more so than any other company, we’ve taken the position that unless the medical board expressly embraces the way we do telehealth, we’re not open for business,” he said. “We need it to be in plain view. … unlike some of the other operators that have always found loopholes to operate in the state of Texas, believing that they won’t be prosecuted or the physicians won’t be prosecuted.”

But now that the law is passed, he sees benefits not just for American Well’s direct-to-consumer business but for their enterprise partnerships as well.

“The bottom line was since the medical board had issues with the formation of a physician-patient relationship, we didn’t operate at all. This impacted many clients of American Well including very large national insurers. Because we didn’t operate in Texas, they were kind of prevented from operating in Texas. Anthem, United, and many others deliver services over the American Well platform,” Schoenberg said. “This new bill that just came in opens the door for American Well and our whole ecosystem to deliver a variety of services there. Users who could only follow up with patients can now open up the system and harness the whole power of it.”

Doctor on Demand CEO Hill Ferguson told MobiHealthNews in an email that his company will build on its mental health business to expand into other areas of care in Texas.

“We have been able to provide mental health services through our video platform in Texas and grown our mental health practice robustly -- saving patients time and money they would have spent in traveling and in the waiting room,” Ferguson wrote. “Building on this success, we look forward to improving access and providing compassionate care to patients in Texas with the new law in place.”

Scott Decker, CEO of MDLive, told MobiHealthNews that Texas is the company’s biggest state, but he isn’t concerned about new competition flowing in now that the playing field has been leveled. 

“It’s not introducing more competitors for the [telephone] market where we’ve already established a big number of visitors. I don’t think we’re going to see all of a sudden a big percentage who are going to switch to video. What we’re really viewing this as is opening a bigger market in Texas. Thankfully we’ve established a good relationship with consumers in Texas and we see this as a net gain for us.”

What’s next?

This is a big victory, but its far from the end of the legislative road for telemedicine. ATA’s Latoya Thomas noted a number of threads her organization is following: restrictive ocular telemedicine bills in Connecticut and Rhode Island, existing prohibitions on telephone visits in Arkansas, and new rules from Iowa’s physical therapy board that could limit telehealth use for licensed physical therapists, to name a few.

“This is a good first step and a good indication to other states that if Texas can do it, other states can follow suit,” she said. “I think other states should be looking at Texas as a way to give telehealth the green light.”

“Certainly there were a lot of eyes on the Texas deliberation of telehealth,” added Teladoc CEO Gorevic. “I’m not sure it’s the proverbial domino, but I would say the vote of support voiced by the Texas legislature is certainly a significant endorsement of the value of telehealth. And the other thing that’s interesting is it coincides with the positive movement in Washington. The CHRONIC bill, for instance, or the 21st Century Cures Act which has a fair amount of positive language relative to telehealth. While none of those is final and overarching, all of them unanimously voice support for the use of telehealth in improving the healthcare system.”

Most agree that the biggest upcoming battle for telemedicine will be the battle for universal reimbursement.

“Obviously the next big legislation domino to fall is Medicare reimbursement across the country for all Medicare type visits,” Decker said. “That’s probably the next big one the industry would love to see move down the path.”

Even in states like Texas, which have parity laws on the books, it can be difficult to get reimbursed in practice. 

“Parity is a very nice wording in the lawbook, but for physicians, if you ask them ‘will I get paid if I see my patients through telehealth?’ the answer is ‘I have no idea.’” Schoenberg said. “I think the root cause of the problem is that Medicare is sitting on the fence. Hopefully that will change, but in the meantime I think everyone is looking at each other, not sure what to do.”

Until the next fight, providers, vendors, and legislators can celebrate what seems to be the rare legislative win-win, a bill it seems just about everyone is happy about.

“This is where we’ve all wanted Texas to get for some time,” Decker said. “We couldn’t be happier. It’s a landmark for a major state like Texas getting in line with where the future is. It's one less barrier to the adoption of virtual care markets.”

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Jonah Comstock
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Before WWDC, brush up on Apple's stealthy healthcare operations

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On Monday, June 5th Apple will present its worldwide developers' conference (WWDC), an annual event where the company announces new features and products it's launching in the near future. While the focus is usually on new iPhones, Macs, or iPads, it wouldn't be out of character for the company to announce news about its various healthcare ventures as well. 

After all, it was at WWDC in 2014 that Apple first announced HealthKit. And in 2015and 2016 the company announced a lot of health-related features for iOS, HealthKit, and the Apple Watch. ResearchKit and CareKit, the next two evolutions of HealthKit, were also announced at big Apple events, though not at WWDC.

At the very least, we can expect some updates to the health and fitness features on the Apple Watch or some updates on ResearchKit and CareKit from the stage tomorrow. But who knows? Apple could also surprise us with something bigger. Since the last WWDC, rumors, leaks, and meaningful public moves about Apple in healthcare haven't exactly been in short supply. Read on for a refresher on what we know, or suspect, Apple is up to in the health sphere.

1) FDA-cleared devices 

Based on emails exchanged between Apple and the FDA between 2013 and 2016, obtained via a FOIA request, MobiHealthNews reported last fall that Apple seemed to be working on two FDA-regulated devices in the cardiac space and an app for diagnosing Parkinson's. I speculated in a follow-up column that the cardiac monitoring device could take the form of a new model of Apple's Airpod wireless headphones.

As for the Parkinson's app, it seems clear that it would build on health applications Apple has previously featured in its public events: the ResearchKit and CareKit apps focused on Parkinson's. When it comes to HealthKit, ResearchKit, and CareKit, Apple has followed a pattern of building on each previous framework and climbing closer and closer to regulated device territory. So if or when that app is launched, it wouldn't be surprising to see it spotlighted at WWDC.

2) A wearable glucometer

More recently, CNBC broke the news that Apple has been working on a wearable glucometer -- possibly for people with diabetes, but possibly as an aid for food tracking and diet management in healthy people. This has been a longterm project for Apple but it's also a very tough nut to crack -- it seems unlikely it will be brought out on stage tomorrow. That said, Apple CEO Tim Cook has apparently been wearing a prototype aroundso maybe it's further along than we realize.

3) Fruits of health-related acquisitions

Apple has actually made three different acquisitions in the last few years with ties to healthcare, and the influence of those acquisitions is likely to show up in Apple's coming feature and product announcements. In 2016, acquired a health data-focused startup called Gliimpse. The main innovation of the product is an AI engine that reads medical records (with patients' permission, accessing them via the patient portal) and breaks down and codes them into a standardized and readable language. This year, Apple acquired sleep monitoring company Beddit and Lattice, an AI company with historical ties to healthcare.

4) A mysterious partnership with Withings

We'll likely hear about this one from Nokia before we hear about it from Apple, but it's worth mentioning that recently when Nokia and Apple settled their patent suit, the announcement of the settlement included the revelation that "Apple and Nokia are exploring future collaboration in digital health initiatives". Nokia recently acquired Withings, a French maker of a line of connected devices that have long been compatible with Apple products.

5) Matchmaking through its Mobility Partners program

Through its Mobility Partners program, Apple connects different companies whose technologies could work well together. The program has been weirdly secret in the past, but recently the company has started to discuss it more. Notably for the healthcare space, the program united mobile EHR drchrono with telerehab platform Physitrack. One way or another, the tech giant is finding its way into hospitals.

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Jonah Comstock
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